Moving Towards A North African Pharmaceutical Market

B U I L D I N G T H E M E D I T E R R A N E A N
Moving towards
a North African
pharmaceutical
market
MOHAMED WADIE ZERHOUNI

L. ASMA EL ALAMI EL FELLOUSSE
September 2013
3 MOVING TOWARDS A NORTH AFRICAN PHARMACEUTICAL MARKET
WARNING
The opinions expressed in the present document are those of its authors
and not of the depar tments they are attached to. This report does not
reflect the position of IPEMED. The objective of IPEMED is to set off an
open debate as part of a smart complementarity between the different
stakeholders. All potential mistakes are only attributable to the authors.
ACKNOWLEDGMENTS
The authors want to thank the members of the RESSMA (North African
network of economy and health systems) and more particularly Hédi
ACHOURI, Miloud KADDAR and Mustapha SEMMOUD for their
valuable advice and directions that guided us in the realisation of this
work.
THE IPEMED “HEALTH IN THE MEDITERRANEAN” APPROACH
In 2011, IPEMED put health at the centre of its reflection on the Medi-
terranean economic integration, in order to lay the groundwork of an open
debate on health in North African countries (Algeria, Morocco and Tunisia).
The choice was made to make a first assessment of health systems with the
colla boration of recognized public health specialists of these countries. A
work team was constituted, country-monographs were created and a diag-
nosis was established and shared.
This first report allowed to underline the common possibilities and

challenges these countries are confronted with. It offers lines of evolution
in terms of public health policies that could be the object of North-South
cooper ation, but also with the countries of the northern shore of the Medi-
terranean. It is about offering solutions allowing each country that would
want to start reforms to find elements of reflection and methodological axis
to support their efforts.
It was the object of a meeting, in the presence of the representatives of

the Algerian, Moroccan, Tunisian, Spanish, French and Italian Ministries of
Health, as well as the General secretariat of the Union for the Mediterranean
(UFM). The objective of this meeting was to favour a work dynamic on tangi-
ble South-South cooperation and with the North as well. It was also a political
approach aiming at making the different ministries aware of the relevance of
the implementation of a “5+5 Dialogue” dedicated to health.
At the end of this meeting, it was decided to constitute a technical and

informal work group by associating the voluntary “5+5 dialogue” countries,
the UFM as well as other players (European Union, World Health Organisa-
tion, partners of the regional development, national and international private
sector, etc.). Common interest themes were identified, among which that of
pharmaceutical policies, medical information, vaccination policy, executive
and manager training.
The first meeting of this technical and informal work group will take
place in 2014.
In order to accompany this work dynamic and relying on the conclu-

sions of the first report, IPEMED launched, in 2013, a study on the North
African pharmaceutical market. Even though it is not exhaustive, this report
explores the situation of North African pharmaceutical markets. It aims at
identifying the obstacles and assets of a greater North African integration
and at offering encouraging orientation for action (North African marketing
authorization, development of the industry, etc.). Not all of the stakeholders
have been consulted in the framework of this report.
The report, which approaches the pharmaceutical question under a

restricted angle and which falls within a long-term reflection aiming at a
better access to cheaper quality care, is a first step. Later, it must allow to
launch an open debate at a larger scale on North-South and South-South
cooperation and on the possibilities of coproduction in the region. This coo-
peration must come from a collective reflection and be shared by all the stake-
holders. Therefore, the report is to be presented and debated with all the
stakeholders (concerned ministries, national and international representa-
tives of the pharmaceutical industry, local players, regulation agencies, etc.).
Macarena NUÑO, IPEMED project manager

TABLE OF CONTENTS
THE IPEMED “HEALTH IN THE MEDITERRANEAN” For a better North African integration
APPROACH . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 of the pharmaceutical market and of a
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 pharmaceutical production industry . . . . . 54
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Complementarities between pharmaceutical
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . 13 markets in north africa. . . . . . . . . . . . . . . . . . . . . 54
The pharmaceutical market in Obstacles and assets linked to the integration

North Africa . . . . . . . . . . . . . . . . . . . . . . . . . . 15 through the market and through production . . . 59
Integration through the pharmaceutical market . .59
The pharmaceutical market in Algeria. . . . . . . 15 Integration through production . . . . . . . . . . . . . . .67
Organization of the pharmaceutical market . . . 16
Medicines demand and its characteristics . . . . . 21
Recommendations and solutions allowing a
Medicines offer. . . . . . . . . . . . . . . . . . . . . . . . . . 21
Research and innovation . . . . . . . . . . . . . . . . . . 26 better integration of the North African
pharmaceutical market . . . . . . . . . . . . . . . . . . . . 71
The pharmaceutical market in Morocco . . . . . 28
Medicines demand and its characteristics . . . . . 35 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Medicines offer. . . . . . . . . . . . . . . . . . . . . . . . . . 36
Research and innovation . . . . . . . . . . . . . . . . . . 40
BIBLIOGRAPHY . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
The pharmaceutical market in Tunisia . . . . . . . 41 APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Medicines demand and its characteristics . . . . . 48
Medicines offer. . . . . . . . . . . . . . . . . . . . . . . . . . 49
Research and innovation . . . . . . . . . . . . . . . . . . 52
ACRONYMS
MA Marketing authorisation
CNAS National Social Insurance Fund
DMEAICO Drugs Medical Equipment and Appliances Importing CO
EMA European Medicines Agency
ENAPHARMA Algerian National Society for Pharmaceutical Products
ENCOPHARM Constantine National Society for Pharmaceutical Products
ENOPHARM Oran National Society for Pharmaceutical Products
EDQM European Directorate for the Quality of Medicines & HealthCare
FDA Food and Drug Administration
LNCPP National Laboratory for the Control of Pharmaceutical Products
MENA Middle East and North of Africa
MSO Medical Supply Organization
ONS National Office of Statistics
PCH Hospitals Central Pharmacy
PCM Central Pharmacy of Morocco
PCT Central Pharmacy of Tunisia
SIPHAT Society of Pharmaceutical Industries of Tunisia
TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights
UNOP National Union of Pharmacy Operators
WHO World Health Organisation
WTC World Trade Organisation

FOREWORD
Towards what medicines policy for North Africa?

By Pr Farid Chaoui
IPEMED co-project officer on Health
Medicines are not industrial and commercial products like others, they
are the “elixir”, the balm that tears you away from disease and suffering.
Thus, it bears not only a scientific, industrial and commercial problematic,
but also an important social dimension that weighs as much, or maybe even
more, on southern countries’ pharmaceutical policies.
Current situation
By 2020, North Africa will have about 100 million inhabitants, among
which more than 12% will be more than 60 years old and 25 to 30% will be
aged 0 to 14 years old. This characteristic of an incomplete demographic
transition will impose on this region the double burden of specific infan-
to-juvenile health problems and those more complex, heavy and expensive of
non-communicable diseases prevalent in the senior population.
This sanitary situation is emphasized by the epidemiological transition.

Beside the morbidity linked to not completely eradicated communicable
diseases, the amount of non-communicable diseases keeps increasing, in
particular cancers, cardiovascular diseases and diabetes.
In the last few years, these two transitions have met a third one, putting
health problems in the list of political priorities: the democratic transition.
Compared with these sanitary challenges, the means, and especially the
financial ones, are not adapted, since the National Health Expenditure (NHE)
in the three central North African countries is estimated today at less than
US$400/inhabitant/year (against 6 to 10 times more in OECD countries).
The share of medicines is estimated at less than US$80/inhabitant/year
which is both little and a lot: it is very little compared to the OECD figures
(more than US$500 in average) but it is a lot when we measure the share of
medicines in the NHE that varies according to the countries from 20 to 50% 1
(12% in the United Kingdom, 16% in France and 7% in New Zealand). Given
these figures, the medicines consumption of North African populations can
be put into perspective. It could increase, but to do so, a better health cover
must be implemented. Purchasing power must be improved because popu-
lations consider that medicines are not accessible enough.
1 See country monographs: in Algeria, according to the Ministry of Health, the share of medicines in the NHE went from 20% in 1995
to 34% in 2006. For Tunisia, it went from 30% in 2001 to 44% in 2010 (Ministry of Health).
Besides, and this is more serious, we know how much we spend for
medicines, but the qualitative information regarding them is limited.
Key issues to promote a national and North African pharmaceutical

dynamic
The medicines policy is only a segment of the health national policy.
Without this essential policy that allows to set sanitary priorities and, therefore,
strategic choices for the development of the national pharmaceutical industry,
the pharmaceutical policy is likely to be taken hostage by particular interests.
The challenge is to implement a relevant and realistic policy according to the
population’s needs, and taking into account the available resources. It is also
about developing national policies by exploiting the existing complementari-
ties between North African countries and by taking advantage of the existing
South-South cooperation as well as with partner-countries of the northern
shore of the Mediterranean.
In order to do so, the main stakes must be debated. They represent many
action axis than can be supported.
■ What pharmaceutical strategy should be implemented?

This question refers to that of the choice of health national policy, health-
care cover, etc. but also to the choice of medicines available on the territory
(according to the WHO less than 200 international non-proprietary names
(INN) are necessary to cure more than 90% of human pathologies) and
those produced locally. Therefore, we should support the definition of a list
of essential medicines that would constitute the basis of the development of
the North African pharmaceutical industry as well as the realization of a treat-
ment guide, dedicated in priority to general practitioners, serving as a basis
for their prescriptions according to medical progress and to the rational use of
medicines. Let’s not forget the importance of developing sanitary information
campaigns for the population regarding the good use of medicines to fight
against self-medication and waste.
■ What national or North African industries to develop to ensure

the local production of medicines?
The three North African countries develop strategies aiming at promoting
the production of generic medicines. Realistic North-South co-production
logics could be implemented, allowing a balance between local production
and importation, given the current industrial weaknesses of southern coun-
tries. In the long term, know-how transfers could allow, for some medicines,
to overcome the current situation and tend to local fabrication.
The implementation of industries raises the question of industrial

and technological capacities of North African countries and of the strategy
to develop in order to obtain the skills that are not available locally. This
refle ction leads to the necessity of developing a modern industrial basis
capable of absorbing this know-how and ensure a reliable and quality produc-
tion of active substances.
Unfortunately, necessary medicines cannot all be made generic. Some

innovative molecules are irreplaceable in the treatment of some heavy
pathologies such as AIDS or hepatitis, or non-communicable diseases like

cancers, metabolic and cardiovascular diseases. These molecules are quite
costly and are protected by patents. Some countries like South Africa, India,
Brazil and Thailand decided to copy any molecule considered necessary to
their sanitary needs by using the rule of “compulsory licensing2”. Given the
increasing cost of non-communicable diseases in the NHE, could this path be
considered for North African countries? Is it realistic and feasible regarding
the skills and means they have at their disposal?
■ What about the training of specialized health-care workers?

What role for innovation and research?
In order for this ambitious policy to succeed and to improve healthcare
quality, we must ask the question of the actions that could be carried out
regarding prescribers in order to improve the level of their academic and
post-university training. What should be the implication of public authori-
ties? What regulations with the private sector? The training policy to imple-
ment does not only concern health-care workers. Reinforcing and developing
the training of specialised legal experts in North Africa is also necessary for
all these transformations imply a high level of legal expertise.
The development of a research and innovation policy in the pharma-

ceutical field is also essential so that North African countries get the techno-
logical skills necessary to the implementation of an efficient pharmaceutical
industry. This research and innovation policy must be organized around clear
priorities. A particular attention must be paid to the diffusion and promotion
of research results towards the production system.
■ Relevance of a Mediterranean cooperation

The implementation of this ambitious policy implies a process in the short
and medium terms implying heavy structural reforms, a high financial and
human investment, etc. In order to succeed, it is desirable to promote a
regional cooperation, among North African countries first, to work on a larger
market, estimated at more than 100 million consumers by 2020. However,
it would be a mistake not to exchange experiences and implement tangible
cooperation with partner-countries of the northern shore.
For southern countries, this is a great challenge: being able to develop a

clear strategy in terms of pharmaceutical policy aiming at “healing better at a
lesser cost”. In the current context, they will not be able to make it without a
better integration in this key sector.
2 WTO agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights) and Doha Ministerial Declaration of November 2011.
ABSTRACT
In April 2012, IPEMED published a report on the situation of healthcare

systems in three North African countries (Morocco, Algeria and Tunisia).
This report showed that the issue of medicines, which remains essential in
the political reflection on the organization of healthcare system, is identical
in these three countries. This report recommended to “implement an increased
regulation of the pharmaceutical market encouraging more convergence and inte-
gration at the North African level”, and encouraged collaboration between the
three countries as well as with the northern shore of the Mediterranean.
IPEMED therefore ordered the realization of an assessment of the phar-

maceutical market in these three countries. This work focuses on the study of
regional pharmaceutical markets through the monographs of each country,
the emphasis on existing complementarities between these markets and the
identification of structuring elements allowing a better integration.
In North Africa, the pharmaceutical sector is evolving. Even though orga-

nization and development vary from one country to another, the three coun-
tries managed, in just a few years, to develop a pharmaceutical industry that
allows them today to cover a large part of the local consumption. However, it
is in Morocco that one can see the most significant results in terms of national
cover and exportation. Today, the pharmaceutical industry, independent from
the state, allows to ensure the cover of 65% of the national market needs
(against 49% in Tunisia and 30% in Algeria) and exports towards African,
Middle-Eastern and European countries.
Moroccan and Tunisian pharmaceutical industries respect international

standards. They are now registered in the European zone for their quality
standards. As for Algeria, it mainly applies the ISO standards but not inter-
national pharmaceutical norms.
Besides, the three North African countries gave the pharmaceutical

market a specific legislation as well as important regulatory basis. They all
have procedures in terms of registration, distribution and control of these
highly sensitive products. They also have a system of centralized medicine
purchase ensured by different institutions (Ministry of Health, Central Phar-
macy, etc.).
What is more, North African countries encourage the local production of

generic medicines in order to reduce healthcare costs and give people easier
access to medicines. However, in spite of the different measures carried out
to favour their fabrication (setting of prices, exemption from VAT, reduction
of custom duties), the development of generic medicines remains limited for
several reasons (absence of right of substitution, prescription and patients
trust issues, multiplicity of fabrication units, dependence for raw material
supply, etc.).
Another issue that can be pointed out concerns the absence of research
and technological innovation activities, especially in Algeria. Morocco and
Tunisia have implemented legal and financial measures to promote research
and development.
In order to develop a better integration of the pharmaceutical market and

of the production industry at the North African scale, one can take a look to
some examples of integration regarding:
• common purchase of medicines and vaccines: an experience that dates
back to the 1980’s and that is the result of cooperation efforts between the
member states of the Arab Maghreb Union (Algeria, Libya, Mauritania,
Morocco and Tunisia);
• standardization of registration and marketing authorization (MA) proce-
dures and their mutual recognition by North African countries, following
the model adopted by the countries of the European Union (EU) and that
of the member states of the West African Economic and Monetary Union
(UEMOA);
• cooperation in terms of medicines production to face the consequences of
the development of new non-communicable diseases, improve medicines
supply in the region and reinforce its accessibility by the population.
Finally, based on the pharmaceutical monographs of the three coun-

tries as well as the obstacles and assets linked to the integration of the three
markets, recommendations are provided in order to encourage the pharma-
ceutical sector in the region. It is mainly about:
• implementing, at the regional level, supranational professional organisms
capable of ensuring a standardization of the regulation joint purchase pro-
cedure for medicines, vaccines and serums; of controlling the good quality
of local productions; of drawing up a development plan for basic infrastruc-
tures for the industrialization of medicines;
• implementing a permanent secretariat in order to ensure a regional coor-
dination for medicines joint purchases and a better development of the
pharmaceutical industry;
• reinforcing the link between the different North African pharmacy univer-
sities, orders of pharmacists, learned societies and all the professionals of
the pharmaceutical sector;
• standardizing the regulatory framework of medicines registration and con-
trol and implementing a network of quality control laboratories;
• developing North African cooperation in terms of medicines production
(especially of generic ones);
• starting the regional integration with the production of vaccines, oncology
products, serums and medicines derived from biotechnology;
• implementing an independent association of medicines manufacturers so
that the pharmaceutical industry can benefit from a scientific, commercial
and industrial exchange space in North Africa;
• organizing workshops, meetings and conferences on standardization pro-
cedures of medicines registration and control.
INTRODUCTION
In 2011-2012, a group of North African public health specialists3 assessed

the healthcare systems in three North African countries (Morocco, Algeria
and Tunisia). This assessment shows that pharmaceutical and health pro-
ducts issues are identical in these countries. It remains essential in the poli-
tical reflection on the organization of the healthcare system.
The share allocated to medicines and health products represents more

than a third of these countries’ global healthcare spending. It represents a
much more important share for households and health-insurance managing
bodies.
The report also highlights that the situation of pharmaceutical markets

varies from one country to another. In Morocco, since the independence,
the pharmaceutical sector underwent undeniable evolutions and can ensure,
today, the cover of 65% of the local market needs thanks to the Moroccan
industry and exports a good share of its products towards African, Middle-
Eastern and even European countries4.
In the last few years, the Ministry of Health made efforts regarding the
setting of prices, fiscalisation of some essential medicines, exemption from
VAT and reduction of custom duties for others, as well as encouraging the
fabrication of generic medicines.
In spite of all these realizations, some problems remain and are linked,
partly, to the weak production of generic medicines, to the multiplicity
of fabrication units, to the dependence on raw material supply and to the
dysfunctions linked to medicines supply management in the public sector.
In Tunisia, the pharmaceutical sector presents specificities requiring

the intervention of public and private players, with the main following
chara cteristics: the sector is regulated and supervised by the Ministry of
Public Health and by some public institutions depending from it, such as the
National laboratory of medicine control, the National centre of pharmacovi-
gilance, the Central Pharmacy of Tunisia (the only organism authorized to
import medicines and vaccines acting as a national purchasing body) and the
Pasteur Institute of Tunis. Up to now, this monopoly allowed to manage the
costs (medicines are acquired through bids) as well as the prices uniformity
and control, the supply regularity in the country and the support to health
programs via the self-compensation mechanism, the principle of which is to
increase the prices of non-indispensable medicines and to use these profits
to balance the medicines used in health programs.
Over the last fifteen years, the medicines local production registered a
high growth. From 1987 to 2008, the consumption covered by the local fabri-
cation went from 8% to nearly 50%.
3 Notes IPEMED n°13, April 2012, “Health systems in Algeria, Morocco and Tunisia: national challenges and joint issues” available at
www.ipemed.coop/fr/nos-projets-r16/sante-c89/chantier-sante-sc89
4 The Moroccan pharmaceutical sector manufactures a large range of products in compliance with the international standards. Therefore, the
WHO classified the Moroccan pharmaceutical industry in the European zone for quality standards.
As for Algeria, the market analysis underlines that this market remains
highly dependent on importations, but that the national production has more
than doubled. Besides, the will of public authorities to promote generic medi-
cines and the local fabrication favoured the consumption of generic medi-
cines in citizens.
Besides, even if some regulatory texts show that there is room for
improvement in the pharmaceutical sector, a lot remains to be done in terms
of market regulation, reinforcement of technico-administrative control, secu-
rity for the supply of public health structures and encouragement of national
production.
The report shows that there are also similarities between North African
countries. They all have an obvious desire to develop their medicines produc-
tion, and especially of generic ones. They all have a multiplicity of small,
non-competitive, production units as well as supply issues especially in the
public sector, etc.
The report advocates “a reinforcement of the cooperation between the three

countries to face the consequences of the development of non-communicable diseases
that are likely to inflate the medicines costs. Not only will these countries have to
manufacture or import medicines in quantity and quality, but they will also have
to consent to the pressure of their populations who will demand to benefit from the
last treatments available.”
Thanks to this study, propositions were made, such as “implementing a

better regulation of the pharmaceutical market encouraging more convergence and
integration at the North African level” and encouraging collaboration between
countries. A better convergence of marketing authorization procedures, the
implementation of a scientific committee common to the concerned coun-
tries for the scientific evaluation of MA request, policies of support to comple-
mentary national productions, etc. could be tangible actions that could lead to
a more integrated pharmaceutical market in North Africa.
This document aims at a better understanding of national pharmaceu-

tical markets in North Africa (Morocco, Algeria and Tunisia). In particular,
its objectives are:
• assessing medicines demand and its characteristics, medicines offer and
market offer (country monographs);
• underlying existing complementarities between countries;
• identifying obstacles and assets for a better North African integration of
the pharmaceutical market (MA, others) and for a North African pharma-
ceutical industry.
Therefore, this report presents examples of integration through the

market and through production, as well as recommendations or potential
solutions allowing this integration.
This work was realized thanks to a document review, existing collections

and the gathering of relevant national and international data. One must point
out that some data date back to the early 2000’s. It was almost impossible, via
the available documentation and websites, to collect more recent data.
The pharmaceutical market in North Africa
The pharmaceutical market in Algeria
A reminder of a few general economic and socio-demographic data is

necessary to better understand the reality of the pharmaceutical market as
well as the constraints weighing over it and over the country’s health system.
According to the annual report of the Bank of Algeria, in 2012 the GDP
growth reached 3.3% against 2.6% in 2011. In sectorial terms, the Algerian
economy is witnessing a return of industrial activities – except for hydrocar-
bons (6.9% in 2012 against 7.2% in 2011). After the 2011 decrease, the added
value of the construction industry grew of 8.2% (that is 3 points more than in
2011). According to the Bank of Algeria, this improvement is mainly due to
the increase in State equipment spending (+13.1% compared with 2011) and
to the boosting of the household construction program.
Regarding the revival of the Algerian industry, the action program of the
Ministry of Industry and Investment Promotion comes from the orientations
of the “Strategy and policies of industrial revival and development” which
encourages industries linked to assembly and conditioning such as electric
and electronic industries, food-processing, capital goods, pharmaceutical and
veterinary industries. In the Algerian pharmaceutical industry, the Group
Saidal has the monopoly. Several other Algerian and foreign private labora-
tory-companies are active in this sector, especially through joint enterprises
between the Group Saidal and foreign groups.
From a sanitary point of view, Algeria, like developing countries, is

currently in a transitory phase both demographically, especially with the
increase in old people (over 60 years old) and epidemiologically with the
eradication of some communicable diseases and the apparition of diseases
such as hypertension and diabetes for example. In Algeria, between 1970 and
2010, the birth rate almost doubled while the death rate was nearly stable,
which led to a quite important surplus of population. Life expectancy at birth
also improved from 52.6 years old in 1970 to 75.7 today. As for mortality, the
rate did not vary much (about 4.5‰) since the beginning of the 1970’s. The
same goes for the cause of these deaths. Cardiovascular diseases come first
with a rate of 26.1%, followed by perinatal illnesses (13.5%), cancers (9.5%)
and traumas (8.6%).
As for the health expenditure, it represented 5.8% of GDP in 2009.

It grows regularly because of the combination of several factors, especially
population growth and evolution of age pyramid, aspiration to well-being,
rapid increase in modern diseases as well as the important social cover and
the standardization of third-party payer. Medicines consumption follows this
tendency and importations keep increasing every year, in spite of an increa-
singly present local production. Indeed, the Algerian pharmaceutical market
is, and will remain for a long time, the most important and the most credit-
worthy in the region thanks to a very generous social protection system.
In spite of the progress registered in the Algerian healthcare system, the

development of healthcare services remains uncontrolled. Since the begin-
ning of the opening up of the economy and the application of liberalization
reforms, the Algerian health system has been characterized by the dualism of
the public/private sectors, at the cost of coordination and complementarity.
Besides, regarding human resources, one must point out that as well
as being insufficient, they are badly allocated over the national territory. Big
cities in the North of Algeria have more practitioners and especially specia-
lists. This poor allocation is due to the fact that practitioners who are located
elsewhere, especially in the South of the country, after their academic course,
go back to the North at the end of their local contracts to set up their private
practice.
Following the liberalization reforms carried out by the public authorities,

the pharmaceutical sector in general, and of medicines in particular, is under-
going deep evolutions. Still today, it is the object of several reforms linked to
the healthcare system and aiming at, among others, reorganizing medicines
financing modes and reimbursement mechanisms; or regarding agreements
with the European Union5 and the adherence to the WTO.
Organization of the pharmaceutical market

The national pharmaceutical sector evolved along with the healthcare
system by adapting progressively to the evolution of the level of the national
demand in pharmaceutical products. However, it also underwent all the diffi-
culties of the national economy management, those linked to a centralized
and procedure-oriented management until 1990, those linked to the libera-
lization and to an opening-up that was too fast and insufficiently controlled.
■ The pharmaceutical sector actors

Currently, one can distinguish four categories of actors at the scale of medi-
cines production and distribution circuit. They are the public sector actors,
private manufacturers, wholesaler-distributors and, finally, public and private
dispensaries in charge of retail distribution.
Actors of the public pharmaceutical sector. Based on a functional separation

of the different bodies (production, importation, wholesale and retail), public
actors are present at the four following steps:
• The production body, represented by Saidal: a public company founded in
1982 that started by taking over the production units of the former Central
Pharmacy of Algeria. Saidal has now started to diversify its production in
particular through partnership agreements with foreign companies.
• Wholesale distribution: represented by Digromed that took over, from
1997, the network of former importation public companies. For several
5 Currently being assessed for a coming adherence.

years, Digromed started to diversify its activity by manufacturing generic

medicines6 before being dissolved in 20097.
• Retail distribution: represented by the company Endimed, in charge of
managing the network of former public retail pharmacies. This network
that represented nearly one thousand pharmacies through all the national
territory, was also dissolved and let its pharmacies to qualified pharma-
cists8.
• Public pharmacies in charge of delivering for free a list of medicines
financed by the National Social Insurance Fund (CNAS) for underprivi-
leged and/or chronically ill people with a very low revenue.
• The Hospitals Central Pharmacy (PCH) which is a public institution with
an industrial and commercial character implemented to coordinate and
rationalize public hospitals supply programs.
One must point out that apart from the PCH, which was given a clear
and precise function towards public hospital structures, the public network
is made of companies that are completely submitted to the commercial code
just like any other private company.
Private manufacturers and importers and private retail pharmacies. From

1963 to 1990, the pharmaceutical market was exclusively under state control.
Since, the suppression of the State monopoly allowed the emergence of
private operators in importation, production and distribution.
Private wholesalers-distributers. They are in charge of the wholesale supply

of the different retail pharmacies over the national territory. Their activity
is controlled by the dispositions of the decree n° 59/MSP of 20 July 1995
setting up the terms of pharmaceutical products wholesale distribution
activity. These wholesaler-distributers ensure an essential regulatory function
and represent an important media to pass on economic information on the
market, products and consumption habits9.
Private sector actors witnessed a large and fast growth both regarding
medicines importation and distribution (wholesale). While they did not exist
at the beginning of the 1990’s, in 2011, they are 135 importers (against 4 in
1991) and 67 manufacturers10 (against 1 in 1991). Registered wholesalers are
360 (against 6 in 1991) and the network of retail pharmacies is animated by
more than 8,600 pharmacists.
6 National Union of Pharmaceutical Operators, « L’organisation du marché national des médicaments : Difficultés et perspectives annoncées face
aux échéances de l’application de l’accord d’association avec l’Union européenne et à l’entrée de l’Algérie à l’OMC », [“Organization of the
national pharmaceutical market: Announced difficulties and perspectives faced with the deadline of the association agreement application with
the European Union and the adherence of Algerian in the WTO”] September 2005.
7 Belhacene O. & Ferfera M. Y., Les effets contrastes de l’implication des laboratoires étrangers dans l’industrie pharmaceutique algérienne.
Colloque International-Algérie : Cinquante ans d’expériences de développement. [Contrastive effects of foreign laboratories implication in the
Algerian pharmaceutical industry. International Algeria-Symposium: Fifty years of experience in development.]
8 Belhacene O. & Ferfera M. Y., Idem.
9 National Union of Pharmaceutical Operators, Idem.
10 Of which 20 conditioners.
■ Supervisory and regulatory administrations

The Algerian pharmaceutical market is regulated by several administrative
departments with a considerable and determining influence on the different
market levels. One can cite, for instance, the Ministries in charge of Public
Health, of Social Protection and of Industry. The Ministry in charge of Health
actually remains, in spite of the huge progress made by liberalization over the
last twenty years, the core of the pharmaceutical market as a whole. It exer-
cises essential regulation and intervention prerogatives regarding the orga-
nization and operating of the pharmaceutical market. They are constraining
but regularly revised procedures that rigorously supervise importation, the
price setting of the Algerian public price (PPA), banking, custom and tax
mechanisms on the one hand, and quality control regulations on the other
hand. Most of these rules refer either to regulatory texts or to specifications.
Besides, the implication of the Ministry of Health and of social Security

in the national pharmaceutical market fundamentally comes from its posi-
tion of supervisory administration of the CNAS. This institution takes part
in the reimbursement to patients of medical care costs as well as medicines
prescribed via the Reimbursement technical committee (CTR) deciding, since
April 2006, of the products to be reimbursed according to a reference price.
Given the importance of health insurance coverage, legally extended to

all registered workers and their families, the CNAS is potentially the ultimate
buyer of most medicines marketed on the national territory. As such, it bene-
fits from a significant negotiation power towards the distribution and supply
system and constitutes a potentially efficient regulation tool.
Finally, the Ministry in charge of Industry, SMBs and investment

promotion, concerned by the development of the Algerian pharmaceutical
industry11, has actually no significant influence on the market and does not
apply a specific policy regarding pharmaceutical companies.
■ Regulatory framework applicable to the pharmaceutical market

The pharmaceutical market is highly regulated because of imperatives linked
to public health protection and promotion. The Algerian regulation applied
to the sector of pharmaceutical products for humans is rather developed and
deals with all the aspects linked to the product’s environment. However, this
regulation lacks legislative authority because of clauses that have long been
considered obsolete and out of date12. Therefore, and after the deep changes
undergone since the beginning of the 1990’s, with an opening process of the
pharmaceutical sector directed to private capital both national and foreign,
important organization measures (on registration, price setting, generic
support, protection of national production, etc.) were taken via circulars, notes
or instructions. This had negative consequences on the regulation coherence
and transparency and probably also on the conditions of its implementation.
From registration to marketing authorization. Pharmaceutical products

designed for the market must be registered. This phase constitutes the entry
11 In the case of public companies acting in the pharmaceutical sector.

12 Clauses regarding medicines from the act 85-05 of 16 February 1985 on health modified by act 90.17 of 31 July 1990 and act 08-13 of 20-07-2008
announcing the “National agency of pharmaceutical products”.
point of all the regulatory architecture that regulated medicines before they can
be prescribed, sold or administrated in Algeria13.
Like in any other country, medicines requesting a marketing authoriza-

tion are assessed by the Ministry and evaluated by the National Laboratory for
the Control of Pharmaceutical Products (LNCPP) and the MA is delivered in
the name of the manufacturing laboratory.
The decree 92-284 of 6 July 1992 and its amending texts plan all the
registration steps of a product, as well as the conditions in which the decisions
made are managed, in the respect of public health objectives. And yet, much
remains to be done to improve efficiency and make it an efficient, rigorous
and transparent tool. It mainly concerns: case processing delays, traceability
of the different processing steps, buyers response delays, mastering of exper-
tise phases, follow-up and information of decisions taken, etc.14
Besides, the decree 80-142 of 17 May 1980 setting the attributions,

composition and operating mode of the national commission in charge of
the classification is inadequate and out of date regarding the central role of
this commission in the regulation of medicine registration. This decree was
amended by an order of the Ministry of Health (n°47 of 10 July 1995) that
modified the composition and organization of the commission.
Regulation of quality control. With the liberalization introduced in the 1990’s,

three decrees were adopted in 1992, 1993 and 1996 regarding the quality
control of pharmaceutical products. Beside the precautions taken regarding
the prior approval of concerned laboratories, we must point out specifically:
• The executive decree 92-65 of 12 February 199215 regarding the confor-
mity control of locally manufactured or imported products. It organizes
the modalities of the law application, for manufacturers, importers, dis-
tributors as well as for State services, to ensure the quality and conformity
of the products they put on the market.
• The executive decree 93-140 of 14 June 1993 about the creation, organiza-
tion and operation of the National Laboratory of pharmaceutical products
control. This text is essential for this public organism regulates the whole
pharmaceutical market. Its role is all the more so important as it applies
before all the process starts. Therefore, no pharmaceutical product can be
marketed without having been controlled first.
• The executive decree 96-355 of 19 October 1996 about the creation, orga-
nization and operation of the network of tests and quality analysis labo-
ratories. This network, gathering the laboratories created at the level of
various ministerial departments, aims at creating the necessary synergy to
reinforce the capacities of analysis and quality control at the national level.
13 Some medicines can be prescribed and administered in hospitals without MA for they benefit from a special authorization delivered by the
Ministry of Health, Population and Hospital Reform.
14 National Union of Pharmaceutical Operators, op.cit.
15 This regulatory text concern all the products, including pharmaceutical products, and was implemented with Act 89-02 of 7 February 1989 on
consumer protection general rules.
Importations regulation. Medicines are one of the only mass consumption

product that remains submitted, to this day, to an administrative authori-
zation prior to importation (Order 03-04 of 19 July 2003). Therefore, this
legal disposition gave a legal base to importation regulation measures that
already existed and that had been gradually implemented by the sanitary
administration for about ten years. One can distinguish three categories of
measures: those aiming at controlling importation operations, those aiming
at a quality development of generic products on the Algerian market and
those regarding the protection of national production.
Development of generic medicines. Given that in Algeria most of the national

consumption comes from importations, supporting generic medicines starts
with the implementation of importation regulation. Therefore, three types of
measures regarding medicines importations were implemented:
• registration of a brand name medicine will only be authorized in the
absence of a generic medicine and in the limits of a potential additional
cost compared to the reference price of the INN at a maximum of 25%;
• the local fabrication of brand products, under their generic form, will be
supported and made easier by the public authorities. In the same context,
the importation of products manufactured locally will no longer be autho-
rized;
• the authorities clearly support the local production of medicines through
an explicit exemption of rights and taxes on inputs and the implementation
of favourable reference price for reimbursement.
We must point out that these measures, aiming at promoting generic

medicines, have never been applied (see section about generic medicines
production).
■ Public policies and support measures

Medicines have always benefited from custom duties and VAT exemption
for importation of inputs and raw materials destined for local production
in order to favour the development of this economic activity. However, the
management of this system is submitted to meticulous and heavy controls by
the three administrations (Ministry of Health, Customs and tax authorities).
■ Institutional framework linked to Euro-Mediterranean, North

African and bilateral economic and technical cooperation agree-
ments
Between 2009 and 2010, Algeria concluded several cooperation and part-
nership agreements with the United States, France, Cuba, Jordan, Poland,
Italy, Russia and Tunisia. The main cooperation and partnership actions and
projects in the pharmaceutical sector consisted in:
• reactivating, consolidating and reinforcing the partnership between the
different actors for the production of generic medicines against cancer,
chronic diseases and intensifying the cooperation in terms of technology
transfer;
• identifying the pharmaceutical market needs in Algeria through the pro-
vision of medicines at a reasonable price, especially for those for people
suffering from chronic diseases and broadening the investigation field
in Algeria by integrating biotechnology and investment in the sector of

generic medicines for the treatment of different forms of cancers;
• modernizing and broadening the capacities of the Group Saidal;
• making a fabrication technology transfer for vaccines and biopharmaceu-
tical products, assisting the conception of pharmaceutical products new
units and implementing research and development in biotechnology;
• reinforcing the cooperation in paediatric and cardiac surgery, medical
equipment as well as training and sharing of experience.
Medicines demand and its characteristics

The consumption of pharmaceutical products in general, and of medi-
cines in particular, represents the first item of expenditure in the health
sector. It represents a serious problem for health policies and systems, espe-
cially with the increased growth of the pharmaceutical market (medicines
offer constituted by the national production and importation significantly
increased in the three countries), with the evolution of healthcare demand
in general and of medicines in particular through the rising living standards,
the epidemiological and demographic transition as well as the improvement
of medical care for some pathologies and medical insurance.
Therapeutic and medical needs evolve towards recent treatments, inno-

vative and more costly products; for instance: anticancer medicines, analog/
pen-injection insulin, monoclonal antibodies and interferon, triple therapies,
prosthesis and sophisticated exploration equipment. The only data authors
could access to show that in 2008, 18% of medicines consumption was linked
to cardiac troubles, 17% to metabolic and digestive troubles, 15% to anti-infec-
tious medicines and 12% to the central nervous system16, etc.
In Algeria, the average consumption per inhabitant (constituted of

purchased medicines and of others supplied for free) was evaluated at US$
14 in 1992 to reach US$21.4 per inhabitant in 1995, US$ 63 per inhabitant
in 2000 and US$ 165 per inhabitant in 2006.
As for the average spending per inhabitant per year for medicines in
Algeria, it reached € 34.7 in 2006 against € 28.2 in 2004. By comparison,
this amount is estimated at € 440 in France while in Morocco and Tunisia,
the estimations reach an average spending of €16.6 and € 27.5 respectively.
Out of the total health spending, the share of medicines expenditure

represents 30% in 2006 against 20.3% in 1995.
Medicines offer
With an average growth of 10% a year, the Algerian pharmaceutical
market is the third market in Africa (US$ 3.45 billion in 201217). However, it
remains structurally importer; local production units focus on generic medi-
cines and on the same pharmaceutical forms that only cover one part of the
needs (essentially under the form of liquids, pastes and dry pills).
16 Semmoud M., “The pharmaceutical sector in Algeria: Datas and perspectives”, 13st class of RESSMA, Marrakech, from 30 May to 09 June 2011.
17 According to a recent study of IMS Health reported by Algérie-Focus on 30 May 2013: www.algerie-focus.com/blog/2013/05/251-medicaments-
toujours-interdits-dimportation-en-algerie.
Besides, whatever its investments in local production, Algeria remains

highly dependent on the global medicines market, as it imports in average
70% of the consumed medicines.
■ Size of the pharmaceutical market

In 2011, the national pharmaceutical market represented US$ 2.0 billion, of
which US$ 1.85 billion were imported medicines and US$ 1.05 billion of local
production, of which 84% goes to the private sector and 16% to the public
sector18.
According to the data of the customs National

Center of Computer and Statistics (CNIS), Algerian importations of phar-
maceutical products19 reached US$ 606.26 million during the first four
months of 2013, decreasing by 13.2% compared with the same period of 2012
(US$ 698.3 million).
Algerian importations of pharmaceutical products reached a total

of US$2.3 billion in 2012, with an increase of 24% compared with 2011
(US$ 1.85 billion), representing the 2nd place of consumption goods after
cereals and the 7th place for importation in absolute terms. Thanks to the
National Office of Statistics data available and to the UNOP survey, one can
make an approximate estimation of the national market values and its evolu-
tion since 2000.
The measures imposing pharmaceutical operators to invest in local

production and forbidding the importation of medicines produced locally
allowed to reduce the medicines bills. Indeed, they decreased (see TABLE 1) by
6% and 4% going from US$ 1,845 million in 2008 to US$ 1,734 in 2009 and
to US$ 1,665 in 2010. However, they started increasing again by 11% and
24% respectively over the period 2010-2011 and 2011-2012.
18 National Union of Pharmaceutical Operators, op. cit.

19 In average, over the last decade, medicines represent nearly 95% of the total of pharmaceutical products bills.
TABLE 1 Evolution of the size of the Algerian pharmaceutical market (in US$)
Evolution (Base 100 : 2000) Share
Estimation of Share of
Local of local
Year Importations the national importa-
Production Local National production
market Importations tions (%)
prod. market (%)
2000 111,442,500 457,094,380 568,536,880 100 100 100 20 80

2001 93,043,200 492,396,377 585,439,577 83 108 103 16 84
2002 106,585,600 619,804,810 726,390,410 96 136 128 15 85
2003 100,843,800 615,483,659 716,327,459 90 135 126 14 86
2004 225,000,000 877,425,980 1,102,425,980 202 192 194 20 80
2005 232,400,000 1,068,678,140 1,301,078,140 209 234 229 18 82
2006 455,000,000 1,185,492,173 1,640,492,173 408 259 289 28 72
2007 586,574,000 1,445,652,495 2,032,226,495 526 316 357 29 71
2008 533,900,400 1,844,557,869 2,378,458,269 479 404 418 22 78
2009 771,324,400 1,734,367,374 2,505,691,774 692 379 441 31 69
2010 800,000,000 1,664,703,324 2,464,703,324 718 364 434 32 68
2011 1,050,000,000 1,850,000,000 2,900,000,000 942 405 510 36 64
2012 1,150,000,000 2,300,000,000 3,450,000,000 1,032 503 607 33 67
Sources: ONS, UNOP and CNIS-DG Douanes
As for local fabrication, it increased by 44% between 2008 and 2009

before slowing down and reaching 10% between 2011 and 2012. The objective
of Algeria is to produce locally 70% of its medicines consumption by the end
of 2015 with the help of foreign laboratories. In order to reach this objective,
the State took important measures to settle a pharmaceutical industry espe-
cially by encouraging investments and settling industrial partnerships.
Besides, in 2011, the share of generic medicines20 represented 35% of

the global consumption of registered medicines against 48.5% in 2009 and
about 38% in 2006 (see TABLE 2).
20 They are generic medicines with a specialty name (“Brand generic”) and are different from generic medicines presented under their INN.
TABLE 2 Evolution
of the share of generic medicines (production,
conditioning, importation) in the global medicines consumption
2004 2005 2006 2009 2011
Generic 31.99% 33.60% 37.92% 48.5% 35%
Brand 78.01% 66.40% 62.08% 51.5% 65%
Source: Ministry of Health
As for local production, it is mostly oriented (75%) towards the fabrica-

tion of generic medicines in 2011, against 81% and 80% respectively in 2008
and 2009.
■ Main manufacturers and importers

In terms of medicines production in Algeria, SAIDAL takes up the greatest
share (39.8%), followed by Sanofi Aventis (26%), while Pfizer only represents
11.5% of medicines manufactured in 200521. However the group SAIDAL
loses shares when it come to the pharmaceutical market (importation and
fabrication) since they went down to 8.7% in 2007. Indeed, the Algerian
pharmaceutical market is mostly controlled by foreign groups. The most
important investors in the pharmaceutical sector in Algeria are, in order of
importance: Sanofi Aventis (14%), Bio Pharm (10%), LPA (4.6%), Pfizer
(4.4%), Laboratoire Salem (4.3%), Hikma pharma (4.2%) and Prodiphal
(4.2%)22.
■ Types of produced medicines

In order to face these needs, Algeria has production units capable of producing
all the required dosage forms. They are the following pharmaceutical forms:
• non-sterile liquid oral forms (syrups and oral suspensions): 16 units (of
which 8 are exclusively dedicated to this form);
• oral dry forms (capsules, pills, powders in packets): 11 units of which 4
dedicated to these forms only, 4 where another form is produced (non-
sterile oral liquid) and 3 more versatile;
• non-sterile liquid forms for external use (antiseptic): 10 fabrication units,
of which 7 units dedicated to this form only or associated with pasty forms
for external use;
• pasty forms: 6 fabrication sites, associated with other forms of fabrications;
• semi-solid forms: 5 production sites, of which 4 are dedicated to this form
(suppository);
• injectable medicines (sterile): 1 site and 1 project of site. These site produce
other forms;
• other sterile liquid forms: 5 producers, of which 3 for large solutes and 2
for collyrium.
■ Access to active substances to produce medicines

In Algeria, the LNCPP created, in its technical structures, a chemical service
specialized in the quality control of the active substance. It aims at:
21 Boutouchent Z. & Lejeune A., « Analyse de la filière industrie pharmaceutique en Algérie » [Analysis of the pharmaceutical industry in Algeria],
Ministry of Small and Medium-sized Enterprises and Crafts & European Commission, SMB Euro-Development main report, Algiers, October 2007.
22 Dahmane L. « Le marketing pharmaceutique : Case complexe Saidal » [Pharmaceutical marketing: the complex case of Saidal], PhD thesis,
University of Economics and Management of Dely Ibrahim – Algeria. Management department, Academic year 2009-2010.
• making the Direction aware of its responsibilities by testifying the authen-

ticity of the supplier/producer;
• vouching for the existence of a quality insurance system;
• mastering the conception with a conformity certificate of the European
pharmacopeia (EPC), a Drug Master File (DMF) or International Comitee
of Harmonization (ICH);
• identifying all the ingredients used in the fabrication of the raw material
(active substance).
■ Exportations
According to the data of the CNIS-DG Douanes, the exportation of medicines
in Algeria was at its best in 2001 and 2009 (TABLE 3). During these years, they
evolved respectively by 61% and 50%. In 2010, their value decreased by 52%
compared to 2009. Since 2007, even though their importance varies every
year, pharmaceutical products are mostly exported towards Libya, Morocco,
France, Jordan and Saudi Arabia. In 2010, more than 85% of exportations are
of benefit for these countries (TABLE 4).
TABLE 3 Evolution of medicines exportations in Algeria (in US$)

2000 2001 2002 2003 2 004 2005* 2006 2007 2008 2009 2010
Exportations 289,419 465,421 563,690 749,850 978,744 — 4,729,430 2,916,413 1,746,961 2,625,872 1,271,019
Sources: CNIS-DG Douanes

*: No data available
Evolution of the breakdown of pharmaceutical products exportations

TABLE 4
in Algeria per country (%)
Year 2000 2001 2002 2003 2004 2005* 2006 2007 2008 2009 2010
Country
Saudi Arabia 0 0 0 0 17.5 0 10.6 1.2 3.2 6.4
Spain 0 0 0 0 0.3 78.3 0 0 9.1 0

France 8.7 73.4 61.2 9.3 22.6 0.9 36.7 40.6 32.9 20.3
Italy 0 0.1 0 50.1 19.9 0.5 0 0.2 0 0
Jordan 1.4 0 0 0 0 0.5 0 2.5 3.1 7
Morocco 88.6 18.4 1.8 0.3 1.8 4.8 18.9 0 5.5 22
Nigeria 0 0 0.2 15.1 10.5 2.8 3.7 6.4 9 1.7
Libya 0 0 0 0 4.7 3.4 15.1 27.6 21.6 29.7
Senegal 1.1 1.9 17.4 17.9 0.2 1.3 0.4 3.6 2.3 2
Yemen 0 0 10 1.2 11.6 0 1.9 3.7 0.6 0
Others 0.2 6.2 9.4 6.1 10.9 7.4 12.7 14.3 12.7 10.9
Total 100 100 100 100 100 100 100 100 100 100
Sources: CNIS-DG Douanes
* : Non-available data
■ Importations
Over the same period (2000-2010), and according to the Customs Direc-
torate, importations of pharmaceutical products are as described in TABLE 5.
Even though they keep decreasing, the most important share is that of medi-
cines conditioned for retail (about 90%). This decrease was realized at the
expense of importations of human or animal blood, serums and vaccines.
TABLE 5Evolution of pharmaceutical product importations in Algeria by category

(in million US$)
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Glands and other 5.776 3.611 3.341 4.068 3.848 5.733 3,711.894 5.901 6.163 5.992 551.439
organs
Human or animal
blood, serums, 12.182 15.836 18.994 24.446 33.451 32.111 38.351 75.183 105.424 126.601 128.565
vaccines
Medicines non-
conditioned for 1.560 3.840 9.360 7.027 13.632 26.994 23.541 25.815 38.865 58.239 34.575
retail
Medicines
conditioned for 427.387 457.780 573.916 565.280 807.843 980.480 1,092.393 1,307.642 1,650.990 1,508.415 1,456.405
retail
Waddings,
Gauzes, Strips and 2.042 2.444 2.210 3.057 5.501 5.955 3.809 5.316 8.054 7.583 7.034
similar items
Preparations
and other 8.147 8.885 11.983 11.606 13.151 17.406 23.688 25.795 35.061 27.538 37.573
pharmaceutical
items
Overall total 457.094 492.396 619.805 615.484 877.426 1,068.678 1,185.492 1,445.652 1,844.558 1,734.367 1,664.703
Source: DG Douanes – CNIS
The evolution over these ten years (from 2000 to 2010) of each of these
pharmaceutical product categories of importation also shows the fast growth
of the category of medicines conditioned for retail until 2005. This growth
slew down in 2008 and 2009, with other decreasing peaks in 2003, 2006
and 2010.
In 2010, the category that underwent an important evolution is that of

preparations and other pharmaceutical items (36%). This increase was also
present in 2006 and 2008.
Research and innovation

The ignorance of the patents system and of patent protection procedures
is at the origin of the low rate of patent registrations in Algeria (1st registra-
tion in 2005). Until April 2010, the Algerian national institute of industrial
property registered 181 patent applications, of which 98 about medicines.
The first observation in scientific research is the total absence of compa-

nies (public and private) from research, while it constitutes the core of any
industrial development, which explains the absence of technological innova-

tions. The second observation is that the research issue in Algeria does not lie
in the allocation of means (human, material and financial) but in the imple-
mentation of a real innovation national policy making the concerned actors
interact. Research in Algeria also suffers from the absence of collective will,
of communication between researchers, of team-work, of relations between
universities and research centres, between research centres and the industry,
and between official structures and researchers.
Considered as a qualitative and quantitative measure indicator of the

research and development activity, scientific publication reflects the efforts
of researchers and remains a good way to highlight innovations. Even though
Algeria is making progress, the publication rate remains incomparable to
that registered in other countries and even in neighbouring countries. The
available data only concern publications in general. Publications on the phar-
maceutical industry are included.
As for innovation in companies, even if the designation is used, the R&D

structure does not exist. Instead, one can find other entities under the form
of laboratories, centres, engineering office, etc. Their main activities concern
the realization of conformity tests and quality control. However, these enti-
ties may sometimes be at the origin of activities leading to modifications/
improvements. Indeed, for almost all companies, the innovations realized
are incremental; they improve the taste, the conditioning or the presentation
of the product. Technological innovation does not exist.
In order to meet the new needs in innovative products coming from the
Algerian population and from the Middle-East and Africa region, the Algerian
government undertook a large project of creation of a biotechnological centre
(including production and R&D sites). The project is starting with the support
of large companies, American academic centres and some major European
companies. This project represents a significant challenge in terms of develo-
pment of new scientific training, skills and expertise. It should encourage
the modernization of biomedical and scientific Algerian academic trainings
that have difficulties renewing themselves, especially to integrate a R&D
and management dimension that currently lacks in local health industries.
Finally, this project can complete the development of a biopharmaceutical
industry currently too oriented on chemical products while the international
drive for competitiveness in health concerns biotechnologies and advanced
technologies.
The pharmaceutical market in Morocco

In spite of an unfavourable international environment these last three years,
Morocco keeps showing encouraging results, characterized by the strengthe-
ning of the macroeconomic framework and a progressive diversification of
the productive basis of the national economy. The implementation of stra-
tegic reforms allowed to maintain the basic principles of the economy.
In 2011, in spite of the crisis, the GDP growth rate reached 5% against
3.7% in 2010 and 4.8% in 2009, thus reflecting a lesser volatility of the
economy thanks to the efforts of the secondary sector (industries, construc-
tion industry, transports and telecommunications) and tertiary sector (banks,
insurance, other services) that are progressively driving growth.
Since the independence, Morocco engaged in large investments to

develop and give the country basic industrial infrastructures. The industrial
sector represents nearly 28% of GDP. Dominated by food-processing, textile
and leather industries for a long time, Moroccan industry rapidly diversi-
fied thanks to the development of various sectors such as chemistry and
parachemistry, paper and cardboard, car equipment and vehicle assembly,
services to businesses, computers, electronic and aeronautic industry.
The Moroccan pharmaceutical industry is the third in Africa in terms of

revenue after South Africa and Algeria. This industry generates a revenue of
Dhs 9 billion per year, or € 900 million per year.
In this macroeconomic context, the country’s sanitary situation is charac-

terized by the reduction of mortality and fecundity rates, announcing the
demographic transition and a change in the morbidity structure, resulting in
the emergence of chronic diseases due to the epidemiologic transition.
The gross mortality rate decreased from 19‰ in 1960 to 5.6‰ in 2010,
however it remains much higher in rural areas (7.2) than in urban areas (4.4).
Infant mortality went from 91‰ in 1979 to 37‰ in 1997 and to 28.8‰
currently. The index of maternal mortality dropped from 359 deceases for
100,000 live births at the end of the 1970’s to 227 at the end of the 1990’s
and to 112 currently. As for life expectancy at birth, it rose from 47 years old
in 1962 to 74.8 in 2012. The total fecundity rate dropped from 4.5 in 1987 to
2.6 in 2011.
Even though these various indicators confirm the efforts made by the
Ministry of Health, many issues remain to be tackled.
■A strengthened but underused infrastructure

In Morocco, the basic healthcare network greatly developed. The same goes
for the hospital network, but at a very low pace. The country thus went up
from 0.58 basic healthcare institutions for 10,000 inhabitants in 1980
(1/17,000 inhabitants) to 0.83 for 10,000 inhabitants (1/12,000) today. In

spite of the efforts of the Ministry of Health to reinforce the sanitary network,
nearly 20% of the population still live at more than ten kilometers of a basic
sanitary infrastructure and the level of use of public curative services remains
remarkably low with 0.6 new case per person per year.
■ Health-care workers shortage

One of the most striking characteristics in the Moroccan health
system is the staff shortage, in spite of the slight improvements
made in the last few years. The density of doctors, both private and public,
rose from 0.43 to 0.62 for 1,000 inhabitants between 1999 and 2012, while
the density of nursing personnel oscillated between 0.89 and 0.97 for 1,000
inhabitants. Besides, more than 40% of Moroccan specialists exclusively
work in the urban private sector.
■ A funding that is still too dependent on direct payments

Morocco progressively increased the amounts dedicated to healthcare. The
total spending rose from Dhs 18.9 billion (US$ 1.7 billion) in 2001 to Dhs
47.8 billion (US$ 5.8 billion) in 2010, that is an average increase of 12.2% per
inhabitant per year.
The greatest share of this spending (53.6% in 2010) is ensured by house-

holds’ direct payments. The high rate of direct payments deepens inequalities
between the different categories of population and puts households at high
risks of financial disaster and impoverishment.
The resources collected by the national healthcare system are dedicated,

for a rather important part (31.7% in 2010 against 33.6% in 2006), to the
purchase of medicines and medical items as final consumption goods for the
patient and not as inputs used by health professionals for healthcare.
■ Medicines remain expensive

The prices of medicines are twice to three times higher in Morocco than in
most neighbouring countries, mainly because of the supply fragmentation
and the absence of competition by quality generic medicines, the penetration
of which does not go beyond 30%.
One must point out that the pharmaceutical market in Morocco, as

everywhere else in the world, keeps evolving. Every day, new specialties are
created, while others are drawn back from the market or have their instruc-
tions modified. The promotion of generic medicines by the public authori-
ties, as part of their policy to give citizens better access to healthcare, and the
competition between the different pharmaceutical companies intensify this
phenomenon.
The growth of the pharmaceutical market increased both in value and in

volume, especially after the introduction of the compulsory health insurance
and more recently of the Assistance Scheme for the Economically Underpri-
vileged (RAMED).

■ Actors of the pharmaceutical sector
The Moroccan pharmaceutical market is entirely controlled by the private
sector from importation to retail distribution, production and wholesale
distribution. There is a supply service of the public healthcare institutions
(Central Pharmacy).
Wholesalers-distributors find themselves between the pharmaceutical

industry and retail pharmacies. Their main activity consists in buying and
selling medicines, therefore it is a service provision activity. They supply 80%
of manufactured medicines; the rest is supplied directly by pharmaceutical
companies themselves.
The second category of actors implicated in the supply chain of pharma-

ceutical products concerns retail pharmacies. They are managed by the owner
and pharmacist, helped by pharmacy-technicians or assistants.
As for the public sector, it covers about 10% of the national market needs
and it is in charge of supplying sanitary establishments under the authority
of the Ministry of Health. The current supply system of the public sector is
entirely ensured by the Supply division. Medicines are distributed freely to
patients. However, the four CHUs (establishments with an administrative
autonomy) get their supplies independently (except occasionally for urgent
supplies, in such case the products are “lent”). By the same token, programs
of the Direction of the population, with for example vaccines and contra-
ceptives, and of the Direction of epidemiology and disease control, with for
instance products against tuberculosis, AIDS and vaccines, buy directly their
medicines and medical items and stock them in the warehouse of the Supply
division that also ensures supplies. The division supplies health provincial
delegations (which in turn supply health centres) and semi-autonomous
hospitals (SEGMA).
The supply organization implemented allows a marketed product to

access in one day the different points of sale present over the whole national
territory.
Schematically, one can represent the organization of pharmaceutical

products supply networks in Morocco as shown in FIGURE 1.
FIGURE 1 Organisation of the medicines supply circuit
Laboratories
80 %
10 % 10%
Wholesalers
1% 99 %
Hospitals and clinics Retail pharmacies
Consumers
Source: AMIP
For a long time now there has been an Order of pharmacists. The
National council of the Order of pharmacists comes from four regional
councils. The members are elected. Industrial companies are mostly repre-
sented by the Moroccan Association for Pharmaceutical Industries (AMIP).
It gathers 25 laboratories. Almost all multinational companies are members
of Health Innovation Morocco (MIS). Some multinational companies are also
members of the AMIP.
The Moroccan association for generic medicines (MAG) is the 3rd profes-
sional association in this sector. It was created in 2010. It gathers exclusively
generic medicines industrials, some of which are already members of the
AMIP. This association mostly aims at developing generic medicines in
Morocco.
Currently, the Moroccan pharmaceutical sector is, in size, the second

on the African continent, after South Africa. It is constituted of 40 industrial
units, 50 suppliers and more than 10,000 retail pharmacies23.
Besides, the pharmaceutical industries are geographically located in the

region of Greater-Casablanca with a total of 32 companies24.

The Ministry of Heath ensures sanitary security in general and medicines
security in particular. On the one hand, it must ensure the availability of vital
products through regular supply, for all the citizens, by traceable circuits.
On the other hand, it must ensure the quality, efficiency and safety of these
medicines. Therefore, medicines and pharmacies are highly regulated and
controlled by the Ministry of Health25.
There are legal dispositions establishing the powers and responsibilities

of the Pharmaceutical regulatory authority represented by the Direction of
Medicine and Pharmacy (DMP). The DMP is part of the Ministry of Health
and is a semi-autonomous organism. It performs a certain number of func-
tions, described in TABLE 6, following the clauses of decree n° 2-94-285 of 17
joumada Il 1415 (21 November 1994) regarding the attributions and organi-
zation of the Ministry of Public Health26.
23 Ministry of Health – WHO, « Rapport des travaux de la commission consultative du médicament et des produits de santé » [“Report of the works
of the medicines and health products consultancy commission”], January 2013.
24 Competition Council, op. cit.
25 Competition Council, « Etude sur la concurrentiabilité du secteur de l’industrie pharmaceutique » [Study on the competition of the
pharmaceutical industry sector], 2011.
26 WHO – Ministry of Health, “Morocco Pharmaceutical Profile”, 2011.
TABLE 6 Functions of the Direction of Medicine and Pharmacy

Functions
Marketing authorization / registration Yes
Inspection Yes
Control of importations Yes
License grant Yes
Market control Yes
Quality control Yes
Promotion control, control of advertisement for medicines Yes
Clinical trials control Yes
Pharmacovigilance Yes
Source: Morocco Pharmaceutical Profile. MS – WHO, 2011
The DMP is a technical, expertise and support tool for the decisions
taken by the Ministry of Health regarding medicines, health products and the
management of the sanitary risk linked to these products. Its main objective
is to guarantee the security of medicine and health products use via a scien-
tific assessment in order to ensure the quality of these products as well as
to meet the legitimate expectations of the public and of health professionals
with quality reliable information. Its security approach has been expanded
to other health products such as medical devices, laboratory reagents for in
vitro diagnosis, foodstuffs and beverages for special diets, childcare items
and biocides.
The DMP has a National Laboratory for the Control of Pharmaceutical

Products (LNCM) playing an essential role in the quality, technical evaluation
and expertise processes. It refers to and applies the international quality
control standards and technical references of: the European Pharmacopeia
(PE), the American pharmacopeia (USP), the directives of the World Health
Organization (WHO), the guidelines of the European Agency for the Evalu-
ation of Medicinal Products (EMEA) and of the European Directorate for the
Quality of Medicines (EDQM), the guidelines of the Food and Drug Admi-
nistration (FAD), the International Conference on Harmonization of Tech-
nical Requirements for Registration of Pharmaceuticals for Human Use
(ICH), the guide to Good Manufacturing Practice (GMP) and national stan-
dards.
The National Laboratory of medicines control is recognized at the

regional and international scales since it is a WHO collaborating laboratory.
A laboratory approved by the Arab League, accredited by the European Direc-
torate for the Quality of Medicines in 2007 and renewed in 2011, prequalified
by the WHO in 2008, associated member of the European Pharmacopeia and
of the American Pharmacopeia in 201027.
27 Doctinews, n°40, January 2012.

Since 196028, in order to better control pharmacy activities, Morocco had

implemented an industrial policy based on the model of import substitution.
Five years later, the Ministry of Health imposed the gradual local fabrication
of some medicines, except products representing small amounts consumed
or requiring a sophisticated and costly technology. The result was the deve-
lopment of a pharmaceutical industry composed of 40 production units
today, against 8 in 1965. Three of these companies are the leaders of the
private Moroccan market (outside of the hospital sector).
■ Regulatory framework applicable to the pharmaceutical market

Morocco adopted very strict regulations29 in comparison with countries with a
developed and structured industry. These regulations, which define precisely
the operating conditions and modalities for each of the different operators,
from industrials to retail pharmacies, are made of natural barriers impeding
anything that could represent a potential danger for citizens since they
precisely aim at protecting them. Besides, these regulations also aim at a free
access, for all citizens, to healthcare in general and medicines in particular30.
As regards the registration procedures for medicines, the MA request

files are submitted to the Direction of Medicine and Pharmacy. The asses-
sment of the administrative file is made at the Pharmacy division while the
assessment of the technical file is made at the National Laboratory for medi-
cines control. The results are then submitted to the national commission
of MAs, composed of experts and medicine professors working in the four
university hospitals (CHUs), who give their opinion on the therapeutic rele-
vance of the medicine. If they are in favour, an agreement in principle is
delivered to import (3 months) or manufacture (12 months) the medicine
and submit samples to the National Laboratory for medicines control for
an analytic expertise. The MA is then accepted if the results of the analysis
comply with the regulations. In other cases (postponed or refused files,
non-compliant analysis), further information or changes are required to
re-examine the MA request files.
There are two types of MA requests: the MA requests for new products
and the requests for the extension of already authorized MAs (an MA is deli-
vered for five years). There are no systems of mutual recognition of the deli-
vered MAs between the DMP and other foreign authorities.
The entry into force, in 2005, of a law on intellectual property led to a peak
in MA requests at the DMP in 2004. In total, 831 requests were submitted, of
which 748 for generic medicines, against half less the following year.
In 2010, 469 MA request were submitted for new products (a request is

for a form, a presentation and/or a dosage) and 252 for MA extensions31. Over
the 469 requests on new products, 342 MA were given, that is nearly 73% of
the requests accepted. One request out of four has however been refused32.
28 Dahir of 1960 defining medicines operating conditions.

29 Act 17-04 on the code of medicines and pharmacy, announced by the Dahir n°1-06-151 of 30 chaoual 1427 (22 November 2006), is the first major
reform of the pharmaceutical sector.
31 National Observatory for Human Development, « Les disparités dans l’accès aux soins au Maroc : Etude de cas » [Disparities in healthcare access
in Morocco: Case study], 2011.
32 National Observatory for Human Development, op. cit.

Beyond the obvious economic issue, the development of the pharmaceutical
sector could improve the health of all Moroccan citizens, through a broad
and accessible offer of medicines and healthcare, while contributing to the
independence of the national health system. In this respect, Morocco imple-
mented, in February 2013, a program for the pharmaceutical industry sector
aiming at supporting a promising sector both on the national and interna-
tional markets. This program is the result of a strategy built with all the public
and private stakeholders. By favouring a targeted approach, and by mobilizing
the concerned partners as well as the necessary resources, it must give this
sector optimal conditions for development. It formalises the commitments
of the partners implied over the period 2013-202333.
This project was born from the combination of two strategies:

• one exportation strategy focused on three major lines: development of
R&D activities, reinforcement of Moroccan manufacturers, setting up of
foreign manufacturers;
• one strategy of development of the national market focused on three major
lines: development of generic medicines, improvement of access to medi-
cines, improvement of access to healthcare.
One must also note that Morocco is the only Arab country to impose
VAT payment on medicines. Custom duties and taxes are imposed on the
importation of several pharmaceutical products.
■ The institutional framework linked to commercial as well as

technical and economic cooperation Euro-Mediterranean, North
African and bilateral agreements
In the context of its liberalization and global opening-up strategy, over the last
decade Morocco updated the legal framework ruling its commercial relations
with its partners through free-trade agreements both with its main partner
– the European Union – and with a certain number of Arab countries of the
European Free Trade Association (EFTA) and Turkey.
Therefore, in the framework of the Barcelona process (November 1995)

aiming at the creation of a Euro-Mediterranean free trade zone by 2012,
Morocco concluded a certain number of agreements with its European and
Mediterranean partners. The most important are the association agreement
signed in February 1996 between Morocco and the UE, that came into force
in March 2000, and the free trade agreement with the EFTA signed on 19
June 1997 and in application since March 2000. These agreements aimed
at, among other things, the gradual implementation of a free trade zone and
planned many cooperation areas on political, economic, social, scientific and
cultural issues.
In the same context, Morocco engaged in a free trade process with a few
Arab countries in regard to the new relations of these countries with the EU.
Therefore, bilateral free trade agreements were signed with Egypt in May
1996, and entered into force on 29 April 1999, and with Tunisia in March
1999. At the regional scale, it signed in February 2004 the quadripartite
33 Ministry of Industry, Trade and New Technologies, « Contrat programme pour le développement du secteur de l’industrie pharmaceutique »
[Program contract for the development of the Pharmaceutical Industry sector], February 2013.
agreement between Morocco, Egypt, Tunisia and Jordan thus implementing

the Agadir declaration of May 2001.
As for other Arab countries, Morocco diversified its outlets and streng-
thened its relationships with its commercial partners, be it at the bilateral
level (United Arab Emirates) or at the regional level in the context of the Arab
free trade area that came into force in January 1998. It also signed a free trade
agreement with Turkey and then with the United States in June 200434.
Since December 2004, Morocco is a member of the World Trade Orga-

nization and has therefore reviewed strictly its regulations on intellectual
property35.
The international agreements concluded by Morocco with various

countries threw the pharmaceutical industry into a new environment where
competition is harsh. It will now have to face an increasingly fierce competi-
tion in order to keep its markets or conquer new ones.

In 2009, the private pharmaceutical consumption (medicines bought in
pharmacies, excluding hospital consumption) in Morocco was of Dhs 372
per inhabitant per year, or nearly US$ 44 per inhabitant per year, which
represents a volume of 8.6 boxes. It remains quite low (France36: US$ 524 per
capita in 2004) because of a very weak social coverage, of a low purchasing
power and of the high price of medicines.
The cumulative change in consumption in terms of value, over the

period 1991-2005, was of +104%. That is a yearly average of +7.5% (FIGURE 2).
This evolution goes down to +44% over the period 2005-2009. That is a
yearly average of +11%. This can be explained mostly by the impact of the
implementation of the compulsory health insurance on medicines consump-
tion37. Besides, while the WHO advises to dedicate at least 10% of GDP to
medicines, this rate does not reach 5% in Morocco.
34 Moroccan Pharmaceutical Industry Association, “Morocco and international agreements”, www.amip.ma/dynamicdata/Secteur_Accords.

aspx?langid=5
35 Act 17-97 of 18 December 2004 amending preexisting texts and ensuring the conformity of Morocco with the WHO; Act 31-05 amending
and completing the previous legislation in order to introduce some of the requirements imposed by the Trademark Law Treaty of the World
Intellectual Property Organization (WIPO) and by the free trade agreement signed with the United States in March 2004.
36 LEEM, « Consommation pharmaceutique et indicateurs de santé publique » [Pharmaceutical consumption and public health indicators], Study
report, May 2009.
FIGURE 2 Evolution of medicines consumption per capita in Morocco (in Dhs)
Source: Belaïche, 2010
Medicines offer
In Morocco, the pharmaceutical industry is young but is rapidly
evolving. It developed very quickly over the last twenty years. Indeed, the
World Health Organization confirms that it has a proven experience and
expertise and places it in the “Europe zone”.

In 2012, the market generated a revenue of about Dhs 11.5 million (including
hospital products and public bids), of which Dhs 8.2 million generated by
the private pharmaceutical market. The share of brand-name medicines
represented nearly 70% of the sales on the private market, against 30% for
generic medicines, that is Dhs 2.5. In volume, the consumption of medicines
reached 289,345 units consumed over the same period against 172,000 units
in 200038.
Morocco produced nearly 65% of its pharmaceutical needs and exports

10% of its production, especially to African countries39. The remaining 35%
are ensured by the importations of low consumption volume and mostly
come from European countries40.
There are currently over 5,000 pharmaceutical specialties covering

nearly all the therapeutic classes41. According to the therapeutic classification
of medicines consumed in 2010 (TABLES 7 & 8), medicines for the digestive
system and metabolism are ranked first with 18% of market share and nearly
Dhs 1.4 billion. Anti-infectious and cardio-vascular medicines are ranked
second and third and respectively take up 16% and 11% of the market42.
38 BMCE Capital Research Flash, « Tour d’horizon : Industrie pharmaceutique » [Overview: Pharmaceutical industry], March 2013.
39 National Observatory for Human Development, op. cit. & L’Opinion, « Industrie pharmaceutique : Jeune et à développement rapide » [The
pharmaceutical industry: young and fast-developing], 14 July 2012.
40 Moroccan Pharmaceutical Industry Association, « Le Médicament au Maroc : Couverture du marché intérieur » [Medicines in Morocco:
covering the national territory], www.amip.ma/dynamicdata/Secteur_Couvert.aspx?langid=5
42 Moroccan Pharmaceutical Industry Association, op. cit.
TABLE 7 The first ten therapeutic classes in value (2010)

Values (Dhs) Market share (%)
Digestive system and metabolism 1,442,612,761 18
Anti-infectious v general 1,265,798,997 16
Cardio-vascular system 884,681,417 11
Nervous system 878,476,765 11
Respiratory system 649,810,252 8
Somatomotor system 609,844,261 7.3
Genit-urin-horm-sex system 581,702,077 7.3
Others 424,129,146 5.3
Dermatology 407,355,122 5.1
Sensory organs 310,723,451 3.9
Total 7,934 048,145 100
Source: AMIP/IMS-Health
TABLE 8 The first ten therapeutic classes in units (2010)

Units (thousands) Market share (%)
Digestive system and metabolism 55,758,334 19.8
Central nervous system 49,377,400 17.5
Respiratory system 31,439,569 11.1
Anti-infectious v general 23,922,804 8.2
Genit-urin-horm-sex system 23,115,894 8.2
Dermatology 21,065,689 7.4
Somatomotor system 20,022,919 7.1
Cardio-vascular system 14,974,985 5.3
Sensory organs 14,673,929 5.2
Others 10,269,427 3.6
Total 281,869,540 100
Source: AMIP/IMS-Health
Today, the private market ensures 80% of the production of these

companies, while the public and foreign markets ensure 10% each. The forty
production sites spread over the territory allow to cover 65% of the popula-
tion’s needs and covers all therapeutic classes43.
As for medicines exportations, they concern Moroccan generic medi-

cines as well as European industrial series relocated by foreign groups, be
they brand-name or generic medicines. They rose from Dhs 241 million in
2005 to 47544 million in 2011 with a sustained growth reaching over 10% per
year. Between 2005 and 2008, these evolutions reached 26%45. In spite of

44 Morocco in figures in 2011 & Currency board, « Rapport du commerce extérieur » [Report on external trade], Final edition, 2011.
this performance, Moroccan exportations remain under that of some coun-

tries in the MENA region, such as Jordan, Turkey and Egypt.
■ Main producers and importers

For the year 2009, Sanofi Aventis comes first with market shares in terms
of value reaching 10.52%, followed by MAPHAR with 9.30% and by
LAPROPHAN (8.63%)46 (FIGURE 3).
FIGURE 3 Market shares in value (Dhs) of pharmaceutical industries
Source: AMIP

The Moroccan pharmaceutical industry is a formulating and packaging
industry, as the WHO regularly points out. Therefore, it highly depends on
foreign suppliers who know about production and marketing of a strategic
good in this sector: the active substance later introduced by the manufac-
turers to obtain syrups, capsules, pills, ointments, etc.
The low production volumes and the dependence on foreign suppliers of

raw materials have direct consequences on the price of medicines. On the one
hand, short series have consequences on prices in an industry where econo-
mies of scale are essential and represent a significant competitive advantage
beside patent ownership or high marketing expenses. On the other hand, the
Moroccan pharmaceutical industry depends on raw materials price fluctua-
tions according to their origin and quality. Besides, since Moroccan compa-
nies produce under license, a consequence is that very often commercial
agreements require the license holder to get his raw material supply to the
company that granted it the license47.
■ Exportations
Morocco mainly exports towards Europe (TABLE 9) with Dhs 733 million in
2012, against Dhs 447 million in 2011 (evolution of +54.6%). The main
client of the Moroccan pharmaceutical industry is France with exportations
reaching up to 71% of exportations towards Europe.
Exportations towards Africa represent 31% of total Moroccan medicines

exportations. The main importing countries are those of Arab Maghreb
46 Competition Council, op. cit. & National Observatory for Human Development, op. cit.
47 National Observatory for Human Development, op. cit.
Union (AMU). The Moroccan industry is trying to reach new markets, espe-
cially in sub-Saharan countries like Senegal and Ivory Coast48.
Table 9 Medicines and pharmaceutical products exportations (2011)

Country Value (Dhs 1,000) Weight (Tons)
European Union, including: 316,172 1.743
France 306,497 1.637
Belgium 4,896 89
Portugal 2,825 7
Arab Maghreb Union 66,833 246
Other countries* 91,076 380
Total 474,081 2.369
Source: Report on external trade – Final edition 2011.
*: By deduction
■ Importations
The importation of medicines is strictly regulated and controlled by the
administration. Indeed, any importation of medicines is subject to the prior
approval of the Ministry of Health. They did not cease to increase over the
period 2005-2011, to reach Dhs 4.9 billion in 201149 (TABLE 10). In 2012, they
slightly decreased by 6% to reach Dhs 4.6 billion50. Through the analysis of
importations, we can make out a strong tendency to import medicines of
French origin followed by far by the United States and Germany51.
TABLE 10 Medicines and pharmaceutical products importations

(2011)
Main countries Value (Dhs 1,000) Weight (Tons)
France 1,461,748 2,917
United States 444,396 148
Germany 359,856 206
Great Britain 292,350 732
Italy 217,301 221
Spain 196,163 505
Belgium 172,610 168
China 85,260 645
Portugal 37,837 67
Saudi Arabia 19,560 130
Brazil 6,174 5
Algeria 1,639 10
Source: Report on external trade – Final edition 2011.
48 Currency board, 2011, op. cit. Currency board, « Rapport du commerce extérieur » [Report on external trade], Provisional edition, 2012,
Competition Council, op. cit.
49 Currency board, 2011, op. cit. Currency board, 2012, op. cit. Competition Council, op. cit.
50 Currency board, 2012, op. cit.
51 Currency board; Report on external trade, Final edition 2011.
Besides, the high ratio of the relation between the imported amount
and volume finds its origin in the predominance of brand-name medicines
in Moroccan importations, either because they all are protected by patents or
because of costly technologies or fabrication processes52. They are mostly the
so-called high-tech medicines, the local fabrication of which remains impos-
sible. This category is mostly dedicated to serious and chronic diseases, espe-
cially to anti-cancer and cardiovascular diseases treatments.
■ Production of generic medicines

Between 2003 and 2007, generic medicines, which represent 30% of medi-
cines global market, increased by 65% in volume and by 51% in value. More
than 50% of the sales of these medicines are constituted by antibiotics53.
Generic medicines are necessary for underprivileged people to access

healthcare and are an unavoidable means to balance the accounts of health
insurance systems (compulsory health insurance, RAMED, etc.)54. Currently,
the greatest share of generic medicines consumption in Morocco is ensured
by the State’s public markets. In 2011, generic medicines represented 78% in
volume of medicines public purchases and 65% in value55.
In 2012, a decree56 regarding the bioequivalence of generic medicines

came into force in the context of the clauses of the act 17-04 on the code of
medicines and pharmacies. This text defines the bioequivalence and sets up
the scientific exemption criteria of the bioequivalence studies for some cate-
gories of pharmaceutical forms. It establishes the obligation, for any labora-
tory, producer or importer, wishing to market generic medicines, to prove by
clinical tests that the generic medicine is bioequivalent to the brand-name
one. This is a step required by the Ministry of Health to obtain marketing
authorization.

For over fifty years, the Moroccan pharmaceutical industry has been
a pillar of the Moroccan economy. Over the last few years, this sector went
through a sustained development, with a high level of performance and
expertise recognized by the WHO. Indeed, the production conformity of the
sector to the international quality standards, and especially the GMPs, allowed
to export 10% of its production towards European, Arab and African coun-
tries57. In order to give more visibility for the ten coming years, the Moroccan
Government concluded, in February 2013, a program contract with the repre-
sentatives of the industrial pharmaceutical sector, aiming at developing the
52 National Observatory for Human Development, op. cit. & L’Opinion, « Industrie pharmaceutique : Jeune et à développement rapide »
[The pharmaceutical industry: young and fast-developing], 14 July 2012.
53 « Industrie pharmaceutique : Jeune et à développement rapide » [The pharmaceutical industry: young and fast-developing], L’Opinion of 14 July
2012.
54 National Observatory for Human Development, op. cit. & L’Opinion, « Industrie pharmaceutique : Jeune et à développement rapide »,
[The pharmaceutical industry: young and fast-developing] 14 July 2012.
55 Ministry of Health – Supply division, « approvisionnement en produits pharmaceutiques : état des lieux et perspectives » [Pharmaceuticals
supply: overview and perspectives], 2011.
56 Decree n° 2-12-198 of 21 rejeb 1433 (12 June 2012) regarding the bioequivalence of generic medicines.
57 Ministry of Industry, Trade and New Technologies, « Secteur industriel – Autres secteurs industriels – Pharmaceutique » [Industrial sector –
Other industrial sectors – Pharmaceutical industry]. www.mcinet.gov.ma/Industrie/Secteurs%20industriels/AutresSecteursIndustriels/Pages/
Parachime.aspx
Moroccan pharmaceutical industry, while covering all production activities,

as well as R&D activities.
The program plans the creation of an integrated industrial platform (P2I)

that should benefit from the network created in the context of the Emergence
Plan for industry in Morocco. The government committed itself to create a
P2I combining several possibilities, especially the rental or sale of land, of
ready-to-use buildings or of customized premises.
1,017 patents for invention were submitted to the Moroccan Office for
Industrial and Commercial Property (OMPIC) in 2012 against 1,022 in 2011.
Almost 200 requests of invention patents were of Moroccan origin and nine
of the accepted ones concerned pharmaceutical products58.
The pharmaceutical market in Tunisia

After the revolution of 2011, Tunisia underwent a serious recession

along with national and regional unrest. The GDP contracted by 1.8% in real
terms, because of a strong drop in tourism and foreign direct investments.
As a result of the economic recession and the return of Tunisian workers
who worked in Libya, unemployment increased to reach 19% in 2011, unem-
ployment among young people reaching 42%. After a deceleration of 3.5% in
2011, inflation increased and reached 5.7 year-on-year in April 2012.
This macro-economic instability led to the recession of the Tuni-

sian economy as well as to the worsening of commercial, financial and tax
imbal ances.
The signs of an economic recovery appeared in early 2012. According to

the preliminary results of the National Institute of Statistics (INS), the GDP
at constant prices increased by 1.2% in the first quarter of 2012 compared to
the fourth quarter of 2011. The national economy thus registered a growth
of 4.8% for the first quarter of 2012 compared to the same period of the
previous year.
The recovery of economic growth in 2012 comes from a good agricultural

campaign and a reinforcement of activity in services (+5.3% against - 3.6% in
2011) and in manufacturing (+1.8 against -4.2%). Over this period, tourism
and foreign direct investments also progressed with a respective growth of
51.8% and 21.1% compared to 2011.
Even though in 1950 the industrial sector was almost non-existent,

preventing local production from developing, Tunisia created the necessary
infrastructures and also tried to develop the sector of new technologies,
58 Moroccan Office for Industrial and Commercial Property activity report, 2012.
among which the site of Sidi Thabet for biotechnologies and pharmaceutical
industry.
Tunisia has unquestionably an unusual history, standing out from all

African Arabo-Muslim countries. The abolition of polygamy, as soon as the
independence (1956), associated to a policy of family planning and to the
progresses of the healthcare system explains, mostly, the transition model
followed by Tunisia.
The infant mortality rate, averaging 200‰ in 1956, reached 17.8‰ in

2009. This decrease in infant mortality resulted in an increase in life expec-
tancy at birth that went from 37 years old at the end of the 1940’s to 52 years
old at the end of the 1960’s and to 74.5 years old in 2009 (72.5 for men
and 76.5 for women). The demographic transition was followed by a multi-
factorial epidemiological transition: a sanitary, social, economic and cultural
transition.
The epidemiological profile of Tunisia is characterized by:

• a sharp decrease, an even the elimination, of “traditional” communica-
ble diseases (malaria, bilharziasis, trachoma, tuberculosis, infectious diar-
rhoea…) and childhood diseases (poliomyelitis, tetanus, neonatal, diphthe-
ria…);
• apparition of chronic and degenerative non-communicable diseases, with
a multifactorial etiology and with a costly medical care;
• an increase in road accidents with significant consequences in terms of
mortality and morbidity.
The healthcare system is no longer adapted to this new context. Several

challenges must be taken up.
■ Healthcare provision
Personal healthcare provision is ensured by a predominant, dense and decen-
tralized public sector (95% of the population lives less than four kilometres
away from a basic health centre) and a private sector with increasingly decen-
tralized ambulatory premises and a growing number of hospitals.
There is a high concentration of hospitals in coastal regions (52% of

public hospitals and most of private ones). Most of this hospital capacity is
located in third-line structures. The same goes for heavy equipment and
healthcare personnel. The medical density varies for general practitioners,
from 96 for 10,000 inhabitants in Tunis to 36 for 10,000 inhabitants in the
Centre-West region. For specialists, it varies from 111 for 10,000 to 12 for
10,000 inhabitants for the same regions.
■ Mobilization of human resources

Tunisia developed important capacities of health-care workers training in
various categories. However, the evolution of the healthcare system requires
the integration of new professions, especially professions linked to manage-
ment, engineering and computers.
The development of medical technologies encouraged the public

author ities to adopt a “sanitary map of heavy equipment” as a regulation
tool for the installation of this equipment. However, the fast development of
private hospitals led to a multiplication of this heavy equipment, faster than
in the public sector, without any assessment of this equipment use.
■ General administration and governance

Tunisia implemented a powerful legal and regulatory arsenal to manage the
health sector, especially the public part. However, the regulation of private
sector healthcare provision remains low, favoured by the absence of interven-
tion levers, such as public funding.
■ Funding system
The health insurance system contains many schemes added up over the years
according to the needs of certain occupational categories. Most of the Tuni-
sian population benefits from a health insurance coverage (98%), according
to different systems : compulsory social security schemes59 (68%), free
medical assistance (28%) 8% of which benefit from free healthcare60 and
22% from reduced prices61. Beside the compulsory scheme, complementary
private insurances can be subscribed to through public and private compa-
nies in favour of their employees and public sector employee mutual funds.
Even though nearly all the Tunisian population benefits from social security
and from total or partial gratuity, the share of household direct spending
remains very high (40% of healthcare total spending) and remains inequi-
table in terms of healthcare access and impoverishment of certain categories
of population.
Tunisia is progressively moving towards a payment scheme linked to the

activity. A new sharing of healthcare financial costs is taking shape in order
to reduce the spending of the Sate and of households and replace them by an
increased contribution of compulsory healthcare coverage.
■ Medicines
Even though the pricing of medicines is under control62 at all the stages and
the homologation is homogeneous over the Tunisian territory (in particular
for retail distribution), the share of specific medicines (anti-cancer medicines)
in the spending is very high.
One must point out that since the adherence of Tunisia to the WTO
in 1995, the Tunisian pharmaceutical sector has known deep changes. It is
now in a quite dynamic transformation phase with the development of the
pharmaceutical industry in general and by the generic medicines industry in
particular. Initiatives and the implementation of an adapted legal and regu-
latory framework favoured, as soon as the 1990’s, the privatization of this
sector as well as its development.
59 Social security schemes are open to employees and employers who must become affiliated. The compulsory social security covers pensions,
family care, health risk and work accidents as well as occupational diseases. Until 2007, all services were provided by two agencies: the CNSS
covering private sector workers and the CNRPS covering civil servants as well as local authorities and public institutions staff. Since then, the
management of health coverage was assigned to one agency (the National Sickness Insurance Fund).
60 This category is defined according the poverty threshold and is constituted of families who benefit from a permanent help program. The decree
N°98-1812 fixes the conditions and attribution or cancellation modalities of the free healthcare card. People who benefit from free healthcare
cannot have access to private healthcare and sometimes have difficulty to obtain or renew their cards.
61 The attribution of reduced prices cards is granted to people with the minimum guaranteed interprofessional wage and according to the size of
the family. The beneficiaries must pay flat-rate contributions to healthcare costs at every contact.
62 It is done by the PCT that submits the different prices to the Ministry of Public Health for approbation.
■ Pharmaceutical sector actors

The organization of the Tunisian pharmaceutical sector presents unique
char acteristics, in particular regarding manufacturing and importation
control of medicines dedicated to both public and private sectors.
Public organizations of medicines importation. Importation is a State

monopoly controlled by the Central Pharmacy of Tunisia (PCT). This orga-
nization gives the PCT the power to negotiate very advantageous prices for it
acts as an unavoidable partner for foreign laboratories. Besides, the
centra lized management of medicines both at the national level and between
the different sectors (hospitals and private sector) gives it room for maneuver
in its management and, in theory, reduces its financial costs. The PCT
represents a model for the different countries of the African and Oriental
Mediterranean areas63.
Thanks to the importation monopoly of the PCT, the support to local

production and generic medicines, Tunisia controls the prices, availability
and quality of medicines as well as their accessibility. This centralization of
all importations is a particularity of the Tunisian system. By controlling the
prices of imported medicines64, it contains medicines supply costs in public
hospitals and improves the financial accessibility of medicines sold in private
pharmacies for most of the population.
Medicines supply through production. The second origin of supply is ensured

by the local fabrication of medicines. This sector has known a very important
evolution.
Supply. In Tunisia, wholesale distribution is partly ensured by the PCT

regarding medicines of chemical origin but also by the network of private
wholesalers-distributors. It exclusively supplies medicines for the public
sector.
Wholesalers-distributors are intermediaries between importers (PCT) or

local manufacturers and retail pharmacies. The official margin of wholesalers
is of 8%. They are present in almost all regions of Tunisia, even though their
turnover is very variable. A numerus clausus controls the installation of day
and night retail pharmacies.
About 60% of the total pharmaceutical consumption is sold by retail

pharmacies. The other 40% are consumed in hospitals. Retail pharmacies
must be the propriety of a pharmacist, who can only own one pharmacy. The
official margin of pharmacists decreases gradually according to the price of
the medicine and varies between 24 and 30%.
63 Areas defined according to the WHO.

64 This price stabilization comes from two mechanisms. First, through a direct payment by the centralized supply organization of the potential
increases of the purchase cost of imported medicines, and second, through joint purchase and the competition of suppliers in the context of
international bids for substitutable medicines supply. The latter increases the negotiation power and reduces management costs.
At the international level, Tunisia stands out by the implementation,

since 1976, of retail pharmacies open only at night with an effective and strict
separation of night and day pharmacies. One must point out that the amounts
of imported medicines are only determined by the prescription volumes and
over-the-counter consumption. They are in no case influenced by the struc-
tures that centralize importations. This dual public/private model combines
an efficient public control of the medicines chain with the flexibility of a
private distribution system. Besides, by offering a mutual right of scrutiny
between the public and private sectors, it prevents conflicts of interest that
could damage the supply system operation.
In November 2011, the sector of medicines for human use gathered 47

laboratories against 30 in 2006 and 27 in 2003. Over the 45 laboratories
registered in 2009, ten export their entire production. These laboratories
work in the following activities:
• fabrication of medicines prepared for therapeutic or prophylactic use (23
laboratories);
• fabrication of medicines for medical, chirurgical, dental or veterinary use
(9 laboratories);
• fabrication of other pharmaceutical products and single-use accessories,
such as syringes (13 laboratories).
In 2003, there were 50 wholesalers-distributors employing 1,000 people

against 49 private wholesalers in 2000. In 2006, the number of retail phar-
macies was of 1,650 with 46 pharmaceutical stores (distribution structures
under the responsibility of a retail pharmacy but without the actual presence
of a pharmacist)65.

In Tunisia, the pharmaceutical market is regulated by several administra-
tive departments. They are the following control and regulatory public orga-
niza tions:
• the Direction of Medicine and Pharmacy (DPM). It is a technico-administra-
tive unit of the Ministry of Public Health. It is in charge of the creation and
follow-up of the national pharmaceutical policy. It delivers all the necessary
authorizations for pharmacy and medicines, especially marketing authori-
zations and clearance authorizations for imported stocks. It manages the
installation of pharmacies according to a waiting list (numerus clausus).
It organizes the collaboration between the different organizations of the
Ministry of Public Health. It also plays the role of interface for all questions
regarding medicines between the relevant Ministry and other Ministries
(Trade as well as Finance and Industry);
• the National Pharmacovigilance Center (CNPV). It collects and operates, at
the national scale, the pharmacovigilance data and gives the alert when it
discovers sanitary problems. It also ensures activities of health monitoring
at the international level and carries out researches in the literature on the
undesirable effects of medicines;
• the Pharmaceutical Inspection Directorate (DIP). It manages all inspec-
tions regarding manufacturers, wholesalers-distributors, retail pharmacies
and all sanitary establishments with a pharmacy service or simply in pos-
session of medicines stocks;
65 National Council of the Tunisian Order of Pharmacists. www.ciopf.org/Fiches-des-pays/Tunisie

• the National Laboratory for the Control of Medicines (LNCM). This labo-
ratory controls the quality of medicines, of medical devices and cosmetic,
corporal hygiene and dietetic products available in Tunisia. It also takes
part in the assessment of MA request files;
• the National Agency of the Sanitary and Environmental Control of Products
(ANCSEP). This recently created agency coordinates the activities sanitary
and environmental control of products of the different public organiza-
tions;
• Customs. They are the entry door of medicines in Tunisia. They check the
legal character of all medicines and health products importations and only
allow goods clearance after getting a unique and specific authorization for
each delivery granted by the DMP (clearance ticket).
■ Regulatory frame applicable to the pharmaceutical market

In Tunisia, the regulation applied to pharmaceutical products is quite deve-
loped and concerns all the aspects linked to the product’s environment.
Medicines registration. The DMP manages the registration procedures for

medicines for human and veterinary use and delivers marketing authoriza-
tions for imported and locally produced medicines. It also deals with MA
follow-up (renewal, cancellation, handover and modification), in accordance
with the regulations in force.
The article 5 of the act n°85-91 regulating the fabrication and registration
of pharmaceuticals dedicated to human medicine and amended by the act
99-73 of 26 July 1999 specifies that no medicinal products can be debited
with or without charge, before prior marketing authorization delivered by the
Ministry of Public Health after agreement of the Technical Committee for
Proprietary Medicinal Products.
The technical committee that gives a consultative opinion on any

MA request submitted to the DPM is a commission, the composition and
ope ration of which are fixed by a decree, the first one dating back to 1987.
One must point out that medicines imported in the context of firm orders do
not need MA in Tunisia. They are an exception to article 5 of the act 85-91 of
22 November 1985 since it is a flexible mechanism adapted to the particular
needs of some patients. Such medicines imported for compassionate use
are generally innovative therapies for serious diseases or prescribed for the
treatment of rare diseases.
Medicines control. According to article 2 of the act 90-76 of 7 August 1990,

the National Laboratory for the Control of Medicines is in charge, among
other things, of controlling the quality of medicines. It intervenes in two ways:
• automatic assessment of the pharmaceutical part of the MA file in compli-
ance with a registration procedure managed by the DPM;
• control of medical samples supplied with the MA request or on units taken
from the importation of a lot or on distribution or supply premises.
Medicines quality can thus be controlled before and after marketing.
The LNCM also created a guide helping people in charge of assessing the
pharmaceutical part of the MA file to give a complete and precise assessment
report, making it easier to decide whether the MA request can be accepted

or modified.
Control and assessment of activities of actors implied in the pharmaceutical

chain66. The Directorate of pharmaceutical inspection is in charge of ensuring
the application of laws and texts organizing pharmaceutical profes sions
as well as pharmaceutical products for human and veterinary use. It
performs the various necessary inspection, assessment and survey operations
in order to guarantee the final quality of the prescribed medicine.
The regulatory framework of inspections mostly relies on the following

legal texts:
• Act 61-15 of 31 May 1961 regarding the inspection of pharmacies and other
pharmaceutical companies;
• Act 69-54 of 26 July 1969 on the regulation of poisonous substances;
• Act 73-55 of 3 August 1973 organizing pharmaceutical professions;
• Act 78-23 of 8 March 1978 organizing veterinary pharmacy;
• Act 83-24 of 7 March 1983 regarding quality control, marketing and infor-
mation on the use of breast milk substitute and similar products;
• Act 85-91 of 22 November 1985 regulating the fabrication and registration
of pharmaceuticals dedicating to human medicine;
• Act 91-63 of 29 July 1991 regarding sanitary organization.
Four types of inspections were defined depending on whether they are

carried out before or after the opening of the establishment.
From a global system of pharmaceutical quality insurance to the implementa-

tion of a visa prior to the marketing of each medicines lots. The Act 99-73 of
26 July 1999 amending the brand-name Act n°85-91 regulating the fabrica-
tion and registration of pharmaceuticals dedicated to human medicine intro-
duced a 16 bis article stipulating that, in order to be marketed, any medicine
must obtain for each lot a visa delivered on demand of the manufacturer or
importer, beside the (marketing) authorization.
The National Agency of the Sanitary and Environmental Control of

Products is in charge of the procedure and makes sure that the visas of the
different control organizations appear on the document, especially the signa-
ture of the DPM representative. It is a visa delivered after the analysis of docu-
ments issued by the manufacturer of the importer and the signatories may
consider it as a purely administrative issue. Without counterfactual analysis,
which is impossible to carry out on all lots routinely, the visa cannot really
guarantee the quality of the marketed lots. Besides, it may vainly postpone
the provision date of the imported or locally produced lots. It also puts into
question the very function of the pharmacist in charge of the production site.

In Tunisia, the public authorities have implemented incentives to this sector
in particular. They are:
• exemption for the purchase of imported raw materials and packaging
items;
66 They are health-care personnel and services (public and private), importation, fabrication and marketing units of medicines and products for
therapeutic use, cosmetics and corporal hygiene and all other assimilated products for human and veterinary medicines.
• reduced VAT, 6% instead of 16.82%;

• possibility to take part in public market bids for more than two MA;
• margin of preference at 10% granted to national companies in the case of
international bids.
■ Institutional framework linked to Euro-Mediterranean, North

African and bilateral economic and technical cooperation agree-
ments
Tunisia signed two major international agreements over the last decade: the
adherence agreement to the WTO in 1994 and the association agreement
with the European Union negotiated in 1995. These two agreements were
concluded on principles of strong liberalization of goods and services inter-
national trade and more generally in a context of States opening up their
economies. In the long term, they may have consequences on the availability
and accessibility of medicines in Tunisia.
The consequence of the agreement on TRIPS, added to the adherence

agreement to the WTO, are quite known to developing countries that must
adopt more constraining regulations in terms of patent recognition for medi-
cines67-68. Tunisia prepared for it. The existing legal framework that already
allowed the recognition of certain types of patents, is now in compliance with
the clauses of the agreement on TRIPS. The practical implementation of
these new measures from the end of the transition period (1st January 2005)
should not lead to substantial modifications of the operating mode of the
Tunisian pharmaceutical system and in particular of that of the PCT.

The studies carried out by the Ministry of Public Health allowed to eva-
luate the value of the pharmaceutical supply (importation price or sale price
of local manufacturers) rather than the consumption. In that sense, the phar-
maceutical consumption in Tunisia rose from about Dt 400 million in 2001
(US$ 278 million) to Dt 530 million in 2005 and to Dt 974 million in 2010
(TABLE 11); showing an average annual increase of 16.75% over the last period.
This consumption is characterized by the important use of medicines dedi-
cated to the treatment of infectious diseases, of diseases linked to the digestive
and nervous systems as well as of cardiac diseases. In 2010, these medicines
represented nearly 70% of the total pharmaceutical market (anti-infectious
medicines: 40%, digestive system: 15%, cardiovascular system: 15%). Medi-
cines linked to the central nervous system represented 10% of this market.
Besides, in 2010, the pharmaceutical spending in Tunisia reached Dt

1,293 million (US$ 895.43 million), that is 44% of the total health spending
(against 30.2% in 2001) and 2.2% of GDP. Only 30% of this spending was
allocated to the public sector. The pharmaceutical spending reached Dt 122.57
(US$ 84.88) per inhabitant in 2010, against Dt 70 in 2006 and Dt 30 in 1995.
67 World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights. Geneva, WHO, 1997.
68 Velásquez G, Boulet P. Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement. Geneva, WHO, 1999.
TABLE 11 Evolution of pharmaceutical consumption in Tunisia (million Dt)

1987 1990 1995 1999 2000 2001 2003 2005 2010
consumption
105.7 109.4 174 346 289 400 440 530 974
Medicines offer

According to the data of the National Institute of Statistics, the pharmaceutical
market in Tunisia represented Dt 896 million in 2010 against dt 620 million
in 2006 and Dt 321 million in 1999. One must point out that the peaks
took place in 2004 (15%) and 2008 (20%). 51% of this market is supplied by
importations. This proportion of importations significantly decreased since
it reached 61% in 2005. As for the national production, it registered peaks in
2006 and 2008 with respectively 24% and 29% increases (TABLE 12).
TABLE 12 Evolution of the pharmaceutical market size in Tunisia (million Dt)

Evolution (Basis: 1999)
National Share of National Share of importa-
Year ImportatIons Total National Importa-
production Total production tions
production tions
1999 144 177 321 100 100 100 45% 55%
2003 183 264 447 127 149 139 41% 59%
2004 209 307 516 145 173 161 41% 59%
2005 220 338 558 153 191 174 39% 61%
2006 272 348 620 189 197 193 44% 56%
2007 280 405 685 194 229 213 41% 59%
2008 360 459 819 250 259 255 44% 56%
2010 436 460 896 303 260 279 49% 51%
Source: National Institute of Statistics and Central Pharmacy of Tunisia
Since the mid-1990’s, the prices of importation medicines have been

increasing much more than the prices of locally produced ones, which
are mostly made of former substances that fell into the public domain. In
parallel, one can note a move towards the consumption of more recent impor-
tation medicines at higher prices. Therefore, the importation global volume
decreased between 1990 and 1999 by nearly 14%, highlighting the increase
of medicines local production, but this decrease in volume does not balance
the increase in the cost of imported medicines (increase of 74% of the impor-
tations value over the same period).
Besides, the increase in the cost of imported medicines in dinars is

very high. This evolution is not due to an increase in quantities since the
volumes imported over the period decreased but they can be explained by the
depreciation of the Tunisian currency compared to the main international
currencies, especially the dollar (the cost of importations in dollars remains

almost constant) and by the strong increase in medicines prices on the global
market, in particular for new treatments.
■ Main producers and importers

In 2009, the laboratories Adwa, Teriak, Saiph, Sanofi Aventis, Siphat,
Galpharma, Unimed, Medis, Winthrop pharma, Berg Life sciences produced
the twenty specialties taking up most of the pharmaceutical market turnover
in Tunisia. As for importation, the Tunisian pharmaceutical market is largely
dominated by foreign groups. The major importers of the pharmaceutical
sector in Tunisia are: Novartis, Aventis pharma, Novo Nordisk, Roche pharma
Schweiz, Norgine pharma, Serono pharma schweiz, BMS, Astra Zeneca.
■ National production
The major effect of the correlation system in Tunisia was that of an important
growth in local production capacities. Indeed, in 2010, the national production
covered 49% of the total consumption, against 45% in 1999, 14% in 1990
and 8% in 1987. This production is divided between brand-name medicines
(39%) and generic medicines (61%). The number of MA delivered for local
products is of 1,733 out of a total of 3,548 marketed MA.
Over the period 2004-2008, the investments realized in the pharma-

ceutical sector reached an annual average of Dt 27 million. They allowed the
creation of 790 jobs in 2008.
■ Importations
Medicines importations progressed of 9% per year in average over the last
decade. In 2008, 97% of imported pharmaceuticals were medicines prepared
for therapeutic use. The pharmaceuticals imported come from 34 countries.
France is the main supplier. In 2010, the share of medicines imported from
France represented 75% of importations69. It was followed by Switzerland
(13%), the United Kingdom (6%), Italy (4%), Denmark (3%) and Germany
(3%).
This distribution between supply countries is not the consequence of a

preference from the Tunisian sanitary authorities for there is no benefit for
products according to their origin in the granting of an MA or in the importa-
tion process. One must point out that the data here above concern the country
of origin and not the country of fabrication of medicines. These data can be
explained by the fact that pharmaceutical laboratories, for practical reasons
probably, tend to organize their importations towards francophone countries
from their branches located in France.
Sorted by therapeutic class, the data available goes back to 2003. Out
of the Dt 236 million of importations realized by the Central Pharmacy of
Tunisia (out of a total of Dt 264 million of all importations), 16% represent
anti-infectious pharmaceuticals, 14% concern cardiology, 13% the digestive
system and 10% the nervous system.
69 The share of pharmaceuticals imported from France significantly decreased since it reached 70% in 2001 and 76% in 1993.
■ Production for exportation

In Tunisia, the exportations of pharmaceutical products reached about Dt 40
million in 2010 against 30 million in 2008 and 19 in 2004. They correspond
to sales on bids rather than to regular exportations. Pharmaceutical expor-
tations were divided as follows: 70% were destined for the North African
market, 15% for Europe and 15% for African and Arab countries. In 2008,
93% of pharmaceutical industries’ exportations were medicines for thera-
peutic use.

The pharmaceutical industry presents an average rate of local integration
of about 40%. Indeed, in Tunisia, there are no production units of active
substances, which makes Tunisian laboratories dependent on the importa-
tions of this necessary input. Other raw materials of local origin are mainly
primary packaging items – except glass packaging that are all imported – and
cardboard printed packaging.
■ Types of marketed pharmaceuticals and products

The range of pharmaceutical and paramedicinal products marketed in Tunisia
is similar to that marketed in developed countries. In 2008, it contained 13,117
articles and was divided as shown in TABLE 13.
TABLE 13 Distribution of pharmaceutical and paramedicinal products

by product family
Product family Number of articles
Medicines for human use 3,146
Veterinary products 504
Dental products 640
Biological reagent 321
Ligatures and dressings 513
Chemical products 1,614
Homeopathy products 127
Accessories 1,015
Pharmaceutical products 5,237
Source: PCT
Sorted by therapeutic class, the distribution of the pharmaceutical market

shows that in 2003, nearly 20% was allocated to anti-infectious medicines,
14.5% to medicines for the digestive system, etc. As for the national fabrica-
tion of pharmaceuticals, it concerns a quite diversified range of products. It
includes pills, capsules, powders, vials, syrups, creams, suppositories, injec-
table medicines, penicillin and sing-use syringes.
Pharmaceuticals in dry form (pills, capsules, powders) represent 44%

of production, against 23% for pasty and semi-solid forms (suppositories,
ointments) and 33% for injectable and drinkable liquids.
■ Production of generic medicines

For several years, Tunisia has implemented a policy to encourage the use of
generic medicines via regulatory measures, sectorial encouragement to the
local fabrication of generic medicines and international bids for the supply of
medicines of interchangeable origin, including for retail pharmacies.
Therefore, Tunisia adopted measures at the beginning of the 1990’s in

order to favour local production:
• exemption of custom duties for raw materials and packaging items;
• reduction of custom duties for equipment, advantageous VAT rate, taxa-
tion of similar imported products;
• benefits granted to local producers in the framework of public markets
regulation;
• correlation system. On demand of a Tunisian manufacturer, the impor-
tation of a pharmaceutical similar to a locally produced one can be sus-
pended according to certain conditions (especially if the manufacturer
commits himself to maintain a minimal stock equivalent to the stock that
the PCT would have of the imported product);
• authorization of subcontracting, making possible the cooperation between
companies and the optimization of production capacities.
This policy of encouragement to the local production of pharmaceuti-

cals, and in particular of generic medicines, thanks to the correlation mecha-
nism, contributed to the fact that in 1997 about two thirds of locally produced
medicines were generic ones.
The market share in value of generic medicines even decreased quite

significantly, and especially in hospitals. In 2001, 37.6% in value of medi-
cines provided in hospitals were generic ones against 47.4 in 1997.
However, generic medicines have not, to this day, known the develop-
ment whished by public authorities. Here is why:
• absence of substitution right by the pharmacist, even though it is legally
recognized;
• mechanisms of price control that make the price difference between brand-
name and generic medicines quite low;
• the culture of prescriptions of brand-name medicines instead of INN;
• the salary of wholesalers-distributors and retail pharmacists is a percentage
of the sale price. It is therefore lower if the sale price is low.

Tunisia implemented legal and financial measures to promote research
and development. It now has 35 research centres, 147 laboratories and 610
units specialized in scientific research, of which 50% specialized in biotech-
nology. Orientation modifications linked to the regulation in terms of medi-
cines patents were implemented. The national legislation came into force on
1st January 2005.
One must point out that, since the adherence of Tunisia to the WTO,
the INNORPI started accepting inventions regarding medicines. From 1995
to the end of 2004, it received no less than 800 patent requests for phar-
maceuticals. These requests were accepted and their delivery procedure was
postponed until January 2005 in virtue of article 103 of the law on patents
and in accordance with article 65 (TRIPS) stipulating that “to the extent that a
developing country Member is obliged by this Agreement to extend product patent
protection to areas of technology not so protectable in its territory on the general date
of application of this Agreement for that Member, it may delay the application of
the provisions on product patents of Section 5 of Part II to such areas of technology
for an additional period of five years.”
For a better North African integration of the

pharmaceutical market and of a pharmaceutical
production industry
The previous section facilitated the understanding of the organization of
the pharmaceutical market in the three North African countries. This section
shows what are the main similarities, differences and complementarities
between these markets and the various assets and obstacles regarding the
possibility to create an integrated North African market.
Complementarities between pharmaceutical markets in

North Africa
The importance of the pharmaceutical market in the three countries,

regarding both local production and importation, encouraged local authori-
ties to give it a specific legislation as well as an important regulatory frame-
work. They all implemented procedures in terms of registration, distribution
and control of these highly sensitive products70.
■ The pharmaceutical sector is characterized by the intervention

of public and private actors with a predominance varying from
one country to another
Since their independence, the three North African countries built a real phar-
maceutical industry in order to produce their own medecines, alone or in
partnership with large multinational groups. They retained, for the pharma-
ceutical sector, the intervention of public and private actors with a predomi-
nance varying from one country to another.
Algeria works with both sectors but greatly favours the public sector. The
pharmaceutical market was, until 1990, exclusively under the control of the
State. Since then, the country targeted the development of its local pharma-
ceutical industry in order to reduce the important costs of importations and
thus become a production platform of generic medicines. The cancellation of
the state monopoly allowed the emergence of private operators that are now
developing quickly71.
Just after its independence, Morocco chose a pharmaceutical industry

in which private initiative was the main development tool. The modalities
of technological transfer in this sector were made possible through the asso-
ciation of the national private capital and the international capital (multina-
tional). Since 1957, the public authorities chose to develop a pharmaceutical
industry with a national production, distribution and marketing open to
the private sector, in the context of a regulated liberal economy under the
authority of the Ministry of Health.
70 Bouguedour R., « Conférence de l’OIE sur les médicaments vétérinaires en Afrique » [Conference of OIE on veterinary medicines in Africa], Dakar,
25-27 March 2008.
71 Ministry of Industry, Small and Medium-size Enterprise and Investment Promotion, op. cit.
Tunisia lies somewhere between these two countries. It made an effort to

regulate the pharmaceutical sector, which presents specificities requiring the
intervention of public and private actors. For many years, the pharmaceutical
policy has been relying on a strong public sector. Public supply structures
centralize importations of medicines destined for both public and private
sectors. The PCT plays an important role and represents the main operator
and regulator72-73.
The liberalization of the sector also allowed the development of a private

industry as well as the reinforcement of partnerships with multinational
companies that entrusted Tunisian laboratories with the production and
marketing of some of their products.
■ The sector is regulated by different public structures of regula-

tion and control with a defined expertise
In the three countries the pharmaceutical sector is regulated by several
administrative departments with a significant and determining influence on
the market. The Ministry in charge of Health remains the department in
charge of exercising the main regulation and control authority in accordance
with rules determined by regulatory texts and via varied structures (Direction
of Medicine and Pharmacy, Pharmacovigilance Center, Medicines control
Laboratory, Directorate of Pharmaceutical Inspection, etc.).
Other departments intervene according to the cases in each country. For

instance: the Ministry of Work and Social Security in Algeria, the Ministry of
Trade and New Technologies in Morocco and Custom Authorities in Morocco
and Tunisia.
Besides, the pharmaceutical market is highly regulated, be it in Algeria,

Morocco or Tunisia. This regulation concerns all the aspects linked to the
environment of pharmaceuticals and defines the conditions and modalities
ruling the sector. The implementing texts are quite varied (decree, order,
circular, resolution, etc.) thus illustrating the variability of their implemen-
tation level. The scope of application of these texts remains rather homoge-
neous and concerns all the pharmaceutical industry (importation, registra-
tion, use, etc.).
Indeed, the three North African countries have a registration procedure

for medicines requiring the intervention of a technical commission placed
under the authority of the Ministry of Health. The MA enquirer must supply
technical and administrative files. The nature of the required documents
varies from one country to another.
Besides, the MA enquirer must supply samples of the product as it is

a compulsory part of the regulatory procedure in the three countries. The
samples are analysed under all their aspects by national laboratories of phar-
maceutical products control74.
72 Chaoui F. & Legros M., “Les systèmes de santé en Algérie, Maroc et Tunisie : défis nationaux et enjeux partagés” [Health systems in Algeria,
Morocco and Tunisia: National challenges and joint issues], IPEMED Notes – Studies and analysis, April 2012.
73 WHO, 2003, op. cit.
74 Bouguedour R. 2008, op. cit.
There are also control procedures for imported medicines, at the border
posts of each of the three countries. They concern MA checks as well as the
physical control of products. This control can also consist in random sampling
to carry out analysis in laboratories75.
■ Morocco and Tunisia apply international standards and tech-

nical references
The Moroccan pharmaceutical industry is known to meet the international
standards. The industry is submitted to a very strict fabrication for compa-
nies must respect the Good Manufacturing Practices recommended by the
WHO and by European medicines agencie. They are also subject to the direct
control of the Ministry of Health via the Direction of Medicine and Pharmacy
(Pharmacy inspection and National laboratory for medicines control).
The quality control refers to international standards and technical refe-

rences, especially European and American pharmacopeias, WHO directives,
European (EMA, EDQM) and American (FDA) guidelines, guidelines of the
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use, the European and WHO
Good Manufacturing Practices guides and international standards76-77-78.
Tunisia also applies a regulatory and legal framework that allowed the
implementation of a national system of medicines quality control in compli-
ance with international standards, the coordination of which is ensured by
the Direction of Medicine and Pharmacy79.
As for Algeria, the standards applied are not in compliance with the
medicines international standards. The deficiencies lie at different levels,
mostly in the administration, management and general organization, with
insufficient computerization. The reference standards applied are mostly
ISO standards and not pharmaceutical standards (BPF/GMP), which are the
only valid standards for a recognition of medicines quality80. The regulatory
and legal framework remains incomplete for some categories of products
(biotechnology medicines, medical devices, OTC and paramedical products)
and obsolete for the upgrading to standards and good practices (BFP, BPD
and BPO) facing the important development of these standards worldwide81.
■ The local production of medicines is booming (local and

foreign investors)
The development of the pharmaceutical industry in the three countries grew
with an increasing number of production units (4 units in 1985 to 56 in 2011
in Algeria, 8 units in 1965 to 40 in 2013 in Morocco, 3 units in 1987 to 31 in
2006 in Tunisia).
75 Daré I. « Harmonisation de l’enregistrement et du contrôle des médicaments vétérinaires en Afrique » [Harmonization of registration and
control of veterinary medicines in Africa], OIE Conference, 2007.
76 Competition Council, 2011, op. cit.
77 Doctinews, 2012, op. cit.
78 Bouhdiba S., « Les systèmes de santé et le VIH au Maghreb » [Health systems and HIV in North Africa], 2008.
79 L’Industrie pharmaceutique en Tunisie 2010 [The pharmaceutical industry in Tunisia], www.cat2012.tn/media/Pharmaceutique.pdf
80 Euro-Développement PME Alger, « Analyse de la filière Industrie Pharmaceutique en Algérie » [Analysis of the Pharmaceutical Industry Sector in
Algeria], October 2007.
81 www.nabni.org/nos-propositions/sante/bilan-et-situation-en-2012/04/08/2013
The national production in Algeria is clearly increasing (it doubled in

five years) thanks to great investment efforts of about Dzd 100 billion realized
over the last ten years. However, it stays behind compared to the fast growing
market. It represents 35% (US$ 1 billion) of the current market even though
the industry has acquired recent equipment up to international standards, it
produces medicines that have fallen into the public domain for a long time,
therefore with a low added value.
However, the Algerian pharmaceutical industry draws the most interest

from multinational group, for its market is considered as the most important
in the region.
Morocco is the most advanced country in medicines production,

however, its industry is still reduced to manufacturing generic medicines
from imported active substances. The 40 industrial pharmaceutical sites
cover 65% of the population’s needs, the rest being imported. Even so, they
only work at 40% of their production capacity and their future remains uncer-
tain in a globalized economy.
Morocco is trying to export part of its production; which could boost

production in better conditions.
Over the period 1999-2008, investments evolved at a sustained pace,

which explains the confidence of operators in this industry’s future. Generally,
investments registered a rapid growth from Dhs 25 million in 1985 to Dhs
100 million in 1990. Since 1995, the annual average lies between Dhs 200
and 300 million.
Tunisia lies somewhere between the other two countries. Over the last
fifteen years, the local production of medicines registered a strong growth.
From 1987 to 2008, the consumption covered by local production went from
8% to nearly 50%82.
■ Centralization of medicines purchase for the public sector

(PCH in Algeria, DA in Morocco and PCT in Tunisia)
The centralization of medicines purchase allows acquiring a real negoti ation
power face to an increasingly important concentration of the global pharma-
ceutical offer. This centralization presents advantages in terms of profitability,
costs and order planning to avoid stockoutage or excess of stock83.
The three North African countries have a centralized system for medi-
cines purchase ensured by different institutions (Central Pharmacy, Ministry
of Health, etc.).
The Hospitals Central Pharmacy in Algeria, legally in charge of supplying

hospitals, supplies them on a regular basis at reasonable prices. As a public
82 Chaoui F. & Legros M., “Les systèmes de santé en Algérie, Maroc et Tunisie : défis nationaux et enjeux partagés” [Health systems in Algeria,
83 BenMansour Sonia; Le Financement des systèmes de santé dans les pays du Maghreb [Financing healthcare systems in North African countries];
Thesis 2012.
organization, it ensures the functions of a purchasing body for public hospi-

tals and takes part in prevention national programs84.
The Supply Division (DA) of the Ministry of Health in Morocco also

plays the role of a medicines purchasing body for hospitals and basic health
centres. In terms of selection, purchasing and distribution of medicines, the
DA implemented tools that should allow a better availability, lower costs and
a better quality of medicines on the public market. The efforts of the Division
mainly focus on the affordability of medicines in the public sector with the
offensive use of bid that, indeed, are not international.
The PCT is the main regulator of the pharmaceutical supply system in

Tunisia. This organization developed a good knowledge of the global phar-
maceutical market and of contract negotiation, which is a valuable skill for
the country’s pharmaceutical system. Until now, this monopoly ensured
cost control (acquisitions through bids), price uniformity and control, supply
regularity of the country and support to healthcare programs through the
mechanism of self-compensation, the principle of which is to increase the
price of non-indispensable medicines and to use these benefits to balance the
price of medicines used in healthcare programs85.
■ A strategic position to reinforce the place of generic medicines

The public authorities of these three countries, aware of the current weak-
ness of the generic medicines market and of their economic interest, fixed
ambitious objectives in their pharmaceutical policies in order to reduce the
colossal healthcare spending leading to deficits in the States’ coffers. The
consumption of generic medicines in Algeria registered a growth of 10 points
in just one year (2008/2009), rising from 28% to 38%86. Algeria needs to
optimize the use of its financial resources while stimulating the access of
citizens to medicines and basic healthcare. To do so, the State encourages the
production of generic medicines rather than their importation. It relies on
promotion campaigns for generic medicines and the implication of doctors,
on tax exemption in the promotion of generic medicines, the cancellation of
the importer status and the creation of a pharmaceutical operating status as
well as a better control of medical promotion.
In Morocco, generic medicines are booming and represented 30% of the

national market in value in 2012. Wishing to reduce healthcare costs as well
as to make access to medicines easier, the State committed itself in a reform
process placing generic medicines at the centre of its priorities. The Ministry
of Health aims at rising the share of generic medicines at 70% of the total
consumption in the country by 2015, most of the current consumption being
dedicated to the public sector. It is about to adopt important measures to
promote the sales of generic medicines (implementation of substitution right
with a revision of the margin system of pharmacists and the application of
progressive margins with a more interesting price scale for generic medicines
in favour of pharmacists87.
84 Hospitals Central Pharmacy; www.santemaghreb.com/algerie/comptes_rendus/jnp.../jour2_1_delih.pdf

85 Pr. N. Achour ; Le système de santé Tunisien : état des lieux et défis [The Tunisian healthcare system: overview and challenges]; 2011.
86 Islamic Centre for Development of Trade; Pharmaceutical industry in the member States of OIC; 2012
87 Observatoire de l’entreprenariat – étude sectorielle pharmaceutique [Observatory of entrepreneuship – Pharmaceutical sectorial study], 2011.
For Tunisia, in 2009, generic medicines represented about 47% of the

value of the pharmaceutical products sold over the country, or nearly Dt 141
million (€ 73 million).
Obstacles and assets linked to the integration through the

market and through production
For years, everyone has agreed that a better integration of the economies
of North African countries is necessary to boost the economic deve lopment
of the area and reduce unemployment. In 2006, the IMF estimated the
volume of economic and commercial North African exchanges at 3% of
all their exchanges with foreign countries. The lost profit coming from the
North African non-integration was estimated at two points of growth for the
region’s countries.
Since then, inter-North African trade increased. In 2008, the exchanges

of Tunisia and Libya progressed of 40%, those with Algeria of 85%, with
Morocco of 24% and with Mauritania of 52%. However, all of these exchanges
only account for 7% of trade in the five UMA countries. During the sympo-
sium organized in February 2009, for the celebration of the 20th anniversary
of the creation of the UMA, the participants highlighted the “huge unexploited
potential of the UMA, which must be exploited in the framework of a complemen-
tary economic union”.
The aim of this partnership is to create a North African space to

contribute to the creation of a real pharmaceutical market in the region. A
better collaboration, through a unified pharmaceutical industry and registra-
tion procedures, could lead to a strong North African economic space in a
betteposition to negotiate with suppliers88.
Integration through the pharmaceutical market
■ Joint purchase of pharmaceuticals

The joint purchase of pharmaceuticals is an experience that dates back to the
1980’s. It is the result of cooperation efforts in the healthcare sector between
the UMA member States (Algeria, Libya, Mauritania, Morocco and Tunisia).
At this time, the pharmaceutical regulation in the UMA member States
was different, the range of products varied from one country to another, the
local production was low and only satisfied a small part of their needs and
purchase prices for the same products varied of more than 30% over the
region. The governments, confronted to the challenge of maintaining and
increasing the quality of life of a growing population, joined their efforts, at
the end of the 1980’s, in an initiative of regional cooperation aiming at medi-
cines joint purchase.
88 « Faire du Maghreb une place forte de la pharmacie mondiale » [Making of North Africa a bastion of the wolrd’s pharmacy], www.livretsante.
com/pharm-info/articles.php?arti=170 01/09/2013
In 1981, Algeria and Tunisia created a “Dual committee for joint

purchases”. This experience, which lasted eight years, allowed buying regu-
larly, and increasingly, medicines, raw materials as well as chemical products.
Following this experience, and after two preliminary meetings in Casablanca
(28-30 June 1988) and in Tripoli (28 November and 1st December 1988),
the Ministers of Health of North African countries decided to broaden
this Mixt committee to include the five North African countries, under the
name of North African Committee for joint purchase. The first meeting of
the Committee was held in Algiers from 3 to 5 April 1988. Two years later
(Algiers, 5 May 1990), the North African Ministries of Health gave it a legal
character by signing the Convention regarding its creation89.
The process of joint purchase by the Committee was meticulously

prepared and the tasks and responsibilities well defined and documented.
Indeed, the Committee created its own procedure of joint purchase

management that starts, each year, by a declaration of bids in one of the North
African countries. This country must establish the procedure regarding the
realization of this bid over three sessions:
• first session: the Committee assesses the results of the previous year’s bid
and revises the conditions as well as the list of medicines that will be con-
cerned by the new bid. It establishes a calendar for the bid process with
the publication date, the deadline for the acceptation of offers and the date
of the next meeting;
• second session: it is dedicated to the opening of envelopes, a first evaluation
of offers and demand of counter-proposals to suppliers previously selected;
• third session: it consists in studying the counter-proposals and to make the
ultimate decision regarding the bids’ attributions.
TABLE 14 presents the realizations of the North African Committee for

Joint Purchase over a period of ten years through the different bids launched
and the evolution of the number of products demanded.
89 North African countries are represented at this committee by: ENAPHARMA, ENCOPHARM, ENOPHARM and PCH (Algeria), PCM (Morocco),
DMEAICO and MSO (Libya), PCT and SIPHAT (Tunisia) and Direction of Medicine and Pharmacy of the Ministry of Health (Mauritania).
Evolution of the number of pharmaceutical products

TABLE 14
bought in the framework of bids launched by the North African
Committee for joint purchase
Minor
Pharma. Raw Packaging
Year Date Place products materials materials medical
equipment
02-05 April
1989 01-03 July Algeria 113 37 — —
17-21 September
29-31 January
1990 07-11 May Tunisia 128 38 — —
16-18 July
07-09 May
1991 23-27 July Morocco 144 42 —
04-05 November
20-22 January
1992 01-04 May Libya 144 42 07 —
28-30 July
02-05 February
1993 18-23 May Mauritania 144 42 09 —
20-23 July
1994 — — — — — —
1995 — — — — — —
24-26 February
1996 30 May – 04 June Algeria 128 39 13 —
05-09 September
26-28 February
1997 14-18 May Tunisia 168 46 09 75
09-11 July
23-25 February
1998 16-20 May Libya 171 46 09 75
14-16 July
12-16 March
1999 02-08 June Mauritania 171 41 07 75
04-08 August
Total 1,311 373 38 225
For two years Morocco did not take part in the joint purchase system. It
had left the Committee three years earlier. Besides, Algeria did not take part
in the last purchase cycle. However, in spite of these withdrawals, the joint
purchase system survived and maintained its operations. The Committee is
still implied in the common purchase system for the three other UMA coun-
tries.
The North African Committee for the joint purchase of medicines was a
flexible, productive and cheap mechanism, without administrative issues. It
allowed the member States to gain new assets. They are mainly:
• better profits in terms of prices90, delivery time and payment modalities;

• reinforcement of the cooperation between national laboratories in Algeria,
Morocco and Tunisia, especially regarding the quality control of the sam-
ples concerned by bids;
• development and broadening of the list of medicines and pharmaceutical
products that can benefit from joint purchase;
• knowledge of the North African pharmaceutical market, essential to the
development of local production;
• encouragement of purchases with North African suppliers through the
selection, among them, of the best candidates;
• encouragement of commercial complementarity and exchanges in the five
North African countries in terms of medicines;
• evaluation of the possibility to standardize medicines registration methods;
• the Committee and its meetings represented some kind of observatory
for information sharing regarding suppliers and pharmaceuticals, which
allowed to choose the best suppliers and medicines and to include the best
technical and scientific demands in the specifications;
• the Committee represents an adequate organization to fight against coun-
terfeit medicines or non-compliant with international standards. Inter-
national reports show that 25% of medicines in developing countries are
either counterfeit medicines or non-compliant with international stan-
dards. This percentage reaches 60% in some poor countries;
• the Committee had started to create a file for each supplier and each medi-
cine in order to provide some follow-up and observe their evolutions.
However, the North African Committee had difficulties regarding the

realization of joint purchase. They are mostly:
• different custom procedures that had, in some cases, a negative impact on
the medicines supply process in the imparted time;
• different legal texts relating to medicines registration, creating difficulties
in the introduction of some medicines in the fixed list;
• lack of precision in the identification of purchased products that can, some-
times, prevent countries from fulfilling their obligations towards suppliers
and undermine the committee’s credibility;
• withdrawal of some members for certain offers. The amounts of medicines
usually necessary were therefore revised downwards, thus impacting the
prices;
• difference between the lists of essential medicines of the different member
States, which prevented the creation of a unified medicines list.
Even though the joint purchase process presented potential positive

effects of medicines accessibility for a wider public, the UMA suppliers were
not always well prepared for this type of regional competition inherent to a
joint purchase system. The production capacities did not suffice and suppliers
had to make concessions in order to offer affordable price.
As for Moroccan producers of generic medicines, they consider that the

joint purchase system is an opportunity rather than a threat. They discovered
an exportation market way bigger than their local sales.
90 The assessment of prices before and after joint purchase, carried out by the Moroccan Ministry of Health, highlighted a price difference (and
therefore savings) going from 1 to 5 thanks to the introduction of generic medicines and competition between suppliers.
In May 2008, the North African Ministers of Health gathered in Tunis

for the 10th Ministerial Council. During this session, the council issued a
certain number of recommendations aiming, among others, at reinforcing
and developing cooperation relations as well as partnerships between North
African countries, through:
• the activation of the medicines and vaccines common purchase medicines;
• the creation of a convention regarding medicines control, including raw
materials;
• the creation of a data bank specific to medicines;
• the organization of a forum for the actors of the pharmaceutical sector;
• the preparation of fixed lists for essential medicines;
• the cooperation in the field of pharmaceutical inspection and protection of
the right of intellectual property in the pharmaceutical sector.
Following these recommendations, a technical commission for medi-

cines purchases was created. It aims at implementing a common mecha-
nism of medicines, vaccines and serums purchase, creating a common list
of basic medicines and a unified list of medicines joint purchases. It also
wishes to facilitate the cooperation between national laboratories carrying
out medicines quality control in order to fight efficiently against illicit trade
of medicines.
Besides, the North African ministerial Committee adopted an exclusive

program regarding, among other things, the joint purchase of medicines,
vaccines, serums and medical items. This program was difficult to implement
because of the absence of a permanent coordination and follow-up mecha-
nism, in spite of the various meetings and encounters. Indeed, regarding
the joint purchase of medicines and medical items, a meeting was held in
December of the same year in order to boost the joint purchase Committee
and broaden its mandate to include joint purchase of vaccines and serums.
The first international bid must have been launched before the end of 2010.
The Technical Committee of medicines joint purchase also addressed,

at the meeting held in Tunisia on 26 and 27 May 2009, the preparation of
medicines, vaccines and serums lists concerned by this bid. It also organized
the calendar of meetings regarding the bid announcement (24-25 February
2010), the opening of envelopes, the study of propositions (May 2010) and
the final attribution of the bid (31 July 2010).
The meeting that was supposed to result in the bid announcement was
cancelled because the representatives of some countries were absent and the
medicines lists of the present countries were not available. Besides, and in
spite of the reminders of the North African ministerial Council, it has not, to
this day, received the lists of medicines, serums and vaccines.
Having noted the difficulties that prevented the announcement of the

first bid in 2010, the North African Council of Ministers of Health, during the
11th session, held in Rabat from 14 to 16 January 201391, asked the medicines
Committee to dedicate its next meeting to the question of the joint purchase
91 In the framework of the follow-up of the implementation of the recommendations of the Council of Ministers for Foreign Affairs of the Arab
Maghreb Union (Rabat, 18 February 2012).
of medicines and vaccines. It concerned the evaluation of past experiences,

the reflection and discussion of the necessary means to overcome the diffi-
culties and obstacles that still prevent the realization of this bid and to make
practical and precise propositions in this respect that would be submitted
during the next Council.
■ Medicines registration
The basis of any system of flow control, and more particularly of the importa-
tion, of pharmaceutical products is their registration. It must allow to check
the existence of a guarantee of fabrication quality, of the therapeutic rele-
vance, of the security and harmlessness of the product, as well as the quality
of joint information92.
As already mentioned, the medicines registration process is well codi-

fied in the existing regulatory texts be it in Morocco, Algeria and Tunisia
and the MA is the final process at the end of which the authority agrees on
the marketing of the medicines object of the request. Indeed, all the coun-
tries in this study demand the registration (or homologation) of all the pro-
ducts marketed on their territories. These local MAs are delivered for a 5-year
period. They can be refused, withdrawn, suspended, and renewed or not.
The marketing authorization request is studied by a commission under the
authority of a Pharmacy Directorate. The authorization is delivered by the
Ministry of Health and registered by a service of the Pharmacy Directorate.
Besides, during the 10th session held in Tunisia in 2008 and the 11th
session held in Rabat in 2013, the North African Council of Ministers of
Health issued a certain number of recommendations aiming at the coope-
ration regarding medicines registration, their organizations and their regu-
lation via the unification of the control systems of medicines quality of UMA
countries and the standardization of scientific and technical files adopted in
that field. In this respect, a workshop should be organized in Algeria for the
redaction of a North African project of coordination of medicines registration
systems. However, the current context in the region did not allow, until now
and in spite of the many encounters on the question, to implement the legal
and regulatory instruments as well as the institutional and organizational
framework to improve the situation.
Therefore, Algeria, Morocco and Tunisia must make an effort to control

the regulatory, economic and moral constraints in order to evolve towards
a better organization of their healthcare authorities and towards a better
control of the pharmaceutical market93. The necessary condition to obtain a
controlled, available and accessible pharmaceutical specialty for consumers is
the attribution of an MA by the concerned healthcare authorities.
A coordinated North African approach and a network of quality control

laboratories is the best way to reach an efficient common system of MA for
medicines within and between the countries. In this respect, the approach
adopted by the European Union is considered as exemplary and can be a
model in terms of standardization of the regulations leading to the marketing
authorization of a medicine in North African countries.
92 C. BRUNETON ; J.P. NABOULET ; B. VAN DER HEIDE ; 1996 ; The drug trade between European countries and developing countries: efficiency of
regulation systems, issues and perspectives.
93 Sabrina Boismenu; Politique de santé et enregistrement d’une spécialité pharmaceutique au Maghreb [Healthcare policy and registration of
pharmaceuticals in North Africa]; 2006.
The European standardization of the regulations of medicines marketing

was ensured by the creation, in 1993, of common registration procedures and
also of the European Agency for the Evaluation of Medicinal Products. Indeed,
while the medicines registration system had remained purely national for
a long time, a European regulatory environment was implemented at the
end of the 1980’s for medicines derived from biotechnologies. This device,
including a peculiar registration procedure for this type of medicines, was
also open to other medicines of public interest. Therefore, most medicines
used against the HIV infection were assessed via this procedure. A collabora-
tive assessment had to take place as soon as the medicines were to be autho-
rized in more than one State of the European Community. This collaborative
procedure allowed the registration of over 80 pharmaceuticals, most of which
are biotechnological products. It also allowed the national regulatory authori-
ties to assess these new types of products simultaneously, with identical files
and in the requested time.
Even though MA decisions remained under the authority of each State

– and were granted without any standardization obligation and at a variable
pace from one State to another – this procedure imposed a sharing of views
at the scientific level, in the framework of a Committee for Proprietary
Medicinal Products (CSP) and through the sharing of scientific reports. This
committee and its working group on the pharmaceutical quality of medicines
derived from biotechnologies represented a forum of scientific and regula-
tory discussions for this type of products. This space of mutual collaboration
between the regulatory authorities of member States was undoubtedly one of
the most productive and contributed to the creation of a European regulatory
expertise over this period. It highly favoured the registration and marketing
of medicines derived from biotechnologies during the first half of the 1990’s.
The success of this procedure was a determining element in the preparation
of the following step, which was the implementation of the centralized proce-
dure and the creation of the European Agency for the Evaluation of Medicinal
Products94.
Currently, to register a medicine in more than one Member State of the

European Union, the enquirer can choose:
• the centralized procedure. The medicine cannot be already registered in
one of the Union’s countries. This procedure is compulsory for medicines
derived from biotechnologies, innovating medicines for veterinary use,
medicines for human use containing a new active substance dedicated to
the treatment of HIV, viral diseases, cancers, neuro-degenerative diseases,
diabetes, autoimmune diseases and other immune dysfunctions as well as
orphan medicinal products;
• the DeCentralized procedure (DCP). The principle of this procedure is the
recognition of the assessment of a Member State (“Reference Member
State” or RMS) by other Member States where the medicine is to be mar-
keted (“Concerned Member States” or CMS);
• the Mutual Recognition Procedure (MRP). The principle of the procedure
is the same as that of the decentralized procedure but for the latter, no MA
needs to have been granted previously in the EU and the file is submitted
simultaneously in all the Member States (RMS + CMS), with the national
94 Patrick Le Courtois, European Agency for the Evaluation of Medicinal Products; Rendre possible un accès plus précoce au médicament [Making
medicines more accessible]; February 2005.
assessment by the RMS and the preparation of the ER in 120 days. The
European phase is the same as for an MRP (comments of the CMS on ER,
etc.).
For the registration of a medicine in only one Member state of the EU,
the enquirer can choose the national procedure95.
Another example to mention in terms of standardization of medicines

registration procedures at a regional scale is that of the Member States of the
West African Economic and Monetary Union (WAEMU) that could serve
as a model to implement a standardization system to regulate registrations
and quality control. The Regional Economic Communities (RECs) offer the
best institutional framework to promote these reforms. The reform started
by WAEMU relies on three complementary devices led by regulatory texts:
• a centralized MA device organized around a Committee for Veteri-
nary Medicinal Products (CVMP) in charge of MA requests;
• a unique device of quality control via a network of reliable laboratories from
the WAEMU Member States;
• a regulatory device, presented by the WAEMU Veterinary Committee, a
consultation body, in charge of coordinating regulatory actions.
In the light of these two examples, two approaches for the standardiza-
tion of MA procedures can be contemplated in North African countries:
• a centralized procedure leading to the granting of a regional MA reco-
gnized by all stakeholder countries. This procedure could be managed by a
Pharmaceutical Agency or by a Regional Committee (a lighter and cheaper
structure, but with less missions than the agency).
• a decentralized procedure, based on the mutual recognition of national
MAs delivered by the competent bodies of the concerned countries.
The procedure choice must come from a thorough analysis of the situ-
ation in order to assess the feasibility of each system, taking into account
the specific characteristics (institutional and political framework, financial
resources, etc.) of the groups of countries willing to commit themselves96.
There is no need to insist on the importance of standardizing the regis-

tration systems to promote rapid access to essential and good quality medi-
cines. This can result in a better efficiency and financial management of the
pharmaceutical regulation national Agencies. One must also point out that
the rapid authorization of the sale of good quality generic medicines rein-
forces competition and can thus lead to a reduction of prices. This reduction
will benefit governments, international donors as well as populations. Phar-
maceutical manufacturers will also benefit from the common documentation
and from a more transparent and standardized authorization procedure.
Besides, the main objective of the standardization of pharmaceu-

tical regulations in terms of medicines registration and control is to put in
common the resources as well as management and assessment expertise of
95 Les entreprises du médicament (Leem); La réglementation du médicament [Medicines regulations]; 2012.

96 I. Daré ; Harmonisation de l’enregistrement et du contrôle des médicaments vétérinaires en Afrique, l’exemple de l’union économique et
monétaire ouest-africaine (UEMOA) [Standardization of the registration and control of veterinary medicines in Africa, the exemple of the West
African Economic and Monetary Union (WAEMU)]; OIE Conf. 2007, 133-147.
a group of countries in order to ensure a controlled flow of these products as

well as their rational use, not presenting any risks for health or the environ-
ment.
The advantages of a common MA procedure would be significant:

• promoting better access to medicines for populations;
• supporting the emergence of a high-level scientific and technical commu-
nity (“regulatory scientific community”) via the sharing of knowledge and
expertise in terms of medicines assessment and regulation between the
concerned countries;
• giving more importance to the concerned countries in their international
negotiations;
• developing the local pharmaceutical industry by making access to phar-
maceutical markets easier at the North African scale (to benefit from eco-
nomies of scale);
• reducing delivery times and the procedure costs.
A better convergence of marketing authorization procedures, the imple-

mentation of a scientific committee common to all concerned countries for
the scientific assessment of MA requests, support policies towards comple-
mentary national productions etc. could be tangible actions converging
towards a better integration of the pharmaceutical market in North Africa.
Integration through production
When talking about a North African common market of medicines and

medical items, alliances in the industrial, commercial and legal sectors, as
well as in the training and research sectors are included.
During the 10th session held in Tunisia in 2008 and the 11th session held
in Rabat in 2013, the North African Council of Ministers of Health had issued
a certain number of recommendations aiming at supporting the partnership
between the countries of the Union in terms of integration of medicines
production. In this regard, the Council invited investors and actors of the
pharmaceutical industry of the countries of the Union to meet in order to
examine the ways of creating a North African association for the pharmaceu-
tical industry.
The cooperation between the three countries must be reinforced in order

to face the consequences of the development of new non-communicable
diseases that must increase the medicines bill. Besides, a better collaboration
in the pharmaceutical industry will also improve the medicines supply in the
region as well as its accessibility to the population.
By its internal specificities and its respect of international norms, the

pharmaceutical sector can tackle many issues in terms of North African
cooperation.
Morocco is the most advanced country in medicines production. The

local production of pharmaceuticals covers the needs up to 65%. But its
industry is still reduced to the fabrication of generic medicines from imported
active substances. As for Algeria, its pharmaceutical industry remains back-

wards since it only covers its needs up to 40%. Tunisia made a lot of progress
in the regulation of the pharmaceutical sector, which presents specificities
implying the intervention of public and private actors. It is currently able to
cover 50% of the needs of the local market.
This sector represents both an investment challenge and opportunity.

The challenge to meet the increasing needs of populations and the opportu-
nity offered to investors by the North African and even African market. It is
indeed positive that the North African cooperation leads to coordinate medi-
cines purchase to multinational groups to obtain a better price and manage to
get the North African preference for granting markets. However, it must also
reach a structural coordination between North African medicines manufac-
turers in order to present themselves as a unified body for the international
bids on African and global markets.
A good regional integration policy as well as well negotiated economic

partnership agreements can support the development of a local pharmaceu-
tical industry, capable of generating important resources, contributing to the
improvement of the healthcare systems and quality of life in these countries.
Partnership opportunities must be imagined in the production of medi-

cines, but also serums and vaccines, especially in promising fields such as
medicines derived from biotechnologies.
Several reasons encourage the development of the pharmaceutical

industry in North African countries:
• a very attractive pharmaceutical market, by its size, growth and added value;
• a rather developed pharmaceutical industry;
• a satisfactory production in compliance with international standards;
• competitive advantages in terms of workers’ productivity and access to con-
sumption markets;
• existence of a large North African market of the OIC’s member States.
The efforts made by Tunisia allowed its pharmaceutical industry to

progress and cover, by 2016, more than 60% of its pharmaceuticals needs.
Tunisia has now started to produce vaccines, but also anti-cancer treatments.
Besides, the implementation of the Sidi Thabet science and technology park
will allow the production of specialties requiring a perfect mastering of
biotechnology.
Moreover, the size of the North African market and its economic weight
can encourage a technology transfer in favour of a network of medicines
production and distribution companies along with the implementation of a
rigorous surveillance system at the national level.
This industry must progressively replace medicines importations and be

sufficiently pro-active to avoid stockoutage.
Yet, the level of performance of the pharmaceutical industry in North

Africa is only capable, for now, to ensure the fabrication of generic medicines
from imported raw materials. Most of the raw materials necessary to the
fabrication of medicines come from Europe, which prevents North African

countries to cooperate in the fabrication and distribution of vaccines in the
region.
These countries are currently confronted with several weaknesses in this

sector97:
• low production of generic medicines, mainly due to a pharmaceutical lobby
and lack of information and awareness of the population but also linked to
some aspects related to the legislation and regulation of medicines prices;
• market fragmentation. The multiplicity of fabrication units, the size of
which cannot face the competition and globalization, the price policy;
• the private pharmaceutical industry that remains mostly dependent upon
foreign countries for raw material supplies that laboratories charge at
prices often superior to the price of the international market;
• the issue also lies at the level of the protection of intellectual property and
of the discriminating character of research and development in favour of
rich countries;
• patents and licenses are the real cornerstones of the prosperity of phar-
maceutical industry giants but they represent the main obstacle for the
emergence of a production in developing countries in general and in North
African countries in particular.
The North African pharmaceutical sector also remains mostly domi-

nated by branches of multinational companies.
Besides, in terms of medicines production, a series of questions

regarding industrial problems, linked to public health issues, can be asked to
the three North African countries98:
• How are they going to get organized to produce their own raw materials in
order to reduce the price of essential medicines?
• How are they going to negotiate their supply in medicines derived from
biotechnologies that are quite costly and that they cannot produce, even
when they fall into public domain?
• How are they going to negotiate with the international pharmaceutical
industry to allow patients to benefit, at a lesser cost, from therapeutic pro-
gress?
• Is there a possibility of cooperation between the three North African coun-
tries and North African countries and Europe?
The other obstacle is that is it impossible to know the state of health

of the population of the three countries and the medicines needs. It is also
impossible to know the updated list of marketed, produced, imported and
exported medicines. The data published on the website www.santemaghreb.
com refer to the list of medicines available in the three countries (see detailed
product list in appendix 1) without mentioning any reference date. The list
still needs to be updated since some laboratories no longer exist today.
TABLE 15 summarizes the data to be updated. It shows that more than one
thousand medicines were available in the three North African countries; a
little more in Tunisia than in Morocco and Algeria.
97 Chaoui F. & Legros M “Les systèmes de santé en Algérie, Maroc et Tunisie : défis nationaux et enjeux partagés” [Health systems in Algeria,
98 idem.
TABLE 15 Number
of medicines available in Algeria, Morocco and Tunisia according to
pharmaceutical laboratories
Laboratory Algeria Morocco Tunisia Laboratory Algeria Morocco Tunisia
Aérocid 2 Leurquin-Médiolanum 1 1
Aguettant 1 Lipha Santé 11 13 12
Alcon 1 Marion Merrel SA 1
Alpharma France 1 Martin Johnson & Johnson 1 13 7
Msd
AstraZeneca 24 35 29
Mayoly-Splinder 1
Aventis 8 4 9
Medeva Pharma 1 2 2
Bailly-Speab 3
Menarini France 3 1 1
Bayer Pharma 2
Merck Génériques 1 1
Biocodex 1 7 7
Monot 2 5 3
Biorga 1
Monsanto France S.A. 2 3 2
Bristol-Myers Squibb 3 6 4
Novartis Pharma SA 22 22 28
Chefaro-Ardeval 1 1 1
Parke Davis 18 13 23
Chiesi SA 2 2 4
Pasteur Vaccins 3 2
Ciba Vision Ophtalmics 3 2
Pfizer 4 2 7
Clément 1 1 1
Pharmacia & UpJohn SA 1 2 2
CS 1 2 1
Pharmafarm 1
Darci Pharma 2 7 2
Pharmygiène-Scat 2 1
Debat 6 5 8
Pierre Fabre 7 11 9
Debat 1 1
Procter & Gamble
Diepharmex 1 1 2 6 8 7
Pharmaceuticals Fce
Dome – Hollister – Stier S.A. 1 1 1 Renaudin 1 1 1
Doms-Recordati 2 5 1 Richelet 1 1
Dupont Pharma SA 1 1 Robapharm 1
EG Labo 2 1 Roussel Diamant 1 2
Elaiapharm 1 1 1 S.E.R.P 2 1
Entéris 2 2 Sanofi-Synthélabo France 27 20 27
Etris 1 Schering S.A. 26 34 26
Europhta 1 1 Schwarz Pharma 1 2 2
Expanpharm International 1 SERB 1 1
Ferlux SA 1 Sinbio 1 1
Fournier SA 1 3 3 Solvay Pharma 14 9 16
FUCA 1 2 Téofarma 3 3 4
Genopharm 1 2 2 Thérabel Lucien Pharma 1 1
Gerda 1 1 1 Théraplix (Aventis) 2 1 3
Glaxo SmithKline 4 3 4 Thératech 2 3
Grimberg 4 UCB Pharma SA 3 8 4
Guerbet 10 10 4 UPSA 11 11 18
Inava 4 4 1 Vedim Pharma 1 1 1
IREX 1 Warner-Lambert 10 9 8
Janssen-Cilag 14 21 20 Whitehall 1 1
Kérapharm 1 1 Wyeth-Lederlé 3 6 4
Lafon 1 4 Total 289 356 364
Laphal 6 5
Source: www.santemaghreb.com
Recommendations and solutions allowing a better integration of the

North African pharmaceutical market
Taking into account the complementarities between the Algerian,

Moroccan and Tunisian pharmaceutical markets, as well as the obstacles
and assets linked to the integration of these three markets, this report offers
recommendations and solutions allowing this integration in order to boost
the pharmaceutical sector in the region. Some of the recommendations
here under have already been issued by official institutions in meetings,
conferences and/or different experts in this field. They are still valid and are
supported by the authors of this report.
■ General recommendations
• Boosting cooperation between all public healthcare actors so patients
remain at the centre of their preoccupations, while keeping in mind that
pharmaceutical issues cannot be separated from public health and sus-
tainable economic development issues (National Council of the Pharma-
cists’ Order of Tunisia – CNOPT);
• Working for the implementation of a North African strategy in the phar-
maceutical sector in the production, mutual recognition of marketing
authorizations and resumption of medicines joint purchase (CNOPT);
• Creating, at a regional level, supranational professional organizations to
ensure the regulation standardization of the joint purchase procedure of
medicines, vaccines and serums, to ensure the good quality of local pro-
ductions, to create a development plan for basic infrastructures for medi-
cines industrialization;
• Ensuring a regional cooperation for medicines purchase and a better deve-
lopment of the pharmaceutical industry via the implementation of a per-
manent secretariat with personnel hired in this view (North African college
of pharmacists – CIP);
• Creating a North African committee to reflect upon the future of the phar-
maceutical sector, given the demographic evolution of populations and
health-care human resources and given the information and communica-
tion technologies revolution going on in this sector (CNOPT);
• Reinforcing the link between the different Pharmacy universities in North
African countries, orders of pharmacists, learned societies and all the pro-
fessionals of the pharmaceutical sector – (CNOPT);
• Guaranteeing initial and ongoing training meeting the current and future
needs of the sector – (CNOPT);
• Taking on the market through performance and managing to balance the
debate between liberalization and protectionism (Coulibaly A99);
• Boosting the North African bureau of pharmaceutical information that
would act as a link between the concerned North African institutions. Its
objective would be to carry out market studies and exchange information
on companies manufacturing medicines in order to standardize the sys-
tems of medicines quality control in compliance with the international
standards and achieve the mutual recognition of medicines conformity
certificates between North African countries (UMA);
• Developing the volume of commercial and scientific exchanges by bringing
North African pharmacists together and establishing privileged partner-
99 « L’industrie pharmaceutique et la production pharmaceutique en Afrique de l’Ouest » [Pharmaceutical industry and production in
West Africa].
ship reports between the professionals of the sector (Inter-Order of North

African Pharmacists – IOPM);
• Reinforcing the regional capacities for the control of locally produced or
imported medicines (Coulibaly A.).
■ Recommendations regarding the integration via medicines

joint purchase
• Reactivating the North African Committee for medicines joint purchase
and giving it the responsibility to buy a list of products defined by joint
agreement (UMA);
• Drawing up a list of the common needs regarding pharmaceutical products
in North African countries while awaiting for the creation of a common list
of basic medicines and the updating of the North African joint purchase
convention (UMA);
• Implementing a permanent commission of bid preparation for medicines
joint purchases;
• Applying to pharmaceuticals and medical items manufactured in North
Africa the principle of national treatment regarding the taxes demanded
in the importer country.
■ Recommendations regarding integration via MA

• Organizing workshops, meetings and symposiums on the standardization
procedures of medicines registration and control;
• Making easier the cooperation between national laboratories of pharma-
ceuticals quality control and carrying on with the fight against counterfeit
medicines or non-compliant with the standards (UMA);
• Implementing a North African project for the coordination of medicines
registration systems (UMA);
• Drawing up the final version of the North African project for the coordina-
tion of medicines registration systems (UMA);
• Accelerating the implementation of the recommendations of the North
African Council of Ministers during the 10th and 11th sessions regarding the
integration of the medicines registration process in North African coun-
tries (UMA).
■ Recommendations regarding integration via medicines

production
• Implementing a structure gathering North African pharmaceutical indus-
trials (IOPM);
• Ensuring a diversification of the production throughout the integration of
the different technologies: injectable forms, aerosols, etc. (Coulibaly A.);
• Ensuring the follow-up of WHO’s indicators aiming at assessing the capa-
cities of the pharmaceutical industry and the measure of the sector’s per-
formances (see APPENDIX N°2);
• Developing infrastructures, promoting human resources, integrating new
information and communication technologies and carrying out technology
transfer;
• Starting the integration by the production of vaccines, oncology products,
serums and medicines derived from biotechnologies;
• Reinforcing the local production capacity via the implementation of an
incentive framework favouring investment in this sector (Coulibaly A.);
• Developing the North African cooperation in terms of medicines produc-

tion (and especially of generic ones);
• Implementing an independent association of medicines manufacturers so
that the pharmaceutical industry can benefit from scientific, commercial
and industrial exchanges (CIP).
TABLE 16 Summary of recommendations by source or institution

Type of Recommendation Source
recommendation
Creating, at a regional level, supranational professional organizations to ensure
General the regulation standardization of the joint purchase procedure of medicines, Authors of this
recommendations vaccines and serums, to ensure the good quality of local productions, to create a report
development plan for basic infrastructures for medicines industrialization
Integration via Implementing a permanent commission of bid preparation for medicines joint Authors of this
common purchase purchases report
Applying to pharmaceuticals and medical items manufactured in North Africa the
Integration via Authors of this
principle of national treatment regarding the taxes demanded in the importer
common purchase report
country
Organizing meetings on the standardization procedures of medicines registration Authors of this
Integration via MA and control report
Ensuring the follow-up of indicators developed by the WHO aiming at assessing
Integration via Authors of this
the capacities of the pharmaceutical industry and the measure of the sector’s
production report
performances
Integration via Developing infrastructures, promoting human resources, integrating new ICTs Authors of this
production and carrying out technology transfer report
Integration via Starting the integration by the production of vaccines, oncology products, serums Authors of this
production and medicines derived from biotechnologies report
Integration via Developing the North African cooperation in terms of medicines production (and Authors of this
production especially of generic ones) report
Ensuring a regional coordination for medicines purchases and a better
General development of the pharmaceutical industry via the implementation of a CIP
recommendations permanent secretariat
Integration via Setting up an independent association of medicines manufacturers CIP
production
Boosting cooperation between all public healthcare actors so that patients
General remain at the centre of their preoccupations, while keeping in mind that CNOPT
recommendations pharmaceutical issues cannot be separated from public health and sustainable
economic development issues
Working for the implementation of a North African strategy in the pharmaceutical
General sector in the production, mutual recognition of marketing authorizations and CNOPT
recommendations resumption of medicines joint purchase
General Creating a North African committee to reflect upon the future of the CNOPT
recommendations pharmaceutical sector
Reinforcing the link between the different Pharmacy universities in North African
General countries, orders of pharmacists, learned societies and all the professionals of the CNOPT
recommendations pharmaceutical sector
General Guaranteeing initial and ongoing training meeting the current and future needs CNOPT
recommendations of the sector
General Taking on the market through performance and managing to balance the debate Dr Assane
recommendations between liberalization and protectionism COULIBALY
Type of Recommendation Source

recommendation
General Reinforcing the regional capacities for the control of locally produced or imported Dr Assane
recommendations medicines COULIBALY
Integration via Ensuring a diversification of the production range for an integration of the Dr Assane
production different technologies COULIBALY
Integration via Reinforcing the local production capacity via the implementation of an incentive Dr Assane
production framework favouring investment in this sector COULIBALY
Developing the volume of commercial and scientific exchanges by bringing North
General
recommendations African pharmacists together and establishing privileged partnership reports IOPM
between the professionals of the sector
Integration via Implementing a structure gathering North African pharmaceutical industrials IOPM
production
General Boosting the North African bureau of pharmaceutical information UMA
recommendations
Integration via Reactivating the North African committee for medicines joint purchase and give it
UMA
common purchase the responsibility to buy a list of products defined by joint agreement
Drawing up a list of the common needs regarding pharmaceutical products in
Integration via North African countries while awaiting for the creation of a common list of basic UMA
common purchase medicines and the updating of the North African joint purchase convention
Making easier the cooperation between national laboratories of pharmaceuticals
Integration via MA quality control and carrying on with the fight against counterfeit medicines or UMA
non-compliant with the standards
Implementing a North African project for the coordination of medicines
Integration via MA UMA
registration systems
Drawing up the final version of the North African project for the coordination of
Integration via MA UMA
medicines registration systems
Accelerating the implementation of the recommendations of the North African
Integration via MA Council of Ministers during the 10th and 11th sessions regarding the integration UMA
of the medicines registration process in North African countries
Conclusion
At the national scale, medicines are key for various players in the phar-
maceutical chain in each of the three North African countries:
• The Ministry of Health must ensure the availability of this vital product
for all citizens, via regular supply and traceable circuits. Besides, it must
ensure the quality, efficiency and safety of medicines. Therefore, medi-
cines and pharmacy are highly regulated and controlled by the Ministry
of Health.
• Insurance organizations aim at offering the best services possible for their
members in terms of healthcare quality. They also aim at maintaining their
financial balance, which guarantee their durability. To do so, they try to
maximize their resources via the use of the most economical therapeutic
alternatives.
• The prescriber has responsibility for choosing the medicines best adapted
to his patient. His objective is a fast and complete recovery for his patient,
its safety and if possible at the lowest cost. The richness and complexity of
the pharmaceutical offer make the prescriber’s choice increasingly difficult
and he is influenced, at different levels, by the pharmaceutical industry,
which is today the main source of pharmaceutical knowledge.
• At the pharmacy, medicines are delivered according to a system where
gross profit margins are fixed, whatever the price of medicines. This
represents a barrier that tend to favour the most expensive medicines in
their categories at the expense of cheaper ones. Today, pharmacists have
the choice to substitute the medicines in order to control the pressure
of med icines costs over health insurance and it works with a system of
variable margins that tend to favour generic medicines.
• Apart from self-medication, the patient cannot always choose his medicines.
The only issues for the patient are therapeutic efficiency, medicine safety
and as much as possible, a low price. When the patient is covered by a
health insurance, the access to medicines is no longer a problem – as long
as this medicine is reimbursable and if the costs that remained to be paid
are quite low.
• The pharmaceutical sector, although it is highly regulated and controlled,
still follows the market forces and the law of free competition. Indeed,
even though medicines are vital and strategic health products, they remain
an industrial and commercial product that follows the market forces and
needs to make profitable the invested capital and win market shares. It is
also a therapeutic product with an obligation of efficiency and safety and
must be accessible both geographically and economically.
• The pharmaceutical industry faces a certain number of constraints. The
limited size of the national market is an obstacle to economies of scale and
leads to an under-use of industrial facilities. Local production is penal ized
by importations and the development of exportation remain difficult,
which also represent obstacles to the development of this sector.
• The pharmaceutical industrial sector can be considered as an industry
evolving in a cutting-edge technology sector. This requires that industrials
adapt to the constraints linked to the evolution of international standards
in terms of medicines production and quality. These adaptations require
from pharmaceutical industrials to make heavy and regular investments.
At the regional scale and for a better integration of the North African
pharmaceutical market, one must also take into account the necessary condi-
tions for its success as well as the challenges to be taken up. They are, in
particular:
• giving more significance to political agreements and commitments taken
by the various Ministries;
• implementing a regional coordination via a permanent secretariat consti-
tuting a data bank and ensuring the communication and diffusion of infor-
mation to the concerned countries;
• signing a framework agreement (internal rules) regulating the different
processes and procedures regarding the North African cooperation con-
templated (joint purchase, MA, production, etc.);
• reinforcing the use of generic medicines in the pharmaceutical markets of
the three countries;
• paying particular attention to the consequences of political instabilities in
the countries on the integration of the pharmaceutical market.
However, even though all these issues do not always converge and obsta-
cles can exist for each different player and at different, national and regional,
levels, the solving of the equation “medicines accessibility” / “conservation
of the pharmaceutical sector” is not impossible. The patients’ interests must
be placed above any other consideration.
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APPENDIX 1
List of medicines available in Algeria, Morocco, Tunisia
Name of the Product Algeria Morocco Tunisia Laboratory

Acidrine – Pills x x x Téofarma
Acti 5 x Pierre Fabre
Activarol C 500 x x x Monot
Activarol C 100 x x x Monot
Acuilix x x x Parke Davis
Acuitel x x x Parke Davis
Adépal x x Wyeth-Lederlé
AGram x Inava
Agyrax pills x x x Vedim Pharma
Aldactazine x x x Monsanto France S.A.
Aldactone 50 mg x Monsanto France S.A.
Aldactone 75 mg x x x Monsanto France S.A.
Algésal – Balm x Solvay Pharma
Algésal suractivé – Ointment x x x Solvay Pharma
Algipan x x Darci Pharma
Allergefon x Lafon
Allergènes x x x Dome – Hollister – Stier S.A.
Alodont – Solution x x Parke Davis
Alphachymotrypsine x x x Sanofi-Synthélabo France
Alphacutanée – Vials x Leurquin-Médiolanum
Alphintern – Pills x Leurquin-Médiolanum
Alpress LP x Pfizer
Alvityl Sugar-coated pills x x Solvay Pharma
Alvityl Syrup x Solvay Pharma
Ametycine x Sanofi-Synthélabo France
Amiklin x Bristol-Myers Squibb
Anaxéryl x Bailly-Speab
Androcur x x x Schering S.A.
Androtardyl x x x Schering S.A.
Angispray x x Monot
Antibio-Aberel gel x x x Janssen-Cilag

Antibio-Aberel tampons x x x Janssen-Cilag
Anusol – ointment x Warner-Lambert
Anusol – suppositories x Warner-Lambert
Apacef (Céfotetan) x x x AstraZeneca
Apaisyl gel x Monot
Aphilan R pills x x x Darci Pharma
Aphtiria – Powder x x Debat
Arimidex x x AstraZeneca
Artane x x x Aventis
Arthrol (Liniment) x x Biocodex
Ascofer x Gerda
Aspirine 100mg sachets x UPSA
Aspirine UPSA 500 mg x UPSA
Aspirine UPSA high in vitamin C x UPSA
Atarax pills x x x UCB Pharma SA
Atarax injectable x UCB Pharma SA
Atarax syrup x x x UCB Pharma SA
Atropine – eye drops x Alcon
Augmentin x Glaxo SmithKline
Avibon x x x Aventis
Avolcardyl (Propanolol) pills x x x AstraZeneca
Avlocardyl Retard (Propanolol) x x x AstraZeneca
Balsamorhinol – drops x Etris
Balsofumine x x Sanofi-Synthélabo France
Basdène x x Doms-Recordati
BCG intradermique x x Pasteur Vaccins
Benylin – syrup x x Parke Davis
Biclinocilline x x x Sanofi-Synthélabo France
Biocidan (collutory) x Menarini France
Biodermine (cream) x x Biocodex
Bleu Patenté x x Guerbet
Bricanyl (pills, injectables, aerosol) x x x AstraZeneca
Bricanyl (syrup) x AstraZeneca
Bricanyl turbuhaler x x x AstraZeneca
Bristopen x x x Bristol-Myers Squibb

Broncoclar syrup x UPSA
CAC 1000 Sandoz – effervescent x x Novartis Pharma SA
tablets
Calcibronat – vials x x x Novartis Pharma SA
Calcibronat – effeverscent tablets x x x Novartis Pharma SA
Calcibronat – syrup x x x Novartis Pharma SA
Calciforte x Grimberg
Calciparine x x x Sanofi-Synthélabo France
Calcium Sandoz forte – effervescent x x x Novartis Pharma SA
tablets
Captolane x Aventis
Carbophos x UPSA
Carbosylane x Grimberg
Casodex x x AstraZeneca
Catalgine (Catalgix in Tunisia) x x x Lipha Santé
Cefacidal x x Bristol-Myers Squibb
Cefaloject x Bristol-Myers Squibb
Celestamine x Schering S.A.
Celestène chronodose x x x Schering S.A.
Celestène drops x x x Schering S.A.
Celestène 2 mg x x x Schering S.A.
Celestène 8 mg / 4 mg inj. x x Schering S.A.
Cepevit K pills x Darci Pharma
Cequinyl fort x Glaxo SmithKline
Cetavlon x CS
Cicatryl – Ointment x x Darci Pharma
Clamoxyl x Glaxo SmithKline
Clarityne x x x Schering S.A.
Clérégil adulte – drinkable vials x Monot
Climène x x x Schering S.A.
Clomid x Marion Merrel SA
Cogitum x Glaxo SmithKline
Collu-Hextril – collutory x x x Warner-Lambert
Combantrin 125 mg – pills x x x Téofarma
Combantrin 15 ml – suspension x Téofarma
Corbionax – pills x IREX
Cordarone x x x Sanofi-Synthélabo France

Corticotulle Lumière – 5 compresses x Solvay Pharma
10 x 10
Corticotulle Lumière – 30 x Solvay Pharma
compresses 20 x 20
Covatine x Bailly-Speab
Cyclo 3 x x x Pierre Fabre
Cytéal x x Sinbio
Dacryne x x Martin Johnson & Johnson Msd
Dacryosérum x x Martin Johnson & Johnson Msd
Dacryoboraline x x Martin Johnson & Johnson Msd
Dafalgan 80 mg – suppositories x UPSA
Dafalgan 150 mg – suppositories x x UPSA
Dafalgan 150 mg – sachets x UPSA
Dafalgan 500 mg – pills x UPSA
Daktarin – pills x x Janssen-Cilag
Daktarin – skin cream x x Janssen-Cilag
Dantrium 25 mg – capsules x Lipha Santé
Dantrium 100 mg – capsules x Lipha Santé
Débridat – comp./susp. drink./ x x Parke Davis
suppo./inj.
Dénoral – pills x x Théraplix (Aventis)
Dénoral – syrup x Théraplix (Aventis)
Dépakine x x x Sanofi-Synthélabo France
Depamide x Sanofi-Synthélabo France
Dermacide x x x CS
Desernil – pills x Novartis Pharma SA
Desuric x x Novartis Pharma SA
Détensiel 10 mg – pills x x Lipha Santé
Diafusor x x Pierre Fabre
Diane 35 x x x Schering S.A.
Diamox x x x Théraplix (Aventis)
Diarsed x x Sanofi-Synthélabo France
Dicetel – pills x x Solvay Pharma
Procter & Gamble Pharmaceuticals
Didronel x x x Fce
Digitaline – vials x x x Fce

Digitaline – pills x x x Fce
Digitaline – solution x x Fce
Digoxine Nativelle – pills x x x Fce
Digoxine – solution x x x Fce
Di-Hydan x x x Genopharm
Dioparine x x Ciba Vision Ophtalmics
Dipipéron – pills x Janssen-Cilag
Diprivan (Propofol) x x AstraZeneca
Diprolène x x Schering S.A.
Diprosalic x x x Schering S.A.
Diprosone all forms x x x Schering S.A.
Diprostène injectable x x x Schering S.A.
Dolgit 5% cream x x Lipha Santé
Dopamine Nativelle – inj. vial x x x Fce
Doxium x x Europhta
Dramamine x x Pharmacia & UpJohn SA
Driptane 5 mg x x Debat
Droleptan – inj. am. solution x x x Janssen-Cilag
Duphalac – drinkable solution x x Solvay Pharma
Duphaston – pills x x x Solvay Pharma
Duspatalin – pills x x x Solvay Pharma
Efferalgan solution x x UPSA
Efferalgan high in vitamin C x x UPSA
Efferalgan 500 mg x x UPSA
Elase – ointment x Parke Davis
Eludril x x Inava
Endotelon x Sanofi-Synthélabo France
Epuram – pills x Pharmafarm
Equanil (inj., suppo., caps.) x x x Sanofi-Synthélabo France
Eryfluid x Pierre Fabre
Esperal x Sanofi-Synthélabo France
Estulic – pills x x x Novartis Pharma SA
Eucalyptine – syrup x Martin Johnson & Johnson Msd

Eucalyptine suppository adults x Martin Johnson & Johnson Msd
Eucalyptine suppository children x Martin Johnson & Johnson Msd
Eucalyptine suppository infants x Martin Johnson & Johnson Msd
Eulexine x x x Schering S.A.
Fasigyne 500 mg – pills x x x Téofarma
Fazol – cream x x Aventis
Fazol – ovules x Aventis
Feldène 20 mg – IM vials x x x Pfizer
Feldène 10 mg – capsules x x x Pfizer
Feldène 20 mg – capsules x Pfizer
Feldène 20 mg – dispersion x Pfizer
Feldène 20 mg – suppositories x x Pfizer
Fentanyl sol. inj. vials x x Merck Génériques
Ferrostrane – syrup x x Parke Davis
Flodil L.P. 5 mg x AstraZeneca
Fludara x Schering S.A.
Fluothane (Halothane) x x x AstraZeneca
Fongeryl x SERB
Fonlipol x Lafon
Formocarbine – granules x x Glaxo SmithKline
Fumafer x x x Sanofi-Synthélabo France
Furadantine – capsules x Lipha Santé
Furadoïne – pills x x x Lipha Santé
Gastralgine x UPSA
Gastrografine x x x Schering S.A.
Gaviscon x x x Glaxo SmithKline
Gel de Polysilane x x UPSA
Geldène x Pfizer
Gélucystine – capsules x x Parke Davis
Gélusil – pills x x x Warner-Lambert
Gentalline 10 – 40 – 80 – 160 x x Schering S.A.
Glucophage 500 mg – pills x Lipha Santé
Glucophage 850 mg – pills x x x Lipha Santé
Glycerotone x x Ciba Vision Ophtalmics
Granudoxy – capsules x Pierre Fabre

Grisefuline – pills x Sanofi-Synthélabo France
Grisefuline – ointment x Sanofi-Synthélabo France
Gynergene caféiné – sugar-coated x x x Novartis Pharma SA
pills
Gynergene caféiné – suppositories x Novartis Pharma SA
Gynergene – vials x Novartis Pharma SA
Gyno-Daktarin – vaginal gel x Janssen-Cilag
Gyno-Daktarin 100 mg – ovules x Janssen-Cilag
Gyno-Daktarin 400 mg – ovules x x Janssen-Cilag
Gyno-Pévaryl 150 – ovules x x Janssen-Cilag
Haldol – vials x x x Janssen-Cilag
Haldol 1 mg – pills x x Janssen-Cilag
Haldol – Drops 2/ x x x Janssen-Cilag
Haldol 5 mg – pills x Janssen-Cilag
Haldol faible 0,5% – drops x x x Janssen-Cilag
Haldol Decanoas – injectable vials x x Janssen-Cilag
Halopéridol x x x Renaudin
Hémoclar x Sanofi-Synthélabo France
Hépadial – pills x Biocodex
Héparine x Sanofi-Synthélabo France
Héparine – Alphachymostrypsine x Sanofi-Synthélabo France
Héparine Calcique Fournier x x Sanofi-Synthélabo France
Hepax x UPSA
Hept-a-Myl x x x Sanofi-Synthélabo France
Héxabrix 160 x x Guerbet
Héxabrix 200 x x x Guerbet
Héxabrix 320 x x x Guerbet
Hexalyse – sublingual pills x Doms-Recordati
Hexapneumine composé – pills x Doms-Recordati
Hexapneumine (syrup, x Doms-Recordati
suppositories)
Hexaspray pressurized collutory x Doms-Recordati
Hexomédine x x x Aventis
Hextril – solution x x x Warner-Lambert
Hiconcil x x UPSA
Hyaluronidase x Sanofi-Synthélabo France

Hydergine – vials x x Novartis Pharma SA
Hydergine – pills x Novartis Pharma SA
Hydergine – solution x x Novartis Pharma SA
Hydrosol Polyvitamine x Doms-Recordati
Ikaran x x x Pierre Fabre
Imodium – capsules x x x Janssen-Cilag
Imodium solution – flask x x x Janssen-Cilag
Imudon – pills x x x Solvay Pharma
Introna x x x Schering S.A.
Iopamiron 200 x Schering S.A.
Iskedyl x x Pierre Fabre
Isobar – pills x Chiesi SA
Isoprinosine x Sanofi-Synthélabo France
Jamylène x Expanpharm International
Josacine – pills x Bayer Pharma
Josacine – suspension x Bayer Pharma
Kaologeais – granules x x Chiesi SA
Karayal – granules x Chiesi SA
Keal x EG Labo
Kératosane x Biorga
Kétalar injectable x x x Parke Davis
Kétoderm – cream x x Janssen-Cilag
Kinurea H x FUCA
Lamaline – suppositories x Solvay Pharma
Lansoyl 225 g x x x Warner-Lambert
Lansoyl 225 g sugar free x x Warner-Lambert
Lespenephryl – solution x Darci Pharma
Lévothyrox 50 µg x x x Lipha Santé
Lévothyrox 100 µg x x x Lipha Santé
Lipanthil 200M x x x Fournier SA
Lipiodol U.F. x x x Guerbet
Lipur – pills x Parke Davis
Locacid x x x Pierre Fabre

Logecine x x Genopharm
Longacor – gel x x x Elaiapharm
Lucidril x x x Lipha Santé
Lysanxia x x Parke Davis
Lysanxia – pills x x x Parke Davis
Lyso 6 – pills x Darci Pharma
Magne B6 x Sanofi-Synthélabo France
Magnevist x x x Schering S.A.
Mantadix x x Dupont Pharma SA
Marcaïne 0,25% – flask x x AstraZeneca
Marcaïne 0,25% – adr. x AstraZeneca
Marcaïne 0,50% – flask x x x AstraZeneca
Marcaïne 0,50% – adr. x AstraZeneca
Marcaïne Rachia. – vials x x AstraZeneca
Maxilase 3000 and syrup x x x Sanofi-Synthélabo France
Maxilase Bacitracine x x Sanofi-Synthélabo France
Mégabyl granules – sachets x Martin Johnson & Johnson Msd
Mégabyl solution – flask x Martin Johnson & Johnson Msd
Meliane x Schering S.A.
Melleril 10 – pills x x x Novartis Pharma SA
Melleril 50 – sugar-coated pills x x Novartis Pharma SA
Melleril solution 4% x x Novartis Pharma SA
Melleril suspension 2% x x Novartis Pharma SA
Mepronizine x x x Sanofi-Synthélabo France
Mercryl Lauryle x x x Menarini France
Merfène colored or colorless x Novartis Pharma SA
tincture
Methergin – vials x x x Novartis Pharma SA
Methergin – solution x x Novartis Pharma SA
Miacalci 80 UI – vials x Novartis Pharma SA
Microlax x x x Pharmacia & UpJohn SA
Mictasol – pills x Martin Johnson & Johnson Msd
Mictasol bleu x x x Martin Johnson & Johnson Msd
Migralgine – capsules x Martin Johnson & Johnson Msd
Milligynon x Schering S.A.
Minipress x Pfizer

Moneva x Schering S.A.
Monicor x x Pierre Fabre
Mopral 10 mg – capsules x x x AstraZeneca
Mopral 20 mg – capsules x x x AstraZeneca
Mopral IV 40 mg – vial x x x AstraZeneca
Motilium – pills x Janssen-Cilag
Motilium drinkable suspension – x Janssen-Cilag
flask
Muciclar – syrup children x x Parke Davis
Muciclar – syrup adults x x Parke Davis
Mucofluid – vials x UCB Pharma SA
Mucothiol – pills x x Thératech
Mucothiol – sachets x x Thératech
Mutagrip x x Pasteur Vaccins
Mycodécyl x x x Diepharmex
Mycoster x x Pierre Fabre
Mynocine capsules x Wyeth-Lederlé
Mynocine IM x Wyeth-Lederlé
Myoviton x x Thérabel Lucien Pharma
Mysoline (Primidone) x x AstraZeneca
Nalorphine Serb x SERB
Natispray x Fce
Néomycine Diamant – eye drops x Roussel Diamant
Netromicine 25 – 50 – 100 – 150 x x Schering S.A.
Nibiol – pills x x x Debat
Nibiol Forte – pills x x x Debat
Nibiol – suspension x x x Debat
Niflugel x UPSA
Nifluril – gingival gel x x UPSA
Nifluril – capsules x x UPSA
Nifluril adult/children suppo. x x UPSA
Nifluril ointment x x x UPSA
Nizoral – pills x Janssen-Cilag
Nizoral – suspension x Janssen-Cilag
Nocertone x Sanofi-Synthélabo France

Noctran x Menarini France
Nolvadex x x AstraZeneca
Nootropyl – capsules x x UCB Pharma SA
Nootropyl injectable x x UCB Pharma SA
Nootropyl drinkable solution x UCB Pharma SA
Norbiline – vials x x Aventis
Noristerat x Schering S.A.
Normogastryl x UPSA
Nova T x Schering S.A.
Octofène 100 mg x Debat
Octofène 200 mg x Debat
Optalidon – sugar-coated pills x Novartis Pharma SA
Optalidon – suppositories x Novartis Pharma SA
Oracéfal x x UPSA
Oracilline x x x Schwarz Pharma
Orap – pills x Janssen-Cilag
Oromédine x x Sanofi-Synthélabo France
Oropivalone x x x Parke Davis
Ospen – pills x x Novartis Pharma SA
Otaralgyl – solution x Martin Johnson & Johnson Msd
Otipax – oto. drops x x x Biocodex
Oxadilène – capsules x Medeva Pharma
Oxyplastine – ointment x x Parke Davis
Ozothine – injection 5 ml x Laphal
Ozothine – syrup x x Laphal
Ozothine – adults, children, infants x x Laphal
suppo.
Ozothine with Diprophylline Suppo x x Laphal
A
Ozothine with Diprophylline – pills x x Laphal
Padéryl x x Gerda
Para Spécial poux – aerosol 90 g. x Pharmygiène-Scat
Parfénac x x Whitehall
Parlodel – pills x x x Novartis Pharma SA
Passiflorine – solution x Thératech
Pereflat – pills x Solvay Pharma

Peridys x Robapharm
Permixon x x x Pierre Fabre
Pévaryl (powder-spray, solution- x x x Janssen-Cilag
spray, lotion)
Pévaryl cream x x Janssen-Cilag
Phaeva x Schering S.A.
Physiomycine x x Laphal
Pilocarpine – eye drops x Ciba Vision Ophtalmics
Pivalone nasal spray x x Parke Davis
Pivalone néomycine x x x Parke Davis
Pivalone endosinus x x Parke Davis
Plastenan x x Kérapharm
Plényl x UPSA
Polaramine 2-6 syrup x x x Schering S.A.
Poly-Karaya x Sanofi-Synthélabo France
Ponstyl – suppositories x x Parke Davis
Ponstyl fort – pills x x Parke Davis
Poudre Dops x x Fuca
Povanyl – pills x Warner-Lambert
Povanyl – suspension x x Warner-Lambert
Praxilène 100 mg – capsules x x x Lipha Santé
Praxilène 200 mg – pills x x x Lipha Santé
Prazinil x Pierre Fabre
Préfagyl x UPSA
Pre-Par – injectable vials x x Solvay Pharma
Pre-Par – pills x x Solvay Pharma
Primalan x Inava
Primolut – Nor – pills x x Schering S.A.
Princi B fort x x S.E.R.P
Princi B simple x S.E.R.P
Proctolog – ointment, syrup x x x Parke Davis
Pro-Dafalgan x x UPSA
Progestérone retard Pharlon x x x Schering S.A.
Progynova x x Schering S.A.
Prorhinel – vials x x Novartis Pharma SA
Protamine choay x Sanofi-Synthélabo France

Pulmicort 200 ug – aerosol x x x AstraZeneca
Pulmicort turbuhaler x AstraZeneca
Pulmofluide simple – flask x x Warner-Lambert
Pulmofluide éphédriné – flask x x Warner-Lambert
Pulmofluide – flask (children, x x Warner-Lambert
infants)
Pulmosérum x Bailly-Speab
Pulvo 47 x x Fournier SA
Pulvo 47 néomycine x x Fournier SA
Pursennide – sugar-coated pills x x Novartis Pharma SA
Pyréflor antipoux (lotion, shampoo) x x x Clément
Pyridoxine x Aguettant
Questran x x x Bristol-Myers Squibb
Quinimax x x Sanofi-Synthélabo France
Quotivit x Mayoly-Splinder
Revitalose C 1000 x Darci Pharma
Rhinofébral – capsules x Martin Johnson & Johnson Msd
Ribatran x Ferlux SA
Ribomunyl x x x Inava
Ricridène x Lipha Santé
Rifadine x Roussel Diamant
Rifinah x Roussel Diamant
Rinutan – pills x Warner-Lambert
Rinutan – syrup x Warner-Lambert
Risordan x x x Aventis
Rocgel x x x Chiesi SA
Rocmaline – drinkable vials x Chiesi SA
Rufol – pills x x x Debat
Rumicine x Schering S.A.
Sacolène x x EG Labo
Salgydal x Doms-Recordati
Sandimmun solution x Novartis Pharma SA
Sanmigran – pills x x Novartis Pharma SA
Savarine x x AstraZeneca
Seglor x x Schwarz Pharma
Sémap – pills x Janssen-Cilag

Septivon x x x Chefaro-Ardeval
Serc – pills x x x Solvay Pharma
Seresta 10 mg – pills x Wyeth-Lederlé
Seresta 50 mg – pills x Wyeth-Lederlé
Sérum anti-rabique Pasteur x Pasteur Vaccins
Sibélium – pills x Janssen-Cilag
Sorbitol Delalande x Sanofi-Synthélabo France
Sotalex x Bristol-Myers Squibb
Soufrane x x x Sanofi-Synthélabo France
Spasfon (vials, pills, suppositories) x x Lafon
Spasmag – vials x Grimberg
Spasmag – capsules x Grimberg
Sprégal / A-Par aerosol x x Pharmygiène-Scat
Stagid – pills x x Lipha Santé
Stédiril x Wyeth-Lederlé
Stimol – vials x x Biocodex
Stresam – capsules x x Biocodex
Sulfarlem – granules x x Solvay Pharma
Sulfarlem S25 x x Solvay Pharma
Sulfuryl inhalant – pills x Aérocid
Sulfuryl Bain – powder x Aérocid
Sureptil x x x Sanofi-Synthélabo France
Surfortan x Diepharmex
Synergon x Lipha Santé
Synthol solution x x Glaxo SmithKline
Syntocinon 2 UI – vials x x Novartis Pharma SA
Syntocinon 5 UI – vials x x Novartis Pharma SA
Tadénan x x x Debat
Tagamet – pills x x Entéris
Tagamet injectable x x Entéris
Tanganil x Pierre Fabre
Télébrix 12 sodium x x Guerbet
Télébrix 38 x x x Guerbet
Télébrix 30 M x x Guerbet
Télébrix Gastro x x Guerbet

Télébrix Hystiro x x Guerbet
Témesta 1 mg – pills x x x Wyeth-Lederlé
Témesta 2,5 mg – pills x x x Wyeth-Lederlé
Temgésic – sublingual pill x x x Schering S.A.
Temgésic injectable x x x Schering S.A.
Ténordate x x AstraZeneca
Téralithe x x Aventis
Tercian x Aventis
Tenormine x AstraZeneca
Théostat x x Inava
Théralène x x x Medeva Pharma
Thiophénicol x x Sanofi-Synthélabo France
Thiovalone x x Parke Davis
Tocomine x Parke Davis
Topaal x x Pierre Fabre
Totapen x x Bristol-Myers Squibb
Tranxène x x x Sanofi-Synthélabo France
Trentadil suppositories x Medeva Pharma
Triaminic – pills x Novartis Pharma SA
Triella oral contraceptive x Janssen-Cilag
Trophigil x Sanofi-Synthélabo France
Trophirès – syrup, suppositories x x x Sanofi-Synthélabo France
Tulle gras Lumière – 10 compresses x x Solvay Pharma
10 x 10
Tulle gras Lumière – 30 compresses x x Solvay Pharma
20 x 20
Ulfon / 20 x Lafon
Ultraderme x x Richelet
Ultralan x Schering S.A.
Ultra-Levure 50 mg – capsules x Biocodex
Ultra-Levure 250 mg – sachets x x Biocodex
Ultravist 300 x x Schering S.A.
Ultravist 370 x x Schering S.A.
UPSA C x UPSA
Uraseptine Rogier x Alpharma France
Urokinase choay x Sanofi-Synthélabo France

Uvéline x x Martin Johnson & Johnson Msd
Xylocaïne gel 15 gr – tube x x AstraZeneca
Xylocaïne 1% – flask x x x AstraZeneca
Xylocaïne 1% – adr. x x x AstraZeneca
Xylocaïne 2% – flask x x x AstraZeneca
Xylocaïne 2% – adr. x x x AstraZeneca
Xylocaïne 5% contact – flask x x x AstraZeneca
Xylocaïne 5% vaporiser x x x AstraZeneca
Xylocaïne 5% naphaz. – flask x x x AstraZeneca
Xylocaïne visqueuse – tube x x x AstraZeneca
Zaditen – capsules x x x Novartis Pharma SA
Zaditen – solution x x Novartis Pharma SA
Zamig x x AstraZeneca
Zarontin – capsules x Parke Davis
Zarontin – syrup x Parke Davis
Zoladex (Goséréline) x x x AstraZeneca
Zymafluor 1/4 mg – pills x x Novartis Pharma SA
Zyrtec x x UCB Pharma SA
APPENDIX 2
WHO’s indicators suggested for the follow-up of the national pharmaceutical

production (WHO Geneva 1996)
General indicators:
• Total value of the national pharmaceutical production sold in the country
(ex-works price);
• Total number of medicines manufacturing units in the country.
Structural indicators:
• Is there a standard checklist form for the inspection of the different phar-
maceutical establishments? (this indicator does not concern only produc-
tion);
• Is there, in the country or abroad, organisms able to perform medicines
quality control? (this indicator does not concern only production);
Performance indicators:
• Number of medicines on the national list of essential medicines manufac-
tured and sold in the country out of the number of medicines on the national
list of essential medicines;
• Value of medicines bought to national manufacturers via bids, over the total
value of medicines purchased via bids in the public sector;
• Number of tested medicines or medicines batches over the number of medi-
cines received (this indicator does not concern only local production);
• Number of medicines or medicines batches that did not pass the quality con-
trol over the total of tested medicines or medicines batches (this indicator does
not concern only local production).
B U I L D I N G T H E M E D I T E R R A N E A N

Moving Towards A North African Pharmaceutical Market

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What is the overall goal of the document?

What is the overall goal of the document?

What approach did IPEMED take to study health systems in North Africa?

What approach did IPEMED take to study health systems in North Africa?

B U I L D I N G T H E M E D I T E R R A N E A N

MOHAMED WADIE ZERHOUNI

THE IPEMED “HEALTH IN THE MEDITERRANEAN” APPROACH

This first report allowed to underline the common possibilities and

It was the object of a meeting, in the presence of the representatives of

At the end of this meeting, it was decided to constitute a technical and

In order to accompany this work dynamic and relying on the conclu-

The report, which approaches the pharmaceutical question under a

Macarena NUÑO, IPEMED project manager

The pharmaceutical market in Obstacles and assets linked to the integration

CNAS National Social Insurance Fund

DMEAICO Drugs Medical Equipment and Appliances Importing CO

EMA European Medicines Agency

ENAPHARMA Algerian National Society for Pharmaceutical Products

ENCOPHARM Constantine National Society for Pharmaceutical Products

ENOPHARM Oran National Society for Pharmaceutical Products

EDQM European Directorate for the Quality of Medicines & HealthCare

FDA Food and Drug Administration

LNCPP National Laboratory for the Control of Pharmaceutical Products

MENA Middle East and North of Africa

MSO Medical Supply Organization

ONS National Office of Statistics

PCH Hospitals Central Pharmacy

PCM Central Pharmacy of Morocco

PCT Central Pharmacy of Tunisia

SIPHAT Society of Pharmaceutical Industries of Tunisia

TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights

UNOP National Union of Pharmacy Operators

WHO World Health Organisation

WTC World Trade Organisation

Towards what medicines policy for North Africa?

This sanitary situation is emphasized by the epidemiological transition.

Key issues to promote a national and North African pharmaceutical

■ What pharmaceutical strategy should be implemented?

■ What national or North African industries to develop to ensure

The implementation of industries raises the question of industrial

Unfortunately, necessary medicines cannot all be made generic. Some

pathologies such as AIDS or hepatitis, or non-communicable diseases like

■ What about the training of specialized health-care workers?

The development of a research and innovation policy in the pharma-

■ Relevance of a Mediterranean cooperation

For southern countries, this is a great challenge: being able to develop a

In April 2012, IPEMED published a report on the situation of healthcare

IPEMED therefore ordered the realization of an assessment of the phar-

In North Africa, the pharmaceutical sector is evolving. Even though orga-

Moroccan and Tunisian pharmaceutical industries respect international

Besides, the three North African countries gave the pharmaceutical

What is more, North African countries encourage the local production of

In order to develop a better integration of the pharmaceutical market and

Finally, based on the pharmaceutical monographs of the three coun-

In 2011-2012, a group of North African public health specialists3 assessed

The share allocated to medicines and health products represents more

The report also highlights that the situation of pharmaceutical markets

In Tunisia, the pharmaceutical sector presents specificities requiring