TACD Resolution On IP Aspects of Pandemics

DOC No.
IP 07-09 DATE ISSUED: May 2009

___________________________________________________________________
Resolution on Intellectual Property Aspect of Pandemics

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Introduction
In recent years there have been several cases of possible new pandemics of
infectious diseases. This includes recently concerns about SARS, and both avian
and A(H1N1) influenza. In cases involving a possible pandemic, health authorities
must address many different issues, including those relating to the availability of
relevant medicines and vaccines, and the policies and practices that ensure
adequate and equitable access to such medicines.
The TACD is concerned that there is insufficient transparency of and focus on

several important issues that concern the availability of medicines and vaccines in
cases of pandemics. On April 29, 2009, the WHO raised its pandemic alert phase for
A(H1N1) to level 5 which means that a pandemic is considered imminent.
Bearing in mind the gravity of the situation arising from the spread of A(H1N1) across
5 continents, TACD calls upon health authorities to create policies that realistically
address concerns over the management of intellectual property and the supply of
and access to generic medicines and vaccines.
TACD agrees to the following recommendations:
1. Patent Landscape. The EU and the US should ask the WHO to develop and make
available to the public information on the patent landscape for products relevant for
the treatment of actual and potential pandemics, including but not limited to influenza,
SARS and HIV/AIDS. Priority should be given to the patent landscape for the
A(H1N1) strain of Influenza.
2. Patent Pool. The EU and the US should ask the WHO to establish immediately an
influenza patent pool (IPP). The pool should include sufficient rights to use patents
to manufacture any necessary medicine or vaccine needed to address an influenza
pandemic, including to address the needs for stockpiles of products. The WHO may
consider collaborating with UNITAID on this activity, assuming the UNITAID mandate
can be sufficiently expanded to deal with pandemic responses, and high-income
countries.
3. Pre-qualification. The EU and the US should ask the WHO to immediately expand
the current WHO pre-qualification program to cover all medicines and vaccines
relevant to influenza or other potential public health emergencies. This should
include any qualified generic supplier, without regarding to intellectual property rights.
4. Restrictive Contracts. The EU, the US and the WHO should request copies of
licenses by Roche, GSK, or other companies with suppliers of activity pharmaceutical
ingredients (APIs), to determine if the contracts include restrictions on the sale of API
to legitimate generic suppliers, and if they do, to immediately ask that such contracts
be revised.
5. Transparency of Expected Demand and Adequacy of Stockpiles. The EU and the

US should ask the WHO should determine the global demand for medicines and
vaccines that would occur if a pandemic takes place, and provide transparent and
accurate assessments of the current state of stockpiles of products by country, and
the strategy and plan to address the demands, in the event a pandemic takes place.
6. Capacity building for generic producers. In November 8, 2005 testimony to the US

Congress, former Secretary of DHHS, Michael Leavett said that in an emergency
pandemic, countries will block exports of medicines, so they can be used for local
populations. If this is true, it would seem important to build developing country
capacity to manufacturer medicines that would be used in a pandemic. The WHO
needs to have a realistic action plan for increasing the capacity of developing
countries to manufacturer medicines in cases of pandemics.
7. Intellectual Property Barriers. The EU and the US should ask the WHO, WTO and
WIPO to collaborate on comprehensive global assessment of all intellectual property
right (IPR) barriers to the manufacturing, distribution and sale of medicines to both
public and private sector markets. This would include issues such as the legal
mechanisms for granting compulsory licenses, including to allow the import and
export of such products when compulsory licenses are involved. This assessment
should include an analysis of the restrictions of the use of the 30 August 2003
decisions of the WTO regarding the exports and imports of medicines manufactured
under a compulsory license, the rules regarding the exclusive rights to use
pharmaceutical test data to register products, and the potential flexibilities under
TRIPS Article 44 to manufacturer, export and import medicines without the
permission of intellectual property right owners.
8. The EU and the US should amend rules on exclusive rights in pharmaceutical test
data to allow the registration of generic products in cases relating to pandemics.
9. The EU Member States and the US should notify that WTO that they are an
“eligible importing Member” of medicines or vaccines, in cases relating to Pandemics
and other National Emergencies.
9. ACTA. The EU and the US should undertake an immediate assessment of the

legal provisions that have been tabled in the current ACTA negotiations regarding the
enforcement of patents to ensure there are no inappropriate barriers to the transit of
legitimate medicines.
10. Patent Rights for Medicines in Stockpiles. The EU and the US should evaluate
the proposal to allow governments to build stockpiles of medicines for pandemics
from generic suppliers with the understanding that patent owners will receive
royalties in the event the stockpiles are actually used.
References:
http://www.youtube.com/watch?v=q3VLE3MabcM
GENERAL COUNCIL, WT/L/540 and Corr.1, 1 September 2003, Implementation of

paragraph 6 of the Doha Declaration on the TRIPS
Agreement and public health, Decision of the General Council of 30
August 2003.
James Love, “A better way of stockpiling emergency medicines, ”FT, October 28,
2005.
EU regulation on data exclusivity:
Commission of the European Communities, Communication: A Stronger European-

based Pharmaceutical Industry for the Benefit of the Patient - A Call for Action
(Brussels: 7 July 2003), COM(2003) 383 final.
European Parliament, Legislative Resolution on the Common Position Adopted by

the Council with a View to Adopting a European Parliament and Council Regulation
Laying Down Community Procedures for the Authorization and Supervision of
Medicinal Products for Human and Veterinary Use and Establishing a European
Medicines Agency (10949/2/2003 – C5-0463/2003 – 2001/0252(COD)) (Strasburg,
17 December 2003), P5_TAPROV(2003)0577.
TACD earlier correspondence and resolutions on these issues:
o TACD letter sent to Ambassador Schwab and Commissioner Mandelson

(European Commissioner for Trade) Re. Compulsory licensing of medicine
patents in Thailand; letter sent on 17 March 2008:
http://tacd.org/index.php?option=com_docman&task=doc_download&gid=44
&Itemid=40
o TACD letter sent to the WHA Executive Board and to the WHO Commission
on Intellectual Property, Innovation and Health
Re: Request to Evaluate Proposal for New Global Medical R&D Treaty; letter
sent on 25 February 2005:
&Itemid=40
o TACD letter sent to Commissioner Lamy and Ambassador Zoellick (USTR)
Re. access to medicines and Paragraph 6 of the Doha Declaration; letter sent
on 17 December 2002:
&Itemid=40
o TACD letter sent to Commissioner Lamy and Ambassador Zoellick Re. the
European Parliament's resolution on access to medicines, paragraph 6 Doha
declaration and WTO rules for patents;letter sent on 13 November 2002:
&Itemid=40
o TACD letter sent to Commissioner Lamy and Ambassador Zoellick Re TACD-
Doha-Declaration on TRIPS; letter sent on 15 February 2002:
&Itemid=40
o TACD letter sent to Commissioner Lamy and Ambassador Zoellick Re. Early
Warning System; letter sent on 5 December 2001:
&Itemid=40
• TACD resolution on global access to health care, DOC NO. TRADE-10-01,
issued May 2001:
&Itemid=40
• TACD resolution on transparency of pharmaceutical economics, DOC NO.
HEALTH-6-00, issued February 2000:
&Itemid=40
• TACD resolution on patents on genetic diagnosis, DOC NO. HEALTH-5-00,
issued February 2000:
&Itemid=40
• TACD resolution on data exclusivity and health registration data, DOC NO.
&Itemid=40
• TACD resolution on access to medicines in developing countries, DOC NO.
&Itemid=40
• TACD resolution on pharmaceuticals, issued April 1999, DOC NO. Health-01-
99:
&Itemid=40

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DOC No.

IP 07-09 DATE ISSUED: May 2009

Resolution on Intellectual Property Aspect of Pandemics

The TACD is concerned that there is insufficient transparency of and focus on

TACD agrees to the following recommendations:

5. Transparency of Expected Demand and Adequacy of Stockpiles. The EU and the

6. Capacity building for generic producers. In November 8, 2005 testimony to the US

9. ACTA. The EU and the US should undertake an immediate assessment of the

GENERAL COUNCIL, WT/L/540 and Corr.1, 1 September 2003, Implementation of

EU regulation on data exclusivity:

Commission of the European Communities, Communication: A Stronger European-

European Parliament, Legislative Resolution on the Common Position Adopted by

TACD earlier correspondence and resolutions on these issues:

o TACD letter sent to Ambassador Schwab and Commissioner Mandelson

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