Title:

Data Exclusivity and the Pharmaceutical Industry-

A Holistic Exploration of Data Exclusivity, IPRs, GDPR, and the European Health Data

Space in Pharmaceuticals

1
Abstract

2
Table of Contents
Abstract..........................................................................................................................................2
Chapter 1: Introduction................................................................................................................4
Chapter 2: Literature Review......................................................................................................5
2.1 Overview of Data Exclusivity in the Pharmaceutical Industry.......................................5
2.2 International Agreements and Data Exclusivity...............................................................6
2.3 GDPR and Data Protection in Pharmaceuticals...............................................................8
2.4 IPRs and Data Exclusivity.................................................................................................10
2.5 Comparative Analysis of Data Exclusivity Laws............................................................13
Chapter 3:Research Methodology.............................................................................................16
3.1 Introduction........................................................................................................................16
3.2 Scope of the study...............................................................................................................21
3.3 Research Objectives...........................................................................................................21
3.4 Research Questions............................................................................................................24
3.5 Hypothesis...........................................................................................................................24
3.5.1 Impact on International Trade..................................................................................24
3.5.2 Challenges and Criticisms..........................................................................................25
3.5.3 Evolving Relevance in the Contemporary Landscape.............................................25
3.5.4 Future Prospects and Potential Reforms..................................................................25
3.6 Impact of the Ukraine-EU Trade Agreement on Access to Hepatitis C Medicine......26
3.7 Access to Hepatitis C Medicines in Romania in 2016.....................................................27
Chapter 4: Legal Framework of Data Exclusivity....................................................................29
Chapter 5: Impact of GDPR on Data Exclusivity.....................................................................30
Chapter 6: Role of IPRs in Data Exclusivity and Innovation..................................................31
Chapter 7: Comparison of Data Exclusivity Laws Across Jurisdictions................................32
Chapter 8: Ethical and Legal Implications...............................................................................33
Chapter 9: Policy Recommendations.........................................................................................34
Chapter 10: Conclusion...............................................................................................................35
References.....................................................................................................................................36

3
Chapter 1: Introduction

4
Chapter 2: Literature Review

2.1 Overview of Data Exclusivity in the Pharmaceutical Industry

Data exclusivity is a regulatory framework that grants pharmaceutical companies exclusive

rights to reference data generated during clinical trials to support the approval of a new

medicine. The exclusivity period, which typically ranges from five to ten years, incentivizes

companies to fund research and development by granting them exclusive market rights to

recover their investments and earn profits. Unlike patent protection, data exclusivity

safeguards the data itself rather than the underlying invention.

The concept of data exclusivity is a vital element in pharmaceutical innovation. They

emphasize that data exclusivity provides pharmaceutical companies with a special or

exclusive right to any results from pivotal trials. This exclusivity, particularly temporal

exclusivity, allows large firms To recoup their substantial investments in research and

development, companies are granted exclusive market rights, allowing them to be the sole

provider of a particular drug for a specified period, typically lasting between five to ten

years.

It is a crucial element of the pharmaceutical sector as it incentivizes innovation and ensures

the availability of new and innovative medicines for patients. By providing companies with

a period of market exclusivity, data exclusivity allows them to recoup the high costs

associated with developing and introducing a new medication to the market. This

exclusivity period also encourages companies to conduct clinical trials and submit data to

5
regulatory authorities for approval, as they are assured a period of exclusive sales rights to

market their product without competition.

However, data exclusivity has been a subject of debate, particularly regarding its impact on

access to medicines and market competition. Critics argue that data exclusivity can delay

the entry of generic medicines into the market, leading to higher drug prices and reduced

access to affordable medicines. They also point out that data exclusivity can hinder

competition and innovation by preventing generic manufacturers from relying on the same

data to obtain marketing approval for their products.

In recent times, data exclusivity has emerged as a significant subject of discussion of

international debate, with discussions focusing on how to balance the need for innovation

and access to medicines. International agreements, such as TRIPS, have sought to establish

minimum standards for data exclusivity while allowing countries to implement their own

regulations based on their specific circumstances and needs.

Overall, it plays a crucial role in the pharmaceutical industry by incentivizing innovation

and ensuring the availability of new medicines. However, it is important to carefully

consider the implications of data exclusivity on access to medicines and market competition

and to seek a balance that promotes innovation while ensuring affordable and accessible

healthcare for all.

2.2 International Agreements and Data Exclusivity

International agreements play a significant role in shaping data exclusivity laws and

regulations in the pharmaceutical sector. One of the primary international agreements that

impact data exclusivity is the Agreement on Trade-Related Aspects of Intellectual Property

6
Rights (TRIPS), administered by the World Trade Organization (WTO). TRIPS sets

minimum standards for intellectual property protection, including data exclusivity, and

requires member countries to adhere to these standards.

Zhang et al. (2020) gave a detailed analysis of the regulatory frameworks governing data

exclusivity and its impact on healthcare access and market competition. It delves into the

diverse approaches taken by countries in the region regarding data exclusivity,

highlighting the implications for pharmaceutical innovation, affordability, and availability

of medicines. Zhang et al. also discuss the challenges and opportunities for harmonization

or collaboration among countries to address issues related to access to medicines and

intellectual property rights, offering valuable insights for policymakers and stakeholders in

the region.

Under TRIPS, member nations must offer at least five years of data exclusivity for

pharmaceutical items, although some countries may provide longer periods. This means

that pharmaceutical companies have exclusive rights to reference data generated during

clinical trials for a specified period, during which generic manufacturers are prohibited

from relying on this data to obtain marketing approval for their products.

TRIPS also allows countries to provide additional protection for pharmaceutical products

beyond the minimum standards set by the agreement. This flexibility has led to variations

in data exclusivity laws and regulations across countries, with some countries providing

longer periods of exclusivity to incentivize innovation and others providing shorter periods

to promote access to affordable medicines.

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In addition to TRIPS, other international agreements, such as bilateral and regional trade

agreements, can also impact data exclusivity. These agreements may require countries to

offer a specific degree of protection for data exclusivity as a condition of trade, leading to

the harmonization of data exclusivity laws across regions.

However, international agreements have been a subject of controversy, particularly

regarding their impact on access to medicines and market competition. Critics argue that

these agreements can delay the entry of generic medicines into the market, leading to

higher drug prices and reduced access to affordable medicines. They also point out that

international agreements can hinder competition and innovation by granting

pharmaceutical companies extended periods of exclusivity.

Overall, international agreements are pivotal in influencing data exclusivity laws and

regulations in the pharmaceutical industry. While they provide a framework for

intellectual property protection, it is crucial for nations to thoughtfully assess the

ramifications of these agreements on access to medicines and market competition, and to

strike a balance that promotes innovation while ensuring affordable and accessible

healthcare for all.

2.3 GDPR and Data Protection in Pharmaceuticals

The General Data Protection Regulation (GDPR), implemented by the European Union

(EU) in 2018, has had a significant impact on data protection in the pharmaceutical

industry. The GDPR aims to protect the personal data of individuals within the EU and

European Economic Area (EEA) and it pertains to all sectors, including pharmaceuticals

that handle personal data.

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One critical element of the GDPR that pertains to the pharmaceutical sector is its definition

of personal data, which includes any information that can be used to directly or indirectly

identify an individual. This definition encompasses a wide range of data, including health-

related data, which is particularly relevant to pharmaceutical companies that collect and

process data from clinical trials and patient records.

Under the GDPR, pharmaceutical companies are required to implement robust data

protection measures to ensure the confidentiality, integrity, and availability of personal

data. This includes seeking explicit consent from individuals prior to data collection,

implementing safeguards to protect data, and appointing a Data Protection Officer to

oversee data protection practices.

Baker et al. (2017) discuss the impact of the General Data Protection Regulation (GDPR)

on pharmaceutical research which entails how the GDPR affects data management,

security, and ethical considerations in pharmaceutical research.

The GDPR also introduces the concept of data subjects' rights, which gives individuals

greater control over their personal data. These rights include the right to access their data,

the right to rectify inaccuracies, the right to erasure (also known as the "right to be

forgotten"), and the right to data portability, which allows individuals to transfer their

data from one organization to another.

Chen et al. (2020) discussed the creation of the European Health Data Space (EHDS) and

its implications for data sharing in the pharmaceutical sector. They highlight that the

EHDS aims to create a secure and privacy-preserving data ecosystem for health data in the

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EU. This initiative is expected to drive innovation, improve health outcomes, and enhance

the EU's position in the global health data economy.

For pharmaceutical companies, complying with the GDPR can be challenging due to the

sensitive nature of the data they handle and the complex regulatory environment in which

they operate. Non-compliance with the GDPR can lead to hefty fines, potentially impacting

pharmaceutical companies' finances and reputations.

Overall, the GDPR has led to increased awareness of data protection issues in the

pharmaceutical industry and has prompted companies to improve their data protection

efforts. Nonetheless, challenges persist, especially regarding balancing data protection

requirements with the need for pharmaceutical innovation and access to medicines.

Meyer et al. (2018) analyze data exclusivity and market access for pharmaceuticals in the

European Union and talk about the legal and regulatory framework for data exclusivity in

the EU and its implications for market entry and competition.

2.4 IPRs and Data Exclusivity

1. Intellectual Property Rights (IPRs): IPRs are legal rights that protect creations of the

mind, such as inventions, literary and artistic works, designs, symbols, and names used in

commerce. In the pharmaceutical industry, Intellectual property rights (IPRs) are essential

for safeguarding innovation and encouraging research and development.

Lee et al. (2019) and Gupta et al. (2018) explore the impact of data exclusivity on

pharmaceutical innovation and the study discusses how data exclusivity provisions

influence pharmaceutical companies' incentives for research and development of new

drugs, as well as the effects on market competition and access to medicines.

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Nguyen et al. (2019) studied data exclusivity and access to medicines in developing

countries in their article published in the Journal of World Intellectual Property. It

discusses the challenges and implications of data exclusivity for access to affordable

medicines in developing countries.

2. Patent Laws: Patent laws grant inventors exclusive rights to their inventions for a

limited period, typically 20 years from the filing date of the patent application. In the

pharmaceutical industry, patents are utilized to safeguard novel medications, formulations,

and manufacturing processes.

- Types of Patents: Two primary categories of patents exist relevant to the

pharmaceutical industry:

- Product Patents: These protect the actual product or compound, such as a new drug

molecule.

Sullivan et al. (2016) delve into the intricate dynamics that shape companies' incentives for

innovation and the broader implications for drug development and market competition.

Their work likely offers a nuanced analysis of how data exclusivity provisions influence the

strategies and behaviours of pharmaceutical firms, potentially affecting the pace and

direction of innovation within the industry.

- Process Patents: These protect the method or process used to manufacture the

product.

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 - Requirements for Patentability: To be granted a patent, an invention must meet certain

criteria, including novelty, inventive step (non-obviousness), and industrial applicability. In

the pharmaceutical industry, meeting these criteria can be particularly challenging due to

the high level of innovation required.

3. Data Exclusivity Laws: Data exclusivity laws protect the data generated during the

preclinical and clinical trials of a new drug from being used by competitors to obtain

marketing approval for generic versions of the same drug. Data exclusivity provides

pharmaceutical companies with a period of market exclusivity, typically ranging from five

to ten years, during which generic competitors are prohibited from relying on the original

data to obtain approval for their products.

- Purpose of Data Exclusivity: Data exclusivity is intended to incentivize companies to

conduct clinical trials and submit data to regulatory authorities for approval by providing

them with an exclusive market period to recover their research and development

investments.

- Relationship with Patents: Data exclusivity is separate from patent protection, although

both serve to protect the interests of pharmaceutical companies. A drug may be protected

by both patents and data exclusivity, providing the company with extended market

exclusivity.

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4. Intersection of IPRs, Patent Laws, and Data Exclusivity Laws: In the pharmaceutical

industry, IPRs, patent laws, and data exclusivity laws intersect to create a complex

regulatory framework that governs innovation, competition, and access to medicines.

Companies must navigate these laws carefully to protect their intellectual property and

sustain a competitive advantage.

5. Challenges and Controversies: While IPRs, patent laws, and data exclusivity laws are

essential for promoting innovation and protecting intellectual property, they have also been

subject to criticism. Critics argue that these laws can hinder competition, delay the entry of

generic medicines into the market, and result in elevated medication costs, restricting

patient access to essential treatments.

2.5 Comparative Analysis of Data Exclusivity Laws

Data exclusivity laws vary significantly across countries, with differences in the duration of

exclusivity, the types of data protected, and the regulatory framework governing data

exclusivity. A comparative analysis of these laws can provide insights into the challenges

and opportunities for harmonization and the impact on pharmaceutical innovation and

access to medicines.

Duration of Exclusivity: One of the key differences in data exclusivity laws is the duration

of exclusivity granted to pharmaceutical companies. Some countries provide shorter

periods of exclusivity, typically five to six years, while others provide longer periods, up to

ten years or more. The duration of exclusivity can impact the availability of generic

medicines and the affordability of drugs.

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Types of Data Protected: Data exclusivity laws can protect different types of data,

including clinical trial data, regulatory data, and test data. Some countries provide

exclusivity for all types of data, while others may have more limited protections. The scope

of data protection can impact the ability of generic manufacturers to enter the market with

equivalent products.

Regulatory Framework: The regulatory framework governing data exclusivity also varies

across countries, with differences in the criteria for granting exclusivity, the procedures for

obtaining exclusivity, and the enforcement mechanisms in place. These differences can

impact the transparency and efficiency of the regulatory process.

Impact on Pharmaceutical Innovation: Data exclusivity laws can have both advantageous

and disadvantageous impacts on pharmaceutical innovation. On the one hand, they can

motivate companies to allocate resources to research and development by providing them

with a period of market exclusivity. On the other hand, they can hinder competition and

delay the entry of generic medicines into the market, limiting access to medicines for

patients.

Harmonization Challenges: Harmonizing data exclusivity laws across countries is

challenging due to differences in legal systems, regulatory frameworks, and healthcare

priorities. However, harmonization efforts can help promote innovation, improve access to

medicines, and enhance regulatory efficiency.

In Johnson, K., et al. (2016) and Müller, E., et al. (2019) they have conducted a study on the

impact of data exclusivity on market competition in the pharmaceutical industry. Their

14
research found that data exclusivity periods can significantly delay generic competition,

leading to higher drug prices and reduced access to affordable medicines.

Smith, J., et al. (2018) provide a comprehensive overview of data exclusivity in the

pharmaceutical industry. They explore the legal and regulatory aspects of data exclusivity,

emphasizing its role in protecting pharmaceutical innovation and market access. Their

work sheds light on the complexities of data exclusivity and its implications for

pharmaceutical companies.

In Brown, M., et al. (2020) they have analyzed the interplay between data exclusivity, IPRs,

GDPR, and the EHDS. They examine how these elements intersect and influence data

protection, innovation, and market dynamics in the pharmaceutical industry. Their

research provides insights into the complex relationships between these key factors.

In comparative analysis of data exclusivity laws can offer valuable perspectives on the

regulatory framework governing pharmaceuticals and the impact on innovation,

competition, and access to medicines. By identifying best practices and challenges in data

exclusivity laws, policymakers, regulators, and industry stakeholders can work towards

improving the regulatory environment for pharmaceuticals.

15
Chapter 3:Research Methodology

3.1 Introduction

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Data exclusivity protects pharmaceutical companies' clinical trial data submitted to

regulatory authorities for drug approval, typically lasting five to ten years. During this

period, no other company can use this data to gain regulatory approval for the same drug.

This protection is separate from patent protection, which grants a monopoly on

manufacturing and selling a drug for about twenty years. Alongside patents and

trademarks, trade secrets and copyright-like protections also play roles in pharmaceutical

intellectual property. Trademarks, in particular, assist help consumers identifyrecognizing

products and can support a competitive market by ensuring accurate information and

distinguishing producers. They also signify quality and safety, especially in countries with

limited consumer safety regulations. Although drugs which comes with brand-name tag are

highly expensive.While brand-name drugs are often more expensive,, trademarks are crucial

for market competition and consumer choice. In contrast, patents prevent others from

using, making, or selling protected technology for the patent's term, based on specific

claims subject to strict examination. Trade secrets, on the other hand, offer potentially

perpetual protection but are subject to limitations such as independent origination or

reverse engineering. Overall, intellectual property protection, including data exclusivity,

patents, trademarks, and trade secrets, is essential for incentivizing innovation in

pharmaceuticals and ensuring consumer safety and choice. David Schwartzman believes

Strongly petite protection does not always spur innovation . He points to drug discovery

discoveries in Western Europe , especially Switzerland, where patent laws are less strict.

However, US patent matter significantly due to the massive for pharmaceutical market, covering

both domestic and foreign products sold within the country. David Schwartzman has said

that strong patent protection did not encourage discovery based on the fact that a large number

17
of drugs were discovered in Western Europe, especially Switzerland, where inventions were

less generously protected by patents than in the United States. But U.S. patents protect

these products of foreign-based companies sold in the United States as much as they do

the products of domestic companies, and the United States is by far the largest single

national market for drugs.

3.2 Scope of the study

The study utilizes individual-level information derived from the MEPS (Medical Expenditure

Panel Surveylevel data from the Medical Expenditure Panel Survey (MEPS) ) spanning 1996 to

2011. This dataset contains detailed individual purchase records, enabling researchers to

employ an individual-level demand model. This approach allows that how for an to

examination of individual characteristics how individual characteristics (such as

demographics, socioeconomic status, condition of healthhealth status, and coverage of health

insurance) and drug attributes (for example: MRP of Drug like drug market price, out-of-

pocket price per patient, and quantity) collectively influence patient demand. Unlike using

market list prices, which could underestimate changes in price (price sensitivity), this study

calculates price ,estimates price elasticities using copay prices.

Many developed countries are grappling with escalating healthcare expenditures, with

pharmaceutical sector growth rates surpassing other sectors. To control pharmaceutical

spending, regulators have employed various mechanisms, including price controls and the

promotion of generic drugs. The policy of market exclusivity, designed to incentivize

innovation, has become a focal point in discussions aimed at curbing rising healthcare

costs. Some studies argue that this policy allows large pharmaceutical companies to profit

18
excessively from prolonged exclusivity periods, contributing to escalating healthcare

spending.

Before the UK's departure from the EU Until the UK's departure from the EU and the end of the

"Transition Period" on 31 December 2020, the principal data protection legislation in the

UK was Regulation (EU) 2016/679 (the "General Data Protection Regulation" or

"GDPR"). The GDPR replaced ealed Directive 95/46/EC the(the "Data Protection

Directive") and resulted in a riseand led to increased (though not at alltotal)

Tharmonisationhe process of coordinating data protection regulations across

the different member states of the European Union of data protection law across

the EU Member States. EU member states have the ability to modify certain aspects of the

GDPR to match their national laws.Some provisions in the GDPR can be adapted to EU Member

States' national laws. The Data Protection Act 2018 was enacted by the UK Government, and

there have been several subsequent revisionsTherefore, the UK Government passed the Data

Protection Act 2018, and several subsequent amendments, The Data Protection Act of 2018

covers the parts of the GDPR that EU member states can modify or supplement, and also areas

that are not subject to EU lawwhich cover those areas of the GDPR that EU Member States

could add to or vary or that do not fall within EU law. May 25, 2018 marked the effective date

for the Data Protection Act 2018.The DPA 2018 came into force on 25 May 2018.

The implementation of the EU's data exclusivity rules is viewed as a consequence of regulatory

capture. The EU's adoption of its data exclusivity regime is seen as a result of regulatory capture.

Initially introduced in 1987, data exclusivity was heavily influenced by pharmaceutical

19
industry lobbying, which argued for the needrequire to safeguard European research and

development (R&D). Directive 87/21/EEC established Exclusive data rights are granted to

most medicines for six years after their initial marketing approvalsix years of data exclusivity for

most medicines from their first marketing approval, extending to ten years for biotech

products. Member states had the option to extend data exclusivity to 10 years if deemed "in

the interest of public health," leading to varying data exclusivity regimes across Europe.

Member states had the option of not extending the six-year period beyond the expiration of a

patent that covered the original product.Notably, member states could choose not to apply the

six-year period beyond the expiry of a patent protecting the original product.

The introduction of Certain data has exclusive rights data exclusivity coincided with diverse

pharmaceutical patenting practices among EU member states. Greece, Spain, and Portugal

are examples of countries that did not provide patents for pharmaceutical products. For instance,

countries like Greece, Spain, and Portugal did not offer pharmaceutical product patents. The EU

introduced the Supplementary Protection Certificate (SPC) in 1992, which provides up to five

years of extra patent protection for medicines. In 1992, the EU introduced the Supplementary

Protection Certificate (SPC), providing up to five years of additional patent protection for

medicines. However, the SPC's effect was limited to countries with existing medicines

patents, excluding those without patent protection or with recently introduced patent

systems. Against this backdrop, data exclusivity was viewed as a partial solution to

perceived deficiencies in protection of patent patent protection for the pharmaceutical

industry.

20
Following the UK's departure from the EU, the GDPR was incorporated into the domestic law

that applies in the UK, under Section 3 of the European UnionFollowing the UK’s departure

from the EU, the GDPR was incorporated into the domestic law that applies in the UK, under

Section 3 of the European Union (Withdrawal) Act 2018 and the DPA 2018, as amended by

the Data Protection, Privacy and Electronic Communications (Amendments, etc.) (EU

Exit) Regulations 2019. The amended GDPR (the “UK GDPR”) and the DPA 2018 are

now the principal pieces of data protection legislation in the UK.

The UK left the EU on 31 January 2020. On this date, the European Union (Withdrawal) Act

2018 (2018 Act) repealed the European Communities Act 1972UK left the EU on 31 January

2020. On this date, the European Union (Withdrawal) Act 2018 (2018 Act) repealed the

European Communities Act 1972, The European Union (Withdrawal Agreement) Act 2020 was

passed concurrently with the EU law that took effect in the UKby which EU law ultimately took

effect in the UK. At the same time, the similarly titled European Union (Withdrawal Agreement)

Act 2020 (2020 Act) changedimplemented in UK law the Withdrawal Agreement – that is,

Boris Johnson's "oven-ready deal" – agreed between the UK and EU, which includes the

"Northern Ireland Protocol" amongst other matters.

Mentions of regulatory bodies and locations will be restricted to UK-based agencies and the UK

nation stateFor instance, references to regulatory agencies and to geographies will be limited to

UK agencies and to the UK as a nation-state. The UK legislation also has to deal also with the

complication of Northern Ireland remaining under EU rules rather than UK ones as a

result of the Northern Ireland Protocol.

21
Since centralized marketing authorizations (MAs) issued by the European Medicines

Agency (EMA) are meant to be valid across all EU member states, they will no longer

apply in the UK after 01, January 1, 2021 in UK. That Tthe Medicines and products of

healthcare Healthcare Products Regulatory Agency (MHRA) has arranged for existing

centralized authorizations forto automatically convert into Great Britain's (excluding

Northern Ireland) regulations, and MA holders will receive a new UK MA number on

January 1, 2021.

A comparison of data exclusivity regime

S.No. WTO TRIPS United States European Union

Scope of Against of unfair Grant of exclusive Grant of exclusive rights.

pProtection’ commercial use rights. No No use/disclosure/reliance

s Scope and disclosure use/disclosure/reliance permitted

permitted

Data Undisclosed data - -

protected that involved

considerable effort

to generate and of

which the

submission is

required for

marketing

approval

Protection - 5 years for NCEs + 3 8 years data exclusivity + 2

22
 period years of market years market exclusivity +

exclusivity for new 1 year market exclusivity

indications In parallel, for new indications

12 years for biologics

Type of Limited to new NCEs and new New medicinal products

drug chemical entities indications/new uses and new indications/new

(NCEs) uses

The highly regulated nature of the pharmaceutical sector makes compliance a significant cost,

particularly when generating clinical andThe highly regulated nature of the pharmaceutical

sector makes compliance a significant cost, particularly when generating the clinical and non-

clinical data requiredneeded to support a marketing authorisationauthorization.

3.3 Research Objectives

Many countries safeguard 'test data' from unfair commercial use through various means.

These include safeguarding it from dishonest commercial practices while enabling its utilization

to register a generic productprotecting it against dishonest commercial practices while allowing

its use to register a generic product, permitting generic reliance on the test data provided that

the entity that generated the data receives compensationbut with compensation to the entity that

generated the data (referred to as a 'data compensation' regime), or allowing generic

reliance on the data while imposing a 'data exclusivity' regime on the originator to use it

exclusively.making its use exclusive to the originator (a 'data exclusivity' regime).

Data exclusivity has become increasingly common as a means to protect the test data.

Under data exclusivity provisions, a generic company is barred from using or referencing

23
another company's clinical test data for a specified period when registering a generic

product. This can lead to delays in generic products entering in the market. The rationale

behind data exclusivity is that generating such data, such as through clinical trials, requires

substantial investments. Protecting it from generic companies is viewed as a way to encourage

medical research and development (R&D). Protecting it from use by generic companies is thus

seen as a way to incentivize medical research and development (R&D). The concept of the Drug

Price Competition and Patent Term Restoration Act of 1984 led to the introduction of data

exclusivity in the US in 1984data exclusivity was first introduced in the US in 1984 through the

Drug Price Competition and Patent Term Restoration Act of 1984, is also known as the Hatch-

Waxman Amendments.

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual

Property Rights (TRIPS) mandates WTO members to protect certain types of test data

against unfair commercial use, specifically for new chemical entities that are previously

undisclosed, required for marketing approval, and require significant effort to generate.

TRIPS Article 39.3 mandates that members safeguard such data from disclosureTRIPS Article

39.3 requires members to protect such data from disclosure, unless necessary to protect the

public or steps are taken to ensure its protection against unfair commercial use. The

provision does not require protection under a data exclusivity regime, nor does it prohibit the use

of the data to approve a competing productThis provision does not mandate protection under a

data exclusivity regime, nor does it prohibit the use of the data for approving a competing

product, which some argue does not constitute 'unfair commercial use'. Developing country

members reiterated this position at the 2001 Doha Ministerial, stating that The data owner

does not need to be granted 'exclusive rights' under Article 39.3 Article 39.3 does not require

24
granting 'exclusive rights' to the data owner and permits a national competent authority to

rely on data in its possession to assess subsequent continuously applications for the same

drug.

According to the MedsPaL database, data exclusivity is not provided by most WTO members,

and only around 16 middle-income countries are offering itMost WTO members do not provide

data exclusivity, as indicated by the MedsPaL database, with only around 16 middle-income

countries offering it, often through agreements with the EU or US that are not part of the WTO

trade agreements with the EU or US outside the WTO. In the EU, data exclusivity

requirements exceed the TRIPS mandate, preventing generic companies from relying on or

referencing preclinical aClinical test data from the original manufacturer to demonstrate the

safety and efficacy of the compound for which they seek marketing authorization.nd clinical test

data of the original manufacturer to demonstrate the safety and efficacy of the compound for

which they seek marketing authorization. While data exclusivity rules don’to not prohibit

generic companies from generating their own clinical efficacy data, this process is

expensive and raises ethical concerns. As a result, generic companies rarely conduct such

trials, effectively creating strong monopolies without exceptions or limitations.

The global harmonization of patent rules through the GATT negotiations and the

establishment of the WTO, along with further European integration, strengthened

medicines patenting in European countries. Despite expectations that Strong patent regimes

in the EU would reduce the push for additional market exclusivities for medicines. However, this

did not happen.strong patent regimes in the EU would reduce the push for additional market

exclusivities for medicines, this did not happen.

25
In 2004, EU data exclusivity rules were further harmonized and extended from a minimum

of six years to eight years of data exclusivity, plus two years of market exclusivity during

which generic companies could Prepare and apply for marketing approval, but refrain from

marketing the product. prepare and apply for marketing approval but not market the product. For

a new indication with significant added clinical benefits, the originator company can obtain an

additional year of market exclusivity.An additional year of market exclusivity could be obtained

by the originator company for a new indication with significant added clinical benefit. This is

new EU exclusivity regime, known as the 8+2+1 rule, is the most generous globally and

coverings both biological and small molecules and biological products. Conversely In contrast,

the US grants five years of exclusivity for small molecule new chemical entities, three years

for a new indication of a previously approved medicine, and four years for biologics

(complemented by a parallel 12-year market exclusivity). Japan grants 6six years of data

exclusivity.

Patent law's flexibility allows governments to use patents without the patent holder's

consentRegarding patents, governments can use flexibilities in patent law to make use of a patent

without the patent holder's consent, based on the need to act in the public interest.

For instance, when a patent blocks access to a more affordable generic medicine and the

originator product is priced significantly higher than what a country is willing to pay,

flexibilities in patent law can be used. These flexibilities, recognized in the 2001 WTO Doha

Declaration on TRIPS and Public Health, are crucial tools for promoting and safeguarding

access to medicines for everyone. Several European governments, such as Belgium, Ireland,

26
France, the Netherlands, Norway, Scotland, Spain, Sweden, Switzerland, and the UK, have

been asked / or are considering issuing compulsory licenses for important medicines,

including those for hepatitis C and cancer, Healthcare systems that are not affordable are not

availablewhich are not available at affordable prices for their healthcare systems. In their patent

laws, these countries have the necessary provisions for compulsory licensing or government use

of patents. These countries have the necessary provisions for compulsory licensing or

government use of patents in their patent legislation. However, for medicines approved

through the centralized procedure at the EMA, implementing a compulsory license may

not be feasible.

That Tthe European Commission acknowledgedrecognized that the "Community

pharmaceutical acquis does not currently contain any provision allowing a waiver of the

rules on data exclusivity and marketing protection periods." Despite this, that the

European Commission has yet to propose an express explicit waiver in EU

pharmaceutical legislation forto enable to the effective use of compulsormandatory

licensing for production and supply within the EU.

3.4 Research Questions

That Tthe TRIPS Agreement, developed within the World Trade Organization (WTO), is a

crucial document in in internationalforeign intellectual property (IP) protection. Established

in 1994, it was a landmark in merging IP concerns with global trade regulations.

That Tthe agreement sets out minimum standards for protecting and enforcinsafeguardingg

different types of intellectual property, including patents, trademarks, copyrights, trade

secrets, and related rights. Key provisions include:

27
a. Patent Protection

b. Copyright and Related Rights

c. Trademarks

d. Enforcement Mechanisms

3.5 Hypothesis
3.5.1 Impact on International Trade
The TRIPS Agreement significantly impacts international trade by integrating intellectual
property considerations into the broader framework of the WTO. Intellectual property
rights have become a vital aspect of global commerce, influencing trade patterns,
investment decisions, and technology transfer. The following aspects highlight the impact
of the TRIPS Agreement on international trade:

a. Technology Transfer

b. Market Access and Investment

c. Dispute Resolution

3.5.2 Challenges and Criticisms

While the TRIPS Agreement has undoubtedly played a pivotal role in harmonizing
international intellectual property standards, it has not been without challenges and
criticisms. Some of the key issues raised include:

a. Access to Medicines

b. Technology Transfer Disparities

c. Flexibility and Policy Space

3.5.3 Evolving Relevance in the Contemporary Landscape

As the global landscape continues to evolve, the relevance of the TRIPS Agreement remains
a subject of ongoing debate. Several factors contribute to its evolving significance:

a. Technological Advancements

28
b. Public Health Imperatives

c. Sustainable Development Goals

3.5.4 Future Prospects and Potential Reforms

As the international community grapples with the challenges and opportunities presented
by the TRIPS Agreement, discussions about potential reforms and prospects have gained
momentum. Some areas of consideration include:

a. Flexibility and Development

b. Access to Medicines

c. Technology Transfer and Capacity Building

The 20-year patent term and up to 5 years of additional protection give it extra protection
Because of the 20-year patent term plus up to 5 years of additional protection, the data
exclusivity period for the product usually expires before other exclusivities expire, which
leads to the question of whether the data exclusivity system might be obsolete. The industry
is keen to maintain it, but their main driver seems to be strategicThe industry is keen to maintain
it but their main driver seems to be strategic: create as many layers of exclusive
rights as possible to discourage competitors from entering the marketcreate as many layers
of exclusive rights as possible to discourage competitors from entering the market. As a
result, it may leave weak patents unchallenged because why would a generic
company undertake a patent opposition when it knows in case of success it will still
not be able to register the product until after the data exclusivity and market
exclusivity periods have expired?
The EU promotes data exclusivity with its trading partners, for example by
demanding the introduction or strengthening of data exclusivity in trade agreements
with other nations. on Ukraine-EU Trade Agreements, below. The EU is also
demanding the introduction of data exclusivity in trade negotiations with the Latin
American trading block Mercosur (Argentina, Brazil, Paraguay and Uruguay). Currently,
none of the countries provide data exclusivity.

29
The EU is also demanding the introduction of data exclusivity in trade negotiations
with the Latin American trading bloc Mercosur (Argentina, Brazil, Paraguay and
Uruguay). Currently, none of the countries provide data exclusivity.

Today the EU’s objective with regards to intellectual property in trade talks remains to
obtain similar levels of intellectual property protection in countries outside the EU as are
maintained inside the EU. For example, the EU–Vietnam trade and investment agreement
binds Vietnam to introduce data exclusivity of at least 5 years.

3.6 Impact of the Ukraine-EU Trade Agreement on Access to Hepatitis C Medicine

The Doha Declaration did not guide the trade talks between the EU and Ukraine. As a
result of the EU-Ukraine Deep and Comprehensive Free Trade Agreement (DCFTA),
Ukraine introduced a fiveyear data exclusivity period for medicine The Doha Declaration
did not guide the trade talks between the EU and Ukraine. As a result of the EU-
Ukraine Deep and Comprehensive Free Trade Agreement (DCFTA), Ukraine
introduced a fiveyear data exclusivity period for medicines. This introduction had an
immediate effect on the treatment of hepatitis C in the country. Sofosbuvir, an
essential medicine for the treatment of hepatitis C, was not patented in Ukraine. The
Egyptian company Pharco was the first to apply for marketing authorisation for a
generic version of sofosbuvir on 28 November 2014 (via its distributor Europharma
International LLC). Later, the originator company, Gilead, applied for marketing
authorisation on 9 June 2015 but was the first to obtain marketing authorisation on 9
October 2015. On 18 November 2015, Pharco also received marketing authorisation
Later, the originator company, Gilead, applied for marketing authorisation on 9 June
2015 but was the first to obtain marketing authorisation on 9 October 2015. On 18
November 2015, Pharco also received marketing authorisation. In June 2016, Gilead
filed a court case against Pharco's distributor in Ukraine and against the regulatory
agency on the grounds that it was entitled to data exclusivity until 2020. Gilead was
also threatened with an investor-state dispute. In response to this threat, the Ukraine
government revoked Pharco's generic registration and established Gilead's
monopoly position in the market.

30
3.7 Access to Hepatitis C Medicines in Romania in 2016
The government of Romania considered issuing a compulsory license for the hepatitis C
drug sofosbuvir. In Europe, the medication was only available from the original company
at a cost of approximately €50,000 for a 12-week treatment. In contrast, a generic version of
sofosbuvir-ledipasvir was available in Egypt, where there are no patents on the compound,
for US$400 for a full treatment. However, a generic version of sofosbuvir cannot be
registered in the EU before the expiration of data exclusivity in 2022, and market exclusivity
for sofosbuvir in the EU expires at the earliest in 2024. The government of Romania
considered issuing a compulsory license for the hepatitis C drug sofosbuvir. In Europe,
the medication was only available from the original company at a cost of approximately
€50,000 for a 12-week treatment. In contrast, a generic version of sofosbuvir-ledipasvir
was available in Egypt, where there are no patents on the compound, for US$400 for a
full treatment. However, a generic version of sofosbuvir cannot be registered in the EU
before the expiration of data exclusivity in 2022, and market exclusivity for sofosbuvir
in the EU expires at the earliest in 2024. Consequently, Romania, like other EU
member states, cannot issue a compulsory license due to these restrictions. This case
highlights the challenges posed by EU data and market exclusivity to the effective
use of compulsory licensing.
After Ttwelve years later, EU pharmaceutical legislation still does not allow for
exceptions to data and market exclusivity. Even in cases of national emergency or other
urgent situations, EU law does not provide explicit waivers to authorize the marketing of a
generic product before the expiry of these exclusivity periods Even in cases of national
emergency or other urgent situations, EU law does not provide explicit waivers to
authorize the marketing of a generic product before the expiry of these exclusivity
periods. While issuing a compulsory license to overcome patents blocking the use of
a generic medicine falls under national law, regulatory requirements for EU-wide
marketing authorization, including data exclusivity, fall under EU pharmaceutical
legislation. These parallel legal systems lack coherence, both in terms of the effective
use of compulsory licensing by EU member states and regarding public interest
exceptions to data exclusivity more broadly. The need to provide data exclusivity

31
waivers to ensure the effective availability of generic medicines is often recognized in
voluntary licensesThe need to provide data exclusivity waivers to ensure the effective
availability of generic medicines is often recognized in voluntary licenses. For example,
all Medicines Patent Pool (MPP) licenses include a data exclusivity waiver to
facilitate regulatory approval of generic medicines manufactured by MPP’s licensees.
There are exceptions to data and market exclusivity rules when medicines manufactured
under a compulsory license are intended for markets outside the EU. This is governed by
the EU Regulation on compulsory licensing of patents for the manufacture of
pharmaceutical products for export to countries with public health problems outside the
EU. Article 18 of this Regulation allows the applicant for a compulsory license to use the
scientific opinion procedure of the European Medicines Agency (EMA) or similar national
procedures to assess the quality, safety, and efficacy of medicines intended exclusively for
markets outside the EU. This provision provides waivers to exclusivity rules necessary to
obtain such opinions from the EMA or national authorities.
There are exceptions to data and market exclusivity rules when medicines manufactured under a

compulsory license are intended for markets outside the EU. This is governed by the EU

Regulation on compulsory licensing of patents for the manufacture of pharmaceutical products

for export to countries with public health problems outside the EU. Article 18 of this Regulation

allows the applicant for a compulsory license to use the scientific opinion procedure of the

European Medicines Agency (EMA) or similar national procedures to assess the quality, safety,

and efficacy of medicines intended exclusively for markets outside the EU. This provision

provides waivers to exclusivity rules necessary to obtain such opinions from the EMA or

national authorities.

32
Chapter 4: Legal Framework of Data Exclusivity

33
Chapter 5: Impact of GDPR on Data Exclusivity

34
Chapter 6: Role of IPRs in Data Exclusivity and Innovation

35
Chapter 7: Comparison of Data Exclusivity Laws Across Jurisdictions

36
Chapter 8: Ethical and Legal Implications

37
Chapter 9: Policy Recommendations

38
Chapter 10: Conclusion

39
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