A Trade Agreement's Impact On Access To Generic Drugs

Shaffer, Ellen R.; Brenner, Joseph E.

doi:10.1377/hlthaff.28.5.w957

Cited by 58 publications

(36 citation statements)

References 2 publications

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“…A 2012 joint report from the WTO, the WHO, and the World Intellectual Property Organization describes the impact of TRIPS-Plus provisions-particularly data exclusivity provisionsdictated by trade agreements in Costa Rica, the Dominican Republic, Colombia, and Jordan, as increasing the expenditure on medicines by tens of millions of dollars (149) (119). The extension of IP protections in FTAs acts as a barrier to the generic pharmaceutical industry's ability to manufacture and distribute cheaper medicines sooner and, thus, acts as a barrier to affordable, timely access to medicine (86).…”

Section: Health Servicesmentioning

confidence: 99%

Trade Policy and Public Health

Friel

Hattersley

Townsend

2015

Annu. Rev. Public Health

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Twenty-first-century trade policy is complex and affects society and population health in direct and indirect ways. Without doubt, trade policy influences the distribution of power, money, and resources between and within countries, which in turn affects the natural environment; people's daily living conditions; and the local availability, quality, affordability, and desirability of products (e.g., food, tobacco, alcohol, and health care); it also affects individuals' enjoyment of the highest attainable standard of health. In this article, we provide an overview of the modern global trade environment, illustrate the pathways between trade and health, and explore the emerging twenty-first-century trade policy landscape and its implications for health and health equity. We conclude with a call for more interdisciplinary research that embraces complexity theory and systems science as well as the political economy of health and that includes monitoring and evaluation of the impact of trade agreements on health.

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Section: Health Servicesmentioning

confidence: 99%

Trade Policy and Public Health

Friel

Hattersley

Townsend

2015

Annu. Rev. Public Health

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“…A recent study showed that the implementation of a data exclusivity regime in Guatemala, mandated by DR-CAFTA, resulted in generic competition being denied entry to the Guatemalan market. 72 In each case, the available originator drugs were priced substantially higher. 73 Especially in those countries which, pre-TRIPS, did not grant patents for pharmaceuticals, data exclusivity can be an efficient method to ensure market exclusivity for originator drugs and prevent generic competition in that market.…”

Section: Data Exclusivity and (Affordable) Access To Medicines In Devmentioning

confidence: 99%

Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

Diependaele¹,

Cockbain²,

Sterckx³

2016

Developing World Bioethics

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Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional 'regulatory' protection for new medicines, known as data exclusivity.Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from 'free-riding' encounters some important problems: Neither legitimize excluding all others.

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“…In Jordan, the application of data exclusivity increased medicine price by 20% from 2001 to 2009 (Shaffer & Brenner, 2009). For cancer and cardiovascular medicines, in particular, prices increased by 2-10 times.…”

Section: The Impact Of Increased Medicine Pricesmentioning

confidence: 99%

“…Studies of the impacts of similar trade agreements, such as the Central America Free Trade Agreement (CAFTA) and other bilateral agreements between the USA and developing countries, revealed that these agreements reduced access to some generic drugs already on the market and delayed the entry of other new generics (Rohit, 2007;Shaffer & Brenner, 2009). During the early 2000s, generic competition led to a precipitous price reduction in antiretroviral therapy (ART) from over USD 10,000 per person per year (ppy) in 2000 to under USD 75 ppy by 2011 (El Said & Kapczynski, 2011).…”

Section: Introductionmentioning

confidence: 99%

Evolving trade policy and the Trans-Pacific Partnership Agreement: Does it threaten Vietnam's access to medicine and its progress towards scaling up HIV prevention, treatment and care?

Linh

Huong

Thuy

2014

Global Public Health

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The Trans-Pacific Partnership Agreement (TPP) has undergone 18 rounds of secretive negotiation between the USA and 11 Asia-Pacific countries. Aiming at a free trade area, this multilateral trade proposal covers all aspects of commercial relations among the countries involved. Despite some anticipated positive impacts in trade, specific articles in this proposal's intellectual property and transparency chapters might negatively impact access to medicine, in general, and to antiretroviral (ARV) drugs, in particular, in Vietnam. Drawing on a desk review and qualitative in-depth interviews with 20 key informants from government, academia, hospitals and civil society, we analyse various provisions of the proposal being negotiated leaked after the 14th round of negotiations in September 2012. Findings suggest that the TPP could lead to increased monopoly protection and could limit technological advancements within the local pharmaceutical manufacturing industry, resulting in higher medicine prices in Vietnam. This outcome would have a significant impact on Vietnam's ability to achieve goals for HIV prevention, treatment and care, and create barriers to universal health-care coverage. This research provides unique evidence for Vietnam to advocate for more equitable pharmaceutical provisions in and to raise awareness of the implications of the TPP among the pharmaceutical stakeholder community in Vietnam.

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A Trade Agreement's Impact On Access To Generic Drugs

Cited by 58 publications

References 2 publications

Trade Policy and Public Health

Trade Policy and Public Health

Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

Evolving trade policy and the Trans-Pacific Partnership Agreement: Does it threaten Vietnam's access to medicine and its progress towards scaling up HIV prevention, treatment and care?

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