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Data exclusivity regulations in India

Short Factsheet:

Data Exclusivity Regulations in India:
Access to HIV/AIDS Treatment and Public Health Implications

Jeremy Clark Ogusky

"As we enjoy great advantages from the inventions of others, we should be glad of an opportunity to serve others by any invention of ours; and this we should do freely and generously.
— Benjamin Franklin
Disparity is a shocking reality that we cannot hide from. This is a global injustice. It is a travesty of human rights on a global scale.
— Nelson Mandela’s remarks on the lack of access to antiretroviral drugs at the International AIDS Society Conference in 2003


India is a major supplier of the world’s generic medicines, drugs that are the bioequivalent to brand name patented ones with respect to pharmacokinetic and pharmacodynamic properties, but normally sold at lower prices [1]. India then exports two-thirds of its generic drugs to developing countries. These exports are critical for addressing and treating a great number of public health illnesses and in the global fight against AIDS. Because of the prohibitive costs of many antiretroviral drugs that fight HIV/AIDS, generic drugs are vital, especially the competition of generic drug production in India. India has been largely responsible for reducing the prices of antiretrovirals by as much as 98% [2] and thus Indian generic manufacturing clearly plays an integral role in the global fight against HIV/AIDS and collective strategy towards Health For All [3].

Today, 6.5 million people around the world urgently require HIV treatment and only 1.3 million are receiving therapy [4]. New Indian pharmaceutical patenting regulations, such as data exclusivity, will severely hinder generic AIDS drugs manufacturing and decrease access to AIDS therapy globally. The world’s poor overwhelmingly make up this population with lack of access [5]. Because of this, moral human rights and distributive justice approaches, in addition to a public health approach that is focused on the health of us all, compel us to take an equity-oriented approach in access to AIDS medicines. If not, the 6.5 million in need of access to AIDS drugs will grow exponentially as the epidemic grows and we will be less able to cope with the epidemic now, in terms in mitigation, and into the future, as access to drugs plays a large role in HIV prevention.

Data Exclusivity

Two Indian laws affect the production of generic medicines in India: the Indian Patent Act and the Indian Drugs and Cosmetics Act. In March of 2005, India amended its 1970 Patent Act in order to gain admittance to the World Trade Organization (WTO) and become compliant with TRIPs (Trade-Related Aspects of Intellectual Property rights), an important WTO regulation. In a special letter to the Prime Minister and President of India on the Amendments to the Patents Act that eventually passed, the Special Envoy of the UN Secretary-General on HIV/AIDS in Africa, Stephen Lewis, urged, “That every flexibility offered by the TRIPs Agreement be incorporated in the President’s Patent Ordinance and that no ‘TRIPS-plus’ provisions are included which would jeopardize the continued supply of crucial, affordable AIDS therapies and other essential medicines by India to the world. It is not possible to exaggerate the international importance of the decisions facing India [6].” The amendments that passed proved not as restrictive to future generic drug production as many feared. They were not TRIPs “plus” additional unneeded regulations, but they did clear the way and left open the strong possibility for future tightening of generic production [7].

In his letter, Lewis wrote of the valuable flexibilities in the TRIPs agreement, two of which are compulsory licensing and parallel imports. These two regulations grant countries the right to locally produce or import generic life-saving medications when the need is deemed to be great [8]. Due to these flexibilities, there have been massive efforts on behalf of the Western pharmaceutical industry at international trade meetings to restrict and repeal these rights and pressure for greater protection of patented medicines. These efforts have largely failed due to global citizen activism and countries advocating in unison against these restrictive efforts.

Because of this, the international pharmaceutical industry has become more focused on the local level, pressuring governments to not take advantage of their TRIPs-designated rights. Pharmaceutical lobbyists have also pressured governments, the Indian one in particular, to introduce more restrictive language into national law and regional trade agreements; language and regulations that include exclusive rights of patent protection and lessened ability for generic drug production. Due to this pressure on behalf of pharmaceutical companies, the US Government and United States Trade Representative (USTR), the Indian government is currently considering the addition of data exclusivity provisions in an amendment to the Indian Drugs and Cosmetics Act. If enacted, these provisions would create tremendously large barriers to registering generic medicines within India, and in turn, negatively affect India’s ability to provide affordable generic drugs to millions of people around the world.

According to the International Federation of Pharmaceutical Manufacturers Association, “Data exclusivity is an independent intellectual property right and should not be confused with the protection provided by other rights, especially patents. It provides the holder with specific rights, namely that the data generated by the holder may not be referred to or used by another person or company for a specific period of time [9].” In effect, the specific right over the product safety and efficacy data created by the patent holder would be tightly held and not applied to off-patent (generic) drugs. The data exclusivity currently up for debate in Indian legislation would last for up to 20 years for newly registered medicines, whether patented or not. This might seem innocuous, but there would be harmful public health consequences.

According to Professor Brook Baker, of the Northeastern University School of Law, data exclusivity would practically bar new generic production of many important drugs.

This exclusivity would ordinarily prevent national drug regulatory authorities from registering a generic alternative of a medicine containing a “new chemical entity” because that competing product could not compare its product for safety and efficacy against the confidential registration data previously submitted by the right holder. Thus, in order to enter even small and marginally profitable markets in developing countries, generic competitors would be required to duplicate costly, time-consuming, and ultimately unethical clinical trials in order to establish safety, quality, and efficacy. Few, if any, will be willing to do so given marginal purchasing power in most developed countries. Unfortunately, even five years of data-exclusivity protection from competition is not enough to satisfy PhRMA [The Pharmaceutical Research and Manufacturers of America] and its USTR proxies. Accordingly, the U.S. is now seeking to link rights of registration to patent status. This linkage, creating an ironclad system of market exclusivity, would require a drug registration authority to postpone registration of a generic competitor until expiration of the entire 20-year patent term. As a practical matter, five-year data exclusivity and patent-term market exclusivity will fully bar access to the newest medicines, relegating consumers in developing countries to the charitable whims of proprietary manufacturers [10].

With data exclusivity regulations in place, generic competitors would not be able to use the data generated by the patent holder for a minimum of five years. The US Trade Representative backed by PhRMA, though, would prefer to lengthen this time period to the entire 20 year patent tenure, and thus generic production of new medicines would come to a virtual stand-still.

As India is one of the largest global suppliers of low-cost generic medicines, without access to these Indian generic drugs, millions of people in developing countries will lose access and die. Many people, such as Indian Nobel laureate and economist Amartya Sen, recognize this and agree that the government of India must subject the issue of patent rights to “greater scrutiny,” adding that, “This is a serious issue where the Government of India must make itself heard in the world community. I hope the government will do this with humanity [11].”

Why data Exclusivity?

Current TRIPs regulations do not include data exclusivity clauses and thus India is not obligated to add these new clauses to their Drugs and Cosmetics Act. Data exclusivity is a new protectionist strategy being advocated by the United States Government and pharmaceutical companies, as they have recently been unable to abolish the rights to issue compulsory licenses and parallel importing of patented drugs, two WTO sanctioned tactics to uphold drug access for the world’s poor. Because these patent-based tactics have been upheld, an alternative registration-based strategy is being advocated and demanded by our country’s official trade delegate. The USTR has openly lobbied for data exclusivity mainly through bilateral and multilateral trade agreements like CAFTA, the new Central American Free Trade Agreement.

One of the key implementation priorities that we have focused on in this year’s review is the implementation of Article 39.3 of the TRIPS Agreement, which requires WTO Members to protect test data submitted by drug companies to health authorities against disclosure of that data and against “unfair commercial use” of that data [12].

The key part of Article 39.3 is in the interpretation of ‘unfair’ use of the test data. If unfair use is defined strictly and data exclusivity enforced, this monopolistic data protection beyond what is contained in TRIPS will obstruct efforts at compulsory licensing and irreparably harm global access to antiretrovirals.

We as activists, US citizens, and supporters of equitable global access to life-saving drugs must all understand what are seemingly mundane trade policies such as data exclusivity and who are their proponents. We must advocate that the United States promote more fair trade policies and that countries like India resist the pressure to adopt unfair policies.

In the words of Brook Baker,

Drug regulatory agencies in developing countries must be permitted to use previously filed proprietary data on drug safety and efficacy in order to access the bio-equivalence of more affordable generic alternatives. Without this option, poor people in the Global South will wait five years at a minimum for access to newer medicines. In many instances, they will wait much longer as drug companies unfold their cynical evergreening strategies designed to extend patent protection well beyond a single 20-year term and thereafter use patent/registration linkage to delay marketing approval for decades [13].

Current TRIPs regulations do not include data exclusivity clauses and thus India is not obligated to add data exclusivity laws to their Drugs and Cosmetics Act. New data exclusivity provisions will disastrously affect our collective worldwide health and thus we all should both urge and demand that the Indian government stand up to the immense pressure of multinational pharmaceutical companies and the United States to bring these TRIPs-plus changes.


[1Wikipedia definition of ‘generic drug.’ Accessed July 12, 2006



[2Health GAP (Global Access Project) Action Alert. “India Could Cut-off Africa’s Access to Affordable AIDS Drugs; Indian Parliament May Begin Considering the Issue March 9.” March 6, 2005. Accessed July 12, 2006

[3For more information, read through the People’s Charter for Health, a document and movement reflecting the 1978 Alma-Ata Conference that called for ‘Health for All by the Year 2000.’ Or see Hall JJ, Taylor R. “Health for all beyond 2000: the demise of the Alma-Ata Declaration and primary health care in developing countries.” Med J Aust. 2003 Jan 6;178(1):17-20. Accessed July 27, 2006

[4Patrick Watt and Tom Sharman. “Mission unaccomplished: One year on from Gleneagles, is the G8 hitting its targets on debt, trade and aid?” Action Aid technical documents, June 2006. Accessed July 27, 2006

[5David McCoy. “Health Sector Responses to HIV/AIDS and treatment access in Southern Africa: Addressing equity.” Equinet Discussion Paper Number 10, October 2003. Accessed July 27, 2006

[6Lewis, Stephen. “Letter from U.N. Special Envoys for HIV/AIDS to the Prime Minister and President of India on the Amendments to the Patents Act Under Debate.” March 11, 2005. Accessed July 26, 2006

[7McNeil, Donald G. “India Tightens Law, Alarming Advocates for AIDS Patients.” New York Times on the web, March 23, 2005. Accessed July 26, 2006

[8Weissman, Robert. “AIDS and Developing Countries: Democratizing Access to Essential Medicines.” Foreign Policy In Focus: A Joint Project of the Interhemispheric Resource Center and the Institute for Policy Studies. Vol. 4, No. 23. August 1999. Accessed July 26, 2006.

[9International Federation of Pharmaceutical Manufacturers Association. “Encouragement of New Clinical Drug Development: the role of data exclusivity.” 2000. Accessed July 12, 2006

[10Baker, Brook K. “Trade, Intellectual Property, and Access to Medicines: US Seeks Data Exclusivity and Registration/Patent Linkage That Will Bar Access to Affordable Generic Medicines. Northeastern University School of Law. March 31, 2006.

[11Kaiser Network Daily HIV/AIDS Report. “U.S. Legal Experts, AIDS Advocates Urge India To Amend Order Preventing Production of Some Generic Antiretroviral Drugs.” March 1, 2005. Accessed July 12, 2006

[12United States Trade Representative. “2004 Special 301 Report.” 2004. Accessed July 12, 2006

[13Baker, Brook K. “USTR’s 2004 Special 301 Report Highlights the U.S. Global Ambition to Use Heightened Protection of Innovators’ Drug Registration Data to Block and Delay Registration of Competing Generic Drugs.” 2004. Accessed July 14, 2006