TRIPS impact on India's pharmaceutical industry (original) (raw)
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The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry
The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various committees were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India's patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.
The Wto Deal on Cheap Drugs: A Critique
The Journal of World Intellectual Property, 2005
In 2005, India amended its Patents Act, 1970 to introduce TRIPS compliant product patent regime. Generally speaking, law and policy makers in India during the time of the amendment were confronted with two major concerns viz. the future of the Indian pharmaceutical industry and access to affordable medicines in India and other developing countries. To address these concerns India along with many other developing countries attempted to incorporate TRIPS flexibilities in their domestic law. However, the success of the TRIPS flexibilities in addressing the question of access to affordable medicines mainly depends on three factors: a) the incorporation of flexibilities in the domestic law; b) the manufacturing capability of a country; and c) the political will to use the public interest safeguards provided in the domestic law. There are only a few countries like India, which satisfy the above-mentioned conditions to a certain extent. This article examines whether these premises hold true after five years into the implementation of the TRIPS compliant patent system in India. In this context the paper identifies and analyzes the legal, policy and institutional challenges that India is currently facing in the implementation of TRIPS flexibilities. It also identifies the main legal, policy and institutional disconnect in the implementation of TRIPS flexibilities in India. It argues that to effectively use TRIPS flexibilities to address access to affordable medicines require changes in three areas viz. law, policy and institutions. It clearly shows that mere incorporation of TRIPS flexibilities in the domestic legislation alone is not enough and the domestic legislation needs to be complemented with policy and institutional framework.
Trade Rules and Intellectual Property Protection for Pharmaceuticals
This paper provides an account of how certain trade and intellectual property (IP) rules agreed at the WTO or in bilateral and regional trade agreements impact upon access to medicines, especially in the developing world. As most changes in the area of pharmaceutical IP protection were set in motion through the WTO TRIPS agreement, the chapter focuses on the actors and rationales that underpinned TRIPS negotiations, making the argument that TRIPS was not negotiated with public health or other social goals in mind. Taking this as the starting point, the chapter then details how TRIPS and ‘TRIPS plus’ IP pharmaceutical provisions pose significant challenges to expanding affordable access to medicines. Awareness about such detrimental consequences has informed the IP-access to medicines contests from the late 1990s onwards and with some (qualified) successes, although many issues still remain contested and unresolved. More broadly, the argument presented here is that most of the problems that present themselves at the intersection of trade rules, IP protection and pharmaceuticals stem from two seemingly irreconcilable frameworks – one that seeks to fashion trade and IP rules regarding pharmaceuticals as a matter of competitiveness (central to the US and EU position), and another that seeks to subdue trade and pharmaceutical IP rules to the achievement of public health goals. Any efforts to improve healthcare worldwide would have to include a reassessment of the social purpose of IPRs: in the case of pharmaceuticals, public access to lifesaving medicines.
Trade, TRIPS, and pharmaceuticals
The Lancet, 2009
and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS fl exibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.
2017
The Access Regime, Patent Law Reforms for Affordable Medicines Ali, Feroz, Oxford University Press, 2016 ISBN-13: 978-0-19-946348-0 Hardcover, pp 263 + xxxviii Price: $60 Danny Friedmann The Republic of India, never a stranger to defining its own path of development,1 realized that different jurisdictions have different needs. The leaders of this populous developing country have made full use of the policy space available to them to make long term decisions to guarantee affordable medicines and create a thriving generics pharmaceutical industry in the process. The book takes the reader from the Indian Patents and Designs Act of 1911 via the Chand and Ayyangar Commitees in the sixties, when medicines were not affordable to most Indians, to the Patents Act 1970 and further. The Patents Act 1970 introduced a prohibition against granting product patents for medicines but allowed process patents for medicines. This prohibition, which lasted until 2005, helped create an indigenous pharmaceutical industry, where generics companies ingeniously worked around patented processes. The generics and active pharmaceutical ingredients were not only in great demand domestically, but also in developing countries that lacked the capacity to manufacture medicines.