India: Trips Plus And Biodrugs: Imperative Poise Between IP Fundamentalism And Access To Biodrugs

Last Updated: 5 November 2018
Article by Khurana And Khurana


TRIPS (standing for Trade Related Intellectual Property Rights) has led to the coming up of unified IPR protection norms or what can be termed as minimum standards of IP Protection across the different jurisdictions in the world. 'TRIPS plus', however, can be termed as a 'much greater set of standard of IP protection than 'TRIPS', 1 that is basically lobbied upon the developing countries, by the developed countries of the world.

On the other hand, Bio drugs are "complexly structured large molecule drugs which are usually derived from metabolic processes of living cells for treatment, diagnosis and prevention of diseases." It encompasses vaccines, insulin, monoclonal antibodies, therapeutic proteins and gene therapy products.

IP Fundamentalism Versus Ensuring Access

The current piece basically focuses on the ever talked debate of what should be the threshold of IP protection, as far as the 'access' of these "biodrugs" to the common populace is concerned. These medicines are usually highly priced as they are the result of the "innovation" by the first mover. The perspective that runs contrary to this says that the developing countries should get due flexibility in enforcing IP standards in their own territories as they already started late in the race for achieving greater standards of IP Protection and thus they must enjoy some leverage.

TRIPS gives immense benefits to the first developers but the developing countries can't really compete to become the first developer owing to nonexistence of required 'deep pockets'. What they are consequently restricted to, is the manufacturing of the off-patented products, partnerships with the western firms on own-friendly terms or innovating in the lesser-interest domains of the larger western firms like a for a local disease affecting a specific territory.

Arguments For And Against Trips Plus

It has been often contented by the developed countries that the faster legal unification that they push forward for would actually speed- up the Research and Development in the developing countries and the 'lash of the whip' by the developed countries would tow the developing countries out of the clutches of technological stagnation and 'technological divide' which might have otherwise retained for even longer periods had this 'push' been absent, however, the same largely seems to be an exaggeratedly shimmering depiction of an empirical explanation, as to how the same would be directly beneficial to the developing economies and help in ensuring greater global welfare. 2

TRIPS intends to cull-out a mechanism where countries give more consideration to the intellectual property and ensure incorporation of at least minimal standards patent protection. It is thus quintessential for countries to dexterously make the best use of the exceptions and concessions provided within the TRIPS agreement. There already exists some rudimentary flexibility in the agreement such as which talk of compulsory licensing, exhaustion of rights and likewise which can be intelligently exploited to safeguard the objectives of larger public good with reference to ensuring access of essential drugs.3 The same has however been proven disadvantageous to the local pharmaceutical industry.

Other arguments to have stricter standards of IP protection include:

  • It protects the first inventor
  • Encourages investment
  • Augments subsequent R and D
  • Promotes health by means of evolving better technology

Whereas, as far as the aspect of health and ensuring access is considered, we must not forget the very reason for the establishment of the World Health Organization (WHO), mentioned under Article 1 as "the attainment by all peoples of the highest possible level of health". Even the Human Rights Council's resolutions reinstate to use the flexibilities of TRIPS in the best possible manner (even through national legislations 4) so as to ensure the right to health. The Human Rights Council's 2011 resolution on HIV/AIDS epidemic stated that IP agreements must not undermine the flexibilities of TRIPS and the concerns of Doha Declaration 5, WTO General Council decision (of 30 August 2007 6) and the objectives of UN Millennium Development Goals. UN in its 2012 report on attainment of Millennium Development Goals concluded by saying that the "overall access of essential medicines in developing countries is still insufficient".

Other factors favouring 'greater access' and milder IP Protection standards include:

  • Safeguards right to health
  • Access through Reverse Engineering
  • Public Welfare through parallel imports
  • Curbs knowledge concentration with few big entities

Conclusion And Suggestion

TRIPS is appropriate in-principle, yet its understanding may have life and demise ramifications for individuals from less developed nations. To whatever degree possible, the generics can come to the rescue. In the event that the same is disallowed by TRIPS, compulsory licensing under particular cluster of conditions may be of assistance. For example, Brazil has effectively utilized the same to pursue its National STD/AIDS Programme 7. It is agreeable that the WTO member countries must 'reasonably' make up for the patents exposed to compulsory licensing and the precedents show that anything that is more than zero is acceptable. To the extent parallel imports and price ceilings are involved, the lesser-developed countries might avail certain leverage however the equivalent can be banished for the rich nations. Indeed, even the patent holders can use differential pricing 8, that is lesser costs for developing nations with lesser per capita incomes and higher for the rich nations as opposed to having all inclusive uniform costs as there exists feeble correlation between wholesale prices and per capita income

In the present occasions, the issue isn't just TRIPS, but rather the two-sided push for a considerably stricter TRIPS+. The effectively reasonable instrument that the developing countries might want to consider is of framing a veto-alliance against ceaseless tightening up of IP standards. Popular NGOs over the globe can advance in and help frame such collusion. The fact that such an alliance has actually brought the attention of members to access to medicines in the special session of TRIPS, thereby suggests that it is a realistically practical possibility. Such a veto shall pose a challenge to the presently soaring limits of transnational activism by developed countries. If not done, the developing nations must be assured about them being picked-off by one of the extensively growing wave of US bilateralism.9

Therefore, greater IPR may augment the competitive advantage of certain countries or companies, but they might not be in favor of developing countries, small producers, and even civil society in large. The developed countries' double standards are much visible on the issue of IP protection and the same countries are largely using the system for using their deep pockets to hegemonize them in the markets and consolidate their positions. It must be ensured that the economically weaker countries do not succumb to the humongous pressure that the developed economies now exert upon them directly and indirectly. They must prioritize health and ensure cheaper access over aspects of trade using flexibilities in TRIPS to their advantage and while exerting due emphasis for their rights before bringing their domestic policies in-line with the international standards.



2 Carlos M. Correa, Harmonisation of Intellectual Property Rights in Latin America: Is there still room for differentiation?, 29 N.Y.U. J. INT'L L. & POL. 109, 126 (1997).

3 Audrey R. Chapman, The Human Rights Implications of Intellectual Property Protection, 5(4) Journal of Int'l Economic Law 861, 880-882 (2002

4 Office of USTR, 2013 Special 301 Report 22 (2013).

5 World Health Assembly, Global health-sector strategy for HIV/AIDS, (WHA56.30, 2003).

6 Commission on Human Rights, Access on Human Rights, Access to Medication in the context of Pandemics such as HIV/AIDS, Tuberculosis and Malaria (E/CN.4/RES/2004/26, 2006).

7 Human Rights Council, The Protection of Human Rights in the context of Human Immunodeficiency Syndrome, (A/HRC/RES/16/28, 2011).

8 CIPR, Integrating Intellectual Property Rights and Development Policy 42 (2002).

9 F.M. Scherer & Jayashree Watal, Post TRIPS Options for Access to Patented Medicines in Developing Countries 45 (Commission on Macroeconomics and Health background paper, 2001)

10 Peter Drahos & John Braithwaite, Information Feudalism 187-192 (Oxford University Press, 2002).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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