Drug Patenting and Access to Medicine: A Balancing Act

By Harshit Rai
Harshit Rai is a third year student at the Symbiosis Law School, Pune.

Access to essential medicines is an iota of the larger mandate of health under various international declarations and conventions. The right to health is the right of all individuals to enjoy the highest attainable standard of physical and mental health. However, access to Medicines in general and life-saving essential drugs in particular is an issue of grave concern across the world. The shortage is particularly rampant in African and Asian underdeveloped countries where economic profiles are low and disease count high. Unlike the developed world where health insurance is common practice, majority people depend on their personal budget to meet health expenses. This has a severe effect when it comes to life threatening diseases.

Advancements in medical science have enabled the treatment of life threatening diseases through drug therapy. HIV, for instance, is treated using a combination of medicines too. This is called antiretroviral therapy (ART). ART isn’t a complete cure, but it can control the virus, which enables one to live a longer, healthier life and reduce the risk of transmitting HIV to others. ART involves taking a combination of HIV medicines every day, exactly as prescribed. [1]

Drug patenting becomes one of the biggest impediments affecting accessibility to medicines. A patent grants a virtual monopoly to a pharmaceutical company on a particular drug, allowing it to ascertain the price of the drug. This is often at exorbitant rates, rendering it unaffordable for the majority of populations.

The TRIPS agreement mandates that basic patenting standards are maintained by all countries and includes a special transition arrangement operating for counties which do not presently provide product patent protection in the area of pharmaceuticals. [2] International Patent law however, does let countries decide the method of implementation of patent laws in their respective jurisdictions and provide exceptions to the same.
In India, Section 3(d) of the Indian Patent Act, 1970 (as amended in 2005) does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. Thus, the Indian Patent Act does not allow evergreening of patents. This has become a matter of concern to the US pharma companies, and Section 3(d) has turned out be a highly criticised patent provision by India. [3] This provision allows patents on variants of only those chemical compounds that show significant enhancement in “therapeutic efficacy,” which is a significant barrier against the monopoly of the multinational drugs. [4]

The Provision can be envisaged to protect the interests of the patient who are dependent on inexpensive generic drugs. Patented drugs are much highly priced than generic drugs and Section 3(d) restricts patenting of pharmaceutical inventions with minor changes and patent expired drugs, while helping balance public goods with improved access of medicine to citizens. [5]

Prices are skyrocketing for the prescribed period as patent-holders seek to maximize returns on their investment and increase profits. For instance, costs of patented drugs which combat the HIV virus are enormous. A month’s worth of Atripla, an anti-HIV drug, costs US$1,300. Such prices are only affordable in industrialized countries due to governmental benefits, which are not available in the developing world. Clearly, it is impossible for most people in the developing world, where most HIV cases arise, to pay such prices. The result is a stark health dichotomy, while HIV remains a death sentence for most sufferers in the developing world, it can be managed for many years by sufferers in the developed world who have access to medication.[6]

However, patents cannot be branded as the main culprits in the quest of access to medicines. The suffering in the developing world will not be alleviated without a global commitment of the world to finance health improvements. As developing countries historically do not have the necessary resources and/or will to finance such an initiative, advanced industrialized countries must take on more responsibility and lead the way in funding the restructuring of the current inadequate medical infrastructure.
There is a need for effective accountability mechanisms to ensure compliance by pharmaceutical companies to their human rights obligations.  Civil society organisations can also take the lead in this regard. Panels can be appointed, to monitor the policies and practices of pharmaceutical companies and hold them publicly accountable for the discharge of their right-to-health responsibilities. [7]






1.      How is Hiv Treated ? https://www.aids.gov/hiv-aids-basics/just-diagnosed-with-hiv-aids/treatment-options/overview-of-hiv-treatments/
2.     Overview: the TRIPS Agreement https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm
3.      US Opposition to Section 3(D) of the Indian Patent Act http://pib.nic.in/newsite/PrintRelease.aspx?relid=107612
4.      Section 3(d) implications and key concerns of pharmaceutical sector http://nopr.niscair.res.in/bitstream/123456789/34013/1/JIPR%2021(1)%2016-26.pdf
5.      Ibid
6. TRIPS and the Right to Health http://www.oxfordscholarship.com/view/10.1093/acprof:oso/9780199565894.001.0001/acprof-9780199565894-chapter-8
7.      Hunt P, Khosla R (2010) Are Drug Companies Living Up to Their Human Rights Responsibilities? The Perspective of the Former United Nations Special Rapporteur (2002-2008). http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000330