India to consider raft of new compulsory licencesBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1094 (Published 24 January 2014) Cite this as: BMJ 2014;348:g1094
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The news to review 20 drug patents in India for issuing Compulsory License (CL) may yet again put India and its Intellectual Property Rights environment at Peril. The CL issued for Bayer’s anti-cancer drug Nexavar had created much furor and debate among various sections of society. India has always been under intense scrutiny for its provisions of Intellectual Property Rights, especially patents and more specifically in pharmaceutical sector, since it agreed to honor Trade Related Aspects of Intellectual Property Rights (TRIPS).
As provision of CL is enshrined in TRIPs agreement, it does not constitute violation of TRIPS agreement. The more prudent issue is when to issue a CL? Many countries like Brazil and Thailand have issued CL in the past for certain patented medicines, in order to protect public health and provide access to affordable medicines. These countries, though, had to face retribution of MNC pharmaceutical companies for issuing CL. Since protection of public health and access to affordable healthcare, including medicines, is a basic right the matters related to protection of Intellectual property and access to affordable medicines require a delicate and careful evaluation of the options available at hand, both by innovative pharmaceutical companies and governments intending to use provisions of CL.
The TRIPS agreement and subsequent discussions at Doha, which culminated with “Doha Declaration on TRIPS and Public Health” confirms that countries are free to determine grounds of issuing CL on meeting a few specified conditions including “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices 1. Section 84 and Section 92 of The Indian Patent Act of 1970 as amended 2005 specifies conditions under which a CL can be issued. These conditions of Indian Patents Act 1970 are in line with provisions of TRIPS agreement.
The CL issued by India in March 2012 was for Soafenib (Nexavar), an anti-cancer treatment. The issuance of CL brought down the prices of medicine and treatment costs from approximately Rs. 2.8 lakhs a month to approximately Rs. 8900 a month, which is substantial. The medicines for treatment of diabetes and arthritis are under consideration for issue of CL by a panel constituted by government of India according to the source. As diabetes and arthritis are chronic and debilitating conditions, it exerts financial pressure on patients as the treatments are to be continued lifelong. Many patients may find these costly treatments unaffordable. Issuance of CL also requires that the innovator or patent holder be compensated through payment of royalty as specified. Also, when deemed necessary, India rejected the issuance of CL. So, it may seem that Indian government and patent office have carefully evaluated and decided on CL applications without affecting rights of innovators or patients. The future decisions to issue a CL also may be based on facts available and careful evaluations.
Since India is actively under the lens for its Intellectual Property environment, it is appropriate that the decisions to issue CL are taken after careful evaluation of all available options and approaches. It is important to work with all stakeholders including innovators and patient right activists to make new treatments accessible to large section of needy patients and ensuring that new medicines are available and innovators are also rewarded for their investments to bring in new therapies.
Competing interests: No competing interests