India’s patent regime is in the news again. This time, there have been reports that the Indian government has ‘privately assured’ the US-India Business Council (USIBC) that ‘ it would not use Compulsory Licenses for commercial purposes.’ To be sure, the Indian government, through its Ministry of Commerce and Industry, has issued a ‘clarification‘ to the effect ‘that such reports are factually incorrect.’
In my view, this issue should not just be framed as one that involves patent rights or trade relations. This issue should equally be framed as a human right issue. Patent rights do have an impact on human rights. Pharmaceutical patent rights can affect the enjoyment of the right to health. Thus, in a situation where a patentee abuses its patent rights by selling its patented drug at a price that is not reasonably affordable, a country is within its right to intervene by issuing a compulsory licence.
India’s patent law contains a provision permitting the grant of compulsory licences where a patented product is sold at a price that is not reasonably affordable (and this provision has only been used once). Nothing in the TRIPS Agreement prevents a country from taking this step. Compulsory licences can actually be used to facilitate greater access to medicines. Compulsory licences (or the threat of issuing one) can thus play a crucial role in ensuring that pharmaceutical patent rights are not exercised in a manner that impedes the enjoyment of the right to health.
It is noteworthy that India’s National Human Rights Commission has also waded into this matter. In a press release published on the 1st of April 2016, the Commission observed that ‘the contents of the press reports, if true, raise questions impinging upon [the] right to health of citizens in India.’ The Commission therefore called for ‘reports within two weeks from the Union Ministries of Commerce & Industries as well as Health, through their Secretaries in the matter.’ In the meantime, it is hoped that the Indian government will not backtrack from its initial clarification that ‘under the Doha Declaration on the TRIPS Agreement [and] Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.’