Thursday, April 11, 2013

Generic drugs and the law in India

A week or so ago, the Supreme Court of India, in a landmark case, ruled against the extension of copyright protections for pharmaceutical compositions that involve only minimal changes from their original patents. It used an important section in current intellectual property (IP) law to determine that slight deviations in the composition of drugs do not warrant new patent protections in the absence of any significant improvement in efficacy or change in overall constitution. The ruling was hailed as a much-need fillip in the fight for greater access to affordable medicines and celebrated by civil society activists and generic drug companies alike as an affirmation of the right of patients to seek affordable, life-saving alternatives to expensive drugs. Two perspectives emerged in the mainstream media after the landmark judgment: the pharmaceutical company involved in the litigation called the verdict an affront to innovation in medical research, while others, particularly groups representing cancer patients and HIV-positive people, described it as a welcome step towards recognition of the generic drugs that are crucial to a developing society like India. Indian generic drugs are used not only in India but are distributed globally by health organizations working across the developing world. Moreover, scientists and manufacturers of generic drug companies argue that major pharmaceuticals generally recuperate their research and development costs in a single year of distribution in a country like the United States, which problematizes the latter's fear of the impact on innovation of a more relaxed patenting regime.

It is, therefore, of great concern to civil society in India that the draft EU-India Free Trade Agreement (FTA) currently under consideration in Germany reportedly contains several provisions that seem to go against the spirit of the Supreme Court verdict. Most of the FTA's IP protections have reportedly been adopted from the Anti-Counterfeit Trade Agreement, which was roundly rejected by the European Parliament and was even more stringent than the WTO-TRIPS Agreement. These provisions allegedly include the right of EU companies to "demand the freezing of bank accounts and seizure of properties of generic companies on the mere allegation of patent-infringement and to drag third parties like treatment-providers into litigation" (Hindu 11 April 2013). They also provide for the establishment of investor-state dispute mechanisms outside the rubric of the state's judicial system (common in trade agreements such as this), which, according to critics, work outside the domain of national laws and therefore disregard the delicate balance between patent rights and the public interest maintained, in a normative sense, in national adjudication.

Health advocates and civil society activists have called on the government to refrain from entering into any agreement detrimental to the country's health needs. However, past experience shows that the Indian government, in pursuit of commercial goals and under pressure from external powers, is entirely capable of ignoring crucial questions of survival to toe the line on international trade policies designed to benefit corporations rather than people. This will be a test not only of economic wisdom but also respect for political and judicial sovereignty.