The high cost of drugs to treat cancer and rare diseases like cystic fibrosis and spinal muscular atrophy, are not luxuries. They are life saving for vulnerable patients.

India’s decision to amend its Patents Act to introduce pharmaceutical product patents as required by the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement has severely limited its ability to produce and supply generic medicines both domestically and globally. Though flexibilities like compulsory and government use licences are ingrained in the Patents Act to override patent protection in the interest of public health, such measures have been sparingly used. The future of such flexibilities stands jeopardised by India’s decision to advance with free trade agreements (FTAs).

India opted out of the RCEP (Regional Comprehensive Economic Partnership) Agreement to protect its vulnerable population, but it has trade negotiations underway with the European Union, the UK and the US. And the concern in these discussions is the loss of policy space to provide public health safeguards against the abuse of patent monopoly.

IP chapter’s proposals

The leaked Intellectual Property (IP) chapter in the draft UK-India FTA revealed proposals to remove safeguards, besides provisions like Patent Term Extension (PTE). Under PTE, India would be required to extend the 20-year patent monopolies by a few more years, resulting in an inordinate delay of generic drugs entering the market. An example of PTE’s effect on cost and availability is illustrated by breast cancer drug Palbociclib. In India, due to loss of patent exclusivity, generic versions of Palbociclib are now available at less than 95 per cent of its original cost of approximately ₹95,000. While Indian patients access the drug at a lower price, their US counterparts will be paying exorbitant prices for the same drug,courtesy PTE.

Similarly, Data Exclusivity (DE) affects generic availability. DE limits the reliance of generic companies on clinical trial data submitted by the originator to regulators for marketing approval, thus lengthening the monopoly of the originator drugs. Discussions are also underway on changes in pre-grant provisions, foreign filing requirements and working of patents.

India should not agree to such ‘TRIPS-plus’ provisions that will undermine public health safeguards. It should ensure, such provisions do not impede access to affordable medicines for millions of patients who look to India as the ‘pharmacy of the world’.

KM Gopakumar

KM Gopakumar

Chetali Rao

Chetali Rao

(The writers are law and policy researchers on access to medicines; and affiliated with the Third World Network (TWN), Views are personal)

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