Economy
India rejects extending drug patents in EU, UK trade talks
Summary
India is the world’s largest provider of generic drugs, accounting for a fifth of global supply. The low cost of generics mean they comprise about 70-80% of the domestic retail market.
New Delhi: India is unlikely to budge from its opposition to the provisions on regulatory data protection and patent extension in free trade talks with the EU and the UK, it has told its negotiating partners, in a move aimed at protecting its generic drug industry and healthcare schemes.
New Delhi’s stand has been “firmly communicated", said a person aware of the development, pointing out that domestic healthcare schemes such as the Pradhan Mantri Bhartiya Janaushadhi Pariyojana are heavily dependent on affordable generic drugs.
India is the world’s largest provider of generic drugs, accounting for a fifth of global supply. The low cost of generics mean they comprise about 70-80% of the domestic retail market. They are also crucial to the well-being of the aging Indian population.
“Regulatory data protection or data exclusivity is something that the EU has been seeking since 2013 and it is a red line for us. Similarly, they are seeking patent term extension and that is a red line for us too and it has been clearly conveyed," the person cited above said requesting anonymity.
“We need generic drugs. Even more than the EU, the UK, being a top innovator in life sciences, built the first vaccines and they are strong. So, naturally, it was their key ask but it is a red line for us."
A patent term extension allows secondary patenting or ‘evergreening’, a technique used by corporations to prevent the entry of generic competitors. Extension is typically sought for additional patents on the original drug, even flippant ‘modifications’ such as new dosages or combinations.
Many pharma companies evergreen by making minor changes to their drugs just before the patent expires at 20 years.
In addition, Médecins Sans Frontières (MSF), which campaigns on health issues, has warned that provisions being pushed by pharma companies and rich nations could undermine India’s public health safeguards by requiring the country to change its national intellectual property and drug approval laws and introduce monopolies on medicines.
The Lancet, a British medical journal, stated that such a clause would hurt not only Indian generic drug manufacturers but also the UK’s National Health Service (NHS), as the Indian bulk drug industry accounts for a quarter of the price-controlled medicines in the UK. They are also a lifeline for some of the world’s poorest nations.
“There will be a departure from some stances [taken by India in FTA talks] which were continued without reason. In government procurement, we can’t compromise on small and medium enterprises," the person added.
As per the Indian government’s public procurement policy, all central ministries, departments and public sector units have to make a quarter of their total annual purchases by value from domestic micro, small and medium enterprises.
In a major policy shift, public procurement contracts worth more than ₹200 crore were opened up in the FTA signed with the UAE last year. Following the move, every country India is negotiating with, including the EU, the UK and Australia, is gunning for access to the public procurement market.
“Access to medicine is extremely important for India and that cannot be compromised. And the generic industry needs to be protected. We have been struggling with the high prices of medicines," Prof Biswajit Dhar of Jawaharlal Nehru University said.
Queries sent to the commerce ministry remained unanswered at press time.
