Experts flag UK-India FTA over patent terms, access to drugs
intellectual property law
and civil society groups in India have raised concerns that provisions in the
UK-India Free Trade Agreement
, Comprehensive Economic and Trade Agreement (CETA), may dilute
compulsory licensing
norms and jeopardise future access to affordable lifesaving medicines.
As part of the Indian Patent Act, the country has the rights to invoke compulsory license for any lifesaving medicines or vaccines and call upon domestic generic players to supply it during a national emergency in the public interest.
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KM Gopakumar, co-convenor of Working Group on Access to Medicines and Treatment, said the deal amounts to giving a backdoor entry to TRIPS (Trade Related Intellectual Property Rights) plus provisions and goes beyond the minimum standards set by the World Trade Organization, which India has so far resisted in multilateral trade forums.
The group said the UK-India FTA provisions on patents tilt the balance in favour of the patent owner and undermines access to medicines.
The UK-India FTA says, "The parties recognise the preferable and optimal route to promote and ensure access to medicines is through voluntary mechanisms, such as
voluntary licensing
, which may include technology transfer on mutually agreed terms."
Biswajit Dhar, retired professor of economics at Jawaharlal Nehru University, noted that India was moving away from its sovereign rights by placing emphasis on voluntary license (VLs).
"It will kill the essence of the compulsory licensing mechanism and even within the legal framework, India has issued only one CL to
Natco Pharma
(for Bayer's kidney cancer drug sorafenib)," he noted.
He said VLs come with restrictions of pricing that are determined by the innovator Big Pharma companies. "Often voluntary license contains onerous conditions on the licensee and fails to bring sharp price reduction compared to the compulsory licenses," Dhar added.
Gopakumar said that India places a higher threshold for examination and grant of patents, but if the FTA deal is any indication, it may result in "functional harmonization" and lead to dilution in the grant of patent.
However, a few other patent experts told ET that the FTA seeks to keep a balance between India's current IP regime with
public health
and the UK's preference of protecting various IP rights. The FTA seeks to create a Working Group on IPR.
On patents, India's important safeguards such as Section 3(d) (which blocks evergreening of patents) of the Indian Patent Act, and oppositions have not been disregarded and it should help in India's status as the world's
generic drug manufacturer
and protect access to medicines for domestic patients.
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