New Delhi: Top Indian pharmaceutical companies have appealed to the central government to stand firm on the Patents Act as it engages on proposed free trade agreements (FTAs) with the UK, US and the European Union, expressing apprehensions that such deals will lead to affordable healthcare. This may adversely affect the service, ThePrint has learnt.
India has been negotiating FTAs with UK, USA and EU for the past several months and the agreement with UK is expected to be signed this year itself. Once India signs these agreements, it will have to amend its patent law. Will also override trade obligations under the FTA WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), of which India is a signatory.
The Patents Act, 1970 ensures that patents are not exploited contrary to the national interest and provides for concise patent terms for products. Furthermore, India, as a TRIPS-compliant country, Patent provides protection to any drug product for a period of 20 years from the date of filing.
In a representation sent to the Union Ministry of Health and the Department of Pharmaceuticals (DoP) last month, the Indian Pharmaceutical Alliance – a network of around 25 of the largest drug manufacturers in India – said: “In recent talks … there is a provision to increase the monopoly of patent holders by extending the life of patent on a drug beyond 20 years, thereby delaying the entry of generic drug.”
In the representation, the companies have said that it is common practice among some innovator companies to make minor changes to proprietary drugs, seek a more “full” period of patent protection on these minor modifications, and repeat the process for as long as possible.
According to media reports, trade deals with the US, UK and EU are also calling for the introduction of a regulatory data protection system, commonly known as “data exclusivity”, for new drugs.
Data exclusivity is a type of intellectual property protection that ensures that a generic drug manufacturer cannot rely on an innovator firm’s data for a specific period of time to obtain drug approval, thereby slowing the entry of generic drugs into the market. It happens.
“This goes beyond the TRIPS agreement, which stipulates protection of test and other data for new chemical entities required for regulatory approval from unfair commercial use,” the Indian companies have said in their representation to the government.
One of the largest suppliers of generic drugs, India accounts for about 20 per cent of their global exports, according to government data.
ThePrint contacted the Indian Pharmaceutical Alliance via a call seeking comment on the government’s report. However, the association declined to comment on the matter.
ThePrint also reached out medicine department via email for comments on the issue. The copy will be updated as soon as the response is received.
‘Delay in launching of generic’
India currently does not have data exclusivity, but if introduced, it could ensure an extended monopoly for originator companies in developing countries such as India, although patents may expire in developed countries.
“This is because innovators launch their new drugs in low-cost countries years after they are launched in developed economies,” the Indian drug makers’ representation said. “This will add to the monopoly period for the promoters and delay the launch of generics.”
However, Suresh Pattathil, president of the Association of Pharmaceutical Producers of India – a network of foreign drug manufacturers in India – said the body believes that a strong and meaningful IP (intellectual property) environment not only supports research and development in India important to promote. India, however, is also addressing its unmet medical needs.
In March this year, over 200 health organizations and community groups reportedly called for the UK’s chief negotiator for the UK-India FTA to resign amid a lack of transparency from the UK government.
The organizations also cited the historic impact of Indian generic drugs, including “a 99 percent reduction in HIV drug prices since 2000.”
Indian drug manufacturers in their representation to the central government have said The replacement of the patent regime in the 1970s acted as a catalyst in promoting the generic drug industry to earn the title of “pharmacy of the world”.
It states that India supplies medicines to more than 200 countries.
The concern expressed by the drug makers also resonated with some independent experts.
Ujjwal Kumar, former national advisor (trade and health) in the health ministry, who works with Delhi-based policy think tank CUTS International (Consumer Unity and Trust Society), told ThePrint: “Any change in the Patents Act, which WTO-TRIPS compliance can adversely affect normal competition and access to medicines, not only within India and poor countries but also in developed countries like the US, UK and EU.
He said that promoting general competition should be imperative for welfare states like India, where the expenditure on health is very high. Ensure public discussion on the same.
(Editing by Anumeha Saxena)
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