TAG: GS 2: INTERNATIONAL RELATIONS
THE CONTEXT: A clause in a draft free trade agreement text being negotiated between India and the European Free Trade Association (EFTA) — Switzerland, Iceland, Lichtenstein and Norway — could delay access to affordable, generic versions of patented drugs in India by a minimum of six years.
EXPLANATION:
- The ongoing negotiations between India and the European Free Trade Association (EFTA) – Switzerland, Iceland, Lichtenstein, and Norway – for the Trade and Economic Partnership Agreement (TEPA) have unveiled a potentially thorny clause.
- This clause, related to data exclusivity, could significantly impact India’s thriving generic drug industry, delaying access to affordable alternatives for patented drugs.
Data Exclusivity Clause: A Potential Setback for Generic Drugs
- The leaked draft of TEPA reveals a clause that could extend the exclusivity period for pharmaceutical companies seeking regulatory approval for patented drugs.
- The specific duration mentioned is six years, during which applicants would be restricted from relying on “undisclosed test data.”
- This provision encompasses not only ‘new’ chemical drugs but also ‘biologics drugs,’ such as monoclonal antibodies and vaccine formulations, posing a significant challenge for Indian biotechnology companies.
Concerns Raised by Experts and Organizations:
- The revelation of this clause has raised concerns among experts and organizations working in the pharmaceutical sector.
- Notable among them is the potential delay in access to essential drugs like bedaquiline for tuberculosis patients.
- Legal researchers and organizations, including Medicine Sans Frontiers, have voiced their apprehensions, emphasizing the adverse impact on public health and access to medicines.
India’s Resistance to Monopoly Rights:
- India, with its thriving generics drug industry, has a history of resisting attempts by foreign pharmaceutical companies to extend monopoly rights over patented drugs.
- The generic drug industry in India ranked as the third largest globally.
- It plays a crucial role in producing over 60,000 generic drugs across various therapeutic categories.
- It contributes significantly to the Jan Aushadhi Scheme that provides free drugs to the economically disadvantaged.
Global Negotiations and Intellectual Property Rights (IPR):
- Recent negotiations between India and EFTA have included discussions on balancing concerns related to intellectual property rights.
- Swiss Economy Minister mentioned “balanced solutions” in a recent statement, emphasizing the significance of IPR in the negotiations.
- The details of these solutions remain undisclosed, raising curiosity about how the interests of both parties will be reconciled.
Data Exclusivity Impact on Drug Accessibility:
- The concept of ‘data exclusivity’ is a contentious issue, especially between original drug inventors, often European pharmaceutical giants, and Indian drug manufacturers specializing in reverse engineering.
- Data exclusivity could limit generic drug makers from relying on published clinical trial data.
- It is potentially leading to increased drug prices and delayed availability of generic versions, as witnessed in the case of Colchicine in the United States.
Global Ramifications and Public Health Concerns:
- Experts warn that implementing data exclusivity in India could have broader global ramifications.
- Over the last two decades, India’s absence of data exclusivity in its laws facilitated the affordable entry of new drugs for HIV, tuberculosis, and viral hepatitis.
- Implementing such provisions now may jeopardize access to essential drugs globally, potentially delaying approval for generic versions of crucial medicines.
European Free Trade Association (EFTA):
- It is an intergovernmental organization established in 1960 by the Stockholm Convention.
- It promotes free trade and economic integration between its members within Europe and globally.
- EFTA currently has 4 member countries: Iceland, Liechtenstein, Norway and Switzerland.
- The EFTA countries have developed one of the largest networks of Free Trade Agreements (FTAs).
- These FTAs span over 60 countries and territories, including the European Union (EU).
- In contrast to the EU, EFTA is not a customs union. This means that the individual EFTA States are free to set their own customs tariffs and arrange other foreign trade measures vis-à-vis the non-EFTA States.
Conclusion:
- As the negotiations between India and EFTA progress, the data exclusivity clause emerges as a critical point of contention.
- Balancing the interests of the pharmaceutical industry, public health, and global access to essential medicines is crucial.
- The potential impact on India’s generic drug industry raises questions about the delicate equilibrium between promoting innovation and ensuring affordable healthcare solutions for a diverse and economically varied population.
- The final agreement’s details will be closely watched for the resolution of these complex issues.