Data Exclusivity Showdown in India-EFTA Trade Negotiations

Data exclusivity refers to a period of time during which regulatory bodies, such as health authorities, cannot use an originator’s or innovator’s data in order to assess generic versions or biosimilars of that product.

• India has been in negotiations for trade agreements involving data exclusivity policies with various regional blocs, including the European Free Trade Association (EFTA) which consists of Iceland, Liechtenstein, Norway, and Switzerland.
• Data exclusivity has emerged as one of the key unresolved issues in these trade talks. There are divergent positions, with EFTA nations seeking longer periods of protection while India argues for shorter durations.

Background on Data Exclusivity

• When companies develop new medicines or treatments, they must submit large amounts of confidential test data to regulatory bodies to prove safety, efficacy and quality of the product.
• Data exclusivity provisions prevent this confidential data from being shared or relied upon for a fixed period of time after marketing approval. This delays entry of cheaper generic products.
• Supporters argue data exclusivity spurs innovation by ensuring originator companies can recoup investments. Critics argue it delays affordable access.

India’s Stance and Concerns

• India has aimed for data exclusivity periods of 3-5 years in its negotiations while EFTA pushes for 10 or more years.
• India argues lengthy exclusivity could hamper its generic drug industry, increase healthcare costs and reduce access to affordable medicines.
• India faces US pressure on intellectual property in other trade talks, so some argue concessions with EFTA could set bad precedent.

Key Differences in the EFTA Group

• Norway aligns more closely with India’s position and has implemented a 5-year exclusivity period domestically.
• Switzerland’s laws allow data exclusivity for 10-15 years depending on type of data. Its big pharma lobby advocates similar terms.
• Iceland and Liechtenstein follow EU standards which provide 8+2+1 years exclusivity for pharmaceuticals plus added terms for new formulations or indications.

Examples from Other Trade Deals

EU-Canada FTA (CETA)

• Data exclusivity term of 8 years with possibility of extending by another 2 years in case new therapeutic indications are approved.

Japan-EU FTA

• Pharmaceutical test data protected for first 5 years and for combination products for first 8 years. Non-cumulative market exclusivity terms beyond this.

US Trade Deals

• Typically aim for 12 years data exclusivity for biologics and between 5-10 years for pharmaceuticals. TPP negotiations became critical precedent for US targets on IP.
• US has not shown flexibility on reducing terms substantially below these numbers with trading partners.

Factors at Play in EFTA-India Talks

Relative negotiating power

• EFTA is a much smaller market than EU. Less leverage for EFTA states to demand full TRIPS-plus IP protections India granted EU.
• But India views EFTA technology imports as valuable, enhancing EFTA leverage on IP matters.

Economic priorities

• For EFTA states pharmaceutical and IP sectors important economically but not dominant industries. More flexibility on exclusivity terms feasible.
• Protecting generics production and supply key priority driving India position in talks.

Healthcare policy aims

• EFTA states have strong public healthcare systems and drug access policies which could conflict with overly long exclusivity. Some domestic policy space key.
• India emphasizes its aim to ensure new trade rules do not undermine generics access or raise healthcare costs.

The Road Ahead

• With reasoned flexibilities on both sides an EFTA-India FTA with shared benefits is achievable and need not set unfavourable IP precedents for India either.
• Confidentiality exceptions could restrict data exclusivity barriers to generic market entry without eliminating provisions entirely.
• Transition periods before full FTA implementation provide time for India to update regulations.