India Denies EU’s ‘Data Exclusivity’ for Drug Firms

India has refused to accept the demand of four European countries to include a data exclusivity provision in the proposed free trade agreements (FTA). The government said it will protect the interests of the domestic generic drug industry, which contributes to India’s exports and provides affordable medicines.

What is data exclusivity?

It is a form of intellectual property protection that prevents competitors from using the clinical trial data of innovator companies to obtain marketing approvals for their generic versions of the same drugs. Data exclusivity can last for several years, depending on the country and the product.

Why do EFTA countries want data exclusivity?

The four European countries, which are part of the European Free Trade Association (EFTA) bloc, are Iceland, Liechtenstein, Norway and Switzerland. They are negotiating a trade and economic partnership agreement (TEPA) with India since 2008. The EFTA countries are home to some of the world’s leading pharmaceutical companies, such as Novartis and Roche. They want data exclusivity to protect their investments in research and development and to prevent generic competition from India and other countries.

How did India respond to the demand?

Commerce Secretary Sunil Barthwal said that India will not enter into any FTA that compromises the interests of the generic drug industry, which is valued at around $25 billion. He said that India rejected the data exclusivity demand of the EFTA countries, as it goes beyond the provisions of the World Trade Organization’s (WTO) agreement on trade-related aspects of intellectual property rights (TRIPS). He added that India is committed to ensuring that the generic drug industry flourishes and provides low-cost medicines to people.

What are the implications of data exclusivity for public health and access to medicines?

It can delay the entry of generic drugs into the market and increase the prices of medicines, affecting public health and access to medicines. India is one of the largest producers and exporters of generic drugs in the world, supplying essential medicines to many developing countries. India is also known as the pharmacy of the world for its role in providing life-saving drugs for diseases such as HIV/AIDS, tuberculosis and malaria.

According to a study by Oxfam International, data exclusivity could increase medicine prices by 10-30% in India and by 100-500% in other developing countries. The study estimated that data exclusivity could cost India an additional $1.9 billion per year in medicine expenditure and could affect millions of people who depend on generic drugs.

What is the status of TEPA negotiations between India and EFTA?

The TEPA negotiations between India and EFTA have been stalled for several years due to differences over issues such as data exclusivity, intellectual property rights, investment protection and agricultural market access. The two sides have held 21 rounds of talks so far, with the last one taking place in January 2024 in Delhi. The EFTA bloc is an important trading partner for India, with bilateral trade amounting to $19.1 billion in 2019-20.

According to a report by the joint EFTA-India study group, a TEPA could boost trade and investment flows between the two sides by reducing tariffs and non-tariff barriers, enhancing cooperation in areas such as services, investment, intellectual property, government procurement and competition policy. The report also suggested that a TEPA could have positive effects on economic growth, employment and welfare in both EFTA and India.

However, some experts have raised concerns about the potential impact of data exclusivity on public health and access to medicines in India. They have argued that data exclusivity could undermine India’s patent law, which allows for compulsory licensing and pre-grant oppositions to ensure that patents are granted only for genuine innovations. They have also warned that data exclusivity could limit the scope of generic competition and increase the monopoly power of innovator companies.

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