Source-This post on European Free Trade Association (EFTA)- India rejects EFTA’s data exclusivity demand in trade talks is based on the article “India rejects EFTA’s data exclusivity demand in trade pact talks” published in “Financial Express” on 16th February 2024.
Why in the News?
Recently, India rejected the European Free Trade Association’s (EFTA) request for ‘data exclusivity‘ in their ongoing free trade agreement negotiations.
About European Free Trade Association (EFTA)
| Aspect | Details |
| About | It is an intergovernmental organization established in 1960 through the Stockholm Convention. |
| Objective | To facilitate free trade and economic integration among its members both within Europe and on a global scale. |
| Members | Iceland, Liechtenstein, Norway, and Switzerland. |
| Function | 1. The organization works alongside the European Union (EU). 2. Unlike the European Union (EU), it does not function as a customs union. 3. All four member states participate in the European Single Market through European Economic Area (EEA) Agreement. |
| Governance | 1. The EFTA Council is its top authority, meeting about 8 times yearly at the ambassadorial level and twice yearly at the ministerial level. 2. The EFTA Surveillance Authority (ESA) oversees compliance with European Economic Area (EEA) rules in Iceland, Liechtenstein, and Norway. 3. EFTA Court– It is Located in Luxembourg. It has the authority to resolve both internal and external disputes concerning the implementation, application, or interpretation of the EEA agreement. 4. The EFTA Secretariat is located in Geneva and supports the EFTA Council in managing relations among the 4 EFTA States. It handles the negotiation and operation of EFTA’s free trade agreements. |
What is Data Exclusivity?
1. Data exclusivity safeguards the clinical trial information of a pharmaceutical company concerning a particular medication.
2. During exclusivity period, generic competitors cannot use the originator’s data to get approval for similar drugs.
What are India’s reasons for rejecting Data Exclusivity?
1. Data exclusivity provisions will prevent India’s domestic generic drug producers from utilizing preclinical test and clinical trial data from former patent holders.
2. If generic medicine manufacturers want to introduce their version of an off-patent drug, they must either produce their own clinical data or wait for the exclusivity period to expire.
3. This will lead to a rise in the cost of affordable medicines in India.
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