India and the European Free Trade Association (EFTA) have been negotiating a free trade agreement.
EFTA’s Demand
EFTA, consisting of Iceland, Liechtenstein, Norway, and Switzerland, requested ‘data exclusivity’ provisions in the agreement.
India’s Rejection
India, represented by commerce secretary Sunil Barthwal, rejected EFTA’s demand for data exclusivity.
Impact on Indian Pharma Industry
The demand would have made it difficult for the Indian pharmaceutical industry to produce generic variants of off-patent products.
Data Exclusivity Provisions
These provisions would bar generic drug producers from using data from preclinical tests and clinical trials of former patent holders.
Consequences for Generic Drug Manufacturers
Generic medicine makers would need to generate their own clinical data or wait for the exclusivity period to end to introduce their versions of off-patent drugs.
India’s Stance
Barthwal reassured that there’s no fear for the Indian generic industry from the agreement, emphasizing the importance of the industry’s flourishing.
Protection of Industry Interests
India aims to protect the interests of its generic drug industry, which contributes significantly to exports.
Status of Negotiations
Negotiations between India and EFTA on the Trade and Economic Partnership Agreement have been ongoing since January 2008.
Progress of Talks
The negotiations cover various chapters including trade in goods, rules of origin, trade and sustainable development, intellectual property rights, and trade facilitation.
Trade Figures
In FY23, India’s exports to EFTA countries amounted to $1.92 billion, while imports stood at $16.74 billion.
Multiple Choice Questions (MCQs):
- Which nations constitute the European Free Trade Association (EFTA)?
- A) France, Germany, Italy, Spain
- B) Iceland, Liechtenstein, Norway, Switzerland
- C) United Kingdom, Belgium, Netherlands, Denmark
- D) Poland, Hungary, Czech Republic, Slovakia
- Answer: B) Iceland, Liechtenstein, Norway, Switzerland
- What is the primary concern raised by India regarding EFTA’s demand for data exclusivity?
- A) It will increase the cost of pharmaceutical products
- B) It will restrict the import of generic drugs
- C) It will hinder the production of generic variants of off-patent products
- D) It will delay the approval process for new drugs
- Answer: C) It will hinder the production of generic variants of off-patent products
- What do data exclusivity provisions entail?
- A) Exclusivity in data access for government agencies
- B) Exclusive rights for data ownership by generic drug producers
- C) Restrictions on the use of preclinical and clinical trial data by generic drug producers
- D) Exemptions for clinical trial data sharing
- Answer: C) Restrictions on the use of preclinical and clinical trial data by generic drug producers
- According to the commerce ministry, what is the status of negotiations between India and EFTA?
- A) Stalled
- B) Just initiated
- C) At an advanced stage
- D) Concluded
- Answer: C) At an advanced stage
- What was the total value of India’s exports to EFTA countries in FY23?
- A) $1.92 billion
- B) $16.74 billion
- C) $25 billion
- D) $0.92 billion
- Answer: A) $1.92 billion