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| Q&A: Brian Ager, DG, European Federation of Pharmaceutical Industries and Associations |
| Pallavi Aiyar / Feb 16, 2011, 00:24 IST |
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 Research and development-based pharmaceuticals accounts for 17 per cent of total business R&D investments in the European Union. Traditionally, Europe has had a massive lead over the rest of the world in the industry. However, competition in the field is heating up. European pharma has been investing in India, which it views as an important market and manufacturing base. But the India-EU Free Trade Agreement, now in the final stages of talks, is seen as crucial to really get pharma synergies going. Brian Ager, the Director-General of Efpia, the main pharma industry body, spoke to Pallavi Aiyar in Brussels about the hopes and concerns of European pharma on the FTA. Edited excerpts:
What are the main apprehensions the European pharma industry has on the FTA?
None. The FTA can bring huge benefits to both parties. India is an important trade partner and growing economic power. It has a young, educated workforce, which opens up tremendous opportunities. Of course, we are concerned about the proper implementation of IPR (intellectual property rights).
How happy is Efpia with current IPR measures in India? How would it like the FTA to improve on these?
The India Patent Act of 2005 was a very encouraging development, signalling that India was getting into the incentivisation of research and development, rather than merely focusing on generics. But we believe enforcement continues to be patchy. More, it’s very difficult to get patents. Andrew Witty the CEO of GlaxoSmithKline and President of Efpia, recently pointed out how despite having been in India for some 100 years, GSK has only been granted one patent for the whole of its business. Another issue has been deficiencies in the IP infrastructure and a lack of appropriate experience. The patent office is faced with a backlog of patent applications – 12,000 were filed in one month alone.
On the FTA, we would like to see something on regulatory data protection. This is an essential legal mechanism to protect, for a limited period (in Europe, it’s 10 years), the huge investments in data necessary to bring a medicine to market.
We do not believe data protection will harm Indian interests. Remember that contrary to the concerns at the time, the 2005 Patent Act has not had a negative impact on India’s pharma industry. To give you examples from other BRIC countries, both Russia and China already apply six years of regulatory data protection.
There have been criticisms against the pharma and IPR section of the ongoing FTA negotiations, alleging that what the European side is pushing for would hamper the access to developing countries to life-saving medicines. What is Efpia’s stand?
Misleading and unwarranted. The industry has made its own substantial contribution to improving access, including through royalty-free licensing to generic manufacturers. Potential IPR provisions in the FTA are not intended to impact access to medicines in India or elsewhere. We support the European Commission’s commitment to ensuring the trade in generic medicines is not unduly affected and that there should be no “step change” in flows of drugs resulting from the FTA.
What we want is an incremental transition to effective enforcement of IPR provisions. For example, the EC has stated it will not object to exceptions to regulatory data protection on public health grounds, whereby the authorities would be allowed to base the authorisation to a second applicant on data provided by the first applicant, if necessary, in view of ensuring access to life-saving medicines.
What is your position regarding the spate of seizures of generic medicines from India in transit at European ports?
It is neither the policy nor the practice of Efpia members to encourage EU member-states to use the powers of detention available to them to prevent the flow of legitimate generics from manufacturers to customers outside the EU. This should also apply to goods in transit through EU countries where IPR legislation could be applied. I suppose the concern in these particular cases was counterfeiting, which then got caught up in bona fide trade. We believe the particular case in question is close to a resolution, to ensure such incidents don’t recur, and we support this move.
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