Brian Ager, the Director-General of European Federation of Pharmaceutical Industries and Associations (EFPIA) says that its global R&D pharmaceutical industry has no desire to restrict access to essential medicines. It is strongly in favour of a free trade agreement (FTA) that helps to support the conditions required to stimulate sustainable investment in R&D in India, but this should never be at the expense of the progress being made on access to medicines in the developing world. Explaining this to FE?s BV Mahalakshmi, Brain Ager says that the recent EU-FTA talks are in an advanced stage and data exclusivity and intellectual property rights in the pharmaceutical sector are one of the most contentious issues on which there are there are major disagreements.
What benefits does the European research-based pharmaceutical industry see from an EU-India Free Trade Agreement?
We believe that a balanced FTA will bring significant benefits to healthcare provision in India and its healthcare sector in the short, medium and long term. Through strengthening a legal framework that fosters innovation and the incremental introduction of measures such as regulatory data protection, it will stimulate the further development of the Indian R&D pharmaceutical industry. We believe that a business environment that encourages investment in innovation, coupled with India?s lower cost yet highly educated workforce has the potential to make India?s R&D capacity a critical factor in tackling health challenges in the years to come.
The Indian government and some NGOs are questioning whether FTA is the best way to achieve the goals you mention. What is your view?
India is already on the right track in creating the right business climate for investment in innovation. We have seen a significant increase in R&D since the introduction of the India Patent Act in 2005; the FTA offers the opportunity to further enhance this system. It is worth noting that the same NGOs raised similar concerns about the impact it would have on the Indian generics industry and access to medicines when the Patent Act was introduced. These fears were proved to be unfounded.
How can a country like India, which is thrice the size of EU, reconcile its many contradictions and demands?
The level of access to healthcare of Indian citizens is one of the lowest among emerging economies. The absence of IPR had no bearing on improving access to medicines. This is why EFPIA supports the inclusion of balanced provisions on IPR within the FTA. At the same time, these provisions should take into account India?s level and rate of development and the size and scope of the healthcare challenges within the country. They should also recognise India?s role in supplying medicines to the developing world.
Why do India?s IPR laws need strengthening and what will be the effect of such measures?
Making Indian?s IPR laws more robust and predictable, would encourage the development of a research based pharmaceutical sector in India. It will give confidence to European companies to make sustained investment and partner with local innovative companies. This protection provides an important complementary IP right to patents, which are already in place in India.Regulatory data protection (RDP) is essential to protect this investment for a limited period
Will strengthening IPR in India affect the supply of essential medicines to the developing world? Will it have a harmful effect on the Indian generics industry?
When the India Patent Act was introduced in 2005, similar fears were raised. Six years on, and it is clear that the generics industry has continued to flourish and is exporting its products to the developing world. At the same time, the anticipated benefits of the Patent Act are beginning to bear fruit. In practical terms, none of the anti-retrovirals (ARVs) recommended by the WHO for first and second line use is patent protected in India. Secondly, as for new ARVs which may be recommended by the WHO sometime in the future and which may be patent protected in India, you would not need a marketing authorization for the Indian market to export them to poor countries.