In the last few months, various patients? groups, community-based organisations and public health groups in India have been protesting against the government?s negotiations over FTAs with the EU, Japan and the European Free Trade Association (EFTA). The EU is also negotiating similar agreements with other developing countries.
The movement has received support from international groups like the REBRIP, who have pointed out that such FTAs will reduce the impact of the good work being done by India as the acknowledged ?pharmacy of the developing world?. The reference is to the fact that 92% of people living with HIV/Aids in low- and middle-income countries use antiretroviral (ARV) medicines made in India.
The fear is that in their current form, these FTAs are likely to drastically reduce access to newer medicines for people living with HIV, cancer and other diseases, both in India and other developing countries.
The main clauses that are of concern, according to such groups, are those that seek to enforce data exclusivity of clinical data, extend the term of pharma patents from the current 20 years by an additional five years to compensate for delays in the patent application process, and finally the enforcement of intellectual property and border measures that will allow consignments of generic drugs to be branded ?fake/fraudulent? at international borders, as has already been happening. Industry lobby groups like the Ficci have also said the agreement, as it stands, is unacceptable.
Domestic firms like Cipla oppose the FTAs on the grounds that they supply ARVs to one in three Aids patients in Africa. MNCs like Novartis and Bayer counter these allegations in open letters to M?decins Sans Fronti?res (MSF). The letter from Novartis says that they would like to expand the pharmacy of the developing world, not to close it. This is in reply to an article posted by Tido von Schoen-Angerer, executive director of Access to Essential Medicines Campaign, MSF, titled India: Will Pharma, Trade Agreements Shut Down the Pharmacy of the Developing World?. Novartis has criticised Section 3(d) of the Indian Patents Act on the grounds that it does not recognise incremental innovations. Novartis?s stand is that India should support incremental innovation as many Indian companies excel at it, and it also benefits patients as it results in safer and better medicines.
Karel De Gucht, commissioner for trade, European Commission (EC), has reiterated that the EC is fully committed to ensuring that people in the world?s poorest countries can access affordable medicines and has gone on to explain the EC?s stand.
Gucht gives an assurance that nothing in the FTA will prevent India from using the compulsory licensing for manufacture and export of life-saving medicines to other developing countries in need. To ensure this, the EC has already proposed a legally binding reference to the Doha Declaration on the TRIPS Agreement and Public Health stating that ?nothing in this agreement shall be construed as to impair the capacity of the parties to promote access to medicines.?
He confirms that the FTA will not interfere with the trade of generic medicines in transit. On data exclusivity and patent term extension, Gucht comments that ?an adequate protection on IP in India is crucial to incite innovative industry for the development of new medicines and to enable EU generic companies to compete with Indian companies on a level playing field.? He also admits that IP must take into account interests related to public health protection. The reference to EU generic companies competing with Indian companies on a level playing field would surely give some domestic generic players cause for worry.
On the data exclusivity issue, too, Gucht says that they are ready to ?show the necessary flexibility here and fully take into account the specificities of the Indian legal system, the policy developments on this issue within India, its developing country status and the role it plays with regard to production of essential generics for the developing world.? He specifies that ?in case of public health needs, we would of course not object to exceptions to data exclusivity….?
The whole issue becomes more complicated as many domestic companies are today more open to see the issue in shades of grey. Many of them today collaborate with MNCs at various levels; either as contract manufacturers, research service providers, etc. These alignments are being seen as steady revenue earners as well as a learning experience on the R&D curve. But to balance all interests, the Indian government will have to build safeguards into the proposed FTAs with the EU.
viveka.r@expressindia.com