PRODUCT PATENT REGIME MAY NOT BE ADVERSE, SAY EXPERTS
Date : 13 Aug 2004
Location : New Delhi
The introduction of the Product Patent regime in India on 1st January 2005 as mandated by the WTO and TRIPS regime need not be adverse to the cause of public health and the viability of the Indian Pharma industry as is perceived. These were some of the observations made by academic experts, industry players and policy professionals at a session hosted by the United Nations Conference Trade and Development (UNCTAD) at the commencement of the "Conference on Global Pharmaceuticals, Biotechnology and Health in the 21st Century: Challenges and Opportunities for India" organised by the Indian Pharmaceutical Association (IPA) and the Institute for Strategic Biotechnology, Health and Training (ISBHT) which held in Mumbai recently (6-8 August).
Participants felt that Public Health concerns in the Patent new regime would need to be addressed at the policy level. It was important that the government utilise all the policy spaces (like compulsory licensing) provided by TRIPS to ensure that the patent regime did not conflict with concerns of public health. It was stressed that given the prohibitive costs of Research and Development for new drugs, proactive partnerships between government, industry and civil society were needed to discover new and potent drugs against malaria, TB, AIDS and other forms of disease that affected the poor. However, recent trends indicate that life style related diseases are becoming as important in India as communicable diseases. Hence, the focus on investment for R&D in such diseases is also expected.
Experts felt that the coming of the Product Patent Regime would pose challenges for the Indian Pharma industry but not undermine its essential strengths. The Indian Pharma industry was in a position to accelerate its growth in the increasingly large global generics market on account of its high skill in process engineering and extremely low costs of production. It was pointed out that already companies such as Dr. Reddy’s and Ranbaxy had over 50% of their sales in the export market. Further the generics market was also set to expand with patented drugs with annual sales of $70 billion going generic in 2007 – Indian generic companies could thus continue to grow at phenomenal rates. Cost competitiveness is also leading MNCs to outsource manufacturing.
While Participants acknowledged that R&D costs pose challenges to Indian companies to develop their own drugs, India had an excellent base in basic biochemical process expertise which is a prerequisite for all forms drug development. There was every reason that given time and adequate support the Indian pharma industry had the capability of developing its capabilities in reverse engineering to product discovery research. The US rates it number 2 only after itself, in terms of R&D capacity. India is in the developing world has filed that largest number of patents.
India could fill up the increasing shortage of technical manpower in countries such as, the USA, which is projected to have a shortfall of 12,000 pharma investigators in 2005. India also had the advantage of low clinical trial costs and easy availability of patients for clinical trials – a strong note of caution was, however, sounded on the need to ensure that the utmost standards of ethics and safety for patients were maintained during clinical trials.
Indian industry will have to use a combination of strategies to take advantage of the Product Patent Regime. While some firms would focus on generics, some would be on the cutting edge of research. Given that research costs in India are roughly one tenth that of that in the US, R&D outsourcing may be a real possibility.