Experts Say No to Data Exclusivity of Pharma Patents

New Delhi, September 08, 2006

“The pharmaceutical industry and the health delivery system including the hospitals, doctors, pharmacists and the diagnostic laboratories need a coordinated framework of regulation. At present there is some regulation only to regulate the pharmaceutical industry while the other components remain more or less unregulated” This is the view that emerged from a national workshop organized at IIC, New Delhi by CUTS International, a Jaipur-based research and advocacy group, along with the World Health Organisation and the Ministry of Health and Family Welfare, Government of India today.

The workshop was essentially to share the findings of a study by CUTS, titled, “Options for Using Competition Law/Policy Tools in Dealing with Anti-competitive Practices in Pharmaceuticals and the Health Delivery System”, also supported by the World Health Organisation and the Ministry of Health and Family Welfare. The Workshop saw a gathering of health and competition experts, as well as from the academia, consumer and other NGO activists and representatives of business associations.

Presenting the report of the study, Nitya Nanda of CUTS, the Principal Investigator of the study emphasized that the pharmaceutical and health delivery system is a peculiar case of market failure as consumers are not the decision makers. It is for the doctors to decide the kind of treatment as well as the medicines, diagnostic testing etc., and they in collusion with the pharmaceutical companies and other players in the market, ignore the interest of the consumers to fulfill their own interests.

On the issue of data exclusivity, which is being widely debated now, the participants including the Executive Director of Indian Drug Manufacturers Association, Gajanan Wakankar agreed that India need not and should not have this.

Referring to the prevailing anti-competitive practices and the alleged ineffectiveness of the MRTP Commission in dealing with them, G R Bhatia, the Additional Director General of the Competition Commission of India, argued that the MRTP Act did have some weaknesses, but the new Competition Act is much improved and hence better effectiveness can be expected as and when it is implemented.

Ujjwal Kumar, a WHO National Consultant with the Ministry of Health and Family Welfare emphasized that some IPR related provisions in the Competition Act should be strengthened, and the Competition Commission should have a role in dealing with issues like compulsory licensing. Mira Shiva of the Voluntary Health Association of India emphasized the need for better education among the people on health issues.

The participants also agreed that though it may not be desirable to put all medicines under price control, prices of all medicines should be monitored.