Date:12/04/2004 URL: http://www.thehindubusinessline.com/2004/04/12/stories/2004041200470300.htm

Back Consumer fora seek to take part in drug-related debates

P.T. Jyothi Datta

Mumbai , April 11

CONSUMER organisations have urged that they be allowed to participate in pharma-related debates that eventually have an impact on the price of drugs and their affordability.

Even as pharma industry associations prepare to make presentations on `data exclusivity' before the inter-Ministerial committee, on Monday - consumer organisations have sought that they too be heard, before any decisions are taken.

Data exclusivity protects "from unfair commercial use", the data submitted by a company to the regulatory authorities. The pharmaceutical and agro-processing industry are split largely along domestic and multinational lines on whether or not data exclusivity should be provided.

Foreign companies are for `data exclusivity' to prevent "me-too" versions from eroding their market, while local companies feel that data is adequately protected by the regulations present in the country.

Giving a new dimension to the debate, a forum of "civil society organisations" and non-Governmental organisations - the affordable medicine treatment campaign - has written to the new Chemicals and Petrochemicals Secretary, Mr Pradush Sinha, seeking that "civil society" be heard on the issue.

"We have learned that the Department of Chemicals and Petrochemicals has set up a high level inter-Ministerial committee to consider the implementation of Article 39 (3) of TRIPS Agreement. We are concerned about the protection of test data (data exclusivity) because such monopoly rights have serious implications on the accessibility and affordability of those drugs. We fear that data exclusivity may lead to patent type protection and thus undermine the right to access drugs, a prime component of right to health," says a letter addressed to Mr Sinha.

Only early last month, and inter-Ministerial committee had been constituted to go into the issue and it's implementation. The committee comprises nine joint-Secretaries from Ministries including Commerce, Health, Agriculture, Science and Technology, Biotechnology and legal affairs. Also on the panel are the Drug Controller General of India, Mr Ashwini Kumar, and legal professionals Ms Pallavi Shroff (Amarchand Mangaldas), Mr Praveen Anand (law firm Anand and Anand) and Mr Biswajit Dhar from the Centre for WTO studies.

AMTC representatives told Business Line that debates relating to food and medicine need to have public participation, because people are at the receiving end of such initiatives.

Responding to whether the issue was not too technical for public participation, the representative said that consumer organisations were equipped to deal with such detail, keeping the consumer interest in mind.

Significantly, the issue over the presence of pesticide residue in bottled-water and soft drinks also surfaced when the Centre for Science and Environment brought the debate to the fore, in the interest of "civil society". The debate resulted in Government changing the norms for water, besides exploring changes for other processed foods, industry-watchers said.