The data-exclusivity debate hots up - P.T. Jyothi Datta

The data-exclusivity debate hots up - P.T. Jyothi Datta

Prime Minister's Office moots high-level meeting on the issue

Data-exclusivity ensures that information submitted by drug or agro-chemical companies while seeking a marketing approval is kept confidential by the Government

Mumbai , June 19
The rumble over data-exclusivity is getting louder, with international aid agencies and political parties joining the debate.
Data-exclusivity ensures that information submitted by drug or agro-chemical companies while seeking a marketing approval is kept confidential by the Government for a fixed period of time, when even the regulatory authority is not allowed to rely on this classified data.

Contentious Issue

And the heightened interest in data-exclusivity is because a high-level meeting mooted by the Prime Minister's Office (PMO) is expected to swing a decision one way or the other. The PMO is said to have initiated the meeting as inter-ministerial interactions failed to chart a course on the contentious issue.

In a recent letter to the Prime Minister, BJP's Dr Murli Manohar Joshi says, "Providing of data exclusivity has serious implications for the role of domestic enterprises in the fields of pharmaceutical and agro-chemical products. If data exclusivity is conceded domestic enterprises would be prevented from taking marketing approvals on the basis of the data submitted by the first enterprise who had generated the data and submitted the same for taking marketing approval."

Intellectual Property Rights

Writing in his capacity as the Member of Parliament (Rajya Sabha) and Chairman, Parliamentary Standing Committee on Commerce, Dr Joshi, echoes the World Health Organisation's recommendation on data exclusivity: That developing countries be well advised to keep the systems of Intellectual Property Rights and drug regulation separate and reject efforts to make connections between the two.

Earlier this month, international aid agency Medecins Sans Frontieres (MSF) — Doctors Without Borders — said in its letter to the Prime Minister that the Drugs and Cosmetics Act was a legislation related to health and improving access to drugs. "An amendment to implement an intellectual property agreement in the Drugs and Cosmetics Act can have a serious impact on the approval and availability of generic versions of essential drugs," the letter said.

Exclusive Rights

"If the Indian Government starts providing exclusive rights over test data, this will delay generic competition from Indian pharmaceutical companies even in cases where the medicines are not patent protected," the MSF letter points out.
But with the debate set to go down to the wire, innovator companies insist that India has an international legal obligation to protect commercially sensitive data generated during the development of regulated products. And protection of this data was important for new products and investments to come into the country.

WHO against data exclusivity that hampers access to medicines
Tuesday, June 20, 2006 08:00 IST Our Bureau, New Delhi

The World Health Organisation has made it clear that it advises against any move to link drug regulatory system and intellectual property system through 'data exclusivity'. In a briefing note on access to medicines, WHO says that two separate legal and regulatory systems, the intellectual property system and the drug regulatory system, have different objectives and should and function independently be administered separately. "Recent efforts to integrate these two systems via data exclusivity "linkage" or other means are likely to have negative implications for access to medicines. Thus, (developing) countries would be well advised to keep these systems separate and to reject any and all efforts to make connections between them," it said. According to WHO briefing note, from the perspective of public health and access to medicines, it is preferable not to grant data exclusivity. It also points out that there is no requirement under international law that countries grant data exclusivity as they have only been asked to provide data protection. However, the briefing note goes on to say that if a country, for some reason does grant data exclusivity or otherwise provides data protection beyond that mandated by TRIPS, it is important to limit its potential negative implications on access to medicines. "This can for example be done by limiting its duration and/or scope (e.g. only for new chemical entities) and by providing that reliance on the originator's safety and efficacy data is allowed in case of compulsory licensing," it stated. Calling data exclusivity provision as a "TRIPS-plus" requirement, it stated that all TRIPS-plus requirements like patent term extensions, limitations of the grounds for compulsory licenses, linkage between patent status and generic registration, etc will complicate and/or delay the marketing of generics, and thereby reduce access to medicines. "Yet, while these requirements are going beyond the TRIPS Agreement -or, in other words, are not required by TRIPS- in recent years, "TRIPS-plus" requirements have at times been incorporated in bilateral or regional free trade negotiations, in bilateral investment agreements and in other international agreements and treaties. From the perspective of access to medicines, this is a worrying trend; countries should therefore be vigilant and should not 'trade away' their people's right to have access to medicines," WHO cautioned.