Pharma industry urges govt to withdraw WHO study on 'data exclusivityThe domestic pharmaceutical industry has urged the government to withdraw a study launched by the World Health Organization (WHO) in consultation with the Union ministry of health on implementing 'Data Exclusivity' in India.

The industry has sought the intervention of the Department of Pharmaceuticals (DoP) to take up the issue with the health ministry so as to immediately withdraw the study on the ‘impact of Satwant Reddy Committee Recommendations on the Indian pharmaceutical industry' . This, the industry feels, is an attempt on the part of the multinational companies (MNCs) to get monopoly by creating a new IP Right.

The industry's suspicion grew all the more over the fact that a lawyer firmAnand and Anand, whose representative Pravin Anand was a member of the Satwant Reddy Committee and has in different forums expressed his views on Article 39.3 that it obligates India to implement data exclusivity, have been commissioned to prepare the study.“It is also general knowledge that the lawyers' firmAnand and Anand is a firm overwhelmingly patronised by multinational companies/clients. It only means that the ultimate aim of the study is to justify Data Exclusivity as a new IP Right”, the industry expressed its anguish to the government.

The industry is appalled by a questionnaire sent to it as part of the study as it suggests that incremental modifications, modifications in old Ayurvedic formulae, traditional knowledge, new uses of old products, combinations of already patented or out of patented drugs, etc should be allowed protection under Data Exclusivity. Industry contends that all these are non-patentable under the Patents Act which was passed by Parliament after considerable consideration.

Contending that India is not under TRIPS obligation to give data exclusivity, the industry points that the Brussels Ministerial of GATT which saw the most exhaustive debates on the subject, the Dunkle Report and the Marakkash Conference, had specifically rejected the United States' demand for a five year exclusivity under Art 39 (3) of TRIPS and they allowed only DataProtection.

To further drive home its point in this regard, the industry puts forth India's official submission to TRIPS Council on 29 June, 2001 (IP/C/W/296) “Art 39.3 of the TRIPS Agreement leaves considerable room for Member countries to implement the obligation to protect test data against unfair competition practices.The Agreement provides that 'undisclosed information' is regulated under the discipline of unfair competition, as contained in Article 10 bis of the Paris Convention. With this provision, the Agreement clearly avoids the treatment of undisclosed information as a 'property' and does not require granting 'exclusive' rights to the owner of the data”.