Pharmabiz
 

NGOs flay 'decision' to provide 5 year data exclusivity

Joe C MathewWednesday, September 20, 2006, 08:00 Hrs  [IST]

Public interest groups in India have protested against the 'decision of the Committee for the Protection of Undisclosed Information under Article 39.3 of the TRIPS Agreement under the chairpersonship of Satwant Reddy, secretary, ministry of chemicals and fertilizers to recommend five year data exclusivity for pharmaceuticals' in India. The NGOs stated that the decision was known to have taken on September 6. There is yet to be an official confirmation on the allegations. The NGO representatives said that the committee had ignored the 'concerns raised by the Ministry of Health and strong opposition from public health groups'. "This decision of the government that directly impacts the availability of affordable drugs in the future, also ignores the concerns and suggestions of the Indian Network for Persons living with HIV/AIDS (INP+), the Medico Friends Circle, the Jan Swasthya Abhiyan (Peoples Health Movement), the Global AIDS Alliance, Torchbearers (mental illness advocacy group), MSF's Campaign for Access to Essential Medicines, the Bangalore HIV and AIDS Forum and the Lawyers Collective HIV/AIDS Unit; all of whom had written to the Prime Minister and the health ministry outlining their opposition to Data Exclusivity for drugs", that stated. According to them, amendments to the Drugs and Cosmetic Act will now be drafted seeking to introduce a 5-year Data Exclusivity term in India . They also felt concerned about the manner in which the drafting of the amendments would be carried out. "It remains to be seen if the amendment Bill will be shared with stakeholders including public health groups. Last year the government introduced amendments to the Indian Patents Act 1970 without sharing the proposed bill with stakeholders and experts" ,they said. Data Exclusivity in a certain length of time during which the Drugs Controller General of India is prohibited from relying on available clinical trial data in order to register a generic version of a drug. Data exclusivity prevents the registration (for marketing approval) of generic versions of medicines even when there is no patent on a medicine, for example when a pharmaceutical does not meet the standards for patentability ( e.g. because it is not new). Generic medication from India has been pivotal to the provision of affordable treatment for millions in India and around the world for HIV/AIDS, cancer, TB, asthma and mental illness, they explained.

 
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