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Shri Kamal Nath, Union Minister of Commerce & Industry, has said that the government has built in enough safeguards to prevent price rise in the Patents (Third Amendment) Act 2005 passed by Parliament recently in order to protect the interests of consumers by ensuring availability of medicines at affordable prices. In a message delivered on the occasion of a Meeting on "Product Patents: Implications for Pharmaceutical Industry and Consumers", jointly organised by the Department of Industrial Policy & Promotion (DIPP), Ministry of Commerce & Industry, Government of India and the United Nations Conference on Trade & Development (UNCTAD) here this morning, Shri Kamal Nath said: "The price of medicines will not shoot up due to patents, because of these strong safeguards, checks and balances. There are comprehensive provisions in the amended Act to deal with issues concerning the price and availability of medicines. These include provisions for compulsory licensing to ensure availability of products at reasonable price; parallel import of products; acquisition of patent rights by the government; revocation of patents in the public interest; and provisions to deal with emergency situations. I must also repeat the point often cited that 97% drugs in the market, and 100% of all essential drugs are not covered by patents".
Further, the Minister said the interests of the domestic pharmaceutical industry were fully protected and listed out the specific provisions in the amended Patent Act which would safeguard the pharma and chemical industry. (a) Domestic companies can continue to manufacture patented products even after a patent is granted, in respect of mailbox applications, on payment of a reasonable royalty to the patent holder, if they had been producing and marketing the concerned product since prior to 1/1/2005. This provides a level playing field for domestic players who have already made substantial investments and have been manufacturing the products for which applications for patents have been received in the mailbox. (b) The system provides for both pre-grant and post-grant opposition avenues, and reduces the timeframe for grant of patents in a cost-effective manner, while taking care of public interest. In fact, pre-grant opposition to patents has been strengthened and all the 11 grounds for pre-grant opposition to patents have been specifically listed in the Act, in the same way as before the Ordinance of December 2004. (c) In order to prevent "evergreening" of patents for pharmaceutical substances, provisions listing out exceptions to patentability (or what cannot be patented) have been suitably amended so as to remove all ambiguity as to the scope of patentability. (d) Conditions for obtaining compulsory licence have been clarified in order to facilitate export of patented pharmaceutical products by Indian companies to countries that do not have adequate production capacities such as least developed countries. (d) ‘Reasonable period’ for negotiations between the patent holder and companies seeking compulsory licence has been fixed at six months; and (f) Exemption of research and development from the ambit of patents, including experimental and educational purposes.
The Minister reiterated that though the impetus for amending the Act might have been India’s obligation under the WTO Agreement on the Trade Related Intellectual Property Rights (TRIPs), the contents of the Patents Amendment Act of 2005 is "not an externally driven, it is nationally driven. It suits us to have a modern patent regime in line with what most countries in the world have already adopted, including China and Brazil". Pointing out that the pharmaceutical industry was amongst India’s most globally competitive industries today, with over one-third of its output being exported, Shri Kamal Nath said that with the expertise and knowledge-base of the domestic pharma industry and her scientists, India could change the paradigm of research and development by investment in technology and protecting her own intellectual properties through patents. Referring to the various concerns expressed over the years about the impact of the patents amendment, Shri Kamal Nath underlined that it was a measure of the government’s responsiveness to such concerns that extensive consultations were held with all stakeholders prior to formulating the Bill in its various stages, both, before and after the promulgation of the Ordinance. "I can say with confidence that all these concerns have been fully taken on board in the final form of the Amendment", he added.
The Minister said that today’s meeting was a timely initiative in bringing together experts, policy makers and other stakeholders to discuss the important issues and challenges in the field of pharmaceuticals, especially in the context of the introduction of the full product patent regime in India with effect from 1st January, 2005. The Meeting was also addressed by Shri Ashok Jha, Secretary, Department of Industrial Policy & Promotion, and Shri G.K. Pillai, Additional Secretary, Ministry of Commerce & Industry, who chaired the meeting.
The findings of the UNCTAD Study on "Product Patents: Implications for Pharmaceutical Industry and Consumers" by Dr. Veena Jha, India Programme Coordinator, UNCTAD were presented at the meeting by Shri James Nedumpara of UNCTAD India.
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