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February 2015 CHANGES
TO INDIA’S IP LAWS COULD IMPACT ACCESS TO MEDICINE The US is putting pressure on India to change its intellectual property regime with severe consequences to the health of many worldwide. By Third World Network Under pressure from the US, the Indian government has announced possible changes to India’s intellectual property (IP) regime, which might adversely affect access to affordable medicines in the developing world. The US pharmaceutical industry has long regarded the Indian generic medicine sector as a bane and exerted pressure to change India’s IP laws to protect the interests of US pharmaceutical companies. And there are signs that the pressure is working. According to inside sources, it appears that India’s Prime Minister Narendra Modi is very keen to assure US President Barack Obama and US multinational companies (MNCs) that India will agree to the changes proposed by them, said former UN Special Rapporteur on the Right to Health, Anand Grover. (1) The changes are said to touch on two issues, namely on data exclusivity and patent linkage. To obtain marketing approval, the original drug manufacturer must undertake various phases of clinical trials, data from which is used to apply for a patent on the drug. When a generic version of the drug is to be registered, the manufacturer has only to prove that the product is a “bio-equivalent” of the original product. The authorities would rely on the trial data of the originator company to evaluate the safety and efficacy of the generic drug. This expedites the entry of generics into the market. But data exclusivity would prevent such reliance on the originator’s trial data, thus delaying market entry for generic drugs.
Both these practices can delay the entry of generic medicines, thus “allowing monopolistic pricing to thrive, even if this means that patients across the world are denied access to affordable medicines,” Grover says. An Oxfam study revealed that after data exclusivity was introduced in Jordan, and in the absence of generic substitutes, the cost of certain medicines spiralled over 1000% compared to neighbouring Egypt. India’s generic pharmaceutical industry is important as it is the largest provider of high-quality and affordable generic medicines not only to patients in India but also to other developing countries. Major donors and leading international treatment providers, including NGOs and the United Nations, rely on quality affordable generic drugs for treatment for AIDS and other diseases, such as tuberculosis, malaria, and a wide range of infectious diseases. The emergence of India as a major supplier of generic medicine was made possible when in the 1970s, faced with patents owned by rich multinational corporations and medicine prices which were amongst the highest in the world, India introduced significant changes in its patent law which did away with product patents and only preserved process patents.
“The Indian Patents Act 1972… provided the legal freedom to the pharmaceutical
industry to emulate the new medicine introduced in the developed country
market,” thus giving gave a huge boost to the Indian generic industry,
KM Gopakumar, a member of the National Working Group on Patent Laws
points out in a editorial published in BusinessLine. Today,
the Indian pharmaceutical industry not only meets more than 90% of
the domestic needs but also supplies affordable medicines to more
than 190 countries. “From being a minor partner to the Western pharmaceutical companies, the Indian generic industry became a dominant force in the market and the pharmacy of the poor across the globe,” adds Grover. When India negotiated the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under the World Trade Organisation, it fought for flexibilities which could allow it to make available life-saving medicines at prices significantly lower than the patented versions. However, all these flexibilities are now under attack by the US government at the behest of their industry. Not only do they want to dismantle India’s existing IP regime but they also seek to introduce so-called TRIPS-plus measures which go beyond the standards in the TRIPS Agreement.
During President Obama’s visit to India in January, the Prime Minister
indicated strongly that measures related to data exclusivity and patent
linkage are in the offing. If these two measures were introduced, Prime Minister Modi “would only be emboldened to dismantle the very core of the Indian IP regime,” which is what the US wants, Grover points out. Resistance, however, is mounting against the proposed changes. Organisations worldwide have signed petitions supporting India's patent law and urging India to stand strong in the face of growing US pressure. Indian civil society groups warned in a statement: "Indian generic medicines are the life-line of millions of patients around the world. US pharmaceutical companies are threatened by our industry and now the Indian government also seems to be bending to their will. Access to affordable generics could be under serious threat if the US companies have their way.” – Third World Network Features. Note: (1) Former UN Special Rapporteur Mr. Anand Grover's note on the Indian Prime Minister's announcement on a change in the IP regime. January 30, 2015. -ends- When reproducing this feature, please credit Third World Network Features and (if applicable) the cooperating magazine or agency involved in the article, and give the byline. Please send us cuttings. And if reproduced on the internet, please send the web link where the article appears to twnet@po.jaring.my. 4195/15
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