New Delhi, 15 March 2016 – Médecins Sans Frontières (MSF) is deeply concerned about the recent revelations in the media that a US industry lobby group – the US India Business Council (USIBC) and US Chamber of Commerce – has received verbal, private assurances from Indian officials that it will not use ‘compulsory licensing’ (CL) for commercial purposes.
The statements are part of USIBC’s submission to USTR’s (US Trade Representative) annual Special 301 report. Many US industries, in particular the pharmaceutical industry, use the report to condemn governments which employ intellectual property (IP) systems that do not match intellectual property laws and practices in the United States. Current US intellectual property laws enable drug makers to charge exorbitant prices for medicines, such as Gilead Sciences, which charge up to US$1,000 a pill for new hepatitis C drug sofosbuvir.
India—the world’s principal producer and supplier of quality generic medicines, including for US-funded treatment programs like PEPFAR that support antiretroviral treatment in developing countries— has in recent years repeatedly been singled out by the US government and the multinational pharmaceutical industry for insufficient enforcement of intellectual property.
MSF responds with the below statement:
“For almost a decade, India has championed affordable access to medicines by setting strict patentability standards and issuing compulsory licences, both of which are legal tools available to all governments under the TRIPS Agreement. These legal tools have never been as crucial as they are today, as the Indian patent office considers patent applications on new life-saving medicines to treat infectious diseases – such as sofosbuvir or dolutegravir for HIV and hepatitis C – and on critical vaccines like the pneumococcal conjugate vaccine (PCV).
“Compulsory licences can be granted on many grounds including but not limited to: non-working of a patent, addressing anti-competitive conduct, reducing prices of unaffordable medicines and addressing public health emergencies. Yet, the USIBC and other pharma lobbies are working to discourage the Indian government, its patent authorities and courts from using these legal tools available under both Indian patent law and international trade rules.
“Any commitment to stop granting compulsory licences and enforce patent law safeguards will defeat the legislative intent of the public health safeguards that are enshrined in India’s patent law, and which were globally welcomed by the United Nations, MSF and developing country governments in 2005. Such a commitment will encourage multinational drug companies to start charging unaffordable prices to Indian patients and governments across the developing world, further undermining access to critical, and life-saving products.”
- Leena Menghaney, Regional Head-South Asia, MSF Access Campaign
In June 2015 MSF launched a campaign using #HandsOffOurMeds, to urge Indian Prime Minister Narendra Modi to stand strong in the face of intensifying pressure from the United States, Japan, Switzerland and the European Union to change India’s laws and policies in ways that would severely restrict the country’s ability to produce affordable medicines, upon which millions of people around the world rely. For more, visit handsoff.msf.org.
Other recent disconcerting developments concerning IPR in India negatively impacting access to medicine
- With the passage of the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Bill in December 2015, IP cases including disputes on pharmaceutical patents have been moved to commercial courts. These specialized commercial courts can narrow a judge’s view and could undermine the critical role the judiciary can play in the future to protect the constitutional right to life, and in particular establishing a balance between the enforcement of private IP rights with the need to implement safeguards in the patent law that protect generic competition.
- Indian patent office is in process of amending the patent rules - under pressure from industry and law firms – to introduce fast track patent examination, which will undermine the ability of patient groups to file pre-grant oppositions in time. The patent system is not transparent enough and it takes years to do a patent landscape to identify multiple patent applications on each drug including the ones that seek to attempt patent term extensions through ever greening.
- The draft national IP policy pending before the cabinet may include proposals that are detrimental to access to medicines and reforming the biomedical innovation system to meet the needs of developing countries.
- The USIBC – a group that receives funding from pharmaceutical companies – was allowed to conduct training for patent examiners who assess applications covering many life saving pharmaceutical products (medicines, vaccines, diagnostics). This allows the US pharmaceutical industry who wants a more favourable patent regime to influence India’s patent office decisions.
Links to Submissions by US Pharma/lobby groups to Special 301 report:
US Chamber of Commerce’s Global Intellectual Property Centre
US- India Business Council
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