The Medicines Patent Pool, which negotiates voluntary licences for lower pharmaceutical prices, has announced the signing of an agreement with Indian generics producer Aurobindo Pharma Limited to manufacture antiretroviral (ARV) medicines. The Patent Pool has recently come under criticism from AIDS activists concerned about its July 2011 licence agreement with drug company Gilead, and it remains to be seen if this action will address their concerns. The Medicines Patent Pool said that the agreement will enable Aurobindo to manufacture ARVs licensed to the Pool by Gilead Sciences in July. The uptake of the listed ARVs by generic manufacturers will help close the gap between the arrival of new medical technology in developed country markets and its often delayed arrival in developing countries, according to the Pool. In particular, Aurobindo took advantage of a key provision negotiated by the Pool so it can sell the ARV, tenofovir, to a larger number of countries without paying royalties. The arrangement is expected to make it possible for Aurobindo to sell tenofovir to a larger number of countries than before.
Health equity in economic and trade policies
Yusuf Hamied, head of Cipla, India's huge generic drugs company, has stirred global controversy by promising to supply Aids drugs for less than $1 a day. Now he has announced that he is ready to take on bird flu. At issue, again, is the whole question of generic versus proprietary drugs, an issue that has pitted Western capitalism against Third World campaigners and, perhaps more than any other dispute, cast moral opprobrium on multinationals attempting to protect the fruits of their expensive research.
Controversial legislation approved by the lower house of India's parliament on 22 March could drastically increase the cost of cheap HIV drugs and other medicines the country produces, according to international humanitarian organisations.The law threatens to affect the provision of healthcare to hundreds of thousands of patients, many of them in Africa, for whom low-cost Indian drugs are the only affordable means of treating AIDS. The new patents bill is intended to bring India's patent regime into line with the World Trade Organization's (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (known as TRIPS), one of the conditions of India's membership of the WTO.
The landmark decision by the Indian Supreme Court in Delhi to uphold India's Patents Act in the face of a seven-year challenge by Swiss pharmaceutical company Novartis is a major victory for patients' access to affordable medicines in developing countries, according to Médecins Sans Frontières (MSF). The court ruling was made on 1 April 2013 in the face of a seven-year legal battle with the pharmaceutical manufacturer. Novartis first took the Indian government to court in 2006 over its 2005 Patents Act because it wanted a more extensive granting of patent protection for its products than what was offered by Indian law. In a first case before the High Court in Chennai, Novartis claimed that the act did not meet rules set down by the World Trade Organisation and was in violation of the Indian constitution. Novartis lost this case in 2007, but launched a subsequent appeal before the Supreme Court in a bid to weaken the interpretation of the law and empty it of substance. Instead of seeking to abuse the patent system by bending the rules and claiming ever-longer patent protection on older medicines, MSF calls on the pharmaceutical industry to focus on real innovation, and governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access.
India’s Intellectual Property Appellate Board has upheld the country’s first compulsory licence on a pharmaceutical product. The much-awaited verdict upholds the compulsory licence issued to Hyderabad-based Natco Pharma Ltd, an Indian generic drug manufacturer, which sells a much cheaper version of German pharmaceutical company Bayer AG’s kidney and liver cancer drug Nexavar in the market. The judge cited affordability and product access as the reasons for the decision to dismiss Bayer’s appeal against the compulsory licence (CL). The decision means that the way has been paved for compulsory licences to be issued on other drugs, now patented in India and priced out of affordable reach, to be produced by generic companies and sold at a fraction of the price. In response to the decision, Médecins Sans Frontières expressed hope that, in the near future, compulsory licences will be issued for the newest drugs to treat HIV and affordable generic versions will be available not only in India, but in the rest of the developing world. Bayer has announced it will appeal the decision.
The World Intellectual Property Organization is seen as in a state of tumult these days, as the global body searches for a new director general and tries to grapple with issues such as implementing a Development Agenda and further harmonising global patent regimes. And some industry observers think it is causing some to lose trust in the organisation.
The international trade union movement has warned of growing social unrest and increased social hardship if trade liberalisation continues against the backdrop of harsh unemployment and austerity measures. Sharan Burrow, General Secretary International Trade Union Confederation (ITUC), said that the World Trade Organisation (WTO) has done nothing to prevent trade imbalances growing to unsustainable levels accompanied by dangerously widening income inequality. Burrow expects that the deal emerging from the eighth meeting of Trade Ministers in Geneva 15 -17 December 2011 will not help trade to drive economic recovery, employment creation and genuine economic development, and ultimately puts the multilateral trading system at risk. The ITUC is calling for an evaluation of the Doha round outcomes to assess its impact on providing decent work, improved living standards and diversifying the economies of developing countries. It argues that, without measuring the impact on developing countries and workers, it makes little sense to move forward with trade liberalisation.
The international trade union movement has warned of growing social unrest and increased social hardship if trade liberalisation continues against the backdrop of harsh unemployment and austerity measures. Sharan Burrow, General Secretary International Trade Union Confederation (ITUC), said that the World Trade Organisation (WTO) has done nothing to prevent trade imbalances growing to unsustainable levels accompanied by dangerously widening income inequality. The ITUC is calling for an evaluation of the Doha round outcomes to assess its impact on providing decent work, improved living standards and diversifying the economies of developing countries. It argues that, without measuring the impact on developing countries and workers, it makes little sense to move forward with trade liberalisation.
After an innovative partnership between a non-governmental group and a pharmaceutical company led to a new cheap non-patented drug against malaria being available in Africa in 2007, the model is being implemented again with another new non-patented anti-malarial drug being delivered to South American patients. Drug research and development being carried out under public funding is a new model that should lead the way, Ann-Marie Sevcsik, DNDi scientific communications manager, told Intellectual Property Watch. “Research and development should be ‘needs-driven’ instead of profit-driven, and not only for neglected diseases but for neglected patients, like cancer patients in the developing world,” she said.
Much has been said in the media about the health innovation and access to medicines impact of the recent decision of the Indian Supreme Court (SC) in the Novartis case. But there are broader implications, argues the author of this article. The ruling is also a revealing tale about the changing role of developing countries in the global intellectual property landscape and the growing influence of the judiciary in these countries in the implementation of international intellectual property rules. The worldwide attention received by the Indian SC ruling and its global implications could represent a turning point, as the Novartis judgment marks the first time that a decision by a judicial authority from a developing country in the area of intellectual property has been so closely scrutinised and so extensively commented upon internationally. The Novartis decision might be spearheading a world where judicial decisions from countries such as China, India and Brazil have an increasing global reach and contribute to shaping global approaches to intellectual property. It is also more generally reflective of the growing assertiveness of developing countries, particularly emerging economies, in the current global intellectual property landscape. However, the author cautions that only the future will tell us is if such a choice is ‘exceptional’ as it touches the highly sensitive issue of drugs affordability – which is of great political and social concern in India – or if it is signalling a broader trend.