In this open letter to Margaret Chan, Director-General of the World Health Organization (WHO), Health Action International (HAI) urges WHO to dissociate itself from the work of IMPACT, a global intellectual property (IP) enforcement body that seeks to impose an IP agenda to deal with broader problems of medical products with compromised quality, safety and efficacy. It further demands that WHO no longer involve itself in IP enforcement with regard to pharmaceuticals and other medical products. It argues that, not only is the IP enforcement agenda ineffective in terms of addressing the wider public health threats from spurious and sub-standard medical products, but it has also been shown to impede access to medicines by undermining competition from generic medicines. WHO should continue to prioritise public health issues over issues of trade, which HAI points out has always been WHO's proper mandate.
Health equity in economic and trade policies
India and Brazil have taken the first step towards raising a dispute at the World Trade Organization (WTO) against the European Union (EU) and the Netherlands over the seizure by EU customs of generic medicines in transit to developing countries. Their request for consultations under the WTO Dispute Settlement Mechanism is the first step in the possible establishment of a panel at the Dispute Settlement Body (DSB), if the consultations fail. Indian ambassador, Ujal Singh Bhatia, said that both India and Brazil were concerned primarily over two considerations. Firstly, the seizures seemed to emanate from complaints made by patent holders in Europe, even though the generic drugs were perfectly legitimate under WTO rules in the source countries, as well as in the destination countries. He noted that the intellectual property issues raised were unmerited and international transit guarantees were being violated. Secondly, he noted that the seizures confused intellectual property rights with substandard or spurious medicines. He believed there was a concerted effort to put together a TRIPS-plus enforcement agenda that does away with the flexibilities that are guaranteed to developing countries under the TRIPS regime.
While the Anti-Counterfeiting Trade Agreement (ACTA) is getting a lot of attention with its draft consolidated version just published, there is another convention dealing with one major aspect it was always said ACTA would tackle. The Medicrime Convention of the Council of Europe sets the first international standard for criminalising the manufacturing and distribution of counterfeited medicine risking public health. Governments that will sign the convention later this year commit to establish as offences 'the intentional manufacturing of counterfeit medical products, active substances, excipients, parts, materials and accessories' (Article 5), 'the supplying or the offering to supply, including brokering, the trafficking, including keeping in stock, importing and exporting of counterfeit medical products, active substances, excipients, parts, materials and accessories' (Article 6) and also the 'falsification of documents' (Article 7). Medicrime also covers falsified medical devices and aims to see 'aiding, abetting and attempt' of the described acts criminalised. According to Medicrime, falsification of generic drugs also would be covered and so would the distribution of legal drugs on the black market like hormones sold without prescription to people who want to build up their muscles or enhance their performance. Also drugs brought to the market without undergoing existing controls will be covered.
More than 45 non-governmental organisations (NGOs), from countries as diverse as Switzerland, India, the United States and Uganda, have voiced concern over the involvement of the World Health Organization (WHO) in the issue of 'counterfeit' medical products. In an open letter to WHO, the NGOs criticised WHO's involvement in the International Medical Product Anti-Counterfeit Taskforce (IMPACT), including its links to entities that are engaged in matters pertaining to intellectual property (IP) enforcement, the central role played by the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in IMPACT's activities, the lack of transparency surrounding IMPACT's activities and the lack of accountability, as IMPACT has operated outside the purview of WHO member states. The open letter said that equating 'counterfeit' with spurious and falsely labelled pharmaceutical products not only undermines confidence in much-needed affordable quality generic products but also results in public health problems being addressed through an IP enforcement lens. It noted that spurious and falsely labelled pharmaceuticals will arise irrespective of whether or not there is an IP violation.
This publication affirms the World Health Organization's commitment to continue to work with member states and relevant regional economic integration organisations on the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. It guarantees to convene the Open-Ended Working Group before the 128th session of the Executive Board and to undertake any necessary technical consultations and studies to support the work of the Open-Ended Working Group in reaching a final agreement.
In 2007, world attention was focused on the World Health Organization (WHO) when claims emerged that WHO’s Global Influenza Surveillance Network (GISN) was unfair to the interests and needs of developing countries. According to this book, GISN has failed to deliver fair and equitable benefit-sharing with regard to vaccines, anti-virals and other technologies by not ensuring these products were available at affordable prices to developing countries that were most affected by the influenza outbreak. At the same time, developed countries profited from the virus sharing system by, for example, having timely access to vaccines and making intellectual property (IP) rights claims over shared biological materials and products developed using such materials. Developing countries thus potentially face astronomical bills for the purchase of vaccines and other medical supplies, as well as difficulties in accessing such supplies, due to their limited availability. Latest technologies were also protected by IP rights, creating more obstacles for developing countries that might seek to build their own production capacity. This book provides an in-depth understanding of the background to, and rationale for, the current WHO negotiations on influenza virus and benefit sharing, as well as a front-line view of the negotiations.
Pharmaceutical and medical device manufacturers argue that the current patent system is crucial for stimulating research and development (R&D), leading to new products that improve medical care. The financial return on their investments that is afforded by patent protection, they claim, is an incentive toward innovation and reinvestment into further R&D. But this view has been challenged in recent years. Many commentators argue that patents are stifling biomedical research, for example by preventing researchers from accessing patented materials or methods they need for their studies. Patents have also been blamed for impeding medical care by raising prices of essential medicines, such as antiretroviral drugs, in poor countries. This debate examines whether and how patents are impeding health care and innovation.
This book explores the history of and current collision between two of the major global phenomena that have characterised the last 30 years: the spread of HIV and other diseases of poverty and the ascendancy of neoliberal economic ideas. The book explains not only how International Monetary Fund policies of restrictive spending have exacerbated public health problems in developing countries, in particular the HIV and AIDS crisis, but also how such issues cannot be resolved under these economic policies. It also suggests how mounting global frustration about this inability to adequately address HIV and AIDS will ultimately lead to challenges to the dominant neoliberal ideas, as other more effective economic ideas for increasing public spending are sought. Rowden offers a unique and in-depth critique of development economics, the political economy dynamics of global foreign aid and health institutions, and how these seemingly abstract factors play out in the real world - from the highest levels of global institutions to African finance and health ministries to rural health outposts in the countryside of developing nations, and back again.
The author of this article asserts that East African countries risk not attaining the Millennium Development Goal (MDG) on universal treatment of people living with HIV and AIDS, malaria and other diseases if the region’s parliament adopts the draft anti-counterfeit laws currently under consideration. Civil society representatives, government officials and intellectual property experts have warned that the region would not meet this MDG if it adopted the proposed policy and bill, as they would block the production and importation of generic medicines used by health care services to treat diseases. The countries affected are Uganda, Tanzania, Rwanda, Burundi and Kenya. The draft laws could erode recent gains in scaling up treatment of people living with HIV and AIDS, according to Tenu Avafia, policy specialist on intellectual property, trade and HIV and AIDS at the United Nations Development Programme (UNDP).
The European Union (EU) is reported to be funding the drafting of Uganda's controversial Counterfeit Goods Bill, a proposed law that has caused an outcry as it threatens access to life-saving generic medicines in this low income East African country. According to the article, about 90% of medicines used in Uganda's health-care system are imported, of which about 93% are generics. According to this article, part of the five million euros that Uganda's ministry on tourism, trade and industry received from the EU in a financing agreement signed in July 2009 was to finance the drafting of this contentious bill that has consistently been criticised as a threat to treatment. The financing agreement is aimed at supporting Uganda's implementation of the economic partnership agreement (EPA) between the EU and East African countries. Health activists have criticised the draft law for defining counterfeiting so broadly as to criminalise the production and importation of generic medicines, including those for HIV and AIDS and malaria. They note that the draft law does not take advantage of the flexibility that Uganda, as a least developed country, has until 2016 before it is obliged to provide patent protection for pharmaceutical products as per the Trade-Related Aspects of Intellectual Property Rights (TRIPS) regime of the World Trade Organisation.