The lack of a global legal framework to guide national action and international cooperation to reduce risk factors related to alcohol abuse and unhealthy diet significantly hinders the capacity of nations worldwide to unilaterally and collectively curb the expanding epidemics of non-communicable diseases (NCDs), according to this paper. A number of commentators have suggested the adoption of comprehensive treaties or framework conventions on obesity, or alcohol or both. Given the legal, political, budgetary, and time-related limitations to the development and adoption of all-encompassing treaty regimes to address obesity and alcohol abuse, the authors recommend an alternative legal strategy to counter these rising NCD epidemics. In particular, they call for the prompt adoption of a WHO/UNICEF global code of practice on the marketing of unhealthy foods and beverages to children. Such a non-binding international legal instrument has significant advantages over a treaty approach at the present time. It would provide a much-needed step towards advancing meaningful engagement with and holding to account all relevant actors, including national governments, private industry, and UN agencies, in protecting children everywhere from harm. The WHO Framework Convention on Tobacco Control (“FCTC”) addresses one of the major risk factors contributing to NCDs by establishing a global legal framework to counter the tobacco pandemic: in response, the authors call on the global community to act collectively to establish a legal architecture to regulate a central component of these two other major risk factors.
Health equity in economic and trade policies
In this policy brief, the author argues that the world Intellectual Property Organisation (WIPO) development agenda is a valuable opportunity to place the notion of the 'public domain' at the centre of the intellectual property debate. In this regard, she proposes the creation of an international register for public domain matters that countries, particularly developing countries and least developed countries (LDCs), should be able to rely on in order to boost their local innovation and creativity. The author recommends that governments and other stakeholders preserve the public domain and support norm-setting processes that promote a robust public domain, initiate discussions on how to further facilitate access to knowledge for developing countries and LDCs in order to foster creativity and innovation, and establish a forum for exchange of experiences on open collaborative projects such as the Human Genome Project.
The World Trade Organisation Doha Round talks ended bitterly on 31 July, but negotiators left town with the general consensus that hard-earned work to date should not be lost and that there might be resumption of talks sometime in the future. The fate of intellectual property (IP) issues at the WTO remains vague and may not come clear for weeks or months, according to some sources, while others said it will be business as usual for international trade rules on IP.
This paper analyses the implications of a tiered pricing and voluntary licensing strategy for access to Direct Acting Antivirals (DAAs) for treating Hepatitis C Virus (HCV). Seven countries in Africa were examined (Egypt, Ethiopia, Nigeria, Democratic Republic of Congo, Cameroon, Rwanda and South Africa) to assess their financial capacity to provide DAAs for treating HCV under present voluntary licensing and tiered-pricing arrangements. The cost of 12-weeks of generic DAA varied from $684 per patient treated in Egypt to $750 per patient treated in other countries. The current prices of DAAs are much higher than the median annual income per capita and the annual health budget of most of these countries. If governments alone were to bear the costs of universal treatment coverage, then the required additional health expenditure from present rates would range from a 4% increase in South Africa to a staggering 403% in Cameroon. The current arrangements for increasing access to DAAs, to eliminate HCV would require increases in expenditure that are too burdensome for governments, individuals and families. The authors argue that countries need to implement the flexibilities in the Doha Declaration on Trade Related Intellectual Property Rights agreement, including compulsory licensing and patent opposition to address this, and this requires political commitment, financial will, global solidarity and civil society activism.
Two proposals to change the current patent system are causing a new diplomatic battle at the World Health Organisation in November. One concerns the launch of new medicines and the other seeks to make existing drugs available at low prices in developing countries. A coalition of developing countries, amongst them Brazil, and non-governmental organisations are defending a “patent pool” to combine intellectual property rights on existing medicines, and a “prize fund” to reward and stimulate discovery of new medicines for so-called neglected diseases. The two initiatives are receiving strong opposition from some rich countries and the pharmaceutical industry. They have also caused a split between the two major Latin American countries. Mexico is moving away from Brazil’s position and is making alliance with the US, alleging that it has commitments in the trade agreement with Washington.
"Major changes in international trade, intellectual property (IP) protections and drug registration requirements are substantially affecting pharmaceutical markets, with significant implications for access to medicines by poor people. Within this framework, and drawing on legal, regulatory, economic and pharmaceutical industry expertise, the UK's Department for International Development (DFID) has commissioned a series of seven studies. The studies, summarised in this paper, examine the policy implications of these trends for emerging producers of generic medicines such as India and China, and for poor people in developing countries.A key question is how strengthened intellectual property protections and heightened registration standards may or may not improve access to medicines in these currently under-served markets."
WHO estimates that currently one third of the world's population lacks access to essential drugs. Over fifty percent of people in the developing world especially in Africa and Asia do not have access to even the most basic essential drugs. There are many factors which influence and maintain the higher and unaffordable prices of drugs, however, lack of price control measures and the pricing policies of multinational pharmaceutical companies are considered the most important contributing factors. This paper presents an overview on Globalization, Intellectual Property Rights (IPRs) and Patents, which have taken a new turn with the introduction of the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs Agreement).
Anti-counterfeiting initiatives might have a negative impact on access to medicines while not addressing the problem of fake medicines, particularly in developing countries, says a panel, which met on 25 September at the World Intellectual Property Organization General Assemblies. Confusion between legitimate generic medicines, poor quality medicines and those illegally copying the trademark of a brand-name product could have a devastating impact, and a precise definition and scope of counterfeiting is needed, they said. IP enforcement measures should only be used against drugs with trademark violations. Counterfeit medicines are products that are packaged to intentionally look like a legitimate product but are not. This is a trademark infringement. On the other hand, substandard medicine is a legitimately produced medicine that does not meet the standards set by the relevant drug regulatory authority. This is an issue of quality control. ‘When we speak about anti-counterfeiting initiatives, we are basically referring to the global IP enforcement agenda,’ Sangeeta Shashikant, senior legal advisor at the Third World Network, said at the meeting.
The Ministers of the African, Caribbean and Pacific (ACP) group of countries have issued their most comprehensive policy statement on the Economic Partnership Agreements (EPAs) at the end of a meeting they held in Brussels on 8-9 November. From the "Conclusions of the meeting" that they issued, it is clear that the Ministers recognised that the six ACP regional groupings are at different stages of negotiations with the European Commission on their respective EPAs, and that there are also differences between the regions on the issues that the EPAs would cover and on whether the negotiations will end by the official 31 December deadline. The Ministers welcomed the results obtained and stressed the need to do everything possible to ensure that the list submitted by the ACP Group regarding the preference erosion is rationalised to render it more credible.
This article is concerned with the Anti-Counterfeiting Trade Agreement (ACTA), an international agreement that seeks to strengthen the power of enforcement agencies, such as customs, to seize products that are fakes and infringe intellectual property rights (IPRs). It would allow customs officials to seize products – including generic medicines - if they believe these are counterfeit. The problem with this, the author argues, is the presumption that customs officials are competent to make such technical judgments, when they are not. These agencies could thus be used by rights holders to launch action against exporters from the developing world in a move that could destroy their business. Initiating proceedings places exporters in a tough financial position even if the goods turn out to be bona fide, as they would have to pay exorbitant legal fees to fight in court. Although ACTA is being presented as an anti-counterfeiting measure, it really has very little to do with controlling the international trade in counterfeit goods, the author argues, whose value has been exaggerated by its proponents. Rather, the effort is to bring about a fundamental shift in the rules governing international trade in a wide variety of knowledge goods - counterfeit or not. For India and the developing world, a primary concern is generic drugs. The article points to the fact that ACTA does not include any due processes, and encourages award of significant damages based on the suggested retail price, which makes valuations and lost profit presumptions in favour of the rights holders. It also extends injunctions to third parties not directly accused as infringers of IPRs.