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.
Health equity in economic and trade policies
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.
On 6 September 2012, Japan’s ruling party, the House of Representatives, ratified the controversial Anti-Counterfeiting Trade Agreement (ACTA) in the absence of opposition parties, counting only the votes of the ruling party. Critics have denounced the move as undemocratic, also claiming that the Japanese mass media has marginalised the issue in the arena of public debate. Meanwhile, processes in several ACTA signatory states seem to be stalled. The author of this article notes that it is unlikely that ACTA will become an international treaty, with an apparent stalemate between the United States administration and legislators about ratification procedures, and the European Union’s recent vote against ratifying the agreement. Besides Japan, seven governments are reported to have signed ACTA, namely Australia, Canada, Morocco, New Zealand, Singapore, South Korea and the United States. Switzerland has not signed nor ratified. ACTA will have significant repercussions for public health, as the treaty aims to strengthen patent protection for pharmaceutical companies, wuth negative consequences for the production of affordable generic medicines in the developing world.
Southern African states are being alerted to the concessions on intellectual property rights that they can take advantage of within the agreement on Trade-Related Aspects on Intellectual Property Rights (TRIPS) by the Southern African Regional Programme of Access to Medicines and Diagnostics (SARPAM). SARPAM is communicating the flexibilities within the TRIPS to protect public health, including compulsory licensing and parallel importation, as they note that many of these concessions are not yet being used by African countries to access essential medicines. They article reports ways that states and activists have advanced use of these flexibilities. For example in 2002, Zimbabwe used of one of them after declaring a period of emergency to override anti-retroviral medicine patents to import generic medicines for HIV. The article notes that the issue still demands activism. In March 2016, for example, activists marched to the Johannesburg offices of the multinational pharmaceutical company Roche to put pressure on the company to lower the extremely high cost of a life-saving cancer drug.
TAC activists picketed at the opening of the Africa Intellectual Property (IP) Forum on 26 February 2013 and handed over a memorandum to Rob Davies, South Africa’s Minister of Trade and Industry. They were demanding that the draft IP policy, which will lead to patent law reform, be made public. TAC also said that those living with HIV and TB and civil society need to be included in the process that will shape laws that will have an impact on access to medicines and healthcare. Minister Davies responded that the draft policy was now in its final stages and would be released for public comment soon. Davies spoke of the need for South Africa’s IP policy to balance the rights of innovators and the rights of humanity by ensuring incentives for innovation as well as ensuring public health and access to medicine. He highlighted the role of generic medicines in fighting disease in South Africa and was clear that generics are not the same as counterfeits. TAC and Médecins Sans Frontières (MSF) are calling for a local patent examination system to replace the existing automatic system. Fewer patents will mean more competition and lower prices, critical in light of the fact that South African patients are paying much more for life-saving drugs than counterparts in other developing nations.