The international debate around patents has been largely framed in terms of ‘protection for’ versus ‘access to’ intellectual property (IP), according to this article. If the framing of the debate shifts to a focus on research and development, this is likely to strengthen the leverage of developing countries to change the dynamics of IP negotiations in trade agreements, the authors argue. In fact, shifting the entire debate from IP rights to the research and development (R&D) gap may help tackle the fundamental problem of a monopoly-based innovation and access system. One example is nonexclusive licensing practices, such as those used by the not-for-profit Drugs for Neglected Diseases Initiative. The initiative finances R&D up front and offers the outcome of its research on a nonexclusive basis to generic producers, allowing for technology transfer and competition among multiple producers. Furthermore, universities currently hold important patents on many life-saving drugs, which prompted Universities Allied for Essential Medicines to propose that when a university licenses a promising new drug candidate to a pharmaceutical company, it should require that the company allow the drug to be made available in low income countries at the lowest possible cost. Another alternative to overcoming current patent barriers is the use of patent pools, as proposed by the World Health Organization, Médecins Sans Frontières, and UNITAID. Here, a number of patents held by different entities, such as companies, universities, or research institutes, are pooled and made available to others for production or further development. The patent holders receive royalties that are paid by those who use the patents. The pool manages the licences, the negotiations with patent holders, and the receipt and payment of royalties, in a manner that facilitates access to medicines in low income countries. The author proposes that other innovative policy proposals, such as the Heath Impact Fund (a strategy to create a publicly funded ‘pot of gold’ that would attract the private sector to create R&D innovations that effectively address priority global heath needs), be implemented. However the author argues that using patents as the financial incentive to encourage the pharmaceutical industry to develop drugs for the world's poor is of limited use, given that the market is nonexistent as neither governments nor patients can afford the end product.
Health equity in economic and trade policies
According to this report by Oxfam, poor-quality, or ‘substandard’, medicines threaten patients and public health in developing countries. Prioritisation of medicines regulation by developing-country governments, with the technical and financial support of rich countries, is badly needed. However, under the guise of helping to address dangerous and ineffective medicines, rich countries are pushing for new intellectual-property rules and reliance on police – rather than health regulatory – action. This approach will not ensure that medicines consistently meet quality standards. Worse, new intellectual property rules can undermine access to affordable generic medicines and damage public health. Oxfam argues. Developing countries must improve medicines regulation – not expand intellectual-property enforcement – in order to ensure medicine quality. Oxfam recommends that developed-country governments should expand funding and support for national and regional initiatives that increase the ability of drug-regulatory authorities in developing countries to protect their populations from harmful products, and stop pursuing TRIPS-plus enforcement measures (intellectual property rules that exceed minimum obligations under global trade rules) through internal regulations, multilateral trade initiatives, bilateral trade agreements, or through technical assistance. Developing-country governments should prioritise the expansion of public health-care infrastructure and invest in drug-regulatory authorities' capacity together with the provision of free essential medicines, as well as promote generic competition in national medicines policies, including implementation of TRIPS flexibilities in national laws, and reject initiatives modeled on ACTA, and any other TRIPS-plus enforcement initiatives. Oxfam calls on the World Health Organisation (WHO) to prioritise its comprehensive programme of work, which underpins access to affordable, quality medicines for its Member States, and disband IMPACT, the controversial task force that inappropriately uses an intellectual property framework to evaluate the public-health problem of unsafe medicines. Oxfam also calls on pharmaceutical companies to adhere consistently to WHO quality standards and to recognise the damage inflicted on public health as a result of the confusion of quality with intellectual-property issues in initiatives such as IMPACT, and correct this fundamental error in their public statements and documents.
This report is an update of Global Financial Integrity’s 2008 report, which found that developing countries lost between US$859 billion and US$1.06 trillion in illicit financial outflows in 2006. On the same basis, this report finds that illicit outflows increased to between US$1.26 and US$1.44 trillion in 2008 and that, on average, developing countries lost from US$725 billion to US$810 billion per year over the nine-year period, 2000-2008. Globally, illicit flows increased by 18% per annum from US$369.3 billion at the start of the decade to US$1.26 trillion in 2008. When adjusted for inflation, the real growth of such outflows was 12.7%. Illicit flows from Africa grew by 21.9% over the nine years, representing 4.5% of total illicit flows. Trade mispricing accounts for 54.7% of cumulative illicit flows from developing countries, according to the report, which identifies bribery, theft, kickbacks and corporate tax evasion as other significant sources of illicit flows.
The United Nations (UN) has been enjoined in a case that claims that enforcement of the Anti-Counterfeit Act 2008 would endanger lives due to limits to access to affordable and essential drugs. The Special Rapporteur from the UN, Mr Anand Grover, intervened in the suit as an interested party to support the constitutional principles of access to essential medicines. The court allowed the importation of generic anti-retrovirals (ARVs), pending the hearing and determination of this case. The interim order issued in April 2010 was aimed at saving the lives of those living with the virus by stopping implementation of three sections of the new Anti-Counterfeit Act, which was enacted by Parliament in 2008. While the objective of the Act was to prohibit trade in counterfeit goods, advocate Omwanza told the court if implemented the clauses would deny people using ARVs access to affordable and essential medication necessary for their fulfillment of the right to life, as enshrined in the Constitution. Although generic drugs for the treatment of HIV and AIDS are available and affordable, the advocate argued that if implemented the clauses would force government to buy more expensive branded medicines.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising, adopted on 29 October 2010 and the Convention of Biological Diversity (CBD), both have implications for the WHO intergovernmental dialogue on influenza preparedness and virus sharing. Article 8 requires countries to ‘pay due regard’ to ‘cases of present or imminent emergencies that threaten or damage human, animal or plan health’. Article 4 calls for ‘due regard’ to be paid to ongoing work or practices, provided such work or practices are supportive of and do not run counter to the objectives of the Convention of Biological Diversity (CBD) and the Protocol. The CBD and protocol are important as they have a legally binding status as they are treaties. Notably the United States is not party to the CBD.
South Africa is set to launch its own development aid agency in 2011. The South African Development Partnership Agency is expected to become operational before mid-2011 and will work with other external funding agencies to coordinate development programmes, mainly on the African continent. Although the government is hoping for contributions from the private sector, most of the funding will come from public money, according to Ayanda Ntsaluba, Director-General of the Department of International Relations and Cooperation. Since 2001, the South African government has channelled its aid contributions through the African Renaissance Fund (ARF), which is administered by the department. Much of the assistance provided by the ARF has focused on conflict resolution and peacekeeping in various countries, including Mali, Zimbabwe, Burundi and the Democratic Republic of Congo. However, transparency and accountability was problematic and Ntsaluba conceded that the tracking of ARF funds had not been optimal. Although the mandate for the new agency was still in draft form, he said South Africa would continue providing assistance to countries recovering from conflict. He assured critics that the new agency would be set up as a separate institution, with the administrative capacity to track and oversee all the programmes it funded.
This article looks at the main challenges to European Union-Africa relations in light of the EU-Africa summit held in Tripoli, Libya from 29-30 November 2010. The Tripoli meeting marked the third Africa-EU Summit since 2000. In 2007, both parties to the JAES pledged to work together to implement the Africa Health Strategy, the EU Project on Human Resources for Health, the Abuja commitment to dedicate 15% of government financing for health, and the European Programme for Action to Tackle the Shortage of Health Workers in Developing Countries. President Jacob Zuma of South Africa openly expressed his concern that after ten years of the partnership, there was still too little to show in terms of tangible implementation of the undertakings made in previous summits. He cautioned the summit against committing to another action plan when commitments made in the past have not been implemented. The author noted that for example the ongoing Economic Partnership Agreement (EPA) negotiations, have become a contentious issue in EU-Africa relations, with clauses for example that may negatively impact on the production of affordable generic medicines for developing countries by rigorously protecting patent holders in developed countries.
At the World Health Organization (WHO) Executive Board meeting, held from 17-25 January 2011, members raised strong concerns that a working group they mandated last May to address problems with WHO policy on counterfeit and substandard medicines has yet to be formed – with only four months remaining before it must report back to members. The Indian delegation called for a halt to WHO activities on anti-counterfeiting until the outcome of the working group is accepted by member states. Members agreed falsified medicines were a threat for global public health but some delegates argued the solution cannot be dominated by intellectual property rights enforcement concerns. The Indian delegate said that the working group was supposed to investigate the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT is a project with international police agency Interpol and other agencies, housed within WHO, and is meant to ‘halt the production, trading and selling of fake medicines around the globe’. It has been criticised in the past by some countries who claim IMPACT has not helped clarify the confusion between substandard, falsified or unsafe drugs and legal, reliable generic medicines.
African countries have stalled on signing economic partnership agreements (EPAs) with the European Commission because they fear negative consequences for their smaller economies, this article reports. To avoid the pitfalls of signing the EPAs in their current form, the article suggests African countries should negotiate trade preferences. The author notes that the 33 least-developed countries (LDCs) in the African Union do not have to sign the EPAs since their trade preferences will continue under the ‘Everything But Arms’ scheme. They should not have to sign EPAs in order to maintain the common external tariffs they have or would like to have with the non-LDCs in their regional economic groupings. Instead, the 14 non-LDCs can request that the EU provide them also with the ‘Everything But Arms’ scheme, without their having to give preferences to the EU in return. He argues that there is a good case for this, as these 14 countries are also poor and vulnerable, and have similar characteristics as the LDCs. Moreover, they belong to regional economic groupings in which LDCs are the majority of the membership, and there is thus also a good case that they be given a similar status as the LDCs so that these groupings can continue with their common tariffs, without the LDCs having to be sacrificed. There are a number of cases in the WTO in which waivers have been given for non-reciprocal agreements between a developed country member and a developing country or region. The article concludes that the best option to resolve the EPA impasse is for Europe to give a non-reciprocal preferential package for Africa as a region, or for the 14 African non-LDCs, in a treatment similar to ‘Everything But Arms’.
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.