An influential manufacturers’ lobbying group in Kenya is pushing the government to start enforcing an anti-counterfeiting law, despite fears from public health advocates that the new rules will impede access to generic drugs and set an unwanted precedent in East Africa. The Kenya Association of Manufacturers (KAM) says it wants the Anti-Counterfeit Act to be implemented as soon as possible and has been in talks with the government to make sure that happens. The law was passed last year but has not yet taken effect because of budgeting and procedural delays. The association claims that counterfeits cost companies 50 billion shillings (US$650 million) and the government 19 billion shillings (US$250 million) in taxes in 2008. Yet public health advocates argue that the Act’s definition of what constitutes a counterfeit product is too vague and could be used to block the import and local manufacture of generic drugs. Civil society organisations also want the two issues of counterfeiting and patent rights to remain separate.
Health equity in economic and trade policies
In the United States, the complex process of getting health care technologies into practice takes place in a competitive health system that is driven by technological innovation. Federal, state and local governments’ roles in the diffusion process are limited. In low-income countries, where competitive markets are not as prominent, diffusing medical innovations requires an alternative understanding of how new technologies are adopted. This paper describes how, in low-income countries, the lack of functioning markets serves as a barrier to the transfer of necessary health technologies and why governments must act as stewards in promoting technologies there.
Leaders at the G8 conference in Italy have made very cautious commitments with regard to the top issue, climate change, but views on intellectual property rights enforcement began to become clear on the second day. Leaders called for a firm push for the Anti-Counterfeiting Trade Agreement (ACTA), which is unchanged from the past. The G8 IP Expert Group (IPEG) reaffirmed the 2000 Okinawa Charter commitment on use of software in full compliance with intellectual property rights that addresses public authorities. It also called on all states to step up consideration about how to combat digital piracy on the internet, which the IPEG sees as growing problem. And it presented the ‘G8 Model Arrangement on Bilateral Information Sharing for Fighting Counterfeiting and Piracy’ to allow the exchange of information between national authorities. Leaders also urged completion of the round of negotiations at the World Trade Organization’s meeting later this year.
The World Trade Organization’s TRIPS Agreement and the TRIPS-plus provisions in free trade agreements (FTAs) have had an adverse impact on prices and availability of medicines, making it difficult for developing countries (DCs) and least-developed countries (LDCs) to meet their obligations to fulfill the right to health, the UN Special Rapporteur on the right to health, Anand Grover, has said. Similarly, lack of capacity coupled with external pressures from developed countries has made it difficult for DCs and LDCs to use TRIPS flexibilities to promote access to medicines. He recommended that DCs and LDCs should not introduce TRIPS-plus standards in their national laws, nor should they enter into TRIPS-plus FTAs that may infringe upon the right to health. He recommended that they should review their laws and policies and consider whether they have made full use of TRIPS flexibilities or included TRIPS-plus measures and, if necessary, amend their laws and policies to make full use of the flexibilities.
The repeated practice of European Community (EC) customs officials seizing shipments of medicines while in transit to developing countries on grounds of alleged intellectual property violations has once again come under sharp criticism in the World Trade Organization (WTO). Protest by developing countries came at a formal session of the TRIPS Council on 8 June. The developing countries expressed concern over the European Union's (EU) commitment to the Doha Declaration on TRIPS and Public Health and the flexibilities inscribed in the TRIPS Agreement. They said that the EU was confusing legitimate generic medicines with counterfeit fakes. Furthermore, the EU was also undermining poor countries' ability to obtain cheaper generic medicines. India called upon the EC to urgently review their legislation and the actions of their national authorities and bring them in conformity with the letter and spirit of the TRIPS Agreement, the rules-based WTO system and the Doha Ministerial Declaration on Public Health.
The World Health Organization’s report and draft resolution, Principles and Elements of National Legislation against Counterfeit Medical Products, presented at their annual meeting in January emphasises counterfeit medical products as the central health problem pertaining to quality, safety and efficacy of medicines, while paying scant attention to equally significant public health problems of falsely labelled, spurious and substandard drugs. This article discusses the ramifications of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which wrote the report and resolution, and concludes that all role players should consider the negative implications of anti-counterfeiting actions, such as how the seizure of suspected intellectual property-infringing medicines in transit will affect access to medicines and the right to health, plus anti-counterfeiting legislation in various countries.
Counterfeit medicines were left off this year’s World Health Assembly agenda in May, and some countries suggested that the World Health Organization (WHO) was overstepping its mandate into intellectual property enforcement rather than public health. ‘WHO will not do the work of WIPO [World Intellectual Property Organization] or the WTO [World Trade Organization]’, by becoming involved in IP, WHO’s director general, Margaret Chan, has said. Nevertheless counterfeit medicines were felt by others to be an isssue, and appear in the medium-term strategic plan, which outlines WHO’s expected activities for the years 2008–2013.
On June 4, in Brussels, the European Union (EU) signed an interim economic partnership agreement with Botswana, Lesotho, Mozambique and Swaziland against the wishes of Angola, Namibia, and South Africa. This has made imminent an acrimonious break-up of Africa's oldest customs union, the Southern African Customs Union (SACU). Such an eventuality also raises doubts over the merger, scheduled for next year, of SACU and the Common Market of Eastern and Southern Africa (COMESA) into a single customs union under the Southern African Development Community (SADC). Signing any agreements that result in reductions in customs revenue could devastate the treasuries of the countries concerned. Lesotho earns about 60% of its state revenue through the SACU revenue-sharing arrangement, while Swaziland earns as much as 70%. Compensating for such loss through taxation could lead to a doubling of value-added tax rates and a tripling of corporate taxes.
Intellectual property (IP) issues were raised at the 124th Session of the World Health Organization’s (WHO) Executive Board in January in respect of the following technical and health matters: pandemic influenza preparedness (sharing of influenza viruses, access to vaccines and other benefits); the role and responsibility of WHO in health research; counterfeit medical products; and a global strategy and plan of action for the Intergovernmental Working Group on Public Health, Innovation and IP. A draft of the ‘WHO Strategy on Research for Health’ was presented.
India’s status as a top world supplier of generic medicines could be threatened by a free trade agreement its government is negotiating with the European Union (EU), according to this study. A draft of the proposed agreement put forward by EU officials recommends that it should incorporate a wide range of intellectual property issues. But at least two of the provisions in the draft could hamper access to affordable medicines for developing countries. One provision could require India to forbid the manufacture of generic versions of patented drugs for up to five years after the patents in question expire. Another provision would offer protection to test data submitted for the approval of branded medicines for a certain length of time (the precise duration has not yet been specified by EU officials). In effect, this would bar makers of generic drugs from using that data. The study notes that the EU recommendations go beyond the scope of the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.