The World Intellectual Property Organization’s (WIPO) committee on the protection of indigenous knowledge, expressions and genetic resources failed to reach consensus on future work at their meeting held from 29 June to 3 July, effectively postponing the issue till the WIPO General Assemblies in September. The mandate of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) expires this year and deciding the next mandate of the group was the key task at the meeting. Some countries wanted to see the text of a possible agreement before deciding what kind of form it might take (such as an instrument or a database), while others wanted to set a goal of a legally binding international instrument and then work on its text. Informal consultations are planned in the interim between now and the assemblies in late September, though details are unclear. Whether the committee still had a mandate after the meeting was a point of confusion, though it appears that the mandate may carry until the end of December.
Health equity in economic and trade policies
A conference at the World Intellectual Property Organization (WIPO), held on 13 and 14 July, explored and clarified the connection between its work and several major public policy issues, ending with a look at public health and food security. The meeting addressed the issue of traditional knowledge. The ‘African renaissance can only be borne on the role of indigenous knowledge systems,’ said Yonah Seleti, director general of South Africa’s Department of Science and Technology. The current intellectual property system fails to protect the knowledge of indigenous people, he said, highlighting his office’s ‘farmer to pharma challenge’, which is intended to unlock the value in biodiversity and traditional medicines. But this means that intellectual property (IP) must be seen as having environmental and social benefits, as well as economic ones. Collaborative research between traditional knowledge and modern medicine can yield great public health benefits, but IP agreements must find ways to protect traditional knowledge.
Many people in developing countries lack access to health technologies. This paper presents seven findings about processes that shape access, based on analysis of six case histories: praziquantel to treat schistosomiasis (a parasitic worm disease), hepatitis B vaccine, the Norplant contraceptive, malaria rapid diagnostic tests, vaccine vial monitors and the female condom. Each case study is assessed with a comprehensive framework that examines the effects of architecture, availability, affordability and adoption on creating access. The analysis shows that access to health technology in poor countries is difficult to achieve because of multiple obstacles, but it can be created under certain conditions.
In response to the report by the United Nations Economic and Social Council (ECOSOC) on their high-level meeting held from 6–9 July in Geneva, Lumumba Di-Aping of Sudan, who spoke on behalf of the Group of 77 and China, said the international community should not let the patent holders deny the right to health. Patent holders should not ‘seek to restrain and unreasonably impose measures that affect the supply chain of medicines and transfer of technology relating to health products.’ Mike Boyd, acting director general of the International Federation of Pharmaceutical Manufacturers and Associations, asserted that pharmaceutical industry made a very significant contribution to helping achieve the health-related UN Millennium Development Goals. International cooperation should be improved in order to ensure access to affordable, good quality and effective medicines, said Maria Nazareth Farani Azevedo of Brazil. Intellectual property rights play a determinant role in the access, affordability, innovation, local production, and trade, she said, adding that member states should resolve the intellectual property agenda.
The World Trade Organization’s (WTO) Doha Development Round was meant to rebalance decades of unfair rules in agriculture and address the needs of developing countries. Instead, the negotiations have betrayed this promise. It has become a ‘market access’ negotiation, in which developing countries are expected to give disproportionately more and will receive little but stale promises of the general benefits of liberalisation. In order to put the Doha Round back on the ‘development’ track, Oxfam recommends that WTO members take actions to: improve the process of negotiations to make them more transparent and inclusive; ensure special and differential treatment for developing countries; promote development by enabling the realization of rights, such as the right to food, ensuring that trade rules respond to the needs of the most vulnerable people first; and strengthen the WTO as an institution to build greater confidence in its ability to achieve fairer trade rules for developing countries.
Pharmaceutical companies are manipulating the intellectual property rights system and are ‘actively trying to delay the entry of generic medicines onto their markets,’ a top EU official has said. As a result, there has been a decline in the number of innovative medicines getting to the market. The European Commissioner for Competition, Neelie Kroes, has announced that the first antitrust case resulting from the inquiry is now open. It alleges breaches of European rules on ‘restrictive business practices’ and ‘abuse of a dominant market position,’ and is filed against French company Les Laboratoires Servier and five generics with which it had made deals, according to a separate press release. The slowdown in novel medicines entering the market – 27 annually since 2000 as compared to 40 annually between 1995 and 1999 – was a systemic problem and the causes need to be identified.
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.
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.