Member governments of the World Health Organisation (WHO) ended a week of intensive negotiations on a global strategy and plan of action to improve access to health care in developing countries, in particular, health research and development on diseases disproportionately affecting developing countries. The negotiations at the WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property Rights, chaired by Peter Oldham of Canada, were suspended on 10 November evening to resume again at a meeting tentatively set for 28 April to 3 May 2008. At the six-day talks, the negotiators are reported to have made some progress in a few areas, but with considerable and difficult negotiations ahead to agree and draw up "a global strategy and plan of action".
Health equity in economic and trade policies
The technical symposium on ‘Access to Medicines, Patent Information and Freedom to Operate’, held on 18 February 2011 in Switzerland, was hosted by the World Health Organisation (WHO) and co-organised by the World Intellectual Property Organisation (WIPO), and the World Trade Organisation (WTO). According to Margaret Chan, WHO’s Director-General, countries could save about 60% of their pharmaceutical expenditures by shifting from originator medicines to generic medicines, but a lack of essential procurement and regulatory capacities are preventing this shift in many developing countries. This is especially so in relation to non-communicable diseases, which is a growing problem in low and middle income countries. She called for more transparent and accessible data on patents to help with decisions on the ‘freedom to operate’, such as a user-friendly database that contains public information on the administrative status of health-related patents. Pascal Lamy, WTO Director-General, said the main aim of the symposium was not to enter policy discussions or legal debates but rather to evaluate the area where the three agencies could collaborate to provide an information base for policy debates. He argued for a move from raw data to accessible, trusted, neutral and relevant information that directs policymaking processes, practical innovation and procurement strategies. However, some participants at the symposium called for greater involvement of the generic industry to provide affordably priced medicines, and questioned the legitimacy of WIPO involvement in public health.
More than twenty technology companies are responding to a call to support the fight against counterfeit medicines spearheaded by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) set up by the World Health Organization (WHO) and partners. They were to join the IMPACT Working Group on Technology for a one-day meeting in Prague to assess technologies which could improve the global prevention, tracking and detection of counterfeit medicines. "In the case of anti counterfeiting, the challenges we face are finding technologies that cannot themselves be counterfeited and transferring them to resource poor settings at an affordable cost. While technology alone cannot solve the problem, some of these solutions could greatly enhance the ability to detect and deter the distribution of counterfeit medicines."
On 26 February 2013, the World Health Organisation (WHO), the World Trade Organisation (WTO) and the World Intellectual Property Organisation (WIPO) presented their trilateral publication ‘Promoting Access to Medical Technologies and Innovation’ to the WIPO Standing Committee on the Law of Patents (included in last month’s newsletter). Promoted by the three organisations as ‘neutral’ and ‘informative’, the report came in for criticism from delegates from developing countries. On behalf of the Africa Group, Algeria said that while the study recognises that there are some limitations to the use of patent flexibilities, it does not look at the constraints developing countries encounter when using the flexibilities. Furthermore, many African countries lacked resources to meet all the formal requirements needed to implement flexibilities. Algeria highlighted the African and Developing Agenda Group (DAG) joint proposal on a patents and health work programme, which calls for further research, information exchange and technical assistance for least-developed countries (LDCs). Delegates from India and Brazil also called for further research into TRIPS flexibilities, arguing that the report had not done enough in this regard.
Developing countries have voiced concerns at a meeting of the Executive Board of the World Health Organization (WHO) over the Secretariat using the term ‘counterfeit’ to describe problems relating to the quality, safety and efficacy of medical products, and addressing such problems through the International Medical Products Anti-Counterfeit Taskforce (IMPACT). Some countries felt the WHO's anti-counterfeit taskforce, IMPACT, was unsuited to address the issue of quality, safety and efficacy (QSE) of medical products because it lacked a mandate from the WHO's governing bodies; and because of its emphasis on counterfeits; the involvement of the private sector in its activities raising issues of conflict of interest; and its lack of transparency.’
There is a pressing need for Africa to bolster its pharmaceuticals industry, but it also requires the right policy framework, argues the author of this article. With limited initial capacity, countries need to be prudent about which drugs are developed. Different countries have different needs, and selection must be made through dialogue between government ministries, pharmaceutical companies, and local drug regulatory authorities. Good regulation is crucial, yet could prove most challenging. Many African states have patchy regulatory systems for quality assurance and little means to ensure drugs testing follows ethical guidelines. They will need to create and enforce watertight regulations to ensure that substandard or ineffective medicines don’t flood the market. But the development of a robust pharmaceutical industry in Africa can’t, and shouldn’t be, uniform, the author argues. States are extremely varied in their scientific ability, level of manufacturing regulation, and financial capacity to invest. She proposes that some countries could first set up a system to simply manufacture drugs based on existing formulations, before progressing to research and development. Others with more advanced biotech industries, such as South Africa, will have the know-how to innovate in drug development.
South Africa recently adopted a new Intellectual Property Policy, which seeks to align IP with the country’s national development plan. What works for the new SA policy is that it addresses the interface between IP and public health. In facilitating local production and export of pharmaceuticals in line with its industrial policy, the new policy recommends the following changes: introduction of substantive patent search and examination, introduction of patent opposition, strengthening of patentability criteria, incorporation of disclosure requirements, parallel importation, exceptions, provisions to regulate voluntary licensing, compulsory licences, use of IP and competition law. All these provisions use flexibilities provided in the TRIPS (Trade related aspects of IP Rights) Agreement to safeguard development objectives. The South African policy mentions that it must engender the ethos of the South African Constitution and also reflect the country’s broader social economic development objectives. In contrast, India’s IP policy fails to take notice of obligations under Fundamental Rights and Directive Principles of the right to health in its Constitution while promoting IP rights. Instead it focuses on enhancing the protection and enforcement of IP rights, which goes beyond its international obligations (referred as ‘TRIPS-plus’) without taking into consideration their negative implications. Despite being at the forefront of international fora in defending the TRIPS flexibilities, the author observes that India ignores their use for itself at the domestic level, and recommends following the South African approach.
Headlining this quarter's HAI Africa network newsletter is a fact sheet about the recent World Trade Organization (WTO) amendment to the TRIPS agreement. WTO member states last year agreed to permanently adopt the "30 August 2003 Decision" as an amendment to TRIPS. This Amendment outlines the circumstances and procedures necessary for compulsory licensing in countries that do not have the capacity for pharmaceutical production. Access to medicines campaigners are denouncing the Amendment as an extraordinarily bad deal for poor countries, but representatives from the US, EU and pharmaceutical industry are, not surprisingly, welcoming it. This fact sheet gives an overview of the Amendment and why it is controversial. It's available on the HAI Africa web site.
The World Intellectual Property Organization (WIPO) is holding with the Japan Patent Office (JPO) an African ministerial conference on intellectual property (IP), in Senegal, November 3-5, in cooperation with the African Union (AU) and the Government of Senegal. The ministerial conference on ‘IP for an Emerging Africa” aims to “explore the opportunities as well as the challenges facing Africa in building a vibrant innovation system and in effectively using the IP system,” according to meeting’s provisional programme. The authors argue that the ministers should embrace a balanced and development-oriented approach to intellectual property. Such an approach ought to take into account the needs, priorities and socio-economic circumstances of African countries as well as the most recent empirical evidence on the dynamics of intellectual property and innovation on the continent.
World Intellectual Property Organisation (WIPO) members are preparing to take the reins of the Development Agenda as it becomes clear that implementation success will depend on their actions. And their actions must not only be focused on specific projects such as patent databases but also on the broader spirit of the agenda for change at WIPO, key developing countries said. A range of stakeholders met at WIPO on 13–14 October at an ‘open-ended forum on proposed Development Agenda projects’. A number of officials said they were pleased with the secretariat’s efforts on implementation and with it holding the event. But there are many problems with that assumption: patents leave out necessary information, some technologies require material transfer in order to be used, and availability of patent information does not equate to permission to use it, she said. In order to be relevant to developing country interests, said Shashikant, WIPO should undertake programmes to help developing countries use compulsory licences as needed to improve access to technology, to document and train in the use of patent oppositions, and to study the degree to which technology transfer is happening under World Trade Organization mechanisms so that WIPO programmes can learn from and improve on problems.