This report from the consultations at the World Intellectual Property Organisation (WIPO)suggests that the United States does not support a focus by the WIPO on patent flexibilities, an issue that developing countries consider to be central to their development concerns. WIPO’s work on patent flexibilities, including on exceptions and limitations to patent rights, has long been encouraged by developing countries participating in WIPO’s Standing Committee on the Law of Patents (SCP). In recent years proposals have been submitted by the Development Agenda Group of several developing countries, the Africa Group and Brazil to deepen analysis on patent flexibilities, which they consider to be central to development concerns. A work program had been agreed on at the last session of the SCP in February 2013 after intense consultations on the following topics: (i) Exceptions and Limitations to Patent Rights; (ii) Quality of Patents, including Opposition Systems; (iii) Patents and Health; (iv) Confidentiality of Communications between Clients and their Patent Advisors; and (v) Transfer of Technology. However, not all WIPO delegations were agreeable to enhancing of WIPO’s work on patent flexibilities. In a lengthy intervention at the Assemblies on 26 September on the agenda item on the SCP, the US expressed its intention to limit WIPO’s work on patent flexibilities. Its sentiment was not shared by developing countries that intervened on the agenda item. Instead they called for more work to be undertaken on the topics of exceptions and limitations to patent rights, the relationship between patents and health, and the improvement of patent quality.
Health equity in economic and trade policies
In this paper the author argues that Brazil follow the same route as India and continue to adopt and apply the regime of absolute novelty to prevent non-innovative patents from being unduly granted. They argue that the patent system should respect Constitutional duties to promote technological, economic and social development, especially as Brazil’s path has implications for other developing countries that are affected by intellectual property rights related to medicines and other pharmaceutical products.
There is a lack of effective and affordable technologies to address health needs in the developing world. In this paper, the authors argue that we can better develop standards for global health technologies if we learn lessons from other industries, such as by speeding the pace of innovation, unlocking health systems from single providers and approaches, and lowering barriers to entry. The authors consider relevant cases of standards development from other industries and propose that standardised platforms can lower barriers to entry, improve affordability, and create a vibrant ecosystem of innovative new global health technologies.
A recent European Union (EU) regulation on customs enforcement of intellectual property rights (N° 608/2013) has raised concerns among civil society actors who find that the regulation might not be an improvement over its previous version under which seizure of legal generic medicines in transit occurred a few years ago, leading to a World Trade Organisation dispute. Civil society organisation, Act-Up Paris has said the new regulation does not solve the problem as it continues to allow the seizing of goods over a simple suspicion of ‘intellectual property’ infringement without checking beforehand whether these goods are headed to the European territory or just in transit. The group argue that the EU did not take into account the December 2011 Court of Justice of the European Communities’ decision which stated that goods coming from a third-party State could not be described as ‘counterfeit goods’ or ‘pirated goods’ just by entering the customs territory of the EU. The in-transit medicines are not intended for commercialisation in EU territory and thus intellectual property status according to the national law of EU countries should be irrelevant. The EU is standing by its new regulation.
This study aims to contribute to the implementation of South Africa’s National Strategic Plan (NSP) on HIV, STIs and TB 2012–2016 by making specific recommendations on law and policy reforms to achieve an enabling and accessible legal framework in three key areas: patent, competition, and medicines law. The South African Patents Act, as it currently stands, does not take full advantage of the flexibilities available in respect of limitations to patent rights. The study recommends that the Patents Act make use of the full range of express exclusions from patentability available under TRIPS, and proposes that the process for issuing compulsory licenses be significantly streamlined, with clear legislative guidelines for determining the grounds upon which compulsory licenses can be granted, as well as their terms and conditions to prevent unnecessary delays. The study concludes by emphasising that its recommendations are aimed at achieving mutually reinforcing goals: promoting access to essential medicines and developing and supporting policies conducive to the growth and development of the domestic generic pharmaceutical industry. The process of reforming South Africa’s laws could benefit from a policymaking approach that is consultative, coherent and developed with the input of all relevant actors, governmental and non-governmental alike.
The ministers of health of the People’s Republic of China and African countries as well as representatives of the African Union, the World Health Organization, UNAIDS, UNFPA, UNICEF, the World Bank, the Global Fund to fight against HIV / AIDS Fund, Tuberculosis and Malaria and GAVI, met in Beijing in August 2013 to implement the Beijing Action Plan 2013-2015, adopted by the 5th China-Africa Cooperation Forum Ministerial in 2012. Under the theme of “Priorities of China-Africa Cooperation Health in the New Era”, the meeting reviewed previous health cooperation between China and Africa and reached consensus on the priorities for and ways of health cooperation. The meeting agreed on various areas of future links including on health worker training; cooperation between research institutions in China and Africa, strengthening of health information systems; prevention and control of communicable and non-communicable diseases; support for health infrastructure development donating modulated clinics to Africa, adapted to local conditions; cooperation in standard setting and inspection of medical products through capacity building and use of appropriate technology and promotion of health technology transfer to reduce the price of health commodities including pharmaceuticals, diagnostics, vaccines and equipment, and to increase their affordability.
Since 2000, China has hosted six ministerial Fora on China-Africa Cooperation (FOCAC), held every three years, in which health is but one of many areas of attention. In the last FOCAC, the accompanying Beijing Action Plan for 2013-15 listed cooperation in many areas – 6 in political, 9 in economic, 6 in cultural, and 6 in development – of which ‘medical aid and public health’ is one. This opinion piece discusses the strengths and challenges of the inaugural forum on health held in August 2013 and the Beijing declaration after the Forum, seen by the author to mark a turning point in the history of Chinese development and health cooperation to Africa. The author notes that China’s top-level leadership clearly sees the political, economic, and perhaps health importance of global engagement especially in Africa.
How to foster agricultural development and food security in East Africa as the effects of climate change become more serious is the subject of the study East African Agriculture and Climate Change: A Comprehensive Analysis. The authors develop several weather-based scenarios for how climate change might affect countries in the region between now and 2050. National contributors from Burundi, the Democratic Republic of Congo (DRC), Eritrea, Ethiopia, Kenya, Madagascar, Rwanda, Sudan, Tanzania, and Uganda review the scenario results for their countries and propose a variety of policies to counter the effects of climate change on agriculture and food security. These policies include greater investment in agricultural research and extension, equitable access to land and inputs such as seeds and fertilizer, expanded irrigation, and improved infrastructure.
In 2012, the World Health Organisation’s Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) proposed a binding convention that would mandate every signatory country to invest a minimum of 0.01% of its gross domestic product (GDP) in research and development (R&D) falling within the established scope. In this article, the author explores the proposed convention’s possible ramifications. In its narrowest interpretation, the convention would only address R&D gaps in areas where no suitable products exist. This would involve funding a publicly-driven pharmaceutical effort since, by definition, no commercial incentive exists in these areas. But even this approach leaves room for interpretation, the author argues. If narrowly interpreted, coverage would be limited to R&D gaps for Type II and III diseases; if more broadly interpreted, coverage would also extend to R&D gaps in Type I products suitable for developing countries. The author argues that, despite advances in global health, developing countries continue to have a shortage of appropriate tools to prevent, diagnose and treat many diseases. The proposed convention is intended to address this problem, but lack of clarity in the convention’s remit has left its scope open to interpretation. He calls for this uncertainty to be resolved in order for discussions to move forward.
The Medicines Patent Pool and Roche have announced an agreement to increase access in developing countries to valganciclovir, a key easy-to-take oral medicine to treat cytomegalovirus (CMV), a viral infection that can cause blindness in people living with HIV. The agreement will significantly improve access to Roche's valganciclovir for people living with HIV in 138 developing countries by making it up to 90% cheaper than current prices. As a second step, the Medicines Patent Pool and Roche will also enter into licensing and technology transfer negotiations to encourage the development of internationally approved quality generic versions of valganciclovir. The most widely used treatment for CMV in developing countries requires injections directly to the eye, which can be painful and also difficult to administer on a large scale. The Medicines Patent Pool will also work with other key stakeholders to develop long-term treatment strategies for scaling up the use of valganciclovir for treatment of HIV-related CMV in developing countries.