153. We are grateful for this opportunity to briefly introduce the World Health Organization's technical cooperation activities in the area of public health, intellectual property and trade.
154. Our overall objective is to strengthen the capacity of developing countries in the areas of health innovation and management of intellectual property. Public health interests should be adequately taken into account in the formulation of national policies and legislation on trade and intellectual property. This includes the implementation and use of the flexibilities provided by the WTO TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health.
155. In the past years, WHO, WIPO and WTO have closely collaborated to foster a better understanding of the linkage between public health and intellectual property policies and to enhance a mutually supportive implementation of those policies. The joint study by the WHO, WIPO and the WTO, "Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade" is the fruit of this new trilateral collaboration. The study was launched on 5 February 2013, by the heads of the three organizations. The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations and to support policy discussions.
156. The study provides a holistic picture of trade, IP and health-related determinants of innovation in and access to medical products. Among the health-related determinants of access covered are regulatory questions, including the need for further convergence of regulatory standards, the importance of more transparency in clinical trials and the challenge of creating safe regulatory pathways for biosimilars. It also addresses rational selection of essential medicines, pricing policies, adequate financing and procurement, as well as supply chain management, including the control of taxes and mark ups.
157. The study also covers the main trade determinants for access, including procurement and competition policy and how it can support access to medical products. It goes on to discuss tariffs on pharmaceutical products and their impact on prices. With respect to intellectual property, the study covers, inter alia, the flexibilities contained in the WTO TRIPS Agreement that WTO Members can use to facilitate access to medicines, including compulsory licences. It also explains the development of socially responsible licensing policies as well as the interface between sub-standard, spurious, false, falsified, counterfeit medicines and the counterfeiting of trademarks. It discusses the different options to protect clinical test data, contains a comprehensive chapter on bilateral and regional trade agreements and describes the relevant IP elements of these agreements and their likely impact on public health. In the area of patent policies, the study explains the problem of "evergreening" of patents as part of the life cycle management of pharmaceutical products and related legislative developments in different developing countries. In this respect the study also highlights the need for incremental innovation and the fact that small changes such as new routes of delivery or new dosage forms can have a huge impact on the life of patients and, for example, may increase patient compliance.
158. The chapter on innovation discusses the cost of R&D of new medical products as well as recent changes in the R&D landscape, particularly in the area of biotechnology. In relation to neglected diseases the study describes models on how to encourage R&D. This is where innovative financing and new ways of working for ensuring needed R&D are discussed, including models that separate the costs of the R&D from the price of the end product in order to make medicines more affordable, a concept referred to as de-linkage. This section also highlights related efforts of the industry, including the renewed commitment in the "London Declaration on Neglected Tropical Diseases" and other positive examples such as the dedicated research institutes for neglected diseases that have been created by a number of pharmaceutical companies.
159. Together with UNAIDS, UNITAID, the Brazilian Government and in collaboration with the Medicines Patent Pool, WIPO and WTO, WHO organized a consultation on access to HIV medicines in middle-income countries (MICs) in Brasilia, Brazil, from 10 to 12/06/2013. The meeting focused on how to increase access to antiretroviral treatment in these countries. In recent years, the global community has seen great progress in access to HIV treatment. Nevertheless, MICs in all regions face significant challenges in sustaining their treatment programmes. In order to frame the debate, WHO in collaboration with the Medicines Patent Pool, drafted a background paper that provides data on the prices paid by MICs for the WHO-recommended first, second and third line HIV treatments. The paper links these prices with data on the patent status of the respective products, voluntary and compulsory licences as well as tariff and regulatory data. The paper identifies the products for which certain countries still pay high prices and aims to identify the underlying reasons and thus provide the facts that will allow local policy makers to take appropriate actions. The meeting highlighted the need for pursuing collaboration among organizations on providing information and strengthening information exchange between the countries on regulatory approvals, IP status and prices of HIV medicines.
160. To implement the 2006 Global Pandemic Influenza Action Plan (GAP), the WHO has facilitated the transfer of influenza vaccine production technology to 14 vaccine manufacturers in developing countries, through a central technology transfer hub. WHO grants to local manufacturers led to a significant increase in local investments in the manufacturing facilities. As a result of the technical and financial assistance, so far five developing countries have established local production of approved influenza vaccines. To date this has resulted in a combined capacity of 330 million pandemic vaccine doses, with the goal to exceed the 500 million dose capacity from these manufacturers by 2016.
161. In addition to influenza vaccine technology, WHO has facilitated access for manufacturers in developing countries to technology for human papillomavirus, other vaccines and delivery devices, and to rabies technology.
162. Within the context of the implementation of the Global strategy and plan of action on public health, innovation and intellectual property, WHO is leading a European Commission supported project on local production, to increase access to medical products in developing countries. The second phase of this project will include a country-based policy analysis to identify the existence of policy coherence across industrial and health policies, the degree of promotion of local production, the development of a price comparison methodology to compare locally produced medicines with imported medicines, and training and capacity-building work to support quality production across a range of medical products for manufacturers and national regulatory authorities. Targeted actions will include the identification of essential medicines that are most suitable for local production, determination of the feasibility of local production of blood products, as well as analysing the patent landscape for a number of medicines in order to assess the possibilities for local and regional production in developing countries. Part of this work is carried out in collaboration with UNCTAD.
163. Training and capacity building are among the core activities of WHO, with regard to public health and intellectual property. WHO regularly contributes to training and capacity building activities organized by WTO and WIPO which leads to a more coherent approach of the three agencies. I would like to highlight the
• Regional Seminar for certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities that was organized by WIPO in cooperation with the Department of Trade and Industry of South Africa in Durban, South Africa in January 2013.
• WTO in close collaboration with WHO, WIPO and the Secretariat of the East-African Community organized a joint training programme on intellectual property and public health for English-speaking African countries in Arusha, Tanzania, from 29-31 May 2013.
• National workshop in South Africa on IP and public health in August 2013 again organized by WTO in close collaboration with WHO, WIPO and the South African Department of Trade and Industry.
164. In the recent past, a number of WHO Member States have been subject to lawsuits and arbitration procedures under bilateral investment agreements with respect to tobacco control measures, including the introduction of plain packaging requirements. This resulted in the need for specific training and capacity building on questions related to international trade rules and tobacco control measures. WHO has organized a number of such regional consultations involving Ministries of Trade and Ministries of Health of about 70 countries throughout 2012 and 2013.
165. More ample information on technical cooperation activities under the WHO programme on public health and intellectual property can be found in document IP/C/W/591/Add.2. We would be glad to answer any questions delegations might have regarding these activities.
