Médicaments et propriété intellectuelle: 10 ans de la stratégie mondiale de l’OMS
Par Dr. Germán Velásquez
Les négociations du Groupe de travail intergouvernemental sur la santé publique, l’innovation et la propriété intellectuelle connu sous le nom de “IGWG” (2006-2008), menées par les Etats Membres de l’OMS, sont le résultat d’une impasse à l’Assemblée mondiale de la santé du 6 décembre 2006 où les Etats Membres n’ont pu parvenir à un accord sur les 60 recommandations du rapport” Santé publique, innovation et propriété intellectuelle “soumis la même année par un groupe d’experts désigné par le Directeur général de l’OMS. Le résultat de ces négociations devint la “Stratégie mondiale et Plan d’action pour la santé publique, l’innovation et la propriété intellectuelle” (GSPOA), approuvé par l’Assemblée mondiale de la santé en 2008. Un des objectifs de la Stratégie mondiale élaboré par l’IGWG était de réformer en profondeur le système d’innovation pharmaceutique, en raison de son incapacité à produire des médicaments abordables contre les maladies qui affligent une grande partie de la population du monde vivant dans les pays en développement. Les droits de propriété intellectuelle (PI) imposés par l’Accord sur les aspects des droits de propriété intellectuelle liés au commerce (ADPIC) et les accords commerciaux pourraient devenir des principaux obstacles à l’accès aux médicaments. Le GSPOA a fait une analyse critique de cette réalité et a mené à la recherche de nouvelles solutions à ce problème. Dix ans après l’approbation du GSPOA, les résultats restent incertains et médiocres.
The UN General Assembly Resolutions on COVID-19: Solemn Assurances for Access to Health Technologies without an Action Plan
By Nirmalya Syam
The United Nations (UN) has the mandate under the Charter of the United Nations to promote solutions to international health problems, such as the global COVID-19 pandemic. While the UN secretariat, led by the Secretary-General, has undertaken a number of initiatives in response to COVID-19, member State initiatives in the UN has so far been limited to two resolutions adopted by the UN General Assembly. Member States are currently negotiating an omnibus resolution of the General Assembly on COVID-19. This policy brief analyzes the extent to which the General Assembly addresses the issue of timely, equitable and affordable access to health technologies, particularly for developing countries who have greater vulnerability to COVID-19. The adopted resolutions make very broad pledges for global solidarity but lack specific commitments to guide actions by member States. The omnibus resolution currently under negotiation should provide specific guidance to member States on actions to be taken based on the principles of solidarity and multilateral cooperation in diverse aspects impacted by COVID-19.
Making Covid-19 Medical Products Affordable: Voluntary Patent Pool and TRIPS Flexibilities
By Sudip Chaudhuri
The proposal of Costa Rica to create a voluntary pool mechanism for medical products and technologies for COVID-19 has evoked huge interest and optimism. The World Health Organization (WHO) and Costa Rica have followed it up through a Solidarity Call emphasizing the need for voluntary licensing on non-exclusive basis to the Medicines Patent Pool (MPP). The success of a voluntary pool critically depends on the willingness of the patentees to join the pool. In a public health crisis, boundaries of public policy must not be determined by the patentees. MPP will work much better if the patentees are compelled or induced to join the pool. International cooperation is important in this regard. Highlighting the virtues of voluntary measures and promoting MPP without adequate emphasis on the use of compulsory licensing and other TRIPS flexibilities, actually weakens the MPP. In the light of the experience of MPP, the basic objective of this paper is to analyze to what extent voluntary pool mechanisms can be relied upon to make COVID-19 medical products affordable and accessible. It is important to appreciate the achievements of MPP. But the constraints under which it operates, and its limitations must also be kept in mind.
Message from the South Centre at the launch of the “Solidarity Call To Action” by the President of Costa Rica and the Director-General of the WHO
The architecture for access to medicines and vaccines, which is already complex to manage in normal times, requires even more structured actions in times of a pandemic by the scale of the demand and the urgency in meeting it. This call for solidarity to bring together the technologies and treatments related to COVID 19 is part of the necessary solution. It complements other available instruments for States to facilitate access to prevention and treatment for the population, including through the use of the flexibilities of the WTO TRIPS Agreement.
The 73rdWorld Health Assembly and Resolution on COVID-19: Quest of Global Solidarity for Equitable Access to Health Products
By Nirmalya Syam, Mirza Alas and Vitor Ido
The annual meeting of the World Health Assembly (WHA) of the World Health Organization (WHO) held virtually on 18-19 May 2020 discussed the global response to COVID-19 and adopted Resolution WHA73.1 on “COVID-19 Response”. The Resolution reaffirms the role of WHO as the directing and coordinating authority on international health work and it recognizes that all countries should have timely and affordable access to diagnostics, therapeutics, medicines and vaccines as well as to essential health technologies and equipment to respond to COVID-19. However, the Resolution does not define concrete actions to address the pandemic. Though the Resolution makes a commitment of ensuring access to medical products, vaccines and equipment for all countries in a timely manner, there are no concrete actions defined. In order to ensure global equitable access, WHO Members should make full use of the flexibilities of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and also enhance transparency of costs of research and development (R&D), openness and sharing of data, tools and technologies, and build more capacity through technology transfer.
Compilation of Extracts from Selected Country Statements during 73rd World Health Assembly supporting Access to Health Products on COVID-19
The compilation below was done on the basis of published statements on the WHO website (https://apps.who.int/gb/statements/WHA73/) and the speeches delivered orally for those delegations which have not submitted their statements. This is a non-official document for information only.
South Centre Statement at the 73rd World Health Assembly (WHA)
Today we are facing a global health, economic and social crisis, the most serious in the last hundred years. The resolution adopted by this World Health Assembly on COVID 19 should have been more ambitious given the dimension of the current crisis. The response to an exceptional challenge must be exceptional. The COVID 19 pandemic forces us to reflect on whether many health systems and the WHO itself were prepared to face this crisis.
Intellectual Property, Human Rights and Access To Medicines: A Selected and Annotated Bibliography (3rd Edition)
About the Book:
The South Centre seeks to provide appropriate technical assistance and country support to developing countries, within comprehensive and coherent national IP strategies to promote implementation of the TRIPS Agreement that is consistent with the protection of public health and the promotion of access to medicines. This selected and annotated bibliography has been prepared to assist developing countries to implement IP policies and regulations consistent with development goals and public health principles. The growing volume of literature on the issue of IP, R&D, human rights and access to medicines can help developing countries to find the opportunities and room for manoeuvre to protect their citizens from the unhealthy environment created by international trade rules. This bibliography is not an exhaustive list but it highlights some of the most pertinent works from the South views and perspectives. The selected references are a valuable instrument for those interested in promoting universal access to medical innovation.
This policy brief provides an overview of the outcomes of selected agenda items that were discussed at the 72nd session of the World Health Assembly (WHA) of the World Health Organization (WHO), held from 21 to 26 May 2019 in Geneva. These items reflect some of the health priorities of developing countries.
Medicines and Intellectual Property: 10 Years of the WHO Global Strategy
By Dr. Germán Velásquez
The negotiations of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) (2006-2008), undertaken by the Member States of the World Health Organization (WHO), were the result of a deadlock in the 2006 World Health Assembly where the Member States were unable to reach an agreement on what to do with the 60 recommendations in the report on Public Health, Innovation and Intellectual Property submitted to the Assembly in the same year by a group of experts designated by the Director-General of the WHO. The result of these negotiations was the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) that was approved by the World Health Assembly in 2008. One of the objectives of the IGWG’s Global Strategy and Plan of Action was to substantially reform the pharmaceutical innovation system in view of its failure to produce affordable medicines for diseases that affect the greater part of the world’s population living in developing countries. The intellectual property (IP) rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the trade agreements could become some of the main obstacles to accessing medicines. The GSPOA made a critical analysis of this reality and opened the door to the search for new solutions to this problem. Ten years after the approval of the GSPOA, the results are uncertain and poor.
South Centre Statement on Access to Biosimilars/Biogeneric Medicines at the WHA 72
The revision of the guidelines on similar therapeutic products mandated by Resolution WHA67.21 is crucial for promoting the availability of and access to biosimilars. The reduction in prices ensuing from the introduction of these products has become essential to address public health needs in developed and developing countries. The WHO Document A72/59 under consideration by the WHA 72 (agenda item 21.3) states in paragraph 80 that “WHO expert committees have approved guidance on (…) biotherapeutics, including an update of the 2009 similar biotherapeutic products guidelines”. This statement is not accurate, as the guidelines were not updated as mandated by Resolution WHA67.21. Below is the South Centre statement in relation to this issue.