Las reformas de la Organización Mundial de la Salud en la época de COVID-19
Por Germán Velásquez
A lo largo de sus 70 años de historia la OMS ha pasado por varias reformas lideradas por varios directores generales, como Halfdan Mahler en la Conferencia de Alma ata sobre la atención primaria de salud, 1978, Gro Harlem Brundtland con su « reach out to the private sector » 1998, Margaret Chan con su inconcluso debate sobre el rol de « los autores no estatales » 2012 . Una vez mas, y de forma contundente la crisis sanitaria del 2020 pone en evidencia la fragilidad de la Organización y nos revela que la OMS no tiene los instrumentos y mecanismos legales necesarios para aplicar sus normas y orientaciones y que su manera de financiamiento no es sostenible y adecuada para responder al desafío de la COVID-19. Este documento trata de identificar cuales son los problemas principales de que sufre la OMS y cuales serian las medidas necesarias que una reforma de la Organización tendría que abordar.
The COVID-19 pandemic has revealed that, despite the magnitude of the global health challenges it has to face, the WHO is currently unable to fully enforce its directives, norms and standards. It also shows that its funding is neither sustainable nor adequate to respond effectively to current and future global health crises. Overreliance on voluntary targeted funding puts at risk its capacity to operate as the global agency responsible for public health. These are some of the main challenges facing the WHO today.
The World Health Organization Reforms in the Time of COVID-19
By Germán Velásquez
During its 70-year history, the World Health Organization (WHO) has undergone various reforms led by several Directors-General, including Halfdan Mahler at the Almaty Conference on primary health care in 1978, Gro Harlem Brundtland with her “reach out to the private sector” in 1998, and Margaret Chan with her unfinished debate on the role of “non-state actors” in 2012. The organization’s fragility is once again being highlighted, as the COVID-19 pandemic has revealed that WHO does not have the legal instruments and mechanisms necessary to enforce its standards and guidelines, and that its funding is not sustainable and adequate to respond to the challenge. This paper seeks to identify the main problems faced by WHO and the necessary measures that a reform of the organization would have to take.
Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19
By Srividya Ravi
This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications.
The medicines considered for the patent analysis in this report are remdesivir, ruxolitinib and favipiravir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.
TRIPS Flexibilities on Patent Enforcement: Lessons from Some Developed Countries Relating to Pharmaceutical Patent Protection
By Joshua D. Sarnoff
Authority for national judiciaries to issue permanent and preliminary injunctions is required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Articles 44 and 50. But the TRIPS Agreement does not require the issuance of injunctions in any particular circumstances, and does not harmonize the laws on which national jurisdictions derive their injunctive relief authorities. Thus, countries remain free to refuse prohibitory injunctive relief for adjudicated or likely patent infringement, particularly if “reasonable compensation” is offered in the form of an “ongoing royalty” or an “interim royalty” payment, which acts similarly to a compulsory license. This paper explains the existing legal standards for permanent and preliminary injunctions in the United States and Canada and discusses trends regarding the issuance or denial of injunctions for pharmaceutical patents in those jurisdictions (with occasional reference to other common-law jurisdictions). Although judges in these jurisdictions more routinely deny preliminary prohibitory injunctions, legislation linking generic pharmaceutical regulatory approvals to the patent system and imposing stays of such approvals normally avoid the need for such preliminary injunctions. Consistent with the TRIPS Agreement, developing country judges may make different choices, based on the ability to provide reasonable compensation for harms or based on a different weighing of the importance of assuring affordable access to medicines relative to providing innovation incentives.
PROPOSAL BY INDIA AND SOUTH AFRICA TO WAIVE CERTAIN PROVISIONS OF THE WTO TRIPS AGREEMENT TO SUPPORT THE GLOBAL COVID-19 PANDEMIC RESPONSE
The prolongation of the coronavirus COVID-19 pandemic threatens developing countries disproportionately, deepening the catastrophic social and economic crisis and reversing the gains made to date to eradicate extreme poverty and meet the Sustainable Development Goals (SDGs). In this situation, ensuring timely access to essential commodities by overcoming acute shortages faced by countries due to high demand and disruptions in the supply chain is critical. There is also an urgent need to speed up development of new vaccines, treatments and diagnostics, at scale, and make these widely available.
As reaffirmed by many delegations in the special session of the WHO Executive Board, transfer of technology and know-how is fundamental for scaling up manufacturing of medical products and equipment. In this regard, India and South Africa have made a joint proposal to the World Trade Organization (WTO) to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global Covid-19 pandemic response.
Today the judicial authority may be faced with balancing patent rights and patients’ rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life.
South Centre Semester Report, 1 January to 30 June 2020
This Semester Report summarizes the activities undertaken by the South Centre during the period 1st January to 30 June 2020. It is intended to provide information, organized by themes, about recent developments in the areas covered by the Centre’s Work Program, meetings organized or co-organized by the Centre to examine particular issues or provide analytical support for negotiations taking place in various international fora, and conferences and other meetings where the Centre has participated. It also informs about publications made.
Re-thinking Global and Local Manufacturing of Medical Products After COVID-19
By Dr. Germán Velásquez
The unprecedented global health crisis caused by the coronavirus (COVID-19) pandemic since the first quarter of 2020 has reopened the now-urgent discussion about the role of local pharmaceutical production in addressing the health needs in developing countries. The COVID-19 crisis has highlighted the interdependencies in the global production of pharmaceuticals—no country is self-sufficient. Many industrialized countries are making the decision to repatriate or initiate the production of active pharmaceutical ingredients (APIs) and medicines. Governments are beginning to talk about ‘pharmaceutical sovereignty’ or ‘health security’. If this becomes a reality and the production of pharmaceuticals is led by nationalistic policies, developing countries that still lack manufacturing capacity will have to start or expand the local production of pharmaceuticals, whether at the national or regional level. The war to get access to the future vaccine for COVID-19 does not look easy with these new developments.
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.
Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base
Par Germán Velásquez
La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.
The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic
By Frederick Abbott
The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.
