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.
The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines
By Viviana Muñoz Tellez
The ongoing rapid spread of COVID-19 is challenging the capacity of governments and of the World Health Organization (WHO) to timely put in place a global coordinated response to the pandemic. Developing countries and Least Developed Countries (LDCs) in particular in Africa are especially vulnerable to the unfolding effects of the public health crisis. A priority area for global collaboration is to advance research and development (R&D) for vaccines and medicines that are made available, affordable and accessible worldwide.
There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.
Intellectual Property and Trade Measures to Address the Covid-19 Crisis by the South Centre
The South Centre views with concern the attempts by some governments and industry players to monopolize the availability of treatments, diagnostics, medicines, medical supplies and devices needed for their own nationalist agenda or to maximize profit, ahead of societal interest in tackling the Covid-19 pandemic. The private enforcement of patents and government trade restrictions may pose a dire threat to the containment of this global public health emergency. Governments should act swiftly to put in place legislation and plans to ensure that patents and trade measures do not become barriers for access to those products.
The Comprehensive and Progressive Agreement for the Trans-Pacific Partnership: Data Exclusivity and Access to Biologics
By Dr. Zeleke Temesgen Boru
The test data rule concerning biological medicines (hereafter biologics) has been suspended from the scope of application of the Comprehensive and Progressive Agreement for the Trans-Pacific Partnership (CPTPP). While the suspension is commendable from the general standpoint of access to medicines and biologics in particular, the suspended provision may not provide assurance for the Parties to the CPTPP that they can rely on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to promote access to biologics. In part this is because the Parties may end the suspension if and when they choose to do so. Simply put, the agreement does not promise that the suspended provision will remain suspended; rather, the Parties may revive the provision as originally negotiated under the Trans-Pacific Partnership (TPP) Agreement. The provision, if revived, may inhibit the Parties from implementing an obligation to ensure access to biologics, medicines that target chronic and rare ailments like cancer, clotting factors and several others.
Against this backdrop, this research paper focuses on the test data rule relating to biologics as negotiated under the TPP. In particular, it explores whether the CPTPP Parties would be able to use TRIPS flexibilities effectively to promote access to biologics, as advanced by international human rights instruments, in particular the International Covenant on Economic, Social and Cultural Rights (ICESCR). The paper also provides potential responses to the question of whether the test data rule deters the realization of access to biologics. In response, the author has determined that the rule on test data can limit access to biologics, as it would delay the entry of affordable biologics (biosimilars) into markets.
Intersección entre Competencia y Patentes: Hacia un Ejercicio Pro- Competitivo de los Derechos de Patente en el Sector Farmacéutico
Por María Juliana Rodríguez Gómez
La interacción entre propiedad industrial, particularmente patentes farmacéuticas, y el derecho de la competencia, tiene un impacto en asuntos de interés general como los derechos a la salud, al acceso a los beneficios de la tecnología y a la libre competencia. La cuestión es cómo hacer compatible un mercado farmacéutico competitivo y dinámico, con el sistema de patentes, que otorga monopolios legales significativamente amplios sobre productos considerados innovaciones. A partir de un análisis legislativo y casuístico, se concluye que son necesarias mejores políticas pro competitivas -en especial en países en desarrollo- para enfrentar prácticas como el reverdecimiento (‘evergreening’) de patentes, los acuerdos para demorar la entrada de competidores y la negativa a licenciar, entre otras usadas en el sector farmacéutico para bloquear la entrada de la competencia. Los competidores, los consumidores y los sistemas de salud son vulnerables al creciente número de patentes y a esas prácticas. Diversas medidas pueden adoptarse, sin embargo, para lograr un balance entre la protección de la innovación y la competencia.
Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa
By Yousuf A Vawda and Bonginkosi Shozi
As we observe the 18th anniversary of the Doha Declaration on the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health, it is appropriate to take stock of intellectual property developments and endeavour to present a comprehensive account of the situation in the African continent in respect of the implementation of TRIPS flexibilities, specifically those regarding access to medicines. This research paper provides an overview of the extent to which selected African countries have adopted legal and policy frameworks with regard to TRIPS flexibilities, examines the actual use of these flexibilities in enabling access to medicines in those countries, and suggests some recommendations for optimising the use of the flexibilities in pursuing public health imperatives.
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.
Second Medical Use Patents – Legal Treatment and Public Health Issues
By Clara Ducimetière
This paper attempts to give an overview of the debate surrounding the patentability of new therapeutic uses for known active ingredients, both in developed and developing countries. After close scrutiny of international patentability standards, this paper concludes that second medical uses do not qualify per se for patent protection and have only been protected in several jurisdictions by means of a legal fiction. The increasing acceptance of second medical use patents seems to result from strategic patent filing from pharmaceutical companies to extend the life of existing patents, justified mainly for financial reasons. However, these practices have a detrimental impact on generic competition and, hence, on the access to medicines and the public health, in particular in developing countries. Therefore, this paper argues that a sound patent policy in line with public health objectives, in particular, an enhanced access to medicines, should not allow for the grant of second medical use patents.
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.
Intellectual Property and Access to Medicines: An Introduction to Key Issues – Some Basic Terms and Concepts
Intellectual property and patents in particular, have become one of the most debated issues on access to medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant, or even determinant, role. During the term of patent protection, the patent holder’s ability to determine prices, in the absence of competition, can result in the medicine being unaffordable to the majority of people living in developing countries. This first issue of the “South Centre Training Materials” aims, in its first part, to provide an introduction to key issues in the field of access to medicines and intellectual property. The second part describes and defines some basic terms and concepts of this relatively new area of pharmaceuticals policies which are the trade related aspects of intellectual property rights that regulate the research, development and supply of medicines and health technologies in general.