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.
Authors: Germán Velásquez, Carlos M. Correa and Vitor Ido
Challenges and Opportunities for Implementing the Declaration of the Right to Development
By Yuefen Li, Daniel Uribe and Danish
The 1986 Declaration on the Right to Development was a milestone for both human rights and development. The Declaration recognizes that the right to development (RTD) is an inalienable human right and introduced an alternative and holistic approach to development that goes beyond the economic field to include social, cultural and political development. Although there are current concerns about the pace of progress in fulfilling the RTD, this Policy Brief examines the linkages of the right to development and different global initiatives tackling current challenges for different aspects of the RTD. This brief shows that there has been broader support by countries and people since 1986 to fulfill the RTD although much still needs to be done for addressing income and other inequalities while empowering people in the processes of formulating and implementing people-centered development policies. Despite challenges, the brief also examines some promising opportunities for the RTD.
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.
The adverse human rights impact of economic inequality
By Blerim Mustafa
Increasing economic inequality is a defining challenge of our time. Economic growth can often be disproportionate and unequal, adversely affecting marginalized and disadvantaged groups in society. Economic inequality has had adverse economic, social and political impacts for social stability and cohesion, political participation, poverty reduction, as well as the enjoyment of human rights. The realization of human rights cannot be separated from broader questions of economic and social justice.
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.
Spotlight: Africa and the Implementation of the Beijing Platform for Action
Regional Round-up on progress in implementing the Beijing Platform of Action in light of the upcoming 25th Anniversary of the platform. Spotlight: Africa.
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.
Contribution of the South Centre to the Report of the Secretary-General on the Implementation of UN General Assembly Resolution A/RES/74/7 dated 12 November 2019 on the “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba”
The imposition of unilateral economic, financial and trade measures against Cuba, in violation of basic principles of the United Nations (UN) Charter, has severe socio-economic impacts on the Cuban population. The UN General Assembly adopted by an overwhelming majority the resolution “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba” (document A/74/L.6). In response to the request in paragraph 4 of this resolution, the South Centre prepared a contribution to the report of the Secretary-General. This highlights, in particular, the obstacles that the US embargo poses for the attainment of the right to health in Cuba.
Antimicrobial Resistance: Examining the Environment as Part of the One Health Approach
By Mirza Alas
Antimicrobial Resistance (AMR) is a serious issue that is threatening the medical and agricultural advances of today. The connections that exist among human health, food production and the environment necessitate a One Health approach to address the challenge of AMR. Recent research points to the environment as an essential factor in the spread of AMR, as well as a possible reservoir of antimicrobial resistant bacteria and genes. The process, however, of the environmental transmission of resistance genes, along with their effects and how to mitigate them, is still being examined. As new research emerges, so to have new challenges regarding the selective pressure of antibiotics on the environment. AMR in the environment is not new, with resistance genes found even in isolated places (e.g. in permafrost or volcanoes) but understanding this natural process and its implications for tackling AMR continue to pose many questions. This paper aims to examine some of the emerging research on AMR from a One Health perspective and in particular to highlight the role of the environment. It will explore the use of antibiotics and their effects in different ecosystems, as well as the challenges they pose for developing countries: in particular, in designing policies to address antimicrobial resistance that take into account the connections among humans, animals and the environment.
Political Declaration on the occasion of the twenty-fifth anniversary of the Fourth World Conference on Women
Ministers and representatives of governments of the Member States of the United Nations met at a special one-day session of the 64th meeting of the Commission on the Status of Women (CSW64) and adopted a Political Declaration commemorating the 25th anniversary of the Fourth World Conference on Women, held in Beijing in 1995, and its major seminal output, the Beijing Declaration and Platform for Action (BD & BPfA).