Propiedad intelectual y acceso a medicamentos: una introducción a cuestiones clave – algunos términos y conceptos básicos
Por Germán Velásquez
La propiedad intelectual y las patentes en particular se han convertido en uno de los temas más debatidos sobre el acceso a los medicamentos, desde la creación de la Organización Mundial del Comercio (OMC) y la entrada en vigor del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). Las patentes no son de ninguna manera las únicas barreras para el acceso a medicamentos que salvan vidas, pero pueden desempeñar un papel significativo, o incluso determinante. Durante el período de protección de la patente, la capacidad del titular de la patente para determinar los precios, en ausencia de competencia, puede hacer que el medicamento resulte inalcanzable para la mayoría de las personas que viven en los países en desarrollo. Este primer número de los “Materiales de capacitación del South Centre” pretende, en su primera parte, ofrecer una introducción a cuestiones clave en el ámbito del acceso a los medicamentos y la propiedad intelectual. La segunda parte describe y define algunos términos y conceptos básicos de esta área relativamente nueva de las políticas farmacéuticas, que son los aspectos comerciales de los derechos de propiedad intelectual que regulan la investigación, el desarrollo y el suministro de medicamentos y las tecnologías sanitarias en general.
Emerging Trends in FTAs and Public Health: Investment Agreements and Intellectual Property
Friday, 28 May 2021 – 16:00-17:30 (CET)
The inclusion of TRIPS-Plus provisions in developing country IP laws, as a result of negotiations of free trade agreements (FTAs) continues to be of concern. In addition, there are various emerging areas that require attention from developing countries, where accumulated knowledge and institutional learning are more limited. These include investment agreements that include ‘intellectual property’ as a category of investment – with subsequent ISDS mechanisms, as well as competition and investment chapters or agreements that may restrict the policy space, such as the China-EU Comprehensive Investment Agreement. There are several important developments to consider for the upcoming years. New negotiations in the period of Covid-19 crisis, when countries are in dire financial situations, may lead to even more unbalanced negotiations. The UK is pursuing new agreements after Brexit with developing countries, while the USA has signaled renewed attention to multilateralism and at the same time is continuing to make use of Section 301 of its trade law to advance reforms in third countries. The AfCFTA negotiations of the intellectual property chapter are set to start this year. Moreover, the RCEP Agreement is to be implemented via national law amendments and attention must be given in particular to the process for Least Developed Countries (LDCs) and the technical assistance offered.
In this context, the South Centre is holding a series of webinars on emerging trends related to free trade agreements (FTAs) and investment agreements that impact public health. In this first session, we will discuss the topic of investment agreements and intellectual property, including varied angles to the issue, such as perspectives for post Covid-19 agreements, the legal construction of IP as a category of investment, the challenges of ISDS and policy reform options, and the analysis of a concrete case.
A New WHO International Treaty on Pandemic Preparedness and Response: Can It Address the Needs of the Global South?
By Dr. Germán Velásquez and Nirmalya Syam
A recent joint communiqué by 25 Heads of Government and the WHO Director-General have called for the negotiation of a pandemic treaty to enable countries around the world to strengthen national, regional and global capacities and resilience to future pandemics. The COVID-19 pandemic has demonstrated the fragility of the mechanisms at the disposal of WHO for preparedness and response to pandemics. The use of binding instruments to promote and protect health in the context of pandemics is needed. If WHO Member States decide that an international treaty to prepare and respond to pandemics is the way forward, it would be important to have clarity from the outset on the elements and areas that will be the subject of negotiation. The first step should be to identify the aspects of pandemic preparedness and response that the current crisis has revealed are not working, and how to build up on the existing instruments, notably the International Health Regulations (IHR). This paper discusses some of the critical issues that should be addressed in such a treaty if negotiations are launched, in view of the needs of countries at different levels of development and with disparate capacities to implement treaty obligations.
Spain’s submission at the EU’s Porto Social Summit
Spain’s submission at the European Union’s Porto Social Summit proposing to adapt global rules on intellectual property, in particular the flexibilities in the Agreement on Trade-Related Intellectual Property Rights (TRIPS), to fight global pandemics is welcome.
An Introduction to the UN Technology Bank for the Least Developed Countries
By Spring Gombe
Adoption, adaptation and diffusion of technology offer Least Developed Countries (LDCs) substantial potential to increase economic productivity and development and to narrow the technological gap with developed countries. It is in recognition of the need for sustained and sustainable mechanisms to enable the transfer of technologies between countries that the United Nations (UN) Technology Bank for the Least Developed Countries was born.
Expanding the production of COVID-19 vaccines to reach developing countries
Lift the barriers to fight the pandemic in the Global South
By Carlos M. Correa
The unfolding of COVID-19 has shown that the international system has been unable to ensure equal access to the vaccines and other products necessary to fight the pandemic. While the need for a strong response remains obvious, proposals for scaling up the production of COVID-19 vaccines across the globe are still blocked in the World Trade Organization.
Misappropriation of Genetic Resources and Associated Traditional Knowledge: Challenges Posed by Intellectual Property and Genetic Sequence Information
By Nirmalya Syam and Thamara Romero
Improper acquisition of genetic resources (GRs) and associated traditional knowledge (TK) without prior informed consent and on mutually agreed terms, in accordance with national laws of the country providing the GR and associated TK, as well as without any fair and equitable sharing of the benefits derived from their utilization, has been a significant concern for developing countries. Intellectual property (IP) rights can serve as one of the means of such misappropriation. One of the mechanisms sought by developing countries to prevent it consists in the establishment of an effective multilateral legal mechanism for defensive protection against misappropriation, primarily through the introduction of a mandatory disclosure requirement about the source and country of origin of such resources in intellectual property right (IPR) applications. These negotiations have been taking place in different fora. However, there is an increased sense of frustration due to the lack of progress in achieving consensus during the last twenty years. Meanwhile, new modes of misappropriation of GRs are evolving through the use of genetic sequence information and data of GRs, and by applying technological developments in synthetic biology. This paper discusses the use of IP and genetic sequence information and data as modes of misappropriation of GRs and associated TK and the deficits of the current international legal framework in preventing such misappropriation. This paper also maps the state of play of the ongoing negotiations in the context of these issues in different fora, and, in conclusion, proposes possible alternative approaches for addressing these pressing issues at the multilateral level.
Compulsory license in Germany: Analysis of a landmark judicial decision
By Christoph Spennemann and Clara Warriner
This policy brief analyzes how the German Federal Court of Justice addressed compulsory licensing under German patent law, where the request for a compulsory license was used in preliminary proceedings as a defense against alleged patent infringement.
Competition Regulation in Healthcare in South Africa
By Hardin Ratshisusu
South Africa’s nascent competition regulatory regime is coming of age and has potential to address historical market concentration challenges previously enabled by the apartheid regime, prior to its dismantling in the 1990s. Many sectors of the economy are highly concentrated, including the private healthcare sector, with market outcomes that breed market failures, lack of competitiveness and high cost of care. Looking through competition in the healthcare sector it becomes evident that the market structure challenges do not only require domestic interventions, but also a global response to address some policy and regulatory gaps.
Need for Extension of the LDC Transition Period Under Article 66.1 of the TRIPS Agreement Until Graduation and Beyond
By Nirmalya Syam
Least developed country (LDC) Members of the World Trade Organization (WTO) have submitted a duly motivated request for the extension of the transition period under Article 66.1 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which exempts LDCs from implementing the obligations for protection and enforcement of intellectual property rights under the Agreement, in view of their vulnerabilities, special needs, economic, administrative and financial constraints, and the need for a sound and viable technological base. This request, submitted prior to the expiry of the current transition period on 1 July 2021, seeks a further extension for as long as those Members remain LDCs, and also for an additional period of 12 years after their graduation. This request is legitimate in view of the varied challenges that LDCs face, which have been aggravated through the reversal of development gains due to the public health and economic impact of the COVID-19 pandemic. These vulnerabilities will also continue to afflict the LDCs even after graduation, as recognized in several reports by different United Nations (UN) agencies as well as resolutions of the UN General Assembly. Therefore, WTO Members must display political will and translate global solidarity pledges into action and unconditionally support the request for extension of the transition period for LDCs under the TRIPS Agreement.
Scope of Compulsory License and Government Use of Patented Medicines in the Context of the COVID-19 Pandemic
To meet public health needs, such as in the current COVID-19 emergency, governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines.
These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted (read our Call for Action on Intellectual Property and Trade Measures to Address the Covid-19 Crisis here).
The South Centre offers a guide for the issuance of compulsory licenses and government use, see here, aquí en español.
The table below provides information of instances of their use.
