Colombia’s Biogenerics Regulation A Preliminary Court Decision in favour of Public Health
By Carolina Gómez
The Council of State of Colombia’s recent ruling on the abbreviated pathway for marketing authorization of biogenerics is a valuable step towards acceptance and uptake of biogenerics, favoring public health, access and market competition.
In 2014, after several years of discussion and heated debate, Colombia issued a regulation for sanitary registration of biotechnological medicines, including biogenerics. The regulation explicitly included an abbreviated pathway for the registration of biogenerics, which allows for reduction or, in some cases, even waivers of comparative efficacy clinical trials. PK/PD and inumunogenicity studies are required. (more…)
The US-Mexico-Canada Agreement: Putting Profits Before Patients
By Maria Fabiana Jorge
In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S. Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements. A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.
2030 Sustainable Development Agenda with Focus on Education Goal – SDG 4
By Kishore Singh
Sustainable Development Goal (SDG) 4 to “ensure inclusive and equitable quality education and promote lifelong learning opportunities for all” of the 2030 Agenda for Sustainable Development must be considered bearing in mind the right to education as an internationally recognized right as well as the right to development. Below is the keynote presentation by Kishore Singh, former United Nations Special Rapporteur on the Right to Education, at the Asian High-level Forum on Human Rights on the occasion of the 70th Anniversary of the Universal Declaration of Human Rights. (more…)
Access to Medicines: Experiences with Compulsory Licenses and Government Use – The case of Hepatitis C
By Dr. Carlos M. Correa and Dr. Germán Velásquez
This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States’ observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).
The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilise patent law to facilitate access to medicines
By Olga Gurgula
The current patentability standards for pharmaceutical inventions, as well as strategic patenting used by pharmaceutical companies, have substantially impacted access to affordable medicines. This has been especially detrimental for developing countries, which are under significant pressure to remain compliant with their international and bilateral obligations, while also providing their people with essential drugs. In order to improve access to medicines, developing countries may choose from a range of various mechanisms that may help to facilitate such access, while also allowing them to remain compliant with their international and bilateral obligations. This policy brief suggests that one of such mechanisms is to strengthen the obviousness requirement by applying the ‘obvious to try with a reasonable expectation of success’ test to pharmaceutical follow-on inventions. It is argued that the application of this test may be an effective tool in addressing the negative effect of strategic patenting. It may help to prevent the extension of patent protection and market exclusivity of existing drugs by pharmaceutical companies and, as a result, may open such medicines up to generic competition.
South-South cooperation for confronting the neglected problem of snakebite envenoming: the role of Costa Rica
By Dr. Jose María Gutiérrez and Ambassador Elayne Whyte Gómez
As of 2018, the international community has a global framework to address the problem of snakebite envenomings, an acute problem that affects rural populations in tropical areas of the world, which mainly affects people from the most vulnerable sectors of the population and leaves significant negative consequences in millions of people around the world. This global framework was adopted by a resolution of the World Health Organization (WHO) at its 71st World Assembly on May 24, 2018, thus providing for a strong mandate to develop a comprehensive plan to address this health problem, work with affected countries, partners, stakeholders and industry, and develop a comprehensive approach that will allow countries to implement an effective response to this health issue.
Scientific and Efficient Establishment of Urban Environmental and Resource Management System
By Youba Sokona
Transformation in urban areas needs to happen now to achieve sustainable development and fight against climate change. This transformation needs to be inclusive by focusing on social justice, power asymmetries and vulnerable populations; and requires all actors at the national and international level to collaborate in order to exchange information, generate and work with accurate data, develop technology and provide the financial resources for the implementation of the right programs and policies. These are messages of the keynote speech by Prof. Youba Sokona, South Centre Senior Adviser on Sustainable Development and Intergovernmental Panel on Climate Change (IPCC) Vice-Chair, at the “Forum on the Implementation of the 2030 Agenda for Sustainable Development”. He also highlighted the main take-aways from the recently released IPCC Special Report on Global Warming of 1.5°C. (more…)
Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?
By Dr. Carlos M. Correa
An amendment to the TRIPS Agreement by incorporation of the text of the decision of the WTO General Council on 30 August 2003 (as article 31bis) has been made in response to the problem identified in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This paragraph sought a solution to situations where patented pharmaceuticals which are not available in a country with no or insufficient manufacturing capacity can be supplied by a foreign provider. As originally adopted, the TRIPS Agreement did not allow the grant of compulsory licenses for exports only, thereby preventing generic manufacturers from exporting the required products to countries unable to produce them. While the new article 31bis is a step forward as it reflects public health concerns, it would be necessary to streamline the procedures to effectively ensure broader access to pharmaceutical products at low cost and in a timely manner.
Setting the pillars to enforce corporate human rights obligations stemming from international law
By Daniel Uribe
The release of the Zero Draft of the Legally Binding Instrument to Regulate, in International Human Rights Law, the Activities of Transnational Corporations and other Business Enterprises by the Chairperson of the Open-ended Intergovernmental Working Group on Business and Human Rights (OEIGWG), is likely to revive discussions on the recognition of corporate entities as subjects of international law. The present brief examines corporate entities’ human rights obligations in the context of the Zero Draft, taking into account the views and comments presented during the first three sessions of the OEIGWG and the need to advance the discussion on those entities’ obligations under international law.
Advancing international cooperation in the service of victims of human rights violations in the context of business activities
By Kinda Mohamadieh
A zero draft of a legally binding instrument to regulate, in international human rights law, the activities of transnational corporations and other business enterprises, is the subject of discussions in an inter-governmental open ended working group under the auspices of the Human Rights Council (15-19 October 2018). The draft aims at harnessing international cooperation among home and host states of business enterprises in order to address barriers to get remedies to victims of human rights violations in the context of business activities of transnational character. This brief discusses the approach to States’ role and obligations as proposed under the zero draft.
