Antivirales de acción directa para la Hepatitis C: evolución de los criterios de patentabilidad y su impacto en la salud pública en Colombia
La hepatitis C en el siglo XXI y el VIH en el final del siglo XX han representado los más relevantes retos de salud pública para la comunidad internacional. No solamente por ser enfermedades infecciosas y transmisibles (razón de ser de la salud pública) sino por su carácter mortal si no se recibe tratamiento de manera oportuna. En Octubre de 2015, la fundación IFARMA solicitó que todos los medicamentos antivirales para la hepatitis C, utilizables para curar una infección crónica transmisible potencialmente mortal, fueran declarados de interés público, dado que su precio amenazaba la sostenibilidad financiera del sistema de salud. Una declaración de interés público para estos medicamentos sería el primer paso para la emisión de licencias obligatorias. Este trabajo se ha llevado a cabo para identificar las patentes existentes en Colombia para estos productos, su alcance y sus consecuencias, en el marco de una discusión sobre la transparencia del sistema de patentes y la evolución del rigor con que se evalúan las solicitudes y se conceden las patentes.
Mainstreaming or Dilution? Intellectual Property and Development in WIPO
In 2007 Member States of the World Intellectual Property Organization (WIPO) unanimously adopted a set of 45 recommendations which constitute the WIPO Development Agenda. Developing countries sought to give new direction to WIPO through the Development Agenda, away from the pursuit of facilitating and strengthening protection, acquisition and enforcement of intellectual property (IP) rights as an end in itself towards an approach that would be sensitive to the impact of IP on development, both in terms of opportunities as well as costs. This paper explores whether development considerations have been adequately addressed by WIPO since its creation as the United International Bureau for the Protection of Intellectual Property (BIRPI) in the nineteenth century. The paper also analyses whether the implementation of the WIPO Development Agenda adopted in 2007 has shaped the current vision of the WIPO Secretariat and its Member States to address the impact of IP on development; and whether implementation of the Development Agenda has facilitated the use of IP law and policy as a tool that responds to advancing innovation, industrial, health, agricultural, education and other development policies in developing countries. The paper finds that the approach towards IP in WIPO continues to be dominated by a perspective that pursues acquisition, protection, management and enforcement of IP rights as an end in itself. Conflicting interpretations of development orientation have adversely impacted the implementation of the Development Agenda in the spirit in which the developing countries had proposed the Development Agenda. The paper recommends developing countries to undertake cross regional coordination to enhance their level of engagement on IP and development, advance specific suggestions for achieving greater impact on addressing development challenges through specific activities including projects in the areas of technical assistance as well as norm-setting, pursue governance reforms in WIPO to ensure greater representation of developing countries in the decision making bodies of WIPO and in the staff composition of the WIPO Secretariat, amend the WIPO Convention to align its mandate on IP promotion to the development needs and challenges of its Member States and the development goals of the United Nations (UN), and also pursue a review of the relationship between the UN and WIPO as a UN specialized agency in the UN Economic and Social Council.
Access to Medicines: Experiences with Compulsory Licenses and Government Use – The case of Hepatitis C
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).
Tax Haven Listing in Multiple Hues: Blind, Winking or Conniving?
Tax havens are among the biggest challenges faced by developing countries in achieving their national development goals. States, international organisations, multilateral agencies and non-governmental organisations have all made several efforts at compiling ‘lists’ of tax havens at the multilateral and national levels, with varying levels of seriousness and outcomes. This research paper examines these efforts by analysing the objectivity of criteria used and the clarity of the final outcome in a comparative manner. The paper is organized into four sections dealing with the tax haven blacklisting by the Organisation for Economic Co-operation and Development (OECD), the countries of the South, the European Union (EU) and an analysis across lists. The concluding section offers some suggestions.
Regulating the Digital Economy: Dilemmas, Trade Offs and Potential Options
The digital economy has been growing exponentially in recent years thanks to new technologies that are promoting a global transformation. Key technologies responsible for this transformation have become the subject of intense discussions under the umbrella term ‘fourth industrial revolution’. This paper offers a discussion on the differentiated impact of digital technologies on unemployment, capabilities building and technological catch-up for developing countries. It articulates some of the key issues and tradeoffs for developing countries that should be considered in policy discussions and deliberations.
Notification and Transparency Issues in the WTO and the US’ November 2018 Communication
Various WTO Members submitted a Communication to the WTO in November 2018 which, if accepted, would affect the implementation of Members’ transparency and notification obligations at the WTO. It would strengthen the already burdensome notification obligations and introduce new punitive administrative measures should obligations not be complied with. This paper provides information about WTO Members’ current notification obligations and their level of compliance; looks at the history of discussions on notifications, particularly in the Working Group on Notification Obligations and Procedures which took place in 1995 – 1996; and provides an analysis of the Communication. The analysis focuses on the extent to which the elements are consistent with or go beyond the current WTO disciplines. It concludes that non-compliance with notification obligations is real. However, rather than expanding obligations and introducing punitive measures, constructive and effective solutions should be based on nuancing of obligations in the context of a Special and Differential Treatment approach and through the use of incentives. It also acknowledges that countries with a chronic lack of capacities will continue to struggle with the WTO’s complex notification obligations and requirements until they attain higher levels of development and, thus, improved institutional capacities.
Key Issues for BAPA+40: South-South Cooperation and the BAPA+40 Subthemes
Developing countries today face multiple interlinked macroeconomic, financial, climate, and development challenges. South-South cooperation is an important element for developing countries to meet these challenges individually and collectively, and in multilateral North-South dialogue and global governance. The overall theme of the Second High-level United Nations Conference on South-South Cooperation (40 years after the Buenos Aires Plan of Action for Promotion and Implementing Technical Cooperation among Developing Countries/BAPA+40) is the “Role of South-South cooperation and the implementation of the 2030 Agenda for Sustainable Development: challenges and opportunities”, with sub-themes. This research paper will present some concepts relating to South-South cooperation that have been developed by the South and the United Nations system, and looks at some issues that would be relevant to discussions that may be undertaken with respect to Subthemes (i) “Comparative advantages and opportunities of South-South cooperation”; (ii) “Challenges and the strengthening of the institutional framework of South-South cooperation and triangular cooperation”; and (iv) “Scaling up the means of implementation of the 2030 Agenda for Sustainable Development in support of South-South cooperation and triangular cooperation”. It concludes by providing recommendations for the consideration of developing countries in response to the various subthemes, as inputs to support the active engagement by developing countries in the negotiations for the BAPA+40 outcome document.
Compulsory Licensing Jurisprudence in South Africa: Do We Have Our Priorities Right?
Compulsory licences are generally available on a variety of grounds, most notably on patents where the patentee is found to have abused its rights in one manner or another. This research paper attempts to review South African case law on applications for compulsory licences since the inception of the current legislation, analyse the interpretations placed on the relevant sections, and draw conclusions about judicial reasoning, impediments to the grant of such licences, and generally the courts’ approach to disputes relating to patents.
History and Politics of Climate Change Adaptation at the United Nations Framework Convention on Climate Change
This research paper provides a perspective on how climate change adaptation has progressed in the multilateral space, under the United Nations Framework Convention on Climate Change (UNFCCC). It describes adaptation and financial institutions under the climate regime and the current scope of their activities. The paper highlights the challenges that lie ahead, particularly around financing, for developing countries to adapt to a rapidly warming world and presents recommendations for the governments to accord higher priority to adaptation.
Assessment of South-South Cooperation and the Global Narrative on the Eve of BAPA+40
This research paper gives a brief account of the fast expansion of South-South cooperation (SSC) in volume, modalities and participating countries and institutions. Though SSC is a de facto development compact, there is a tendency to overstate the total concessional financial element of SSC compared to Official Development Assistance (ODA), as SSC constitutes only a small portion of the total ODA from traditional donors. North-South cooperation (NSC) is still the dominant pillar of development finance; hence SSC needs to be regarded as a complement to and not a substitute for NSC. (more…)
Stemming ‘Commercial’ Illicit Financial Flows & Developing Country Innovations in the Global Tax Reform Agenda
Illicit Financial Flows generated due to the commercial activities of multinational enterprises are quantitatively the most important challenge faced by developing countries in achieving the Sustainable Development Goals. Current efforts for stemming these illicit flows and reforming the international tax system are however being led by developed countries, with developing country interests poorly reflected in the reform agenda. This research paper highlights the tax issues of great priority for developing countries and how international tax cooperation can contribute to preventing such illicit flows.
US’ Section 301 Actions: Why They are Illegitimate and Misguided
This research paper examines the US’ Section 301 unilateral actions against China, stemming from the US’ concerns over China’s ambitious industrial policies and its rapid technological advancements. It outlines the accusations of the US regarding China’s conditions for technology transfer and what the US sees as overly intrusive Chinese government involvement in investments. It looks in detail at why the US’ actions are in fact illegitimate and misguided. (more…)