Antivirales de acción directa para la Hepatitis C: evolución de los criterios de patentabilidad y su impacto en la salud pública en Colombia
Por Francisco A. Rossi B. y Claudia M. Vargas P.
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.
Inequality is one of the greatest challenges that the world needs to face. Inequality is intimately linked with poverty. Although there has been progress in reducing poverty, a large part of the global population (overwhelmingly living in developing countries) is still denied access to a dignified life. While no poverty and reduced inequality are two of the outstanding Sustainable Development Goals, these and other goals are unlikely to be achieved by 2030. In fact, inequality is on the rise. Changing this situation will certainly require significant efforts at the national and regional level. But it also requires an international architecture that supports those efforts by respecting the policy space that countries need and coordinating constructive actions within the multilateral system. The current initiatives to ‘reform’ this system will only be legitimate if they recognize the gaps in the levels of development and contribute to effectively address them under a fair, pro-development system of rules. Please see last month’s SouthViews on “Understanding global inequality in the 21st century” by Jayati Ghosh, development economist and Professor of Economics at Jawaharlal Nehru University.
Understanding global inequality in the 21st century
By Jayati Ghosh
Inequality has increased since it caught the attention of the international community. The claims that global inequality has decreased because of the faster rise in per capita incomes in populous countries like China and India must be tempered by several considerations. National policies are crucial in this worsening state of affairs and the international economic architecture and associated patterns of trade and capital flows encourage such policies. More national policy space is required for governments, especially in developing countries, to pursue policies that would move towards more sustainable and equitable development which in turn requires significant changes in the global architecture. None of this can be done without some international coordination, and there is a need to revive a progressive and acceptable form of multilateralism that supports the working people across the world, rather than the interests of large capital. (more…)
Mainstreaming or Dilution? Intellectual Property and Development in WIPO
By Nirmalya Syam
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.
BAPA+40 is an Impetus to the Implementation of the 2030 Agenda for Sustainable Development
By Yuefen LI
The United Nations Second High-level Conference on South-South Cooperation (BAPA+40) not only gave an impetus to the further expansion of South-South and Triangular Cooperation (SSTrC) but also to the attainment of the 2030 Agenda for Sustainable Development. Currently, the main task is how to implement the outcome document of BAPA+40. (more…)
The most expensive drug in the history of the pharmaceutical industry
By Germán Velásquez
On May 27, 2019 the US FDA gave marketing authorization for Zolgensma gene therapy, from the Swiss firm Novartis. The price of the drug, administered in a single dose, is 2.125 million dollars, making it the most expensive drug in the history of the pharmaceutical industry. (more…)
Time for a Collective Response to the United States Special 301 Report on Intellectual Property
By Viviana Muñoz-Tellez, Nirmalya Syam and Thamara Romero
This policy brief discusses the annual Special 301 report issued by the Office of the United States Trade Representative (USTR). The report is a unilateral tool of the US to pursue its foreign intellectual property (IP) policy by exerting pressure on countries to reform their IP laws and practices. Developing countries are particularly susceptible to this threat. The report identifies countries that are considered by the US as not providing adequate and effective protection of IP of rights holders from the US. The selection of countries is biased to the concerns raised by segments of the US industry. The report targets balanced provisions in countries’ legislations to ensure that IP rights do not hinder the ability of the government to adopt measures for promoting development priorities, particularly in the area of public health. A uniform and collective international response by the affected countries is long overdue. The way forward is to continue dialogue in appropriate multilateral fora, recognizing the need for all countries to maintain policy space to use IP as a domestic policy tool.
Improving Transfer Pricing Audit Challenges in Africa through Modern Legislation and Regulations
By Thulani Shongwe
Auditing multinational enterprises often involves a broad range of complex technical issues, and transfer pricing (TP) is often the most important one. This policy brief looks at some of the key aspects of the modern TP legislation and illustrates how different drafting of regulations can assist in additional revenue collection as well as increased compliance. It further provides practical examples from real cases to show where poor legislation has given rise to tax planning and to profit shifting. Lastly, the brief offers practical solutions to some of the transactions illustrated through the African Tax Administration Forum (ATAF) Suggested Approach to Drafting Transfer Pricing Legislation.
The USMCA must be amended to ensure access to affordable drugs in Mexico
By Maria Fabiana Jorge
The intellectual property rights (IPRs) chapter of the U.S.-Mexico-Canada-Agreement (USMCA) grants longer and broader monopolies to originator pharmaceutical companies than those currently in force in Mexico, at the expense of patients and taxpayers. Among other things, Mexico would be required to provide patent term extensions both for delays in the granting of patents and for those incurred in the regulatory approval process, broader and longer exclusivity periods, including for expensive biologic drugs, as well as to adopt broader patentability standards, for example by requiring the granting of patents for new uses. Mexico is, without doubt, the country in the USMCA that will be most negatively impacted, but if the Democratic Members of the US House of Representatives are able to renegotiate some of these provisions to restore some balance between the need to foster innovation and competition, the Administration of President López Obrador and the Mexican Congress can still make a difference.
UN tax committee gets a boost through new working methods
By Abdul Muheet Chowdhary
The UN in May published a document titled ‘Practices and Working Methods for the Committee Of Experts On International Cooperation In Tax Matters’. For those who believe that the UN should play a stronger role in the governance of international tax, this is a welcome development. The document further deepens the institutionalisation of the UN Committee of Experts on International Cooperation in Tax Matters (henceforth UN tax committee) by developing new working methods and making several clarifications. Some of these are welcome while others are problematic. Overall, it is clarified that the working methods must be read in conjunction with the rules of procedure of the United Nations Economic and Social Council (ECOSOC) and in the case of inconsistency, the ECOSOC rules are to prevail. (more…)
‘Phase 1B’ of the African Continental Free Trade Area (AfCFTA) negotiations
By Peter Lunenborg
The African Continental Free Trade Area (AfCFTA), which entered into force on 30 May 2019, represents a unique collaborative effort by African countries to bolster regional and continental economic integration, in a world marked by increasing protectionism and use of unilateral trade measures.
In order to make the agreement operational for trade in goods, negotiations on tariff concessions need to be concluded and negotiating outcomes need to be inserted into the agreement. This policy brief focuses on the expected economic impacts of tariff liberalization under the AfCFTA, the tariff negotiation modalities and discusses some legal and practical issues related to the implementation of these modalities.
