Publications

SouthViews No. 206, 25 September 2020

Digital Transformation: Prioritizing Data Localization

By Bilal Zaka

After years of rather stable and predictable growth of telecommunications and software systems, the last decade has witnessed a tremendous shift towards unpredictable and disruptive innovations in every field of life. Today, we are experiencing the true social, political, financial and cultural effects of what is termed as globalization, deregulation, liberalization and convergence. Some major factors influencing this change are proliferation of mobile devices, ubiquitous wireless access to internet and increasing interventions of online or internet-driven technologies. While this digital transformation is inevitable, it is imperative that we equip ourselves to handle the negative implications of external influence caused by foreign dependencies and the non-regulatory nature of the new information ecosystem.

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Policy Brief 84, September 2020

A New Trend in Trade Agreements: Ensuring Access to Cancer Drugs

By Maria Fabiana Jorge

A World Health Organization (WHO) report on cancer indicates that the cancer burden will increase at least by 60% over the next two decades, straining health systems and communities.  Companies develop cancer drugs in part because payers are less resistant to paying high drug prices for these drugs.  As Barbara Rimer, Dean of the University of North Carolina and Chair of the U.S. President’s Cancer Panel stated, “[m]ost cancer drugs launched in the United States between 2009 and 2014 were priced at more than $100,000 per patient for one year of treatment.”  Many of the new cancer drugs are biologics. Such prices are clearly out of reach for most patients who will need them increasingly more to stay alive.  While competition is critical to ensure lower drug prices, we have seen a number of strategies, including through trade agreements, to prevent competition and extend monopolies over these drugs and their very high drug prices.  It is no accident that the exclusivity granted to biologic drugs has been one of the most conflictive provisions in recent trade agreements such as the United States-Mexico-Canada Agreement (USMCA) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).  Nevertheless a new trend in trade agreements started in 2007 when U.S. Members of Congress pushed back against the interests of powerful economic groups seeking longer monopolies for drugs.  These Members of the U.S. Congress prevailed then in restoring some balance in the trade agreements with Peru, Colombia and Panama and further consolidated this new trend in 2019 in the USMCA.  Moreover, following the U.S. withdrawal from the original Trans-Pacific Partnership (TPP), the negotiators of the remaining 11 countries also pushed back to ensure a better balance between innovation and access in the CPTPP.  People around the world need to be aware of these precedents and ensure that they also work for access to medicines for their own citizens.

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Research Paper 118, September 2020

Re-thinking Global and Local Manufacturing of Medical Products After COVID-19

By Dr. Germán Velásquez

The unprecedented global health crisis caused by the coronavirus (COVID-19) pandemic since the first quarter of 2020 has reopened the now-urgent discussion about the role of local pharmaceutical production in addressing the health needs in developing countries. The COVID-19 crisis has highlighted the interdependencies in the global production of pharmaceuticals—no country is self-sufficient. Many industrialized countries are making the decision to repatriate or initiate the production of active pharmaceutical ingredients (APIs) and medicines. Governments are beginning to talk about ‘pharmaceutical sovereignty’ or ‘health security’. If this becomes a reality and the production of pharmaceuticals is led by nationalistic policies, developing countries that still lack manufacturing capacity will have to start or expand the local production of pharmaceuticals, whether at the national or regional level. The war to get access to the future vaccine for COVID-19 does not look easy with these new developments.

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Document de Recherche 100, Septembre 2020

Médicaments et propriété intellectuelle: 10 ans de la stratégie mondiale de l’OMS

Par Dr. Germán Velásquez

Les négociations du Groupe de travail intergouvernemental sur la santé publique, l’innovation et la propriété intellectuelle connu sous le nom de “IGWG” (2006-2008), menées par les Etats Membres de l’OMS, sont le résultat d’une impasse à l’Assemblée mondiale de la santé du 6 décembre 2006 où les Etats Membres n’ont pu parvenir à un accord sur les 60 recommandations du rapport” Santé publique, innovation et propriété intellectuelle “soumis la même année par un groupe d’experts désigné par le Directeur général de l’OMS. Le résultat de ces négociations devint la “Stratégie mondiale et Plan d’action pour la santé publique, l’innovation et la propriété intellectuelle” (GSPOA), approuvé par l’Assemblée mondiale de la santé en 2008. Un des objectifs de la Stratégie mondiale élaboré par l’IGWG était de réformer en profondeur le système d’innovation pharmaceutique, en raison de son incapacité à produire des médicaments abordables contre les maladies qui affligent une grande partie de la population du monde vivant dans les pays en développement. Les droits de propriété intellectuelle (PI) imposés par l’Accord sur les aspects des droits de propriété intellectuelle liés au commerce (ADPIC) et les accords commerciaux pourraient devenir des principaux obstacles à l’accès aux médicaments. Le GSPOA a fait une analyse critique de cette réalité et a mené à la recherche de nouvelles solutions à ce problème. Dix ans après l’approbation du GSPOA, les résultats restent incertains et médiocres.

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Document de Recherche 111, Septembre 2020

Mesures nationales sur l’imposition de l’économie numérique

Par Veronica Grondona, Abdul Muheet Chowdhary, Daniel Uribe

Le Cadre inclusif sur le BEPS de l’Organisation de coopération et de développement économiques (OCDE) envisage une approche fondée sur deux piliers en matière de taxation de l’économie numérique. Les premières estimations concernant l’impact de ses recommandations montrent une modeste augmentation de la collecte de l’impôt sur les sociétés, dont les bénéfices devraient revenir principalement aux pays développés. Dans le même temps, les mesures nationales de taxation de l’économie numérique se multiplient, en conséquence de la pandémie de COVID-19. Le droit international reconnaît pleinement ce droit aux pays, bien que cette approche soit considérée comme une forme d’unilatéralisme. Ce document de recherche met en lumière les mesures de fiscalité directe prises par différents pays et présente les trois approches clés retenues pour taxer l’économie numérique : (1) l’imposition de taxes sur les services numériques ; (2) l’élaboration de règles permettant d’établir un lien fiscal pour les entreprises numériques qui opère par l’intermédiaire d’une présence numérique significative ; (3) des retenues à la source sur les transactions numériques.

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Documento de Investigación 111, Septiembre 2020

Medidas Tributarias Nacionales  sobre la Economia Digital

Por Veronica Grondona, Abdul Muheet Chowdhary, Daniel Uribe

El Marco Inclusivo de la Organización de Cooperación y Desarrollo Económicos (OCDE) está considerando un enfoque de dos pilares en relación con el cobro de impuestos sobre la economía digital. Las estimaciones preliminares acerca de la repercusión de sus recomendaciones indican un modesto incremento en la recaudación de impuestos sobre la renta de las sociedades, cuyos beneficios se prevén que se dirijan principalmente a los países desarrollados. Al mismo tiempo, están proliferando las medidas nacionales en materia de cobro de impuestos sobre la economía digital, un cambio estimulado por el comienzo de la pandemia de COVID-19. Los países también tienen plenos derechos a aplicarlas en virtud del derecho internacional, pese a las etiquetas de “unilateralismo”. En este documento de investigación se ponen de relieve las medidas en materia de impuestos directos que están adoptando diversos países y se exponen tres enfoques fundamentales con respecto al cobro de impuestos sobre la economía digital: 1) impuestos sobre los servicios digitales; 2) normas sobre un nexo en base a una presencia digital significativa; y 3) retenciones en origen sobre las transacciones digitales.

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Book by the South Centre, 2020

WTO reform and the crisis of multilateralism – A Developing Country Perspective

About the Book:

The WTO has not been able to recover since the collapse of the Doha Round in July 2008. Several ministerial conferences including the Buenos Aires meeting in December 2017 failed to reach agreement. The US Trump Administration launched a campaign to reform the WTO in 2018 and 2019. This book argues that the Trump Administration reform proposals have been much more aggressive and far-reaching than the Obama Administration before it, threatening to erode hard-won special and differential treatment rights of developing countries. By blocking the appointment of new Appellate Body members, the US has effectively paralysed the Appellate Body and deepened the crisis of the multilateral trading system. Developing countries have responded to the proposals and called for the WTO to be development-oriented and inclusive. This book provides a critical analysis of the US-led reform proposals and seeks to build a discourse around an alternative set of concepts or principles to guide the multilateral trading system based on fairness, solidarity, social justice, inclusiveness and sustainability.

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Research Paper 117, September 2020

Data in Legal Limbo: Ownership, sovereignty, or a digital public goods regime?

By Dr. Carlos M. Correa

The legal characterization and design of a legal regime for data poses one of the most important contemporary challenges to law professionals and policy makers. How such a framework is designed matters for what kind of insertion a society will have in the digital economy, and the extent to which a country will be able to benefit from the opportunities opened by big data. The current policy space to devise legal regimes adapted to national circumstances allows countries to seek for new solutions that take into account differences in legal systems, levels of economic and technological development, and national objectives and priorities.

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SouthViews No. 205, 31 August 2020

Digital Sequence Information (DSI) and national measures: approaches and perspectives

By Jorge Cabrera Medaglia

Digital sequence information (DSI, or genetic sequence data) is an emerging aspect of synthetic biology which involves certain functional genetic sequences being shared by different means. The genetic sequences from plants, animals or micro-organisms could be used to support conservation and sustainable use of biological diversity, to develop and commercialize new products and processes, or for other purposes. The regulation of the use of DSI for both commercial and non-commercial entities may have huge implications for the access and benefit-sharing (ABS) regimen established in the international instruments, ongoing processes and regional and national legislation that implement these conventions. International guidance is needed to promote a coordinated approach to secure fair and equitable sharing of benefits while avoiding a negative impact on the non-commercial benefits arising from the genetic data.

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Documents de Formation 1, Août 2020

Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base

Par Germán Velásquez

La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.

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Research Paper 116, August 2020

The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

By Frederick Abbott

The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

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Policy Brief 83, August 2020

United States: An Obsolete Trade Practice Undermines Access to the Most Expensive Drugs at More Affordable Prices

By Maria Fabiana Jorge

Access to affordable drugs is a top policy priority for the United States with real bipartisan support but it increasingly seems to be an unreachable goal, in part, due to conflicting government policies. While the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted the importance of competition to ensure lower drug prices, U.S. trade policy in general, and the Special 301 Annual Review in particular, do exactly the opposite: broaden and lengthen the monopolies granted to pharmaceutical companies thus delaying or deterring the launch of generic and biosimilar drugs and with that, the chances of lowering drug prices. The pharmaceutical industry has changed a great deal in the past 30 years, among other things by developing complex biotechnology drugs that while critical for the treatment of illnesses such as cancer, are out of reach for many patients. While some parts of the government are trying to increase access to medicines through competition provided by generic and biosimilar drugs, their efforts are being undermined by a trade policy that was defined 30 years ago. It is time to adjust U.S. trade policy to the realities of 2020 and stop acting as if it was still 1989.

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