The Nagoya Protocol International Access and Benefit Sharing Regime
By Viviana Munoz Tellez
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity entered into force in October 2014. Ten years have now passed since the adoption of the Protocol by the Parties to the Convention on Biological Diversity, now with 129 Parties. The Protocol requires countries to set up access and benefit sharing rules and procedures for the Protocol’s implementation at the national level. This policy brief describes the main characteristics of the Protocol and makes recommendations for countries to advance in its implementation. Importantly, the Protocol’s language empowers countries with considerable policy space for the design of domestic access and benefit-sharing rules.
Política de industrialización de litio, el caso boliviano
Por Hortensia Jimenez Rivera
El litio es un mineral de gran importancia en la industria tecnológica mundial, lo que lo convierte en un recurso estratégico para un país. Por ello, es responsabilidad del Estado asegurar que su explotación sea una oportunidad para el desarrollo y el bienestar, protegiendo los intereses de su población y maximizando sus beneficios de manera que la gestión de su riqueza no lleve a más pobreza y dependencia.
Las políticas que se adopten para el aprovechamiento de los recursos naturales pasan por definir el régimen de propiedad sobre los recursos y el grado de industrialización en el país, lo que implica –de manera directa– ingresos y desarrollo, para luego resolver aspectos de orden tecnológico, financiero, institucional, legal y de mercado.
Este informe describe la experiencia boliviana de la industrialización del litio, las características de su industrialización bajo una política de desarrollo nacional y revela cómo el tipo de política implementada es determinante para la explotación de un recurso natural.
Base Erosion and Profit Shifting in the Extractive Industries
By Danish and Daniel Uribe
Developing countries with significant natural resources have not fully utilised them for financing their development aspirations. Extractive industries and the revenue generated from their extractive activities need to constitute a larger share of domestic resource mobilisation. However, the sector remains beset with massive tax base erosion and profit shifting by large multinational companies. This policy brief therefore looks at the extractive industries, and the potential impact of their practices on the national policies and regulations in developing countries. It further also considers some current initiatives at the international level for enabling countries to obtain more revenue from natural resource extraction, and offers some observations on the policy options available to developing countries.
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.
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.
Pathways for leapfrogging to reconcile development and climate change imperatives in Africa
By Smail Khennas and Youba Sokona
A just energy transition toward low carbon emissions pathways is increasingly a priority not only to cope with the adverse impacts of climate change but also for achieving more sustainable economic and social development of the African continent. Fortunately, to optimize its energy mix for development according to sustainability criteria, Africa can take advantage of a rapid energy transition, thanks to its huge and largely untapped renewable energy potential and its abundance of a less polluting fossil fuel, namely, natural gas. Moreover, the fact that most of the infrastructure for energy systems in Africa is not yet built, particularly in sub-Saharan countries, offers these countries a good opportunity for leapfrogging. This Policy Brief explores guiding principles and pathways for a low carbon energy transition, including leapfrogging opportunities, energy system design and social innovation.
Examining antimicrobial resistance in the light of the COVID-19 pandemic
By Mirfin Mpundu, Caline Mattar and Mirza Alas
The COVID-19 pandemic provides an opportunity to strengthen the capacity of health systems not only to be better prepared for the next pandemic but also to address ongoing crises such as antimicrobial resistance. The unfolding crisis due to antimicrobial resistance is, unfortunately, similar to the current health crisis due to the COVID-19 pandemic, albeit at a slower pace. As countries address the pandemic, there is a need to identify interlinkages between the pandemic and antimicrobial resistance and to continue strengthening the actions needed to slow down the emergence of antimicrobial resistance.
The UN General Assembly Resolutions on COVID-19: Solemn Assurances for Access to Health Technologies without an Action Plan
By Nirmalya Syam
The United Nations (UN) has the mandate under the Charter of the United Nations to promote solutions to international health problems, such as the global COVID-19 pandemic. While the UN secretariat, led by the Secretary-General, has undertaken a number of initiatives in response to COVID-19, member State initiatives in the UN has so far been limited to two resolutions adopted by the UN General Assembly. Member States are currently negotiating an omnibus resolution of the General Assembly on COVID-19. This policy brief analyzes the extent to which the General Assembly addresses the issue of timely, equitable and affordable access to health technologies, particularly for developing countries who have greater vulnerability to COVID-19. The adopted resolutions make very broad pledges for global solidarity but lack specific commitments to guide actions by member States. The omnibus resolution currently under negotiation should provide specific guidance to member States on actions to be taken based on the principles of solidarity and multilateral cooperation in diverse aspects impacted by COVID-19.
Intellectual Property, Innovation and Access to Health Products for COVID-19: A Review of Measures Taken by Different Countries
By Nirmalya Syam
The rising incidence of COVID-19 will require all countries, particularly developing and least developed countries, to be able to procure and manufacture the products required for the diagnosis, prevention and treatment of COVID-19. Intellectual property (IP) rights over such products can constrain the ability of countries to rapidly procure and produce and supply the products required at a mass scale. This Policy Brief describes the measures and actions taken by different countries to address potential IP barriers to access to the products required for COVID-19. A number of countries, both developed and developing, have adopted measures to enable governments to take action to overcome IP barriers in case they constrain access to the products required for COVID-19. In addition to these measures, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) also allows considerable flexibility to adopt a number of other possible measures which can be considered by developing countries where necessary.
Articles 7 and 8 as the basis for interpretation of the TRIPS Agreement
By Thamara Romero
Articles 7 and 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) play a central role in assuring the members of the World Trade Organization (WTO) the right to implement public health measures. The Doha Declaration on the TRIPS Agreement and Public Health is also an important element for the interpretation of any provision of the TRIPS Agreement that may have public health implications. The most recent and prominent example of the use of articles 7 and 8 for interpretation in WTO law can be found in the WTO Panel decision of 2018 on the Australia – Tobacco Plain Packaging dispute.
The 73rdWorld Health Assembly and Resolution on COVID-19: Quest of Global Solidarity for Equitable Access to Health Products
By Nirmalya Syam, Mirza Alas and Vitor Ido
The annual meeting of the World Health Assembly (WHA) of the World Health Organization (WHO) held virtually on 18-19 May 2020 discussed the global response to COVID-19 and adopted Resolution WHA73.1 on “COVID-19 Response”. The Resolution reaffirms the role of WHO as the directing and coordinating authority on international health work and it recognizes that all countries should have timely and affordable access to diagnostics, therapeutics, medicines and vaccines as well as to essential health technologies and equipment to respond to COVID-19. However, the Resolution does not define concrete actions to address the pandemic. Though the Resolution makes a commitment of ensuring access to medical products, vaccines and equipment for all countries in a timely manner, there are no concrete actions defined. In order to ensure global equitable access, WHO Members should make full use of the flexibilities of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and also enhance transparency of costs of research and development (R&D), openness and sharing of data, tools and technologies, and build more capacity through technology transfer.
La pandemia de COVID-19: el fomento de la I+D y la gestión de la propiedad intelectual para acceder a diagnósticos, medicamentos y vacunas
PorViviana Muñoz Tellez
La rápida difusión actual de COVID-19 está poniendo a prueba la capacidad de los gobiernos y de la Organización Mun-dial de la Salud (OMS) para poner en marcha una respuesta mundial coordinada a la pandemia. Los países en desarrollo y los países menos adelantados (PMA), en particular los de África, son particularmente vulnerables a los efectos de la crisis de salud pública. Una esfera prioritaria para la colaboración mundial es el fomento de la investigación y el desar-rollo de vacunas y medicamentos que estén disponibles, sean asequibles y accesibles en todo el mundo. En la actualidad no existe una vacuna ni una terapia directa segura y eficaz probada para COVID-19. También es necesario acelerar la capacidad y los instrumentos de ensayo en los países en desarrollo y los países menos adelantados con un mayor acceso a diagnósticos de bajo costo. El enfoque de la gestión de los derechos de propiedad intelectual por parte de las instituci-ones de investigación, las empresas farmacéuticas y biotecnológicas y las entidades de financiación de la investigación y el desarrollo afectará de manera decisiva a la disponibilidad y el acceso, así como a la transferencia de tecnología y conocimientos técnicos. Los gobiernos deben asegurarse de que disponen de marcos legislativos y de procedimiento que les permitan superar cualquier barrera de patentes, de exclusividad de datos y de secretos comerciales para adquirir y producir diagnósticos, vacunas, medicamentos y otros productos terapéuticos de COVID-19.