Canada’s Political Choices Restrain Vaccine Equity: The Bolivia-Biolyse Case
By Muhammad Zaheer Abbas, PhD
The COVID-19 pandemic has already claimed more than 4.6 million lives and caused significant economic harm. The Coronavirus is still circulating to cause further damage. In this context, this research paper argues that Canada’s political choices have restrained the equitable distribution of COVID-19 vaccines. Part I evaluates Canada’s nationalistic approach of procuring COVID-19 vaccines more than its needs through secretly concluded pre-purchase agreements with brand-name pharmaceutical corporations as advised by a secretly born task force having clear ties with the vaccine industry. Part II examines Canada’s wavering and non-committal position on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver proposal. Canada’s confusing position of ‘not blocking’ the TRIPS Waiver while not supporting it either lacks legal clarity. Part III analyses the Bolivia-Biolyse case which highlights clear contradictions between statements and actions of the Canadian government. Since March 2021, Biolyse Pharma has been hamstrung by the first step in Canada’s Access to Medicines Regime (CAMR), where a preliminary requirement is that the COVID-19 vaccine must be added to Schedule 1 of the Canadian federal Patent Act before applying for an export-oriented compulsory licence. The Bolivia-Biolyse case is important as a test case for the CAMR system. Workability of this export-oriented compulsory licensing regime is critical for low- and middle-income countries in the Global South lacking the domestic capacity to manufacture COVID-19 vaccines. The Bolivia-Biolyse case is also important as Canada has argued at the World Trade Organization (WTO) that the TRIPS Waiver is not required because the existing mechanisms are working as intended.
Implementation of a TRIPS Waiver for Health Technologies and Products for COVID-19: Preventing Claims Under Free Trade and Investment Agreements
by Carlos M. Correa, Nirmalya Syam and Daniel Uribe
While increasing support from WTO members for a proposed waiver from certain obligations under the TRIPS Agreement with regard to health products required for responding to COVID-19 has made a decision on the TRIPS waiver imminent, the waiver will have to be implemented domestically by WTO members through appropriate legislative, administrative or judicial measures, including through executive orders that have been utilized to implement emergency measures in the context of the COVID-19 pandemic. In this regard, the scope of the TRIPS waiver, as well as the terms of applicable free trade agreements (FTAs) and international investment agreements (IIAs) will also impact the policy space available to countries to implement the waiver. Ensuring a broad scope of the waiver, as well as complementary measures to safeguard the implementation of the waiver from potential challenges under FTAs or IIAs will be critical. This research paper discusses some options that could be explored to enable the implementation of the TRIPS waiver by overcoming possible impediments that could arise under such agreements.
The South Centre welcomes the UN Tax Committee’s invitation of public comments into its draft agenda and four-year work plan. By engaging the public in preparing the work plan, the UN Tax Committee’s work can be more responsive to the needs of developing countries, and of UN Member States as a whole. By stating that “the goal to ensure that the Committee’s agenda is practical and relevant to developing countries and includes the most pressing challenges they face in tax policy and administration” the Committee has shown a laudable intent which is also in line with its mandate, which is to give special attention to developing countries. The South Centre offers its written comments on the three topics on which inputs have been requested. These have been prepared based on consultation with the South Centre’s Member States, which are exclusively developing countries.
Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer
By Dr. Olga Gurgula
This policy brief explains that the currently discussed proposals at the WTO related to increasing the production of COVID-19 vaccines, including the EU proposal to clarify the use of compulsory licensing and the submission by South Africa and India on the intellectual property (IP) waiver, require complementary mechanisms to rapidly improve the production of COVID-19 vaccines that are urgently needed today. The key problem is that to accelerate the manufac- ture of COVID-19 vaccines, access to knowledge and know-how, that are protected by trade secrets owned by several pharmaceutical companies, is required. It is therefore important that governments implement an additional mechanism of compulsory licensing of trade secrets that would allow an involuntary transfer of COVID-19 vaccine technologies. Such a mechanism would be compliant with the TRIPS Agreement and relevant whether the TRIPS waiver is adopted or not agreed upon. While this mechanism must provide full access to the information necessary to manufacture the vaccines in question, it must also ensure the protection of the transferred trade secrets.
Contribution of the South Centre to the Report of the Secretary-General on the Implementation of UN General Assembly Resolution A/75/L.97 dated 9 June 2021 on the “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba”
This input by the South Centre is prepared in response to the UN Secretary-General’s request as a contribution to the report of the Secretary-General as per resolution A/75/L.97, with respect to the imposition of unilateral economic, financial and trade measures against Cuba, in violation of basic principles of the UN Charter.
O papel dos tribunais na implementação das flexibilidades do TRIPS: Supremo Tribunal Federal (STF) do Brasil declara inconstitucionais as extensões automáticas de prazos de patentes
Por Vitor Henrique Pinto Ido
Este policy brief traz uma contextualização, um resumo e uma análise da decisão do Supremo Tribunal Federal do Brasil, de 6 de maio de 2021, que declarou inconstitucionais as extensões automáticas de prazos de patentes, revogando o Artigo 40, Parágrafo Único, da Lei de Propriedade Industrial do Brasil, de 1996. Conclui-se que esta é uma decisão histórica que contribui para a implementação de um regime de patentes mais equilibrado no Brasil, com impacto positivo no acesso a medicamentos no país. É um precedente importante no que se refere ao papel que os tribunais podem desempenhar na definição dos contornos da proteção à propriedade intelectual e das flexibilidades do Acordo TRIPS.
Patenting of Plants and Exceptions to Exclusive Rights: Lessons from European Law
Biotechnology has increased the use of patent law to protect the outcomes of plant breeding. While the TRIPS Agreement allows countries to exclude the patentability of plants and essentially biological processes to obtain them, many developing countries are granting patents on plants and plant components, such as seeds, cells, and genes. These patents can limit access to plant materials for further research and breeding and prevent farmers from saving and re-using seeds that incorporate patented materials. This study shows how European legislation has sought to strike a balance between the protection of plant-related inventions and the rights of breeders and farmers through the introduction of specific exceptions to patent rights and discusses what lessons can be drawn for developing countries.
The purpose of this report is to analyse the vaccines industry under the focus of Industrial Economics as an input for the design of the pertinent instruments to promote development, manufacturing and distribution of vaccines against SARS-CoV-2 in sufficient amounts to immunize all countries as soon as possible. We also need to be prepared for future emerging infectious diseases with the potential of global expansion.
The report shows that the vaccines industry is – and has been for a long time – far away from the competitive market paradigm with notorious market failures. As a result, the industry is underperforming with shortages and stockouts, exit of firms from the industry, underinvestment in research and development (R&D) and manufacturing, even an “anaemic development pipeline”, all signs of market failure.
After a brief review of policies implemented to tackle these problems we conclude that after the COVID-19 pandemic there is a need to implement a profound overhauling of the industry and to fundamentally reformulate and extend global public policies to stimulate R&D, manufacturing, distribution and access.
Combatting Tax Treaty Abuse: Tools available under the BEPS Multilateral Instrument
By Kuldeep Sharma, ADIT (CIOT,UK)
The anxiety of taxpayers, consultants and advisors over the consistent application of Principal Purpose Test (PPT) provisions in tax treaties can now be put to rest as tax authorities are expected to consistently read the PPT provisions in conjunction with the preamble, i.e. the key to application of PPT provisions lies in the preamble of the treaty itself. This follows on taking a leaf out of the Preamble to the Multilateral Convention to Implement Tax Treaty Related Measures to Prevent Base Erosion & Profit Shifting (MLI), Vienna Convention, Commentaries on PPT in the respective Organisation for Economic Co-operation and Development (OECD) and United Nations (UN) Model Tax Convention (MTC), 2017 and Australian Taxation Office’s (ATO) instructions on PPT which abundantly highlight on conjoint application of the preamble in the course of invocation of PPT provisions. Now, the entire focus of extending treaty benefits has shifted to undertaking bonafide transactions and preventing double taxation as against a tendency of securing tax savings through tax avoidance. Therefore, PPT as read with the preamble can clearly be invoked to combat treaty-shopping arrangements, abusive tax planning and abusive tax avoidance arrangements or transactions. At the same time, tax authorities in any part of the world may not be inclined to invoke PPT as read with the preamble in respect of any arrangement or transaction when taxpayers are able to discharge their onus establishing that (below mentioned conditions to be satisfied in tandem):
– genuine business and commercial reasons for a transaction exist;
– a purpose for the transaction cannot be ascribed to non-taxation or reduced taxation through tax evasion or tax avoidance;
– despite no tax advantages, the transaction would be carried out exactly in the same way; and
– it cannot reasonably be considered that one of the principal purposes of the arrangement or transaction is to obtain treaty benefits and that the object and purpose of the treaty is getting defeated.
Guidelines for the examination of patent applications relating to pharmaceuticals
By Carlos M. Correa
This document represents a follow-up to an earlier document, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, which was published in 2007 as a working paper by the International Centre for Trade and Sustainable Development (ICTSD), the United Nations Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO).
The present document takes into account developments since the publication of the ICTSD-UNCTAD-WHO working paper in 2007. It includes new examples of patent applications and/or grants, and analysis of and references to the initiatives of a number of countries that have adopted laws and/or policies that seek to factor in public health considerations in the examination of patent applications.
With this document, the aim is to provide guidance for the development or revision of guidelines on patent examination processes in developing countries in response to concerns about the rise of patent numbers in the pharmaceutical sector. For this purpose, a number of recommendations are made with regard to the examination of the patentability of applications relating to pharmaceutical products and processes.
Issues in Financing Education as a Human Right: Central principles for public policy responses
by Kishore Singh
The realization of the right to education requires adequate financing of education. Public policy responses to the need and importance of financing education remain inadequate. And now there is a trend towards decreasing public investment in education. Not only should States shoulder the primary responsibility for education under human rights law, but non-State actors should also invest in education because of corporate social responsibility. Besides, the need and importance of preserving education as a public good and public interest in education should be kept in the forefront as regards multi-stakeholders and provision of education through public-private partnerships. The role devolves upon the parliamentarians in shaping regional and global architecture. In the conclusion, the author proposes ten central principles for a Global Alliance to do the task of world-wide advocacy in support of the architecture for financing education.
The Investment Facilitation Framework & Most Favoured Nation (MFN) Treatment
By Peter Lunenborg
The issue of Investment Facilitation (IF) is one of the ‘Joint Statement Initiatives’ which has been under negotiation for a number of years between certain World Trade Organization (WTO) Members. It has not been without controversy as there is no multilateral mandate at the WTO for these negotiations. Questions have been raised about how the outcomes of these IF negotiations can be brought into the WTO framework. Despite these uncertainties, there is a draft Investment Facilitation Framework (IFF) text. This Policy Brief discusses the Most Favoured Nation (MFN) treatment as contained in Article 2 of the Investment Facilitation Framework (IFF), also referred to as the Investment Facilitation for Development Agreement (IFDA). This brief highlights the potential implications of the proposed text and proposes some options.
