Category Access to Medicine

A Critical Appraisal of the COVID-19 TRIPS Waiver

[Peter Yu] This chapter offers a critical appraisal of the COVID-19 TRIPS waiver proposal. It begins by identifying the arguments for the waiver. It then turns to arguments against the proposal, including those made by policymakers and commentators who question the waiver's effectiveness. After documenting both sides of the debate, this chapter concludes by exploring whether we should support the text-based negotiations on this instrument – and if so, whether we should also support its adoption.

Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law

[Carlos M. Correa and Reto M. Hilty, eds.] This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9– 10 December 2019. It examines topics of particular relevance for shaping intellectual property regimes that take into account public health concerns. It provides not only deep analyses but options for the interpretation of existing regulations or the adoption of new legislation that, being consistent with the TRIPS Agreement, can allow the judiciary and policy makers to take such concerns into account. In different chapters, the book addresses various dimensions of the flexibilities allowed under the TRIPS Agreement. Although there is a significant literature and statements on the subject, such as the ‘Declaration on Patent Protection. Regulatory Sovereignty under TRIPS’ elaborated under the auspices of the MPI, the book contains new reflections and examines recent developments in case law and legislation. Click here for more.

Non-Patent Intellectual Property Barriers to COVID-19 Vaccines, Treatment and Containment

[Sean Flynn, Erica Nkrumah and Luca Schirru] Abstract: As the World Trade Organization considers a proposal to waive or otherwise address intellectual property barriers to the global response to the COVID-19 pandemic, most of the attention given by scholars and policy makers has been focused on patents. The original proposals by South Africa and India, as well as the groundbreaking support of the United States, however, explicitly applied to all forms of intellectual property. This paper documents many instances where non-patent forms of intellectual property create barriers to the global scale up of access to vaccines, treatments, and the ability to contain the virus through social distancing. Addressing the full scope of such barriers would assist the global efforts to combat COVID-19.

Compulsory licensing vs. the IP waiver: what is the best way to end the COVID-19 pandemic?

[Olga Gurgula] This policy brief examines the currently discussed proposals at the World Trade Organization (WTO) that aim to resolve the problem of the production shortages of COVID-19 vaccines. This includes the two key submissions, i.e. the proposal by South Africa and India on the Intellectual Property (IP) waiver, partially supported by the United States (US), and the European Union (EU) proposal to clarify the use of compulsory licensing.

Medicines Patent Pool signs first Covid-19 licence agreement with Merck Sharp & Dohme: Others must follow

[Medicines Law & Policy] The Medicines Patent Pool, a UN-backed organisation whose mission is to expand access to essential medicines around the world, today announced its first agreement on a Covid-19 therapy. The deal comes in the form of a licence and technology transfer agreement with Merck Sharp & Dohme (MSD) on molnupiravir, an investigational therapy for Covid-19 patients. The Medicines Patent Pool expanded its mandate to include Covid-19 technologies in March 2020.

The Civil Rights Challenge to Gene Patenting

[Jorge Contreras] In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

EU’s Proposal on Convergence on WTO TRIPS Waiver only addresses compulsory licensing on patents, ignores trade secrets, and is wholly inadequate to solve inequitable access

[Brook Baker] The EU draft proposal entitled “Ideas on the points of convergence on the TRIPS issues for discussion” (below) tries to make a silk purse out of a cow’s ear, by relying on moderately revised compulsory licensing on patents as the sole IP solution to the glaring problem of artificially restricted supplies, profiteering prices, and grossly inequitable distribution of COVID-19 health products. 

Call for Abstracts – 20 years of the Doha Declaration on TRIPS and Public Health

The Doha Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’) represented a groundbreaking moment in the history of intellectual property (IP) international policy, recognizing that Member States should not be prevented from taking measures to protect public health, reaffirming the right to use the so-called TRIPS flexibilities to that aim, such as compulsory licensing and parallel imports. The impact of IP protection on public health has continued to be at the forefront of debate to ensure equitable and affordable access to medicines and other medical products globally, and especially in the global South. The Covid-19 pandemic brought new challenges. Solutions are being discussed beyond use of TRIPS flexibilities, such as a temporary waiver to TRIPS during the pandemic.

Open Letter to Presidents of Latin America and the Caribbean: COVID-19 Vaccine Access

[Civil society letter endorsed by 81 organizations and individuals] ...Vaccine production has been insufficient to vaccinate the entire world population, therefore we consider that it is necessary to restructure the acquisition and production models to improve the availability of doses at the most favorable price for our region, which at the same time is going through a serious economic crisis. Therefore, it is imperative that pharmaceutical companies share technology and knowledge with other qualified producers as soon as possible and it is important that the countries of the region take a firm position towards the industry.

Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer

[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.

Restructuring the Global Vaccine Industry

[Felix Lobo] 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.