Category Access to Medicine

Vaccine Nationalism

[Prof. Ujal Singh Bhatia ] Abstract: The author posits that the global public health impact of the Covid-19 pandemic along with the economic and distributional aspects of vaccines and treatments, involves a market failure without the underlying institutional safety nets for an effective, globally coordinated response. He proposes strong, self-standing institutions with clear mandates and resources to make effective interventions at three levels: political, financial and regulatory. Also, the WTO rules regarding export restrictions are at present too accommodative to allow for a quick response. For Intellectual Property, both manufacturing and licensing, and relaxation of IP rules should be considered.

Defending Access to Medicines in Regional Trade Agreements: Lessons From the Regional Comprehensive Economic Partnership – A Qualitative Study of Policy Actors’ Views

[Belinda Townsend] ...The RCEP negotiations were initially framed as focused on the needs of low income countries. Public health concerns emerged however when draft negotiating chapters were leaked online, revealing pressures on countries to agree to intellectual property and investment measures that could exacerbate issues of access to medicines and seeds, and protecting regulatory space for public health. A concerted Asia Pacific civil society campaign emerged in response to these concerns, and in 2019, media and government reporting suggested that several of these measures had been taken off the table, which was subsequently confirmed in the release of the signed text in November 2020.

Academic Open Letter in Support of the TRIPS Intellectual Property Waiver Proposal

[Letter endorsed by 124 Academics] The temporary TRIPS waiver - as proposed by India and South Africa and supported by more than 100 countries - is a necessary and proportionate legal measure towards the clearing of existing intellectual property barriers to scaling up of production of COVID-19 health technologies in a direct, consistent and effective fashion. We call on the governments of the United Kingdom of Great Britain and Northern Ireland, Australia, Brazil, Japan, Norway, Switzerland and the European Union to drop their opposition to the TRIPS Waiver proposal at the World Trade Organisation and to support the waiver.

Public Lies and Public Goods: Ten Lessons From When Patents and Pandemics Meet

[Peter Drahos] Abstract: The paper examines three decades of the history of patents and pandemics that begins with the HIV/AIDS pandemic and TRIPS. This history demonstrates that the patent system is itself a huge source of risk when it comes to managing the risks of pandemics. From this history ten core lessons are extracted. The central message of the paper is that developing countries will have to focus on collaborations among themselves with the aim of building a wide base of rich manufacturing experience in the production of medicines and therapies. They can expect no priority of treatment under the present patent-mediated response to pandemics.

Save the Date – Global Congress #IPWeek2021 – October 25-29

[Fundación Karisma] The organizers of the Global Congress on Intellectual Property and the Public Interest will host an #IPWeek October 25-29, 2021. A call-for-proposals will be open soon, and in this edition, we will include a call for creative pieces about the intellectual property / public interest relationship in a post-pandemic world.

Interpreting the Flexibilities Under the TRIPS Agreement

[Carlos M. Correa] While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions.

Compulsory Licensing of Trade Secrets: Ensuring Access to COVID-19 Vaccines via Involuntary Technology Transfer

[Olga Gurgula and John Hull] Abstract: This paper considers how vaccine technology to meet the challenges of the COVID-19 pandemic can be made available to increase the production of the vaccines. Its primary focus is on trade secrets which are one of the main intellectual property rights protecting the complex manufacturing processes for vaccine production.

The Role of Courts in Implementing TRIPS Flexibilities: Brazilian Supreme Court Rules Automatic Patent Term Extensions Unconstitutional

[Vitor Henrique Pinto Ido] This policy brief provides a background, summary and analysis of the Brazilian Federal Supreme Court decision of 6 May 2021 that ruled automatic patent term extensions unconstitutional, striking down Article 40, Sole Paragraph, of the Brazilian Industrial Property Code of 1996. It concludes that this is a landmark ruling that contributes to the implementation of a more balanced patent regime in Brazil, with a positive impact on access to medicines in the country. It is an important precedent in relation to the role that courts may play in defining the contours of intellectual property protection and the TRIPS flexibilities.

The Impracticality of Relying on Compulsory Licenses to Expand Production Capacity for COVID-19 Vaccines

[Brook Baker] The complications and limitations of compulsory-license-reliant measures to respond to the COVID-19 pandemic need to be better explained. The European Union and several other countries espousing reliance on TRIPS-compliant compulsory licenses to overcome patent barriers have opposed the India/South Africa temporary intellectual property (IP) waiver proposal on COVID-19 health technologies at the World Trade Organization. Although compulsory licenses (CLs) on patent alone may be sufficient to allow generic production of small molecule medicines, CLs are unlikely to suffice with respect to vaccines, biologic medicines, including monoclonal antibodies, and more complex diagnostic tests, medical devices, and respirators.

Disinformation, Diversion, and Delay: The Real Text of the European Union’s Communication to the WTO TRIPS Council – Urgent Trade Policy Responses to the COVID-19 Crisis

[Brook Baker] If the European Union’s Communication to the TRIPS Council – Urgent Policy Responses to the COVID-19 Crisis has no real substance, then it is fair to conclude that its true purpose is disinformation, diversion, and delay. The Communication purports to address clarifications needed to make existing TRIPS flexibilities more operational for countries that might need to issue compulsory licenses to access COVID-19 vaccines and therapeutics. However, the proposed clarifications have no substance beyond what is already well established in the text of Articles 31 and 31bis of the TRIPS Agreement and of the Doha Declaration on the TRIPS Agreement and Public Health. When a powerful group of nations, like the E.U., offers a set of “pseudo” proposals with no substance, we can look beyond the façade to see that their real intention is to misinform decision-makers, the press, and the public and to divert attention from the proposal by India, South Africa and 61 other countries to the WTO to waive intellectual property protections on COVID-19 health products and technologies for at least three years.

The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic

[Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang, and Graham Dutfield] ...This paper elucidates the legal issues surrounding the ‘TRIPS waiver’ proposal ... We analyse the different intellectual property rights relevant to the proposal – focusing primarily on patent rights and trade secrets – which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, both in terms of procedure and legal substance The extent of the current health crisis posed by COVID-19 is as undeniable as the current global response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that mandatory mechanisms are needed. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable access. Click here for more.

The Proposed Pandemic Treaty and the Challenge of the South for a Robust Diplomacy

[Obijiofor Aginam] The motivation for a pandemic treaty is infallible because of the ‘globalization of public health’ in a rapidly evolving interdependence of nations, societies, and peoples. Notwithstanding the lofty purposes of the proposed pandemic treaty as a tool for effective cooperation by member-states of the WHO to address emerging and re-emerging disease pandemics in an inter-dependent world, the proposal nonetheless raises some structural and procedural conundrums for the Global South. The negotiation of a pandemic treaty should, as a matter of necessity, take into account the asymmetries of World Health Organization member-states and the interests of the Global South.