Category Access to Medicine

Science Held Hostage: How Pharma Is Using mRNA Vaccine Contracts With Government to Delay Future Innovation

[Emily Bass] Clinical trials that are crucial to future pandemic prevention and current responses to SARS CoV-2 are being delayed by pharmaceutical companies. These companies are able to use government contracts specifying when, where and how current vaccines owned by goverments can be used to delay and defer access to these vaccines for research. Current SARS CoV-2 vaccines are a vital part of research for next-generation products such as nasal vaccines and pan-coronavirus vaccines. Nextgeneration candidates need to be tested in animals who have been vaccinated with presently available vaccines to evaluated safety and effectiveness in the context of prior immunization. However, for over two years, the terms of government contracts with industry have had the inadvertent effect of delaying sometimes effectively blocking access to these products for research purposes. Over the course of a six-month research effort, PrEP4All spoke with US government agencies, research groups, private philanthropy and industry to better understand the causes and consequences of this challenge.

Pandemic Accord: MSF’s Comments on Equity Provisions in WHO’s Zero Draft

[Médecins Sans Frontières] In this briefing document, MSF analyses provisions related to transparency, intellectual property (IP), research and development (R&D), antimicrobial resistance (AMR), stockpiling, and access and benefit sharing in the accord zero draft. The definitions and scope of these provisions, as well as the nature of obligations contained therein, are key to determining the extent to which the accord can meaningfully address inequity.

Civil Society Letter to UK Secretary of State on UK-India FTA

[Letter endorsed by 208 Civil Society groups] We write to you as representatives of health organisations, patient groups, civil society and community organisations from across the globe to raise concerns over the negotiations between the UK and India on an ongoing free trade agreement. The leaked text of a chapter on Intellectual Property (IP) presents serious challenges to access to pharmaceutical products globally. While we recognise that the leaked text may not reflect the current state of demands from the UK on this topic, the lack of transparency leaves us without assurances that all damaging provisions will be removed from the list of demands your team is putting forward.

US ITC Investigation on Whether to Extend TRIPS Waiver Is Accepting Comments Through Friday, March 17

[Mike Palmedo] The U.S. International Trade Commission is writing a report (requested by USTR) investigating "whether to extend flexibilities under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to COVID-19 diagnostics and therapeutics." It is seeking comments from all interested parties on this question and a broad set of sub-questions related to TRIPS flexibilities and access to medicines. The deadline to submit comments is this Friday, March 17.

Evaluating the Impact of Data Exclusivity on the Price of Pharmaceutical Imports

[Mike Palmedo] I have a new paper in the Journal of Globalization and Development. "Evaluating the Impact of Data Exclusivity on the Price of Pharmaceutical Imports" finds large increases in the price of imported medicines when the U.S.'s trading partners implement data exclusivity to meet FTA obligations. The full impact of data exclusivity laws took many years to become apparent though observation of aggregated prices, because the laws themselves only applied to medicines new medicines.

Health Civil Society Organization Statement on Kenya-US STIP

[Joint statement endorsed by 11 Kenyan Civil Society Organizations] This statement is in reference to the Statement on the Kenya – United States First Round of the Strategic Trade and Investment Partnership Talks... without endorsing the negotiations, we would like to take this opportunity to congratulate the Ministry for ensuring that intellectual property is not one of the identified areas of negotiation. We would like to urge the Ministry to ensure that this position is maintained throughout these negotiations.

Cystic Fibrosis: Court Battle Looms Over Life-Saving Drug

[Faith Mutizira] Without treatment, Cystic Fibrosis patients often die in infancy, and their life expectancy is just 20 years in South Africa... A new class of medicines has revolutionised treatment and significantly extended the life expectancy of patients in several high-income countries. However, Vertex Pharmaceuticals, an American company, holds intellectual property (IP) monopolies on all of these drugs – known as CFTR modulators. The extremely high prices they set on elexacaftor/ivacaftor/tezacaftor (Trikafta/Kaftrio) drugs have led to global controversy and huge inequalities of access... Cheri Nel, a South African CF patient, submitted papers to the Gauteng High Court in Johannesburg seeking a compulsory licence – a form of IP flexibility – on Trikafta.

Analysis of COVID-Related Patents for Antibodies and Vaccines

[Kausalya Santhanam] This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The antibody combination considered for the patent analysis in this paper are Casirivimab and Imdevimab. The vaccines considered for the patent analysis are mRNA-1273, Sputnik, ChAdOx1 nCoV-19 vaccine (AZD1222). The analysis was completed in May 2022.

USITC Launches Investigation on Covid-19 Diagnostics and Therapeutics, and Flexibilities Under the TRIPS Agreement

[Mike Palmedo] The U.S. International Trade Commission has launched an investigation (USITC) "to inform consideration of whether to extend flexibilities under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to COVID-19 diagnostics and therapeutics." The investigation was requested by USTR. The announcement includes a request for comments from "foreign governments, non-governmental health advocates, and diagnostic and therapeutic manufacturers." There will be an open public hearing on March 29, and requests to testify are due by March 15. The deadline for written comments is May 5.

Trade Secrets in Biologic Medicine: The Boundary with Patents

[Robin Feldman] Abstract: ... There is a dearth of legal literature on the topic of trade secrets in the biologic space and almost nothing regarding how trade secrets interact with the patent system in that domain. These scientific and legal areas are sufficiently complex that even the most intrepid scholars fear to tread. This article explains in detailed and accessible language how the systems are working together to the detriment of society. To address the problem, this article argues that a company receiving a patent on a drug product should be required to disclose the full range of trade secrets necessary to make that drug.

Compelling Trade Secret Transfers

[David S. Levine and Joshua D. Sarnoff] Abstract: The unprecedented COVID-19 virus has brought to the forefront many challenges associated with exclusive rights in information, data, and know-how, all of which may constitute protected trade secrets. While patents have received more attention, trade secret information has limited the ability to perform research, develop, test, gain regulatory approval for, manufacture, and distribute globally and at sufficient scale and affordable prices the needed vaccines, therapeutics, diagnostics, medical devices, and personal protective equipment. Voluntary licensing efforts have proven inadequate to supply pandemic needs. Thus, compelling the transfer or licensing of trade secrets is needed to properly address COVID-19, but more importantly, to address future pandemics and other serious global problems such as climate change.