COUNTERMEASURE INNOVATION AND ACCESS
WHAT IS THE ISSUE?
Global access to countermeasures - meaning personal protective equipment (PPE), therapeutics, diagnostics and vaccines - is critical for preventing, detecting and responding to disease outbreaks that may escalate into health emergencies. Four issues arise: First, public investment in R&D is critical to develop countermeasures for emerging infectious diseases, as market uncertainties make it unlikely that private firms will do so prior to a large-scale outbreak. Public investment has not been adequate, however. Second, ensuring globally equitable access to countermeasures is a major challenge in pandemics. Many producing countries blocked exports of PPE and drugs early in the Covid-19 pandemic. When vaccines later became available, much of the world’s supply was secured by the wealthiest countries, leaving many developing countries with severe shortages - a repeat of the 2009 H1N1 pandemic. Third, reliable rapid international sharing of pathogen samples and related data (e.g. genomic sequencing data) is critical for the development of countermeasures, but rests on informal norms; scientists and governments that do not receive benefits flowing from shared pathogen samples, and/or that face challenges accessing countermeasures, may hesitate to share such samples internationally in the future. Addressing both pathogen- and benefit-sharing (PBS) is critical to ensure rapid innovation and equitable access to countermeasures. Cutting across all three challenges are binding international intellectual property rules (TRIPS), which may incentivize private R&D investment for normal commercial products, but do not adequately do so for pathogens of pandemic potential, and may also restrict follow-on innovation and sufficient manufacturing. International IP rules are binding, whereas arrangements on access to countermeasures are largely informal and voluntary.
WHAT WAS DONE BEFORE COVID-19 TO ADDRESS THIS ISSUE?
The Coalition for Epidemic Preparedness Innovations (CEPI) was launched in 2017 in the wake of the Ebola crisis to mobilize funds from multiple countries to invest in R&D for vaccines for pathogens of pandemic potential, and to ensure global access to any resulting products. Pre-Covid, global stockpiles and allocation guidelines were developed for a limited supply of vaccines for a few pathogens (e.g. cholera, Ebola). Regarding PBS, in 2011 governments agreed upon the WHO Pandemic Influenza Preparedness Framework to ensure the rapid sharing of samples of influenza strains of pandemic potential, in exchange for access to at least some volume of the countermeasures that would subsequently be developed. In addition, regional production capacity for influenza vaccines was increased through a WHO technology transfer program.
In the Covid-19 pandemic, CEPI was a major investor in vaccine R&D and manufacturing, alongside a number of governments that made bilateral investments. The Global Initiative on Sharing Avian Influenza Data (GISAID) adapted its platform to include SARS-COV-2 genomic sequencing data, and now hosts the highest number of publicly available sequences. The Access to Covid-19 Tools Accelerator (ACT-A) was launched in April 2020 as an international collaboration of nearly a dozen global health initiatives to ensure access to diagnostics, drugs and vaccines, and provide guidance for ethical allocation internationally and nationally. Regarding IP, WHO launched the Covid-19 Technology Access Pool, and the Medicines Patent Pool extended its work to Covid-19 health technologies. In 2020, several high and middle-income countries amended their laws or policies to facilitate the granting of compulsory licenses. South Africa and India proposed a temporary waiver on IP protection on Covid-19 technologies at the World Trade Organization, which may now be moving to text-based negotiations. Regarding PBS, the WHO BioHub Facility was launched in Switzerland as a centre for receiving, sequencing, storing and preparing biological materials for distribution to other laboratories. An mRNA technology transfer hub is also being set up in South Africa to facilitate vaccine production. All of these initiatives are ongoing, and further evaluation is needed to understand better their strengths and limitations.
WHAT HAVE COVID-19 INTERNATIONAL REVIEW PANELS RECOMMENDED TO ADDRESS THIS PROBLEM? *
Reform panels urged countries to commit to financing the ACT-A, including sharing vaccine doses acquired through bilateral agreements ¹ ². They highlight the importance of voluntary licensing and technology transfer arrangements for Covid-19 vaccines, or instituting an IP waiver under the TRIPS agreement ². They also state the need for a political agreement for sharing and distributing countermeasures based on ability to pay ², and distributing countermeasures based on epidemiological impact and fair allocation principles¹.
It is recommended that the WHO develop a global framework to strengthen the genetic sequence data (GSD) infrastructure ⁴, and that the WHE programme build on the success of influenza GSD sharing to leverage existing R&D systems ⁴. They also emphasize the need for effective and sustainable financing mechanisms for health emergencies R&D ¹.
WHICH REFORMS ARE UNDER DISCUSSION?
Ensuring globally equitable access to countermeasures has been flagged repeatedly by a wide range of actors as a priority for reforms, but it remains unclear which specific proposals will be supported. Within the INB and WGPR, access to countermeasures is usually considered under the umbrella term “equity.” Efforts to strengthen local production capacity have been launched, including a WHO-supported mRNA technology transfer hub in South Africa in 2021 and biomanufacturing training hub in the Republic of Korea in 2022, in addition to regional and private sector initiatives. Negotiations at the WTO regarding the proposed temporary TRIPS waiver continue as of May 2022. Efforts to limit hoarding, export bans and ensure sharing of technology and intellectual property in future potential pandemics have been very limited to date.
* This section is derived from a systematic comparison (available here) of recommendations from four international reviews: ¹ the Global Preparedness Monitoring Board (GPMB), ² the Independent Panel for Pandemic Preparedness and Response (IPPPR), ³ the Independent Oversight and Advisory Committee (IOAC) for the WHO Health Emergencies Programme, and ⁴ the International Health Regulations (2005) Review Committee.