The U.S. Department of Health and Human Services Office of Global Affairs (OGA) held a Stakeholder Listening Session on Amendments to the International Health Regulations (2005) (IHR) on June 20, 2023. The IHR provide a legal framework that defines countries’ rights and obligations in handling public health events and emergencies that have the potential to cross borders. In 2022, World Health Organization Member States agreed to begin the process to amend the current Regulations, building on lessons learned from the COVID-19 pandemic. The Listening Session aimed to seek input from stakeholders and experts on the proposed amendments, and to help inform the U.S. government for engagement with the Working Group on the Amendments to the International Health Regulations.
Peter Maybarduk, Director of Public Citizen’s Access to Medicines Program, delivered the following statement on June 20, 2023 at the OGA Stakeholder Listening Session on Amendments to the International Health Regulations:
We appreciate the United States taking an active role in the negotiations of the International Health Regulations (2005). We recognize that the United States’ engaged participation in the negotiations is not automatic, and the country’s ongoing commitment speaks well of this Administration.
We also appreciate the continued coordination between the Working Group on Amendments to the International Health Regulations (2005) and the Intergovernmental Negotiating Body to draft a Pandemic Accord. This coordination is key to ensuring synergy and coherence between the instruments, resulting in an effective pandemic response framework. Thank you for the U.S. leadership in that regard.
I will address three articles during my remarks: Articles 6, 13, and 44, covering benefit sharing, access to health products, and financing.
Article 13: Public Health Response
The International Health Regulations (2005) have concrete legal obligations on preparedness, surveillance, detection, and notification. But there have been no concrete legal obligations on a coordinated public health response, particularly on ensuring equitable access to health products.
Inequitable access to health products during the COVID-19 pandemic is one of the largest issues the world has faced over the past several years, and was a significant impetus to amend the Regulations. Developing countries flagged this gap in the IHR (2005) 15-20 years ago, but the problem continues today. It is clear that we need to have strong and equitable commitments in the IHR for access to medical products.
The Regulations should also include strong commitments from States Parties, particularly from Northern governments, to support a WHO-led public health emergency response. And for the WHO in turn to provide the needed support to developing countries. We note with interest proposals from the Africa Group and Bangladesh for a new Article 13A. We encourage the U.S. government to have a close look at those proposals.
Article 6: Notification
We believe in the importance of benefit sharing. Access to genetic sequence data and timely reporting is critical. But it would be regrettable if IHR were to amount effectively to surveillance of the South without shared benefits with the countries reporting genetic sequence and other pathogen data. This necessary complementarity of health and justice is among the lessons of the pandemic.
We note with interest KEI’s proposal on the open source divided as a model for benefit sharing.
We have to reconsider the ways of the old system, ensuring multilateral access and benefit sharing for pathogen data.
New Article 44A
We note with interest the new Article 44A proposed by the Africa Group.
Money is a proxy for will. Many components of the Regulations are important but won’t be effective if there is not sustainable and equitable financing. We encourage the WHO and Member States to be serious in the commitments made in the IHR by ensuring financing for their implementation. This may entail expanding pandemic preparedness financing capacities beyond the Pandemic Fund and generating will through the Regulations.
Your work to amend the IHR (2005) is challenging, we appreciate that. Thank you for your work and for listening to us today.