From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways for pharmaceutical companies.

First, the EB took a meaningful step towards amending the International Health Regulations (“IHR”).  The IHR constitute a key legal instrument setting out countries’ responsibilities during public health events and emergencies that have the potential to cross borders.  It legally binds 196 countries, including the 194 WHO Member States.  The IHR play a crucial role in global pandemic preparedness and response, for example by imposing reporting requirements on countries and outlining the criteria to determine whether a health event represents a “public health emergency of international concern.”  Nevertheless, the instrument dates back from 2005, and with the experiences from COVID-19 fresh in countries’ minds, the push for reforms is growing.  The United States for example has reportedly proposed to introduce further obligations for countries where potential public health threats appear, including accelerated sharing of information (such as through the introduction of an early warning system), sharing of genetic sequence information and the facilitating of access to outbreak sites for public health experts.  These proposals, however, are controversial.  Certain Member States fear that the reforms may undermine their sovereign interests and could result in international investigations on the government’s handling of public health threats.  Other actors, such as the EU, consider that some of the shortcomings of the IHR would be better addressed in a new legal instrument, for example in an International Pandemic Treaty.

Despite the controversy, the EB now decided to mandate the Member States’ “Working Group on Strengthening WHO Preparedness and Response to Health Emergencies” to discuss the strengthening of the IHR, including through potential amendments.  In addition, the EB called on countries to “take all appropriate measures to consider potential amendments” to the IHR, but also noted that this would not lead to reopening the entire instrument for renegotiation.  The adoption of the decision paves the way for potentially significant changes in the management of global health emergencies, though the scope and timeline for the review of the IHR still remain to be determined.

Second, the EB discussed a report by the Director-General Dr. Tedros Adhanom Ghebreyesus on influenza preparedness and the “Global Influenza Surveillance and Response System” (“GISRS”).  GISRS is an international platform for the monitoring, risk assessment and risk surveillance of influenza.  It is characterised by an intensive and year-round collaboration between public stakeholders, such as National Influenza Centers, WHO Collaborating Centers and Essential Regulatory Laboratories, as well as private actors, such as vaccine developers.  The platform has existed for 70 years, and has been very successful in mitigating the negative public health impact of seasonal influenza.  However, recent years have seen major challenges with the sharing of influenza viruses and data between countries, as a result of national laws implementing the Nagoya Protocol on access to genetic resources and benefit-sharing.  The Director-General’s report proposed to expand GISRS to include other respiratory viruses with epidemic and pandemic potential, while also stressing the need for “sensitizing Member States to the importance of timely influenza virus sharing and use.”  This was noted by the EB, but decisions were not yet adopted.  To a certain extent, this is caused by the issue of access and benefit-sharing for pathogens as it is hotly contested among the Member States.

The 151st session of the EB will take place in May 2022, following the 75th meeting of the World Health Assembly.  Pharmaceutical companies active in manufacturing vaccines, diagnostics and treatments relating to infectious diseases are well advised to closely monitor the developments surrounding the IHR and GISRS.

With the assistance of Machteld van Egmond.

Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.