The penultimate meeting of a World Health Organization (WHO) working group to amend the International Health Regulations (IHR) began in Geneva on Monday amid stakeholder praise and criticism for the latest 64-page draft.

The IHR are legally binding and sets out countries’ rights and obligations in handling public health events and emergencies that have the potential to cross borders. But they were found lacking during the COVID-19 pandemic and the Working Group on Amendments to the IHR (WGIHR) has been considering over 300 amendments over the past two years.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the draft “reflects the patience, flexibility and commitment” of the WGIHR.

He also expressed appreciation for the inclusion “pandemic emergency” within the process of declaring a Public Health Emergency of International Concern (PHEIC).  Amazingly, the current  IHR neither mention nor define a pandemic.

However, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) described the “pandemic emergency” along with several other new definitions as “excessively vague”,  which made it “very difficult for industry to assess the overall instrument”. 

Other terms condemned for vagueness include “early action alerts”, stages in the PHEIC process, and “references to health products”, said the IFPMA’s Grega Kumer.

The IFPMA also believes the process of declaring the early action alerts and PHEIC leaves room for “discretion and interpretation” instead of being “based on science and evidence-based criteria”. 

Article 13 attracts the most attention

The IHR’s amended  Article 13, dealing with the “public health response, including access to health products”, attracted the most attention from stakeholders.

Knowledge Ecology International (KEI) welcomed the” transparency mandate” contained in Article 13 (9C). 

This calls on state parties to publish “relevant terms of government-funded research agreements for health products needed to respond to a public health emergency of international concern as well as information where relevant on pricing policies regarding these products and technologies to support equitable access”, said KEI’s Thiru Balasubramaniam.

“Article 13.7 envisions that WHO plays a coordinating role among state parties during public health emergencies of international concern. This coordinating role involves the facilitation of equitable access to health products, including through technology transfer on mutually agreed terms,” added Balasubramaniam.

KEI suggested two options to encourage technology transfer and know-how to facilitate the development of drugs, vaccines and other countermeasures. 

One would “create incentives for parties to share some rights acquired from publicly funded R&D or procurements in a reciprocal manner with parties that also share”. The other would “provide money or other incentives to acquire rights to patented inventions, know-how and other inputs from private rights holders”.

The Coalition for Epidemic Preparedness Innovations (CEPI) described as “commendable” that Article 13 made provision for state parties to allocate sustainable financing, but added that “they should have the support of the WHO in building, strengthening and maintaining core capacities” and in public health emergency, this should extend to “local production capacity development”. 

“Equally, in this article, we would like to see broader requirements for embedding equitable access terms in public funding contracts, including data sharing, affordable and sustainable pricing, manufacturing scale-up and technology transfers,” said CEPI.

Third World Network (TWN), an alliance of non-profit organisations from the Global South, welcomed the proposed language on WHO’s role in equitable access to deliver health products, but said “specific methods for achieving this remain absent, particularly in Article 13.7.”

TWN also that Article 4.2 bis and 13.1 shift the “implementation burden to state parties, contradicting the common but differentiated responsibilities principle and abandoning support for developing countries”.

Health Action International’s Senior Policy Advisor, Jaume Vidal, condemned attempts by some countries to “water down and remove suggested amendments seeking to scale up production, diversify manufacturing and guarantee a steady supply of health technologies”.

The IFPMA said that some recommendations in Article 13 lack balance and pre-empt the outcome of the pandemic agreement negotiations, “in particular, the WHO-coordinated mechanisms and networks”.

Threat of avian flu

Although the WGIHR meeting is set to close on Friday to enable the intergovernmental negotiation body (INB) on the pandemic agreement to resume next week, Tedros encouraged the group to “take more sessions together if you need them”.

But WGIHR co-chair Dr Ashley Bloomfield urged member states to “work towards Friday this week as a firm deadline”. 

“We are all aware the INB process remains live with another two weeks of intense negotiations scheduled following this meeting,” said Bloomfield. “We continue to work closely with the INB co-chairs and the Bureau to ensure our work is aligned.

“One reason it is important for us to complete our work this week is so that there can be a full focus on the INB negotiations in the following two weeks to maximise the chance of success in that crucial process.”

Bloomfield added: “You will all be aware of the growing concern about the threat of H5N1 bird flu highlighted by the WHO just last week. We have the opportunity to ensure that the world is better prepared both individual countries and collectively to address that thread through strengthening core capacities in all states parties.”