Statement 22 April 2024

Eighth Meeting of the Working Group on Amendments to the International Health Regulations (2005)

By IFPMA
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On 22 April 2024, IFPMA delivered a statement at the Eighth Meeting of the Working Group on Amendments to the International Health Regulations (2005) in Geneva, Switzerland.

This final meeting of the WGIHR is the critical window to ensure that the proposed amendments are workable, fit-for-purpose, and implementable.

It is imperative that Member States and relevant stakeholders have a common understanding of potential solutions and that they are validated for feasibility as early as possible.

We have three key concerns that could lead to uncertainty and would benefit from clear science- and evidence-based criteria to avoid politicization:

  • The proposed definitions of “Early Action Alerts,” “Public Health Emergency of International Concern (PHEIC), including a Pandemic Emergency,” and “Pandemics” as well as references to “health products” (including “relevant health products”) are excessively vague. This makes it very difficult for industry to assess the overall instrument.
  • The decision-making process to determine and make recommendations on “Early Action Alerts” and “PHEIC, including a Pandemic Emergency” leaves room for discretion and interpretation when it should be based on science- and evidence-based criteria.
  • There are recommendations in Article 13 that pre-empt the outcomes of the INB to improve equitable access, in particular the WHO-coordinated mechanisms and networks, and do not strike a balanced approach. It would be premature and potentially counterproductive to include it in IHR.

Before the final hour, amendments must be fully assessed in order to mitigate any risks of potential unintended consequences.

Given the binding nature of the IHR, it is of the utmost importance to course-correct before it is too late. We reiterate our full commitment to this work and remain available to constructively contribute.

About IFPMA

IFPMA represents the innovative pharmaceutical industry at the international level, engaging in official relations with the United Nations and multilateral organizations. Our vision is to ensure that scientific progress translates into the next generation of medicines and vaccines that deliver a healthier future for people everywhere.

To achieve this, we act as a trusted partner, bringing our members' expertise to champion pharmaceutical innovation, drive policy that supports the research, development, and delivery of health technologies, and create sustainable solutions that advance global health.

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Elliot Dunster
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