What changed between the draft committee report and the plenary report

The International Health Regulations (2005) are the primary instrument under international law to notify the World Health Organization (WHO) of disease outbreaks, and defining the Parties’ rights and obligations in handling public health events and emergencies that have a cross-border potential. They are legally binding for 196 countries.

In light of the experience of the COVID-19 pandemic, in January 2022, the Executive Board of WHO, through decision EB150(3), urged Member States to take all appropriate measures to consider potential amendments to the International Health Regulations (2005), to strengthen the global preparedness and response capacity to public health emergencies.

Amongst other, the amendments have introduced a “pandemic emergency”, which constitutes the highest level of global alert that the Director-General may issue.

They imply the issuance of Temporary Recommendations to States Parties – which, by definition, are not legally binding – to guide them in preparing for and responding to the Public Health Emergency of International Concern (PHEIC). They also enshrine the principle of solidarity and equity through increased cooperation between the Member States themselves, as well as with WHO, and set up a coordinating financial mechanism for more efficient use of funds to build up the core capacities needed for the IHR.

Countries are better supported by WHO when investigating undetermined disease outbreaks and the WHO’s publication of information on events that threaten public health is simplified. Furthermore, the amendment package includes provisions on possible recommendations by WHO on the availability and distribution of relevant healthcare products, the maintenance of essential supply chains, the travel possibilities by healthcare staff, and the possibility of using digital proof in healthcare crises.

This Decision does not make use of the possibility for the Union to exercise its external competence concerning areas in relation to which Union rules do not already exist. The Member States remain competent in respect of the matters covered by the amendments, as far as the amendments do not affect Union rules or alter the scope thereof, including foreseeable future developments of those rules. In addition, Member States remain solely responsible for the definition of their health policy and for the organisation and delivery of health services and medical care, in accordance with Article 168(7) TFEU. Furthermore, this Decision does not create additional financial obligations for Member States. None of the amendments is contrary to Union law, and it is therefore not necessary to make reservations in respect of the amendments falling within the competence of the Union.

The Union needs to be ready for more effective independent actions, but needs to also be ready to cooperate with international partners. Only within the framework of international cooperation, future global health threats can be prevent and mitigated effectively.

The Rapporteur welcomes the finalization of the IHR amendments negotiations by the Commission, and supports the Council Decision inviting Member States to accept, in the interest of the European Union, the amendments to the International Health Regulations (2005).