The Council adopted a decision to authorise the opening of negotiations for an international agreement on pandemic prevention, preparedness and response. The decision also clears the way for negotiating complementary amendments to the International Health Regulations.
The decision authorises the Commission, for matters falling within Union competence, to negotiate an international agreement on pandemic prevention, preparedness and response. The negotiating directives, annexed to the decision, outline the objectives and principles of the agreement. The negotiating directives can be revised and further developed as appropriate depending on the evolution of the negotiations.
Response to COVID-19
COVID-19 illustrated the need for enhanced preparedness and closer cooperation at global level. Improved collaboration between research centers around the globe and better coordination of international funding could improve monitoring of risks and knowledge-sharing about new infectious deseases. Global coordination of stockpiling could ensure countries have access to essential supplies. A pandemic agreement could also lead to better response mechanisms and tackle inequities in access to vaccines, medicines and diagnostics.
Source: European Council
Regulation on EMA’s extended mandate becomes applicable
Moreover, the EMA is now responsible for monitoring drug shortages that may lead to a crisis situation, as well as reporting on critical drug shortages during a crisis. The Agency will also coordinate EU/EEA countries’ responses to shortages of critical medical devices and in vitro diagnostics in crisis situations, following an initial transition period until February 2, 2023.
In preparation for the application of the new regulation, EMA has set up the permanent secretariat to support 12 medical device expert panels established by the Medical Devices Regulation in order to improve the safety of medical devices marketed in the EU / EEA. The expert panels, previously managed by the Commission’s Joint Research Centre, provide opinions and views to notified bodies on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in-vitro diagnostics.
In addition, in order to ensure a robust response to major events in relation to shortages, the legislation establishes an Executive Steering Group on Shortages and Safety of Medicinal Products (also known as the Medicines Shortages Steering Group, MSSG).
The Emergency Task Force (ETF) is expected to start operating under the new rules from mid-April. Its responsibilities include: providing scientific advice on the development of products intended for use during a public health emergency, reviewing scientific data, providing recommendations on the use of unauthorised medicines, and coordinating independent vaccine effectiveness and safety monitoring studies. The composition and Rules of Procedure of the MSSG and ETF will be considered for endorsement by EMA’s Management Board in March.
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