On Friday 9 July, the EU Council Working Party on Pharmaceuticals and Medical Devices will discuss the Slovenian Presidency’s first compromise proposal on the future regulation on serious cross-border health threats (see EUROPE 12722/27).
In this new version of the text, of which EUROPE has obtained a copy, the article on the joint purchase of medicines and medical devices has been further expanded.
The previous draft compromise (see EUROPE 12750/7) suggested that the EU27 could decide to use a non-exclusive joint procurement procedure in some cases, or, in other cases, an exclusive procedure. Under the latter option, states would not be able to use any other channel to obtain the required medicine.
A new paragraph has therefore been introduced on this subject in the text to be discussed on Friday and suggests that, “in duly justified cases related public health protection or national security, Member States may at any point of time deviate from the requirement for exclusivity”.
The EU Council is thus moving further away from the text initially proposed by the Commission, which simply argued that in the event of a cross-border health crisis, the EU27, the EFTA countries and the candidate countries should be able to obtain treatment “through that procedure and not through other channels”.
Preparedness reports. Another notable change in the Slovenian compromise concerns the regular reporting by states to the Commission on their preparedness and ability to respond to cross-border health threats.
The new draft compromise specifies that Member States will not be “required” to “disclose” sensitive information in the report , the presence of which in such a report would be “contrary to their essential interests of security”.
Health Security Committee. Finally, the text requires that the Health Security Committee - which will be established through this regulation - should not only be chaired by a representative of the Commission, but also by a representative of the rotating Presidency of the EU Council.
This claim echoes some of the changes made by the EU27 to the draft regulation on the new mandate of the European Medicines Agency (see EUROPE 12741/7). (Original version in French by Agathe Cherki)