The European Commission’s proposal to introduce mandatory health technology assessments at EU level has received a negative opinion from France, Germany, Czech Republic and Poland. According to a Commission official and publicly available documents, all four countries have raised complaints that the proposal infringes their national responsibilities.
Germany has been most outspoken following the German government’s endorsement of the opposition.
The Czech Chamber of Deputies affirmed that the clinical aspects of health technology assessment envisaged at EU level cannot be separated from their economic aspects — a prerogative for national governments. It announced in a statement, “Therefore, the proposed regulation interferes with member states’ responsibility for medical care and management of health services,”.
The Polish senate’s foreign and EU affairs committee said the proposal is not proportionate, as it would have been sufficient to oblige countries to take EU HTA into account “without simultaneously prohibiting the conduct of own clinical assessment.”
The French senate’s European affairs committee echoed some of Poland’s concerns. It noted the European Commission does not have the legal basis within the EU Treaty to enforce cooperation on public health.
These four countries would constitute a blocking minority if they vote against the proposal in the Council of the EU which is required to approve the plan by a qualified majority for it to become law.
The European Commission wants EU countries to cooperate more closely in determining the added value of new therapies by conducting joint clinical assessments.
If the plans are rejected by the Council, then the Brussels’ executive would be forced to go back to the drawing board on its plans.