Centralized HTA on EU level is taking on shape

The Presidency determined to focus on the Joint Clinical Assessment (JCA), particularly on the proposal's articles 5 to 9. Most delegations agreed that a stepwise approach was necessary, gradually increasing the number of health technologies to be subject to JCA. Each step would take two to three years. Moreover, several delegations agreed that JCA was obligatory for a large number of centrally authorized medicinal products. In accordance with a stepwise approach, the Presidency suggested which categories of medicinal products, that are already defined in annex I of the regulation (EG) Nr. 726/2004, should undergo JCA. In addition, the procedure of JCA was specified further to address the delegations' concerns about JCA's quality and time schedule.

During the whole negotiations, the delegations requested a more important role of the Coordination Group in the execution and authorization of the JCA and a less prominent role of the Commission. The Presidency specified the Coordination Group's role by explicitly defining their tasks in the regulation. Thereby, some functions of the Commission were eliminated. Many delegations support the Presidency's approach. However, other delegations do request a stronger role of the Commission. The member states' obligations to incorporate JCA were eased. Nevertheless, member states are still obliged to consider JCA during national HTA procedures.

Since a large part of the discussion focused on medicinal products, the evaluation of the regulations for medical devices has not come this far yet. In-depth discussions will be necessary during the upcoming EU Council Presidency of Germany.

Source: Bundesverband der Pharmazeutischen Industrie e.V