The European Commisison has opened a consultation on 28 March on the revision of the Transparency Directive, the EU directive that regulates certain formalities with regard to reimbursement of medicinal products in the EU member states’ national reimbursement systems.

Oversimplified the Transparency Directive provides that EU member states must take a decision about inclusion of the medicinal product in the national reimbursement system within a fixed period (90 days) and according to transparent criteria.

The Commission writes in the clarification of the consultation document:

At present, the Transparency Directive only applies to medicinal products. Nevertheless, medical devices can also be subject to pricing and reimbursement regulation in the Member States. For this reason, this consultation also calls for contributions regarding the relevant of the directive to the medical devices market.

These initiatives need to be seen in conjunction with other EU initiatives touching on the pricing and reimbursement of medical devices, such as the upcoming Cross Border Healthcare Directive, which provides for a basis for cross-border health technology assessment that will obviously have an influence on pricing and reimbursement. So, even though the EU has no competence to legislate directly on the subject of pricing and reimbursement of healthcare, it finds its ways to exert indirect influence where possible. The medical devices industry stands to gain a lot however from more transparent and predictable rules and procedures with respect to pricing and reimbursement.

The consultation period ends on 25 May 2011 and is an opportunity that the medical devices industry to make its views known in the EU that it should not miss.