EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.

In addition, the consultation will involve evaluating whether the directive should also apply to medical devices. Contributions from interested parties will be accepted until May 25; commissioners are particularly interested in comments from economic operators, health care professionals, public interest organizations and national authorities. If regulators ultimately do extend the Transparency Directive to medical devices, that could lead to a more simplified and efficient pricing and reimbursement infrastructure for manufacturers across Europe.