On 1 March 2012, the European Commission adopted a proposal of new Directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems. This new Directive shall repeal and replace the so-called Transparency Directive (Directive 89/105/EEC).
Indeed, the Transparency Directive has never been reviewed over more than 20 years, although the pharmaceutical reality has changed dramatically during this period.
In these times of increasing needs and prices of medicinal products, the responsibility of Member States to organizing their healthcare system (pursuant to Article 168 of the Treaty on the Functioning of the European Union) could lead those authorities to manage consumption of healthcare products. Those policies are susceptible to create barriers to trade.
Through case-law of the Court of Justice of the European Union, the role of the Member States has been settled over the years.
By this proposal for a new Directive, the Commission aims to adapt regulation to the current pharmaceutical environment. Therefore, the new Directive shall clarify the procedural obligations for the member States and enhance the effectiveness of the new regulation.
Through this proposal, the scope has been described more clearly (e.g. by excluding voluntary contractual agreements concluded between public authorities and the holder of a marketing authorization to enable the effective provision of medicines to patients under specific conditions), a more comprehensive coverage of national measures has been foreseen, to induce more legal clarity, time limits for pricing and reimbursement have been reviewed, the non-interference with patent and safety issues has been enhanced and enforcement tools have been adapted.
Such new regulation will probably lead to new case-law and further integration of social security provision through Europe.
This proposal will have to be followed up, in order to adapt national measures to this evolution.
