Brussels, 01/03/2012 (Agence Europe) - On 1 March, the European Commission proposed provisions to revise the 1989 Transparency Directive on pharmaceutical products, so that patients obtain faster access to medicines. The new directive represents an important simplification measure and repeals and replaces the earlier directive, which no longer reflected the increased complexity of pricing and reimbursement procedures in member states. The European Commission intends to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines. In the future, such decisions should be taken within 120 days for innovative medicines, as a rule, and for generic medicinal products within only 30, instead of 180, days today. The Commission also proposes strong enforcement measures in case the decisions do not comply with the time limits, as these are often exceeded by member states. Antonio Tajani, the commissioner for industry and entrepreneurship, was pleased to point out that the proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products. It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness. The commissioner added: “We need faster decisions leading to pricing and reimbursement to maintain a dynamic pharmaceutical market and to offer citizens better access to pharmaceuticals.”
After the quality, safety and efficacy of the medicinal products are established during the process of marketing authorisation, each member state makes a further evaluation to decide whether the medicine is eligible for reimbursement, in compliance with the common procedural rules established under the Transparency Directive. Complexity of national measures related to the pricing of medicinal products has increased since 1989. At that time, pricing and reimbursement procedures mainly involved the submission of an application followed by a decision-making process to determine the price of the medicine and/or its eligibility for reimbursement. However, the increasing diversity since 1989 has led to complex pricing and reimbursement schemes. The Court of Justice ruled in its case-law that all national measures to control the prices of medicinal products or to restrict the range of medicinal products must comply with the directive. The proposal aims at reflecting the relevant case-law of the Court in the text of the directive. (IL/transl.fl)