Medicines should enter the market faster. With this intention the European Commission has proposed 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.
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.
The new Directive represents an important simplification measure and shall repeal and replace the longstanding Directive from 1989, which no longer reflected the increased complexity of the pricing and reimbursement procedures in the Member States.
Presenting this proposal the European Commission Vice President Antonio Tajani, responsible for Industry and Entrepreneurship, underlined: "We need faster decisions leading to pricing and reimbursement to maintain a dynamic pharmaceutical market and to offer citizens better access to pharmaceuticals. Our 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."