Medicines should enter the market faster. With this intention the European Commission has proposed today 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 (1), 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."
After the quality, safety and efficacy of the medicinal products are established during the process of marketing authorisation,(2) 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, when the Transparency Directive for pharmaceutical products was adopted. By then, 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 to reimbursement. However, the increasing diversity since 1989 led to complex pricing and reimbursement schemes (e.g. some of these schemes contain different categories of reimbursement). 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(3). The proposal aims at reflecting the relevant case-law of the Court in the text of the Directive.
This revision is a follow up to the Commission report on the pharmaceutical sector in 2009 (Pharmaceutical Sector Inquiry) (4) which revealed long and cumbersome pricing and reimbursement decisions. Studies have shown that delays in pricing and reimbursement decisions can go up to 700 days for innovative medicines(5) and up to 250 days for generics.(6)
Today's proposal aims at introducing the following main changes:
- Guaranteeing shorter time limits for national, regional or local decisions on pricing and reimbursement of:
- all medicinal products in general (120 days instead of 180 days, except for more complex procedures) and
- generic medicinal products in particular (30 days instead of 180 days) when the price of the reference product has already been approved or it has already been included in the public health insurance system.
- Increasing the effectiveness of the directive by proposing strong enforcement measures, i.e. in case of non-compliance with the time limits, a Member State has to designate a body entrusted with the powers to take rapid measures such as:
- adopting interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned;
- awarding damages to the applicant;
- imposing a penalty payment, calculated by day of delay.
- Introducing the obligation fro Member States to regularly reporting on their decisions and the time involved.
- Notifying national pricing and reimbursement draft measures to the Commission to facilitate compliance from the beginning.
- Ensuring legal clarity and consistency with the Court of Justice case-law and clarifying the scope of transparency obligations.
- Addressing the uncertainties relating to innovative pricing and reimbursement procedures: e.g. exclusion of tendering (covered by public procurement law) and of managed entry agreements (covered by contractual/administrative law) from the scope of application of the Directive.
1. Directive 89/105/EEC, 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 [1989] OJ L40/8
2. Directive 2001/83/EC as amended, OJ L 311, 28.11.2001, p.67 , and Regulation (EC) N°726/2004, OJ L 136, 30.4.2004, p. 1.
3. Case C-229/00 Commission of the European Communities v Republic of Finland [2003] ECR 5727
4. Communication from the Commission "Executive Summary of the Pharmaceutical Sector Inquiry Report" (COM (2009)351 final) and the annexed Staff Working Document: "Report on the Pharmaceutical Sector Inquiry".
5. OECD (2008) Health Policy Studies Pharmaceutical Pricing Policies in a Global Market, pg. 133
6. European Generic Medicines Association (2009) How to increase patient access to generic medicines in the European Union; http://www.egagenerics.com/doc/ega_increase-patient-access_update_072009.pdf