WRITTEN QUESTION E-1941/01

by John Purvis (PPE-DE) to the Commission

(3 July 2001)

Subject: Drug price regulation

An article in Business Europe claimed that it can take up to four years, after approval by the EMEA, for patients to have access to new drugs, due to the time lag to put them on the official reimbursement lists of each Member State's health service. Furthermore national cost-containment measures prevent doctors from using more expensive new drugs. As a consequence, EU citizens are not being given access to the most up-to-date products and so are not receiving the best world standard health care. It is also damaging to the EU pharmaceutical industry, impeding the development of new medical products and techniques by blocking innovation and competition.

What action is the European Commission taking to speed up this process and make EU pharmaceutical markets more open to competition?

Answer given by Mr Liikanen on behalf of the Commission

(1 October 2001)

It is true that there have been complaints surrounding the length of time taken by some Member States to agree on price and reimbursement rates for medicinal products. However, pricing and reimbursement of medicinal products are matters for the individual Member States; cost-containment measures form part of national social security policy and are conceived according to public health considerations of the Member States. The Commission has limited scope of intervention in that field on the basis of Directive 89/105/EC(1), which gives pharmaceutical companies assurances as to the transparency of the procedures used to control pharmaceutical prices, profits and reimbursement in each Member State.

With regard particularly to medicinal products included in a positive list of products and covered by the national health system, Article 6 of this Directive provides for a detailed procedure to be followed by any marketing authorisation holder. The evaluation process is accompanied by procedural guarantees. A decision on an application submitted has to be adopted and communicated to the applicant within strict and rather short deadlines; it is worth noting that the periods of time laid down in the directive are mandatory and not optional. Furthermore, any decision not to include a medicinal product in the list of products covered by the health insurance system has to contain a statement of reasons based upon objective and verifiable criteria, including, if appropriate, any expert opinions or recommendation on which the decision is based. In addition, the applicant must be informed of the remedies available to him in terms of national procedural law. Finally, the directive sets transparency requirements including both publication of the lists of products as well as communication to the Commission of the lists and of the criteria used.

In fact, the procedure itself, as established in the directive, cannot be considered as lengthy, taken into consideration that many checks have to be carried out by national authorities. Nevertheless, the problem of drug accessibility lies very often with Member States, and that despite the fact that Directive 89/105/EEC provides for a maximum period of 180 days for pricing and reimbursement approval by the Member States, after the marketing authorisation has been granted. To deal with those cases of non-respect of the Directive, the Commission has already launched legal proceedings pursuant to article 226 (ex Article 169) of the EC Treaty and will continue to monitor closely the situation.

Apart from the Directive cited, the Commission has limited scope for action. Nevertheless, the issue is high on the agenda of patient groups, the industry and national authorities, and is one of the key subjects for discussion within a High level Group on Innovation and the Provision of Medicines, which began work in March 2001. The group is intended to bring together a small number of key figures from each sector in order to look at the issues and seek ways forward, and will report to the President of the Commission in May 2002.

(1) Council Directive 89/105/EC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989).