92000E4059

WRITTEN QUESTION P-4059/00

by Willy De Clercq (ELDR) to the Commission

(20 December 2000)

Subject: Access to innovative medicines

Council Directive 89/105/EEC(1) of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems provides for a maximum period of 180 days for pricing and reimbursement approval by the Member States, once marketing approval has been granted. Some Member States, such as Belgium, still take up to four times as long to grant pricing and reimbursement approval for new medicinal products. This deprives patients from access to crucial new pharmaceutical products. Can the Commission inform Parliament on what it has done or what it will do to ensure that patients are not denied access to new drugs because of bureaucratic inefficiency?

(1) OJ L 40, 11.2.1989, p. 8.

Answer given by Mr Liikanen on behalf of the Commission

(20 February 2001)

The Council Directive 89/105/EEC, of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems has been fully transposed into national law by all Member States. It is worth noting that the periods of time laid down in the Directive to which the question makes reference are mandatory, and not optional.

It is indeed true that there have been complaints surrounding the length of time taken by some Member States to agree on prices and reimbursement rates for medicinal products, and the Commission will continue to monitor the situation closely.

The specific facts to which the question makes reference are currently a matter of law. The Commission has instituted infraction proceedings against Belgium Cases 1999/5305, 2000/4442 and 2000/4544 form a linked dossier, and are being actively pursued by the Commission.