WRITTEN QUESTION P-4059/00 by Willy De Clercq (ELDR) to the Commission. Access to innovative medicines.
Date: 2000-12-20
Institutions: European Parliament, Provisional data
Subjects: Belgium, application of EU law, medicinal product, social-security harmonisation

C 174 E/224

Official Journal of the European Communities

EN

19.6.2001

Inspections (meat and border) by the authorities of the Member States are not necessarily conducted on a
24 hour basis, 365 days a year. Thus any consignments arriving outside of conventional hours at the place
of destination may have to await inspection until resumption of work by the inspection staff. For import
controls Community legislation provides for pre-notification of the consignments in order to allow
veterinary staff to be made aware of the arrival of consignments and to ensure that the import checks
can be carried out if necessary outside of official working hours.

(2001/C 174 E/240)

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 (cid:129) Cases 1999/5305, 2000/4442 and 2000/4544
form a linked dossier, and are being actively pursued by the Commission.

(2001/C 174 E/241)

WRITTEN QUESTION E-4063/00

by Isidoro SÆnchez Garc(cid:237)a (ELDR) to the Commission

Subject: Businesses and the EU-Mexico Agreement

(9 January 2001)

The Agreement between the European Union and Mexico was signed in December 1999 and entered into
force on 1 July 2000. Its content means that the agreement provides the future framework for cooperation
between firms on both sides. The achievement of one of the key objectives of the agreement, to adjust the
balance in view of Mexico(cid:146)s excessive economic, commercial and financial dependence on its North
American neighbour, will depend on the success of such business cooperation.