WRITTEN QUESTION E-1399/00 by Phillip Whitehead (PSE) to the Commission. Certificate of Pharmaceutical Products.
Date: 2000-05-04
Institutions: European Parliament, Provisional data
Subjects: common commercial policy, developing countries, exclusive distribution agreement, export licence, market approval, medicinal product

C 72 E/52

Official Journal of the European Communities

EN

6.3.2001

Answer given by Mr Liikanen on behalf of the Commission

(16 June 2000)

The legislative provisions governing technical requirements for tyres and their fitting are contained in
Directive 97/24/EC of the Parliament and of the Council of 17 June 1997 on certain components and
characteristics of two or three-wheel motor vehicles (1).

The Commission was informed of tyre brand restrictions attaching to certain passenger cars manufactured
in Germany. Following exchanges of correspondence with the Commission, the German authorities
addressed a communication dated 29 February 2000 to the Commission in which type-approval
authorities have been instructed not to include in the future any such brand restrictions in vehicle
documents. The communication also states that any existing brand restrictions contained in vehicle
documentation are devoid of legal effect.

The Commission is of the view that tyre brand specifications for motorcycles are similarly unacceptable.
The Commission will contact the German authorities in order to clarify the situation.

(1) OJ L 226, 18.8.1997.

(2001/C 72 E/058)

WRITTEN QUESTION E-1399/00

by Phillip Whitehead (PSE) to the Commission

(4 May 2000)

Subject: Certificate of Pharmaceutical Products

Can the principles of free trade be reconciled with the concept of exclusive distribution rights, which is an
indirect effect of the Certificate of Pharmaceutical Products, particularly in respect of the supply of essential
medicines for emerging countries?

Answer given by Mr Liikanen on behalf of the Commission

(16 June 2000)

The export certificates ((cid:145)certificate of pharmaceutical products(cid:146)) drawn up by the national or Community
authorities are based on the WHO (World Health Organisation) model.

Their main aim is to certify that the medicine for which the certificate has been requested is indeed
covered by a marketing authorisation granted by the authorities in the exporting country.

That main aim is thus linked to the marketing authorisation and not to the distribution system or to access
to the pharmaceuticals market. As such it does not confer any exclusive-distribution right. The certificate
constitutes a guarantee and makes pharmaceutical products more accessible in the less-developed import-
ing countries.

(2001/C 72 E/059)

WRITTEN QUESTION E-1400/00

by Mar(cid:237)a Sornosa Mart(cid:237)nez (PSE) to the Commission

Subject: Safety risks in Spanish mining dams

(5 May 2000)

According to data made available by the WWF environmentalist group, there are at present 743 mining
dams in Spain, of which 161 are subject to the risk of an accident similar to that which occurred in
Romania in January 2000. On that occasion, the overflow of a tailings dam into a gold mine led to the
pollution of the Danube and one of its tributaries.