WRITTEN QUESTION No. 2146/98 by José VALVERDE LÓPEZ to the Commission. Sale of medicinal products via the Internet
Date: 1998-07-13
Institutions: European Parliament, VALVERDE LOPEZ
Subjects: World Health Organisation, advertising malpractice, consumer protection, distance selling, marketing, medicinal product, pharmaceutical legislation, public health, selective dissemination of information, transmission network













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91998E2146

WRITTEN QUESTION No. 2146/98 by José VALVERDE LÓPEZ to the Commission. Sale of medicinal products via the Internet  


Official Journal C 096 , 08/04/1999 P. 0046 





WRITTEN QUESTION E-2146/98by José Valverde López (PPE) to the Commission(13 July 1998)Subject: Sale of medicinal products via the InternetThe safety, quality and effectiveness of medicinal products for human use are guaranteed by means of a number of directives such as Directive 65/65(1), which requires administrative authorization for the marketing of medicinal products in the Union, or Directive 92/27(2), which lays down the requirement for package leaflets to be included with medicinal products.In view of the emergence of new marketing methods via the Internet (concerning in particular the marketing of medicinal products), the guarantees provided by Community law do not appear to be entirely effective.Can the Commission say what action has been taken at European level to alleviate what has become a serious problem? Can it say whether the matter has been included on the European agenda for future trade negotiations with the USA and within the World Trade Organization (WTO)?Answer given by Mr Bangemann on behalf of the Commission(9 September 1998)The Commission remains concerned about such sale on the Internet, as this may constitute an infringement of Community law - whether of Directive 65/65/EEC (on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products) where the product in question has not been issued with a valid marketing authorization, or of Directive 92/28/EEC of 31 March 1992(3) which prohibits the public advertising of prescription medicines.It may, additionally, violate national law - in those Member States which have exercised their right under Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997(4) (on the protection of consumers in respect of distance contracts) to ban the marketing of certain products by distance contracts where they adjudge this to be in the "in the general interest", and in those which have accorded pharmacists a monopoly of the sale of medicines.Restrictive measures may be feasible where operators are established within the Community territory; not so where they are located outside it, as is frequently the case (given the trans-frontier nature of the Net). For this reason - and to ensure maximum efficacy for any measures taken by the Commission/Member States - contacts have been initiated with the WHO (which encompasses the countries most concerned by this phenomenon). This dialogue may lead to early publication of a guide for Internet users to the trans-frontier advertising and sale of medical products (including medicaments). Also, the action plan for safer use of the Net proposed by the Commission - dealing with a number of illegal or harmful activities on the Web and promoting general measures to restrict these - may extend to certain forms of distribution of illicit drugs or medicaments.(1) OJ 22, 9.2.1965, p. 369.(2) OJ L 113, 30.4.1992, p. 8.(3) OJ L 113, 30 April 1992.(4) OJ L 144, 4 June 1997.