WRITTEN QUESTION E-3077/00

by Erik Meijer (GUE/NGL) to the Commission

(2 October 2000)

Subject: Sale over the Internet of substances for human consumption which are regarded as harmful in America

1. Is the Commission aware of a report published by Associated Press on 7 September and reproduced, inter alia, on the website Discovery Health: Health News on:

http://www.discoveryhealth.com/DH/ihtIH/EMDSC000/333/333/296934.html

under the title FDA Cracks Down on Laetrile Resurgence, which refers to a product distributed in America under the names Laetrile, Amygdalin and Vitamin B 17 by organisations with such names as World Without Cancer Inc., Health World International Inc. and Health Genesis Corp.?

2. Can the Commission confirm that the ingredients of Laetrile include apricot stones, which according to a long-standing popular belief can prevent cancer? Does the Commission have an opinion on the extent to which apricot stones can prevent or cause cancer? To what extent are these characteristics of apricot stones affected for better or for worse by other substances contained in Laetrile?

3. Is the Commission aware of the efforts of the United States Food and Drug Administration (FDA) to combat trade in Laetrile, on the assumption that this substance is carcinogenic and can also cause cyanide poisoning? Does the Commission have an opinion concerning the arguments for and against this adverse assessment and about the resultant ban on the substance's sale in the United States?

4. The sale of Laetrile is now continuing over the Internet, so that it is increasingly becoming available on the European market. Other substances for human consumption whose benefits or harmful effects have not been ascertained are likewise being sold in this way. Does the Commission share the concern of the FDA, and does it therefore consider such substances harmful to European consumers?

5. If the answer to Question 4 is affirmative, and bearing in mind the international nature of this problem, will the Commission promote coordinated action by the Member States and applicant countries to inform European consumers about any adverse effects which have been shown to arise from substances for human consumption available over the Internet?

Answer by Mr Liikanen on behalf of the Commission

(23 November 2000)

The Commission is aware of the possible risk to the health of European citizens posed by the Internet sale of medicinal products by companies established outside the Community.

For over twenty years now, products derived from laetrile have been put forward, especially in the United States of America, as an alternative to conventional cancer treatment. The research carried out on these products has established that laetrile has not been effective in the treatment of cancer and indeed could prove to be toxic in some cases. Moreover, given the ineffectiveness of the claimed indications and the side effects associated with the release of cyanide, these products are have not been authorised for marketing.

The Food and Drug Administration (FDA) in the United States is currently taking action to halt the manufacture, packaging, promotion, distribution and marketing of products derived from laetrile or apricot stones. Laetrile has been banned by the FDA and is not authorised for sale as a medicinal product in the Community.

The authorisation, advertising and sale of pharmaceutical products within Europe is regulated by specific Community directives which apply both to the sale of those products by electronic means and to their sale by more conventional means. In addition, the recently adopted Directive 2000/31/EC of the Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce)(1) provides for transparency requirements, administrative cooperation among Member States and effective control in the Member State where the on-line service is located.

Moreover, in the case of provision of pharmaceuticals by pharmacists, the latter are, of course, subject to the rules of conduct of their own professional bodies.

However, as pointed out by the Honourable Member, the global nature of the Internet allows for the advertising and sale of pharmaceuticals to European consumers by operators from third countries, thereby bypassing the protection provided by Community legislation. The Commission has begun working with the Member States to address this problem and the Commission is considering promoting the use of codes of conduct, and possibly running consumer awareness campaigns.

(1) OJ L 178, 17.7.2000.