WRITTEN QUESTION E-3299/00 by Eryl McNally (PSE) to the Commission. Generic Medicines.
Date: 2000-10-25
Institutions: European Parliament, Provisional data
Subjects: European patent, European social policy, generic drug

C 151 E/126

Official Journal of the European Communities

EN

22.5.2001

Answer given by Mr Byrne on behalf of the Commission

(13 December 2000)

Article 6(2) of former Directive 98/43/EC of the Parliament and of the Council of 6 July 1998, on the
approximation of the laws, regulations and administrative provisions of the Member States relating to the
advertising and sponsorship of tobacco products (1) required Member States to communicate to the
Commission the main provisions of domestic law they adopt in the field covered by the Directive.

However, no Member State has made such communication. This did not entail an infringement of
Community legislation, as the deadline for compliance with the Directive was 30 July 2001. In these
in a position to provide the information requested by the
circumstances,
Honourable Member.

the Commission is not

Following the annulment of Directive 98/43/EC by the Court of justice on 5 October 2000, Member States
are no longer obliged to communicate to the Commission their legislation in the field of advertising and
sponsorship of tobacco products.

Council Directive 89/552/EEC of 3 October 1989 (2) as amended by Directive 97/36/EC of the Parliament
and of the Council of 30 June 1997 on the coordination of certain provisions laid down by law, regulation
or administrative action in Member States concerning the pursuit of television broadcasting activities (3)
lays down the legal framework for television broadcasting within the Community. It prohibits all forms of
television advertising for cigarettes and other tobacco products. In addition, television programmes may
not be sponsored by undertakings whose principal activity is the manufacture or sale of cigarettes and
other tobacco products. All Member States have implemented these provisions.

(1) OJ L 213, 30.7.1998.
(2) OJ L 298, 17.10.1989.
(3) OJ L 202, 30.7.1997.

(2001/C 151 E/141)

WRITTEN QUESTION E-3299/00

by Eryl McNally (PSE) to the Commission

(25 October 2000)

Subject: Generic Medicines

Generic medicines are playing an important role within EU public healthcare but in contrast to most of the
generic industries outside the EU, EU-legislation does not allow for experimental use and testing for
registration purposes. The European Parliament has asked for similar legislation which would mean saving
13 000 jobs in the EU and permitting it to be competitive.

The Commission in its Communication on the Single Market in Pharmaceuticals (COM(98) 588) com-
mitted itself to ensuring that consumers have access to lower-prices generic medicines as soon as possible
after the patent protection of the originator product expires.

What action is the Commission taking to introduce legislation to ensure that European generic manufac-
turers remain internationally competitive and that patients have access to affordable medicines?

22.5.2001

EN

Official Journal of the European Communities

C 151 E/127

Answer given by Mr Liikanen on behalf of the Commission

(8 December 2000)

The Commission is currently undertaking a review of the regulatory process, and a final report is expected
shortly. As regards the effects of patent protection, it should be noted that it is possible to register a
generic product using data generated elsewhere, which means that generic products are often able to come
to market within the Community immediately upon patent expiry. The Commission currently has no plans
to propose changes to the patent position, although it naturally remains open to the views of producers
and consumers of pharmaceutical products on this question.

(2001/C 151 E/142)

WRITTEN QUESTION E-3300/00

by Eryl McNally (PSE) to the Commission

(25 October 2000)

Subject: Soy products

There are different opinions on the benefits of the consumption of soy products: on the one hand the
United States Food and Drug Administration has allowed most soy products to have (cid:145)health claims(cid:146)
labelling but independent scientists claim that increased consumption of soy products can provoke serious
health hazards, with defects or chronic diseases, such as vaginal adenocarcinoma or penile deformities in
new-born babies.

Is the Commission doing any research on the effects of soy consumption on human beings?

Answer given by Mr Busquin on behalf of the Commission

(14 December 2000)

The Commission would inform the Honourable Member that a research project is about to be funded on
the effects of soy consumption on human beings within the scope of key action 1 (Food, nutrition and
health) of the specific programme (cid:145)Quality of life and management of living resources(cid:146) of the Fifth
framework programme for Research and technological development (RTD) (1). This project has been
negotiated successfully and is
is entitled
(cid:145)The prevention of osteoporosis by nutritional phytoestrogens(cid:146). The coordinator is Dr Francesco Branca
of the Istituto nazionale di ricerca per gli alimenti e la nutrizione in Italy. A large-scale, multicentre,
randomised intervention trial will be conducted in three Member States using specially designed foods that
are enriched with isoflavones isolated from soy. Acceptability of these foods among the target population
(women 45 years old and more) and expectations created by different nutritional claims will be addressed
by a survey in five Member States.

selection by the Commission.

in the procedure of

It

Another project was funded in the fourth framework programme within the programme FAIR. This
project, entitled (cid:145)Phenolic phytoprotectants (PPP) (cid:129) Role in preventing initiation, promotion and progres-
sion of cancer(cid:146), was coordinated by Dr Herman Adlercreutz of the University of Helsinki and ended
in December 1998. The objectives were to identify and quantify PPPs in plants and foods including soy
products, assess their bioavailability and the role of intestinal microflora in their metabolism as well as to
evaluate anticancer effects. A soy-PPP-containing diet had no anticarcinogenic effect in a mouse model in
short-term experiments. However, when rats were fed with soy before and after transplantation of rat
prostate cancer into the back of the animals, there was a significant delay in the development of the
cancer.