WRITTEN QUESTION E-2386/02 by Brice Hortefeux (PPE-DE) to the Commission. Dangers of directly promoting certain medicines.
Date: 2002-08-02
Institutions: European Parliament, Provisional data
Subjects: European Medicines Agency, advertising, consumer information, consumer protection, medicinal product, pharmaceutical legislation, public health

C 192 E/60

Official Journal of the European Union

EN

14.8.2003

have contributed to tackling the issues raised by the Honourable Member. The CSF3 agreed in 2000 (for
the period 2000-2006) to provide financial assistance for actions to tackle these issues. In particular, under
the Operational Programme for Health and Welfare,
just over EUR 513 million is available under five
priority axes, including health, mental health and welfare measures. A number of actions have already
begun which specifically target improvements in the situation of children with disabilities.

In the context of the right to free movement for persons in the Union, the Commission would refer in the
first place to Regulation (EEC) No 1408/71 (1) which co-ordinates the national social security schemes. As
far as the care for disabled children could be considered as health care, there is the possibility of invoking
the provisions of Article 22 of this Regulation concerning persons who deliberately go to another Member
State to receive medical care. In this case, Article 22 of Regulation (EEC) No 1408/71 stipulates that this
person must obtain prior authorisation from the sickness insurance institution where he is insured. This
prior authorisation may not be refused when the medical care provided for under the legislation of the
Member State of residence cannot be provided within the time normally necessary for obtaining the
treatment in question, taking account of the person’s state of health and the probable course of the disease.
In all other instances, the sickness institution enjoys a large margin of discretion in deciding whether to
grant its authorisation or not.

Nevertheless, in the decisions Kohll (C-155/96), Decker (C-120/95), Smits and Peerbooms (C-157/99) and
Vanbraekel (C-368/98), the Court of Justice stated that when exercising their powers, Member States must
comply with Community Law. In these decisions the Court indicated that Regulation (EEC) No 1408/71 is
not designed to regulate the reimbursement by Member States as such and hence does not in any way
prevent Member States from reimbursing costs at the tariffs in force in the competent Member State,
which incurred in connection with treatment provided in another Member State, even without prior
authorisation. According to the Court, tourists, persons receiving medical treatment and persons travelling
for the purpose of education or business are all to be regarded as recipients of services, so that they benefit
from the freedom to provide services as mentioned in Article 49 of the EC Treaty, even without having
been authorised. Furthermore, in the Kohll judgement the Court confirmed that a Member State should
provide for the reimbursement of the costs of medical treatment obtained in another Member State in so
far as the treatment obtained in the other Member State is part of the medical services paid for by the
social insurance system of the Member State of insurance and the tariffs of the Member State of insurance
applied. However, it depends on the specific circumstances, especially on the desired kind of treatment,
whether the national legislation can be considered as justified.

Regarding the European Year of People with Disabilities, within the establishing Council Decision (2), each
Member State must establish or designate a national co-ordinating body which is responsible for the
implementation of the European Year within its territory. One of the roles of this body will be to establish
a strategy and key priorities for the Member State in question. It is therefore the national co-ordinating
body in Greece which must decide whether there should be particular focus on disabled children in Greece
during the Year.

(1) Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to

employed persons and their families moving within the Community (cid:1) OJ L 82, 27.3.1980.

(2) 2001/903/EC: Council Decision of 3 December 2001 on the European Year of People with Disabilities 2003 (cid:1)

OJ L 335, 19.12.2001.

(2003/C 192 E/058)

WRITTEN QUESTION E-2386/02

by Brice Hortefeux (PPE-DE) to the Commission

(2 August 2002)

Subject: Dangers of directly promoting certain medicines

The Commission plans to amend Community legislation to authorise the direct consumer advertising of
certain medicines available only on prescription.

14.8.2003

EN

Official Journal of the European Union

C 192 E/61

However, American experience is this area should serve as a warning as to what might happen in Europe.
According to a recent study in the United States, direct advertising misleads consumers, generates large-
scale use of expensive new products and doubles inflation for expenditure on medicines. An identical
phenomenon has occurred in New Zealand,
the only other country to authorise direct consumer
advertising.

Under these circumstances, does the Commission not consider that, in authorising direct advertising, it is
opening the way for escalating costs and excessive use of medicines in Europe, as has happened in the
United States?

Answer given by Mr Liikanen on behalf of the Commission

(5 September 2002)

Medicinal products are distinct from most other products, in so far as from a public health point of view
they should not be used as much as possible, but as little as necessary.

Consequently, the current legislation on advertising of medicinal products for human use provides in
Article 88 paragraph 1 of Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001
on the Community code relating to medicinal products for human use (1) that Member States shall prohibit
the advertising to the general public of medicinal products, which are available on medical prescription
only.

The Commission’s proposals to amend the existing pharmaceutical legislation (2) does not touch upon this
strict ban of advertising of prescription-only medicines to the general public. The Commission is fully
aware of experiences with direct-to-consumer advertising in other countries and does not have the
intention to move into this direction.

The modifications that the Commission has proposed to Article 88 of Directive 2001/83/EC relate to
information and not to advertising. This distinction is important since information is meant to serve the
interest of the patients, whereas advertising shall promote the marketing of the product and serve the
interest of pharmaceutical industry.

The proposals foresee a pilot phase where the dissemination of certain information to the public on some
prescription-only medicines directly by the industry would be allowed under strict conditions. These
conditions require compliance with principles of good information practice and a control by the European
Medicines Evaluation Agency in London before the information is released to the public.

The focus of this proposal is exclusively the patients and their need for better information. This objective is
clearly reflected by the choice of three specific disease groups (diabetes, acquired immune deficiency
syndrome (AIDS) and asthma) to which the Commission’s proposal is limited at present. All of them are
diseases which are long-term and chronic, where there is specific patient demand for information. Over
and above this, the patients suffering from these diseases are generally already taking specific medicines. So
the improved information will have a positive impact for the patient, but is not expected to increase or
create a need for these medicines.

(1) OJ L 311, 28.11.2001.
(2) OJ C 75 E, 26.3.2002.

(2003/C 192 E/059)

WRITTEN QUESTION E-2396/02

by Glyn Ford (PSE) to the Commission

(5 August 2002)

Subject: Cooperation with Iranian authorities in fight against drug trafficking

Iran is one of
the countries that drug traffickers use to transport hard drugs from countries like
Afghanistan and Pakistan to the European Union. The Iranian Drug Control Headquarters is central to the