WRITTEN QUESTION E-0051/03 by Struan Stevenson (PPE-DE) to the Commission. Prescribed drug abuse.
Date: 2003-01-22
Institutions: European Parliament, Provisional data
Subjects: EU financing, consumer information, consumer protection, food supplement, health policy, labelling, market approval, marketing, medical plant, scientific research

C 192 E/150

Official Journal of the European Union

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14.8.2003

Answer given by Mrs Diamantopoulou on behalf of the Commission

(7 March 2003)

The Commission would like to inform the Honourable Member that Yasaki Saltano SA has received the
following support from the European Social Fund in Portugal:

(cid:1) Old Funds

DAFSE (‘Departamento para os Assuntos do Fundo Social Europeu’): in 1988 the company received
received
PTE 108 907 495 under dossiers 881079 P1 and 881086 P1, and in 1989 it
PTE 171 483 668 under dossiers 890617 P1 and 890694 P1;

(cid:1) Community Support Framework I

In 1990 the company received support from the ‘Insituto do Emprego e Formação Profissional’ (IEFP):
project No 2/90 (cid:1) PTE 1097064. In 1993 it received support from the ‘Programa Especifico para o
Desenvolvimento Industrial Português’ (PEDIP): project No 6431/90 (cid:1) PTE 7616008;

(cid:1) Community Support Framework II

The company has received the following ESF assistance via the Aveiro Employment Centre (IEFP):

(cid:1) in 1994, EUR 24 409 under the vocational training and employment OP (Pessoa) for employment
and vocational training programmes as part of the ‘job start and initial qualifications’ measure,

(cid:1) in 1999, EUR 5 504 under the health and social integration OP’s sub-programme for economic
and social integration for disadvantaged groups (Integrar) for rehabilitation projects as part of the
‘socio-economic integration of people with disabilities’ measure.

The Commission has contacted the other Member States to ask whether Yasaki Saltano SA has also
received Community aid there. It will forward any information received to the Honourable Member.

As regards the Honourable Member’s second question, it should be pointed out that Council Directive 98/
59/EC (1) concerning collective redundancies provides for information and consultation with the workers’
representatives in cases where the employer is contemplating such redundancies. These consultations
should be carried out in good time with a view to reaching agreement and cover, at least, ways and means
of avoiding collective redundancies or reducing the number of workers affected as well as of mitigating the
consequences by recourse to accompanying social measures. These measures aim inter alia at aid for
redeploying or retraining workers made redundant.

As regards relocation of enterprises, the Commission advocates the idea that, when taking decisions,
enterprises should always take into account the effects that those decisions could have on their employees
as well as on the social and regional context. This has recently been underlined in the Commission
responsibility: A business contribution to sustainable
Communication concerning corporate social
development (2).

Furthermore, the Commission has invited the European social partners to engage in a dialogue on
anticipating and managing change with a view to apply a dynamic approach to the social aspects

(1) Directive 98/59/EC of 20 July 1998 on the approximation of the laws of the Member States relating to collective

redundancies (cid:1) OJ L 225, 12.8.1998.

(2) COM(2002) 347 final.

(2003/C 192 E/186)

WRITTEN QUESTION E-0051/03

by Struan Stevenson (PPE-DE) to the Commission

(22 January 2003)

Subject: Prescribed drug abuse

In moving to stop over-the-counter sales of certain food supplements and herbal products, what research
has the Commission conducted to prove any detrimental effect from such products, and are there copies of
the information on which the decision was made, available for examination?

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What funding has the Commission made available to biomedical research and development in human
medicine within Europe?

What funding has the Commission made available for research into the long-term effects of prescribed
psychiatric drugs on patients in medical services in Europe?

What is the diagnosed rate of the following conditions within the European Union: autistic spectrum
disease, attention deficit disorder, attention deficit hyperactivity disorder,
schizophrenia, dyslexia,
dyspraxia, Down’s syndrome?

What auditing system is in place to ensure that information supplied by pharmaceutical companies when
registering new drugs is the full
information is not withheld from
information and that adverse trial
patients and the licensing authorities?

Answer given by Mr Byrne on behalf of the Commission

(21 March 2003)

In June 2002 the Parliament and the Council adopted Directive 2002/46/EC of 10 June 2002, on food
supplements (1). The Directive covers products marketed as foods and does not apply to OTC (over-the-
counter) products. In any case the aim of the Directive is not to stop the sale of any food supplements but
to ensure that when marketed, such products are safe and bear adequate labelling. This will allow
consumers to make informed choices, suitable for their individual needs, from a wide range of safe
products.

The Commission’s proposal for a Directive on traditional herbal medicinal products (2) intends to ensure
patients’ access to traditionally used herbal medicines for which the information on traditional use allows
the assumption of their safety and efficacy. It provides for a simplified registration of such products, which
do not require medical prescription. So the range of available herbal medicines fulfilling the necessary
criteria of quality, safety and efficacy is broadened and not limited.

There is a lot of information available on risks related to herbal medicinal products. Apart from scientific
literature, which regularly deals with this issue, some information is also available on the medicines
agencies web sites (3).

Under the 5th Framework Programme (1998-2002), a total of EUR 1,27 billion was committed to
supporting health-related research activities.

The breakdown by programme area was as follows:

(cid:1) Key action 1: Food, Nutrition and Health (cid:1) 110 million;

(cid:1) Key action 2: Control of Infectious Diseases (cid:1) 267,8 million;

(cid:1) Key action 3: Cell Factory (cid:1) health part (cid:1) 194,4 million;

(cid:1) Key action 6: The Ageing Population and Disabilities (cid:1) 169,3 million;

(cid:1) Generic Activities (cid:1) 449,8 million;

(cid:1) Support for Research Infrastructures (cid:1) 82,2 million.

Under the 6th Framework Programme most of the health-related research is concentrated under the
Priority Thematic Area ‘Life Sciences, Genomics and Biotechnology for Health’ where EUR 2,255 billion is
available over the period 2003 to 2006. Some funding (cid:1) probably around 40 million (cid:1) is also available
for policy-related research in the health and linked areas. It is not possible at this stage to identify the likely
biomedical research component since the programme is only just starting.

The public health programmes have not made available funding for research into the areas mentioned.

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The Commission does not collect data concerning the prevalence of the conditions mentioned. The
Community Public Health Programme 2003-2008 is intended to set in place a health monitoring system
which will collect information on a series of health data.

Directive 2001/83/EC (4) lays down the obligation that the applicant provides in the application for a
marketing authorisation for a medicinal product all information, which is relevant to the evaluation of the
product, whether favourable or unfavourable. In particular, all relevant details shall be given of any
incomplete or abandoned pharmacotoxicological or clinical test or trial. Where an applicant submits
incomplete or falsified applications, the application has to be rejected. In addition, Member States have to
establish the necessary mechanisms to ensure that these obligations are respected in practice.

(1) OJ L 183, 12.7.2002.
(2) OJ C 126 E, 28.5.2002.
(3)

(see e.g. http://www.emea.eu.int/ for the European Medicines Evaluation Agency,
http://heads.medagencies.org/ for links to the national agencies and http://www.fda.gov/ for the USA agency).
(4) 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 (cid:1) OJ L 311, 28.11.2001.

(2003/C 192 E/187)

WRITTEN QUESTION E-0056/03

by Camilo Nogueira Román (Verts/ALE) to the Commission

(22 January 2003)

Subject: CFP reform and the legal situation of the Portuguese and Spanish fleets

the end of

At
the long transitional period granted when Portugal and Spain joined the European
Community, in what areas of the CFP reform which has been approved by the Council are the Portuguese
and Spanish fleets granted the same fishing and catch entitlements as are granted to the other EU Member
States, in particular entitlements identical to those of the countries which were Member States at the time
when the CFP was drawn up?

Answer given by Mr Fischler on behalf of the Commission

(25 February 2003)

In accordance with Article 211 of the EC Treaty, the Commission is the Community institution which acts
as the guardian of Community law. This entails ensuring application of the Treaty and compliance with
the general principles of Community law. These include the principle of equal treatment originating in the
principle of non-discrimination, particularly as regards nationality, deriving from the provisions of the
Treaties (see, for example, Article 6 of the Treaty on European Union and Articles 12 and 13 of the
EC Treaty).

It should also be noted that, in applying the provisions of the Treaty, the Court of Justice has always
regarded them as expressing the general principle of equal treatment, which is a fundamental principle of
the Community legal system (1).

The Commission’s obligation to ensure compliance with this principle clearly includes when it is exercising
its power of initiative. The proposal for a Council Regulation on the management of the fishing effort
relating to certain Community fishing areas and resources and modifying Regulationg (EEC) No 2847/93 (2)
constitutes a recent example of applying the equal treatment principle under the common fisheries policy,
the aim of the proposal being to ensure equal operating conditions and to eliminate all discrimination
between Member States on the basis of nationality.

(1) See judgments in Joined Cases 124/76 and 20/77 ([1977] ECR 1795) and Case 237/83 ([1984] ECR 3153).
(2) COM(2002) 739 final.