WRITTEN QUESTION E-0091/02 by Astrid Thors (ELDR) to the Commission. Testing of medicinal products in Europe.
Date: 2002-01-25
Institutions: European Parliament, Provisional data
Subjects: EU law, Europe, United States, code of conduct, disease of the nervous system, experiment on humans, imprisonment, medicinal product, pharmaceutical legislation, pharmaceutical product, public health

20.6.2002

EN

Official Journal of the European Communities

C 147 E/239

erratum (which is sent direct to the Honourable Member and to Parliament’s Secretariat) containing the
modifications accepted by the Committee.

The Commission reserves the right to take the final decision on the appropriate follow up action. This is
keeping in mind with the view that while scientific risk assessment must be carried out independently and
transparently, risk management is a matter for the Commission and the other Community institutions. In
the case of fur farming, the Commission will therefore decide whether follow-up action, if any, is required
and will submit proposals accordingly to the Member States and/or the Parliament. The opinion of the
Scientific Committee on Animal Health and Animal Welfare will be taken into account in this process.

(1) OJ L 237, 28.8.1997.

(2002/C 147 E/256)

WRITTEN QUESTION E-0091/02

by Astrid Thors (ELDR) to the Commission

(25 January 2002)

Subject: Testing of medicinal products in Europe

In December 2001, Professor Urpo Rinne of
the University of Åbo/Turku received a four-year
unconditional prison sentence for misconduct and embezzlement in connection with research projects he
had been in charge of. According to newspaper reports, the research projects related inter alia to the
testing of medicines for the treatment of Parkinson’s disease and patients’ safety was put at risk. Given that
licence approvals in the USA has fallen (1996: 53; 2000: 27; 2001: 16), will the
the number of
Commission state whether the rules on the testing of medicinal products are less stringent in Europe and
whether pharmaceuticals firms have switched testing to Europe and Finland owing to differences in the
rules on the licensing of medicines? Are there any other major differences, which could put patients at
risk, that have attracted such ‘research projects’ to Finland?

Answer given by Mr Liikanen on behalf of the Commission

(5 March 2002)

The rules on the testing of medicinal products in Europe are no less stringent than those that apply in the
US.

According to Directive 2001/83/EC, all phases of clinical investigation on a medicinal product shall be
designed,
in
accordance with the ethical principles laid down in the Declaration of Helsinki. The internationally
harmonised guideline on good clinical practice applies in Europe, the US and Japan.

implemented and reported in accordance with good clinical practice and carried out

In addition, Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
approximation of the laws, regulations and administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials on medicinal products for human
use sets out the rules relating to the design, conduct, recording and reporting of such clinical trials in the
European Union. This Directive sets out strict rules for the conduct of clinical trials and their audit and
inspection, which are already set out in the harmonised guideline on good clinical practice.

Other European texts provide guidance on clinical trials in general and on the development of particular
medicinal products in different therapeutic areas, including Parkinson’s disease.

C 147 E/240

Official Journal of the European Communities

EN

20.6.2002

The number of licence approvals in a country, whether falling or rising, bears no relation to the number of
clinical trials conducted in that country and there is no evidence that companies are switched from the US
to conduct trials in the EU because of a laxer clinical trial environment.

(2002/C 147 E/257)

WRITTEN QUESTION P-0093/02

by Gabriele Stauner (PPE-DE) to the Commission

(21 January 2002)

Subject: Irregularities involving ESF funds in North Rhine-Westphalia

The European Court of Auditors states in paragraph 3.39(d) of its annual report for 2000 (1) that an audit
concerning the European Social Fund in North Rhine-Westphalia showed that the 1998 closure of an
operational programme (CI Employment 1994 to 1999, Germany) included a proportion of ineligible
expenditure amounting to 15,7 %.

The Court of Auditors found that advance payments had been declared instead of actual expenditure,
whilst the use of flat rates had also led to overstatement of expenditure and parts of the public co-
financing had not been identified.

In its reply to the Court’s findings, the Commission stated that its Employment DG had contacted the
competent authorities to rectify the situation described by the Court.

Can the Commission say:

E how much money was wrongfully claimed?

E how it has rectified the situation?

E whether the circumstances identified by the Court constitute an isolated case, or whether it must be
assumed that similar errors have occurred in other programmes implemented in North Rhine-
Westphalia?

(1) OJ C 359, 15.12.2001, p. 163.

Answer given by Mrs Diamantopoulou on behalf of the Commission

(26 February 2002)

The European Court of Auditors states in paragraph 3.39 (d) of its annual report for 2000 that an audit
concerning the European Social Fund (ESF) in North Rhine-Westphalia showed that the 1998 closure of an
operational programme (CI Employment 1994-1999, Germany)
ineligible
expenditure amounting to 15,7 %. According to the sampling methodology of the Court of Auditors the
Integra share of North Rhine-Westphalia was selected. The Court decided to make an in depth audit and to
control the expenditure declarations for all 30 projects.

included a proportion of

As a result of the control the Court identified three types of error:

E Advance payments had been declared instead of actual expenditure

The last advances were paid end 1998. The annual expenditure declarations were only made in
January 1999. In some cases the declared expenditure was lower than foreseen which is caused by
early departures of participants (e.g. after finding of a new job). The promoters reimbursed the
difference in February 1999. This was thus accounted for in the ESF accounting system for 1999.

This situation was considered as an error by the Court because the Declaration of Assurance (DAS)
exercise focuses only on the financial year 1999, but it has no financial impact as it is an adjustment
problem.