WRITTEN QUESTION P-2337/01 by Maurizio Turco (TDI) to the Commission. Internal restructuring of OLAF.
Date: 2001-07-26
Institutions: European Parliament, Provisional data
Subjects: European Anti-fraud Office, administration of the Institutions, data processing, personal data, protection of privacy

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(2002/C 40 E/258)

WRITTEN QUESTION E-2325/01

by Pat Gallagher (UEN) to the Commission

(31 July 2001)

Subject: Obstacles to the publication of research results which have important public health and consumer

implications

In order to conduct research into antibiotic resistance, research laboratories need supplies of antibiotic
powder. It is the practice of some pharmaceutical companies to condition sale of this powder on an
undertaking by the laboratory not to publish their research results without obtaining permission from the
company.

Is the Commission aware of this practice and does the Commission share the view that this restrictive sales
practice not only infringes the rules on the free movement of goods, but also raises serious concerns for
public health and consumer protection? Can the Commission indicate what action it proposes taking to
put an end to this practice?

Answer given by Mr Liikanen on behalf of the Commission

(10 October 2001)

to written questions P-1509/01 by Mrs Doyle (1) and P-1770/01 by
As indicated in its answer
Mrs Banotti (2) respectively,
the Commission has already taken contact with several pharmaceutical
companies concerning their policies with respect to supplies of antibiotic powder for research purposes. It
in general, pharmaceutical companies are ready to supply
is the Commission(cid:146)s understanding that,
antibiotic substances for research purposes. In addition, the majority of these antibiotic substances may be
purchased directly through commercial warehouses.

The Commission understands that it is standard practice for some companies who supply antibiotic free of
charge to researchers to request undertakings from these researchers to ensure that the research is
legitimate and appropriate vis (cid:224) vis public health and to request sight of the research results in advance of
publication. The Commission has no element to consider that these requests have any impact either on the
free movement of pharmaceutical goods or on issues of public health and consumer protection. The
Commission does not intend to take any action in this field.

In this respect, it is worth mentioning that the issue of antimicrobial resistance forms an inherent part of
the Community(cid:146)s health strategy and comprises actions in all the relevant sectors including public health,
veterinary and phytosanitary. In June 2001, the Commission adopted a communication on a community
strategy against antimicrobial resistance (3), including details of its proposals in the area of research and
product development and a proposal for a Council recommendation on the prudent use of antimicrobial
agents in human medicine (3).

(1) OJ C 318 E, 13.11.2001, p. 245.
(2) OJ C 340 E, 4.12.2001.
(3) COM(2001) 333 final, Volume I.

(2002/C 40 E/259)

WRITTEN QUESTION P-2337/01

by Maurizio Turco (TDI) to the Commission

(26 July 2001)

Subject: Internal restructuring of OLAF

On 3 July, as part of its internal restructuring, the European Union(cid:146)s Office to combat corruption and
fraud affections the EU(cid:146)s financial interests (OLAF) introduced a new structure for its directorate C, which
is to deal with (cid:145)intelligence, operational strategies and information technologies(cid:146).

What are the specific tasks of this directorate?

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Official Journal of the European Communities

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Will it be managing sensitive data? What procedures will it be using?

In view of the clear implications as regards privacy, does the Commission not think that adequate
monitoring of these procedures is necessary and that it would therefore be useful to introduce regulated
supervision of them by the European Parliament as a matter of urgency?

Answer given by Ms Schreyer on behalf of the Commission

(13 September 2001)

The new Directorate C of
infrastructure and of gathering and analysing all information that is relevant to its functions.

the European Anti-Fraud Office (OLAF)

is in charge of

the Office(cid:146)s IT

In this context Directorate C is interested only in data that is directly or indirectly linked with the forms of
conduct described in Article 2 of Decision No 1999/352/EC, ECSC, Euratom (1) and Article 1 of Regulations
Nos 1073/1999 and 1074/1999 (2),
including personal data. Data is either transmitted by public
authorities or gathered in the course of the Office(cid:146)s investigations. It is also gathered from open sources
(commercial databases, Internet etc.).

Data protection is organised in accordance with Regulation No 45/2001 (3). The designation of a data
protection officer is in motion. A European data protection controller is established by that Regulation as
an independent control authority.

Article 8 of Regulations Nos 1073/1999 and 1074/1999 requires the Director of the Office to ensure that
his staff comply with Community and national provisions relating to data protection, particularly as
regards the data to which Directive 95/46/EC (4) applies, and the Supervisory Committee monitors
compliance with that Article.

(1) Commission Decision of 28 April 1999 establishing the European Anti-Fraud Office (OLAF) (OJ L 136, 31.5.1999).
(2) Parliament and Council Regulations (EC) No 1073/1999 and (Euratom) No 1074/1999 of 25 May 1999 concerning

investigations conducted by the European Anti-Fraud Office (OLAF) (OJ L 136, 31.5.1999).

(3) Parliament and Council Regulation (EC) No 45/2001 of 18 December 2000 on the protection of individuals with
regard to the processing of personal data by the Community institutions and bodies and on the free movement of
such data (OJ L 8, 12.1.2001).

(4) Parliament and Council Directive No 95/46/EC of 24 October 1995 on the protection of individuals with regard to

the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995).

(2002/C 40 E/260)

WRITTEN QUESTION E-2360/01

by Cristiana Muscardini (UEN) to the Commission

(6 August 2001)

Subject: Continuing anomaly regarding supplementary patent protection certificates for Italian medicinal

products

Under Article 1 of the Italian Law No 349 of 19 October 1991, holders of a patent for an industrial
invention applying in Italy to a medicinal product or a process for the manufacture of such a product may
obtain a supplementary protection certificate valid for not more than 18 years from the date on which the
patent reaches the end of its legal life. Regulation (EEC) No 1768/92 (1) has laid down standard rules
governing the issue of such certificates by all Member States with effect from 2 January 1993. Article 20,
however, stipulates that the Regulation does not apply to rights acquired before the date of its publication
in the Official
Journal. Given that the force of the certificates issued under the pre-existing Italian
legislation will not expire until 2011, it is clear that products protected by the Italian legislation are being