WRITTEN QUESTION E-0673/00 by Cristiana Muscardini (UEN) and Roberta Angelilli (UEN) to the Commission. Transfer of personal data and respect for privacy.
Date: 2000-03-09
Institutions: European Parliament, Provisional data
Subjects: United States, protection of privacy, tariff negotiations

C 374 E/130

Official Journal of the European Communities

EN

28.12.2000

How does it intend to uphold fundamental human rights and ensure that, unlike in countries such as the
United States and Japan,
it is impossible in the European Union to patent procedures involving the
manipulation of the genetic structure of cells for the purpose of creating living organisms?

How does it intend to ensure that the document approved by the Patent Office categorically rules out the
cloning of human beings?

Answer given by Mr Bolkestein on behalf of the Commission

(25 April 2000)

The actions of the European Patent Office (EPO), which is not a Community institution, are governed by
the European Patent Convention (EPC). This Convention is an international agreement to which 19 coun-
tries including all the Member States are a party. The implementing regulations to the EPC were amended
last year to take account of Directive 98/44/EC of the Parliament and of the Council of 6 July 1998 on the
inventions (1). The regulations,
in following the wording of the
legal protection of biotechnological
directive, specifically exclude from patentability processes for cloning human beings, processes for
modifying the germ line genetic identity of human beings and uses of human embryos for industrial or
commercial purposes.

In response to the controversy surrounding European patent EP0695351, the Commission wrote to the
EPO expressing concern about the granting of this patent and seeking a swift amendment of this patent. In
response, the EPO has agreed to constitute an opposition division earlier than normal to consider the
oppositions that have already been filed in respect of this patent. This opposition division was duly
constituted on 29 March 2000 and is expected to issue a preliminary ruling shortly. The Commission will
continue to monitor developments and, should the action of the EPO prove inadequate, will consider
further action including the possibility of the Commission or the Community formally opposing this
patent before the EPO.

(1) OJ L 213, 30.7.1998.

(2000/C 374 E/155)

WRITTEN QUESTION E-0673/00

by Cristiana Muscardini (UEN) and Roberta Angelilli (UEN) to the Commission

Subject: Transfer of personal data and respect for privacy

(9 March 2000)

Pursuant to Articles 29 and 31 of Directive 95/46 (1) on the protection of individuals with regard to the
processing of personal data, the Working Party on Protection of Individuals and the data protection
committee have been recognised as essential bodies in the debate on fixing the rules governing the
application of the directive in question outside EU territory and notably in the United States. Negotiations
with that country have now been in progress for two years, with no date set for their conclusion.

Can the Commission say:

1. What points does the EU consider as essential as regards guarantees and which cannot be agreed

under the approach currently being adopted in the negotiations?

2. Are the differences between the legal systems concerned so great as to prevent a compromise solution

being reached that would provide firm guarantees for citizens and consumers?

3. Would not acceptance by Europe of the self-regulation principle proposed by the United States ((cid:145)safe
harbour(cid:146)) be liable to weaken the protection of privacy and undermine the rules laid down in the
directive?

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Official Journal of the European Communities

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4. Given the danger that the conclusion of the negotiations may be postponed indefinitely, would it not
be better to use contractual models for the transfer of data outside the European Union, such as those
drawn up by the Council of Europe and the International Chamber of Commerce?

5. Does the Commission not think that, in any case, the EU(cid:146)s main requirement should be to provide
adequate protection of personal data for European citizens and ensure legal certainty for European
businesses?

(1) OJ L 281, 23.11.1995, p. 31.

Answer given by Mr Bolkestein on behalf of the Commission

(2 May 2000)

The informal dialogue that the Commission has been conducting with the United States Department of
commerce in accordance with Article 25 of Directive 95/46/EC of the Parliament and of the Council 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 reached a provisional conclusion at the end of March 2000. The
Parliament has already been informed that the Commission is presently recommending that Member
States, meeting in the management committee set up under Article 31 of the data protection Directive,
examine the American proposal for a (cid:145)safe harbor(cid:146) with a view to issuing a positive opinion on the level of
protection it provides. When such an opinion is delivered it will enable the Commission, on the basis of
Article 25.6 of the data protection Directive, to adopt a decision recognising the safe harbor as providing
adequate protection for the transfer of personal data to the American companies participating.

Companies that voluntarily adhere to self-regulatory system of the safe harbor will be required to disclose
unambiguously and publicly their commitment to comply with the safe harbor principles and to be subject
to the statutory powers of an American public body. In case of non-compliance with the principles, such a
body must be empowered to investigate complaints and to obtain relief against unfair or deceptive
practices as well as redress for individuals, irrespective of their country of residence or nationality.

The Commission considers these guarantees to be sufficient for both Community operators and citizens
and hence does not consider that the proposed adequacy finding will undermine the rules laid down in the
directive. In particular the Commission recalls the approach of the working party of data protection
commissioners established under Article 29 of the Directive, recognising that self-regulation can in
principle deliver effective privacy protection (1).

The Commission(cid:146)s goal is not only to conclude the discussions with the United States as soon as possible,
but also to initiate proceedings leading to the adoption of a Commission decision, based on Article 26.4 of
the data protection Directive, recognising standard contractual clauses which offer sufficient safeguards for
data transfers to any third country. The Commission considers that such clauses are needed to complement
adequacy findings for specific third countries or sectors thereof, by providing an instrument available to
Community operators to export data to any third country on a case by case basis.

The Commission agrees with the Honourable Members that the Community(cid:146)s primary concern should be
to provide adequate protection of personal data transfers to third countries and legal certainty for
European businesses. It believes that it has successfully worked towards achieving both these goals.

(1) Working Document WP 12 (cid:145)Transfers of personal data to third countries: Applying Articles 25 and 26 of the EU

data protection directive(cid:146), adopted on 24 July 1998 and available at http://europa.eu.int/comm/internal.