WRITTEN QUESTION E-3200/02 by Paul Lannoye (Verts/ALE) and Caroline Lucas (Verts/ALE) to the Commission. Vigilance concerning vaccines.
Date: 2002-11-08
Institutions: European Parliament, Provisional data
Subjects: disease prevention, health control, health policy, infectious disease, information network, public health, vaccine

18.9.2003

EN

Official Journal of the European Union

C 222 E/51

At all events, it is always the responsibility of the national authorities to investigate such behaviour, if it
emerges that there has been a violation of one or more Community directives laying down minimum
requirements in the field of industrial relations, and to enforce the rights in question where necessary.

The strategy to promote Corporate Social Responsibility (CSR) in the Union, which was proposed by the
Commission in its Green Paper and in the subsequent Communication (1), does not make provision for
sanctions mechanisms, as it defines CSR as company behaviour which goes beyond legal requirements.
However, the Commission has pointed out that the legal requirements laid down in legislation must be
respected and enforced.

(1) COM(2002) 347 final.

(2003/C 222 E/055)

WRITTEN QUESTION E-3200/02

by Paul Lannoye (Verts/ALE) and Caroline Lucas (Verts/ALE) to the Commission

Subject: Vigilance concerning vaccines

(8 November 2002)

Although vaccines fall within the category of medical preparations and a growing number of studies show
to
that
pharmacovigilance, which is compulsory in order to detect any side-effects of medicines.

there is no vigilance concerning vaccines equivalent

they have many undesirable effects,

However, Decision 2119/98/EC (1) of the European Parliament and of the Council, whose purpose ‘is to set
up a network at Community level to promote cooperation and coordination between the Member States,
with the assistance of the Commission, with a view to improving the prevention and control, in the
Community, of categories of communicable diseases,
including diseases preventable by vaccination’,
already forms part of a policy of Community vigilance with regard to vaccines.

the specific research,

Moreover,
technological development and demonstration programme to be
implemented through direct measures by the Joint Research Centre for the period 2002-2006 also
provides for specific research activities focusing on vaccine safety.

Does the Commission not therefore feel that a system of vigilance concerning vaccines should be set up as
soon as possible at European level, in line with the provisions of Decision 2119/98/EC?

(1) OJ L 268, 3.10.1998, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(11 December 2002)

The Commission is working closely with the Member States, under Decision No 2119/98/EC (1),
to strengthen the surveillance of communicable diseases including the major vaccine preventable diseases.
All the major vaccine preventable diseases are included in the list of communicable diseases to be
progressively covered by the Community network (Commission Decision 2000/96/EC (2)) and a standard-
ised case definition for reporting is defined (Commission Decision 2002/253/EC (3)).

An early warning and rapid response system is in place and it will ensure an appropriate public health
response in case of notification of new events caused by major vaccine preventable diseases (Commission
Decision 2000/57/EC (4)),
infections caused by Haemophilus influenzae type b,
influenza, measles, mumps, pertussis, poliomyelitis, rubella, hepatitis A and B, meningococcal disease, and
pneumococcal infections.

including: diphtheria,

C 222 E/52

Official Journal of the European Union

EN

18.9.2003

Medicinal products for human use, including vaccines, are closely monitored to allow timely evaluation of
new information relevant to the risks and benefits of these products, so that appropriate action may be
taken, when necessary, to protect public health. The conduct of pharmacovigilance rests on a number of
parties, i.e. the Member States, the Commission, the European Agency for the Evaluation of Medicinal
Products (EMEA) and the Marketing Authorisation Holders.

All relevant information about suspected adverse reactions caused by medicinal products for human use
occurring within or outside the Union will be taken into account in accordance with Articles 19-26 of
‘Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the
authorization and supervision of medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (5)’ and Articles 101-109 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 (6). The Commission submitted to Parliament and Council a proposal to
modify the above-mentioned Regulation and Directive in order to strengthen the safety of medicinal
products within the Community.

Nevertheless, there is still a lack of scientific knowledge in many respects. For that reason the Commission
has funded, within the 5th Framework Program, more than 65 research projects related to vaccine
development and vaccination strategies.
it is
relevant to mention two projects: ‘European research programme for improved vaccine safety surveillance’,
designed to provide a scientific basis for improved vaccine safety surveillance and ‘European Sero-
Epidemiology Network 2’, aiming at co-ordinating and harmonising the serological surveillance of
immunity to a variety of vaccine preventable infections (measles, mumps, rubella, diphtheria, pertussis,
varicella zoster virus, hepatitis A and hepatitis B).

In particular regarding surveillance and adverse effects,

(1) Decision No 2119/98/EC of the Parliament and of the Council of 24 September 1998 setting up a network for the

epidemiological surveillance and control of communicable diseases in the Community.

(2) Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to be progressively
covered by the Community network under Decision No 2119/98/EEC of the Parliament and of the Council (cid:1)
OJ L 28, 3.2.2000.

(3) Commission Decision 2002/253/EC of 19 March 2002 laying down case definitions for reporting communicable
diseases to the Community network under Decision No 2119/98/EC of the Parliament and of the Council (cid:1)
OJ L 86, 3.4.2002.

(4) 2000/57/EC: Commission Decision of 22 December 1999 on the early warning and response system for the
prevention and control of communicable diseases under Decision No 2119/98/EC of the Parliament and of the
Council (cid:1) OJ L 21, 26.1.2000.

(5) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization
and supervision of medicinal products for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (cid:1) OJ L 214, 24.8.1993.

(6) OJ L 311, 28.11.2001.

(2003/C 222 E/056)

WRITTEN QUESTION P-3218/02

by Marianne Eriksson (GUE/NGL) to the Council

(7 November 2002)

Subject: Visa enabling Russian citizens to enter the EU

In September this year I invited three women who work at a women’s crisis centre in Murmansk to
participate in a European Parliament conference on prostitution and trafficking in women, on
9/10 October 2002. When I spoke to Belgian diplomatic staff in Moscow and St Petersburg about the
possibility of obtaining visas for them, everyone I spoke to gave different answers, but it seemed clear that
the women would have to go to Moscow with my original invitation, and that even then they would not
be certain of obtaining a visa. I also spoke to the Swedish visa authorities about the possibiltiy of their
flying via Sweden, but was told that a visa for Sweden would not be sufficient for them to travel on to
Belgium (Schengen agreement), and that they would require a visa for each separate EU country. I think it