WRITTEN QUESTION P-0110/03 by Peter Liese (PPE-DE) to the Commission. Vaccination against smallpox in the Member States.
Date: 2003-01-21
Institutions: European Parliament, Provisional data
Subjects: area of freedom, security and justice, biological weapon, health control, infectious disease, public safety, terrorism, vaccination, vaccine

8.4.2004

EN

Official Journal of the European Union

C 88 E/315

facts and are in the public domain. The Commission is aware, for instance, that the disaster began with a
fire breaking out in a semi-trailer towing vehicle a few minutes after it had driven through the Chamonix
toll-station. Various possible explanations have been put forward as to how this fire actually started in the
towing vehicle. At the moment, none of these theories can be either confirmed or ruled out, and it is up to
the experts appointed by the examining magistrate to check their relevance.

On 30 December 2002 the Commission submitted a proposal
for a Directive on minimum safety
requirements for tunnels in the trans-European road network, in order to prevent such accidents and to
protect tunnel users.

The Commission also intends to make it mandatory for hand-held fire extinguishers or fire extinguishing
systems to be fitted in all vehicles with a maximum mass of more than 3,5 tonnes. It will also endeavour
to resolve the safety problems posed by the additional fuel tanks which may be mounted on heavy goods
vehicles.

Lastly, in the course of 2003, the Commission will submit a proposal to extend Community type-approval
to commercial vehicles. In the meantime, type-approval of such vehicles remains the responsibility of each
Member State and national regulations apply to the construction standards governing such vehicles.

(2004/C 88 E/0320)

WRITTEN QUESTION P-0110/03

by Peter Liese (PPE-DE) to the Commission

(21 January 2003)

Subject: Vaccination against smallpox in the Member States

Various preparations are currently being made in the Member States to combat possible terrorist attacks
using the smallpox virus. Media reports have caused great alarm among the general public. Since the
smallpox virus would obviously not stop at the frontiers of the Member States, an EU-wide approach is
essential.

Does the European Commission have any information about the various strategies in the Member States?
What plans are there for transfrontier coordination of the various strategies of the individual Member
States? Can the Commission offer to assist the Member States, with particular regard to an assessment of
the possible side effects of vaccination against smallpox? To what extent will
it be possible to take
advantage of the benefits of the single market in order to ensure that supplies of highly-effective vaccines
which have minimal side effects are available in all the Member States as rapidly as possible when
required?

Answer given by Mr Byrne on behalf of the Commission

(12 February 2003)

As indicated in its Communications ‘Civil protection (cid:1) State of preventive alert against possible
emergencies’ (1) and ‘Civil protection (cid:1) Progress made in implementing the programme for preparedness
for possible emergencies’ (2),
the Commission and the Member States are working together in the
framework of a programme on health security to strengthen preparedness for and response to deliberate
the confidential
releases of biological and chemical agents to cause harm. This involves,
exchange of information and sharing of best practice on national strategies to face up to a smallpox
outbreak and allow the highest possible degree of co-ordination in introducing counter-measures. It also
involves the dissemination of information, reviews and guidelines for health professionals on priority issues
such as surveillance, detection, laboratory analysis and case management.

inter alia,

The side-effects of smallpox vaccination dating from the World Health Organisation’s (WHO) eradication
programme have been well documented and published. New data arising out of planned vaccination in
some countries will, however, be disseminated by the Commission’s Task Force on Health Security once
they become available.

C 88 E/316

Official Journal of the European Union

EN

8.4.2004

There are currently no authorised small pox vaccines in the Community. New vaccines are in development,
but no application for marketing authorisation has been received yet. In the absence of a product that has
received market authorisation in the Community, Member States are building up national stocks from
either first generation or second generation unlicensed vaccines.

The ad hoc expert group on vaccines established at the request of the Commission by the European
Medicines Evaluation Agency (EMEA) developed guidance on the development of vaccinia virus vaccines
against small pox (3). This was published on the Commission and EMEA websites in July 2002. It includes
a section on the assessment of safety and post-authorisation studies.

Any new vaccine would be eligible to apply for marketing authorisation through the centralised procedure,
for which an accelerated assessment could be provided. If the necessary criteria of safety, efficacy and
quality were met this would result in a Community authorisation, immediately applicable in all Member
States.

Under the Sixth Framework Research Programme, research leading to new vaccines against potential bio
agents and novel therapeutics will be supported.

(1) COM(2001) 707 final.
(2) COM(2002) 302 final.
(3) Note for guidance on the development of vaccinia virus based vaccines against

macos.eudra.org/F2/home.html or http://www.emea.eu.int/.

smallpox. http://phar-

(2004/C 88 E/0321)

WRITTEN QUESTION E-0131/03

by Joan Colom i Naval (PSE) to the Commission

(28 January 2003)

Subject: Implementation of budget heading B2-1411 (Support for regions bordering candidate countries)

Budget heading B2-1411 (Support for regions bordering candidate countries) was created under the 2002
budget procedure and was allocated EUR 30 million in commitment appropriations and EUR 14 million in
payment appropriations.

According to the Commission report on the implementation of commitments and payments as at
31 December 2002, the implementation rate for the commitment appropriations was 100 % but for the
payment appropriations only 14 %.

Will the Commission state the reasons for such a low rate of payment-appropriation implementation?

Answer given by Mr Barnier on behalf of the Commission

(4 March 2003)

The Honourable Member is requested to refer to the Commission’s answer to Written Question E-3917/02
by Mr Naranjo Escobar (1).

(1) See page 310.