WRITTEN QUESTION E-1684/01 by Marit Paulsen (ELDR) to the Commission. Malaria vaccine.
Date: 2001-06-14
Institutions: European Parliament, Provisional data
Subjects: EU aid, EU initiative, developing countries, development aid, infectious disease, pharmaceutical industry, research and development, vaccine

16.5.2002

EN

Official Journal of the European Communities

C 115 E/9

A summary description of this ongoing programme is sent directly to the Honourable Member and to
Parliament’s Secretariat.

(2002/C 115 E/008)

WRITTEN QUESTION E-1684/01

by Marit Paulsen (ELDR) to the Commission

(14 June 2001)

Subject: Malaria vaccine

In October 1999, I asked the Commission whether it could submit a proposal, as an aspect of aid policy,
under which the Member States would place an order for a malaria vaccine with the pharmaceutical
companies and undertake to pay a certain price for a dose of vaccine.

The Commission subsequently replied that creativity and new partnerships were required to bridge the
enormous gap between human needs, scientific input and market profits, that initial talks were being held
in the Community on such an approach in relation to an AIDS vaccine for the developing countries and
that similar strategies could and should be developed for malaria.
It was also pointed out that the
Community was funding a pilot project for clinical demonstration in Gambia in partnership with a
pharmaceutical company.

According to the Commission, the Community was at that point, in November 1999, still in the initial
stages of developing that approach. 18 months have since passed, culminating in a major debate on AIDS
and the conduct of the pharmaceutical companies in South Africa. Will the Commission, therefore, say
what the results of the talks concerning an AIDS vaccine were, what measures were taken concerning an
AIDS vaccine for the developing countries on the basis of those results, and what the outcome of the pilot
project in Gambia was?

Answer given by Mr Nielson on behalf of the Commission

(3 September 2001)

There has been significant progress on malaria vaccine research since the Honourable Member’s Written
Question E-1790/99 (1). With Community support 14 candidate vaccines have been studied. This
represents a major share of the global effort. The Quality of Life and the International Cooperation
programmes of General Directorate Research have considerably increased resources dedicated to malaria
vaccine and malaria drug development. It is expected that at the end of the Fifth Framework Programme
for Research and Technological Development (R & D) of the Community more than € 30 million will be
spent on malaria research alone. In addition major integrated research consortia ‘Clusters’ including major
European vaccine manufacturers have been established. The European Malaria Vaccine Initiative (EMVI) has
capitalised on this Community research strengths. EMVI is a response to an acknowledged bottleneck in
publicly-funded vaccine research, whereby R & D efforts frequently stop at the late pre-clinical stage and do
not move into clinical validation, due to lack of funds and technical know-how.

The Community’s support to the African Malaria Vaccine Testing Network (AMVTN) represents a critical
links long-term and ongoing
opportunity to link the Commission with partners in the South.
investments into malaria vaccine development with capacity building in developing countries. The specific
partnership between EMVI and AMVTN, which was conceived to move promising vaccine candidates
further down the development pipeline, has added a great deal of credibility to the endeavour. The
AMVTN, under the ownership of developing countries, represents a major opportunity over the coming
years to further develop and assess efficacy and field effectiveness of malaria vaccines.

It

C 115 E/10

Official Journal of the European Communities

EN

16.5.2002

AMVTN is now developing trial sites based on earlier extensive epidemiological ground-work carried out
by three African countries with support from the Community and Member States. The current effort to
establish itself as a legal body under Tanzanian law is an important prerequisite to play an active role in
supporting the expansion of clinical trials in the region.

Following a positive evaluation of a malaria vaccine candidate in adults, the Community funded Gambia
pilot project is now conducting trials of safety, tolerance,
immunogenicity and protective efficacy in
children living in endemic areas.

Current research and development of human immunodeficiency virus (HIV) vaccines has shown that new
vaccination approaches can work in animal models. These include approaches developed in the private
sector (Merck, Glaxo Smith Kline) and under the current Community funded project cluster Eurovac in
partnership with Aventis/Pasteur. Trials are starting in humans to establish safety, and the first results can
be expected in 2002/2003. The Community is also funding preparatory work for trials in China and
Tanzania. Again the European consortia are at the forefront of this research.

In the Commission’s Programme for Action ‘Accelerated action on HIV/acquired immune deficiency
syndrome (AIDS), malaria and tuberculosis in the context of poverty reduction’ (2), endorsed by the General
Affairs Council of 14 May 2001, and in the Commission’s proposal for the specific programmes of the
Research Framework Programme 2002-2006 (3), the Commission proposed the creation of a European
Clinical Trials Platform (ECTP) as a joint activity of Member States and the Community to support the fight
against HIV/AIDS, malaria and tuberculosis in developing countries. The ECTP should have three main
functions:
to strengthen trial
infrastructures in endemic countries and to sponsor its own trial activities.

the networking and pooling of national

trial activities,

to support

(1) OJ C 203 E, 18.7.2000.
(2) COM(2001) 96 final.
(3) COM(2001) 279 final.

(2002/C 115 E/009)

WRITTEN QUESTION E-1749/01

by José García-Margallo y Marfil (PPE-DE) to the Commission

(15 June 2001)

Subject: Communication on intra-Community investment

In 1997 the Commission adopted an interpretative communication (1) on intra-Community investment
which it did not submit to either Parliament or the Council. According to Commissioner Bolkestein, the
objective of the communication was to ‘indicate,
to national authorities (…), how the Commission
interprets the provisions of (…) the Treaty on capital movements and the right of establishment’.

The Presidency conclusions of the Stockholm European Council state that ‘the Commission will also ensure
that those enterprises which still benefit from a monopoly situation on their national market will not
unduly benefit from that situation’.

Parliament recently adopted a resolution (PE 303.051) in which it ‘calls on the Commission to cease using
the above-mentioned communication as the basis for its infringement procedures and immediately to
propose a directive to replace the above-mentioned communication’.

When will the Commission propose this directive?

(1) OJ C 220, 19.7.1997, p. 15.