WRITTEN QUESTION E-2001/01 by Concepció Ferrer (PPE-DE) to the Commission. Distribution of pharmaceutical products in the Third World.
Date: 2001-07-06
Institutions: European Parliament, Provisional data
Subjects: World Health Organisation, developing countries, medicinal product, pharmaceutical legislation, product quality, public health

C 93 E/44

Official Journal of the European Communities

EN

18.4.2002

Answer given by Mrs de Palacio on behalf of the Commission

(21 September 2001)

On 15 May 2001 the Commission adopted a communication on a European strategy for sustainable
development (1). The strategy proposed by the Commission provides in particular for the gradual removal
by 2010 of subsidies for the production and consumption of fossil fuels. Aware, however, of the possible
impact of certain decisions on the security of long-term energy supply in the Union, the Commission said
there was a need to look into whether it was necessary to create a coal reserve or whether a minimum
production of coal could be maintained. The communication also stated that the Commission would be
submitting a proposal to the Council in the course of 2001 with a view to the adoption of a system of
State aids to the coal industry before the ECSC Treaty expires in July 2002.

Thus, despite the fact that it favours the development of more environmentally friendly energy sources, the
sustainable development strategy proposed by the Commission is consistent with the approach developed
in the Green Paper on a European strategy for the security of energy supply adopted by the Commission
on 29 November 2000 (2), since it does not rule out the possibility of measures for maintaining a
it acknowledges the need to find a compromise between
minimum of coal production.
environmental protection on the one hand and improving the security of energy supply on the other.

In fact

Based on these principles, the Commission adopted by its Decision of 25 July 2001 a proposal for a
Council Regulation on State aid to the coal industry (3) after the expiry of the ECSC Treaty. The system
proposed amounts to the creation by the Member States of an indigenous base of primary energy sources,
in order to improve the Union’s security of energy supply.

The Commission does not intend to prohibit the production of electricity from coal in the Union. On the
contrary, the Green Paper ‘Towards a European strategy for the security of energy supply’ says that
electricity production will in future have to be covered by a range of energy products available on the
market: natural gas, coal, oil, nuclear and renewables.

The Commission has put in place a number of legislative measures in connection with the reduction of
pollutant emissions due to electricity production from fossil fuels, in particular Council Directive 88/609/
EEC of 24 November 1988 on the limitation of emissions of certain pollutants into the air from large
combustion plants (4) and Council Directive 96/61/EC of 24 September 1996 concerning integrated
pollution prevention and control (5).

In addition, with programmes like Energy, Carnot and the ECSC Research Programme the Commission is
supporting the development, demonstration and dissemination of clean technologies for producing energy
from fossil fuels.

(1) COM(2001) 264 final.
(2) COM(2000) 769 final.
(3) COM(2001) 423 final.
(4) OJ L 336, 7.12.1988.
(5) OJ L 257, 10.10.1996.

(2002/C 93 E/058)

WRITTEN QUESTION E-2001/01

by Concepció Ferrer (PPE-DE) to the Commission

(6 July 2001)

Subject: Distribution of pharmaceutical products in the Third World

Reports have recently appeared in the media to the effect that almost 50 % of pharmaceutical products
sent to the Third World are counterfeit or are in a very poor condition.

18.4.2002

EN

Official Journal of the European Communities

C 93 E/45

The reports mention two studies carried out in Nigeria and South-east Asia and coordinated by Aberdeen’s
Robert Gordon University. According to the studies’
findings, 48 % of the pharmaceutical products
intended to combat malaria, bacteria and tuberculosis have levels of active ingredients which are either
higher or lower than the recommended levels.

The pharmaceutical products analysed in Nigeria come from 12 different countries.

An earlier report by the World Health Organisation found that the quality of 31 % of pharmaceutical
products imported into Burma and Vietnam and 46 % of pharmaceutical products produced locally were
substandard.

Has the Commission any information regarding these statistics? If so, what action is being taken in the
European Union in order to prevent substandard pharmaceutical products from being exported to third-
world countries?

Answer given by Mr Nielson on behalf of the Commission

(13 September 2001)

The Commission is aware that the quality of pharmaceutical products on the market in many countries
remains a major public health concern and recognises that even if pharmaceutical products are available,
weak regulation may mean that they are substandard or counterfeit. Irrational use of pharmaceutical
products and globalisation of the pharmaceutical industry are also bringing other safety issues to the fore.

In this regard, it has to be highlighted that all proprietary medicinal products manufactured and used in
the Community or manufactured and imported from third countries are subject to tight regulations before
marketing authorisations can be delivered. Provisions are laid down in Community directives (1) and
guarantee the quality and safety of products. These regulations also apply to medicines exported to third
countries.

The Commission’s recent Communication on accelerated action on human immunodeficiency virus/
acquired immune deficiency syndrome (HIV/AIDS), malaria and tuberculosis in the context of poverty
reduction (2), also stipulates that the Community will support the development of local production capacity
in developing countries and the strengthening of pharmaceutical policy and practice through national and
regional co-operation, capacity building and financial and technical assistance. Particular efforts will inter
alia be made to improve quality assurance, distribution and optimal use of pharmaceuticals.

The development worldwide of norms, standards and guidelines to promote quality assurance and quality
control for the key pharmaceuticals and medicines is an integral part of World Health Organisation’s
Constitution and mandate.

(1) Second Council Directive 75/319/EEC C OJ L 147, 9.6.1975, p. 13.
(2) COM(2001) 96 final.

(2002/C 93 E/059)

WRITTEN QUESTION P-2012/01

by Christopher Heaton-Harris (PPE-DE) to the Commission

Subject: White Paper on Governance in the European Union

(3 July 2001)

When will the Commission publish the White Paper on Governance in the European Union?

Who were the chief contributors to this White Paper, and will the Commission provide full details of the
budget available for its production, including, for example, the cost of organising seminars, payment of
experts and external consultancies, and all other related costs?