WRITTEN QUESTION P-2012/01 by Christopher Heaton-Harris (PPE-DE) to the Commission. White Paper on Governance in the European Union.
Date: 2001-07-03
Institutions: European Parliament, Provisional data
Subjects: EU publication, European Union, budget, operation of the Institutions

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 = 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?

C 93 E/46

Official Journal of the European Communities

EN

18.4.2002

Answer given by Mr Prodi on behalf of the Commission

(8 October 2001)

The White Paper was adopted by the Commission on 25 July 2001 (1). The text is available on the Europa
site (http://europa.eu.int/governance/white_paper/index_en.htm) and will shortly be published in brochure
form by the Publications Office.

The White Paper was drafted by the Commission. Preparatory work involved most departments, meeting
within twelve working parties set up and coordinated by a team reporting to the Secretary-General. The
themes and working methods were adopted by the Commission on 11 October 2000 (2).

Preparatory work included workshops, surveys, consultations and hearings of people outside the
Commission. A detailed report on these consultations has been drawn up. It will be included in the
preparatory documents to the White Paper which will be published shortly. A copy of the report is being
sent direct to the Honourable Member and Parliament’s Secretariat.

The White Paper did not have a budget of its own. The necessary human and financial resources were
financed from administrative appropriations regularly allocated by the budgetary authority to the
Commission in order to carry out its tasks.

(1) COM(2001) 428 final.
(2) SEC(2000) 1547/7 final, published on http://europa.eu.int/comm/governance/work/en.pdf.

(2002/C 93 E/060)

WRITTEN QUESTION E-2015/01

by Chris Davies (ELDR) and Monica Frassoni (Verts/ALE) to the Commission

Subject: Lefke Copper Mines, Cyprus

(13 July 2001)

Has the Commission any concerns about possible future damage to the ecology of the Mediterranean Sea
as a result of cyanide and other pollutants escaping from the workings around the abandoned copper
mines at Lefke in occupied northern Cyprus?

Will the Commission give consideration to the possibility of using funds allocated for bi-communal
activities on Cyprus to carry out a study into this issue?

Answer given by Mr Verheugen on behalf of the Commission

(4 September 2001)

The Commission is aware of the Lefke copper mine in northern Cyprus and the environmental fears that
have been expressed from some quarters. The Commission will decide whether there is scope for a
Community initiative in this area on the basis of the results of an assessment study being launched by the
United Nations Office for Project Services (UNOPS).

(2002/C 93 E/061)

WRITTEN QUESTION E-2017/01

by Chris Davies (ELDR) and Monica Frassoni (Verts/ALE) to the Commission

Subject: Bi-communal projects on Cyprus

(13 July 2001)

What allocation of funding towards bi-communal projects on Cyprus has been made in each financial year
since an allocation was first agreed?