WRITTEN QUESTION E-2808/03 by Albert Maat (PPE-DE) to the Commission. Risks of hormone therapies.
Date: 2003-09-19
Institutions: European Parliament, Provisional data
Subjects: cancer, consumer information, disease prevention, drug surveillance, hormone, therapeutics

3.4.2004

EN

Official Journal of the European Union

C 84 E/39

Can the secrecy which has so far existed with regard to officials’ being assigned or deprived of special
5.
adviser status soon be replaced with public arrangements which do not afford any scope for rumours or
accusations of arbitrariness?

Answer given by Mr Kinnock on behalf of the Commission

(4 November 2003)

1.
As appointing authority the Commission may, under the provisions of the Staff Regulations and
operational rules, decide to reassign an official from a management position to a non-management
function at any time, if it considers this to be in the interest of the service. Directors can therefore be
reassigned to a function of ‘principal adviser’. The corresponding non-managerial function for Directors
General and Deputy Directors General is ‘adviser hors classe’.

‘Special advisers’ are individuals who -on account of their expertise and qualifications- are given a contract
as special adviser and are attached to one of the Commissioners. They can be outside experts or retired
(high level) Commission officials, and in the latter case are only entitled to reimbursement of expenses.
Special advisers to the Commission are not (or no longer) Commission officials and hence do not exercise
managerial functions, nor do they appear in the organisation chart.

Persons who occupy a function as ‘principal adviser’ or as ‘adviser hors classe’ feature in the
2.
organisation chart. An assignment to these functions can either be for a long or short period and the tasks
and responsibilities are defined by the relevant appointing authority.

The Commission agrees that it is desirable that officials to whom such status has been assigned

3.
should remain available to serve the institution, unless the interest of the service requires otherwise.

4. Mrs Andreasen has not been removed from the organisation chart which is drawn up for
information purposes and in any case has no legal status. Her name is included in the most recent
version (16 September 2003) of the organisation chart of Directorate General (DG) for Personnel and
Administration as well as in the updated Commission Directory recently published on the Commission’s
intranet ‘IntraComm’.

5.
‘Special advisers’ are not officials but staff falling under the scope of the Conditions of Other Servants
of the Communities. As indicated under point 1, they are attached to one of the Commissioners and are
selected for their expert capabilities to serve the Institution on that basis. The Commission is not aware of
any ‘rumours or accusations of arbitrariness’, or of any evidence of arbitrariness in their selection.

(2004/C 84 E/0043)

WRITTEN QUESTION E-2808/03

by Albert Maat (PPE-DE) to the Commission

(19 September 2003)

Subject: Risks of hormone therapies

At the beginning of August the British journal The Lancet published findings which demonstrated the
existence of a link between certain hormone therapies and breast cancer. The findings were particularly
concerned with hormone therapies for problems associated with the menopause or osteoporosis using
estrogens and the synthetic hormone tibolon, and with preparations combining estrogens and
progestogens.

Moreover, research by the University of Groningen has shown that the use of hormones after the
menopause can also increase the risk of cardiovascular diseases, whereas previously it was assumed that
hormone therapies actually afforded protection against cardiovascular diseases and osteoporosis.

What is the Commission doing to protect citizens of the Union and consumers of such products against
these recently demonstrated risks, and to inform them of the dangers?

C 84 E/40

Official Journal of the European Union

EN

3.4.2004

Answer given by Mr Liikanen on behalf of the Commission

(15 October 2003)

Hormone Replacement Therapy (HRT) products are authorised for
symptoms. Some products are also authorised for the prevention of osteoporosis.

the treatment of menopausal

The increased risk of breast cancer with HRT has been recognised for some time. New data regarding the
risks of breast cancer, as well as data suggesting an increased risk of cardiovascular disease have recently
become available.

A working group on HRT with experts from the Member States, of the Mutual Recognition Facilitation
Group (MRFG) has been updating a European ‘core’ Summary of Product Characteristics (SPC) for the last
few years. An SPC has two functions. Firstly it is part of the Marketing Authorisation of a product and
secondly it is a communication document to inform healthcare professionals about a particular product
and how to use it safely. Because most HRT products are authorised nationally a European ‘core’ SPC was
developed. This is used as a template by the Member States as the basis for the national HRT SPCs. The
European ‘core’ SPC contains clear warnings about the risks of breast cancer and cardiovascular disease.
Hence these warnings appear in national SPCs. The HRT Working Group of the MRFG meets at the
European Agency for the Evaluation of Medicinal Products (EMEA) and takes advice from the Committee
for Proprietary Medicinal Product’s- (CPMP) Pharmacovigilance Working Party.

In light of the new data on the risks of HRT, national competent authorities in the Member States have
communicated with healthcare professionals and users of HRT with information about the risks of HRT
therapy. At a European level, the EMEA has made available funds for a new CPMP ad-hoc working group
on HRT. This working group will build on the work already done by the MRFG Working Group and will
advise CPMP what further action, if any, is required to protect the citizens of the Union from the risks of
HRT. In addition, the Community under its three consecutive ‘Europe against Cancer’ programs has helped
to set up a system of cancer surveillance through the European Network of Cancer Registries (ENCR) as
well as a large European prospective investigation into cancer and nutrition (EPIC), which studies among
522 000 volunteers, of which about 320 000 are women, risk factors for cancer related to diet, lifestyle
and physical activity. This prospective study is also expected to contribute evidence on the relative risks for
breast cancer related to hormone replacement therapy.

(2004/C 84 E/0044)

WRITTEN QUESTION E-2902/03

by Miet Smet (PPE-DE) to the Council

(1 October 2003)

Subject: Suspension of cooperation agreements and postponement of their signature

In its answer to my Question E-0520/03 (1) of 13 February 2003 about respect for women’s rights in
Pakistan, the Council has told me that, so far, not one agreement with a third country in which a human
rights clause has been incorporated as an ‘essential element’ has been suspended.

It is true that the EU has in a number of cases where the essential elements of the agreement have been
infringed suspended some provisions of the agreement. This was the case for the financial provisions of
the Cotonou Agreement with Zimbabwe (2002), Comoros (2000), Côte d’Ivoire (2000), Fiji (2000), Haiti
(2000) and Liberia (2001). What infringements of essential elements took place in these six countries?

In the case of Croatia (1995), Pakistan (1999), Algeria (1998) and Russia (1995) the signature of the
cooperation agreements was postponed because of concern about human rights.
is of
course a broad term. What kind of infringements of human rights were involved in this case in these four
countries?

‘Human rights’

(1) OJ C 280 E, 21.11.2003, p. 62.