WRITTEN QUESTION P-1979/03 by Ian Hudghton (Verts/ALE) to the Commission. Synthetic progestins in contraceptive pills and Hormone Replacement Therapy.
Date: 2003-06-10
Institutions: European Parliament, Provisional data
Subjects: consumer information, contraception, disease prevention, drug surveillance, health risk, medical research, pharmaceutical product

C 78 E/394

Official Journal of the European Union

EN

27.3.2004

the public. Indeed, these are the only meaningful figures for policy purposes. Methodological differences do
not allow us to produce eurozone (and EU non-eurozone) aggregates comparable to ECB aggregates.

As regards trade plus services data, information from tables 1 and 2 cannot be added because table 1
includes c.i.f. data, and therefore addition would imply double counting of those costs.

(1) OJ C 28 E, 6.2.2003.
(2) OJ C 268 E, 7.11.2003, p. 188.
(3)

For further details see ECB Monthly Bulletin (cid:1) euro area statistics, Methodological Notes, Chapter 8, page 4, http://
www.ecb.int/stats/mb/ecb_bull_8note.pdf

(2004/C 78 E/0417)

WRITTEN QUESTION P-1979/03

by Ian Hudghton (Verts/ALE) to the Commission

(10 June 2003)

Subject: Synthetic progestins in contraceptive pills and Hormone Replacement Therapy

There is growing concern amongst users of oral contraceptives and HRT treatments which contain
synthetic progestins following reports on possible links between synthetic progestins and breast cancer, as
well as other health risks. Synthetic progestins are known to lead to oestrogen dominance which is, in
turn, linked with breast cancer.

Can the Commission indicate what research is being undertaken to establish whether women are at risk
from synthetic progestins; what guidance is being given to medical practitioners about using products
containing synthetic progestins while the safety of these products is in doubt; and what public information
is being provided to EU citizens to enable them to make informed choices about pharmaceutical products
containing synthetic progestins?

Answer given by Mr Liikanen on behalf of the Commission

(2 July 2003)

The Commission is aware of the concern amongst users of combined oral contraceptives (COCs) and
Hormone Replacement Therapy (HRT).

The European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Proprietary
Medicinal Products (CPMP) on 28 September 2001 adopted a Public Assessment Report on ‘Combined oral
contraceptives and venous thromboembolism’ and a Position statement after its assessment of ‘third
generation combined contraceptives containing the progestins desogestrel or gestodene and the risk of
venous thromboembolism.’

In this report the CPMP considers that the Summaries of Products Characteristics (SPC) (i.e. the scientific
documentation related to the products) and the User Package Leaflets should reflect the precautions for use
of these products and should be communicated to the prescribers of COCs as well as the women in need
of contraceptive therapy.

Last December 2002 the Member States medicine authorities adopted a core SPC for HRT with
information on the risk of cardiovascular disease and cancer.

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On the other hand in order to assess the raised pharmacovigilance signals on venous thromboembolism,
COCs and HRT are involved in a specific study and review at the Pharmacovigilance working group of the
CPMP. There is not yet a definitive scientific position as the evaluation is going on.

In addition, the Commission is financing the European Prospective Investigation into Cancer and nutrition
(EPIC). This study might also contribute to unravelling an increased or decreased, but so far unknown,
relative risk for breast cancer linked to COC and/or HRT.

(2004/C 78 E/0418)

WRITTEN QUESTION E-2121/03

by Isabelle Caullery (UEN) to the Commission

(25 June 2003)

Subject: Developing infrastructure and promoting employment in Madagascar

Can the Commission inform us of the various types of aid, measures, programmes and/or budget lines that
can be used for development measures in Madagascar, particularly:

1.

2.

3.

4.

in the renewable energy sector (including wind energy), in a country which depends essentially on
hydrocarbon imports;

for promoting reafforestation (given that the country has seen 65 % of its forests disappear);

for building rural villages, using bricks as the raw material, an activity which creates a great many jobs
and whose objective is to establish populations in their place of origin in the best possible conditions;

for building tourist villages or complexes which could generate employment and steady incomes for
local populations?

Can the EDF (European Development Fund) be called upon to contribute to such projects, and in
accordance with which procedures?

Can the Commission also tell us what facilities are offered by the EIB to promote all or some of these
projects?

Answer given by Mr Nielson on behalf of the Commission

(4 August 2003)

The Community has allocated,
the 9th European Development Fund (EDF),
development aid to Madagascar for a total amount of EUR 327 million for the period 2002-2007. Main
sectors of intervention, agreed with the Madagascar Government, are transport, rural development and
food security, macro-economic support and good governance, with particular attention to actions aimed at
strengthening civil society by developing representation and legitimacy.

in the framework of

EDF development aid is complemented by yearly contributions from the Community budget, particularly
for food aid.

1.
There is not an explicit policy on promoting renewable energy in the present country co-operation
strategy. However in the past, some micro hydro-electrical plants have been financed. Besides, there are
not initiatives in this specific sector at national level or promoted by other donors and windmills and solar
energy would require substantial investments, which the target group is not able to sustain at this stage.

2.
Reforestation is foreseen in the framework of the 9th EDF rural development programme in the
context of watershed development interventions. In addition, in the context of the budget line ‘Tropical
Forests’, community-based management of plantation forests is promoted.