WRITTEN QUESTION P-0961/01 by Alexander de Roo (Verts/ALE) to the Commission. Health problems with the third generation contraceptive pill.
Date: 2001-03-19
Institutions: European Parliament, Provisional data
Subjects: consumer information, contraception, health risk, public health

21.8.2001

EN

Official Journal of the European Communities

C 235 E/249

(cid:129) with regard to the proposed developments in Teulada and Cala Giunco-Stagno Notteri, whether any
Community funding is earmarked? If so, does the Commission intend to freeze it pending confirma-
tion that the developments comply with Community legislation concerning LIFE and the Natura 2000
network?

(1) OJ C 136 E, 8.5.2001, p. 156.
(2) OJ C 151 E, 22.5.2001, p. 140.
(3) OJ C 151 E, 22.5.2001, p. 141.
(4) OJ C 151 E, 22.5.2001, p. 133.
(5) OJ L 206, 22.7.1992, p. 7.

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(15 May 2001)

The Commission is collecting the information it needs to answer the question. It will communicate its
findings as soon as possible.

(2001/C 235 E/294)

WRITTEN QUESTION P-0961/01

by Alexander de Roo (Verts/ALE) to the Commission

(19 March 2001)

Subject: Health problems with the third generation contraceptive pill

The Dutch consumers(cid:146) association is advising women and girls not to take the third generation contra-
ceptive pill. The book (cid:145)Nieuwe Medicijnen(cid:146) (New Medicines) says that this lighter pill affords a much
greater risk of thrombosis than the second generation pill. The third generation contraceptive pill was on
the agenda of the European Agency for the Evaluation of Medicinal Products (EMA) in late February 2001.
It appears that the re-evaluation of this type of pill was not positive because of possible health problems,
such as a significantly higher risk of thrombosis.

In April the EMA is organising a hearing with the companies involved, one major feature of which will be
the Wyeth report (report GMR 29549, December 1997) written by Axel Olson (of Wyeth). In addition, the
companies in question will apparently be submitting a more recent report.

Can the Commission make public the Wyeth report?

Is it true that in May the EMA will be taking a final decision on the admissibility of, and any changes to,
the patient information leaflet included with this sort of pill?

Does the Commission agree that transparency in this question (cid:129) when the health of millions of women
and girls is at stake (cid:129) is the first requirement?

Answer given by Mr Liikanen on behalf of the Commission

(4 May 2001)

In October 1995 and in January 1997, the European Agency for the Evaluation of Medicinal Products
(EMEA) published two position statements of the Committee for Proprietary Medicinal Products (CPMP) on
the third generation contraceptive pill or pill containing gestodene or desogestrol. These documents are
available on the EMEA website: http://www.emea.eu.int.

C 235 E/250

Official Journal of the European Communities

EN

21.8.2001

The Committee for Proprietary Medicinal Products (CPMP) indicated that the risk of venous thrombosis
was greater for females taking the third generation contraceptive pill than those taking the second
generation contraceptive pill which contains levonorgestrel. Therefore the CPMP considered it necessary
to re-evaluate the data available to ensure that they are not confusing or biased.

In order to carry out this re-evaluation, the CPMP is examining the initial data, the recent information
available and the data provided by the marketing authorisation holders of third generation contraceptives.

The CPMP is currently conducting a scientific analysis of all the data. During its last meeting in February
2001, it advised that a subsequent hearing of the marketing authorisation holders was necessary.

Following this hearing and when the scientific evaluation of the data is completed, the EMEA will publish
the CPMP recommendations on use to complement the two aforementioned position statements. They will
be also be made public on the EMEA website.

It should be noted that such a recommendation is not an irrevocable act.

(2001/C 235 E/295)

WRITTEN QUESTION E-1001/01

by Paulo Casaca (PSE) to the Commission

(30 March 2001)

Subject: 1999 discharge (cid:129) agriculture

The information provided by the Commission in connection with question 2.7 of the second questionnaire
on the granting of the discharge in respect of the implementation of the general budget of the European
Union for the 1999 financial year does not reply to the questions raised in various aspects.

Can the Commission therefore clarify the following points:

(cid:129) With regard to question 2.7(a):

(cid:129) Point 36. Can the Commission provide the relevant OLAF report?

(cid:129) Point 42. The reply does not correspond to the question. The question concerned the actions of the
Dutch authorities mentioned in point 42 and not those of the Belgian authorities mentioned in the
same point. Consequently, the Commission is asked once again to reply to question 2.7(a).

Answer given by Mr Fischler on behalf of the Commission

(3 May 2001)

The Commission is collecting the information it needs to answer the question. It will communicate its
findings as soon as possible.

(2001/C 235 E/296)

WRITTEN QUESTION E-1031/01

by John Bowis (PPE-DE) to the Commission

(3 April 2001)

Subject: Pet crematoria

What information does the Commission have on the number of pet crematoria in each Member State?