WRITTEN QUESTION E-0912/00 by Hiltrud Breyer (Verts/ALE) to the Commission. Viagra.
Date: 2000-03-29
Institutions: European Parliament, Provisional data
Subjects: European social policy, drug surveillance, market approval

13.2.2001

EN

Official Journal of the European Communities

C 46 E/77

The Commission, as guardian of the Treaties, will investigate the case to check that Community law was
impact assessment presented by the company concerned was
not infringed when the environmental
prepared.
it will decide whether
infringement proceedings should be initiated against Greece under Article 226 (ex Article 169) of the EC
Treaty.

If the Commission finds that Community law has been infringed,

(1) Council Directive 97/11/EC of 3 March 1997 amending Directive 85/337/EEC on the assessment of certain public

and private projects on the environment, OJ L 73, 14.3.1997.

(2001/C 46 E/081)

WRITTEN QUESTION E-0908/00

by Isidoro SÆnchez Garc(cid:237)a (ELDR) to the Council

(24 March 2000)

Subject: Referendum in Western Sahara

On 29 February 2000 the UN Security Council adopted a resolution on Western Sahara in connection
with the Peace Plan drawn up for this territory, which had been accepted and signed by the parties
concerned (cid:129) the Kingdom of Morocco and the Saharoui Democratic Republic (cid:129) with a view to holding a
referendum to determine the future of the area.

Does the Council intend, via the High Representative for the common foreign and security policy, to
include in its work programme participation in the control and monitoring of issues affecting the future of
the Sahara, in particular as regards the referendum, since all this may directly affect certain areas of the
European Union?

Reply

(10 July 2000)

The Council closely follows issues affecting the future of Western Sahara. It fully supports the efforts of the
United Nations Secretary-General, his Special Representative for Western Sahara and his Personal Envoy,
James Baker, concerning the future of Western Sahara. The Council is willing to contribute to this process
and help build a climate of confidence and trust among the interested parties in order to find a solution
acceptable to all interested parties of the region and based on respect for human rights and democratic
principles.

The Council takes note of the observation in the latest report of the United Nations Secretary-General that
the timetable envisaged is no longer valid and that the date for the referendum can still not be set with
certainty at this juncture. It welcomes the intention of the Secretary-General to ask his Personal Envoy to
explore ways and means to achieve an early, durable and agreed solution of the dispute. The Council also
supports Mr Baker(cid:146)s initiative with respect to direct talks and welcomes the holding of a first meeting on
14 May in London.

(2001/C 46 E/082)

WRITTEN QUESTION E-0912/00

by Hiltrud Breyer (Verts/ALE) to the Commission

(29 March 2000)

Subject: Viagra

1. Why has viagra been authorised as a drug by the European Agency for the Evaluation of Medicinal
Products although, in trials, out of 4000 people taking part, 22 cases of death occurred in the group to
which the active substance was administered (compared with two deaths in the group to which a placebo
was administered)?

C 46 E/78

Official Journal of the European Communities

EN

13.2.2001

In view of the dramatic increase in deaths linked to viagra, does the Commission consider that

2.
authorisation should be withdrawn, and, if not, what are its reasons?

3. What does the Commission intend to do in the face of the increasing number of deaths linked to
viagra?

4.
Could the Commission explain why, at the forthcoming meeting between the Agency for the
Evaluation of Medicinal Products and representatives of the Member States, viagra will again not be on
the agenda despite the large number of deaths?

Is the Commission aware that the product information given in the package leaflet is incomplete?

5.
What action does it intend to take about this?

Answer given by Mr Liikanen on behalf of the Commission

(12 May 2000)

1.
The Commission authorised Viagra on the basis of a favourable opinion from the Committee for
Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA).
The clinical trial reports indicating 22 deaths with Viagra as opposed to 2 deaths with the placebo fail to
take account of the different number of patients in each group and the duration of the treatment. In fact,
the rates are comparable, at around 0,5 deaths per 100 patients treated over the course of one year.
Moreover, analysis suggests that none of these 22 deaths is attributable to treatment with Viagra.

2.
To date there have been no data to suggest a dramatic increase in the number of deaths, even though
the number of patients treated has risen from a few thousand to several million. It must be borne in mind
that this is a medicinal product intended for patients suffering from erectile dysfunction, which affects
more than 50 % of men over the age of 70. This means that, in many cases, death may be due to vascular
problems.

The Commission ensures that holders of authorisation to place products on the market send the
3.
EMEA regular data on safety. For Viagra, the holder has been asked to supply such data on a monthly
basis, i.e. more regularly than is normally required.

Viagra is being monitored closely, and there is no need to alter the current position. Should new

4.
information indicate otherwise, measures would be taken without delay to protect patients.

The information given in the package leaflet has also been evaluated by the EMEA and authorised by
5.
it includes all the information given in the
the Commission. Using language accessible to patients,
summary of product characteristics intended for health care professionals. Any changes to the summary
are automatically made to the leaflet.

(2001/C 46 E/083)

WRITTEN QUESTION E-0915/00

by Christopher Huhne (ELDR) to the Commission

(25 March 2000)

Subject: Repeal of legislation

How many pieces of legislation (directives, regulations, decisions) have been repealed in each year for the
last ten years?