WRITTEN QUESTION E-0915/00 by Christopher Huhne (ELDR) to the Commission. Repeal of legislation.
Date: 2000-03-25
Institutions: European Parliament, Provisional data
Subjects: EU act, EU statistics, repeal

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authorisation should be withdrawn, and, if not, what are its reasons?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

13.2.2001

EN

Official Journal of the European Communities

C 46 E/79

Answer given by Mr Prodi on behalf of the Commission

(18 May 2000)

Number of Council/European Parliament instruments and European Parliament instruments
that were repealed or expired in the year concerned

Year

1999

1998

1997

1996

1995

1994

1993

1992

1991

1990

Regulations

Directives

Decisions

193

146

271

227

457

356

416

317

278

315

57

44

38

23

50

27

29

28

13

17

127

187

82

20

27

49

28

46

25

35

Source: General Report (1997-1999); Celex base (1990-1996).

Number of autonomous Commission instruments
that were repealed or expired in the year concerned (1)

Regulations

Directives

Decisions

612

551

503

698

957

922

949

848

884

881

17

13

27

8

7

10

6

12

22

6

381

260

199

227

241

390

483

237

242

228

Year

1999

1998

1997

1996

1995

1994

1993

1992

1991

1990

Source: General Report (1997-1999); Celex base (1990-1996).
(1)

Except for instruments not published in the Official Journal or published in light type (routine
management instruments valid for a limited period).

(2001/C 46 E/084)

WRITTEN QUESTION P-0926/00

by JosØ Ribeiro e Castro (UEN) to the Commission

Subject: New relations between the EU and Indonesia

(22 March 2000)

The Commission has announced that it wishes to adopt a new policy vis-(cid:224)-vis Indonesia and that it is
preparing a cooperation agreement. President Abdurrahman Wahid recently visited Brussels where he had
meetings with the Commission President, Romano Prodi, during which the topic was apparently raised. As
a follow-up, Chris Patten, Commissioner, is due to make a working visit to Indonesia.