WRITTEN QUESTION E-0915/00 by Christopher Huhne (ELDR) to the Commission. Repeal of legislation.
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 authorisation should be withdrawn, and, if not, what are its reasons? 3.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-à-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