WRITTEN QUESTION P-0080/00 by Mary Banotti (PPE-DE) to the Commission. European Medicinal Evaluation Agency (EMEA).
C 280 E/172 Official Journal of the European Communities EN 3. 10. 2000 (2000/C 280 E/195) WRITTEN QUESTION E-0078/00 by Bart Staes (Verts/ALE) to the Commission (24 January 2000) Subject: European initiatives to celebrate the work of the writer Giovannino Guareschi The books of the writer, journalist, illustrator and humorist Giovannino Guareschi, which include Favola di Nataleí ( Christmas Storyí), written while he was held in a Nazi concentration camp in December 1944, and the Don Camillo stories, written after the war, have been translated into almost all of the official languages of the European Union, as well as into Icelandic, Serbo-Croat, Vietnamese, Arabic and Lithuanian. Guareschiís books, writings, cartoons and other works, all of which seek to uphold individual freedoms and human dignity and to combat totalitarianism in all its forms (from Nazism and Fascism to Stalinist Communism), form a vital part of Europeís cultural heritage. In recent years, in places such as Roncole Verdi (Parma), Brescello (Reggio Emilia) and Fontanelle (Parma), private citizens and public bodies have set up museums, permanent exhibitions and trails to guide tourists around the Little Worldí ü the Lower Emilia area of the Po Valley, where Guareschi set his stories. How does the Commission view the idea of funding cultural projects involving town twinning arrange- ments and other initiatives between various European countries, aimed at bringing Giovannino Guareschi and his work to the attention of a new audience? What are its views on the establishment of a Giovannino Guareschi European Prizeí, sponsored by the European Union and aimed at artists and humorists whose work makes use of Guareschiís traditional tools of humour and satire to promote freedom of thought and uphold human dignity? Answer given by Mrs Reding on behalf of the Commission (28 February 2000) The Commission may grant support for cultural initiatives only within the framework and according to the criteria of its existing programmes. The Commission wishes to draw the attention of the Honourable Member to the fact that, in the course of March 2000, a call for proposals relating to the first Culture 2000í framework programme will be published in the Official Journal, with Internet consultation also possible. In the context of the Culture 2000í programme, funding earmarked for the field of books, reading and translation will probably account for around 11 % of the annual budget. Cultural operators hoping to obtain financial support will thus have an opportunity to present projects in line with the programmeís conditions and criteria. As far as a prize is concerned, the Honourable Member is advised that, as provided for by the programme, the Commission will give due consideration to this idea and others, in the course of the year, with a view to establishing a coherent policy for European cultural prizesí. (2000/C 280 E/196) WRITTEN QUESTION P-0080/00 by Mary Banotti (PPE-DE) to the Commission (18 January 2000) Subject: European Medicinal Evaluation Agency (EMEA) Given that áearly access programmesí for new medicinal products are at present subject to national legislation, which results in serious delays as fifteen different authorities negotiate with pharmaceutical companies, compared to the USA, where one central authority, the FDA, grants such access and that this 3. 10. 2000 EN Official Journal of the European Communities C 280 E/173 laborious process can mean that several years elapse before European patients, unlike their American counterparts, can join such early access programmes, therefore denying them the possible benefits of promising new treatments, which in the case of HIV patients, for example, can mean the difference between a good quality of life and, at worst, death. Will the Commission consider drawing up proposals to amend present legislation in order to allow the European Medicinal Evaluation Agency to represent the 15 Member States when negotiating early access programmes with the pharmaceutical industry, thereby closing the gap and ending the disparity between European and American patients? Answer given by Mr Liikanen on behalf of the Commission (9 February 2000) Most of the Member States have laid down procedures to allow patients with serious illnesses to have access in particular to medicinal products for which marketing authorisation has not yet been given. There are no Community rules and the above procedures are not harmonised. However, for medicinal products which are able to use the centralised procedure provided for in Council Regulation No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (1), when the application for authorisation to place a product in the market is ready, the applicant has the possibility of submitting the application to the European Agency for the Evaluation of Medicinal Products where a Community evaluation is carried out to enable the Commission to issue a marketing authorisation which is valid in all Member States and with identical information in the eleven languages. In the framework of the review of the marketing authorisation procedures planned for the year 2000, which are likely to lead to proposals for amendments of the current rules in 2001, the Commission could consider proposing harmonisation of the access to new major medicinal products once there are sufficient safety and efficacy data to allow this. The evaluation of those data could take place as part of a centralised evaluation with the possibility of a continuing review as supplementary data become available. (1) OJ L 214, 24. 8. 1993. (2000/C 280 E/197) WRITTEN QUESTION E-0081/00 by Alexandros Alavanos (GUE/NGL) to the Commission (24 January 2000) Subject: Proposals for amending Directive 85/374/EEC on liability for defective products With a view to improving Directive 85/374/EEC (1) on liability for defective products the Commission called on áinterested partiesí to submit their comments on questions raised in the Green Paper on liability for defective products before the expiry of a period of four months from the date of publication of the Green Paper. As the Green Paper itself states: The announcement of this move naturally aroused the interest of the economic operators, consumers and public administrationsí. Does the Commission consider that the response of the economic operators and public administra- 1. tions in the Member States to the questions in the Green Paper has been satisfactory? From which Greek consumer organisations has it received comments? Did the General Secretariat for 2. Consumers respond? (1) OJ L 210, 7. 8. 1985, p. 29