WRITTEN QUESTION E-0081/00 by Alexandros Alavanos (GUE/NGL) to the Commission. Proposals for amending Directive 85/374/EEC on liability for defective products.
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. C 280 E/174 Official Journal of the European Communities EN 3. 10. 2000 Answer given by Mr Bolkestein on behalf of the Commission (7 March 2000) The Commission can inform the Honourable Member that it has received nearly 100 comments on 1. the green paper (1). Replies emanate from national and European consumer organisations, sectors of industry concerned (in particular pharmaceuticals, cars, insurance, chemicals, agricultural products, electrical equipment), public administrations of Member States (Denmark, Germany, Greece, France, Austria, Portugal, Finland, United Kingdom) and third countries (Iceland, Norway, Slovenia, Switzerland) and bodies specialising in product liability (e. g. Pan-European organisation of personal injury lawyers, United States Defense research institute, Special committee on European product liability law). The Commission published the comments on the Internet (http://europa. eu. int/internal_market/en/goods/ liability/replies. htm). At this stage, it is premature to judge the substance of the replies. 2. No reaction has so far been received from any Greek consumer organisation. (1) COM(99) 396 final. (2000/C 280 E/198) WRITTEN QUESTION E-0082/00 by Alexandros Alavanos (GUE/NGL) to the Commission Subject: Lack of transparency in respect of projects funded by the EU (24 January 2000) Article 61 of the contract for the construction of the Attica highway (Elefsina Avenue ü Stavros ü Spata Airport) contains the term áconfidentialityí and stresses that áthe contracting parties specifically agree and accept that all information, correspondence, documents, plans, are confidential and shall not be given to any third party, or be reproduced in any manner or be published in any formí and that áthe obligation of confidentiality shall obtain for the entire duration of the contract and shall continue for a period of three years following the expiry thereofí. Given that the requirement that public works and supplies contracts cofunded by the European Union should be fully transparent applies generally and also that comparable terms may exist in other contracts or may constitute a precedent for future practice, will the Commission say: 1. How will it ensure the transparency of funding and the proper implementation of projects which are cofunded? 2. Does the above-mentioned áconfidentialityí clause also apply to the Commission? 3. Will Article 61 of Law 2445/96 not make it difficult to trace the causes of the recent collapse of the bridge on the Attica highway? 4. What measures does it intend to take to remove the unacceptable wording of Article 61 which refers to áconfidentialityí and the ánon-publicationí of information? Answer given by Mr Bolkestein on behalf of the Commission (9 March 2000) On the basis of the information available to the Commission, the confidentiality clause in the text quoted by the Honourable Member refers to relations between the parties to the concession contract, i. e. the State and the enterprises to whom the contract in question has been awarded. This provision in no way affects