WRITTEN QUESTION P-0064/00 by Peter Skinner (PSE) to the Commission. Definition of fundamental change in pharmaceutical products.
C 280 E/168 Official Journal of the European Communities EN 3. 10. 2000 that they satisfy the conditions laid down ü in particular that they are provided direct to final consumers and are covered by the list of eligible sectors. The Council changed the Commissionís proposal (2) by introducing an exhaustive list which in the building sector covers only services consisting of the renovation and repairing of private dwellings, excluding materials which form a significant part of the value of the service supplied. Following the Councilís decision, work to repair historic buildings will qualify for VAT reductions, but only where the buildings contain private dwellings and the Member State has made a request. The Member States that have made requests are Belgium, Spain (for masonry work only), France, Italy, the Netherlands (for painting and plastering only), Portugal and the United Kingdom (for the Isle of Man only). (1) OJ C 102, 13. 4. 1999. (2) COM(99) 705 final. (2000/C 280 E/191) WRITTEN QUESTION P-0064/00 by Peter Skinner (PSE) to the Commission (18 January 2000) Subject: Definition of fundamental change in pharmaceutical products Commission Regulation (EC) No 541/95 (1) states that certain changes to the terms of a pharmaceutical product marketing authorisation are fundamental and as such require that a new, complete scientific evaluation be conducted (such as in the case of replacement of the active substance by a different salt/ester. Can the Commission confirm that: 1. The rationale for defining fundamental changes and requiring them to be the subject of new applications rather than variation applications was that special scrutiny of the research data relating to that change would be required by the competent authorities before it could properly be concluded that the public health criteria of quality, safety and efficacy were still met for the production in question, and In principle the same cautious approach should apply if the same fundamental differences exist 2. between two products where it is claimed that one is a generic copy of the other and that that copy can be authorised on the basis of the research data generated for the first product? (1) OJ L 55, 11. 3. 1995, p. 7. Answer given by Mr Liikanen on behalf of the Commission (11 February 2000) Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State, and Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/ 93 (1), as amended (2), lay down rules governing the examination of variations to a marketing authorisation granted for a medicinal product by either of the following Community procedures: the mutual recognition procedure or the centralised procedure. The Regulations provide for three types of variation to the terms of a marketing authorisation, depending on their importance and the time allowed for their assessment: minor variations (type I), listed in Annex I, major variations (type II) and changes which fundamentally alter the terms of the authorisation. The latter 3. 10. 2000 EN Official Journal of the European Communities C 280 E/169 must be approved by a complete assessment procedure similar to that for new applications for marketing authorisation and the assessment period (210 days) is exactly the same as that for new applications. Such changes are listed in Annex II. They include changes to the active substance(s), the therapeutic indications or the strength, pharmaceutical form and route of administration. However, it should be noted that even these are always variations to an authorisation which has already been granted for a given medicinal product. With regard to the examination of data, the same criteria of quality, safety and efficacy must be met in all cases. The same assessment criteria of quality, safety and efficacy apply to generic products. The applicant can be exempted from safety and efficacy trials only if he can show that the product for which the authorisation has been requested is essentially the same as another products which already has a marketing authorisa- tion. (1) OJ L 55, 11. 3. 1995. (2) OJ L 159, 3. 6. 1998. (2000/C 280 E/192) WRITTEN QUESTION E-0069/00 by Bart Staes (Verts/ALE) to the Council (24 January 2000) Subject: Checks on data exchange and telecommunications in the EU Member States As part of the annual Ilets (International Law Enforcement Telecommunications Seminar) consultation process the police forces of the fifteen Member States are working on the sophisticated interception practices of the National Security Agency (NSA), the American secret service responsible for telecommu- nications and data exchange. At the request of the NSA, Lotus, Microsoft and Netscape have lowered the security level of their Internet and e-mail programmes for users outside the United Status. The interception facilities are used mainly for industrial espionage. In the EU report Interception capabilities 2000í Duncan Campbell says that the result is that virtually every computer in Europe has, as a built-in standard feature, a system that enables the NSA alone to crack the userís code and to read secured messages. The messages are intercepted at US Internet nodes or are picked up by the Echelon espionage network of the US, UK, Canada, New Zealand and Australia (the UKUSAí group). The NSA bases its interception practices on the Communications Assistance for Law Enforcement Act (Calea) which was adopted by Congress in 1994. Since then American telecommunications forms have been obliged to build interception facilities into all digital satellite and mobile communications media. In January 1995 the Council adopted a (non-binding) resolution which is virtually identical to Calea. Approval of the use of these radical measures has never been subject to any parliamentary scrutiny. 1. Can the Council give me a copy of the (non-binding) Calea resolution, as adopted in January 1995? If not: (a) why not, and (b) does this refusal not violate the principle of parliamentary accountability in a constitutional state governed by the rule of law?