Activites

• 1996/05/13 Final act published in Official Journal
• #1917
• 1996/04/23 Council Meeting
• 1996/04/16 Debate in Parliament
  • Debate in Parliament
  • T4-0170/1996 summary

    In adopting the report by Mrs Irene SOLTWEDEL-SCHÄFER (V) by 233 votes to 162 and 5 abstentions, Parliament called for: - governments to cut back the cost of using medicines. A critical eye should be kept on the resultant restructuring, to ensure that monopoly situations do not arise; - the close monitoring of mergers in this sector, an increase in the cost effectiveness of research rather than the pursuit of an industrial policy based on deregulation and subsidies; - an end to the industry's frenetic use of advertising; - the encouragement of genuine innovation; - the maintenance of protection for new medicinal products by intellectual property rights; - the introduction of measures, in advance of patent or supplementary protection certificate expiry, enabling the beginning of such laboratory experiments and regulatory preparations as may be required for the registration of generic pharmaceuticals, so that they may be available on the market after the expiry of the patent; - the focusing of research on innovative therapies, diseases which cannot yet be treated satisfactorily, and rare diseases; - the establishment of a dialogue between the politicians, employers, unions and patients; - better access to research and development for SMEs, particularly in the biotechnology field; - the development of the European Medicines Evaluation Agency into a Community-wide licensing authority; - the reduction of animal experiments; - improvement in the marketing of herbal and homeopathic medicines through the adjustment of the authorization procedure and the setting-up of a Traditional Medicines Evaluation Agency; - the encouragement of responsible self-medication; - the introduction of a responsible policy on exports; - the Commission to consider what instruments were best suited to disseminating information, independent of the industry, on the effects and the risks of medicinal products (Green amendments). It should be noted that Parliament accepts that, whilst some fears have been expressed about the risks of genetic engineering, it is justified and desirable that all types of research should continue, with scrupulous respect for human and animal life, particularly in the development of new therapies for diseases which are not as yet susceptible to any form of treatment. �

• 1996/03/19 Vote in committee, 1st reading/single reading
  • A4-0104/1996
• 1994/05/02 Committee referral announced in Parliament, 1st reading/single reading
• 1994/03/02 Non-legislative basic document published
  • COM(1993)0718 summary

    This communication aimed to outline the industrial policy guidelines to be applied to the pharmaceutical sector in the Community. On the basis of the idea that this industry required a market that was better integrated and where competition was freer, the Commission intended to give priority to the following aspects: - consolidating and progressively updating existing pharmaceutical legislation in a manner that was codified, transparent and easily accessible to health enterprises and professions, and ensuring that Community legislation was fully and correctly transposed by the Member States; - implementing as soon as possible the future system for the authorisation of medicines for human and animal use, particularly by contributing to the establishment of the European Medicines Evaluation Agency, in close cooperation with the competent national authorities and firms concerned; - ensuring and improving the protection of intellectual property for genuinely innovative therapeutic inventions, so as to ensure protection similar to that available in the main rival markets; - creating a more favourable environment for biotechnology through the adaptation of the regulatory framework to the needs of research and current international developments; - promoting the integration and coordination of research and development work in the pharmaceutical sector within the context of the fourth framework programme for R&D - monitoring the effects on the operation of the internal market of national measures to control prices and reimburse medicines where they were of a discriminatory nature and with the aim of ensuring transparency and exploring the need to adapt Directive 89/105/EEC relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems, in the light of experience; - increasing competition in the pharmaceutical market, by making it more transparent and by making it possible to encourage competition through prices; - providing health professionals and consumers with sufficient information to promote the rational use of medicines, particularly through the harmonisation of labels and indications for use, and the updating of a computerised database on medicines that would subsequently be available to the public (ECPHIN); - continuing and stepping up harmonisation efforts at global level in order to reduce the costs of research and development in the pharmaceutical sector and facilitate the opening up of external markets to medicines produced in the Community. �

Documents

• Non-legislative basic document published: COM(1993)0718
• Committee report tabled for plenary, single reading: A4-0104/1996
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T4-0170/1996

History

(these mark the time of scraping, not the official date of the change)