COUNCIL RESOLUTION of 23 April 1996 designed to implement the outlines of an industrial policy in the pharmaceutical sector in the European Union (96/C 136/04)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Commission communication of 14 September 1994 entitled 'An industrial competitiveness policy for the European Union`,

Recalling its resolution of 21 November 1994 on strengthening the competitiveness of Community industry (1), and its conclusions of 7 April 1995 on an industrial competitiveness policy,

Having regard to the communication of 7 March 1994 from the Commission to the European Parliament and the Council on the outlines of an industrial policy for the pharmaceutical sector in the European Community,

Whereas the European Union has an important role to play in creating a favourable environment for the expansion of activities relating to research, development, production and distribution of medicinal products and in encouraging the development of an innovative and effective European pharmaceutical industry in terms of competitiveness on the world market;

Whereas European industrial policy must necessarily take account of the special nature of this sector, which relates both to public health and to social policy; whereas social security systems bear a considerable proportion of pharmaceutical expenditure; whereas this is a matter which falls within the competence of the Member States;

Whereas the European Union has the responsibility of sketching out guidelines for the promotion of Community activities in this sector,

HAS ADOPTED THIS RESOLUTION:

I. WITH RESPECT TO THE SITUATION IN THE PHARMACEUTICAL INDUSTRY

1. RECALLS that the European pharmaceutical industry plays an essential role in public health, remains a high-technology industry with considerable added value, which is particularly successful, generates highly skilled jobs and makes a significant contribution to the European Union's balance of trade;

2. CONSIDERS that, now that it is facing increasingly intense international competition, the European pharmaceutical industry must also prepare itself to face new challenges, in particular as a result of the growing cost of pharmaceutical research and development, the emergence of new technologies and the international trend towards greater concentration of capital;

3. EMPHASIZES that sufficient profitability is necessary if the European pharmaceutical industry is to cover the investment required to guarantee its capacity for innovation and thus ensure its competitiveness at international level;

4. STRESSES the importance of innovation for the whole pharmaceutical sector, including the research industry as well as the non-proprietary medicinal products and proprietary medicines industry;

5. EMPHASIZES the importance of giving consideration within Member States to links between policies to control public health spending and measures to ensure the competitiveness of the European pharmaceutical industry;

6. BELIEVES that the major moves towards mergers and links between undertakings which are increasingly involving European firms are a response to these new constraints;

7. ASKS the Commission to ensure that this reorganization takes places in a manner consistent with Community competition rules and to study its consequences in terms of employment and the location of investment.

II. WITH RESPECT TO RESEARCH AND PHARMACEUTICAL INNOVATION

1. NOTES with satisfaction that the 4th Framework Programme of Community Activities in the field of Research, Technological Development and Demonstration takes into account the special characteristics of pharmaceutical research in a specific programme relating to biomedicine and health;

2. NOTES that the Commission is setting up a Task Force on vaccinations and viral diseases which it considers will encourage partnership between industry, public research institutes and university circles;

3. NOTES with interest, having regard in particular to the Council Resolution of 20 December 1995 (2), that the Commission will carry out studies and, where necessary, submit appropriate proposals to create an economic environment which encourages the pharmaceutical industry to carry out research in the field of orphan drugs;

4. UNDERLINES the need to continue to guarantee the protection of intellectual property with regard to pharmaceutical innovations;

5. STRESSES the importance of an efficient chemical industry in the process of innovation of the pharmaceutical industry;

6. UNDERLINES the growing importance of biotechnology in the pharmaceutical sector; is aware of the problems and new opportunities opened up by biotechnology; invites the Commission to continue its efforts to ensure a stable and safe environment for biotechnology, particularly by tailoring regulations to the actual risk taken while maintaining an appropriate level of safety and seeking a favourable framework for stimulating investment in Europe;

7. NOTES with interest that the Commission has submitted a new proposal to the European Parliament and to the Council on the legal protection of biotechnological inventions in order to improve legal protection and Community harmonization in matters relating to the patentability of biotechnological inventions, with due regard for bioethics and the cultural roots of Europe.

III. WITH RESPECT TO SMALL AND MEDIUM-SIZED ENTERPRISES

1. POINTS OUT that small and medium-sized enterprises (SMEs) play an important part in this sector; that in fact such SMEs have potential in terms of know-how, innovation and adjustment to the medical requirements of the local market concerned which they should be able to exploit more satisfactorily;

2. NOTES, however, that SMEs active in the area of research remain particularly vulnerable, given the constraints of the pharmaceutical industry;

3. RECALLS the high priority attached to a policy in favour of SMEs, as shown in the report submitted by the Commission to the Madrid European Council on the role played by SMEs as a dynamic source of jobs, growth and competitiveness in the European Union, in which the Commission in particular recommends energetic action to promote research, innovation, training and cooperation in SMEs;

4. RECALLS its conclusions of 6 and 7 November 1995 on the feasibility of creating a European capital market for SMEs;

5. therefore INVITES the Commission to look into the situation of SMEs on the European pharmaceutical market and explore the possibilities afforded by current policies relating to SMEs and those which might be opened up by the Council's possible adoption of the future multiannual programme for SMEs and the craft sector for the period 1997 to 2000.

IV. WITH RESPECT TO THE OPERATION OF THE INTERNAL MARKET

1. RECALLS the importance of the harmonization work achieved and the breakthrough for the internal market represented by the entry into force of new Community procedures for the authorization and monitoring of medicinal products and the setting up of the European Agency for the Evaluation of Medicinal Products;

2. in particular CONSIDERS that it has the responsibility of ensuring that a stable and predictable regulatory framework is set up which can protect the health of patients by guaranteeing the quality, effectiveness and safety of medicinal products placed at their disposal, ensure rapid access to the market and encourage therapeutic innovation;

3. BELIEVES that pharmaceutical legislation should be more easily accessible and invites the Commission to continue with its consolidation into a coherent, structured whole, to ensure that it is more efficiently disseminated and to impose more stringent checks on its incorporation into national law and its application;

4. ASKS the Commission to look with the Member States at the situation of producers of medicinal products sold without prescription and preparations obtained from medicinal plants;

5. WOULD LIKE the Commission to investigate with the Member States the appropriateness of tightening the common classification system laid down by Directive 92/26/EEC (3), which distinguishes between prescription and non-prescription medicinal products;

6. ASKS the Commission to consider, with the Member States, any relationship to be established between packaging of medicinal products and therapeutic prescription practices;

7. POINTS OUT that Member States retain responsibility for organizing and funding their public health expenditure;

8. INVITES the Commission to take stock of the operation of the internal market in this area, with regard, inter alia, to the transparency of national measures of price control and reimbursement, with a view to evaluating at the earliest opportunity the effects of Council Directive 89/105/EEC of 21 December 1988 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 (4).

V. WITH RESPECT TO THE TRANSPARENCY OF THE PHARMACEUTICAL MARKET

1. INVITES the Commission to promote greater transparency in this sector, in the interests of the various parties concerned, namely industry, patients, health professionals, social security bodies and private insurers;

2. STRESSES the importance for achieving improved transparency in the pharmaceutical sector of applying the techniques of the information society by setting up, where appropriate, within the framework of the IDA programme, electronic exchange of pharmaceutical data, a computerized system for collecting information on pharmacovigilance and creating an economic database on medicinal products based on information supplied voluntarily by the enterprises and organizations concerned;

3. EMPHASIZES the advantages of the cooperation begun with the Member States within the Committee set up by Directive 89/105/EEC, and invites the Member States, where appropriate, to reinforce it;

VI. WITH RESPECT TO COMPETITION ON THE PHARMACEUTICAL MARKET

1. NOTES that the pharmaceutical market has characteristics which distinguish it from markets in other industrial products, particularly with regard to pricing;

2. BELIEVES that it is for each Member State to determine, depending on the particular nature of its system, the measures best suited to increasing competition while contributing to balancing the social security budget, the possibilities offered by the pharmaceutical sector for technological, economic and employment development and health care savings;

3. CALLS ON the Member States to begin to cooperate in the areas referred to in section I.4 above, particularly as regards the role of non-proprietary medicinal products as a means of encouraging competition and encourages the Commission rapidly to draft the report provided for in the Council resolution of 20 December 1995;

VII. WITH RESPECT TO INDUSTRIAL COOPERATION WITH THIRD COUNTRIES

1. EMPHASIZES the importance of adequate preparation in this sector being started in the period prior to the accession of the countries of Central and Eastern Europe and other applicant countries, particularly as regards adapting their legislation to the acquis communautaire, the setting up of suitable infrastructure for authorization and control of medicinal products, protection of industrial and commercial property and the development of undistorted market conditions;

2. INVITES the Commission to study the possibilities opened up in this sector by the Euro-Mediterranean partnership;

3. INVITES the Commission to involve more intensively in this sector the other regional areas and third countries with which the Union has traditionally had close relations.

VIII. WITH RESPECT TO ACCESS TO THIRD COUNTRY MARKETS

1. UNDERLINES the importance of the third-countries market to the pharmaceutical industry of the European Union, which remains the principal world centre for the production and export of medicinal products;

2. CONSIDERS that, strengthened by the acquis communautaire in this sector, the European Union should endeavour to improve the conditions for access to third-country markets for medicinal products invented and developed by the European pharmaceutical industry;

3. POINTS OUT that the very high degree of regulation in the pharmaceutical sector means that it is also subject to a considerable number of barriers to trade, which often force the pharmaceutical industry to repeat tests on medicinal products and checking operations;

4. NOTES the efforts made in the context of the International Conference on Harmonization (ICH) with regard to harmonizing statutory requirements for pharmaceuticals and invites the Commission to submit a report to the Council on the results achieved after the first round of conferences and the aims to be set for the continuation of the proceedings;

5. ENCOURAGES the Commission to continue the negotiations now under way on mutual recognition agreements relating to inspection and control of medicinal products, in particular with regard to equivalence of good manufacturing practice, with the European Union's trading partners;

6. RECALLS the importance of intellectual property rights for the pharmaceutical industry and the crucial part played by effective, complete and respected protection of these rights in ensuring financing for ever more costly innovative research;

7. ENCOURAGES the fight against fraud and asks the Commission and the Member States to cooperate with the appropriate bodies at international level to combat counterfeiting and ensure the implementation of the agreement on trade-related aspects of intellectual property rights (TRIPs) concluded within the GATT framework;

IX. FINAL PROVISIONS

INVITES the Member States and the Commission to work towards the achievement of the objectives referred to in this resolution within their respective spheres of competence.

(1) OJ No C 343, 6. 12. 1994, p. 1.

(2) OJ No C 350, 30. 12. 1995, p. 3.

(3) OJ No L 113, 30. 4. 1992, p. 5.

(4) OJ No L 40, 11. 2. 1989, p. 8. Directive as last amended by the 1994 Act of Accession.