A4-0104/96

Resolution on the communication from the Commission to the Council and the European Parliament on the outlines of an industrial policy for the pharmaceutical sector in the European Community (COM(93)0718 - C3-0121/94)

The European Parliament,

- having regard to Article 3(l) and (m) of the EC Treaty, which provide for the strengthening of the competitiveness of Community industry and the promotion of research and technological development,

- having regard to Article 130(1) of the EC Treaty, which provides for better exploitation of the industrial potential of policies of innovation, research and technological development,

- having regard to Articles 129 and 129a of the EC Treaty, which provide for a high level of human health protection and protection of the economic interests of consumers,

- having regard to the communication from the Commission to the Council and the European Parliament on the outlines of an industrial policy for the pharmaceutical sector in the European Community (COM(93)0718 - C3-0121/94),

- having regard to its resolution of 14 February 1996 ((Minutes of that sitting, Part II, Item 4.)) on the Commission's 24th report on Competition Policy,

- having regard to the relevant provisions of its Rules of Procedure,

- having regard to the report of its Committee on Economic and Monetary Affairs and Industrial Policy and the opinions of the Committee on the Environment, Public Health and Consumer Protection and the Committee on Social Affairs and Employment (A4-0104/96),

A. whereas the pharmaceutical sector is undergoing a period of radical change world-wide, characterized by stiffening international competition, increasing research costs and cost-containment measures in national health services,

B. whereas it is necessary to maintain the basic economic strength of the EU pharmaceutical sector and its competitiveness since this represents an asset for the economy of the EU, in terms of growth and employment,

C. whereas innovation and industrial investment are essential factors for progress in the patient's interest and in that of society as a whole, and bearing in mind the challenges of supplying the public with effective and cheap medicinal products which are an important therapeutic instrument, whose cost/profit ratio is in certain cases better than those of other treatments, and of preserving the industry's capacity for innovation,

D. whereas responsible self-medication is also in line with the orientations for health policy as defined by the European Institutions in recent years,

E. whereas an industrial policy for the pharmaceutical sector should have as its first priority a guaranteed supply of safe, effective drugs for the public and it cannot therefore be separated from aspects of public health and social security on the one hand, and support for industrial development and employment in the Union on the other hand,

F. whereas the Members States' health and cost-reimbursement systems vary because their political priorities and economic situations are different and are unlikely to be standardized completely in the foreseeable future,

G. whereas significant distortions in the European market for pharmaceuticals occur as a result of Member States' different pricing and reimbursement systems,

H. whereas an industrial policy for the pharmaceutical industry must take into account to the same extent the legitimate interests of all economic agents: industry doing research, producers of generic medicines, phytopharmaceuticals, herbal and homeopathic medicines, traders and pharmacists,

I. whereas an industrial policy for the pharmaceutical industry should be based on standards that allow those involved to operate on a level with worldwide competition, and whereas, through increasing competition and costs for research and development, the European pharmaceutical sector is in danger of falling behind its main competitors in research-based innovative medicine; whereas it is important to maintain and strengthen its competitiveness,

1. Notes that the pharmaceutical industry is characterized by the absence of normal market mechanisms, so that excessive prices are not curbed by a cessation of demand;

2. Notes that all the Member States have responded to this special situation in the pharmaceutical sector with different systems designed to keep costs under control;

3. Considers that the Commission's communication does not take account of basic aspects of a balanced industrial policy for the pharmaceutical industry;

4. Takes the view that the Commission is out of touch with reality in claiming that normal market operation is feasible in the pharmaceutical industry and that it is merely necessary to cut back government intervention schemes to achieve this end;

5. Regrets that what the Commission is presenting as 'an industrial policy for the pharmaceutical sector' amounts to nothing more than cutting back what is seen as obstructive government intervention;

6. Takes the view that the need for governments to cut back the cost of using medicines is forcing the pharmaceutical industry in Europe to rationalize not only its research but also its production;

7. Takes the view that this is a normal and healthy process that other industries have mostly been through already, and that this is very necessary in the pharmaceutical industry, which combines very high, inflation-proof earnings with exceptionally high advertising costs and a high degree of fragmentation;

8. Calls on the Commission to keep a critical eye on this essential process of restructuring, to ensure that monopoly situations do not arise for some groups of products;

9. Expects the Commission to produce guidelines for a realistic industrial policy that will

- direct European research more towards real innovation ('more bang for a buck'),

- cut the length and cost of the required approval procedures for new medicines, without putting public health at risk (restoring the effective patent period),

- reduce the fragmentation of research and production,

- put an end to the industry's frenetic use of advertising;

10. Considers that an EU industrial policy for the pharmaceutical industry should be based on the following principles:

- encouraging innovation through a competitive market and an appropriate regulatory framework,

- protecting new medicinal products by intellectual property rights both in the EU and in third countries,

- guaranteeing the availability of medicinal products providing optimum health protection for European citizens,

- creating the right conditions so that important medicinal products are actually available throughout the Community,

- focusing EU measures to promote research on innovative therapies which are particularly important from the point of view of public health and encouraging research into diseases which cannot yet be treated satisfactorily and into rare diseases;

11. Points out that, while the quantity of drugs taken cannot be statistically related to the health of the population, innovative drugs can have a particularly beneficial impact on specific diseases;

12. Attaches importance, therefore, to the qualitative aspect of health care, which should be taken into consideration through research into preventive medicine and the different determinants of health and into the many causes of diseases;

13. Considers that, in order to formulate an industrial policy and secure jobs in the pharmaceutical sector, there should be dialogue between the politicians, employers, unions and patients concerned;

14. Calls on the Commission to ensure that the development of an industrial policy for the pharmaceutical sector is accompanied by a high level of health protection and adequate social security for employees;

15. Considers that measures to foster research and protect intellectual property should cover new medicinal products which represent a significant therapeutic advance;

16. Recognises that, in the nature of pharmaceutical research, important therapeutic advances are normally incremental; that it is difficult to tell what is significant until many years after patent protection has been obtained and a substance developed; and that to try to confine patent protection to notional 'significant advances¨ would be both impractical and damaging;

17. Considers that in order for the EU to be competitive in the growing European and international non-proprietary markets, measures should be introduced which enable pharmaceutical companies to begin, in advance of patent or supplementary protection certificate expiry, such laboratory experiments and regulatory preparations as may be required only for the registration of generic pharmaceuticals developed in the EU to be available on the market immediately, but only after the expiry of a patent or supplementary protection certificate for a proprietary product;

18. Considers that the development of a European-based generic pharmaceutical industry forms a positive contribution to pharmaceutical competition, including both independent SMEs and research-based firms;

19. Welcomes the request made by the Council to the Commission to draw up a report concerning policy on generic medicinal products in the Member States of the European Union and in the other OECD countries, in particular the USA, Canada and Japan ((Council Resolution of 20 December 1995 on generic medicinal products, OJC350, 30.12.1995, p. 7.)) as a preliminary step before - if appropriate - taking measures to encourage greater use of generic medicinal products, bearing in mind the differences in health systems between the EU and other OECD countries;

20. Requires the Commission to monitor closely mergers in the pharmaceutical sector in compliance with Community competition policy;

21. Recommends that the Commission focus its measures on increasing the cost- effectiveness of European research rather than conducting an industrial policy based on deregulation and subsidies;

22. Requests that the Commission do all in its power to make Europe a centre for research and innovation with particular reference to smaller university- based or other research establishments on whose skills innovative companies may draw;

23. Recognizes the close and invaluable links already established between innovative pharmaceutical research companies, universities and other research institutions, which ensures that basic research is geared towards public-health priorities, and hopes that these links will be further consolidated;

24. Pleads for better access for SMEs to scientific databases and public resources in the research and development sphere so as to improve their flexibility and potential for niche innovations;

25. Points out also that the European pharmaceutical industry's international competitiveness will not improve unless it invests substantial sums in pharmaceutical research, and calls on the Commission to adopt appropriate measures to foster the capacity and readiness of the European pharmaceutical industry to make its research self-financing (synergy between public and private research) and to further the coordination of the efforts for research and development, as proposed in the 4th framework programme (1994- 1998) in the field of research, technological development and demonstration;

26. Calls for measures designed to encourage patients and health professionals to use medicinal products in a better and more rational way and to motivate doctors to take more account of the cost factor of the overall treatment;

27. Considers that measures to increase cost-consciousness and waste-avoidance should be encouraged and increased through better information at all levels;

28. Calls for full, objective and responsible information for health professionals and 'consumers' about pharmaceuticals, both as regards their pharmacological effect (indications, correct usage, side effects, risks) and the financial aspects (price of the drug, cost of medicinal treatment, insurance cover), which is a crucial factor in achieving rational use of the products;

29. Calls on the Commission to consider what instruments might be used to promote impartial information on the action of medicines and the risks they entail;

30. Recommends support for schemes that encourage the restrained and appropriate use of medicines in order to lower health-care costs, in particular by reducing hospitalization due to misuse of medicines;

31. Supports the forthcoming creation of the ECPHIN, a European data bank providing specific information on pharmaceutical products, to be accessed using telematic networks;

32. Insists that the database to be established should make available comprehensive, freely accessible information, particularly on prices, trade names, active substances, side-effects, alternative medications and methods of treatment, the use of animal experiments and genetic engineering procedures, and that the industry should be required to make the necessary information available;

33. Calls on the Commission to prepare proposals on how the data from tests carried out in connection with the authorization of a medicinal product and from those instituted after registration can be made available to interested members of the public, and considers that governments and licensing authorities should make available complete summaries of the clinical evidence which caused a medicinal product to be authorized or withdrawn;

34. Welcomes the establishment of the European Medicine Evaluation Agency (EMEA) as a step towards Community regulation of the pharmaceutical market and calls for it to be rapidly developed into a Community-wide licensing authority with transparent procedures in order to avoid unnecessary duplication of work and ensure uniform standards;

35. Considers, nevertheless, that the pharmaceutical industry should also be subject to the rule that the cost of authorizing products should be borne by producers and warns against allowing the EMEA to become a permanent recipient of EU subsidies;

36. Believes that the EMEA should be provided with adequate resources in order to minimize delay in bringing new products onto the market;

37. Insists at the same time that this authority should have a wider duty of disclosure and calls on the Commission to ensure that patients' representatives participate in its board of management and scientific committees (Committee for Medicinal Products (CPMP) and Committee for Veterinary Products (CVMP));

38. Calls for an ethics committee to be established within the EMEA, with its members appointed by the European Parliament and the Council on an equal basis and with the task of drawing up a code of ethics, and considers that, after safety, effectiveness and quality, ethical factors should become the fourth condition for the patentability of medicinal products;

39. Accepts that, although misgivings have been expressed about the possible dangers of genetic experimentation, it is justified and desirable for all kinds of research to proceed, with due care and with due respect for human and animal life, especially in the pursuit of new therapies for diseases for which no treatment is yet known;

40. Requires the Commission to ensure that the European legal framework for biotechnology takes account both of the ethical implications and the economic potential of this new technology;

41. Requests the Commission to examine whether, in collaboration with the European pharmaceutical industry, it would be possible to agree to a voluntary commitment by those concerned on biotechnological development and respect for human rights, based on the European Convention on Human Rights;

42. Stresses that genetic engineering is a promising technique in many fields, not least in the pharmaceutical sector, where activities to develop new medicines with a view to treating complex diseases or achieve particularly high quality levels offer hope to patients;

43. Calls on the Commission to adopt appropriate measures to reduce drastically the number of animal experiments performed during the development of medicinal products; points out that the convention on the protection of vertebrates, concluded as early as 1986, is being disregarded in many Member States, which do not always fulfil their obligation to provide information;

44. Calls for use to be made of alternatives in order substantially to reduce animal testing in pharmaceutical development, and for regulatory requirements to be adapted to make the findings of valid alternative methods acceptable for marketing authorization purposes; demands, therefore, the rapid development of the European centre for alternative methods of testing medicinal products;

45. Points out to the Commission that citizens' attitudes towards health have changed and demand has consequently shifted because there is greater awareness of 'gentle' forms of healing (e.g. physiotherapy) and 'alternative' medicines (herbal and homeopathic) among doctors and patients, and even today alternative treatments provide significant employment opportunities in small and medium-sized enterprises;

46. Calls on the Commission to prepare additional proposals on how also to facilitate the European marketing of herbal and homeopathic medicines (complementing Directive 92/73/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products ((OJ L 297, 13.10.1992, p. 8.))); requests the Commission to adjust the authorization procedure to allow such medicines to be generally available throughout the Community and in pursuit of such, calls for the setting up of a Traditional Medicines Evaluation Agency, comprising experts in this field, to assess the worth of phytomedicines;

47. Supports the gradual harmonization of the packaging of medicinal products (labelling, quantity per package, information for doctors and patients) to make the pharmaceuticals market more transparent throughout Europe and to make larger, more economic production runs possible;

48. Points out with concern that the market leaders in the pharmaceutical sector are rapidly expanding their range of activities through horizontal (generic medicines, biotechnology) and especially vertical (marketing organizations) integration, which puts pressure on wholesalers, who in turn form alliances and buy up pharmacists, so that smaller wholesalers are excluded and small and medium-sized pharmacists lose their independence;

49. Considers that responsible self-medication should be further promoted, which will foster the growing desire of the European Union's citizens to take responsibility for their own health and also help reduce health expenditure. In recent years, responsible self-medication has been identified as an important element in long-term health policy by the institutions of the European Community. As part of the process of improving the legal environment for non-prescription medicines, it will be important to establish more transparent procedures which define the method by which prescription medicines can be transferred to non-prescription status;

50. Considers it appropriate to persuade Member States' health authorities, jointly or severally, to adopt multiannual targets so as to achieve measurable and - in the case of some diseases - 'costable' improvements in the health of their population, not least as regards those diseases considered as 'scourges';

51. Considers that, in the pharmaceuticals sector, the effects of the production, use and disposal of medicinal products on the environment should be determined from every aspect using specific monitoring measures;

52. Categorically supports the promotion of industrial and administrative cooperation with the countries of eastern Europe in the run-up to negotiations on accession or cooperation and opening up to the Mediterranean countries as part of the new Mediterranean policy;

53. Stresses that a responsible industrial policy must also encompass a corresponding policy on exports, particularly to developing countries, and that a minimum requirement should be that medicinal products which have not been authorized on safety grounds in the country of origin may not be exported either; considers that for advertising by European pharmaceutical producers, particularly for Third World markets, a code of conduct should be sought, covering, among other things, the provision of candid information about the risks and benefits of the medicinal products;

54. Considers that a genuine industrial policy should create a transparent, stable and predictable environment in which the European pharmaceutical industry can continue to serve humanity successfully, increasing knowledge of disease and the ability to combat it;

55. Attaches great importance to efforts towards achieving the harmonization of pharmaceutical registration requirements both within the EU and worldwide under the framework of the International Conferences on Harmonization;

56. Recommends that the current safeguards on intellectual property be rigorously maintained and, in line with the TRIPS chapter of the GATT Uruguay Round, all the necessary steps be taken to protect EU pharmaceutical patents in third-country markets, particularly in central and eastern Europe;

57. Instructs its President to forward this report to the Commission, the Council and the parliaments of the Member States.