COMMON POSITION (EC) No 9/95 adopted by the Council on 2 June 1995 with a view to adopting a European Parliament and Council Decision of . . . adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000) (95/C 216/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 129 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure provided for in Article 189b of the Treaty (4),

(1) Whereas, at its meetings in Milan in June 1985 and in Luxembourg in December 1985, the European Council underlined the advantages of launching a European programme against cancer;

(2) Whereas the Council and the Representatives of the Governments of the Member States meeting within the Council adopted on 7 July 1986 a resolution on a first programme of action of the European Communities against cancer (5) and on 17 May 1990 Decision 90/238/Euratom, ECSC, EEC adopting a 1990 to 1994 action plan in the context of the 'Europe against cancer' programme (6);

(3) Whereas the European Parliament, in its resolution of 19 November 1993 (7), asked that activities against cancer be intensified;

(4) Whereas in its resolution of 13 December 1993 (8) the Council invited the Commission, to submit in due course a draft third action plan, taking into account the Council resolution of 27 May 1993 on future action in the field of public health as well as the objectives and improvements set out in the Annex (9);

(5) Whereas the Council, in its resolution of 2 June 1994 (10), in response to the Commission communication of 29 March 1994 on the framework for action in the field of public health, included cancer among the priority areas for Community action for which the Commission was invited to bring forward proposals for action;

(6) Whereas, by reason of its scale and effects, Community action in support of cancer prevention enables the desired objectives to be reached more effectively;

(7) Whereas policies and programmes formulated and implemented at Community level should be compatible with the targets and objectives of Community action on cancer prevention; whereas, in particular, implementation of actions under the Community's biomedical and health research programme should be closely coordinated with the implementation of Community actions on cancer prevention;

(8) Whereas cooperation with the competent international organizations and with non-member countries should be strengthened;

(9) Whereas cancer is a major disease associated with lifestyles; whereas the inherent risk factors need to be overcome, especially tobacco consumption, which will also have an effect on combating other diseases, in particular cardiovascular diseases;

(10) Whereas, by ensuring wider dissemination of knowledge of the causes of cancer and of its prevention, by ensuring improved comparability and dissemination of information on these subjects, and by developing complementary actions especially in health education, this plan will contribute to the achievement of the Community objectives set out in Article 129 of the Treaty;

(11) Whereas it is important that the Commission ensure implementation of this plan in close cooperation with the Member States; whereas, to that end, provision must be made for a procedure to ensure that Member States are fully involved in implementing the plan;

(12) Whereas agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning measures implementing acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994;

(13) Whereas moreover, in order to have available to it all the necessary scientific information, the Commission cooperates with a high-level committee of scientific experts appointed by the Member States;

(14) Whereas, from the operational point of view, the investment made under the preceding action plans in terms of both the European pilot networks and of the mobilization of all those involved in combating cancer should be safeguarded and developed;

(15) Whereas, however, possible duplication of effort should be avoided by the promotion of exchanges of experiences and by the joint development of basic information modules for the general public, for health education and for training members of the health professions, which may be targeted on specific groups;

(16) Whereas a Community contribution to combating cancer includes all aspects of primary, secondary and tertiary prevention, including those helping to alleviate the effect of the disease, to improve its curability and the quality of life of sufferers;

(17) Whereas, in order to increase the value and impact of this plan, a continuous assessment of the measures undertaken should be carried out, with particular regard to their effectiveness and the achievement of objectives both at national and Community level and, where appropriate, to make the necessary adjustments;

(18) Whereas the objectives of this plan and the actions implementing it form part of the requirements concerning health protection referred to in the third subparagraph of Article 129 (1) of the Treaty and by virtue thereof form part of the Community's other policies;

(19) Whereas this Decision lays down, for the entire duration of the action plan, a financial framework constituting the principal point of reference, within the meaning of point 1 of the Declaration of the European Parliament, the Council and Commission of 6 March 1995, for the budgetary authority during the annual budgetary procedure;

(20) Whereas this plan should be of five-year duration in order to allow sufficient time for actions to be implemented to achieve the objectives set,

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the plan

1. A Community plan of action against cancer entitled 'Europe against cancer', hereinafter referred to as 'this plan', shall be adopted for the period 1 January 1996 to 31 December 2000 within the framework for action in the field of public health.

2. This plan shall have as its objective to contribute towards ensuring a high level of health protection and shall comprise actions aimed at:

- preventing premature deaths due to cancer,

- reducing mortality and morbidity due to cancer,

- promoting the quality of life by improving the general health situation,

- promoting the general well-being of the population, particularly by minimizing the economic and social consequences of cancer.

3. The actions to be implemented under this plan and their specific objectives are set out in the Annex under the following headings:

A. Data collection and research,

B. Information and health education

C. Early detection and screening

D. Training and quality control and guarantees

4. The actions to be undertaken shall include in particular:

- the establishment of common objectives,

- the standardization and collection of comparable and compatible data on health,

- programmes for exchange of experience and of health professionals and for the dissemination of the most effective practices,

- the creation of information networks,

- European-scale studies and dissemination of the results,

- implementation of pilot programmes and pilot projects,

- compilation of reports, especially to monitor the measures taken.

Article 2

Implementation

1. The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions set out in the Annex in accordance with the procedure laid down in Article 5.

2. The Commission shall also cooperate with institutions and organizations active in combating cancer.

3. Member States are called upon to take the necessary measures to coordinate and organize the implementation of this plan at national level.

Article 3

Budget

1. The Budget for implementing this plan for the period referred to in Article 1 is set at ECU 59 million.

2. The annual appropriations shall be authorized by the budget authority within the limits of the financial perspective.

Article 4

Consistency and complementarity

The Commission and the Member States shall ensure that there is consistency and complementarity between actions to be implemented under this plan and other relevant Community programmes and initiatives, including the biomedical and health research programme under the Community's framework programme for research and programmes introducing an integrated information network (information technology in areas of general interest).

Article 5

Committee

1. The Commission shall be assisted by a committee, hereinafter referred to as 'the committee', consisting of two members designated by each Member State and chaired by a representative of the Commission.

2. The repesentative of the Commission shall submit to the committee a draft of the measures to be taken, relating to:

(a) the committee's rules of procedure;

(b) an annual work programme indicating the priorities for action;

(c) the arrangements, criteria and procedures for selecting and financing projects under this plan, including those involving cooperation with international organizations competent in the field of public health, and participation of the countries referred to in Article 6 (2);

(d) the evaluation procedure;

(e) the arrangements for dissemination and transfer of results;

(f) the arrangements for cooperating with the institutions and organizations referred to in Article (2).

The committee shall deliver its opinion on the draft measures referred to above within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall forthwith be communicated by the Commission to the Council. In that event, the Commission shall defer application of the measures which it has decided upon for a period of two months from the date of such communication.

The Council, acting by a qualified majority, may take a different decision within the time limit laid down in the previous subparagraph.

3. In addition, the Commission may consult the committee on any other matter concerning the implementation of this plan.

The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its opinion recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.

4. The representative of the Commission shall keep the committee regularly informed about:

- financial assistance granted under this plan (amounts, duration, breakdown, beneficiaries),

- Commission proposals or Community initiatives and the implementation of programmes in other areas which are directly relevant to achievement of the objectives of this plan, with a view to ensuring the consistency and complementarity required pursuant to Article 4.

Article 6

International cooperation

1. In the course of implementing this plan, cooperation with non-member countries and with international organizations competent in the field of public health, in particular the World Health Organization and the International Agency for Research on Cancer, will be encouraged and implemented in accordance with the procedure laid down in Article 5.

2. The associated countries of central and eastern Europe (CCEE) may participate in this plan in accordance with the conditions laid down in Additional Protocols to the Association Agremeents concerning participation in Community programmes, to be concluded with those countries. This plan shall be open to Cyprus and Malta on the basis of additional appropriations under the same rules as those applied to the EFTA countries, in accordance with procedures to be agreed with those countries.

Article 2

Monitoring and evaluation

1. The Commission, taking into account the reports drawn up by the Member States and with the participation, where necessary, of independent experts, shall ensure that evaluation is made of the actions undertaken.

2. The Commission shall submit to the European Parliament and the Council an interim report half way through and a final report on completion of this plan. The reports shall highlight, in particular, the complementarity between this plan and the other actions mentioned in Article 4. The Commission shall incorporate into these reports the results of the evaluations. It shall also send the reports to the Economic and Social Committee and the Committee of the Regions.

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ No C 139, 21. 5. 1994, p. 12.

(2) OJ No C 393, 31. 12. 1994, p. 8.

(3) Opinion delivered on 28 September 1994 (not yet published in the Official Journal).

(4) Opinion of the European Parliament of 1 March 1995 (OJ No C 68, 20. 3. 1995, p. 17), Council common position of . . . (not yet published in the Official Journal) and European Parliament Decision of . . . (not yet published in the Official Journal).

(5) OJ No C 184, 23. 7. 1986, p. 19.

(6) OJ No L 137, 30. 5. 1990, p. 31.

(7) OJ No C 329, 6. 12. 1993, p. 375.

(8) OJ No C 15, 18. 1. 1994, p. 1.

(9) OJ No C 174, 25. 6. 1993, p. 1.

(10) OJ No C 165, 17. 6. 1994, p. 1.

ANNEX

SPECIFIC OBJECTIVES AND ACTIONS

A. Data collection and research

Objective

To extend and improve knowledge of the causes, prevention and treatment of cancer and to facilitate the collection of reliable and comparable data on the incidence of cancer, including data on paediatric oncology, in particular to identify trends and to devise European-scale epidemiological studies.

Actions

1. Support for exchanges of information and experience relating to the collection and dissemination of reliable and comparable data for cancer registers (prevalence, incidence, mortality, survival rate and age groups). Development and strengthening of a European network in cooperation with the Inernational Agency for Research on Cancer (IARC).

2. Support for the carrying out of epidemiological studies at European level and for the dissemination of their conclusions with regard to the identification of carcinogens (physical, chemical and biological), with special attention to environmental factors and related conditions at work, the risks rising from exposure to them (types of exposure and population subgroups affected), methods of prevention and the introduction of programmes for objectively assessing survival rates on the basis of specific criteria (age, sex, position of the tumour, stage of development, histological type, etc.) and for assessing sources of disparities in those rates. On the basis of these conclusions, support for the drawing up and dissemination of recommendations. Cohort studies on cancer, diet and health (EPIC network), support for epidemiological studies based on research intro nutrition as a potential preventive factor (identification of protective agents, modification of specific dietary factors) and, where appropriate, preventive chemical agents.

3. Contribution to the selection of priorities for cancer research to be carried out under the Community's framework programmes for research, and specifically the biomedical and health research programme, which includes basic and clinical cancer research, and promoting research methods aimed at early, accurate and reliable diagnosis by means of laboratory diagnosis techniques, in particular based on immunology and genetics. Support for the establishment of an inventory of European basic and clinical cancer research measures; help with the transfer to clinical trials of the results of basic research; information exchange networks for clinical trials in progress, and help with the launching of multiple-centre and multinational clinical testing in order to speed up the assessment of new methods of care.

B. Information and health education

Objectives

To help to improve knowledge of cancer risks and cancer prevention among European citizens and encourage them to adopt healthy lifestyles;

to promote and assess policies and measures related to cancer causes and exposures.

Actions

4. Establishment of an annual 'Europe against cancer' week.

5. Improving the dissemination and effectiveness of cancer prevention messages, in particular the recommendations of the European code against cancer, by supporting targeted measures (for teachers, general practitioners, etc.) and pilot projects, studies and analyses of health promotion techniques and assessments of action in this field.

6. Supporting and extending pilot action networks for providing information and exchanges with regard to cancer prevention, taking into account the recommendations of the European code against cancer and those of the committees of experts meeting for this purpose in order to contribute to the highlighting and dissemination of best practice.

7. Promoting information and awareness-raising campaigns for specific population groups on health promotion and cancer prevention, particularly in public places and at work.

8. Encouraging projects with a European dimension relating to the prevention of tobacco consumption; assessment of the implementation of recommendations on the use of tobacco in public places, particularly on public transport and in education establishments. Promotion of strategies aimed at protecting the most vulnerable groups, in particular pregnant women and children, from the risk of passive smoking. Assessment of the effect of measures taken in the Member States to reduce tobacco consumption, for example by the banning or control of direct or indirect advertising, the effects of taxation measures, exclusion of tobacco from the price index and dissemination of knowledge acquired from such assessments. Support and assessment of pilot measures for preventing tobacco consumption as part of the exchange networks between Member States, for example networks of no-smoking towns, no-smoking hospitals and youth clubs in cooperation with healthcare workers and teachers.

9. Selection, dissemination and evaluation of the impact of the best methods of reducing tobacco consumption in Member States as part of pilot measures to implement these methods in liaison with healthcare workers. Continuing classification of dangerous substances and preparations with the aim of improving packaging and labelling.

10. Contributing to the formulation and implementation of integrated health and education programmes in different contexts, with cancer prevention given a particularly important role. Definition and implementation of supplementary cancer prevention projects for specific groups in different contexts.

Evaluation of health education initiatives targeted at young people, with priority being given to making individuals more aware of their responsibility for their own health, preventing tobacco consumption as well as excessive alcohol consumption, promoting a healthy diet, especially the consumption of fruit and vegetables, appropriate healthy diet advertising campaigns and making people aware of the risks associated with excessive exposure of the skin to ultraviolet radiation.

11. Support for exchanges of experience under the integrated health education programmes with the aim of improving initial and continuing training for teachers and project supervisors in the field of cancer prevention, taking account in this context of the experience gained in the framework of programmes such as Erasmus and the supporting actions of the Commission in the education field.

12. Support for the production, dissemination and evaluation of the impact of Community teaching materials relating to cancer prevention, particularly those tested in the pilot networks.

13. Implementation of studies and dissemination of their conclusions, making it possible to improve the level of knowledge of the perceptions of young people with regard to cancer, tobacco, diet and the risks associated with excessive exposure of the skin to ultraviolet radiation. Carrying out analyses with the aim of increasing the effectiveness of preventive programmes among children and young people.

C. Early detection and screening

Objective

To help improve and increase the possibilities of early detection, in particular through the development and dissemination of effective screening programmes and appropriate practices.

Actions

14. Support for the introduction and evaluation of European pilot project networks in the field of mass screening for breast and cervical cancer, on the basis of recommendations established at European level with regard to ensuring the quality of screening, and support for the organization of meetings to examine the feasibility of extending pilot projects to national and regional levels.

15. Support for the preparation and dissemination at European level of a common terminology and classification in order to improve the quality of national and cytopathological interpretation, particularly of suspect growths in the breast and uterus, in particular for anatomists and cytopathologists in the Community.

16. Support for European feasibility studies on mass screening for other cancers (of the ovary, prostate, skin, colon/rectum and mouth), taking particular account of the medical, psychological, social and economic aspects.

D. Training and quality control

Objective

To help improve cancer-related training for healthcare workers, including training in paediatric oncology, and quality control methods.

Actions

17. Further implementation of the Commission recommendation of 8 November 1989 concerning the training of health personnel in the matter of cancer; assistance with the introduction of periodic assessment of the impact of the European pilot networks on initial and continuing training in cancer for the medical, nursing and dentistry professions, in particular for health personnel working in paediatric oncology.

18. Support for the mobility of the health professions (particularly trainers), in order to improve theoretical and practical knowledge of cancer (in particularly primary prevention, early diagnosis, mass screening, particularly for cervical and breast cancer, and quality assurance), between those centres of excellence in Member States offering training of a high quality, where such mobility is not ensured under existing Community programmes such as Comett II or Force.

19. Support for exchanges of experience and the drawing up and dissemination of conference recommendations for a consensus on good practice in the field of combating cancer and of recommendations by groups of experts in order to speed up the dissemination and implementation of the results of controlled studies.

20. Preparation of teaching materials of European interest, aimed at improving training in cancer for healthcare workers, particularly through the use of interactive computer programmes; assessment of the impact of those materials in the pilot networks. In particular, support for the development, implementation and evaluation of prevention modules intended for the health professions, and of models to assist in diagnosis and in making decisions on measures to prevent the development of the disease and risks of relapse.

21. Promotion of initiatives and support for European studies and dissemination of their conclusions, particularly in the context of European-level meetings and exchanges of experience, in order to gain a better understanding and improve the effectiveness of quality control methods for measures aimed at correct early detection of the disease and prevention of its development, risks of relapse and associated syndromes, taking into account the psychological and social aspects, in particular the quality of life of patients, including palliative methods.

22. Support for pilot projects in the aera of quality assurance, including dissemination and evaluation of the results, with particular reference to practices connected with checks on radiotherapy installations and the training of health personnel.

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 April 1994 the Commission submitted a proposal based on Article 129 of the EC Treaty for a Decision adopting an action plan 1995 to 1999 to combat cancer within the framework for action in the field of public health.

2. The European Parliament, the Economic and Social Committee and the Committee of the Regions delivered their opinions on 1 March 1995 (1), 14 September 1994 (2) and 27 August 1994 (3) respectively.

In the light of those opinions, the Commission submitted an amended proposal for a Decision on 21 April 1995 (4).

3. On 2 June 1995 the Council adopted its common position in accordance with Article 189b of the Treaty.

II. OBJECTIVE OF THE PROPOSAL

The objective of the proposal is to implement one of the priorities set out by the Commission in its communication on the framework for action in the field of public health, and by the Council in its resolution of 2 June 1994, as a subject for multiannual Community action, in accordance also with the wishes expressed by the Parliament.

This action is also a continuation of that already undertaken as part of the 'Europe against cancer' programme, the last plan under that programme having concluded at the end of 1994.

This action, which runs for five years, defines:

- in the Articles, the general framework of the action (general provisions for establishing, operating, implementing and monitoring the plan),

- in the Annex, the actions to be implemented.

III. ANALYSIS OF THE COMMON POSITION

1. General remarks

In its common position the Council has retained the essence of the Commission proposal while making what it regards as necessary amendments to general aspects of the presentation and implementation of the plan.

2. Specific remarks:

2.1. Amendments made by the Council to the amended Commission proposal

The main amendments made by the Council to the Commission proposal concern the following aspects:

(a) Establishment of the plan (Article 1)

The amendments made (additions) are intended to clarify the main basic features of the plan:

the general objective (paragraph 2), the structure (paragraph 3) and the main forms of action (paragraph 4).

The text adopted by the Council thus embraces - or follows the same lines as - the amendments made by the Parliament (amendments 13 and following) and the amendment made by the Commission to Article 2 of its proposal.

(b) Implementation (Article 2) and committee procedure (Article 5)

The main purpose of the adjustments made to the implementing provisions and procedures is:

- to identify more clearly (Article 2) the respective roles and contributions of the Commission (paragraph 1), of the institutions and organizations active in this field (paragraph 2) and of Member States (paragraphs 1 and 3) in implementing the plan,

- in order to reconcile the need for flexibility in managing the programme with that of more active involvement of Member States in certain important decisions, the Council has opted for a committee operating - depending on the topics - either as a management committee or as an advisory committee (Article 5).

Furthermore, the regular information on financial assistance granted and on activities in other areas directly relevant to achievement of the plan's objectives, as provided for in paragraph 4, meets a concern for transparency and effectiveness (regarding the provision in Article 4 in particular).

(c) Budget (Article 3 (1))

The Council has amended Article 3 in accordance with the Parliament/Council/Commission statement of 6 March 1995 on the incorporation of financial provisions into legislative acts by entering in this Article the amount of the total appropriation to be earmarked for the implementation of the plan. An appropriate penultimate recital has also been added.

The amount adopted - ECU 59 million - represents a balance between the desire to maintain support for activities in this field while keeping the Community contribution at a level at least equivalent to that granted in previous years and the need to take into account the requirements of budgetary discipline.

(d) International cooperation (Article 6)

The Council has simply made amendments to ensure consistency:

- between paragraph 1 and the provision in Article 5 (2) (f),

- between paragraph 2 and the agreements in existence or being negotiated with the countries concerned.

(e) Monitoring and evaluation

The amendments made do not alter the substance of the text and are aimed solely at clarifying the conditions for monitoring in general and evaluation in particular.

In order to be realistic, the Council has followed the line taken by the Commission, which in its amended proposal omitted the requirement to submit an annual report.

(f) Annex

The purpose of the main change made by the Council to the proposed text is to gather the acts under several broad headings and to indicate in each case what the specific objective is (as laid down in Article 1 (3)).

2.2. European Parliament amendments

(a) Amendments accepted by the Commission

- The Council has accepted most of the 26 amendments which the Commission accepted fully or partly (5), as they stood, wholly or partly, or in substance, in a different form or in a more general form.

- The Council was unable to accept some of these amendments:

- on practical implementing procedures, which can be covered by the different approach adopted (Articles 2 and 5): amendments 10, 13 and 20,

- on an action focused directly on the media, which could look like a form of interference: amendments 8 and 25,

- which were linked too specifically to therapeutic practices or care systems, except in so far as research aspects covered elsewhere were concerned: amendments 31, 32 and 34.

(b) Amendments not accepted by the Community

The Council generally followed the reasoning which led the Commission not to accept some of the Parliament's amendments.

However, of the 10 amendments which the Commission said it could not accept (6) in its amended proposal, the following are covered partially or in some other form by the Council's common position:

- amendment 3 on the wording of the sixth recital,

- amendments 36 and 43, referring to the 13th recital (reference to a high-level committee of experts) and to the second indent of Article 5 (4) of this text.

CONCLUSIONS

The Council has adopted the substance of the proposed plan bearing in mind the Parliament's opinion. By making certain adjustments to the structure and to the implementing procedures it has endeavoured to enhance the conditions for ensuring as much transparency, effectiveness and monitoring as possible.

(1) OJ No C 68, 20. 3. 1995, p. 17.

(2) OJ No C 393, 31. 12. 1994, p. 8.

(3) Not yet published in the Official Journal.

(4) Not yet published in the Official Journal.

(5) Amendments 1, 2, 6, 7, 8, 10, 12, 13, 14, 15, 16, 18, 20, 21, 22, 23, 25, 26, 28, 30, 31, 32, 33, 34, 35 and 42.

(6) Amendments 3, 4, 9, 17, 19, 27, 29, 36, 43 and 46.