CELEX: 51988PC0315
Language: en
Date: 1988-05-31
Title: AMENDED PROPOSAL FOR A COUNCIL DECISION ON A COMMUNITY ACTION IN THE FIELD OF INFORMATION TECHNOLOGY AND TELECOMMUNICATIONS APPLIED TO HEALTH CARE AIM ( ADVANCED INFORMATICS IN MEDICINE ) - EXPLORATORY ACTION -

No C 214/2                              Official Journal of the European Communities                                     16. 8. 88
                            Article 2                                The Member States shall communicate to the Commission
                                                                     the texts of the main provisions of national law which they
                                                                     adopt in the field covered by this Directive.
 After consulting the Commission, the Member States shall
 bring into force the laws, regulations and administrative                                      Article 3
 provisions necessary to comply with this Directive before
 1 July 1989.                                                        This Directive is addressed to the Member States.
               Amended proposal for a Council Decision on a Community action in the field of information
               technology and telecommunications applied to health care — Advanced informatics in medicine
                                                   (AIM) — Exploratory action
                                                  COM(88) 315 final — SYN 95
                (Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty on 9 June 1988)
                                                           (88/C 214/02)
 THE COUNCIL'OF THE EUROPEAN COMMUNITIES,                           Whereas the Economic and Social Committee supports
                                                                     initiatives in this domain;
 Having regard to the Treaty establishing the European
Economic Community, and in particular Article 130Q (2)
thereof,                                                            Whereas with the emergence of advanced and mobile
                                                                    communication services and the progressive introduction
                                                                    of computing in health care and services, the conditions for
 Having regard to the proposal from the Commission (*),             major improvements for health care and possibilities for
                                                                    improved cost-effectiveness may be emerging;
In cooperation with the European Parliament,
Having regard to the opinion of the Economic and Social             Whereas it is important for increasing the quality,
Committee,                                                          flexibility and accessibility of health care in the Community
                                                                    that there should be adequate consultation of organizations
                                                                    working in this field;
Whereas the Community has as its task, by establishing a
common market and progressively approximating the
economic policies of Member States, inter alia to promote
throughout the Community a harmonious development of                Whereas particular attention must be paid to questions of
economic activity and closer relations between the States           privacy, confidentiality and data protection and this can
belonging to it;                                                    build on related work carried out in the framework of
                                                                    ESPRIT and RACE;
Whereas the Heads of State and Government emphasized
the importance of health care as a major factor for
                                                                    Whereas developments in health care will benefit the
economic growth and social development;
                                                                    general public and the building of a competitive European
                                                                    industry for developing and sustaining advances in health
Whereas the European Parliament, in its assessment of the           services;
situation, stressed the role of cooperation in health care and
related areas for the future political, social and economic
development of the Community;
                                                                    Whereas advances in health care will contribute to
                                                                    resolving pressing social needs associated with changing
Whereas the European Parliament, in its assessment of               age structures 'in the Community, and to the earliest
biotechnology in Europe, has stressed the importance of             possible recognition of new diseases and health-care
medical biotechnology and bioinformatics ( 2 );                     problems;
(!) OJ No C 355, 31. 12. 1987, p. 10.                               Whereas the concerted efforts in this domain will
(2) OJ No C 76, 23. 3. 1987, p. 25.                                 contribute to the creation of the internal market and
 ---pagebreak--- 16. 8. 88                                Official Journal of the European Communities                                No C 214/3
prevent the formation of new internal frontiers to health           overall harmonious development, while being consistent
care;                                                               with the pursuit of scientific and technical quality; whereas
                                                                    it is intended that the AIM action should contribute to the
Whereas the development of common functional speci-                 achievement of these objectives;
fications for equipment and services will permit the less
developed regions to benefit fully from the efforts of              Whereas the need is recognised to construct a specific
Member States piloting the improvements of health care,             European infrastructure in which existing and advanced
management and infrastructure developments in the                   technologies can be developed and focused to solving
Community;                                                          problems of health care; whereas the end beneficiary must
                                                                    be the individual patient;
Whereas the development of common functional speci-
fications for equipment and services will enable the better         Whereas the building of this infrastructure and achieving
targeting of effort and use of scarce resources;                    the human objectives is an urgent necessity; whereas the
                                                                    attainment of these objectives is best brought about by
Whereas the development of a European health care                   unifying the efforts of health care providers, research
infrastructure technology will encourage and draw upon              establishment, undertakings including small and medium
the best work in the Community and will ensure the                  sized enterprises and other bodies in the Community;
passage of such work into the processes of health care.
                                                                    Whereas exploratory investigations have confirmed the
Whereas the development of the health care infrastructure           need and the advantages of building a programme of
technology and services offers a wide range of opportu-             Community cooperation in this field;
nities for small and medium sized companies in the
manufacture of equipment and in the provision of                    Whereas it is in the Community's interest to consolidate the
specialized services for the provision of health care within        scientific and financial basis of European research by
the Community;                                                      means of the involvement to a greater extent of participants
                                                                    from European third countries in certain Community
Whereas cooperation in pre-normative and pre-competi-               programmes and particularly in programmes involving
tive R&D towards the development of standards can make              cooperation in medical bio-informatics;
a major contribution, notably by facilitating the evolution
towards future more effective health care also at regional          Whereas the AIM exploratory action will benefit from the
and local levels;                                                   results of ESPRIT and RACE as well as the on-going efforts
                                                                    in standardization;
Whereas, by its Decision of 87/516/Euratom/EEC ( ] ), the
Council adopted a framework programme of Community                  Whereas the Community's programme in biotechnology
activities in the field of research and technological               (1985 to 1989) will include the application of medical bio-
development (1987 to 1991) providing for research to be             informatics and draw on the results of the work to be
undertaken in the field of the application of information           undertaken under AIM;
technology and telecommunications to meet common
social needs; whereas the framework programme contains              Whereas there exists a need for close coordination with
special provision for a Community action in the field of            actions on the national level and periodic reviews; whereas
medical and bio-informatics ( 2 );                                  it is therefore necessary for the execution of the exploratory
                                                                    action that the Commission be assisted by a Committee;
Whereas the terms of Article 130K of the Treaty provide
that implementation of the framework programme be                   Whereas the implementation of concerted actions in the
carried out by means of specific programmes developed               COST framework is an essential element to complement
within each of its action lines;                                    industrially-oriented R&D projects;
Whereas the Council Decision of 28 September 1987                   Whereas the Scientific and Technical Research Committee
concerning the framework programme for Community                    (CREST) has expressed its opinion,
activities in the field of R & T & D provides that a particular
aim of Community research shall be to strengthen the
scientific and technological basis of European industry             HAS ADOPTED THIS DECISION:
especially in strategic areas of high technology and to
encourage it to become more competitive at international
level;                                                                                          Article 1
Whereas the same decision further provides that Com-
munity action is justified where research contributes inter         1. An exploratory Community action in the field of
alia to the strengthening of the economic and social                Information Technology and Telecommunications applied
cohesion of the Community and the promotion of its                  to health care, called AIM, is adopted for an initial period
                                                                    of 18 months commencing on 1 June 1988.
0) OJ No L 302, 24. 10. 1987, p. 1.                                 2. The Community action is designed to make available
(2) Action Line 2.3, new services of common interest.               to citizens and health services, at minimum cost and
 ---pagebreak---  No C 214/4                              Official Journal of the European Communities                                   16. 8. 88
 minimum delay, improvements in health care, thereby                2. The proposals for projects shall, as a rule, be submitted
 contributing to social and economic objectives.                    in reply to an open invitation to tender and involve the
                                                                    participation of at least two independent partners not all
 3. The Community action is designed to promote                     established in the same Member State. At least one of the
 development of a European infrastructure and framework             partners shall be an industrial undertaking. Within each
 within which existing developments and new advances can            project at least one partner should represent health care
 be brought to health care by cooperation between public            interests. The invitation to tender shall be published in the
 and private activities at national and international levels.       Official Journal of the European Communities.
                                                                    3. In exceptional cases concerning projects indispensable
                           Article 2                                for implementing key requirements of the workplan:
 1. The action shall consist of the development of a                    — where a proposal would involve:
common conceptual framework for cooperation, pre-
 normative work and technology exploration and the                      i) unreasonable burden on the participants, par-
 investigation of the non-technological factors as required                  ticularly small and medium sized enterprises and
 for the objective of concerting European efforts in                         research establishments,
improving health care by means of medical and bio-
informatics.                                                            ii) only one independent partner,
2. The action is intended to provide cost effective                     iii) only independent partners established in the same
advances in the care of the individual citizen and in the                    Member State, or
development, planning and management of health care
services. In work relating to patient information, the action           — where an open tendering procedure would be
will place priority on the development of safe and reliable                  unjustified on grounds of cost or efficiency, or
methods for the protection of medical records against loss,
corruption or unauthorised disclosure.
                                                                        — where the amount of Community's contribution to
                                                                             the cost does not exceed 0,25 million ECU,
3.    The field of application of the action includes:
 (1) development of a common conceptual framework for               it may be decided, in accordance with the procedures laid
     cooperation;                                                   down in Article 8, to depart from the general provisions set
                                                                    out in paragraphs 1 and 2 of this Article.
 (2) medical informatics environment;
                                                                    4. The contracts for all parts of the action         shall be
 (3) data structures and medical records;                           concluded with undertakings, including small and     medium
                                                                    sized enterprises, service providers, universities,  research
 (4) communication and functional integration;                      establishments and other bodies established           in the
                                                                    Community.
 (5) integration of knowledge-based systems into health
     care;
                                                                                               Article 4
(6) advanced instrumentation, equipment and services for
     health care and medical research environment;
                                                                   Where Framework Agreements for scientific and technical
                                                                   cooperation between non-Community European countries
(7) non-technological factors.
                                                                    and the European Community have been concluded,
                                                                   organizations and enterprises established in these countries
The summary and objectives of the AIM are set out in more
                                                                   may, in accordance with the procedures laid down in
detail in Annex II.
                                                                   Articles 3 and 8, become partners to a project undertaken
                                                                   within this action.
                           Article 3
                                                                                               Article 5
1. Projects relating to the action shall be executed by
means of shared cost contracts. Contractors shall be
expected to bear a substantial proportion of the costs,             1. The funds estimated as necessary for the Community
which should normally be at least 50 % of the total                contribution to the execution of the exploratory action
expenditure.                                                       amount to 20 million ECU over 18 months, including
                                                                   expenditure on staff (nine A, two B and four C temporary
Alternatively, in respect of universities and research             officials).
institutes carrying out projects or actions, the Community
may bear up to 100 % of the additional expenditure                 2. The indicative allocation of these funds is set out in
involved.                                                          Annex 1.
 ---pagebreak--- 16. 8. 88                               Official Journal of the European Communities                                No C 214/5
                           Article 6                               measures to be adopted to the Committee. The Committee
                                                                   delivers an opinion within a time limit which shall normally
1. The Commission shall ensure that the action is                  be one month and shall in no case exceed two months. The
properly performed and establish the appropriate im-               opinion is delivered by the majority specified in Ar-
plementation measures.                                             ticle 48(2) of the Treaty for decisions which the Council is
                                                                   required to adopt on a proposal from the Commission, the
2. The Commission shall establish a draft workplan
                                                                   votes of the representatives of the Member States being
defining the detailed objectives, the type of projects and
                                                                   weighted as indicated in that Article. The chairman does
actions to be undertaken and the corresponding financial
                                                                   not vote.
plan.
3.   The procedure laid down in Article 8 shall apply to:          3. The Commission shall adopt measures which shall
                                                                   apply immediately. However, if these measures are not in
— the establishment of the workplan referred to in                 accordance with the opinion of the Committee they shall be
    paragraph 2 of this Article,                                   communicated by the Commission to the Council forth-
                                                                   with. In that event:
— any departure from the general conditions laid down in
    Article 3(1) and (2),                                          — the Commission may defer application of the measures
                                                                       which it had decided for a period of not more than one
— the evaluation of work undertaken in respect of each                 month from the date of such communication,
    part of the exploratory action by appropriate organi-
    zations, groups and other bodies,                              — the Council acting by a qualified majority may take a
                                                                       different decision within the time limit referred to in the
— the assessment of the proposed projects for the                      previous paragraph.
    implementation and the Community financial contri-
    bution for a project when this contribution is in excess
    of 0,4 million ECU,                                                                       Article 9
— the participation in any project by European organiza-           1. The result of the action shall be reviewed by the
    tions and enterprises not established in the Community.        Commission after 12 months. The Commission shall
                                                                   report to the Council and the European Parliament on the
4. The Commission may consult the Committee referred               results of this review.
to in Article 7 on any matter falling within the scope of this
decision.                                                          2. After completion of the action, the Commission shall
                                                                   send to the Council and the European Parliament a report
                           Article 7                               on the performance and results of the action.
                                                                   3. The abovementioned report will be carried out in
The Commission shall be assisted in the performance of its
                                                                   relation to the precise objectives set out in Annex II to this
tasks by a committee, hereinafter referred to as 'the
                                                                   Decision and in conformity with the provisions of
Committee'. The Committee, consisting of two re-
                                                                   Article 2(2) of the framework programme.
presentatives of each Member State, shall be set up by the
Commission on the basis of nominations by the Member
States.                                                                                      Article 10
Members of the Committee may be assisted by experts or             With regard to the concertation activities provided for in
advisors depending on the nature of the issues under               Article 1(2), the Member States and the Commission shall
consideration.                                                     exchange all appropriate information to which they have
                                                                   access and which they are free to disclose concerning
The Committee shall be chaired by a Commission                     activities in the areas covered by this Decision, whether or
representative.                                                    not planned or carried out under their authority.
The proceedings of the Committee shall be confidential.            Information shall be exchanged according to a procedure
The Committee shall adopt its own rules of procedure. The          to be definied by the Commission after consulting the
secretarial services shall be provided by the Commission.          Committee, and shall be treated as confidential at the
                                                                   supplier's request.
                           Article 8
1. Where the procedure laid down in this Article is to be                                    Article 11
followed, the Chairman shall refer the matter to the
                                                                   This Decision shall apply from 1 June 1988.
Committee, either on his own initiative or at the request of
one of its members.
                                                                                             Article 12
2. Under this procedure, the representative of the
Commission, who acts as chairman, refers the draft of the          This Decision is addressed to the Member States.
 ---pagebreak--- No C 214/6                                 Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                   16. 8. 88
                                                                     ANNEX /
                                                        AIM EXPLORATORY ACTION
            Action line I
           IMPROVEMENT OF THE EFFECTIVENESS OF PUBLIC AND PRIVATE ACTIONS                                              4,80 (!)
           1. Development of a common conceptual framework for cooperation
            Action line II
           STRENGTHENING EUROPE'S POSITION IN MBI AND HEALTH CARE                                                     10,70 (!)
           2. Medical informatics        environment
           3. Data structures and medical records
           4. Communication        and functional     integration
           5. Integration of knowledge-based         systems into health care
           6. Advanced instrumentation,         equipment and services for health care and medical research
               environment
            Action line III
           CREATION OF AN ENVIRONMENT FAVOURABLE TO THE RAPID INTRO-
           DUCTION AND APPROPRIATE APPLICATION OF MBI IN HEALTH CARE                                                   2,25 (!)
           7. Non-technological       factors
               Personnel costs                                                                                         1,69 (i)
               Administrative costs                                                                                     0,56(])
                                                                                                               Total  20,00 f1)
           (*) Estimated Community contribution in million ECU.
                                                                     ANNEX 11
                                            PROGRAMME SUMMARY AND OBJECTIVES
                                                                  1. RATIONALE
           The accurate understanding of the nature, role and use of information in the medical domain is fundamental to
           the success of any system designed to be an effective aid to satisfy society's health needs because health care is in
           a process of continuous evolution and so is the technology supporting it. Information-related activities are
           growing rapidly and the cost of such activities in many health care organisations has become very significant.
           The impetus behind a progressive implementation of an integrated health environment (IHE) at the national
           and international level stems from various factors.
           Firstly, there is the rising cost of medical care, the major element of which comes from hospital services. In the
           context of a more efficient use of resources devoted to health care, there is a strong need:
 ---pagebreak--- 16. 8. 88                               Official Journal of the European Communities                                           No C 214/7
          — to obtain adequate indicators of performance and of quality of care,
          — to make these indicators available and comparable on computerized systems in order to better understand
              variations in costs as well as in practices and outcomes of care,
          — to provide the primary care physician with the advanced IT tools needed to allow him to perform his 'gate
              keeping function' by referring patients only when appropriate for hospital investigation or specialist
              opinion,
          — to define the requirements for allowing a breakthrough in the provision of hospital information services
              which today are not optimized because clinical and administrative processes and procedures are generating
              numerous records for each patient, complicating storage, retrieval, and analysis of information required to
              support hospital functions,
          — to shorten the delays related to the health care process by increasing the level of interaction between the
              health care providers through the facilitation of the flow and utilization of the existing skills and structures
              in the system (specialist availability, clinical data, health and pharmaceutical information, administrative
              mailing, professional documentation).
          Secondly, the rapid development of information technology and telecommunications provides a great
          opportunity to improve quality, accessibility, efficiency and economy of health care services. But this can be
          achieved only if a progressive standardization matches the growth of computerized information in health care
          which is now leading to a proliferation of independent systems in Europe. International, or at least European
          standardization does not mean a strict uniformity of measurement systems, but rather an increase in consistency
          of approaches through a better transparency of results and a more systematic exchange of comparable
          information. Early agreement by sector actors on open standards and requirements supporting IHE
          implementation will simultaneously provide transparency in practices, outcomes and costs of health care, a
          larger potential market in Europe, economies of scale to producers, a minimization of investment risks.
                                         2. GLOBAL OBJECTIVES AND DELIVERABLES
          The development and application of advanced technologies in health care will allow a breakthrough in the
          performance of health care systems, a major increase of the productivity of medical and bio(techno)logical
          research and development, and a significant reduction in the growth rate of health expenditures.
          AIM will set a framework for possible government support to speed implementation of potentially beneficial
          developments in both the provision and management of health care in Europe.
          AIM will be a very significant contribution to the creation of an integrated health environment (IHE). This
          means that it will be concerned with all forms of care, from preventive medicine through primary care to
          secondary care.
          This Community programme will initially focus on common users requirements and technological and
          functional options concerning the development and application of advanced technology to health care. It will
          concentrate on complementing the cooperative efforts in which research institutions, hospitals and industry are
          already engaged, taking into account the requirements of public administrations, and on harmonizing industrial
          and medical priorities to advance the prenormative work needed for the introduction of an integrated health
          environment (IHE) throughout Europe.
          Both industry and health care professionals need, and have asked for, the cooperation of public authorities
          because the new systems which could be introduced require:
          — common standards at the European level, and if possible at the international level
          — design, development and management,
          — certification of those systems which are concerned with public health, data protection and ethical aspects in
              general,
          — public and political acceptance as reflected in regulatory provisions.
 ---pagebreak--- No C 214/8                              Official Journal of the European Communities                                          16. 8. 88
           The theme of AIM is the sustained improvement of health care in the Community within economically
           acceptable limits by exploiting the potential of medical and bio-informatics (MBI).
           Given this general objective, AIM will be concerned with realization of the following goals:
           1. Improve the quality, accessibility, and flexibility of health care.
           2. Increase the effectiveness of patient care, bringing about a reduction of unit costs.
           3. Contribute to the establishment of minimum standards and common functional specifications.
           4. Contribute to agreed codes of good practice, protection of privacy and reliability.
           5. Stimulate collaboration and concertation in the analysis of the requirements and opportunities of medical
              bio-informatics and its application.
           6. Contribute to the common adaptation of the regulatory framework to advances in the nature of health care.
           These goals are best served by a phased approach of which the present action covers the exploratory phase
           concentrating on the identification of user requirements, systems R&D elucidating cost-benefits as well as the
           choice of technological options, and the development of the appropriate evaluation tools.
           The deliverables and precise objectives of the AIM exploratory action include:
           — development of a practical approach to interdisciplinary working on a European scale in this domain
              mobilizing the different actors involved in health care and setting up the required fora for the identification
              of common needs, definition of the best approaches and consensus building.
           — development of a conceptual model for health care information systems, by identifying its functions,
              components, requirements and interrelations. This model should cover the different levels of care (primary,
              secondary and tertiary care) and should be the basis for a common understanding of health care, leading to
              the further development of compatible procedures, services and systems.
           — definition of data requirements and information flows at the different levels of the health care system, taking
              into consideration the specific needs and constraints at the patient, clinical, scientific and administrative
              level. This should lead to the study of the medical record architecture and be followed by the evaluation of
              the different codification systems, their state of advance in the different countries and the agreement of
              common codification systems.
           — identification and definition of the minimum standards, recommendations and common agreed practices
              required to facilitate harmonious development of hospital information systems. This work should be done
              in close coordination with other international organizations in this field.
           — tailoring of existing or developing technologies for their introduction and acceptance in the health care
              environment. The work will be focussed on the specific requirements as the human factor, the integration of
              systems and the acceptability and practical use in daily work. The different applications of knowledge-
              based systems and the advanced instrumentation will be considered.
           — the implementation of pilot projects aimed at testing the application and integration of developing
              technologies and methodologies in health care.
           — detailed evaluation of the potential of information technology and telecommunications to address ethical,
              social and economic problems in the field of health care. This evaluation will pay special attention to the
              protection of privacy of information, authorized access to systems, data security, impact on doctor patient
              relationship, human factor in systems engineering in order to facilitate the acceptability of new systems, and
              legal aspects concerning responsability issues and the practical use of advanced systems in health care.
 ---pagebreak--- 16. 8. 88                                  Official Journal of the European Communities                                          No C 214/9
             These deliverables, as detailed in the Draft Workplan, will represent useful results in their own right. In addition
             the scope and orientation of the work has been chosen to prepare and facilitate future European collaboration in
             this domain independent of the framework in which this may be undertaken.
             Amendment to the proposal for a Council Directive amending for the third time Directive 75/726/
             EEC on the approximation of the laws of the Member States concerning fruit juices and certain
                                                            similar products
                                                           COM(88) 319 final
              (Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty on 9 June 1988)
                                                             (88/C 214/03)
             Having regard to the opinion delivered by the European Parliament on 13 April 1988 with regard to
             the proposal submitted by the Commission to the Council for a Directive on the approximation of
             the laws of the Member States concerning fruit juices and certain similar products (*) and pursuant
             to Article 149(3) of the Treaty establishing the European Economic Community, the Commission
             has decided to amend the abovementioned proposal as follows:
             The fifth recital is hereby deleted.
             (!) OJ No C 24, 31. 1. 1987, p. 12.
             Amended proposal for a Council Directive amending for the fourth time Directive 76/768/EEC on
                   the approximation of the laws of the Member States relating to cosmetic products (*)
                                                    COM(88) 323 final — SYN 84
                        (Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty
                                                            on 15 June V.
                                                             (88/C 214/04)
             (!) OJ No C 86, 1. 4. 1987, p. 3.
                          INITIAL TEXT                                                                MODIFIED TEXT
Proposal for a Council Directive amending for the fourth                  Amended proposal for a Council Directive amending for
time Directive 76/768/EEC on the approximation of the                     the fourth time Directive 76/768/EEC
laws of the Member States relating to cosmetic products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European                     Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100                         Economic Community, and in particular Article 100A
thereof,                                                                  thereof,
Having regard to the proposal from the Commission,
In cooperation with the European Parliament,
Having regard to the opinion of the Economic and Social
Committee,