Ministers’ Deputies
CM Documents

CM(2010)14 2 February 20101
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1079 Meeting, 10 March 2010
6 Social cohesion

6.1 European Health Committee (CDSP) –
Draft Recommendation CM/Rec(2010)… of the Committee of Ministers to member states
on good governance in health systems

For consideration by the GR-SOC at its meeting of 23 February 2010
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Draft Recommendation CM/Rec(2010)… of the Committee of Ministers to member states
on good governance in health systems

(Adopted by the Committee of Ministers on … 2010
at the … meeting of the Ministers’ Deputies)

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

Recalling the Warsaw Declaration (2005) wherein it is stated that: “effective democracy and good governance at all levels are essential for preventing conflicts, promoting stability, facilitating economic and social progress”;

Having regard to its Recommendation CM/Rec(2007)7 to member states on good administration, its Recommendation No. R (2000) 10 on codes of conduct for public officials, and its Recommendation No. R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, wherein member states are encouraged to create, where appropriate, policies and structures that support the development and implementation of such systems;

Building on the achievements of the Council of Europe in fighting corruption, notably by the Group of States against Corruption (GRECO), and promoting good administration;

Bearing in mind the contributions brought to the field of good governance in health systems by, in particular, the European Healthcare Fraud and Corruption Network (EHFCN) and Transparency International;

Noting the relevance of the World Health Organization’s resolutions and decisions, in particular the Ljubljana Charter on reforming health care (1996), the Health for All policy framework (2005) and the Tallinn Charter: Health Systems for Health and Wealth (2008);

Recognising that good governance should be driven by the fundamental values of human rights, the rule of law and democracy;

Recalling Part I of the revised European Social Charter (ETS No. 163) which provides that the Parties thereto accept as the aim of their policy, to be pursued by all appropriate means both national and international in character, the attainment of conditions in which the right of everyone to benefit from any measures enabling him to enjoy the highest possible standard of health attainable may be effectively realised;

Recalling the Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164), in particular:

- Article 1 on the protection of the dignity and identity of all human beings and on guaranteeing everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms,
- Article 2 on the primacy of the interests and welfare of the human being over the sole interest of society,
- Article 3 on the equitable access to health care of appropriate quality,
- Article 4 stating that any intervention in the health field must be carried out in accordance with relevant professional obligations and standards,
- Article 28 stipulating that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion and that their possible application is made the subject of appropriate consultation, and
- Chapter V on scientific research;

Considering that there are values of good governance which are particularly important in the context of health systems, namely universality, solidarity and equity;

Recognising that key principles of good governance in public services have a special relevance for health systems, in particular transparency, participation, accountability, effectiveness, efficiency and quality;

Recognising that good governance in health systems cannot be achieved without a long-term strategy and a commitment to achieving political legitimacy, social cohesion and sustainability;

Bearing in mind that decision-making processes should be participatory and transparent to all stakeholders, in particular for citizens;

Recognising the importance of promoting a culture of good governance, as well as developing capacities for policy analysis, advocacy and intersectorial action for health;

Considering that policy-making and planning should be informed by the best knowledge available on the issues at hand, including contributions from all relevant disciplines and experiences;

Recognising that a good governance system should contain built-in mechanisms for monitoring and evaluation, as well as performance assessment of the health system based on clear objectives;

Considering that policy making for health systems, like other public governance, should incorporate health impact assessments applied both within health services and in relation to the determinants of health in other policies which can influence health;

Considering that ethical aspects play a particularly important role in achieving good governance in health systems by fostering a culture of integrity and finding appropriate ways of framing codes of conduct, monitoring good governance, managing conflicts of interest and taking measures to prevent and counter fraud and corruption;

Considering that the good governance principles mentioned above apply to the public and private sector of the health system and to all levels of governance (national, regional, local) following the principle of subsidiarity by focusing on an optimal division of tasks between the relevant levels,

A. Recommends that governments of member states, having due regard to their specific national, regional or local structures and respective responsibilities:

i. take appropriate steps to ensure good governance of health systems that is based on:

- fundamental values of human rights, the rule of law and democracy;
- principles underpinning health systems such as universality, solidarity and equity;
- good governance principles for public services: transparency, accountability, effectiveness, efficiency, and quality;
- ensuring that these values and principles should guide practical action taken at all levels and dimensions of the health system including education, training and monitoring;

ii. respond rapidly and effectively to the changing medical, economic and social environment by ensuring the planning and development of institutional and human good governance capacities;

iii. develop and adopt a set of ethical principles for health system governance, with special emphasis on the structural determinants, legislative guidelines and codes of conduct in health systems, which aim to prevent and counter corruption, manage conflicts of interest and monitor good governance;

iv. support an active dissemination of this recommendation and its explanatory report, targeting in particular policy makers, public administration staff and organisations involved in decision-making within the health system;

v. take necessary steps to implement the guidelines contained in the appendix to this recommendation.

B. Entrusts the European Health Committee (CDSP) to monitor and evaluate the implementation of the recommendation in member states.

Appendix to draft Recommendation CM/Rec(2010)…

GUIDELINES

These guidelines contain:

- a general framework for codes of conduct in the health sector (attachment I)
- a general framework for monitoring governance in the health sector (attachment II), and
- an example of a good governance assessment matrix

I. Laws and regulations for the good governance of a health system based on fundamental values and principles

1. In all member states the legislative framework of any given health system should be based on the three fundamental values of the Council of Europe: human rights and human dignity, the rule of law and democracy. To this should be added the right to health protection built on the principles of universality, equity and solidarity.

2. Each member state, taking into account the recommendations of the Council of Europe’s High-Level Task Force on Social Cohesion in the 21st Century, should develop a value-based good governance framework for its health system, which should:

- be based on the key principles of accountability, transparency, sustainability and respect for patients’ rights,
- target the prevention of corruption and foster a culture of countering it,
- concentrate efforts on improving the management of conflicts of interest,
- appeal to the shared responsibility of all stakeholders in society.

3. A monitoring system should be put into place to systematically assess the contribution and adequacy of governance mechanisms, such as legislation, policies and regulatory activities aimed at achieving the goals of good governance.

II. Promoting codes of conduct for good governance of a health system

4. Considering the complexity and the professional nature of health services, health legislation in all member states should be complemented by clear and explicit codes of conduct and other self-regulatory tools.

5. Codes of conduct should be developed for different stakeholders in the health sector, such as administrators, managers, policy makers, professionals and their organisations, as well as for all health-related industries, including the media.

6. Codes of conduct should include effective mechanisms for their implementation, monitoring and enforcement.

7. Codes of conduct for health professionals should include specific clauses on conflicts of interest.

8. Governments of member states should promote, subject to national law and the principles of good public policy, the adoption of codes of conduct for good governance in health systems based on the framework presented in attachment I to this appendix.

III. Monitoring good governance of a health systems

9. Explicit values and principles of good governance should become an integral part of a health system, and a shared vision for all stakeholders should be developed in order to enable their implementation and assessment.

10. Assessment tools should be developed to monitor good governance in health systems. The overall objectives for monitoring good governance should be threefold:

i. to measure governance in health systems at a national as well as organisational level,
ii. to monitor the impact of governance from the perspectives of all stakeholders,
iii. to raise awareness and promote a common understanding of governance in health systems.

11. Member states should use assessment tools to benchmark the extent of good governance of their health systems within and across member states. These benchmarks should provide governments, organisations and, ultimately patients with information regarding areas for improvement as well as good practices.

12. Assessment frameworks should be based on the premise that improved governance influences all other health system functions, which in turn results in improved performance of the health system and ultimately leads to better health outcomes. Therefore the framework should consist of the following components:

- values: human rights, rule of law and democracy,
- principles: universality, equity and solidarity,
- governance mechanisms: planning, decision-making, regulation, control and evaluation,
- outcomes: transparency, accountability, access, participation, effectiveness and efficiency.

A general framework for monitoring governance in the health sector is presented in attachment II to this appendix.

IV. Managing conflicts of interest in health systems

13. Member states should proactively attempt to identify areas where conflicts of interest in relation to the health system may arise, and to prevent and counter such conflicts, whether caused by public officials or by non-public agents (private sector), by ensuring that private interests do not interfere with the performance of public or private health-related duties.

14. Special attention should be paid to conflicts of interest of those holding public responsibilities. Appropriate legislation should therefore be developed and a culture in public administration fostered requiring public officials to be accountable and personally responsible. Public officials should:

- be alert to any actual or potential conflict of interest, including nepotism,
- take steps to avoid such conflict,
- disclose any conflict of interests as soon as he or she becomes aware of its existence,
- comply with any final decisions to withdraw from the situation or to divest him/or herself of the advantage causing the conflict,
- declare whether or not he or she has a conflict of interest.

15. All candidates applying for employment in the public service sector should be required to declare any possible conflict of interest, and provision should be made to resolve any such conflict in due time before the appointment is decided.

16. At all levels of the health system there should be adequate regulatory and specific organisational measures making it possible to detect conflicts of interest and to take legal or other actions. This should be managed at individual, institutional and national levels.

17. Any potential conflict of interests related to clinical research activities should be registered and monitored by an independent authority. Information should include all relevant financial and non-financial benefits. Clinical research should be monitored by research ethics committees.

18. Scientific and vocational activities, including continuous medical education intended for health professionals should be organised in such a way as to guarantee their integrity and avoid influence from commercial interests.

19. There should be legal provisions for compulsory financial disclosure of expenditures made by commercial healthcare insurers, healthcare providers or health-related industries for marketing their products and services. Such data should be publicly available with the same level of detail as that requested for research and development.

V. A good governance framework against fraud and corruption

20. Fraud and corruption should be explicitly defined and tackled in all relevant regulatory frameworks at every level of the health system, making it an integral part of all health regulations.

21. Member states should consider establishing an independent anti-corruption body, covering all sectors of activities, at national level. Such a body should be able to take legal and other actions should the need arise.

22. To foster a culture of integrity and thus to prevent corruption, fraud and nepotism, a comprehensive and systemic strategy should be in place. This strategy should include:

- specific guidelines for transparency and enforcing mechanisms at every level of the health system, from national to individual institutional level,

- a high level of political priority and public visibility for the fight against corruption and fraud,

- provisions for professional investigation and public reporting of all cases of detected or alleged health system fraud and corruption,

- arrangements for the possible enforcement of multiple sanctions, such as civil, criminal and/or disciplinary processes, should health system fraud and corruption be proved,

- a system of compensation for the resources lost to fraud and corruption, and the return of the recovered losses,

- a national reporting system with periodic reports on the progress made against fraud and corruption.

VI. Preparing health-related professionals for good governance: the education and training of health professionals, administrators, managers and policy makers in value-based good governance in health systems

23. Governments of member states should promote the idea of establishing a framework for the education and training of health-related professionals to include the acquisition of adequate competences for good governance and efficient management of health institutions and programmes.

24. Member states should ensure that a competent post-graduate training institution is available at national level, as well as in large regions, with links to both academic and health administrations. Such an institution should contribute to the dissemination of developments in public health and health-service research, as well as serving as a resource for the development, reform and evaluation of health systems.

* * *

ATTACHMENT I TO THE GUIDELINES

General framework for codes of conduct in the health sector
(as referred to in paragraph 8 of the Guidelines)

1. Introduction

2. Values and ethical references

3. Legal framework of reference

4. Example of areas to be regulated by a code of conduct in the health sector

NB. Not all areas are applicable to all situations. The order of the items does not reflect priority ranking. The list is non-exhaustive and the items are for illustrative purposes only.

a. Good professional practice

    i. Respect for the dignity of people (employees, patients, customers)
    ii. Honesty and confidentiality
    iii. Keeping up-to-date professional competence
    iv. Use of the best scientific evidence
    v. Compliance with accepted standards
    vi. Compliance with regulations and legislation
    vii. Awareness of the needs, demands and expectations of the population, patients and customers
    viii. Cooperation with colleagues
    ix. Spirit of moderation, reconciliation, tolerance and appeasement

b. Use of resources of the service/system

    i. Cost-effectiveness practice in the use of resources
    ii. Avoiding using public resources for private gain
    iii. Prevention of fraud and corruption

c. Handling of conflict of interests in the best interest of patients and population, whether

    i. economic
    ii. non-economic

d. Proper access, sharing and use of information

    i. Research of any information necessary for decision-making
    ii. Duty to disclose all relevant information to the public and authorities
    iii. Duty to provide information to patients with respect to their needs and preferences

e. Handling of gifts and benefits

    i. Existence of an explicit policy concerning gifts
    ii. Transparency regarding gifts received from interested parties

f. Research-related topics

    i. Clinical trials (Helsinki Declaration)
    ii. Truthful claims of research potential
    iii. Patient consent with full disclosure of risks

g. Relationships with other actors in the health sector

    i. Colleagues and other health professionals
    ii. Patients and their families
    iii. Insurers, third-party payers
    iv. Health-related industries (pharmaceutical, food, advertisement, cosmetic, medical devices, etc.), and other interest groups
    v. Government officers of health and other sectors (police)
    vi. Patients and self-help organisations, NGOs, etc.
    vii. Media

h. Good corporate governance of health institutions/services/centres

i. Issues of multiculturalism, tolerance and respect

5. Enforcement of the code of conduct

a. Recognition of violations
b. Composition of the body responsible for dealing with enforcement
c. Transparency of procedures and public scrutiny
d. Complaints system

6. Updating, monitoring and development of the code of conduct

a. Process of development of codes of conducts: initiative, ownership, legitimacy
b. Comprehensiveness
c. Limitations of codes of conduct
d. Codes of conduct and legislation

* * *

ATTACHMENT II TO THE GUIDELINES

General framework for monitoring governance in the health sector
(as referred to in paragraph 12 of the Guidelines)

1. Introduction: a conceptual framework to define, promote and monitor accountability in the field of health policy as both a means of ensuring good governance and as a preventive measure against corruption and other negative issues.

2. Values and principles underpinning the framework: human dignity, equity, solidarity and professional ethics as articulated in the Ljubljana Charter on Reforming Health Care (World Health Organization, 1996) and the World Bank governance indicators.

3. Scope of the conceptual framework: organisational, regional, national and international monitoring.

4. Objectives of monitoring:

- to serve as a reference framework that can become a common instrument for measuring governance in health systems at international, national and organisational level;
- to observe the impact of governance from the perspectives of all stakeholders;
- to raise awareness, build public confidence, facilitate learning and promote a common understanding of good governance in health systems.

5. Governance mechanisms: recent work carried out, for example, by the WHO and in Canada (Cirano project), demonstrates that a number of mechanisms can be used in exercising political, economic and administrative authority in the management of health systems. This includes mechanisms for planning, resource management, decision-making, providing incentives, control, monitoring and evaluation.

6. Examples of areas to be covered by the assessment matrix (see table below):

    a. control of corruption – measuring the ability of state institutions and agencies to tackle fraud and prevent corruption;
    b. transparent and participatory decision making processes – measuring the level and quality of the equal involvement of all stakeholders in decision-making processes;
    c. accountability – measuring the impact of existing arrangements established to achieve accountability for performance;
    d. rule of law – measuring the effective compliance with rules and laws;
    e. open reporting – measuring the openness and willingness of governing bodies to present and share information publicly.

7. Assessment process:

    a. establish an expert group/observatory for governance monitoring;
    b. data collection, using a variety of sources, including existing databases and information such as the World Bank governance indicators and the European Observatory on Health Systems and Policies, or WHO Regional Office for Europe;
    c. self-assessment, including performance indicators and surveying key stakeholders using questionnaires;
    d. reporting and dissemination of findings, through interactive web portals.

8. Enforcement of the framework:

- composition of a body responsible for dealing with enforcement
- transparency of process, and
- public reporting.

Principle
Governance mechanism
Key outcomes
Outcome indicators
Questions

Transparency
Decision-making
Transparent decisions are decisions in which the decision-maker clearly presents to others the motivation behind the decisions and explains the reasoning leading to the conclusion (i.e. the actual decision)

Privileged access for industry interests undermines public trust

Central register for lobbyists

National guidelines for consultation process

Complaint and redress mechanism to address concerns
Does a central register for lobbyists exist in this member state?

Has the member state produced a national set of guidelines to ensure transparency in consultative processes?

Does a complaint and redress mechanism exist?

Are inspection reports available to the public?

Participation
Decision-making
Participatory decision-making implies that each actor has a say in decisions directly proportional to the degree to which the particular decision affects him or her

Patients’ representation at board level of state agencies, for example the national institute for health and welfare

Are patients’ views represented at board level of the member states’ health agencies or institutions?

Accountability
Regulatory interventions - monitoring
Accountability for performance is relevant at all levels, from policy-making to clinical practice

Systematic approach to assure quality and safety

Code of conduct to govern the behaviour of health administrators and clinical practitioners

Do national standards exist which aim to assure quality and safety in health services?

Does the member state have a national code of conduct for administrators and clinical practitioners?

Efficiency
Regulatory interventions - monitoring
Achieving greater efficiency and better value for money is a key governance objective
Member states activities to detect and counteract fraud and corruption

Capacity for independent technology assessment

Have particular institutions or agencies been established to tackle fraud and corruption?

Do member states’ agencies or institutions participate in the European Healthcare Fraud and Corruption Network (EHFCN)?

Do these institutions have a capacity for independent assessment?

An example of a good governance assessment matrix

Note 1 This document has been classified restricted at the date of issue; it will be declassified in accordance with Resolution Res(2001)6 on access to Council of Europe documents.


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