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Keeping quality self-regulatory

Partner Institute: 
PRAXIS Center for Policy Studies, Tallinn
Survey no: 
Teele Orgse
Health Policy Issues: 
Quality Improvement
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes no no no


While the EU has given out a recommendation, WHO a resolution on patient safety and health care quality, and the common values in EU health systems list quality as its number 1 operating principle and the EU health strategy lists quality as one of its 3 strategic objectives, Estonia has chosen a self-regulatory approach on quality assurance and played the cards on a surveillance mechanism that was lately renewed with a structural reform creating a new governmental agency ? the Health Board.

Purpose of health policy or idea

In 2002 all main reforms - decentralization of the system, creation of health insurance, creation of a primary health care system and reorganization of the hospital network - to bring the Estonian health care system out of the the Soviet heritage had reached their primary targets and one of the results was the adoption of the Health Care Services Act. The Act stipulates the main definitions and describes how health care is to be delivered and organized. For the first time, health care quality as an independent topic also got its place in legislation, although attempts to regulate or describe quality issues had been made since 1998 already. The Act itself does not even define quality, but sets it as the Minister of Social Affairs' duty to set quality assurance requirements, which resulted in the Social Ministers Decree.

Since 2004, when the country became a member of the European Union, Estonia has implemented the European legislative requirements very accuratly. Thus also the Social Ministers Decree on health care services quality assurance was first changed in 2004, giving all main health care quality dimensions some kind of requirements. This year the decree was again ammended due to structural reforms - 3 different inspectorate and surveillance institutions were united into one big Health Board - and so the references in the decree were corrected. Even though the main idea of uniting the different governmental institutions carried the principle of centralizing surveillance activities and thus among other things the goal is to enhance health care quality assurance both at service provider and national level, the ammendment of the decree and the decree itselt is still only structural.

The Quality Policy of Estonian Health Care was presented to the Government already in 1998, but health care quality is today holistically still only described in the above mentioned decree giving ISO system and Avedis Donabedian-followed definitions and a few requirements derived directly from other, namely also from European, legislative acts.

So in short conclusion the purpose of this policy is to stipulate structural frames so that in health care services delivery basic European quality requirements would be assured.

Main points

Main objectives

The Social Minister's Decree on Health Care Services Quality Assurance stipulates requirements to be fulfilled by the health care providers - hospitals, ambulance and primary health care services providers. It describes what kind of self-regulatory documents health care providers must implement. The main tool to be used is an internal management handbook that should include all risk management strategies. In addition certain guidelines are made compulsory - on transfusion, bed sores, adverse drug events, hospital acquired infection, radiance and pre-operative preparation. The decree contains several links to other decrees and acts and briefly mentions the documentation requirements. All personell competence matters are regulated on a voluntary professionals' organizations basis and on the other hand the right to carry out surveillance is given to both the Health Board and the Health Insurance Fund. Patients' rights for information, service standards and the obligation to study patient satisfaction is also mentioned.

There is no mentioning of systematic analysis of adverse events nor near misses, no mentioning of any national quality related databasis. Also once again - all competency matters are left voluntary.

There are other laws and different decrees in addition to the above mentioned one that also cover one aspect or another of health care quality or patient safety (the latter as a term is never used in legislation) such as complaint management, documentation quality, health care aqcuired infections, laboratory standards, transfusion, medicines, etc, but they all exist idependently.

Type of incentives

The incentive is non-financial describing minimum standards and cannot be described as a holistic approach on quality management or improvent. The approach is more on offering possibilities for self-regulation and giving governmental agencies the right to carry out surveillance.

Groups affected

Health care services providers, governmental agencies (Health Board and Health Insurance Fund), patients

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Characteristics of this policy

Degree of Innovation traditional traditional innovative
Degree of Controversy consensual neutral highly controversial
Structural or Systemic Impact marginal neutral fundamental
Public Visibility very low very low very high
Transferability strongly system-dependent neutral system-neutral

The policy is mainly structural not having a huge impact on overall health care system functioning.

Political and economic background

On October 13th, 2006, the Government issued an order to draw up a National Health Strategy Plan, which was later officially adopted on July 17th 2008. The Strategy's main goal is to extend healthy life years, but it's main health policy goal is to ensure quality health services to all people through optimum use of resources.

To in turn ensure the latter the Ministry declares that the management and health policy implementation have to be taken to a new, more efficient level.

Therefore three different government agencies (The Health Inspectorate, Health Care Board and Chemical Notification Centre) were united into one - Health Board. The benefit expected from this change is that the readiness for different emergency situations would be higher, surveillance over all health and health care related matters would be more transparent and effective and that by avoiding duplicative assignements, the system itself would be more efficient and thus create more and better outcome.

The Minister's decree on quality assurance was not essentially changed, thus the system created in 2001 and superficially ammended in 2004 was left the same.

The pressure that should be counted from the European Union or the WHO on patient safety was ignored - i.e. the Council Recommendation on Patient Safety from 2009 or the World Health Assembly resolution from 2002 on patient safety. On the other hand, even though the specific ministers decree only mentions hospital aquired infections with a link to Communicable Diseases Prevention and Control Act, the topic on health care associated infections is very well regulated according to different EU legislative and indicative documents.

Complies with

EU regulations

Could comply with council recommendation, but does so only partly.


The demand to cut govenrmental expenditures by making public sector management more efficient.

Change based on an overall national health policy statement

The national health strategy plan is cited in the overall policy change through argumentation on efficiency, but this might only be a pretext.

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes no no no

Origins of health policy idea

The idea to reform health care management has solely come from the Ministry of Social Affairs and has not been widely discussed, even though the health strategy plan does give the idea a strong political framework.

The idea to describe basic health care quality assurance through a Minister's decree has originated from 2000 - 2001 when the Health Care Services Act was drawn up. Since the Quality Policy of Estonian Health Care didn't get the government's approval back in 1998 and therefore never became "official", enthusiasts and policy makers that were well educated on quality matters during the quality policy's writing period and were involved in writing the system reforming Act as well, saw the need and opportunity to have quality assurance written into the Estonian health care system legislation.

The main idea of the health care services quality assurance decree is to establish basic and comparable rules and standards for service providers. In addition, the decree gives an obligation to have an internal management system that forced all bigger hospitals in Estonia (with a service area of 100 000 or more) to hire quality managers or establish quality assurance systems/ management departments.

Even though quality assurance is described by a decree, much of substantive quality assurance is still left self-regulatory or voluntary. For example re-certification of health care workers is by law totally voluntary and ought to be organized by specialists' organizations. Also use and creation of guidelines or carepathways is non-governmental.

On the other hand, a lot is expected from surveillance. In 2004 the predecessor of the Health Board - a government agency called Health Care Board, created by the Health Care Services Act out of different ministry's departments on the principle of separation of powers -established a quality officer post to their surveillance department. Thus in conclusion it could be said that quality assurance by Estonian legislator is considered as the use of surveillance.

Now that the new Health Board was created with the main pretext of improving surveillance and the quality assurance decree itself only got technical ammendments within the reofrm, it can be concluded that quality will still be left as a matter of self-regulation and meeting of basic legislative requirements.

Initiators of idea/main actors

  • Government: This section will cover government as a whole. Government is supportive of the idea of making public sector management more effective especially if it leads to cost reduction, but hasn't shown any interest in health care quality systematically.
  • Parliament: The parliament has discussed health care quality related issues mainly surveillance-oriented once in 2009-2010 and the issue of uniting institutions into one agency
  • Providers: The provides were not involved into the discussion of uniting the agencies and have not been involved in quality assurance discussions for at least 5 years when the last official recommendation document was written.
  • Payers: The Estonian Health Insurance Fund has on many attempts tried to implement new regulations on quality assurance or control, but unsuccessfully.
  • Patients, Consumers: The only media coverage on health care quality have been liability suits or patient complaints. Health Board establishment only got press-relase type media coverage.
  • Civil Society: There have been no discussions on patient safety or health care quality matters.
  • Scientific Community: There are no special quality-related scientific communities or groups in Estonia.
  • Media: The only media coverage on health care quality have been liability suits or patient complaints. Health Board establishment only got press-relase type media coverage.

Approach of idea

The approach of the idea is described as:
amended: The creation of the Health Board only technically specified or clarified surveillance activities and the quality decree was only ammended in its references.

Stakeholder positions

The decree on quality assurance was, as mentioned above, introduced through the Health Care Services Act and was silently accepted by the providers. The Estonian Health Insurance Fund has sent out signals of interest to essentially ammend the decree, but those ideas or proposals have not been recognized by the ministry with an excuse that Estonian health care system needs more structural readiness for more in depth quality activities.

As the merger of surveillance activites into one agency did not include process changes, stakeholders were not influenced by this policy change either.

Actors and positions

Description of actors and their positions
Ministry of Social Affairsvery supportiveneutral strongly opposed
Pleanary Sessionvery supportiveneutral strongly opposed
Hospitalsvery supportiveneutral strongly opposed
Primary Care providers - family practionersvery supportiveneutral strongly opposed
Estonian Health Insurance Fundvery supportivevery supportive strongly opposed
Patients, Consumers
Estonian Patients' Unionvery supportivesupportive strongly opposed
Civil Society
Public debatesvery supportiveneutral strongly opposed
Scientific Community
University of Tartu Health Care Institutevery supportivesupportive strongly opposed
Mediavery supportivesupportive strongly opposed

Influences in policy making and legislation

As there is no public nor political discussion over health care quality or patient safety, the current status quo is accepted and the changes in legislation on system-wide quality assurance and quality control have been technical.

The original proposal of quality assurance - dating back to 1998 with the formulation of the Quality Policy of Estonian Health Care - has been changed in current legislation with regard to the fact that there is still no national quality assurance agency or body that would somehow be responsible for quality improvment nation-wide. Also there is no holistic approach on quality surveillance/ measurement/ monitoring.

On the other hand the quality decree has been changed in accordance with the most urgent health care quality related European legal documents - namely infection control, drug control and transfusions.

The original idea of the separation of powers that was created with the adoption of the Health Care Services Act is carried on with the establishment of the new Health Board.

Legislative outcome


Actors and influence

Description of actors and their influence

Ministry of Social Affairsvery strongvery strong none
Pleanary Sessionvery strongstrong none
Hospitalsvery strongstrong none
Primary Care providers - family practionersvery strongstrong none
Estonian Health Insurance Fundvery strongvery strong none
Patients, Consumers
Estonian Patients' Unionvery strongweak none
Civil Society
Public debatesvery strongweak none
Scientific Community
University of Tartu Health Care Institutevery strongneutral none
Mediavery strongvery strong none
Estonian Health Insurance FundEstonian Patients' UnionUniversity of Tartu Health Care InstituteMediaPublic debatesPleanary Session, Hospitals, Primary Care providers - family practionersMinistry of Social Affairs

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Adoption and implementation

The process is moderated by the Ministry of Social Affairs. The main stakeholders will be the health care providers from the implementation side and the Ministry from the legislator side. The government or the political parties have not yet discussed health care quality or patient safety publicly nor from the political debate arena. The Health Board will continue to be the main health care services surveillance and monitoring body and there are no big changes to be awaited from their side - the structure, not the content was reformed.

The implementation of the decree on quality assurance could be evaluated as successful to the extent that quality managers in hospitals are now systematically working on quality assurance. The main obstacle of implementing the idea of self-regulatory/ half-voluntary quality assurance is the fact that no measurement is built into the system with the exception of infection control and that could lead to only formal quality assurance that will not give any real better health, efficiency or other outcome.

Opponents of the policy are not known since all changes are minor and not with large consenquences.

Monitoring and evaluation

The policy does not forsee a mechanism of regular review except for a part that the National Health Strategy Plan has a review mechanism written into it and thus there is a slight possibility that if there is a political or other influencial stakeholder which exerts strong pressure for change, quality assurance regulation or strategy might also be reviewed.

Results of evaluation


Expected outcome

The policy's - health care services quality assurance decree - objective is really not defined since it is descriptive of basic standards.

The objective of uniting government agencies and thus improve public sector efficency and surveillance mechanisms will yet be seen. The main obstacle can be the lack of a holistic approach.

Impact of this policy

Quality of Health Care Services marginal marginal fundamental
Level of Equity system less equitable neutral system more equitable
Cost Efficiency very low very low very high

The impact is very dependent on the concrete health care services providers and also from the other side, the surveillanve agency's desire to deal with the subject.


Sources of Information

Author/s and/or contributors to this survey

Teele Orgse

Teele Orgse, MD, MSW, CQM, is a hospital quality manager, has previously worked as a quality specialist in both the ministry and the health insurance fund and has worked with quality related issues since 2002.

Suggested citation for this online article

Teele Orgse. "Keeping quality self-regulatory". Health Policy Monitor, October 2010. Available at