Procedures for the Development, Evaluation, Registration and Implementation of Clinical Guidelines

Issued pursuant to
Section 9.¹, Paragraph two
of Medical Treatment Law

1. This Regulation prescribes the procedures by which clinical guidelines shall be developed, evaluated, registered and implemented (hereinafter - guidelines).

2. The purpose of this Regulation is to promote the development of guidelines created by single criteria and based on evidence in the State and application thereof in medical treatment, training programmes for medical education, in the development of tariffs for services to be paid from the State budget and payment conditions thereof, as well as in the quality control and supervision of provision of health care services.

3. Professional organisations of medical practitioners, medical treatment institutions and institutions of higher education which implement academic and second level vocational study programmes in medicine (hereinafter - developer of guidelines) are entitled to develop draft guidelines and submit them to the Centre of Health Economics (hereinafter - Centre) for registration thereof in the database of guidelines to be used in medical treatment (hereinafter - database).

4. The developer of guidelines shall submit the following to the Centre:

4.1. an application;

4.2. full text of draft guidelines;

4.3. summary of draft guidelines;

4.4. description of the process of development of draft guidelines specifying information regarding developer, reviewers of draft guidelines, discussion thereof in the professional organisation of medical practitioners, medical treatment and scientific institutions, seminars or conferences; and

4.5. information regarding the type of draft guidelines specifying whether it is original, adapted or translated. If the draft guidelines are adapted or translated, a copy of the original of the guidelines shall be submitted.

5. The following information shall be included in the draft guidelines:

5.1. name of the guidelines;

5.2. developer of the guidelines;

5.3. objective and tasks of the guidelines;

5.4. planned users of the guidelines;

5.5. benefits, side-effects and risks which may arise observing recommendations of the guidelines;

5.6. target group of application of the guidelines, specifying diagnoses or groups of diagnoses of patients and corresponding code thereof in accordance with the 10th edition of the International Statistical Classification of Diseases and Related Health Problems adopted by the World Health Organisation;

5.7. information sources of evidence and criteria for selection thereof;

5.8. recommendations for a medical practitioner regarding particular medical activities, including diagnostics, prophylaxis, medical treatment methods, observation tactics, rehabilitation and specifying which technologies referred to in the guidelines (medicinal products, medical devices, methods, procedures) may be applied in Latvia;

5.9. the level of recommendation evidence in accordance with the following classification:

5.9.1. level A - evidence with high credibility obtained in several good quality randomised clinical researches regarding which a meta-analysis has been performed;

5.9.2. level B - evidence with medium credibility obtained during separate good quality randomised clinical researches or meta-analysis regarding several well organised researches with a control group (clinical researches without randomisation, case control researches, researches of cohorts);

5.9.3. level C - evidence with low credibility obtained during separate researches with a control group (clinical researches without randomisation, case control researches, researches of cohorts);

5.9.4. level D - insufficient evidence obtained during observation of series of cases or regarding which unanimous recommendation has been received from experts;

5.10. linking of recommendations used in the guidelines with evidence specifying particular references; and

5.11. sponsor of development of the guidelines.

6. The Centre shall evaluate the compliance of the documents submitted by the developer of guidelines with the requirements referred to in Paragraphs 4 and 5 of this Regulation.

7. If non-compliance of documents is determined, the Centre shall request additional information from the developer of guidelines.

8. The Centre shall send draft guidelines for evaluation to the main specialists in the relevant health sector of the Ministry of Health and to the Health Sector Strategic Council (hereinafter - Council).

9. The Council shall be established by and the by-law thereof shall be approved by the Minister for Health. The Council is a consultative institution for the creation and implementation of health policy and the composition thereof shall include representatives of associations of health sector, as well as of State and local government institutions.

10. The Centre is entitled to send draft guidelines for evaluation to other institutions related to health care, professional organisations of medical practitioners or experts who are specialists of the particular health sector and comply with at least one of the following criteria - a doctor's degree of medical sciences; a docent of institution of higher education, an associate professor, a professor or a person with the training right or a leading researcher; an experience in appropriate medical speciality of at least five years.

11. If the institutions and experts referred to in Paragraphs 8 and 10 of this Regulation have not submitted the evaluation of the draft guidelines to the Centre within a month, the draft guidelines shall be considered as co-ordinated.

12. If the institutions and experts referred to in Paragraphs 8 and 10 of this Regulation have objections towards the draft guidelines, the Centre shall inform the developer of guidelines thereof.

13. The developer of guidelines shall, within a month, evaluate the objections and correct the draft guidelines or reject objections, providing the Centre with a substantiated explanation in writing.

14. If the developer of guidelines does not perform corrections in the draft guidelines and does not also provide substantiated explanation in writing, the Centre shall not register the draft guidelines.

15. If necessary, the Centre may organise an additional examination of the draft guidelines in the Council. The developer of guidelines and representatives and experts of the institutions referred to in Paragraphs 8 and 10 of this Regulation shall be invited to participate in the Council meeting.

16. The Centre shall register the guidelines in the database, if the objections of the institutions and experts referred to in Paragraphs 8 and 10 of this Regulation:

16.1. have not been received;

16.2. have been taken into account and the relevant corrections have been made in the draft guidelines; or

16.3. have been reasonably rejected.

17. The database of guidelines shall be established, updated and maintained by the Centre. The database shall be available in the Internet homepage of the Centre. The database shall contain the following information:

17.1. name of guidelines;

17.2. developer of guidelines;

17.3. date of registration of guidelines and number thereof in the database;

17.4. summary of guidelines;

17.5. full text of guidelines;

17.6. list of the approved medicinal technologies to be used in medical treatment that is included in the guidelines; and

17.7. information regarding the results of application of guidelines.

18. The Centre shall notify the Ministry of Health in writing regarding registration of guidelines in the database.

19. Medical treatment institutions shall implement the guidelines in compliance with the financial possibilities of the relevant medical treatment institution.

20. Cabinet Regulation No. 250 of 24 March 2009, Procedures for the Development, Evaluation, Registration and Implementation of Clinical Guidelines (Latvijas Vēstnesis, 2009, No. 49) is repealed.

Acting for the Prime Minister -
Minister for Environment R. Vējonis

Minister for Health D.Gavars

Translation © 2011 Valsts valodas centrs (State Language Centre)