View of The Importance and Legal Status of the Recommendations and Guidelines

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Professional article

The importance and legal status of the recommendations and guidelines

Bojan Popovič

Abstract

Guidelines are a scientific contribution based on the consensual recommendations with a high quality and level of evidence aimed at giving high quality answers to decision makers, especially health care providers and payors. Guidelines are not legally binding, but because of the legal principle of due diligence they are difficult to ignore when decisions are made. Authors of guidelines must disclose any actual or potential conflict of interest. Foreign guidelines are considered as recommendations in Slovenia and cannot be directly used as Slovenian guidelines until Slovenian studies are considered. In Slovenia, the recommendations and clinical guidelines are prepared by professional medical associations and approved by professional committees and the Main Professional Committee established by the Slovenian Medical Association. Currently, the Health Council at the Ministry of Health is responsible to approve the national guidelines, but an independent agency would be more appropriate.

Cite as: Popovič B. Pomen in pravni status priporočil in smernic. Zdrav Vestn. 2018;87(7–8):365–77.

DOI: 10.6016/ZdravVestn.2485

1 From research to recommendations

Medicine is a scientific discipline based on scientific knowledge and findings.

In science, there is no such thing as a formal supreme authority that would adopt laws which would then be binding on all.

The starting point of scientific research is a hypothesis, the claim made by the rese- archer, who attempts to either confirm or deny it in the course of the research process. A confirmed hypothesis becomes a theory or the authors’ position, and as such one of the possible explanations of the investigated phenomenon. Theories then become the subject of scientific de- bate in which different researchers test

it under different conditions and in different populations until various professional associations have reached a certain consensus. Positions that represent the opinion of official representatives of professional medical associations or professional medical organisations, but which have not yet been fully prepared in accordance with standard established criteria for the systematic review and evidence-based evaluation, are referred to as clinical position statements (adapted from Predlog poti sprejemanja strokovnih priporočil, kliničnih smernic in nacionalnih smerni / Proposal of the pro-

Dermadent d.o.o., Ljubljana, Slovenia Correspondence:

Bojan Popovič, e: bojan.

popovic@dermadent.si Key words:

position statement;

recommendation; clinical guideline; national guideline; standard;

clinical path; due care;

negligence; universal healthcare; Health Council; extended professional committee;

professional council;

conflict of interests Received: 1. 2. 2017 Accepted: 13. 7. 2018

@running-header: Pomen in pravni status priporočil in smernic

@reference-en: Zdrav Vestn | July – August 2018 | Volume 87

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cedure for adopting expert recommenda- tions, clinical guidelines and national gui- delines, Slovenian Medical Association, a letter to the Health Council, No. 18–18/1 of 30 January 2018, hereinafter the SMA Proposal).

In order to further objectivise the credibility of positions, formal and standardised adoption systems have been developed, which are also carried out by professional medical associations, in which, in addition to the findings of scientific research, the already existing clinical and international guidelines should also be taken into account, which in practice means that they are backed by a significantly larger number of studies generally carried out on an international level and in a significantly larger population and a wider geographical area, over a longer period of time, thus having a higher level of credibility than positions. According to the SZD Proposal, such texts are referred to as professional recommendations.

However, even expert recommendations do not yet include a systematic overview of international and national professional literature with documented evidence evaluation, and therefore not all of them are equally trustworthy. According to U:S: Preventive Services Task Force (USPSTF), the quality of recommendations is ranked as A, B, C, D, I, which refle- cts the net effect (i.e. the risk/benefit ra- tio) of the implementation of a particular recommendation in practice, taking into account the number and size of studies that served as a basis for that recommendation (1). Similar such systems are the Oxford CEBM Levels of Evidence (2) and the GRADE system (Grading of Recommendations Assessment, Development and Evaluation) (3), which classify positions according to the quality of their evidence.

2 Recommendations structure

A recommendation is a consensual agreement of a large number of experts working within a particular professional association, regarding a simple and clear statement consisting of two sentences, linked to each other with the word “should” or “should not”. While the first sen- tence describes the situation, the second one refers to either desired (“should”) or undesirable (“should not”) conduct in such situation. Example: “Clinicians should not carry out tests or initiate antibiotic therapy in patients with bronchi- tis, unless pneumonia is suspected” (4).

This is then furnished by argu- mentation, whereby the authors of the recommendation in the introductory part explain the motifs for their implementation along with the main epidemiological indicators. This is followed by a description of the standardised methodology with the list of databases from which the authors obtained their data or evidence. Of course, there should also be a list of literature and sources enclosed, including the already existing clinical and international guidelines.

An important integral part of recommendations is the liability clau- se. In their recommendations, authors generally exclude their liability for any damage that may result from the use of the recommendations. This is however logical since the document is non-binding, and it is up to the practitioner to assess its applicability and sensibility in the particular case.

3 From recommendations to guidelines

Guidelines are recommendations that form the basis for elaborating a particular strategy or policy. They differ from

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recommendations primarily in that the latter are not addressed to anyone in particular and on their own do not have practical effects while the guidelines are those recommendations used by the decision maker or the performer uses in planning or carrying our their activiti- es, strategies or decisions (5). The World Health Organisation explicitly states that recommendations with an impact on the implementation of public policies or clinical practice should be regarded as guidelines (6). The reasons why a decision maker would need guidelines are different. The following two reasons, however, are most frequent:

• the management of legal risks, i.e. unfavourable outcome of legal procedures that may befall the contracting authority of the guidelines, and

• deciding on the financing of programmes.

Since guidelines are documents that have both legal and economic effects, of course, not every recommendation can be deemed to be a guideline.

In the first case, the decision makers (usually the healthcare providers) want to know which procedures can be reaso- nably expected to prevent damage as a basis of damage liability. Therefore, they are interested in those recommendations that are credible enough to enable a potential victim to prove any lack of due diligence if the healthcare provider failed to respect them. In the SZD proposal endorsed by the Health Council such recommendations are referred to as clinical guidelines, and this term applies only to those recommendations that are based on the highest level of evidence quality available at a given moment, and which were prepared through a multidi- sciplinary cooperation of various experts and other interested stakeholders, usual-

ly also representatives of patient organisations.

The second case is associated with the definition of public healthcare. This is a system that ensures everyone, without discrimination, access to necessary and professionally justified health services within a reasonable time. Thus, the public healthcare system must at the macro level ensure everyone, in essence, exactly what each individual healthcare provider must provide to an individual patient at the micro level. The organizer of public healthcare needs to know which healthcare services or procedures should be made available to the users in order not to violate the definition of public healthcare. In the SZD proposal such recommendations are referred to as na- tional guidelines. They must also include an economic assessment of resources (personnel, equipment and premises), logistics or implementation and risk management.

There should be no major differences between the clinical and national guidelines. In both cases, the users are interested in the best possible selection of recommendations that are hard to ignore because of their professional credibility, and in both cases they seek to be as far as possible disburdened of recommendations that are either irrelevant for their goal attainment or are not sufficiently convincing.

4 Legal status of

recommendations and guidelines

Guidelines are not by definition a rule, because the service user cannot hold the service provider liable for providing them the service according to the procedure laid down in the guidelines.

However, insofar as they are professi-

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onally credible, it is quite probable that a patient will be able to prove his claim for damages on the basis of a proven violation of the guidelines Likewise, in the case of an action before the social court in the event of a violation of the guidelines, it is quite likely that the patient will be able to prove a violation of public health insurance rights or an impediment of access to the service that the public healthcare system must provide.

Guidelines are not algorithms or clinical pathways and do not give the practitioner instructions on how to perform the procedure. They are strategic documents that take a stand on the scientific prove- nance of various ideas or suggestions for action in defined circumstances. The practitioners then themselves decide which of the recommended procedures or which combination thereof they will use.

Theoretically, guidelines by definition do not play a decisive role in determining whether a physician has acted unlawful- ly or not. Patients may themselves study medical literature to find any evidence (e.g. a study, a research, etc.) from which it is possible to prove that in a given case some other method or a different approach would yield a different result. In this respect, guidelines significantly differ from the normative acts – the latter are valid as long as they are adopted by the legislator, irrespective of their scientific or actual persuasiveness, while guidelines are valid only to the extent that there is no other more convincing evidence.

But nevertheless, guidelines may have an important role in establishing damage liability in the issues of due diligence (7).

One of the key elements of damage liability is a causal link, which determines whether a doctor’s conduct or omission thereof has caused the damage suffered by the patient. It is the guidelines that can best answer this question, as it is easy to derive from them which procedures

have already been proposed in certain cases, and what is their scientific persuasiveness. Procedures that are not suppor- ted by strong and convincing evidence of their effectiveness, or those that have already been proven ineffective (or. insuf- ficiently differing from placebo), do not fall within the sphere of the physician’s due diligence, as it cannot be proven that their omission has caused the damage.

And, of course, vice versa: when physicians performs such a procedure, in the event of side effects, they should be able to prove that the patient has previously been informed of the risks and benefits expected, and that the patient has given their consent.

There are numerous cases in the German case-law where the courts defined the role of guidelines in that manner (8). The same status is attributed to them by Hurwitz (9).

5 Are the guidelines a

leverage for obtaining public funds?

Properly prepared guidelines should not be a direct leverage for the acquisition of additional public funds, since they give the contractor a considerable autonomy in choosing the recommended procedures and also in terms of their logistical or organizational performance. The price approved by the financier for an individual service is determined by statistical processing of the costs of a large number of providers in relation to a group of comparable treatments that are classified in many countries according to the DRG system (diagnose related groups). The average includes those who achieve goals with cheaper alter- natives as well as those achieving them with more expensive ones and those se-

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eking different combinations (i.e. case- -mix) (10).

6 The role of guidelines in epidemiology and the problem of biased guideline interpretation

When discussing the procedures to be provided by the public healthcare, an epidemiological aspect should always be taken into account, since every service offered by the public healthcare should be made available to every resident in a reasonable time under the same conditions, i.e. at the same phase and stage of their disease. Therefore, in the public health system, “the process” is not only a process that takes place when the patient is seen in the physician’s office, but also all measures which ensure that a person with a certain health problem indeed receives the necessary medical service.

In terms of epidemiology, guidelines for resuscitation are not particularly helpful if the logistics does not allow the help to arrive in time. In legal terms, there is no enforceable right of the population to e.g. a high survival rate after myocardi- al infarction, since the population, being a statistical group, does not have a legal capacity and as such can not file a case against the state or an individual service provider. However, poor logistics increa- ses the risk that a person who has a myo- cardial infarction will die, an outcome that could be prevented by a timely and adequate intervention. In judicial proceedings, public healthcare service providers generally cannot effectively themselves with the argument of personnel or spatial deficiency. Even at the individual level, physicians can only defend themselves if they prove that in a particular situation they had to triage the patients who sought their help at the same time

according to the level of emergency, and that the treatment of a patient had to be postponed because there was another patient at a greater risk. The argument that the order has been determined according to the administrative rule

“first come, first served” fails in the court, because the fact that somebody came earlier does not mean that they need the service more urgently. Public service providers and organisers cannot justify their defence by the argument of being overburdened; they are found guilty in every instance of timely service omission (11).

Public health service providers therefore find themselves in severe legal situation when, on the one hand, they have to provide a certain health service according to the guidelines, but on the other, they are not able to do that, because of a lack of resources. There is an inevita- ble conflict between the guidelines as a kind of professional axiom that should be beyond any doubt, and the fact that resources available for health service providing are always limited. It is therefore necessary to continuously adapt the processes to the epidemiological situation (i.e. the demand for health services) to new scientific knowledge and to the rational use of available resources (12).

For example, if the guidelines sug- gest that in the event of upper respiratory tract infection an antibiotic shall not be given in the first week (13), this statement does not specify that on the first day of infection the physician must recommend to the patient a sympto- matic therapy and follow-up its effectiveness on the 8^th day of treatment. The research has even shown that 50 % of parents who prior to visiting their physician expected that their child would be prescribed an antibiotic are not less sa- tisfied with the service if antibiotic has not been prescribed (14). The guidelines

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can be implemented in several different ways, among others also by instructing such patients that in the first week of an uncomplicated respiratory infection they need not visit their physician at all.

or by ordering the patient to appear for the first check in one week time, when the physician will be able to produce a more comprehensive anamnesis and decide either on the termination of sick le- ave or its prolongation and introduction of an antibiotic.

A common mistake in the interpretation of the guidelines stems from the fact that there are many possible appro- aches to addressing a problem, however, the effectiveness of none of them is evidence-based. In such cases, it is first of all necessary to explain to the patient the nature of their disease and the fact that we do not have an effective therapy for it.

This is not a news that the patient wants to hear, but we cannot avoid it by beating around the bush and experimenting.

The next common mistake occurs in the cases when physicians first make use of an evidence-based procedure, and only when that turns out ineffective, they begin to employ procedures that are not evidence-based. This stems from an in- tuitive wish to try helping the patient at any price and finding a “miracle medicine”. Although appearing altruistic and pleasing to patients, such an approach in public healthcare is detrimental for its accessibility to patients, who expect of the same physician an evidence-based treatment, but due to the limited resources cannot get it in due time.

Biased interpretation of guidelines can also be a motive for introducing some informal preventive programmes, which are by definition not evidence-based. For example, if the guidelines claim that the timely diagnosis and excision of a certain type of cancer reduces this disease-related mortality, this does not

mean that every inhabitant should be invited once a year to the screening program until there is evidence supporting the belief that systematic checks once a year reduce mortality due to this particular type of cancer. A similar example was the recommendation for the screening program for pregnancy-related diabetes, according to which all pregnant women in Slovenia should be tested (16), although it was known already in 2001 that the effectiveness of such screening programs was not sufficiently clearly de- monstrated (17), and in 2006 the World Health Organization developed criteria for assessing the need for such testing in relation to the existing or known risk fa- ctors (18).

7 Conflict of interests and the problem of biased writing of guidelines

Problems associated with biased writing of guidelines are even more pressing than those associated with their interpretation. Namely, the authors are under constant pressure from both the industry and colleagues to ascribe a higher degree of scientific credibility to certain procedures, in order to use it for un- derpinning their negotiation position for the acquisition of additional public funds, capacities, personnel and the like.

These interests are very short-sighted, as we know that too lenient guidelines cre- ate excellent conditions for damages claims against physicians (an unfavourable outcome of the judicial proceedings due to the abandonment of a procedure which is scientifically unconvincing) and for the emergence of catch 22 situations in which physicians – because of the limited resources – can not provide what is expected of them by the guidelines. Too lenient guidelines are therefore mainly

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in the interest of the industry, researchers and a small group of stakeholders (lobbies), while the service providers, physicians employed by them, healthcare budget and before all patients who are the main beneficiaries of the healthcare system, are their victims.

Therefore, it is necessary to intro- duce some safety measures that are adopted from the systemic opinion of the Commission for the Prevention of Corruption, no 06211–9/2012/23 of 3 July 2012 (19):

• the obligation to disclose the guidelines’ authors, their employment, income and connections, in particular to the industry, and to assess the possibility of conflict of interests;

• the exclusion of experts from the commissions adopting the guidelines, in the case that the disclosure findings reveal an actual or potential conflict of interests;

• strengthening the responsibility of the drafters of guidelines for achieving public health objectives, including the maintenance of waiting periods within reasonable limits and the reduction of incidence or the con- sequences of the conditions addressed by the guidelines.

The conflict of interests is established when a member of the guidelines commission is in legal or economic relation with someone who has their own particular interest as regards the content of the guidelines. The current Integrity and Prevention of Corruption Act provides the following two definitions: “Conflict of interest” means circumstances in which the private interest of an official person influences or appears to influence the impartial and objective performance of their public duties; “Private interest of an official person” means a pecuniary or non-pecuniary benefit which is either to

his advantage or to the advantage of his family members or other natural or legal persons with whom he maintains or has maintained personal, business or political relations (20).

This interest need not necessarily be of financial nature; e.g. a physician who is expecting a more attractive position or a job may have such interest, or a re- searcher who would obtain a study population or research funds through the implementation of the guidelines, etc.

It is important to emphasize that the very fact that someone has received a fee from the industry does not yet prove conflict of interests. It is also important whether the fee is proportionate to the ef- fort involved, how often members of the commission receive it and whether they distributes their part-time work among the different stakeholders, whether they are paid for publishing a specific result, etc. (21).

The authors of the guidelines should keep in mind that almost any deviation in the guidelines from the evidence-based findings results in material benefit for the operators offering in-the guidelines-permissible procedures, and for their suppliers in the industry,

Where there is also an intent (i.e. deli- berately omitted alternative), the second element is fulfilled (unlawful conduct), which is already a criminal offence. Such practices can and must be prevented by raising awareness and prosecutions, as otherwise the writing of guidelines becomes a convenient tool for overpowe- ring competing healthcare providers and non-transparent implementation of the interests of lobbyist groups.

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8 Strengthening the implementation of guidelines in practice

8.1 Financing system

Even with the established system of guidelines, physicians shall maintain autonomy in choosing the type of diagnosis or treatment they offer to the patient.

For the sake of legal certainty, it is ad- visable that physicians decide for one of the methods recommended by the guidelines, but nevertheless, they may also choose another one, if it may be reaso- nably expected that the patient will not be harmed by it and that in the case of an action for damages they can prove that sufficient attention was paid to the patient’s safety.

The question that raises greater con- cern is who bears the costs if a physician chooses a more expensive alternative.

In any case, this should not be a health insurance company that should pay the same price regardless of the method chosen. But, among the operators, their practices differ. Some will let physicians make their own decisions as long as these are rational and more expensive methods are chosen only exceptionally. Where this turns out insufficient, the operators implement stricter rules and require that physicians obtain consent from the mul- tidisciplinary team or the expert management of the institution prior to choosing a more expensive method.

Of course, the patient should always be informed about all the methods available by the guidelines, and they should be free to choose any of them. However, the patient’s choice may not influence the operator’s costs. If a patient selects a more expensive method, although the healthcare operator considers that the cheaper method is sufficient, the pati-

ent should be treated as a private patient (the choice of a service that is considered unnecessary by an authorised physician – item 7 of Article 25 of the Compulsory Health Insurance Rules), of course, provided that the patient consents to being treated as a private patient (22,23).

8.2 Clinical pathways and their link to the guidelines

Clinical pathway is a flow chart of procedures and decisions used by the operator in dealing with a particular clinical problem. Guidelines most easily and completely find their way into practice through clinical pathways. In terms of structure, clinical pathway is a protocol describing in more detail the implementation of guidelines in a local environment according to the existing conditions. As a standardised multi- disciplinary care plan it identifies the sequence of clinical measures, timefra- mes, milestones and expected results of a homogeneous group of patients.

Guidelines generally cover several clinical problems, wile clinical pathways are more focused on a particular problem or its part. Therefore, individual guidelines are generally associated with several clinical pathways. (24).

Compared to guidelines, a clinical pathway is much more defined, as it also includes steps that the guidelines do not specify. Clinical pathways ensure that the patient is treated by the right experts, in the right order, in the right place, at the right time, with appropriate means, with the correct outcome of the treatment and in accordance with the needs and expectations of the patient (25).

Sometimes the operators also expect the authors of the guidelines to provide answers to the questions how to implement the guideline in the organizational or financial sense. They often do

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this by creating a conflict of interest, i.e., by using their position as an employer to make a member of the commission, otherwise employed by the contractor, reach the adaptation of the guideline to the clinical pathway of an individual operator. All these practices are corrupt and members who are exposed to such pressures should be excluded from the committees. The guidelines may only include evidence-based knowledge, irrespective of whether or not this evidence supports the practice or organization of a particular operator and its budget. The guidelines shall not include anything that we find sensible or logical but is not evidence-based. A guideline always al- lows for more possibilities of implementation, and the search for these options is a matter for the operators and not the authors of the guidelines. This can not be easily introduced in the Slovenian context, since we use to adapt the solutions and even the public health objectives to the given organization and financing models rather than being the opposite.

In Slovenia, there is also a persistent practice of prescribing business processes of leading operators, or even processes as have been implemented by the leading operator (generally the UMC Ljubljana). Even to the extent that they sometimes want to use them as a guideline. This, of course is not an evidence-based clinical practice, as such a finding would require a study with strong evidence that the clinical pathway of such operator is statistically significantly more effective than the average practices of healthcare institutions worldwide.

8.3 Standards and their link to the guidelines

By definition (SIST EN 45020), a standard is a document generated by consensus and approved by a recogni-

sed authority, which sets out the rules, guidelines or characteristics of the acti- vities and their results (26). Standards are similar to the guidelines in that they contain a simple statement that covers a particular situation. However, they differ from the guidelines in that they have in addition to the recommendatory also a prescriptive part which specifies:

• what needs to be done in a particular situation;

• sometimes also who is responsible for doing that;

• what are the expected results or indicators.

Standards are essentially a kind of draft regulation. They are composed in such a way that they can be used as a regulation, but they get their binding nature only when they are introduced with a certain regulation, a general act of an organization or a contract, i.e. with a legally binding document. The essen- tial difference between the standard and the guideline is in that the operators use standard either because they have com- mitted themselves to it (e.g. by a contract, a bid, a binding statement, etc.) or because a certain authority prescribed them to respect it by means of a regulation, a general act of the organization, etc., while the operator uses the guideline because it is difficult to ignore due to its professional conviction.

However, standards differ from a standard regulation in that they also have recommendatory part on the basis of which they are adopted. While a regulation is exclusively a matter of the will of those who adopt it and does not require any objective justification for its validity, standards must be based on guidelines, i.e. on a professional consensus.

We could say that standards are regulati- ons that were developed on the basis of the knowledge of the profession. The fact

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that the operator has acted according to the standard does not of itself exclude liability for damages, but the latter is excluded under the same assumptions as in the guidelines, i.e. when there is no convincing evidence that a different (non-standard) approach would prevent the harmful effect.

The role of standards is primarily in that it is possible to compare two different products of two different services with each other. Standards do not con- stitute an exhaustive description that would not allow the user of the standard to have any autonomy as regards the method of implementation. They only define a minimum set of characteristics for which there is a consensus of the profession that they are necessary in order for a service or a product to be what the operator claims it to be.

In the context of public healthcare, the adoption of standards is necessary in particular in two cases:

• when the operator or the public healthcare system intends to provide the patient with a specific procedure and it needs to be assessed whether or not the patient has received it;

• when a procedure is divided among several operators or institutions and the next holder cannot take over the procedure before its previous phase has been completed in accordance with the standard.

9 Transfer of foreign guidelines

Science is universal and convincing in itself, and its findings reach beyond national or political borders. Therefore, we often follow the principle that guidelines need not be created in each country separately, and that nothing can really go wrong if we copy the guidelines that

have already been prepared by someone else.

However, we have to distinguish between the following two levels:

• large-scale multicentric studies, which serve as a basis for foreign guidelines the credibility of which is difficult to contest;

• the authorities which adopt a particular recommendation.

In the Slovenian legal setting, foreign guidelines and recommendations have the status of a good review article. This means that they can be one of the sources from which Slovenian recommendations are drawn up, and also a guide that can be used by Slovenian practitioners in the absence of Slovenian recommendations; but they should not be the only source. The Slovenian authorities that adopt guidelines must review all the world’s credible literature, including the recommendations and guidelines from foreign countries, and use that to draw up their own recommendation as an independent work. The results of Slovenian studies should be reviewed and included in the recommendations when they are not statistically significantly different from those from world literature. However, if they statistically significantly differ, an appropriate position should be taken, and it should be determined whether the differences are attributable to a smaller sample of the Slovenian study or a greater specificity of the Slovenian population. We can speak of specificity only when a study carried out on a Slovenian population sample is at least approximately equivalent to foreign reference studies in terms of their methodology and sample size. When the Slovenian studies statistically significantly differ from foreign ones on a small sample, they should not affect the content of national recommendations, since

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the difference is more likely to be due to the sampling or methodological error than the biological differences between the inhabitants of Slovenia and other Europeans or Earth people in general.

It is also necessary to mention various European guidelines. These can be used directly in cross-border projects, e.g. in making decisions on project funding by the EU institutions. Furthermore, European guidelines could also be directly used in the case of cross-border healthcare services, e.g. when an operator from one state attracts patients in the territory of another state. However, in the Slovenian national system (e.g. in decisions on financing by the Slovenian state or HIIS) they have – likewise all other foreign recommendations – only the status of a good review article, and in drawing up the Slovenian national guidelines they have to be assessed within the context of other available sources.

It is very important to consider whether it is reasonable for Slovenia to have its own system of guidelines, given the fact that, according to the do- cumentary sources that underlie them, it is difficult to expect that they will differ significantly from those from other countries. On the other hand, the question is whether this can be avoided at all, if we do not want to have a situation when e.g.

someone will follow Spanish, the other Canadian and the third one Australian guidelines. This problem is generally sol- ved by the internalisation of foreign or international guidelines in such a way that the authority responsible for adopting the Slovenian guidelines adopts the international guideline and at the same time implements it as a national one.

However, there are some prerequisites:

• the guidelines must meet all standards that the Slovenian clinical or national guidelines would fulfil;

• - an international recommendation should be accompanied by a statement from the Slovenian authority that an international recommendation should also be considered as a Slovenian national recommendation;

• internalised recommendations should be consistent with, or at least should not be contradictory to the results of the Slovenian expert literature, which should be thoroughly reviewed before adopting the foreign guidelines.

This is a fairly practical approach, since in this case there are no differences between the standards on the domestic and cross-border markets.

10 Competent Authorities for the adoption of

guidelines in Slovenia

Health Services Act (ZZDej) does not include terms »guidelines« or

»recommendations«, therefore the com- petences for drawing up guidelines should be derived mutatis mutandis from Article 74 of the ZZDej. In accordance with this, the General Expert Collegiums (hereinafter: RSK) shall establish professional doctrine with respect to health enhancement, prevention, identification, treatment, the nursing and rehabilitation of people taken ill or injured and persons with mental and physical development disorders. According to the ZZDej, the RSK is the highest expert body in a particular area, which coordinates proposals of university hospitals, professional associations and chambers, higher education institutions, health institutions and individual experts. Based on this definition we would conclude that the documents drawn up by the RSK have the status of recommendation until confirmed by the Health Council.

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Pursuant to the first paragraph of Article 75 of the ZZDej, the Health Council is competent for the transition of recommendations into guidelines.

According to this provision, the professional proposals of the RSK affecting the content and scope of health care, and thus health policy and healthcare financing, are dealt with and endorsed by the Health Council as the highest professional coordinating body in the field of health care. The Health Council shall design the content of health programmes in terms of their feasibility, the uniform development of all disciplines and the principle of equal accessibility. It may require the General Expert Collegiums to adapt professional doctrine to economic capacities of the country or to propose the implementation of the programmes according to priorities and to a limited extent.The Health Council is established at the ministry responsible for health, and consists of health care representatives, councillors, senior councillors, faculty teachers and other renowned experts in the field of health care, health economics and healthcare organisations. (27).

The Slovenian Medical Association has prepared a draft pathway for the adoption of professional recommendations, clinical guidelines and national guidelines, which was also approved by the Health Council on 7 March 2013 (28).

Clinical guidelines and recommendati- ons shall be prepared by working gro- ups within the framework of professional associations, societies and sections, which are organised in the association of medical societies – the Slovenian Medical Association (hereinafter: SZD).

The prepared text is confirmed at a mee- ting of associations, societies or sections.

Afterwards, a recommendation or a clinical guideline shall be submitted to the expert council for a particular area, whi-

ch will forward their harmonised and finalised version for consideration to the General Expert Council of the SZD.

When the text has been confirmed by the latter, it may be published in Zdravniški vestnik.

A draft national guideline is first reviewed and endorsed by the RSK for a particular area, and then sent to the Health Council for consideration and approval.

Prior to discussion, a working group for the guideline shall be constituted to pre- pare an economic assessment of resources, and the Health Council may request the applicant to amend their proposal as necessary.

Because the national guidelines - un- like clinical guidelines and recommendations - do not only express the consensus of the profession but respond to a question of a decision-maker who is interested in the legal or financial aspects of dealing with a particular medical issue, we need an authority in Slovenia, which would also take into account these aspects, as professional councils and their members are not responsible for healthcare financing. It is questionable, however, whether the Health Council is the best solution because, due to its affi- liation to the Ministry of Health, it does not provide a sufficient guarantee of in- dependence and impartiality since its members are appointed by the Minister with the consent of the Government.

Furthermore, pursuant to the first paragraph of Article 7 of the Rules con- cerning the Health Council, the term of office of its members is linked with the term of office of the Minister of Health.

It would be more appropriate for the guidelines to be adopted by independent institutions, e.g. an independent public agency or an institute for healthcare quality. Although the British NICE (National Institute for Health and Care Excellence) is also responsible for its work to the

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Ministry of Health, it is autonomous in operational respect (30). In the USA, guidelines are adopted by the Agency for Healthcare and Quality (AHRO), which functions as an independent body within the Ministry of Health (31). In Germany, guidelines are adopted by a kind of independent mixed commission (Gemeinsamer Bundesauschuss), which – in line with the tradition of the German

healthcare system - consists of healthcare stakeholders, i.e. healthcare insurance companies and healthcare service providers (32). A similar body called Haute Autorité de Santé (HAS) also exists in France; this body too is composed of stakeholders in health sector, and financed by French public healthcare funders, i.e.

the state and insurance companies (33).

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