Both the Courts and regulators might have regard to all such guidance when making a decision. However, all of these are guidance and as such cannot have the force of primary or secondary legislation. Below legislation in the hierarchy would come specific guidance produced to explain legislation (e.g. explanatory memoranda and Codes of Practice). All the materials you mention would sit at the bottom of any such hierarchy. Within this I would suggest an integrated care pathway would have least significance of all as it has little direct bearing on crucial i.e. life and death outcomes. I speak from a purely english perspective of course where the Courts can be sceptical about administrative guidelines or corporate policies, although the latter would be more important where they closely follow say employment or health and safety legislation. Thus the link firstly to legislation and secondly to Parliament's intentions in making it are fundamental.

Guidelines: these are what guide how a particular practice/ procedure is to be carried out and thus incase of any issue that arises out of a procedure or a medical action then these are what are referred to.

Policies and protocols : any organisation / healthcare institution has policies that have to be adhered to and thus they form a key element in any legal implication. one is able to ascertain out of these if what was carried out is within the medical policies olr no.

Thank you, Dr. Andrew William McCulloch for replying and providing your insight firsthand.

Random discussions with several colleagues from clinical (different medical and surgical specialties) and administrative staff at some large teaching hospitals in the Eastern Mediterranean (or MENA) Region (namely in Egypt, Saudi Arabia, and Tunisia) have revealed a general perception that mainly 'Policies and procedures' and to a lesser degree 'Clinical protocols' have a greater medico-legal significance. While 'Clinical practice guidelines' and 'Care pathways' are merely for general guidance and clinical decision support but are not and/or should not be 'legally' compelling for clinicians to avoid losing their clinical autonomy.

Fear of global practice of defensive medicine ( https://www.merriam-webster.com/dictionary/defensive%20medicine ) was a major concern!

Do you agree?

I think that the issue of medico-legal significance will vary according to circumstance and institution/ health service unit. Thus in general NICE guidelines, for example, are the 'standard' in the NHS ( not merely for guidance) and clinicians are expected to adhere to them and will be 'judged' accordingly in the event of 'mishap' for not complying. However NICE doesn't cover all clinical topics settings or scenarios

Thanks, dear Dr. Zbys Fedorowicz for your insight!

Indeed, the impact of NICE's evidence, guidance, quality standards, and other syntheses is well known locally in the UK and internationally as well.

You've inspired another relevant query here; in the case of 'adaptation of an evidence-based CPG to another context in another country', actually, NICE guidance is a good example as they've been adapted or adopted in several instances outside the UK, so, for example, would you recommend considering giving them the same (or at least slightly similar) weight in terms of legal significance in the adapting country which could be included in a more high-level quality improvement or reform initiative? OR Otherwise, do you see that this is totally irrelevant due to the possible variation in local health systems, regulations, and laws? Especially, if we consider that the adapting country is classified as a high-income economy, similar to the UK, rather than LMICs to avoid the possible confounders of limited resources.

I believe that NICE international is up and running again and that possibly means that NICE will work with local cadres to ensure a closer fit to local conditions. It maybe worth asking more directly/ seeking confirmation

Useful resources to inspire the discussion:-

1- https://qualitysafety.bmj.com/content/3/1/37

2- https://www.gponline.com/medico-legal-legal-status-clinical-guidelines/article/1451396

3- https://www.guidelinesinpractice.co.uk/your-practice/covert-medication-decisions-must-follow-the-law-and-nice-guidance-/454559.article

4- https://www.channelnewsasia.com/news/singapore/moh-to-issue-legally-binding-clinical-practice-guidance-11399688

5- Article Inside general practice ethics: Guidelines ‘and’ ‘of’ or ‘fo...

6- Article Clinical practice guidelines and risk management: A medicole...

Thx a lot Dr yasser for initiating this discussion, for mem whatever locally approved by the administration (Guideline, Protocol, policy) I think it will have a medicolegal impact on the endusers (physicians or other target users by these documents.

But I think that the area of freedom for customizing clinical decision is wider in CPGs rather than the ICP or even the clinical protocols

Let me approach this question from a different perspective.

Clinical Practice Guidelines, Protocols, and Policies and Procedures are generally in the category of the so-called soft laws or norms. Soft norm refers to some quasi-legal instruments, rules or guidelines of behaviour that are neither strictly binding in nature nor completely lacking legal significance such as non-binding resolutions, declarations, and guidelines created by governments and private organizations.

Those various kinds of quasi-legal instruments, within the context of the healthcare sector, may include guidelines, policy declarations, or codes of conduct that set standards of conduct couched in the normative moods. Soft norms are usually not directly binding or enforceable in accordance with formal techniques of international law but are capable of exerting a powerful influence over the behaviour of the parties to which it applies. Soft norm is not an alternative to the ‘traditional’ lawmaking, but rather, a complement to it. It is fast becoming a major ‘legalisation form’ of the norm-like activities of private and public-private crossbreed authorities where the new type of informal soft norm has come to be primarily relied on by such authorities owing to its flexible and context-dependent nature.

Soft norms are preferred for a variety of reasons. For instance, it is preferred to solve straightforward situations in which the existence of a focal point is enough to generate compliance, or loss avoidance theory, where a non-compliance with a hard law could attract higher sanctions to deter more violations. Soft-law instruments cope better with diversity and provide greater flexibility to cope with uncertainty and allow for adjustments over time. Therefore, soft-norm instruments are easier to negotiate, less costly, and allow parties to be more ambitious and engage in “deeper” cooperation than they would if they had to worry about enforcement.

Conversely, hard law refers generally to legal obligations that are legally binding on, and therefore, enforceable by the parties involved before a court. Generally, hard-law instruments allow parties to commit themselves more credibly to agreements, to avoid the increased cost of reneging due to sanctions. Hard-law instruments have direct legal effects and create mechanisms for the interpretation of the legal commitments, and for enforcement of commitments through either courts or alternative dispute-settlement bodies.

It may seem to be a good question to ask, why adopting a “soft norm” while we already have the hard law. Critics of hard law have raised a number of significant issues. For instance, hard law tends to be set of fixed rules, for universal application, presupposes a prior knowledge, and is difficult to change. While on the other hand, soft norms allow for flexibility, diversity, experimentation and adjustments, and internalization of the hard laws themselves in order to ease in enforcement and to achieve an optimal outcome.

In the contemporary situation that needs flexible compliance with, and enforcement of the laws to achieve maximum results, the application of a hybrid of soft and hard law would seem imperative. Soft norms, by their design, encourage adherence to the standards and allows for substantial flexibility in methods to reach sustainability that fit with their institutional needs and peculiarities, supplementing the hard law that includes a set of fixed rules that define what constitutes a wrongful act and provides sanctions for noncompliance with these rules serving as deterrents.

Coming back to your question as to which one of Clinical Practice Guidelines, Protocols, or Policies and Procedures is preferred, I would say that they all the same in terms of legal weight. Although under some jurisdiction they do not form a legal weight, it is still used as a base fr establishing the legal duty of care, and the standard of care before finally deciding if the health professional is liable in negligence. For instance, see Bolam v Friern Hospital Management Committee [1957] 1 WLR 583 under the UK jurisdiction. Under some other jurisdictions, non-compliance with Clinical Practice Guidelines, Protocols, or Policies and Procedures could carry legal liability (See Article 31 of the Saudi Law on Practicing Healthcare Professions). It is an offence to violate relevant codes of practice or acts contrary to professional conduct or ethics, which could attract disciplinary action that includes a warning, fine (up to 10,000 riyals or revocation of licence Article 33).

While I did not specifically answer your question, I thought it is an opportunity to give a different perspective o the question.

Thanks, dear Dr. Abba Amsami Elgujja for this eye-opening and invaluable contribution to this discussion from an expert legal in addition to healthcare perspective.