The Legal Effect of

Standards and Guidelines

Most regulators publish informal documents for their members. These documents can be called standards of practice, guidelines, codes, practice parameters, or position statements. Typically, these informal documents provide assistance to members in areas of practice, ethics, regulator expectations or even legal developments.

However, unless those documents are enacted in a regulation or similar form of delegated legislation, they are not “legally binding”. That is, one could not discipline or otherwise prosecute a member simply for failing to comply with the requirements set out in the documents: Brett v. Ontario (Board of Directors of Physiotherapy) (1991), 77 D.L.R. (4^th) 144 (Ont.Div.Ct.), aff’d 104 (D.L.R.) (4^th) 421 (Ont.C.A.). Indeed such documents should not even be worded as if they were legally binding or else the courts may declare them to be unenforceable: Ainsley Financial Corp. v. Ontario Securities Commission (1994), 21 O.R. (3d) 104 (Ont.C.A.).

Having said that, it would also be untrue to say that informal documents published by a regulator have no legal effect. Some legal commentators call such informal documents “soft law”. This concept is described by Angela Campbell and Kathleen Cranley Glass in their article: The Legal Status of Clinical and Ethics Policies, Codes, and Guidelines in Medical Practice and Research as follows:

This body of policies, codes, and guidelines has been referred to as “soft law” because of its uncertain legal status. When the “soft law” at issue deals with professional, rather than social, standards of conduct, the question of how it should be applied by a court becomes even more complex. Because the policies, codes, and guidelines have not been accepted in law or regulations, it may be argued that they are not binding on a court. Judges may therefore disregard “soft law” if the standards set by it are inadequate for ensuring that reasonable care and diligence are exercised in the execution of professional responsibilities. The counter-argument is that professional “soft law” should be shown deference by a court, given that judges do not usually have sufficient expertise in the field from which the standard emanates and thus are not fit to substitute their own views for professional opinion. This article provides an analysis of the legal status of “soft law” in medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. In this context, guidance for physicians and researchers often comes from non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. Clarification of their legal status is thus an important issue.

The legal effect of such “soft law” probably includes the following:

1.      The publications provide a defence against negligence or misconduct claims. If one complies with the publication one can argue that one did what was professionally expected. Courts and tribunals may still, in an extreme case, conclude that either the publication was unreasonable or its application to the specific facts of the case was unreasonable. However, this will be rare and great deference will usually be shown.

2.      The publications might provide some evidence of the standard of practice. While the strongest evidence of the standard of practice is usually expert testimony, the publications may support or reinforce the expert testimony and make it more likely to be accepted. The impact of the publications is increased if it is the result of a consultation process among leading practitioners in the field. Even if there is no consultation, the lifecycle of a standard of practice often is a publication by a regulator followed by a gradual acceptance of the principles stated in the publication by the profession leading to a standard of practice supported by expert testimony.

3.      The publications can serve as a warning to the profession. For example, members can be warned about studies identifying a newly discovered practice problem or about developing expectations (e.g., privacy rights, sexualized or discriminatory behaviour). It then becomes more difficult for a member to claim that they were unaware of the issue since they are expected to review all regulatory publications.

4.      The publications can be used in non-enforcement contexts. Even if publications cannot be directly enforced in prosecutions before Discipline Committees or the courts, they can be used in a manner that enhances practice. For examples, many Complaints Committees provide reminders and advice or even negotiate undertakings in which members are encouraged to examine and implement regulatory publications. Similarly, some quality assurance programs use regulatory publications as the basis for assessments of practices and upgrading suggestions.

5.      The publications can always be used as a true guideline. That is, the publications can be a true suggestion that provokes reflection and voluntary changes of behaviour by practitioners.

A copy of the article upon which some of the above points are based can be found at: http://www.journal.law.mcgill.ca/arts/462campb.pdf. In a future issue we will examine the various types of regulatory publications used by regulators and the appropriate language to be used for each.

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