Do clinical practice guidelines have legal implications?

8:11 am Health Care, Medicine

Call guidelines as guidance or advisories
Dr KK Aggarwal
National President IMA
Clinical practice guidelines are becoming an increasingly common feature of the health care. The government has developed Standard Treatment Guidelines under the Clinical Establishments Act (CEA), for example, for critical care, orthopaedics, cardiovascular diseases, general surgery etc. There are 21 such guidelines. “To ensure compliance with Standard Treatment Guidelines as may be determined and issued by the Central Government or State Government, as the case may be, from time to time” is one of the conditions to be fulfilled for registration and renewal of a clinical establishment under CEA (Clinical Establishments Act FAQs).

The government has three functions to perform

• Administrative through bureaucracy
• Regulatory through Medical Council of India and state councils
• Legislative through law ministry

Developing guidelines and updating them therefore is not the job of the Govt; instead it should be the job of professional bodies such as medical associations, which represent the collective consciousness of the medical fraternity. Unlike the Medical Associations, the Expert Panel enlisted by the Govt. to develop the guidelines does not represent the collective consciousness medical fraternity.

In UK, the guidelines are regularly developed by the National Institute of Clinical Excellence (NICE), Royal medical colleges and the universities.

Clinical practice guidelines are recommendations and suggestions that are evidence-based and show potential benefit or harm. They standardize treatment and improve quality of care. But they are not without their limitations. They cannot be generalized i.e. applied on each and every individual. Each patient is different and hence treatment has to be individualized. Also, western data cannot be extrapolated to our Indian settings.

There is a need for a balanced perspective.

Lawyers should really have no part to play in the development of clinical guidelines, as they are not clinicians.

The basic legal premise to work from in designing clinical guidelines is the “Bolam principle”, which would be applied in any dispute about the correctness or otherwise of a clinical guideline.
Basically, a clinical guideline would be viewed as proper if it satisfied the Bolam test.

Lord Browne-Wilkinson stated in Bolitho v City and Hackney HA [1998] Lloyd’s Rep Med 26 the test: “The locus classicus of the test for the standard of care required of a doctor or any other person professing some skill or competence is the direction to the jury given by McNair J, in Bolam v Friern Hospital Management Committee [1957] 1WLR 583,587. “I myself would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of men skilled in that particular art … Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.”

There are many ways to treat patients and any court would look to experts in the medical or nursing professions to help them assess whether the clinical guideline used in the case was proper or not.

The views of experts are however not definitive; they may show that a reasonable body of medical opinion may have designed and used a clinical guideline in a certain way, but the judge in the case will have the final say.

Issues to be considered when developing clinical guidelines:

• The objectives for the clinical guidelines need to be clear, and clearly stated. This will affect their subsequent legal standing.
• The intended use and applicability of clinical guidelines should be spelt out clearly, in the introduction.
• The guidelines must make clear for whom they are intended.
• Clinical guidelines that no longer reflect best practice might conceivably become actionable, and developers need to incorporate specific statements about their validity and review procedure.
• They should be constructed in such a way that allows deviation and does not suffocate initiative that might bring about further improvements.
• The development of clinical guidelines must involve all the relevant professionals and managers.

In Jacob Mathew vs State of Punjab & Anr on 5 August, 2005, the Hon’ble Supreme Court of India has acknowledged that neither the investigating officer or the complainant or judges are experts as they do not have knowledge of medicine. It also held that “one man clearly is not negligent merely because his conclusion differs from that of other professional men … Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence.”

“Non-adherence to established guidelines does not necessarily bode an adverse outcome for the defendant. Adherence to guidelines may not exonerate the defendant” (J R Soc Med. 2003 Mar;96(3):133-8).

So, differ with a reason. You should be able to justify your action or inaction and explain to the Court as to why you took the decision that you did.

To remove the confusion and possible legal implications, do not call guidelines as guidelines but as ‘Advisory’ or ‘Guidance’.

Dr KK Aggarwal
National President IMA & HCFI

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