The Indian government recently introduced the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2020.
This amendment has incorporated the ‘Telemedicine Practice Guidelines’ as an appendix to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 (“Ethics Regulations”).
While the guidelines primarily lay down the norms and standards that a ‘registered medical practitioner’ (doctor) must follow while providing telemedicine consultations, it also seeks to regulate technology platforms enabling telemedicine.
While the regulation of such platforms may have noble intentions, it is likely ultra vires the parent statute and possibly the Constitution as well.
The guidelines say that telemedicine platforms must follow five rules:
1) That patients are consulting with appropriately registered doctors;
2) That they report any non-compliance on the part of doctors to the Board of Governors, in supersession to the Medical Council of India who may take appropriate action;
3) Conduct due diligence before listing any doctor on its online portal;
4) Cease using any artificial intelligence or machine learning tools to counsel and prescribe medicines to patients;
5) Develop a proper mechanism to address the grievances of consumers.
Crucially, the guidelines specify that any platform that does not fulfil these requirements can be blacklisted, and no doctor can then use such a blacklisted platform for telemedicine consultation.
The Ethics Regulations and the Guidelines incorporated thereunder, have been issued under Section 33(m) and Section 20A of the Indian Medical Council Act, 1956 (“IMC Act”). The scope of these provisions are limited to permitting the MCI to frame the standards of professional conduct, etiquette and code of ethics to be observed by doctors.
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In Union of India v. S. Srinivasan, the Supreme Court observed:
“If a rule goes beyond the rule-making power conferred by the statute, the same has to be declared ultra vires. If a rule supplants any provision for which power has not been conferred, it becomes ultra vires. The basic test is to determine and consider the source of power which is relatable to the rule. Similarly, a rule must be in accord with the parent statute as it cannot travel beyond it.”
Accordingly, while it is clear that the MCI has the power to frame rules and regulations to regulate the conduct of doctors, the IMC Act does not provide the MCI the power and ability to regulate and direct the affairs and conduct of platforms. Consequently, the provisions of the guidelines which seek to regulate platforms are ultra vires the IMC Act and are therefore liable to be struck down.
A larger question that emanates from this discussion is whether an amendment of the IMC Act will prove sufficient to legitimise the regulation of these platforms through delegated legislation.
The Constitution of India distributes legislative powers between the central and state legislatures as per Schedule VII to the constitution. This schedule contains three lists – only the parliament can enact laws for subject matters listed in List I, only state legislatures can enact laws for subject matters listed in List II and both the central and state government can legislate on matters listed in List III, subject to certain restrictions.
The IMC Act has been enacted by the central government with the objective of regulating the medical profession (and not medico-tech platforms) through the MCI.
The power to regulate the medical profession falls in Entry 26, List III. As the regulation of the medical profession does not extend to the regulation of a Platform, even an amendment to the IMC Act to authorise the MCI to regulate Platforms would probably not pass muster the constitutional test of legislative competence.
Regulation of such Platforms would likely fall in either Entry 6, List II which deals with “Public health and sanitation; hospitals and dispensaries,” or Entry 31, List I which deals with “Posts and telegraphs; telephones, wireless, broadcasting and other like forms of communication.”
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In Zameer Ahmed Latifur Rehman Sheikh v. State of Maharashtra, the Supreme Court held that where the question for determination is whether a particular law relates to a particular subject mentioned in one list or the other, the court looks into the substance of the enactment. If the substance of the enactment falls within the Union List, then the incidental encroachment by the enactment on the State List would not make it invalid and vice-versa.
In our opinion, while there may be some incidental encroachment onto List I and List III, the pith and substance of the regulation of these platforms will fall within Entry 6, List II (State List).
This is because:
(a) they help facilitate public health by connecting patients to doctors;
(b) in many ways, they perform the role of virtual hospitals; and
(c) in some cases, they even provide the option of ordering prescription drugs on their platform.
Accordingly, the central government will not have the power to regulate these platforms. Consequently, not only is the regulation of these platforms ultra vires the parent act, the central government does not even have the legislative competence to remedy the situation by widening the scope of the IMC Act.
Crucially however, given the ubiquitous nature of these medico-tech platforms, enacting a separate country-wide uniform legislation may be a practical necessity. To overcome the aforementioned limitations, the central government may consider utilising Article 252 of the Constitution. This Article provides that the Parliament acquires the power to legislate on an issue of the State List if it is requested by two or more states under the procedure provided therein.
While such legislation would only be mandatorily applicable to the requesting states, other states would have the option to adopt the legislation as well. Interestingly, this method was adopted while enacting the Drugs and Cosmetics Act, 1940 (wherein all provincial legislatures provided their assent) and the Clinical Establishments (Registrations and Regulations) Act, 2010.
To be fair, the Central government’s concern and intent to regulate telemedicine platforms is appreciable and indeed, vital. The proper regulation of such platforms, which facilitate healthcare services and handle sensitive personal data of thousands of patients, is the need of the hour.
However, such regulation must be done in a manner that is compatible with the parent statute i.e., the IMC Act and more importantly, the constitution of India.
Samraat Basu is a technology and data protection lawyer. Soumya Tiwari is a fourth year student of law at Rajiv Gandhi National University of Law, Punjab, India.