A few weeks back, I had the opportunity of being a part of a panel discussion that covered a range of regulatory issues that are currently facing the pharmaceutical, healthcare and medical devices industries.

While discussing the basic legal concerns that arise from the Medical Device Rules of 2017, one of the questions from the audience particularly stood out during the discussion.

The audience member indicated that he was an importer of a medical device that carries out a certain function which currently rendered it outside the scope of the Medical Device Rules 2017 (prior to the draft rules of 18th October 2019) and was also not forming a part of the list of notified medical devices under the Drugs & Cosmetics Rules 1940. Accordingly, the questioner wanted to know (apart from the standard licenses) what were the basic precautions and requirements that he would have to fulfil or be aware of in order to promote the product in India.

There is a gamut of varying (and at times contradictory) licenses, permits and authorisations that govern the sale and promotion of medical devices in India. Apart from navigating this sphere, the most crucial area of concern that needs to be dealt with is the kind of consent that’s required from a patient prior to the treatment. In this regard, it would be useful to understand the laws surrounding patient consent in India.

Under Indian medical / healthcare laws, “consent” or “patient consent” is briefly covered under the Indian Penal Code (“IPC”)1 and the Indian Medical Council (Professional Conduct, Etiquette And Ethics) Regulations, 2002. “Consent” has also been analyzed by Indian courts on a couple of occasions.

However, the concept of “patient consent” has not undergone the same extensive analysis as it has under US or UK laws. The US and UK courts have closely scrutinized this concept, and have created two separate legal tests on the constitution of adequate consent, namely “informed consent” under US laws and “real / true consent” under UK laws.

The differences between the US and UK approaches towards consent hinge entirely on this third limb, on what constitutes an acceptable threshold of information being provided by the doctor to the patient. While US laws emphasize a patient centric approach where the patient is provided with all of the information necessary in order to arrive at an “informed opinion” on the matter, the UK approach is a physician centric one, where the Doctor/physician is expected to evaluate and provide the relevant or pertinent information for this aspect. In other words, to put it in a rudimentary way, in the UK context, the doctor acts as a filter of sorts in presenting a course of action, based on his/her expert opinion of the matter, while the US approach requires the doctor to present the full gamut of options to the patient.

Apart from the MCI Regulations and the IPC, “patient consent” under Indian laws has been analyzed with close reference to Indian contract and tort laws.

Regulation 7.16 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, sets out the requirements for obtaining consent where there is a need to carry out an operation or surgery on a patient. These regulations however do not cover the consent requirements for other kinds of medical treatments or procedures.

Similarly, drug and pharmaceutical laws also contain consent requirements for obtaining consent in order to test a new drug or formulation in case of a clinical trial. It may be noted here that the consent in this context leans towards ‘informed consent’ from the participants of a clinical trial. The application of these rules is, again, limited to clinical trials.

Thus far, except in the context of clinical trials, Indian courts appear to show a leaning towards the UK principle of “real / true consent”, as opposed to the US notion of “informed consent”.

Looking at the scenario in totality, one needs to ask questions on what kind of a consent should be taken from a patient when administering treatment under a possibly novel medical device.

Should the consent be real or informed? Arguments for seeking ‘real consent’ could hinge on the following:

If the treatment is not a well established or not a ‘routine’ treatment then the physician’s expertise and capability in understanding the gravity of the patient’s circumstances would be crucial in assessing the treatment.

Also, in a country like India where education levels vary dramatically and access to information on medical treatments, is at best, asymmetrical for the population at large, then the emphasis should lie on the physician’s skill in determining what is best for the patient, as opposed to leaving it to the patient’s ability to comprehend his/her circumstances.

The implication of this approach is that the doctor or physician invariably assumes greater responsibility in determining the course of action as well as in providing the guiding perspective.

On the other hand, to argue in favour of informed consent, a novel or potentially new treatment (through the said medical device) is one that would require the patient to understand the potential ‘uncertainty’ or ‘novel’ nature of the treatment; it would also require the patient to understand the fact that unlike an established treatment/procedure, there are not enough reference points to ascertain the long-term implications of such treatment or the usage of such device.

Now how does this apply in the context of sales and promotion of medical devices that are not directly regulated under the Medical Device Rules 2017 (or under the draft amendment published on October 18, 2019)?

Firstly, the usage of such a medical device clearly requires the patient consent, that is taken through the doctor or hospital in question.

It specifically requires an assessment of the nature of the treatment that is being provided and possibly explaining all of the known consequences of such treatment, while at the same time explaining the possible uncertainties involved in the usage of such a device. This leans more in the nature of informed consent, the US doctrine, versus the UK doctrine of real consent.

Apart from looking at consent in the context of such medical devices, the other issue for consideration is the possible risk of tort-based claims being made in such a scenario. Tort, being a civil wrong, would well cover the fallout of any negligent manufacturing, usage or administration of a device, both in the hands of the manufacturer, importer or physician. Appreciating the nature of this broad risk becomes essential in such a context.

While the challenges that arise in this case are difficult to fully predict, the consent taken from the patient as well as the potential tortious liability (and possibly even adverse regulatory or public response) in the face of any unforeseen outcome, remain the existential challenges in promoting medical devices that fall outside the current purview of the regulations.