The covid-19 pandemic has seen changes in practices across the world, ranging from frequent hand washing to revisions of long standing standard contractual clauses. A notable change was in the government budget earlier this year, which, probably for the first time allocated substantial sums to healthcare. The week leading up to the budget saw various proposals suggested for reform in the healthcare sector, which the government viewed favourably.
The number of developments in the healthcare sector suggests that legal practices may benefit from exploring sub-topics under the broad umbrella of health law. Rather than moving away from a Valeant approach, in which disparate health services are brought under a single entity, which then administers them, this alternative approach may even enhance it and produce greater opportunities. This approach deals with different sub-practice areas, although there will be considerable overlap between them, offering scope for expansion.
The first sub-practice area is the practice of clinical negligence. Any law firm providing dispute resolution services will already have adequate experience in clinical negligence matters before the various consumer forums. The field could examine alternative dispute resolution, including no-fault compensation; the funding of claims and defences, and advising on avoiding potential claims, especially in the light of Samira Kohli v Dr Prabha Manchanda & Anr, while also considering proposals for reform.
The second sub-practice area is that of human reproduction. India has seen some developments and proposals to reform the law relating to surrogacy; to amend the Medical Termination of Pregnancy Act, 1971, and to regulate the assisted reproduction technology services sector. Private equity players have invested substantially in organizations offering services in this sector. Law firms may draft surrogacy agreements, advise fertility firms on regulation and counsel hospitals and medical professionals on the practice of abortion and its potential pitfalls. They could use regulatory sandboxes to propose reforms including the deployment of tools, such as the gene editing technology CRISPR, in the provision of healthcare services.
The next sub-practice area, and possibly the prime one from a current regulatory perspective, is the field of pharmaceutical products. In addition to undertaking the substantial work involved in the licensing regime under drugs laws, firms could focus on clinical trial consent agreements and documentation, liability under the new consumer protection regime for pharmaceuticals and medical devices, including the potential liability of online search engines for misleading search results, telemedicine and intellectual property exploitation.
The sub-practice area of mental health law could see firms assist in the regulatory aspects of the Mental Healthcare Act, 2017, advise on advance directives and counsel organizations on the important aspects of consent. They may also suggest proposals for reform, including the implementation of the proposed National Mental Health Programme.
Moving to the sub-practice field of death and related matters, firms could undertake work on living wills and passive euthanasia, in the light of Common Cause (A Registered Society) v Union Of India and Aruna Ramchandra Shanbaug v Union Of India & Ors, organ transplantation, involving both living and deceased donors and advising on succession and inheritance. They could propose reforms such as the printing of 3-D organs within the confines of regulatory sandboxes.
The largest sector is healthcare delivery and public health. Work involves advising hospital systems in relation to all the above-mentioned sub-practice areas, health and safety, data protection and cybersecurity. Firms may engage with public and private health institutions; advise on the establishment of hospitals and how to obtain and comply with general and specific licences, and deal with health insurance contracts and policies. They may work in public health with community health centres, on a pro bono basis.
With the prioritization of healthcare, the New England Journal of Medicine and the Medical Law Review may be as much required reading as the Wall Street Journal, in order to meet current health challenges.
Arjun Krishnamoorthy is a senior associate at J Sagar Associates
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Bengaluru 560 001, India
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