Concept Note – XIV NLSIR-Samvad Partners Symposium: Strategising A Healthcare Framework for India: Headways, Dilemmas, and the Way Forward

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This is the Concept Note for the XIV NLSIR-Samvad Partners Symposium, to be held on May 9, 2021.

India’s public healthcare framework and the laws governing the same have often received minimal attention within legal and policy circles. Healthcare in India, being a state subject, is highly decentralized and disorganized. Efforts to establish a comprehensive and integrated framework to govern healthcare had always come to a naught. Thus, when COVID-19 struck India, the country had to fall back on a colonial-era legislation and administrative mechanisms so as to adequately deal with the public health crisis. The COVID-19 pandemic exposed the gaping vulnerabilities in the country’s public healthcare system. States struggled to ramp up their healthcare facilities, hospitals were quick to run out of beds, the costs of medical facilities and drugs rose steeply, and many individuals belonging to socio- economically vulnerable communities were unable to access healthcare facilities. Apart from these larger structural problems, a few specific issues stood out. This included India’s drug regulator giving emergency approval for COVAXIN – the homegrown COVID-19 vaccine, even before it had completed its Phase III clinical trials. The COVID-19 vaccine trials in the country came under a cloud due to alleged irregularities in the manner in which they were conducted. Additionally, pseudo-scientific and traditional medicines were frequently promoted by the highest echelons of the administration, as a cure for COVID-19, without any scientific evidence to back up the claim. Apart from these issues which are limited to India in their scope, the question of Intellectual Property Rights (‘IPR’) waiver for COVID-19 vaccines is something that the entire world has had to grapple with. This issue, in its turn, is closely linked to issues concerning the distribution, accessibility, and costs of vaccines and drugs which the pandemic brought to the fore.

These burning issues of the day, which also have grave implications for the future, are the focus of the XIV NLSIR-Samvad: Partners Symposium. Through this Symposium, we hope to address some of the pressing concerns relating to India’s public healthcare system and hope to reconceptualize the country’s healthcare framework in a holistic manner.

The Symposium is divided into three Sessions. Session I is titled ‘Assessing India’s Clinical Trial Rules: Developments and Some Festering Concerns for the Healthcare System’. In this Session, we seek to critically analyse India’s clinical trial regime and hope to address the gaps in the system with regards to its regulation of scientific and traditional medicines. Session II titled ‘The Ecosystem of Healthcare: Patent and Trade’ delves into India’s patent regime and the issues that it throws up in the context of the COVID-19 pandemic. It also seeks to discuss the changes that may be required in the international IPR framework in light of concerns regarding the accessibility of COVID-19 vaccines. Lastly, Session III is titled ‘The Law and Model Framework to Provide Universal Right to Health and Healthcare Infrastructure’. In this Session, we assess India’s current public health system, its drawbacks, consequences, and the way forward for the system.

Session I – Assessing India’s Clinical Trial Rules: Developments and Some Festering Concerns for the Healthcare System 

One of the most fundamental aspects of any healthcare system is the existence of a robust clinical trial procedure. The legal regime governing clinical research in India has had a chequered developmental history. With India’s IPR regime becoming consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS’) in 2005, India became one of the most promising global hubs for conducting clinical research. This was on account of the availability of a large number of trained and English-speaking medical professionals, the sheer size and diversity of the population that allowed for large-scale clinical trials, and the illiteracy of the subjects that allowed pharmaceutical companies to dodge liability. This was further facilitated by a weak regulatory regime which prevailed despite frequent reports of unethical clinical trials that jeopardized the safety of Indian citizens.

As a result, in 2013, the Supreme Court halted the approvals of new clinical trials in India unless the existing regime was updated. This prompted the government regulator (the Central Drugs Standard Control Organisation) to revise the clinical trial regulations in order to secure the health and safety of the participants in these trials. However, these new regulations led to confusion and uncertainty among the sponsors of clinical trials in India. Despite introducing several changes over the years to overcome these challenges, the number of clinical trials approved by the Indian regulator did not reach the pre-2013 levels.

To overcome this challenge of reduced clinical research in India, the regulator revisited the clinical trial rules, and introduced the New Drugs and Clinical Trials Rules, 2019 (‘the 2019 Rules’). As soon as these rules came into force, they found their first large-scale application in the COVID-19 vaccine development research in India. This Session seeks to explore the issues that prevail in the 2019 Rules. This Session will consider the experience of their implementation in the past year and will determine whether the rules achieve the twin goals of increasing clinical research in India while ensuring the safety of its participants.

Such a discussion must necessarily focus on various aspects, including, the role of ethics committees: their functions and responsibilities, amongst others; the compensation mechanism provided in the new rules (or the lack thereof) to address adverse events arising out of clinical trials; the right of a hearing with regards to compensation, including the legal remedies available to claim a right to the compensation; the (in)efficiencies of availing

compensation under writ jurisdiction as against having a robust private law infrastructure for the same. Apart from these issues, the 2019 Rules present several sui generis concerns as well. One such example is that of the thresholds prescribed for extending accelerated approvals to drugs or vaccines on the standard of proportionality. This includes an evaluation of the Indian accelerated approval regime under Schedule II of the 2019 Rules for approval of a drug during Phase II trial. The 2019 Rules lack provisions for the more popular ‘emergency use authorization’ process, as is present in other jurisdictions globally. Even so, the government’s fast-track approval of multiple Covid-19 vaccines deserves critical scrutiny in the absence of an emergency usage regime in India. As the 2019 Rules majorly rely on its parent legislation – the Drugs & Cosmetics Act – it is imperative to evaluate the efficacy of administrative processes under the outmoded Act for conducting modern day clinical trials.

Apart from a discussion of the approval procedures for scientific drugs and vaccines, it is equally important to discuss the rigours attached (or the lack thereof) to clinical research for traditional medicines. The use of traditional medicines as an alternative to scientifically approved medicines has been encouraged by successive Central Governments, particularly in the last few years. The onset of COVID-19 saw several Ayurvedic and homeopathic medicines being touted as a cure to the disease. Significantly, even the Central Government had, at the outset of the pandemic, prescribed a homeopathic medicine to prevent the spread of the virus. The Central Council for Research in Homeopathy (‘CCRH’) has recently claimed that three homeopathic vaccines against COVID-19 are being tested and are at the Phase III stage.

Traditional medicines have been used since time immemorial for the treatment of several health ailments. However, there are serious concerns regarding the safety and efficacy of traditional medicines that are available presently. Concerns around the safety of traditional medicines include their excessive lead content, use of steroids, or the toxic integrative use of modern and traditional medicines in many Ayurvedic products available in the market.

Arguably, the regulation of traditional medicines has lagged behind when compared to the increased interest in their use. The current legal regime for traditional medicines provides for basic requirements such as a licensing process, but misses out on many necessary requirements such as the need for mandatory clinical trials. Consequently, the regulation of traditional medicines suffers from multiple lacunae on a whole range of issues such as, the protection of human research participants, compensation in case of injury or death during clinical trials, need for informed consent, verification of therapeutic or efficacy claims, amongst others.

Devising the necessary and appropriate regulation for traditional medicines is a complex issue, with different considerations that need to be weighed. One such consideration pertains to the extent of reliance on scientific processes such as clinical trials while addressing the particularities of traditional medicines. Another important consideration is whether greater regulation ought to be the way forward, since the implementation of the existing provisions remains highly doubtful.

Thus, as demonstrated above, a clinical trial regime has wide-ranging implications for all the stakeholders within a healthcare system. Therefore, it becomes extremely vital to determine the drawbacks and emerging areas of concerns within a clinical trial regime. This Session aims to achieve the same, by engaging in a discussion on India’s clinical trial system and its particular complications with regards to scientific and traditional medicines respectively.

Session II – The Ecosystem of Healthcare: Patent and Trade

Session I deals with a formative aspect of the healthcare system- the manner and process of approving drugs. Session II entails a discussion on the ecosystem of patents and trading which enables the research and development inherent in clinical trials. In this Session, we hope to discuss three themes – first, the concept of evergreening; second, ensuring accessibility of vaccines through national IPR tools such as compulsory licensing; and third, ensuring accessibility of vaccines through international IPR regimes.

India has a complex patenting legal system that is well-integrated into the global patent regime. It is a simple rule of any technological or medical progress that, with research come costs. A patent incentivizes progress, even in the face of daunting costs associated with the research. This is done by protecting the exclusivity of that product to enable its maker to manufacture and market the product at the latter’s convenience. However, for patent laws to apply, a product must meet certain threshold criteria. One of the most controversial but important criterion for healthcare products is that they must be non-obvious (or involve an inventive step). A product is considered to be non-obvious or comprising an inventive step if it involves a technical advance compared to the existing state of knowledge. In the pharmaceutical industry in particular, the issue of evergreening of patents has posed a challenge to these requirements. Evergreening refers to the process of making minute modifications (called trivial incremental innovations) to an existing product to renew its patent, to prolong one’s exclusivity over it.

Evergreening in India has resulted in strong censure from the courts – with the Supreme Court adopting more rigorous interpretations of ‘inventiveness’ so as to discourage the practice. But this process is not universally discredited. Countries like the United States of America have condemned the Indian approach, which they believe discourages research and development as companies are not able to recover the costs they undertook to make the original product. While there are sufficient case studies in the healthcare sector through which to debate these ideas, a prospective avenue of study is offered by the COVID-19 pandemic. In the last one year itself, at least three mutations of the coronavirus have been discovered, thereby halting business operations and international trade all over again. The vaccines – originally developed for COVID-19 – are likely to undergo further research and development to make them viable against such variants, thereby posing, in its wake, new questions for the patent system and the practice of evergreening.

Apart from issues pertaining to evergreening and its implications for vaccine development in India, another concern associated with the healthcare system is the issue of prices and the availability of essential drugs, vaccines, and medicines. Once again, the pandemic offers a fantastic lens through which we may study and critique our existing legal infrastructure. The prices and availability of various vaccines and drugs are often prohibitive, but such costs are protected by the patent. However, there are multiple in-built mechanisms within the Patents Act that the government can employ for the good of the public – ranging from a voluntary license, parallel imports, acquisition of patent by the government, and the ever-controversial option of compulsory licensing. The value of each of these mechanisms, the economic and political constraints that restrict their use, and the extent to which they enable constitutional aspirations of the right to health (or universal vaccination) are issues worth considering.

However, rethinking national IPR laws in and of themselves are not sufficient to ensure the global availability of vaccines. As we have already noticed with the Covid-19 pandemic, the distribution of vaccines among nations is highly skewed towards developed nations. This is because these nations have the ability to hoard vaccines and often also control the patents to the vaccines. In light of this, there have been calls from several countries, including India, to amend the TRIPS framework, to allow for a lenient regime with regards to essential medicines and vaccines. In this context, the changes that are required in the international IPR framework to facilitate global access to vaccines and the manner in which such changes interact with changes in domestic frameworks, are worth a discussion.

This Session considers two competing interests- incentives for research and development on the one hand, and affordability and accessibility of vital drugs, on the other hand. The constant tussle between these two interests has taken on gargantuan proportions in the midst of the COVID- 19 pandemic. It is in this context that Session II considers India’s patent regime and the need to rethink our national and international IPR frameworks.

Session III – The Law and Model Framework to Provide Universal Right to Health and Healthcare Infrastructure  

Session I and Session II delve into specific aspects of India’s healthcare framework- the clinical trial and patent regime in the country. However, Session III seeks to holistically engage with the broader healthcare system in the country and looks at suitable trajectories that the country could possibly adopt. The COVID-19 pandemic has shed light on the dilapidated healthcare infrastructure in India. This Session seeks to engage with the country’s existing healthcare infrastructure, to examine the suitability of suggestions of institutional and legislative reform, and finally, seeks to critically analyse the role of the judiciary in enforcing universal healthcare in India.

The Session first seeks to engage with the existing health infrastructure in India. The relevant legislative framework in India is the Epidemic Diseases Act of 1897. However, the Act fails to be an adequate preventive or curative instrument for a public health crisis, characterized by a lack of definitions and disproportionate criminal sanctions. Moreover, the discontent with the legal framework for public health in India pertains to its fundamental failure to integrate statutory and administrative authorities, which could facilitate a concerted response to health catastrophes. Administrative integration of healthcare services was also recommended, as far back as in 1946, by the Bhore Committee, which focused on health services and development. As a result of the failure to integrate statutory and administrative authorities, the criminal justice enforcement system and the disaster management machinery are often invoked to implement containment provisions. Similarly, various urban and rural functionaries, such as under the National Health Mission and the Accredited Social Health Activist (‘ASHA’) workforce, remain institutionally sequestered from the overarching legal framework of public health. The lack of state-funded and concentrated health facilities has compelled citizens to privately fund healthcare services. This disproportionately affects the socio-economically vulnerable citizenry. The Session seeks to acknowledge and address this legislative, institutional, and administrative fragmentation of public health in India.

The Session also seeks to fill the legislative gap with regards to public health and seeks to moot an overarching public health model for India. In the past, several bills have unsuccessfully engaged in this exercise, including the Model Public Health Act of 1955 updated in 1987, the National Health Bill 2009, and the Public Health (Prevention, Control and Management of Epidemics, Bio-terrorism, and Disasters) Bill in 2017. These bills envisaged a statutory right to health, Public Health Boards to formulate national policies, review strategies and to establish minimum standards of healthcare, and a unified and tiered health administration with monitoring agencies. The bills also defined rights and obligations of patients and caregivers. This Session seeks to build on the legislative drafts, and reimagine the underlying model and principles of healthcare in India. Scholarship on model healthcare regimes points to the importance of incorporating principles of solidarity (with respect to access and equity in healthcare services), proportionality (with respect to sanctions for non- compliance), and transparency (inter alia, in health data and technological reliance). This Session aims to deliberate on balancing the demands of health exigencies with these principles, in a model legislation on healthcare in India. Simultaneously, this Session will attempt to examine the suitability of the out-of-pocket model prevalent in India, tethered to the socio-political and economic context of the Indian state and citizenry. This discussion will entail a comparative exercise of healthcare models around the world, so as to explore the healthcare model that might be suitable for India.

A popular reform proposal on public health has been to shift the subject of ‘public health and sanitation; hospitals and dispensaries’ from the State List to the Concurrent List in Schedule VII of the Constitution. This was most recently reiterated by a High-Level Group of the 15th Finance Commission in 2019. However, recent experiences with fiscal federalism in the Goods and Services Tax (‘GST’) regime, as well as constitutionally-enforced subsidiarity of state administration in healthcare, raises pressing questions. The Session hopes to address the fiscal, federal, and constitutional challenges of such a proposal.

Finally, the Session seeks to delineate the appropriate role of the judiciary in a model public health regime. Within this, it is crucial to examine the judiciary’s proactive role in declaring and enforcing the right to healthcare. By relying on an expansive interpretation of the Article 21 right to life and the Directive Principles of State Policy, courts have granted relief in challenges pertaining to the state’s disregard or denial of essential healthcare facilities. However, the efficiency and sustainability of such ad-hoc judicial administration of the right to health merits critical scrutiny. It is equally vital to examine the competency and democratic deficit of the judiciary in adjudicating on matters of healthcare, which involves polycentric and highly technical questions such as price fixation for COVID-19 tests and the insurance coverage policy under the Ayushman Bharat scheme. This Session also seeks to explore the possibility of a rights-enforcing dialogue between the executive and the judiciary, to balance competing imperatives of a healthcare emergency.

This Session seeks to engage in a comprehensive discussion on the status quo of public health in India, its varied actors and stakeholders, so as to inform the conceptualization of an eventual universal right to healthcare in India.

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