The Access To Life-Saving Drugs - A Fundamental Right
Author: LawSphereX
Category: Constitutional & Human Rights
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THE ACCESS TO LIFE-SAVING DRUGS: A FUNDAMENTAL
RIGHT Veenavarthini A, BBA LLB (Hons.), VIT Chennai K Chaitanya, BBA LLB (Hons.), VIT Chennai
Jesventhi S D, BBA LLB (Hons.), VIT Chennai
ABSTRACT
This research paper explores disparities in the healthcare sector, access to medicines and availability for human populations, assessing how pandemic situations paved the way for affordable healthcare. With a strong focus on life-saving drugs, this study pioneers a combination of empirical and nonempirical research methodology, also adhering to the constitutional mandates. For the non-empirical part of the research, narratives of literature reviews, research articles, case studies, landmark cases and government databases have been effectively scrutinised. This study included a surveybased approach, ensuring stakeholder participation in collecting empirical data. The stakeholder inclusive approach involved people from urban and rural populations, varying age groups, and ed.
Throughout the research paper, various issues are met, such as the availability of healthcare access, treatment facilities, and areas of improvement among racial, ethnic, and socioeconomic groups. The idea is to provide recommendations to policymakers and government institutions in improving healthcare. The paper opposes the notion that fluctuations in physical and mental health among high-risk groups are solely the result of individual life choices. Rather, it draws attention to how stigma, discrimination, one-sided legislation, inadequate laws and government policies negatively affect the mental health of people doomed in such situations. This point of view underlines the importance of recognising ways to overcome hurdles in ensuring equity in healthcare.
The requirement for community involvement and a commitment to addressing issues in hand, calls for combined efforts of all stakeholders, policymakers and the government. Thus, the urgent need to address the accessibility of life-saving drugs to the public must ensure that no individual is left behind. Keywords: healthcare disparities, pandemic, life-saving drugs, access to healthcare, survey methodology, legal framework, constitution, disparities, equity.
INTRODUCTION
For millions around the globe, the ‘Right to Health’ is still unattainable and far from what could be done in reality, especially in developing countries like India. This ultimately questions the kind of life that a citizen of a sovereign state is pushed into and his entitlement to human dignity. Access to life-saving medications should be regarded as a branch of the right to health under part III fundamental rights enshrined in our Constitution. We live in a world influenced by rapid advances in medical science and technology, nevertheless, the risk of contagious diseases is also high. The health and well-being of populations depend on the ability to obtain life-saving medications. It is a matter of fact that the texture, compositions and variations in the kind of medicines we consume today, are a lot different to what it was earlier.
Life expectancy has increased, cancer-curing drugs have made their way into marketplaces, and the spread of contagious diseases has been stopped with a lot of experimentation. However, the COVID-19 pandemic caused national emergencies all over the globe, indicating how well-equipped healthcare measures should have been to handle pandemics. Major challenges include mitigating climate changes and, the surge in diseases related to lifestyle changes, unprecedented migrations, lack of protection for refugees and rise in evergreening of lifesaving drugs. Women are prone to deaths caused due to pregnancy, miscarriage and childbirth. To put an end to countless deaths caused from failure to access life-saving drugs calls for a collaborated effort from the side of the government, non-governmental organisations and the public.
THE LEGAL AND HISTORICAL BASIS OF THE FUNDAMENTAL RIGHT TO HEALTH The Constitution has made several amendments to improve public health providing individuals with healthcare. The 15th Finance Commission in September 2019 strongly emphasised the need to recognize right to health as fundamental right. Further recommendations included shifting Right to Health into the ambit of Concurrent List. 1 This enactment has a huge possibility of improving an individual’s access to life saving drugs. It also ensures that the state government are empowered by the Constitution of India, to enact, enforce and make regulations to public health rules. If states are deprived of their right to enact legislations in the healthcare 1 Paul Nightingale & Marion J. Rigby, The Morality of Patenting Life-Saving Drugs, LSE Impact Blog (Aug. 6, 2014), https://blogs. lse. ac.
uk/impactofsocialsciences/2014/08/06/the-morality-of-patenting-life-saving-drugs/. sector. 2 The Central Governments approach may fail to include the defects in smaller territories thus neglecting their needs. It was remarkable to see how control over healthcare legislations while delegated to states, gave a surprisingly huge outcome in the state of Kerala during COVID-19.
RIGHT TO HEALTH AND ACCESS TO LIFE-SAVING DRUGS – A NEXUS
1. The Interplay between Health and access to essential medicines.
Which drugs can be considered as essential medicines? The World Health Organization (WHO) defines essential medicines as those that "satisfy the priority healthcare needs of the population," and they are chosen based on their estimated current and future public health relevance, and comparative cost-effectiveness. Every two years, WHO’s model list of essential medicines is updated and modified according to the country or regional health requirements and publishes these medications that adhere to the guidelines of national essential medicines list (EML). The right to access life-saving drugs can be described as the entitlement of every person to timely, affordable, and equitable access to medications that have been scientifically shown to prevent, mitigate, or treat life-threatening illnesses.
3 This includes not just the provision of drugs but also the infrastructure needed for their delivery, accessibility, and education. Since poor countries have the highest need and the minimal access to medications, there is still an inherent connection between poverty and the fulfilment of the right to health. Access to medicines is irretrievably related to the values of equality and non-discrimination, transparency, participation, and responsibility from a human rights perspective. The development of national health laws and policies, as well as the improvement of national health systems, are required for all states.
2. Life-Saving Drugs and Their Significance in Healthcare Industry
In underdeveloped nations, 40 million deaths have been recorded in just one year, with onethird occurring in children under the age of five. Despite this, the majority of the main causes
2 Prince Mathews Thomas, India’s Drug Price Fix Is Hurting Healthcare, Mint (Oct. 31, 2019),
https://www.livemint.com/politics/policy/india-s-drug-price-fix-is-hurting-healthcare-11572334594083.html.
3 Aastha Gupta, Analysis of Novartis AG v. Union of India, Legal Serv. India,
https://www. legalserviceindia. com/legal/article-7600-analysis-of-novartis-ag-v-s-union-of-india. html. of death and disability can be avoided or treated using affordable, necessary medications. Acute respiratory infections, diarrheal diseases, tuberculosis, and malaria each cause ten million deaths; for each of these illnesses, safe, affordable, and necessary medications can save lives. In most affluent nations, spending on medicines amounts to less than a fifth of all public and private health expenditures, but in developing nations, it can reach as high as 66%. The accessibility of affordable medications has great significance in India due to the elevated cost of healthcare and the enormous portion of the population living below the poverty criterion.
After human costs and household health spending, medicines represent the majority of lowincome countries' highest public health expenditure. 4 Despite this significant expenditure on drugs, there are still significant global public health issues related to poor drug quality, irrational drug use, and lack of access to necessary medications. One of the most cost-effective components of contemporary healthcare, essential medications have a tremendous capacity to improve health. The delicate interplay between scientific advancement, ethical discussion, and the need to preserve and increase human welfare is made apparent by the existence and accessibility of life-saving drugs that have the potential to save lives.
The availability of the right pharmaceuticals can drastically change a person's health trajectory, from acute infections to chronic illnesses like diabetes, cancer, and cardiovascular disorders. In addition to preventing mortality, life-saving medications improve the general quality of life for those who use them, enabling them to lead productive, happy lives. Every person has a right to the "highest attainable standard of health," according to the World Health Organization (WHO) Constitution. 5 However, in reality, what is possible under the current legal system is still unclear because only a small number of countries and powerful pharmaceutical companies have access to drugs, vaccines, and medical technologies.
The equitable provision of life-saving drugs is intricately linked to health justice, as it empowers individuals across diverse socio-economic strata to avail themselves of the benefits of medical progress. By facilitating access to these drugs, societies can reduce the burden of disease, alleviate suffering, and foster a more robust legal framework. 4 Gautam Bhatia, Delhi High Court Rules on Article 21 and Access to Medicine, Indian Const. L. & Phil. (Apr. 17, 2014), https://indconlawphil. wordpress. com/2014/04/17/delhi-high-court-rules-on-article-21-and-access-tomedicine/.
5 Sarah McKune, A Legal Framework for Global Health Equity, 21 B.U. Int’l L.J. 325 (2003),
https://www.bu.edu/law/journals-archive/international/volume21n2/325-372.pdf.pdf.
3. Challenges
related to access to medicines encompass several key aspects: Neglected Diseases: Pharmaceutical corporations pay little attention to diseases with small patient populations, which are frequently found in poor nations because they are not profitable. These illnesses are referred to as "Neglected Diseases," and they include illnesses like leishmaniasis, onchocerciasis, and leprosy. The development of effective medicines for these diseases is hampered by the lack of funding for research and development (R&D). Marketing and Outsourcing: To reduce costs, many pharmaceutical companies outsource their manufacturing, which could result in variances in the quality of the drugs. Additionally, some businesses spend more on marketing and advertising than on research and development, taking funds away from essential research projects.
Quality of Medicines: The state is in charge of ensuring the efficacy and quality of medications. The safety and effectiveness of drugs that are accessible in both the public and commercial sectors, however, are questioned due to insufficient regulation. Price Control in India: With over 67% of health-related spending going towards buying medications, India has among the highest Out-of-Pocket costs for healthcare. Families and individuals are put under financial strain as a result. The Drug Pricing Control Order (DPCO) is the legal framework in place in India for regulating drug prices. The National List of Important Medicines (NLEM) is a list of important and life-saving medications that are monitored and subject to price restriction by the National Pharmaceutical Pricing Authority (NPPA).
6 However, some pharmaceutical firms take advantage of gaps by adding unrecognised chemical substances to medicines, raising the cost of those medications. State Responsibility: The right to health, which includes access to necessary medications, is established by the International Covenant on Economic, Social, and Cultural Rights (ICESCR). The availability, accessibility, acceptability, and high quality of healthcare facilities, products, and services, including medications, must be ensured by the state. R&D and CPSEs: States are required to support R&D for medical requirements. However, India's low R&D spending (0. 6-0. 7% of GDP) limits its capacity to create innovative, potent 6 World Health Organization, Health Is a Fundamental Human Right (Dec. 2017), https://www. who.
int/newsroom/commentaries/detail/health-is-a-fundamental-humanright#:~:text=The%20right%20to%20health%20for,the%20health%20services%20they%20need. pharmaceuticals. Additionally, Central Public Sector Enterprises (CPSEs) perform inconsistently in the pharmaceutical industry, with some of them experiencing financial difficulties. In order to overcome these obstacles, a comprehensive strategy that includes strong R&D initiatives, 7efficient medical regulation, equitable pricing mechanisms, and a persistent state commitment to ensuring everyone has access to health care is needed. CONSTITUTIONAL APPROACHES TO RECOGNIZING THE RIGHT TO ACCESS LIFE-SAVING DRUGS Analyzing Constitutional Provisions Relevant to Healthcare Rights The preamble of the Constitution reflects the goals set out for the welfare of the country and its citizens to achieve the goals.
It confers certain rights upon the people, imposes duties upon the citizens and issues certain directives to the state. The right to health is recognized as a fundamental right in India under Article 21 of the Constitution. The scope of fundamental rights guaranteed by India's Constitution has been expanded based on international human rights instruments. 8 In the Indian Constitution, the provisions relevant to healthcare rights primarily revolve around the right to life, the directive principles of state policy, and specific articles related to health and healthcare. From the perception of the right to health, the following constitutional provisions carry importance.
Right to Life (Article 21): Article 21 of the Constitution guarantees the fundamental right to life, and it has been interpreted by the judiciary to include the right to a dignified life, which encompasses access to healthcare services. This interpretation forms the basis for recognizing healthcare as an integral component of an individual's right to life. Within the constitutional framework, there is a link between the right to life and access to life-saving drugs. Ensuring free access to life 7 ‘Access to Medicines and the Right to Health’ (OHCHR) accessed 20 August 2023 8 Grover, A. , & Citro, B. (2011). India: access to affordable drugs and the right to health. Lancet (London, England), 377(9770), 976–977. https://doi. org/10.
1016/S0140-6736(10)62042-9 saving drugs is becoming an integral part to uphold fundamental right to life, as it directly impacts the human survival and a life devoid of preventable suffering. Directive Principles of State Policy (Article 47): Article 47 directs the state to improve public health and raise the level of nutrition and the standard of living. It emphasizes the importance of working towards the prohibition of the consumption of intoxicating drinks and drugs that are injurious to health. While the directive principles are not legally enforceable, they provide a guiding framework for legislation and policy-making. Right to Education (Article 21A): While not directly related to healthcare, the right to education is essential for creating awareness about health and hygiene, thus indirectly impacting the overall health of the population.
Specific Provisions (Article 39, Article 42, Article 43): These articles underscore the state's responsibility in securing the health and well-being of its citizens. Article 39 directs the state to ensure that the operation of the economic system does not result in the concentration of wealth and means of production to the detriment of the common good, and to ensure equal access to material resources for the well-being of all. Article 42 emphasizes provisions for just and humane conditions of work and maternity relief. Ensuring access to necessary medical treatments, including life-saving drugs, is essential for promoting humane working conditions and maternal health. Article 43 highlights the state's responsibility to secure a living wage and conditions of work ensuring a decent standard of life.
Directive Principle of State Policy (Article 39(e) and (f)): Article 39 emphasizes the state's duty to secure that the health and strength of workers, men, women, and children are not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength. Ensuring access to necessary medications, including life-saving drugs, contributes to achieving this directive. The Indian judiciary has played a significant role in interpreting and expanding the scope of healthcare rights by linking them to fundamental rights like the right to life. Over time, court rulings have reinforced the state's responsibility to ensure access to affordable and quality healthcare services for all citizens.
LANDMARK CASES THAT SHAPED THE ACCESSIBILITY OF LIFE-SAVING DRUGS Several landmark legal cases have significantly shaped the right to access life-saving drugs in India, reinforcing the importance of healthcare as a fundamental right. Mohd Ahmed v. Union of India case The constitutional right of an infant with Gaucher disease to expensive medical treatment is the main question before the court, and it is closely examined in this section. The government's argument regarding the distribution of healthcare resources and the petitioner's contention that denial of treatment violates his right to health laid the groundwork for a complex legal examination.
The study examines the court's consideration of the question of whether a lack of resources can justify deferring medical care and if the level of deference should change depending on variables like the severity of the sickness and the availability of treatments. The court's reasoning, which skillfully incorporated international human rights concepts into its analysis, is closely examined in the study. A thorough framework for assessing the right to health is established by the court's explicit citation of Article 21 as well as the International Covenant on Economic, Social, and Cultural Rights (ICESCR) and General Comment. The necessity of fair healthcare access is underlined by the court's declaration that everyone has a basic right to humane and easily accessible healthcare.
This emphasises the court's view that a person's inability to pay for medical care cannot be used as an excuse for failing to fulfil a fundamental commitment. The Mohd Ahmed v. Union of India case establishes a new precedent for constitutional rights and healthcare access law. The focus placed in the judgement on the right to health and access to necessary medications, particularly for uncommon diseases, helps to the dialogue on the right to health under Article 21 as it develops. The case's ramifications for the constitutionalization of intellectual property law also offer the potential to rebalance the relationship between IP rights and more general societal needs. One notable case is the "Vishaka v. State of Rajasthan" (1997), which laid the foundation for recognizing the right to a safe and healthy environment, including healthcare.
Another pivotal case is "Consumer Education and Research Centre v. Union of India" (1995), where the Supreme Court emphasized citizens' right to essential drugs at affordable prices. In Hoffmann-La Roche Ltd. v. Cipla Ltd. , an injunction case was filed by Roche against Cipla with regard to the production of patented drugs of the former by the latter. The Delhi High Court refused such an injunction and said that the court could not be careless with regard to the right of the general public to have access to life-saving drugs. If an injunction were granted, then the access to such life-saving drugs would be denied and would affect stifling Article 21 of the Indian Constitution, which specifically provides for the Right to life, which forms the bedrock of the Right to health. Additionally, the "Novartis AG v.
Union of India" (2013) case set a significant precedent by upholding the Indian patent law's provisions for promoting access to generic medicines. These cases collectively underline the judiciary's role in safeguarding the right to access life-saving drugs and shaping policies that prioritize citizens' health and well-being. LIFE-SAVING DRUGS & CONTEMPORARY ISSUES Ø COVID-19 perspective “The COVID-19 pandemic - A call for action to advance equitable access to Medicines” Statistically, before the pandemic 2 billion people lacked access to necessary medications. Access to life-saving drugs was a longstanding sustainable development goal of the UN, Universal Health Coverage. After many COVID-19 cases were recorded in Wuhan, a city in China, many parts of the world succumbed to such infectious transmissions.
It was remarkable how Kerala tackled the pandemic and set a benchmark for other states to follow. Despite having a low-lying healthcare structure, the district of Kasargod managed to pull off a hundred per cent recovery rate for the public in Kerala. Their steady investments in healthcare and education, despite being economically unstable. High literacy rates among men and women and, a combination of private and public sector engagement ensured progress in the state. Statistics show that a major portion of nurses graduated from various colleges in Kerala, and worked in the US and UK, showing that the state’s healthcare system is at par with developed nations. The majority of the cases that were reported were from people who returned from overseas. Kerala has already encountered the deadly Nipah virus, transmitted from fruit bats feeding on fruit-bearing trees.
The state individually holds protocols for infections spread by viruses. Stringent guidelines were in place for isolating patients, quarantining and collecting samples for detecting COVID-19. In the Kerala – Tamil Nadu border, vehicles were permitted within Kerala only after a thorough symptom analysis. Even individuals who don’t show any symptoms were asked to be in home quarantine. All persons in contact with a contaminated person were sent to quarantine. In this control process, laboratory tests for discovering vaccines, and dissemination of intellectual information through press briefings and live statistics were given importance. During the pandemic, fruitful discussions were required to address issues ranging from who will have access to the COVID-19 vaccine upon its development, cost, methods of distribution and safeguards against fake vaccines being circulated in the market.
It is to be structured and properly analysed by the Indian Government if the country could survive another wave of the pandemic in future. There are fair chance that the transmission of infectious diseases might put a lot of pressure on the Government and academic laboratories resulting in the release of unfinished products into the market. Vaccination was considered to be the only way to prevent the transmission of infectious diseases. Prioritizing immunizations for vulnerable populations is definitely in place for the right reasons, but there is a possibility of concern that people outside of the targeted age groups may not be in a position to execute their fundamental rights—most notably, the right to receive life-saving medications—violated.
This raises a question as to whether the fundamental rights of other age groups would be violated while propagating vaccines for the aged and infant population. Occupational hazards or underlying medical conditions that the teen and adult population suffer, cause a prejudice to their existing health conditions. Ensuring that everyone has equal access to medical treatment without discrimination based on age, gender, or any other characteristic is crucial, as the right to receive medication is a fundamental component of healthcare systems in democratic nations. This method of distributing vaccines could hinder the major purpose of enforcing fundamental rights. Fairness and justice are two ethical concepts that are essential to consider while assessing public health strategies.
Keeping age as the only criterion for providing vaccines will cause age-related bias, thereby the public eventually loses their faith in the judiciary. A more thorough strategy could be articulated by giving equal weightage to exposure risks, underlying medical conditions, how prone they are to transmission of the virus and occupation in addition to age. This strategy would guarantee that individuals who are more likely to experience serious consequences get fair access to vaccinations, which would be more in line with ethical standards. Ø Other drugs: People living with HIV/AIDS: For diseases such as HIV-AIDs, the standard treatment that is used is Antiretroviral (ARV) therapy which involves a combination of at least three antiretroviral drugs that effectively suppress the HIV virus and prevent the development of the disease.
This ARV therapy serves as both a life-saving treatment and a preventive measure against HIV/AIDS. In 2011, in lowand middle-income countries only 54% of individuals were eligible to receive the ARV treatment. Children: Annually, over 8 million children under the age of five are affected by illnesses such as diarrhoea, tuberculosis, malaria, HIV/AIDS and pneumonia. Due to the slow progress in the prevention, treatment and diagnosis of HIV, young people and children are among the worst affected by the HIV epidemic. Particularly children’s in large part due to mother-to-children transmission. And their young age renders them severely malnourished, leading to death. Although there are effective treatments to cure such illness, pediatric versions of these lifesaving drugs are not available.
Children require dosages that would be suitable for their respective age, physical condition and their body weight. Children suffer from indigestion of adult-sized medicines. Oral solutions and syrups as much more tolerable but these medications are not available for all or they are too expensive to be used in low-income settings. To address such gaps, pediatric ARV development projects shall be initiated. There were few strides made in R&D for child-friendly medicines but administrating clinical trial on children were difficult. Though the improvements have been slow, civil society organisations and governments shall begin to develop better quality and safer medicines tailored to the children’s needs. Women Women are especially vulnerable to the violation of seeking their rights in access to medicines, particularly for sexual and reproductive health care services.
For instance, in many developing countries women face a shortage of ‘prophylactic uterotonic’ a drug that would help them prevent and treat Postpartum Haemorrhage (PPH). This PPH is a blood loss that occurs within
24 hours after giving birth, which is the leading cause of maternal mortality globally. Without
access to the said drug, pregnant women might suffer from long-term disability, and severe maternal conditions that would lead to substantial blood loss, or they might die. Therefore, the provision of essential medicine for sexual and reproductive health is a core duty of the state. Moreover, women and girls who are trafficked for prostitution are specifically vulnerable for sexually transmitted diseases such as the HIV/AIDS. Many women from marginalised communities lack adequate access to such information and necessary services to ensure their sexual health. Thus, states shall ensure that women and adolescent girls receive the right to sexual health information, education and services available without any discrimination or prejudice. Detained persons In most countries, prisoners and detained persons do not relinquish their rights when they enter the jail system.
Since they are dependent on the prison system, they face the violation of their rights which includes access to medicines as well. There is a high risk of spread of HIV/AIDS inside the prison due to unprotected sex or sexual violence, coercion and rape. Apart from these, the risk of infection also occurs due to unsafe drug injections, blood exchange and usage of non-sterile needles for tattooing purposes. Even poor prison conditions such as overcrowding, malnutrition and lack of health facilities & staff are causes of the spread of HIV and other diseases. The states shall separate the infected persons from the general prison to another to prevent the spread of diseases. In addition to all this, detained persons are considered not free individuals who are allowed to go to pharmacies or hospitals and get treated.
They are dependent on the prison system and they shall fund the required medicines. Both of these aspects clearly obstruct prisoners from their right to access medicines. And due to the high cost of such drugs, the prison management system usually ignores them. Older persons Elderly individuals often are vulnerable to challenges associated with non-communicable diseases (NCDs) such as Cancer, Heart disease, Diabetes, etc. The medication for these NCDs often involves a prolonged and costly treatment which may be unavailable or financially burdensome for people. Since the primary recourse for treatment among elderly persons are government-funded medications, many individuals in this group shall bear out-of-pocket expenses to obtain that medication for the chronic conditions. These put the older persons in a difficult choice between essential medicines and their financial stability.
The situation is even more exacerbated considering the introduction of new, expensive medications with proven therapeutic benefits for treating conditions like cancer. In many developing countries, expensive pharmaceuticals are limited and these unaffordable medications leave the elderly persons with pain control as the only viable option. In order to address the illicit drug markets, the global drug control framework, comprising the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the United Nations Convention on Illicit Traffic in Narcotic and Psychotropic Drugs, has been designed. However, they lack coherence with the obligations stemming from human rights law. The narrow interpretation of the control mechanisms outlined in the international drug control treaties directly impedes states' access to controlled substances for medical purposes.
THE LEGAL LANDSCAPE, POLICIES & PROGRAMS In India the laws related to life saving drugs plays a crucial role in ensuring that people have access to drugs for their health along with affordability. Some key legislative frameworks and regulations include:
Drugs and Cosmetics Act, 1940: This law oversees the regulation, manufacturing, distribution, sale and import of drugs and cosmetics in India. It establishes standards for quality, packaging, labeling and advertising of life saving pharmaceutical drugs. • Patents Act, 1970: This act is vital in balancing the rights of patent holders with respect to public's health needs. It allows for compulsory licensing under certain circumstances to manufacture life-saving drugs when deemed necessary to address public healthcare emergencies and to ensure affordability. • Price Control Orders: It is governed by the Essential Commodities Act of 1955 . The price control orders are issued by the government to regulate the prices of medicines including life saving drugs. The National Pharmaceutical Pricing Authority (NPPA) oversees drug pricing through Drug Price Control Orders (DPCO).
9 • National List of Essential Medicines (NLEM): This list includes medicines considered essential for health. It acts as a guide for procurement, pricing and distribution to ensure that life saving drugs are accessible and affordable to all. • Clinical Trials Regulations: The New Drugs and Clinical Trials Rules, 2019 outline guidelines and rules for conducting clinical trials, promoting ethical and transparent practices while ensuring patient safety for both new and life-saving drugs. • Pharmacy Practice Regulations: The Pharmacy Practice Regulations, 2015, establish standards for pharmacists and pharmacies, guaranteeing proper dispensation and patient counseling for life-saving drugs and other medications. • Biological Diversity Act, 2002: This act addresses access and benefit-sharing concerning biological resources and traditional knowledge.
It impacts the development of bio-based life-saving drugs and treatments. • Compulsory Licensing Guidelines: It is guided by the Patents Act, the government has issued guidelines for issuing compulsory licenses in specific situations, allowing the manufacturing of patented life-saving drugs to address urgent healthcare needs and
9 Prince Mathews Thomas, India’s Drug Price Fix Is Hurting Healthcare, Mint (Oct. 31, 2019),
https://www. livemint. com/politics/policy/india-s-drug-price-fix-is-hurting-healthcare-11572334594083. html. also to balance affordability. Government Policies in Addressing Economic Barriers – improving healthcare & infrastructure & affordability In India, the government has implemented various policies to address economic barriers and enhance healthcare infrastructure and affordability, with the aim of ensuring better access to medical services for all citizens. certain key government policies are: • National Health Policy, 2017: This policy focuses on achieving universal health coverage by promoting preventive healthcare, strengthening healthcare infrastructure, and increasing access to quality medical services. It emphasizes prioritizing primary healthcare and reducing out-of-pocket expenses for patients.
• Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (PM-JAY) was Launched in 2018, this flagship scheme aims to provide health insurance coverage to over 100 million vulnerable families, offering cashless treatment for a range of medical conditions at empanelled hospitals. The scheme targets economically disadvantaged sections and provides financial protection against high medical expenses. • National Medical Commission (NMC) Act, 2019: This act replaces the erstwhile Medical Council of India (MCI) and aims to reform medical education and improve healthcare quality. It emphasizes expanding medical education infrastructure, promoting ethical practices, and ensuring affordable and accessible healthcare services.
• Janani Suraksha Yojana (JSY): This initiative provides financial assistance to pregnant women to encourage institutional deliveries and reduce maternal and infant mortality rates. It covers costs related to prenatal care, hospitalization, and postnatal care, thus addressing economic barriers in maternal healthcare. • Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): This scheme focuses on providing affordable generic medicines to citizens through dedicated Jan Aushadhi Kendras (outlets). It aims to reduce the financial burden of medical expenses by making essential medications more accessible and affordable.
• Rashtriya Swasthya Bima Yojana (RSBY): Although merged with the Ayushman Bharat scheme, RSBY was an initiative that provided health insurance to underpriveldged families which offered coverage for hospitalization expenses and thus addressing economic barriers to healthcare. • Telemedicine Guidelines: The Ministry of Health and Family Welfare released guidelines to facilitate telemedicine services, enabling remote healthcare consultations. This enhances access to medical advice and services, particularly for individuals in remote areas. • Infrastructure Development: The government has taken initiatives to strengthen healthcare infrastructure, including the establishment of new medical colleges, upgrading existing healthcare facilities, and building AIIMS (All India Institutes of Medical Sciences) in various states.
ACCESS TO MEDICATIONS AS A RIGHT UNDER INTERNATIONAL LAW Access to essential drugs, nested in the right to the highest attainable standard of health, is the top most priority in international law. The (WHO) World health organisation and the (UDHR) Universal declaration of human rights predominantly recognizes the right to heath. It is well affirmed in ICESCR that the right to health includes access to healthcare facilities and all kinds of necessary goods and services. Irrespective of progressive realization, the ICESCR also establishes fundamental obligations which must be immediately met. These unassailable core obligations of ICESCR encompass critical aspects such as ensuring access to essential medicines. There are four interrelated elements upon which the right to access medicines is contingent:
1. Available
2. Accessible
3. Acceptable
4. Good quality
Official and non-governmental initiatives and international support: The obligation to uphold the right to health compels nations for their enhancement in access to medicines through international cooperation and assistance. 10 In pursuit of these commitments, the Global Fund to Fight AIDS, Tuberculosis and Malaria emerged in 2002 as an independent, multilateral financing entity. This fund allocates resources to countries to bolster their efforts against the diseases such as HIV/AIDS, tuberculosis, and malaria, representing the largest multilateral funding program facilitating access to treatments. Another innovative initiative is UNITAID, an international financing facility for drug purchases.
Through coordinated multilateral efforts and strategic interventions are put up in the market, UNITAID incentivizes the pharmaceutical sector to better address the global health needs and necessity. Additionally, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) serves as a crucial health financing mechanism, significantly contributing to the containment of the HIV/AIDS epidemic by supporting antiretroviral treatment for nearly 9. 5 million individuals worldwide. Governance and flexibilities permitted under TRIPS: Members of the World Trade Organization (WTO) are obligated to fully utilize Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to facilitate access to medicines.
According to Article 8 of the TRIPS agreement, states have the right to "adopt measures that are necessary to protect the public health" as they formulate or amend their laws and regulations. Furthermore, states should leverage the policy space provided in Article 27 by adopting and applying stringent definitions of invention and patentability in the best interests of public health. Flexibilities need to be explicitly integrated into national policies and legislation. And most importantly, laws should be revised to promote compulsory licensing, allow parallel importation, encourage pre-grant opposition, reinforce antitrust measures against the abuse of monopoly power, and enhance patentability criteria so as to ensure patents are granted only for "genuine innovation. "11
CHALLENGES
TO REALIZING THE RIGHT: COST, PATENTS, AND PHARMACEUTICAL INDUSTRY Intellectual Property rights deeply influence access to life-saving drugs, we route to one major goal that all market players are trying to achieve – capitalism. The evergreening of Patents is
10 Drug Price Control in India, Econ. & Pol. Wkly., Dec. 10, 2022,
https://www.epw.in/journal/2022/50/commentary/drug-price-control-india.html.
11 ‘Access to Medicines and Human Rights’ (Health and Human Rights Resource Guide, 12 June 2017)
accessed 24 November to help in market dominance by extending the patent’s validity. This concept received criticism from stakeholders in almost all sectors. While incentivising innovation, it obstructs parallel developments in that field, thus restricting the benefit of better innovations from reaching the public. High Cost of Life-Saving Drugs Today, access to quality healthcare is a privilege and not a fundamental human right. Drug manufacturers exercising patents have the upper hand over other market players, creating a monopoly. Once a monopoly is created, prices are skyrocketing, thereby increasing profit. The only solution to prevent monopoly is to improve parallel research and development on patented drugs. Lack of infrastructure, manpower and skills required for innovative creations is prevalent in developing countries.
Public awareness must also go hand in hand with an extra push being provided to both public and private sectors. On the other side, high rates of taxes, poor regulatory policies, and less funding for healthcare infrastructure are all causes of concern. Most life-saving drugs are developed in laboratories and academic institutions, often the rural people are the most affected. A substantial part of their savings is spent on such medicines. In the process of creating intellectual property protection, almost all developed countries are holding poor patients as victims to changing market dynamics. The major question to be addressed is, whether a level playing field is created in terms of equity, especially for the poor countries. Nothing can be more inhumane than equating maximising of profit with the worth of a human life.
Case Study: A case study in Ethiopia revealed that operations that cost one day's income or less are considered affordable, even if it can be difficult to assess actual affordability. As a result, the current study calculated that most people could not afford about 30% of the pharmaceuticals in the public sector and 50% of those in the private sector. This indicates that a significant section of the population would struggle to pay for their prescription drugs. Even drugs like amoxicillin, paracetamol tablets, and gentamicin that were appropriate for the lowest government income may be out of reach for a substantial number of Ethiopians because 30% of the country's population lives below the international poverty line.
Considering that these expenses do not even cover consultation and diagnostic test fees, families with many children in need of medication may incur huge expenses on medicines and lost income. Low wages, poor working conditions, and excessive migration to poverty-filled areas worsen the pre-existing conditions. Only government-run establishments and nongovernmental organisations can provide medicines to those below the poverty line either free of cost or at subsidised rates. Intellectual Property Rights and the Debate over Patents Experts in Intellectual Property Laws, have stated that changes in India’s patent laws can cause the prices of drugs that cure AIDS, Tuberculosis and Cancer to be unaffordable to the public. One such victim of tuberculosis was Nandita Venkatesan who became deaf as a side effect of the kanamycin drug that was used to treat her.
Parallelly a company named Johnson and Johnson were evergreening their existing patent on Bedaquiline. This drug was a much safer option for curing TB. As opposed to this application for an extension of the patent period, Nandita seeks opposition thereby Johnson’s patent grant application gets rejected. If that opposition had not been filed in the courts of law then the affordable and generic versions of the drug that cures TB wouldn’t be available to the public till 2027. After the patent period ended, the price of the TB-curing drug decreased drastically. The debate over the granting of patents has been going on for years today. According to the current system, the pre-grant opposition and post-grant opposition can be filed, with the latter coming with a fixed fee to be paid. The fees would vary depending on the kind of drug, the complexity of the issue, and so on.
It ranges from 40,000 a month to more than 70,000 rupees. For the majority of the Indian population, they would have to let go of their monthly salary to file an opposition for patents granted. This huge cost incurred in filing an opposition application must be brought down, otherwise, it is similar to paying a huge sum for filing a writ petition. Many people, mostly in developing countries, do not have access to life-saving drugs. When the human right to life-saving pharmaceuticals is subjected to market trends, how can individual choices be responsible for ill health? BRIDGING THE GAP – SUGGESTIONS
1. Governments must regulate the imbalances in getting access to life-saving drugs.
Extensive and intensive research in developing life-saving drugs could be the most useful method for reducing the costs of these drugs. The standards of exchanging ideas, technology transfer, and making useful information available in public domains must be accelerated. Such information must be treated as public property rather than private.
2. Creating a patent pool in the global arena, promotes the exchange of research ideas and
newer innovations without any restrictions on information and intellect transfer.
3. Many research models developed in other parts of the world such as Bangladesh and
Bolivia propagate the idea of creating a central government-run fund for promoting innovations. Research on antibiotics and vaccines would be the primary area of focus. For the treatment of HIV/AIDS, the United Nations is funding the Swiz Government to establish an information-sharing platform at the global level. However, this can be a challenging decision for any government-led state.
4. One major goal should be to bring under the control of the Central Government the
research and development activities related to life-saving drugs and allow huge companies to get involved in the chain of distribution and supply only.
5. Insurance programs, subsidies, and state and central funding of life-saving medications
can help improve healthcare.
6. Stringent amendments in Intellectual Property Laws, will help prevent the prolongation
of the patent period, preventing business giants from establishing monopolies in the markets.
7. In the case of distributing drugs to remote areas such as islands and villages,
pharmaceutical companies could establish tie-ups with drone companies.
8. Adequate training must be given to healthcare workers on the effective use of
medicines, and their roles and responsibilities at par with developed nations.
9. In addition to foreign sector, the private sector has played a huge role in India's
healthcare reforms. The optimum course of action would have been to advance towards state supply and public financing of healthcare and place the entire healthcare system under governmental control. We must, however, look into measures to reduce the price of drugs and equipment given the pressure that the state and federal budgets are currently facing.12
10. A strong healthcare infrastructure is required, as well as more public spending on health.
This shall prioritise patient safety, fosters innovation, and lowers costs. India must promote the establishment of research-based organisations there. We are left with the second-best choice, which is to allow the vast private sector to play a larger role in the provision of pharmaceuticals and vaccines, in the absence of these. Currently, the state apparatus is largely missing, and the private sector provides healthcare. The majority of medical costs—nearly three-fourths—go towards privately administered treatment.
11. Poor health infrastructure, complicated drug approval processes, and high tariffs and
levies in underdeveloped nations, according to analysts, also serve as barriers to this access. Research universities and public sector research organizations in developed countries are the target of one suggested remedy to this issue. The majority or a large portion of the most significant pharmaceuticals and public health technologies ever created were created in academic laboratories. The type of research, licensing, and patenting decisions made by these universities have a significant impact on how accessible they are to people living in developing countries.
12. Governments can actively intervene in this situation to balance out the disparity in
access to life-saving medications. States should stimulate broad and thorough research in the development of life-saving medications by providing research infrastructure at public expense and by directly rewarding researchers and scientists. This still holds true today since the state, unlike other pharmaceutical and biotechnology firms, which are only motivated by long-term financial concerns, enters the pharmaceutical market with a focus on social returns and health impact. To ensure a higher-level interchange of ideas and information, the state should also support scholarly and high-level academic research in this area.
13. The results of R&D on life-saving medications should be considered public goods
rather than private property. The democratization of pharmaceutical production systems
12 ‘Patenting of Life-Saving Drugs Has Created a Global Health Crisis Where Human Life Has Become a
Commercial Commodity.’ (Impact of Social Sciences, 7 August 2014) accessed 20 August 2023 can make this concept a reality. A global patent pool that is built on a system of unrestricted research interchange without the usual proprietary constraints is one option. This would protect the public's access to scientific advancements and technologies that might be used to create cures. One good illustration of such is the International Genome Project.
14. A centralized innovation fund, which would combine research and create treatments
like antibiotics and vaccines targeted at assisting vulnerable areas, was another research concept offered to the World Health Organization by Bangladesh, Barbados, Bolivia, and Suriname in 2009. The Medicines Patent Pool, based in Switzerland and supported by the United Nations, has already built a global knowledge-sharing platform for HIV/AIDS drug development to increase the manufacturing of affordable medicines.13
15. For effective governance and to maintain the public's confidence in public
administration, the transparency concept is essential. Information must be readily available, easily accessible, and distributed throughout the community in order to effectively permit the inspection of decisions made by the government and of its supported institutions. Accountability and dependability go hand in hand with the notion of transparency. Transparency will assist in maintaining the stability of public institutions, retain the public's confidence in them, and keep the cost of pharmaceuticals and medical services from rising out of control in the context of the right to health and healthcare.
16. Recent attempts to employ big data analytics to track patients and trace contacts through
programs like Aarogya Setu need to adhere to the principle of protecting personal data, and any usage or dissemination should be done with the citizens' prior consent and in a transparent manner. People's faith has been impacted by several reports of data manipulation in COVID-19 cases in India. 17. The Jan Aushadi scheme and drugs should be promoted and different types of lifesaving drugs must be added to the Jan Aushadi drugs lists. Further, in order to increase the accessibility to Jan Aushadi scheme apps and online purchasing options should be
13 Khan AU, ‘India’s Drug Price Fix Is Hurting Healthcare’ (mint, 29 October 2019)
accessed 20 August 2023 enabled with a database which is centrally and systematically controlled to have a check on the stock of the life-saving drugs.
18. India should formally recognize the fundamental nature of the right to health. A society
that is more resilient to pandemics and other public health emergencies will benefit from strong health legislation. Emergency situations cannot be handled at the expense of human rights commitments. So it is crucial that the principles of transparency, proportionality, and solidarity be used to execute the right to health. The COVID-19 experience has also shown the value of a decentralized/polycentric reaction, which calls for strengthening India's cooperative federalism. Therefore, a constitutional amendment to protect access to health must be established as there is no separate provision. Thus, it has been suggested to amend and include a new Article, i.e., Right to Health, by adding a new clause to Article 21 of the Indian Constitution.
CONCLUSION
"Better access to drugs, especially in poor countries, could save 10 million lives each year," said an independent UN expert as he published a set of proposed guidelines for pharmaceutical companies on access to drugs. India's constitution, legal precedents and international commitments lay a foundation for healthcare ensuring access to health care services as a recognised right. This establishes a sense of responsibility and accountability. To ensure these healthcare provisions and facilitate access to health services India should consider enacting an amendment akin to the 93rd Amendment that granted legal status to the right to education. While these provisions set the foundation for the state's obligations in promoting health and well-being, it is essential to enact policies, laws and regulations including access to life-saving drugs to all citizens.
Consolidatedly, these laws and regulations form the core of India's healthcare structure by guaranteeing that life-saving drugs are within reach, affordable and maintain high-quality standards for enhancing the health and well-being of its citizens. It is crucial to recognize that healthcare legislation is an evolving field that adapts and improves in response, to emerging healthcare challenges and access to life-saving drugs should be present irrespective of the dynamic nature of the healthcare field.
REFERENCES
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3. https://www.orfonline.org/expert-speak/declaring-the-right-to-health-a-fundamentalright/
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8. https://www.bu.edu/law/journals-archive/international/volume21n2/325-372.pdf.pdf
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13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9013034/