WHO's Impact on Global Health Law
WHO's Impact on Global Health Law
The World Health Organization (WHO), established in 1948 as a UN agency, plays a central
role in shaping international health law by developing and updating frameworks like the
International Health Regulations (IHR), setting standards, and providing technical assistance
to countries to implement and comply with these regulations. It also leads global health
initiatives, coordinates responses to health emergencies, and promotes health equity and
access to healthcare worldwide.
1. WHO formulates both binding and non-binding legal instruments that shape the
legal framework governing global health.
a) International Health Regulations (IHR, 2005)
A legally binding international legal instrument adopted by 196 countries.
It aims to prevent and respond to Public Health Emergencies of
International Concern (PHEIC), such as pandemics.
Example: During the COVID-19 pandemic, WHO declared COVID-19 a PHEIC
under the IHR framework and issued recommendations for surveillance,
reporting, quarantine, and travel restrictions.
b) Framework Convention on Tobacco Control (FCTC, 2003)
WHO’s first international treaty, adopted by over 180 countries.
It sets international legal standards for reducing tobacco consumption and exposure.
Indian Medical Association v. Union of India (2011) 7 SCC 179: The Court
emphasized the state’s obligation to ensure medical services and formulate
policies promoting health.
Common Cause (A Regd. Society) v. Union of India (2018) 5 SCC 1: Affirmed the
right to health as part of the right to life, including access to affordable treatment.
3. International Commitments
India is a signatory to several international instruments that recognize the right to health as a
basic human right, such as:
The Indian Contract Act, 1872 and principles of tort law provide the basis
for imposing vicarious liability.
The Consumer Protection Act, 1986 (now 2019) also supports claims
against hospitals for deficiencies caused by their employees.
4. Landmark Case:
Held: The hospital and doctor were held vicariously liable. The Supreme
Court awarded compensation to both the child and the parents (as consumers).
Importance: Affirmed that both employer hospitals and treating doctors can
be held liable in cases of gross medical negligence.
Explain the concepts of Private Liability and Public Liability in healthcare with
reference to relevant laws and landmark cases.
Legal Framework:
The primary law governing private liability in India is the Consumer Protection Act,
1986 (now updated to the Consumer Protection Act, 2019), under which patients are
treated as consumers and can seek compensation for medical negligence.
Landmark Cases:
o Dr. Laxman Balkrishna Joshi vs. Dr. Trimbak Bapu Godbole (1969):
Established that doctors owe a duty of care and can be liable for negligence
under consumer law.
o Indian Medical Association vs. V.P. Shantha (1995): The Supreme
Court declared that medical services fall within the scope of the
Consumer
Protection Act, making private doctors and hospitals accountable for
negligence
Legal Framework:
The constitutional right to health is derived from Article 21 (Right to Life) of the
Indian Constitution. Additionally, the Public Liability Insurance Act, 1991 and
various Supreme Court rulings enforce State accountability in public healthcare.
Landmark Cases:
o Paschim Banga Khet Mazdoor Samity vs. State of West Bengal (1996): The
Supreme Court held that the State must provide adequate healthcare
facilities, and failure to do so violates Article 21.
o M.C. Mehta vs. Union of India (1986): Established the principle of absolute
liability of the State for hazardous activities, extending the duty to ensure
public health and safety.
Explain in detail the application of the Consumer Protection Act in cases of medical
negligence.
Medical negligence occurs when a healthcare professional or institution fails to provide the
standard of care expected, causing harm or injury to the patient. The Consumer Protection
Act (CPA) provides a legal mechanism for patients to seek redress for such negligence by
classifying healthcare services as “services” under the Act and patients as “consumers.” This
has significantly enhanced patients’ rights and accountability of healthcare providers.
Impact of Consumer Protection Act on Medical Profession- The CPA has brought about
increased accountability in the medical profession by:
Empowering patients to claim compensation for medical errors.
Encouraging healthcare providers to maintain higher standards of care.
Motivating hospitals and clinics to ensure better service delivery and
informed consent practices.
Surgical errors
Wrong diagnosis or delayed diagnosis
No Age Limit: All members of eligible families, including senior citizens, are
covered under the scheme.
Implementation and Impact
Digital Integration: The Ayushman Bharat Digital Mission aims to create a digital
health ecosystem, linking patients and healthcare providers through real-time health
records. (Wikipedia)
Infrastructure Expansion: The establishment of HWCs and Ayushman
Arogya Kendras (AAKs) has enhanced healthcare access, especially in rural
areas. (The Times of India)
Healthcare Workforce Enhancement: Training programs for Accredited Social
Health Activists (ASHAs) and the recruitment of additional healthcare workers
have strengthened service delivery. (The Times of India)
Challenges
Private Sector Participation: Some private hospitals express concerns over
package rates and reimbursement delays, affecting their participation in the scheme.
(The Times of India)
Awareness and Accessibility: Efforts are ongoing to increase awareness and
ensure that eligible beneficiaries, especially in remote areas, are informed about the
scheme and can access its benefits.
Recent Developments
Expansion of Coverage: As of May 2025, the scheme has been extended to
include all citizens above 70 years of age, irrespective of their economic status.
(Wikipedia)
Special Campaigns: In Bihar, a special drive from May 26 to 28 aims to prepare
and distribute Ayushman cards at the panchayat level, enhancing accessibility for
rural populations. (The Times of India)
Conclusion
Ayushman Bharat stands as a transformative step towards achieving Universal Health Coverage
in India. By integrating digital health solutions, expanding infrastructure, and enhancing
healthcare access, the scheme aims to provide equitable healthcare to all,
particularly the underserved and vulnerable populations.
Certainly! Here's a detailed explanation of Dying Declaration from the medical sector
perspective, including legal provisions and important case laws:
Dying Declaration: Medical Perspective with Legal Provisions and Case Laws
A dying declaration is a statement made by a person who is in the last stage of life
(believing death is imminent) regarding the cause or circumstances of the injury or event that led
to their critical condition or impending death.
It is treated as a crucial piece of evidence in legal cases, especially in criminal trials involving
homicide or assault.
Nature of Evidence
A dying declaration is substantive evidence; it can form the basis for conviction
even if there is no other corroborative evidence.
However, courts prefer corroboration where possible, but conviction solely based on
a dying declaration is valid if it inspires confidence.
1. Criminal Negligence
Definition:
Criminal negligence refers to a situation where a healthcare provider’s conduct is so careless or
reckless that it shows a gross disregard for human life or safety, thereby constituting a
criminal offense. Unlike ordinary negligence, criminal negligence involves a higher degree of
fault and attracts penal consequences.
Legal Provisions:
Indian Penal Code (IPC) Section 304A – Causing death by negligence:
This section penalizes causing death by a rash or negligent act not amounting to
culpable homicide. For example, a doctor’s gross negligence leading to patient death.
IPC Sections 336, 337, 338 – Acts endangering life or personal
safety: These sections punish negligent acts that cause injury or
endanger life.
Key Characteristics:
The negligence must be gross or reckless, not merely a simple error or oversight.
Dr. Laxman Balkrishna Joshi vs Dr. Trimbak Bapu Godbole (1969) AIR 128
The Supreme Court held that a doctor will not be held criminally liable for an
honest error of judgment but will be liable if the negligence is gross and reckless,
showing disregard for life or safety.
2. Tortious Negligence
Definition:
Tortious negligence is a civil wrong arising from a healthcare provider’s failure to exercise the
standard of care that a reasonably competent professional would provide, resulting in harm
or injury to a patient. It gives rise to a claim for compensation (damages) rather than
criminal punishment.
Legal Framework:
The law of torts (common law principles) governs medical negligence as a tort.
The claimant (patient) must prove:
o Duty of care owed by the healthcare provider.
Key Characteristics:
The negligence involves a failure to take reasonable care.
The fault is less severe than criminal negligence.
Landmark Case:
Bolam vs Friern Hospital Management Committee (1957)
The "Bolam test" was established, stating that a doctor is not negligent if acting in
accordance with a practice accepted as proper by a responsible body of medical
opinion.
Confidentiality:
Maintain strict confidentiality of all patient information unless legally required to
disclose it.
Informed Consent:
Obtain valid consent before any examination or treatment. Patients should be
informed about the nature, risks, benefits, and alternatives.
Non-Discrimination:
Treat all patients equally without discrimination based on race, religion, caste, gender,
economic status, or social background.
Avoid Exploitation:
Doctors must not exploit patients financially or emotionally.
2. Duty to Society
Health Promotion:
Doctors should actively promote public health awareness and preventive medicine.
Participate in National Health Programs:
Support and contribute to government health initiatives and emergency care.
Uphold Medical Ethics:
Maintain the dignity and reputation of the medical profession.
3. Duty to Colleagues
Respect Colleagues:
Maintain respectful and professional relationships with fellow doctors and healthcare
workers.
Collaboration:
Cooperate with other professionals for the benefit of patients.
Avoid Malpractice:
Avoid negligent practices and maintain high standards of medical care.
No Overcharging or Kickbacks:
Avoid unethical financial practices like overcharging, unnecessary tests for profit, or
accepting commissions for referrals.
6. Duty in Emergencies
No Refusal in Emergencies:
It is unethical to refuse emergency treatment for any patient.
Meaning of Epidemic
An epidemic refers to the sudden and rapid increase in the number of cases of a
particular disease in a specific geographic area or population, beyond what is normally
expected.
It involves more cases than usual occurring in a community or region during
a particular period.
Epidemics can be caused by infectious agents such as bacteria, viruses, or other
pathogens.
Example: The outbreak of the Ebola virus in West Africa (2014-2016) was an epidemic.
Significance of Epidemic
1. Public Health Impact
Epidemics pose serious health risks and can overwhelm healthcare systems, leading
to high morbidity (illness) and mortality (death) rates. Epidemics necessitate public
health interventions like vaccination campaigns, quarantine, and isolation to control
the spread
2. Early Detection and Control
Recognizing an epidemic early allows for timely public health interventions like
quarantine, vaccination drives, and treatment protocols to control the spread.
3. Resource Allocation
Understanding an epidemic helps governments and health authorities allocate medical
resources, personnel, and funding effectively.
4. Policy and Preparedness
Epidemics highlight weaknesses in public health infrastructure, prompting the
development of better disease surveillance and emergency preparedness plans.
5. Economic and Social Impact
Epidemics can disrupt social life, economies, trade, and education, making control
measures crucial to minimizing these effects.
Surrogacy is a method of assisted reproduction where a woman (the surrogate mother) agrees to carry
and deliver a child for another person or couple (intended parents). It is typically used when
pregnancy is medically impossible or risky for the intended mother.
ART refers to all fertility treatments where both eggs and sperm are handled outside the body. This
includes:
Surrogacy
India has introduced two major laws to regulate surrogacy and ART services:
National and State Surrogacy Boards: These are created to regulate and oversee
surrogacy clinics and services.
ART Clinics and Banks Must Register: Clinics and sperm/egg banks must be
registered with the National Registry.
Consent and Counseling: Informed written consent must be obtained from all
parties, including donors and intended parents.
o A female donor can donate oocytes only once in her lifetime and not more than
7 oocytes in one cycle.
Penalties:
1. Commercial vs. Altruistic Surrogacy India allowed commercial surrogacy until 2015,
making it lucrative but also controversial due to exploitation risks. The surrogate mothers,
often from economically weaker sections, faced issues of coercion, inadequate medical
care, and social stigma. Recognizing this, the Indian government banned commercial
surrogacy through the Surrogacy (Regulation) Act, 2021, permitting only altruistic
surrogacy for Indian couples, thereby outlawing surrogacy for foreign nationals and single
individuals.
2. Parentage and Custody Establishing legal parentage of the child born through surrogacy is
complex. Indian laws initially lacked clarity on who the legal parents were—the surrogate
or the commissioning couple. The Surrogacy (Regulation) Act, 2021now declares the
intending couple as the legal parents from birth, addressing parentage and custody issues. The
Act also prohibits commercial contracts, mandating registration of surrogacy agreements to
protect surrogate mothers and commissioning parents.
3. Consent and Autonomy of Surrogate Mothers Ensuring the surrogate mother's informed
consent is a critical legal and ethical concern. There have been instances where women
were
compelled or deceived into surrogacy. The Act prescribes strict consent requirements and
welfare provisions for surrogate mothers, including medical expenses and insurance coverage
during and after pregnancy.
Both laws restrict ART and surrogacy access to married heterosexual couples, excluding:
o LGBTQ+ individuals
o Live-in partners
UK: Only altruistic surrogacy allowed; legal parentage must be transferred post-birth.
Facts: A Japanese couple commissioned a surrogacy in India but separated before the
child was born. The grandmother sought custody.
Held: The Supreme Court allowed the child to leave India, emphasizing the need for
legal regulation of surrogacy.
Impact: It was a significant case that accelerated the debate on regulating surrogacy in India.
Facts: A German couple had twins via Indian surrogate, but citizenship and passport
issues arose.
Held: Gujarat High Court granted Indian passports, but the case highlighted legal
ambiguities regarding parentage and citizenship.
Conclusion
Surrogacy and ART are transformative medical technologies offering hope to infertile couples, but
they raise complex legal, ethical, and social questions. The Surrogacy (Regulation) Act, 2021
and the ART (Regulation) Act, 2021 aim to address these challenges through strict regulations,
but
concerns remain about inclusivity, autonomy, and reproductive rights.
TRIPS and Pharmaceutical Patents- TRIPS requires member countries to grant patent protection
for pharmaceutical products for at least 20 years. This was a significant shift for India, which prior to
2005 only recognized process patents for drugs, allowing generic manufacturers to produce
affordable medicines through alternative processes. Post-TRIPS compliance necessitated amending
India’s Patent Act, 1970, culminating in the Patents (Amendment) Act, 2005, which introduced
product
patents in pharmaceuticals. This shift raised concerns about access to essential medicines, especially
for the economically disadvantaged, as patent monopolies could potentially lead to higher drug prices
and restrict availability.
Public Health Safeguards in Indian Law: TRIPS Flexibilities- India has utilized the flexibilities
provided under TRIPS to protect public health interests. Notably, Section 3(d) of
the Indian Patent Act restricts patents for new forms of known substances unless they significantly
enhance efficacy. This provision prevents 'evergreening', a practice where minor modifications extend
patent monopolies without therapeutic benefits. The Supreme Court’s decision in Novartis AG v.
Union of India (2013) 6 SCC 1 upheld this safeguard, denying a patent for the cancer drug Glivec.
The ruling was hailed as a landmark in preserving affordable access to medicines and reaffirmed
India’s commitment to public health under TRIPS.
Compulsory Licensing and Access to Medicines- One of the most important TRIPS flexibilities is
the provision for compulsory licensing (CL), allowing a government to authorize generic production
of patented drugs in the public interest without the patent holder's consent. India’s Patent Act
incorporates this mechanism under Section 84.
The issuance of India’s first compulsory license in Natco Pharma Ltd. v. Bayer Corporation
(2013) 5 SCC 705 for the cancer drug Nexavar was a watershed moment. The government granted
the license on grounds of affordability and unmet public need, allowing Natco to produce a cheaper
generic version. This action demonstrated how TRIPS flexibilities empower India to address public
health challenges while respecting international obligations.
Impact on Public Health Law and Policy- TRIPS has influenced the formulation of India’s public
health policies, reinforcing the need to balance patent protection with affordable healthcare. The
government and judiciary have recognized the primacy of health over commercial interests, aligning
with the World Health Organization’s emphasis on access to medicines as a human right.
India has also been proactive in negotiating at WTO forums to safeguard these flexibilities and resist
pressures for stricter IP norms that could undermine public health. The Doha Declaration on TRIPS
and Public Health (2001), which India supported, explicitly affirmed the right of WTO members to
protect public health and promote access to medicines.
Challenges and Ongoing Debates- Despite these advances, challenges remain. Multinational
pharmaceutical companies and some developed countries continue to push for "TRIPS-plus"
provisions through bilateral and regional trade agreements, which could limit India’s ability to use
public health safeguards effectively. Additionally, the global COVID-19 pandemic has reignited
debates on patent waivers for vaccines and therapeutics. India, alongside South Africa, has
spearheaded efforts at the WTO to temporarily waive certain TRIPS provisions to enhance vaccine
access for developing countries, underscoring the continuing tension between IP rights and public
health imperatives.
1. Encourages Innovation:
o Permits tools like compulsory licensing and parallel imports in public health
emergencies.
o 20-year patent protection delays the entry of cheaper generics into the market.
o Patent holders can monopolize pricing, making medicines unaffordable to the poor.
o Often discouraged from using TRIPS flexibilities due to fear of trade retaliation.
The MTP Act was enacted to provide legal access to safe abortion and reduce unsafe and illegal
abortions. The MTP (Amendment) Act, 2021, brought significant changes to align the law with
medical advancements and women's reproductive rights.
Up to 20 Weeks of Gestation:
There is a substantial risk that the child would be born with serious physical
or mental abnormalities.
20 to 24 Weeks of Gestation:
Minors
Beyond 24 Weeks:
o Termination is allowed only in cases of substantial fetal abnormalities, as
diagnosed by a Medical Board constituted by the state government (comprising a
gynecologist, radiologist, pediatrician, and other specialists).
o A government hospital or
The 20 or 24-week time limit is not applicable if a registered medical practitioner is of the
opinion that the abortion is immediately necessary to save the life of the pregnant
woman.
Section 3B – Categories of Women Eligible for Termination Between 20–24 Weeks (Inserted by
2021 Amendment)
These include:
Incest victims
Minors
Consent Requirements
Section 312 IPC: Causing miscarriage is a criminal offence unless it is done in good faith
to save the woman’s life.
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Section 313 IPC: Causing miscarriage without the consent of the woman is punishable
even if it is done to save her life.
Section 314 IPC: If the woman dies due to miscarriage caused without proper procedure, it
is punishable with imprisonment up to 10 years.
Section 315 IPC: Any act with intent to prevent a child from being born alive or to cause
its death before birth is also punishable.
The Supreme Court held that a woman's right to make reproductive choices is part of Article
21 of the Constitution (Right to Life and Personal Liberty).
Set precedent for the judiciary to intervene in exceptional cases where continuation
of pregnancy could cause mental or physical trauma.
Ensures safe and legal abortions, thereby reducing maternal mortality and morbidity due
to unsafe procedures.
Protects the reproductive rights of women and recognizes their autonomy and mental
health as valid grounds.
• Right to Life and Personal Liberty (Article 21): Courts interpret this to include
bodily autonomy and reproductive choice, allowing a woman to decide on abortion within legal
limits.
The MTP Act strikes a balance between safeguarding women’s health and protecting fetal life,
incorporating medical, ethical, and social considerations.
Public Health and Social Impact- Legal provisions for termination of pregnancy aim to prevent
unsafe abortions, a major cause of maternal mortality and morbidity in India. By regulating the
conditions under which abortion is lawful, the Act encourages safe medical procedures and reduces
the stigma associated with abortion. Access to legal abortion services remains a challenge in rural
areas due to inadequate facilities, lack of awareness, and social taboos, highlighting the need for
robust implementation and public health outreach.
The gestation limit for termination was extended to 24 weeks for special categories of
women, including survivors of rape, incest, minors, women with disabilities, and those
in humanitarian crises.
For pregnancies up to 20 weeks, the opinion of one medical practitioner is sufficient; for
pregnancies between 20 and 24 weeks, the opinion of two medical practitioners is
required.
Pregnancies beyond 24 weeks may be terminated only if the pregnancy is diagnosed
with fatal fetal abnormalities, as certified by a medical board.
The amendment also introduced provisions to maintain confidentiality and prohibits
the requirement of the woman’s consent for abortion in the case of minors if the
guardian consents.
Although the Right to Health is not explicitly mentioned as a fundamental right in the Indian
Constitution, various provisions under the Constitution indirectly guarantee and promote the right to
health and healthcare.
Article 21 states: “No person shall be deprived of his life or personal liberty except
according to procedure established by law.”
The Supreme Court has interpreted the right to life to include the right to live with
human dignity, which encompasses the right to health and medical care.
The DPSPs, though not enforceable by courts, guide the government to make
policies ensuring citizens' welfare, including health.
Article 39(e) and (f): The state shall direct its policy to secure the health and strength
of workers and children.
Article 41: The state shall, within its economic capacity, make provisions for
public assistance in cases of sickness and disablement.
Article 42: The state shall make provisions for securing just and humane conditions of
work and for maternity relief.
Article 47: This is particularly significant — it states: “The State shall regard the raising
of the level of nutrition and the standard of living of its people and the improvement of
public health as among its primary duties.”
The Supreme Court held that the right to live with human dignity includes protection of the health and
strength of workers and access to medical care.
The Court explicitly held that the right to health and medical care is a fundamental right under
Article 21, especially for workers.
The Supreme Court ruled that the failure of a government hospital to provide timely medical
treatment to a person in need violates Article 21.
Reaffirmed that the right to health is integral to Article 21 and that the government has a
constitutional obligation to provide health facilities.
India’s interpretation and recognition of the right to health as a fundamental right have been
significantly influenced by international commitments and legal instruments. These frameworks
establish health as a basic human right and guide national policies.
Article 25 of the UDHR recognizes the right of every individual to a standard of living
adequate for their health and well-being, including food, clothing, housing, and
medical care.
Although the UDHR is not legally binding, it serves as the foundation for many
binding treaties and reflects global consensus on basic human rights.
Article 12 explicitly states that every individual has the right to the highest
attainable standard of physical and mental health.
It obligates signatory nations, including India, to take steps for the prevention, treatment,
and control of diseases, and to create conditions for access to medical care for all.
Declares that "the enjoyment of the highest attainable standard of health is one of
the fundamental rights of every human being."
This forms the ideological basis of global health rights and influences member
countries’ public health policies.
Goal 3: "Ensure healthy lives and promote well-being for all at all ages."
This includes targets like reducing maternal and child mortality, combating epidemics,
achieving universal health coverage, and ensuring access to essential medicines and vaccines.
Duty of Care: Doctors are obligated to provide a reasonable standard of care to their
patients, which means acting with competence, diligence, and skill. Failure to do so may
result in
negligence claims.
Duty to Obtain Consent: Doctors must obtain informed consent from patients before
any examination, investigation, or treatment, respecting patient autonomy and rights.
Duty to Provide Emergency Care: Medical professionals have an ethical and often legal
obligation to provide urgent care in emergencies, regardless of the patient’s background
or ability to pay.
Duty to Keep Updated: Doctors must continually update their knowledge and skills
to provide the best care based on current medical standards.
Duty to Respect Patients: Doctors must respect patients' dignity, rights, and cultural beliefs.
The medical profession is self-regulated to a large extent, with oversight by statutory bodies, ethical
codes, and legal frameworks to ensure accountability, quality of care, and professional integrity.
o These are statutory bodies responsible for regulating medical education and practice
in India.
o They can impose penalties such as suspension or removal from the medical register
in cases of unethical behavior or malpractice.
o Issued by regulatory bodies like MCI (now NMC), this code outlines the
ethical duties and conduct expected from doctors.
o It covers aspects like patient care, confidentiality, advertising
restrictions, relationships with colleagues, and avoiding exploitation.
Legal Oversight:
o Doctors must comply with laws such as the Consumer Protection Act, Indian
Penal Code (IPC) (sections related to medical negligence and criminal negligence),
and
other relevant statutes.
o Courts can hold medical practitioners liable for negligence, breach of duty,
or malpractice.
Professional Accountability:
o Doctors are accountable not only to patients but also to the profession and society.
o Doctors play a vital role in disease prevention, health education, and implementing
government health policies.
o They are responsible for reporting certain diseases to authorities and participating
in vaccination and epidemic control efforts.
Protects Patients: Ensures patients receive safe, competent, and ethical care.
Maintains Trust: Builds trust between patients and doctors essential for effective treatment.
Safeguards Public Health: Doctors’ compliance with public health regulations is critical
for community well-being.