Introduction

Children’s right to health is recognized in several United Nations and international agreements. These instruments establish the state as primarily responsible for observing and protecting this right.

The growing economic power of multinational enterprises (MNEs) and pharmaceutical giants raises new questions. Many ask whether these private, non‑state entities also have an obligation to ensure children’s right to health.

The WHO has highlighted alarming statistics. Millions of children suffer from preventable and treatable diseases, even though affordable treatment exists.

Lower‑ and middle‑income countries often lack access to these treatments. Their efforts are also challenged by MNEs and by the home states that support those companies.

South Africa and Brazil show how states can face legal pushback when they take legislative action to protect their people’s health.

Children’s Right to Health (in the READ MORE section below)

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Children’s right to health is confirmed in several United Nations agreements.

One foundational instrument is the Universal Declaration of Human Rights. Article 25 states that everyone has the right to a standard of living adequate for health and well‑being. It also says that children are entitled to special care and assistance.

The International Covenant on Economic, Social and Cultural Rights further develops this right. Its Preamble recognizes that the rights enumerated in the Covenant derive from the inherent dignity of the human person.

Article 12 of the Covenant recognizes the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. States that are parties to the Covenant must take steps to ensure full realization of this right. This includes making provision for the healthy development of the child. It also includes preventing, treating, and controlling diseases. States must create conditions that ensure medical service and attention to all in the event of sickness.

The Convention on the Rights of the Child (CRC) also reaffirms these principles. Article 24 recognizes the child’s right to the highest attainable standard of health. It also affirms a right to facilities for the treatment of illness and the rehabilitation of health.

Article 24 requires parties to strive to ensure that no child is deprived of access to health‑care services. It directs parties to take appropriate measures to diminish infant and child mortality. It also requires them to ensure the provision of necessary medical assistance and health care to all children.

Parties must combat disease and malnutrition through the application of readily available technology. Article 24 also establishes a duty to take effective and appropriate international cooperative measures. These measures should aim to abolish traditional practices that are prejudicial to children’s health. The Article emphasizes that special account should be taken of the needs of developing countries.

Not all states that have signed the Convention have also ratified it. States that have signed and ratified the CRC include Canada, the UK, France, Australia, China, the Netherlands, South Africa, Switzerland, Sweden, and Nigeria.

The US has signed the Convention but has not ratified it. This means the US does not have a binding legal obligation under the CRC. However, it must refrain from acts that would defeat or undermine the treaty’s object and purpose.​

Who is Responsible for Ensuring Children’s Right to Health

In all the relevant international treaties, conventions, covenants, and agreements, the state holds primary responsibility. States must ensure that children’s right to health is observed.

State membership in the United Nations and adherence to UN founding documents is recognized in the Charter of the United Nations.

The Convention on the Rights of the Child clarifies state obligations. Article 2 requires state parties to respect the rights set forth in the Convention. States must ensure these rights within their jurisdiction without discrimination.

Article 4 states that parties shall undertake all appropriate legislative and administrative measures to implement the rights in the Convention. They must do so to the maximum extent of their available resources. They must also seek international cooperation where necessary.

The International Covenant on Economic, Social and Cultural Rights also affirms state responsibility. Article 2 confirms that states are responsible for ensuring observance of children’s right to health.

State of International/Global Children’s Health

Despite the existence of an established right to health and clear guidelines for its protection, children’s health indicators are alarming.

The WHO and UNICEF maintain a Child Health and Well‑Being Dashboard. This tool allows users to monitor and compare data and statistics on various child health indicators.

In 2020, an estimated 5 million children under five died. Most deaths were from preventable and treatable causes. The WHO states that access to vaccinations and treatment for common childhood diseases can save many young lives. Doing so requires a mix of community‑based and facility‑based care.​

In 2024, 14.3 million infants did not receive an initial dose of the DTP vaccine. This suggests major gaps in access to immunization. Another 5.6 million infants received only partial vaccinations.​

Avoidable deaths from childhood cancers in low‑ and middle‑income countries are another concern. More than 80% of affected children could be cured with better access to essential medicines and technologies.​

The WHO’s World Children’s Day message underscores that millions of children still fall ill and die from preventable diseases. These include HIV, tuberculosis, and hepatitis.

In 2024, 1.4 million children were living with HIV. Another 1.2 million children fell ill with tuberculosis. Over 170,000 children died, most of them under five.​

Children also bear a significant share of chronic hepatitis B infections. Fifteen percent of the 254 million global chronic hepatitis B infections occur in children. Vaccination has reduced prevalence in children under five, but major gaps remain in global vaccination rates. Without timely prevention and treatment, hepatitis can lead to lifelong liver disease and cancer.

The WHO created the Global Accelerator for Paediatric Formulations (GAP‑f). GAP‑f coordinates efforts to speed up and improve access to medicines for children and to address systemic failures that leave children behind.

Low‑ and middle‑income countries face major gaps in access to safe, effective, and appropriate medicines. Only 29% of low‑income countries report that cancer medicines are available to their populations. By contrast, 96% of high‑income countries report such availability.

Sickle cell disease affects over 300,000 children each year. Treatment is often low‑cost, but it still does not reach many children who need it.

Through GAP‑f, the WHO aims to drive innovation and optimization in product development. It seeks to strengthen paediatric clinical research to inform drug approval and to improve regulatory pathways.

IP Rights of Multinational Enterprises (MNEs) and Pharmaceutical Companies

Development of the TRIPS Agreement

After the Second World War, the US and its allies promoted a new multilateral trade regime. The General Agreement on Tariffs and Trade (GATT) was created in 1947. It focused on liberalizing trade between industrialized countries by reducing or eliminating tariffs and trade barriers.

During the Uruguay Round of trade negotiations, members revised and expanded the GATT system. This process led to the creation of the World Trade Organization (WTO) in 1995.

A major addition to the international trade framework was the Agreement on Trade‑Related Aspects of Intellectual Property Rights (TRIPS Agreement).

TRIPS aims to promote effective and adequate protection of intellectual property rights (IPRs). It seeks to support technological innovation. It also recognizes the special needs of least‑developed country members.

Article 8 of TRIPS states that member states may adopt measures necessary to protect public health. However, such measures must be consistent with the Agreement. They cannot arbitrarily or unjustifiably distort international trade.

IPRs held by MNEs and pharmaceutical companies can be a major challenge for states. Strong patents and exclusivities may limit a state’s ability to protect children’s right to health and to expand access to life‑saving medicines.

To understand this challenge, it is necessary to review key terms and the development of these IP rights.

Definitions of Important Terms

The WTO maintains a Glossary with definitions of several important terms.

Intellectual Property Rights (IPRs) refer to ownership of ideas. This includes literary and artistic works (protected by copyright), inventions (protected by patents), and signs distinguishing goods of an enterprise (protected by trademarks). It also covers other elements of industrial property.

A basic patent right is the legal mechanism that allows an inventor to prevent others from making, using, or selling a new invention for a limited period. This protection usually lasts 20 years from the filing date of the patent application, subject to exceptions.​

A compulsory licence is a mechanism for patents. Under a compulsory licence, authorities allow companies or individuals other than the patent owner to use the patented invention without the owner’s permission. This includes making, using, selling, or importing a product under patent. TRIPS allows compulsory licences if certain procedures and conditions are met.

Compulsory licensing of pharmaceuticals allows exploitation of a drug or process without the patent holder’s consent. Governments may authorize production and export of more affordable generic versions, especially in national emergencies.​

Parallel imports occur when a legally produced product is imported without the permission of the IPR holder. These products are not pirated; they have been sold under IPR in another country. Some countries allow parallel imports; others do not.

The International Institute for Sustainable Development explains parallel importation in more detail. A product or service is first sold under an IPR in one country. It is then imported into another country’s territory.

Parallel‑imported medicines are not counterfeit or unlawfully produced. They are not necessarily of substandard quality.

Producers and IPR holders argue that allowing wholesalers and distributors to export IPR‑protected goods undermines profitability in higher‑priced markets. They claim this reduces available funds for research and development.

Christopher Heath of the Max Planck Institute notes a consistent pattern in parallel import cases. IPR owners often use economic power to obtain the outcomes they want.

The Trade Law Centre for Southern Africa has highlighted case law alleging that pharmaceutical companies engaged in excessive pricing and refused to grant licences to generic manufacturers. These practices were linked to premature, predictable, and avoidable loss of life.​

Patent monopolies place pharmaceutical companies in a strong position to set high prices. Such pricing can deeply affect poorer countries’ ability to obtain treatments for major diseases.

The following case studies show how MNEs and pharmaceutical companies have sometimes failed in legal actions aimed at stopping state use of compulsory licences and parallel imports.

Case Study: South Africa

South Africa enacted the Medicines and Related Substances Control Amendment Act (No. 90 of 1997). This law allows for compulsory licensing and parallel imports into South Africa.

The Preamble sets out several objectives:

• Provide measures for supplying more affordable medicines in certain circumstances.

• License certain persons to compound, dispense, or manufacture medicines.

• Provide for generic substitution of medicines.

• Establish a pricing committee.

Section 10 authorizes the Minister of Health to set conditions for the supply of more affordable medicines in specific circumstances. The purpose is to protect public health.

Section 14 allows for generic substitution of brand‑name medicines. It requires pharmacists to inform all customers about the benefits of substituting branded medicine with interchangeable multi‑source medicine. Pharmacists must dispense the interchangeable product unless the patient expressly refuses or the generic is more expensive than the branded product.

Several major pharmaceutical companies challenged sections of the Act. They argued that provisions allowing importation or production of cheaper drugs overrode their patent rights.​

These companies claimed it was necessary to uphold IPRs and invalidate the law. They argued this was needed to encourage drug research and innovation.

Companies involved included Bristol‑Myers Squibb and Merck (US), GlaxoSmithKline (UK), Hoffmann‑La Roche (Switzerland), and Boehringer Ingelheim (Germany).

South Africa also faced pressure from foreign states. The US Congress threatened to cut aid unless South Africa withdrew provisions allowing local manufacturing or importation of cheaper medicines.

After international protests from NGOs and broad public attention, the pharmaceutical companies withdrew their lawsuit.

Industry analyst Hemant K. Shah described the case as a public relations disaster for the companies. He suggested it reduced the likelihood that drug firms would sue developing countries over life‑saving medicines in the future.

However, the withdrawal was only a partial victory. States, especially the US, continued to cut funding for life‑saving programs in South Africa. These programs include tracing, testing, research, and community health jobs.​

A policy discussion paper on IPRs and sustainable development notes another concern. Developing WTO members no longer have the policy flexibility that earlier industrialized countries enjoyed when using IPRs to support national development. Pressure to comply with TRIPS limits their options.

As a result, developing countries and states facing health emergencies struggle to enact laws that enable affordable generic medicines. They fear legal repercussions for alleged IPR violations. They also fear loss of essential health funding from powerful states or institutions.

Case Study: Brazil

Brazil adopted Law No. 9.279 of May 14, 1996, which regulates rights and obligations related to industrial property.

Chapter 7, Section 3 addresses compulsory licences. It allows compulsory licences where a patent holder uses the patent abusively or abuses economic power through the patent. A compulsory licence is also possible when the patent owner fails to meet national emergency or public interest needs.

Brazil used these provisions to challenge high drug prices. The Brazilian government overrode the patent of a Swiss pharmaceutical company. It granted compulsory licences to national manufacturers.

The company produced a drug that was essential in Brazil’s AIDS treatment program. That program had reduced AIDS‑related deaths. However, the drug was extremely costly.

Brazil spent about 28% of its anti‑AIDS budget on that single drug. In one year, 90,000 people received the drug through the national program at a cost of USD 15,000 per person.

The government argued that this price threatened the viability of its national health program. It stated that a generic version would save about USD 240 million.​

The Ministry of Health estimated that using drugs produced by local labs under compulsory licences would cut costs by 40%. Local labs had the technical capacity to reverse engineer the patented drug.

This ability would allow Brazil to produce the medicine domestically. It would also give the government strong leverage in price negotiations with foreign pharmaceutical companies.

The government stressed that citizens urgently needed the medication and that it could not afford existing prices charged by foreign suppliers.

Pharmaceutical companies argued that Brazil’s actions sent a “chilling” signal to the industry. The US‑Brazil Business Council claimed the policy would divert investment to other countries and undermine Brazil’s ability to attract future investment.

Negotiations followed. Ultimately, Brazil and the foreign companies reached an agreement that allowed local production under certain terms.

Do MNEs Have a Responsibility to Ensure Children’s Right to Health?

Brazil and South Africa occupy a relatively strong bargaining position. Both have technical capacity and facilities to produce, import, and export generic alternatives to branded medicines.

Even so, both countries faced legal challenges from public and private actors. This occurred despite TRIPS provisions that allow compulsory licensing and parallel imports.

MNEs and large pharmaceutical companies are private entities or individuals. They are not directly bound by UN treaties that define state responsibilities.

Yet some MNEs possess more economic power than many small states. These firms often hold monopolies in crucial industries. They can also challenge important state actions through domestic and international legal systems.

This raises a key question: does such economic and legal power create a responsibility for MNEs? Should they be required to use their power in ways that protect children’s right to health, rather than only in pursuit of profit?

The International Covenant on Economic, Social and Cultural Rights offers one starting point. Its Preamble recognizes that individuals have duties to other individuals and to the community.

This duty places individuals under a responsibility to strive for promotion and observance of the rights recognized in the Covenant. Those rights include the healthy development of children.

The OECD Guidelines for Multinational Enterprises on Responsible Business Conduct further elaborate corporate responsibilities.

The Guidelines address adverse impacts of business activities on people, the planet, and society. They are recommendations issued by governments. Their goal is to encourage MNEs to contribute positively to sustainable development and to the protection and promotion of human rights.

The Guidelines recommend that MNEs should contribute to fair and equitable sharing of benefits arising from the use of genetic resources. This includes benefits from developing pharmaceutical drugs based on local or foreign genetic resources.

The text recognizes that MNE activities can have especially severe impacts in some industries and on some groups. Children are one such vulnerable group. In these cases, companies must pay heightened attention to risk.

Depending on circumstances, MNEs may need to consider additional standards when their activities affect children.

However, the Guidelines remain recommendations. They do not create a positive legal duty of care. They do not impose a binding legal obligation on MNEs to protect children’s right to health or even to consider this right during decision‑making.

UNICEF’s Children’s Rights and Business Principles provide a complementary framework. These Principles guide companies on how to respect and support children’s rights in the workplace, marketplace, and community.

The Principles define the scope of corporate responsibility toward children. They highlight the many ways corporate practices affect children. This includes labour relations, marketing, community impacts, and environmental effects.

The document notes growing attention to the role of business alongside governments and other societal actors. It emphasizes the importance of focusing on how business impacts children.

One Principle urges businesses to ensure their products and services are safe and to seek ways to support children’s rights. Another Principle calls on businesses to reinforce community and government efforts to protect and fulfil children’s rights. Companies should not undermine government initiatives. They should contribute to existing programs where appropriate.

The Principles stress that children are particularly vulnerable to violence, exploitation, and abuse, especially during emergencies.

Governments at all levels hold the core duty to protect, respect, and fulfil children’s rights. However, all societal actors—including businesses—must comply with national law and respect international standards on children’s rights.

The central question remains: how can we reconcile the IPRs of MNEs and pharmaceutical companies with children’s right to health?

In practice, IPRs and patents often stand in tension with upholding children’s right to health. MNEs frequently undermine state efforts to protect children’s health or to respond to emergencies. They do this despite guidelines urging more responsible conduct.

The economic power of MNEs, combined with support from their home states, can exert strong pressure on smaller or less industrialized countries. These states may be pushed into adopting laws that favor MNEs. They may fear losing investment or facing costly litigation.

Research and development into child‑specific or child‑safe medicines is often neglected unless companies see major profit potential.

Protecting and encouraging innovation is important. But MNEs must not ignore the communities and customers they serve. This is especially critical in national or global emergencies, where children are among the most vulnerable and have a right to heightened protection.

One proposed step is to transform the OECD MNE Guidelines into hard law through state legislation. Doing so would create positive legal duties for MNEs and pharmaceutical companies to respect children’s right to health.

A clear legal duty, backed by meaningful consequences for non‑compliance, could deter MNEs from undermining or challenging legitimate state action taken to protect children’s right to health.

 

KARA/KIDS AT RISK ACTION/INVISIBLE CHILDREN