1. Introduction

Cross-border vaccine injury compensation refers to the legal mechanisms through which an individual seeks compensation for death, disability, physical injury, or other recognised harm allegedly caused by a vaccine administered, manufactured, distributed, or supplied in a country different from the country in which the injured person resides.

It is an important area of international health law, pharmaceutical regulation, product liability, private international law, human rights law, and international dispute resolution.

The issue becomes particularly complicated when:

A vaccine is manufactured in one country but administered in another.

A person receives vaccination while travelling abroad.

A multinational pharmaceutical company supplies vaccines across several jurisdictions.

A vaccine injury becomes apparent after the individual returns to their home country.

The manufacturer, government, distributor, and vaccination provider are situated in different countries.

A country provides a no-fault compensation scheme while another requires proof of negligence or product defect.

A vaccine procurement agreement contains indemnity, limitation-of-liability, or jurisdiction clauses.

Central legal question: Which country is responsible for compensating the injured person, which legal system applies, and how can compensation be enforced when the relevant parties and evidence are located across national borders?

There is no single universal international vaccine-injury compensation system. The applicable remedy depends on domestic legislation, international agreements, contractual arrangements, applicable product-liability rules, and the circumstances of the injury.

2. Meaning and Nature of Cross-Border Vaccine Injury

A vaccine injury claim generally involves an allegation that vaccination caused a medically recognised adverse outcome.

The legal claim may arise from:

Manufacturing defect: Contamination, incorrect formulation, or manufacturing failure.

Design defect: An alleged inherent safety defect in the vaccine's formulation.

Failure to warn: Inadequate information concerning risks, contraindications, or adverse reactions.

Negligent administration: Incorrect dosage, improper storage, or administration contrary to medical protocols.

Regulatory failure: Alleged failure to adequately assess, monitor, or respond to vaccine safety concerns.

Contractual liability: Breach of vaccine supply, procurement, or distribution obligations.

No-fault compensation: Compensation payable under a statutory scheme without requiring proof of negligence.

An important distinction must be maintained between an adverse event following immunisation (AEFI) and a legally established vaccine injury. Temporal association alone does not establish causation.

3. International Legal Framework

A. World Health Organization (WHO)

The World Health Organization recognises vaccine injury compensation programmes as mechanisms for protecting individuals who suffer serious adverse effects associated with vaccination.

WHO distinguishes between:

Vaccine safety surveillance.

Investigation of adverse events following immunisation.

Scientific assessment of causation.

No-fault compensation.

Civil litigation against manufacturers or healthcare providers.

A no-fault compensation programme does not require the claimant to establish negligence by the manufacturer, government, or healthcare provider. However, the claimant generally must establish a sufficient causal connection between vaccination and the injury.

WHO's Global Advisory Committee on Vaccine Safety has discussed the role of these schemes in improving access to compensation and maintaining public confidence in immunisation programmes.

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B. COVAX No-Fault Compensation Programme

Important international precedent

The COVAX No-Fault Compensation Programme was established in 2021.

It was designed for 92 eligible low- and middle-income countries and economies participating in the Gavi COVAX Advance Market Commitment.

Its principal characteristics included:

Compensation for eligible serious adverse events associated with COVAX-distributed COVID-19 vaccines.

Coverage for permanent impairment and death.

An administrative claims procedure.

Medical documentation supporting the claim.

Independent claims administration through ESIS.

Funding through a levy on doses supported by the COVAX AMC.

A mechanism intended to reduce the need for lengthy court proceedings.

The programme covered eligible vaccinations through 30 June 2022. It is therefore an important historical example, not a general, permanently open global compensation scheme.

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Legal significance: COVAX demonstrated that an international vaccination programme could incorporate a compensation mechanism even where vaccine manufacturers, governments, healthcare providers, and injured individuals were situated in different countries.

C. International Covenant on Economic, Social and Cultural Rights

Article 12 of the International Covenant on Economic, Social and Cultural Rights recognises the right to the highest attainable standard of physical and mental health.

Its relevance includes:

Access to safe and effective healthcare.

Appropriate public-health safeguards.

Non-discriminatory access to healthcare.

Accountability for serious failures in public-health administration.

However, Article 12 does not itself establish a universal, directly enforceable vaccine injury compensation tribunal. The availability of compensation depends on applicable domestic and international legal obligations.

D. International Health Regulations, 2005

The International Health Regulations (2005) provide an international framework for preventing and responding to public-health risks.

They are relevant to cross-border vaccination programmes because they concern international public-health cooperation, surveillance, notification, and response.

However, the IHR do not establish a general individual compensation mechanism for vaccine injuries.

E. Pharmaceutical Product Liability and International Trade

Cross-border vaccine compensation may also involve:

The WTO Agreement on Technical Barriers to Trade.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.

National pharmaceutical regulatory legislation.

International product safety standards.

Vaccine supply and procurement agreements.

These instruments may affect vaccine approval, manufacturing standards, market access, and contractual responsibility. They should not be mistaken for independent compensation entitlements.

4. Jurisdiction: Which Country Can Hear the Claim?

Jurisdiction is one of the most difficult issues in cross-border vaccine injury litigation.

A claimant may have connections with several countries.

A. Jurisdiction based on vaccination

If an individual receives a vaccine in Country A and suffers an injury there, the courts of Country A may have jurisdiction over claims arising from administration.

For example, a tourist vaccinated at a foreign medical facility may bring a claim involving:

Incorrect dosage.

Improper storage.

Inadequate screening.

Negligent administration.

Failure to obtain informed consent.

B. Jurisdiction based on manufacture

Where a vaccine is manufactured in Country B and administered in Country A, a manufacturing-defect claim may involve the manufacturer in Country B.

The claimant must nevertheless establish a legally recognised basis for jurisdiction over the manufacturer.

The mere fact that a vaccine was manufactured in a particular country does not automatically mean that its courts have exclusive jurisdiction over every injury worldwide.

C. Jurisdiction based on residence

A claimant returning home after vaccination may seek relief in the country of residence.

The home-country court must consider:

Whether it has personal jurisdiction over the defendant.

Whether the relevant legislation permits the claim.

Which country's substantive law governs the dispute.

Whether a foreign judgment can be recognised and enforced.

Whether limitation periods have expired.

D. Forum non conveniens

A defendant may argue that another country is the more appropriate forum because:

Medical witnesses are located there.

Vaccination records are maintained there.

The alleged negligent act occurred there.

The relevant regulatory authorities operate there.

However, the court must balance convenience against access to justice, including whether the alternative forum can realistically provide an effective remedy.

5. No-Fault Compensation Versus Fault-Based Liability

Two major compensation models operate internationally.

A. No-fault liability

Under this model, compensation is available without proving that the manufacturer or government acted negligently.

The claimant ordinarily establishes:

Receipt of an eligible vaccine.

A qualifying injury or death.

A sufficient causal relationship.

Compliance with the scheme's filing and documentation requirements.

The policy justification is that vaccination programmes provide collective public-health benefits, while a small number of individuals may suffer serious vaccine-related harm.

B. Fault-based liability

Fault-based claims may be brought against:

Vaccine manufacturers.

Importers.

Distributors.

Hospitals.

Vaccination centres.

Medical practitioners.

Government agencies, where legally permissible.

The claimant may allege negligence, defective products, inadequate warnings, breach of statutory duties, or breach of contract.

C. Concurrent remedies

A claimant may potentially have several legal routes, but cannot automatically recover twice for the same injury.

The following questions must be examined:

Does the statutory compensation scheme exclude civil litigation?

Must the claimant first pursue an administrative remedy?

Does acceptance of compensation waive further claims?

Does the scheme permit recovery from a manufacturer?

Are collateral benefits deducted from damages?

These questions are particularly important where the vaccination country and the claimant's residence country have different compensation systems.

6. Important International Case Laws

Case 1: W and Others v Sanofi Pasteur MSD (2017), Case C-621/15

Leading vaccine causation precedent

Facts:

The claimant received a hepatitis B vaccination and subsequently developed multiple sclerosis.

The claimant alleged that the vaccine was defective and caused the neurological condition.

There was no definitive scientific consensus establishing the causal connection.

Legal issue:

Whether national courts could establish vaccine defect and causation through serious, specific and consistent circumstantial evidence even in the absence of scientific consensus.

Judgment:

The Court of Justice of the European Union held that national courts could consider a body of serious, specific and consistent evidence when determining whether a vaccine was defective and whether it caused the injury.

Relevant circumstances could include:

Temporal proximity between vaccination and the onset of illness.

Absence of a personal or family history of the disease.

Other reported cases following vaccination.

The complete evidentiary circumstances of the individual case.

However, the Court did not permit automatic presumptions of defect or causation merely because an illness followed vaccination.

Legal principle:

Scientific uncertainty does not necessarily prevent a claimant from proving causation through admissible circumstantial evidence.

Cross-border significance:

This decision is important where medical research, vaccination records, and injury evidence originate in different countries. Courts may have to evaluate evidence from several jurisdictions rather than depend exclusively on one country's scientific assessment.

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Case 2: Bruesewitz v. Wyeth LLC (2011), 562 U.S. 223

Facts:

A child suffered serious neurological injuries following administration of a DTP vaccine.

The parents brought a claim against the vaccine manufacturer, alleging that the vaccine's design was defective.

Legal issue:

Whether the National Childhood Vaccine Injury Act of 1986 prevented vaccine recipients from bringing design-defect claims against manufacturers.

Judgment:

The United States Supreme Court held that the Act pre-empts state-law design-defect claims against vaccine manufacturers for injuries caused by vaccine side effects.

The legislation provides a special compensation system intended to provide an alternative to conventional litigation.

Legal principle:

Special vaccine compensation legislation can substantially restrict ordinary product-liability claims.

Cross-border significance:

A foreign claimant seeking to sue a US vaccine manufacturer cannot assume that ordinary US product-liability rules will apply without statutory restrictions.

The claimant must examine:

Whether the vaccine falls within the statutory programme.

Whether the vaccination satisfies territorial and eligibility requirements.

Whether the statutory compensation procedure must be followed.

Whether any residual tort remedy remains available.

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Case 3: Jacob Puliyel v. Union of India (2022), W.P. (C) No. 607 of 2021

Facts:

The petitioner challenged aspects of the COVID-19 vaccination policy, including vaccine safety information, adverse-event monitoring, and informed consent.

Legal issues:

Transparency of vaccine safety information.

Monitoring of adverse events following immunisation.

Access to vaccination-related information.

Individual autonomy and informed decision-making.

Judgment and significance:

The Supreme Court examined the statutory vaccine approval framework and the system for monitoring adverse events following immunisation.

It emphasised the importance of making relevant adverse-event information accessible while protecting the confidentiality of persons reporting such events.

The Court also directed that individuals and private doctors should be able to report suspected adverse events through an accessible platform and that such reports should be publicly accessible with appropriate confidentiality safeguards.

Cross-border significance:

This case is relevant to international compensation claims because transparent adverse-event reporting, access to medical records, and reliable causality assessments are essential when evidence is spread across multiple countries.

It is also an important foundation for understanding the later decision in Rachana Gangu.

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Case 4: Rachana Gangu v. Union of India (10 March 2026), 2026 INSC 218

Major Indian compensation precedent

Facts:

The case concerned families who alleged that serious injuries and deaths had occurred following COVID-19 vaccination.

The proceedings included claims involving cerebral venous sinus thrombosis, thrombocytopenia, intracranial bleeding, and other serious medical conditions.

The petitioners sought compensation, improved adverse-event monitoring, and a mechanism for investigating vaccine-related deaths.

Legal issues:

Whether the State had a constitutional responsibility to provide an accessible compensation mechanism.

Whether families should be required to prove negligence in every case.

Whether India should establish a no-fault vaccine injury compensation policy.

Whether adverse-event surveillance information should be made publicly available.

Judgment:

The Supreme Court recognised that the right to life under Article 21 has implications beyond conventional fault-based liability.

The Court observed that when the State undertakes a large-scale public-health intervention, serious adverse consequences require an accessible institutional mechanism of redress.

The Court also discussed international compensation models, including those of Australia, the United Kingdom, Japan, and COVAX.

Important directions:

The Court directed the Union Government, through the Ministry of Health and Family Welfare, to:

Expeditiously formulate a no-fault compensation framework for serious adverse events following COVID-19 vaccination.

Continue existing AEFI surveillance mechanisms.

Periodically publish relevant data transparently.

Maintain the existing scientific assessment mechanism rather than establish a parallel court-appointed expert body.

Importantly, the Court clarified that the new compensation framework would not amount to an admission of governmental fault or liability and would not prevent individuals from pursuing other remedies available under law.

Legal principle:

The State's responsibility in a large-scale vaccination programme cannot necessarily end with monitoring vaccine safety; it also extends to providing an accessible compensation mechanism for serious vaccine-related harm.

Cross-border significance:

This judgment is particularly important where Indian residents receive vaccines supplied through international procurement arrangements. It supports a constitutional argument for accessible domestic redress even where the vaccine manufacturer, supplier, or procurement chain has an international dimension.

However, it does not automatically make foreign manufacturers liable under Indian law, nor does it establish an international compensation tribunal.

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Case 5: Sanofi Pasteur (2026), Case C-338/24

Facts:

The litigation concerned an individual who received a Revaxis vaccine manufactured by Sanofi Pasteur and subsequently reported progressive health problems.

The dispute involved the relationship between vaccine liability, fault-based claims, product liability, and limitation periods.

Legal significance:

The proceedings illustrate how long-term or progressive injuries complicate the calculation of limitation periods.

The European Court of Justice's treatment of the applicable questions is relevant to determining when an injured person can reasonably be expected to bring a claim and how national product-liability rules interact with other liability routes.

Cross-border significance:

A vaccine injury may become medically identifiable years after vaccination. A claimant who returns to another country may face different limitation periods, evidentiary requirements, and rules governing progressive injury.

The precise holding must be distinguished from the earlier Advocate General's opinion and the subsequent judgment; they are not interchangeable.

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7. Comparative National Compensation Systems

Different countries have adopted different approaches to vaccine injury compensation.

Front Steps and Facade of the U.S. Supreme Court in Washington DC

United States – National Vaccine Injury Compensation Program (VICP)

Established under the National Childhood Vaccine Injury Act, 1986.

No-fault compensation for eligible vaccines.

Claims adjudicated by special masters in the US Court of Federal Claims.

Vaccine Injury Table provides presumptive causation for specified injuries.

Certain civil actions are restricted until the statutory process has been followed.

Legal basis: 42 U.S.C. §§ 300aa-10 to 300aa-34.

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Dozens of divorces wrongly approved due to online system error, High Court told | The Independent

United Kingdom – Vaccine Damage Payments Scheme

Established under the Vaccine Damage Payments Act 1979.

Provides statutory financial assistance for qualifying severe disablement.

Covers specified vaccine-related injuries.

Includes COVID-19 vaccination within the scheme.

Is administered by the NHS Business Services Authority.

Legal basis: Vaccine Damage Payments Act 1979.

Canberra, Australia's Capital of Culture, Nature and Adventure | Female.com.au

Australia – COVID-19 Vaccine Claims Scheme

Australia introduced the COVID-19 Vaccine Claims Scheme Policy 2021.

Financial assistance for qualifying vaccine-related injuries.

Recognition of death and serious injury.

Medical expenses and loss of earnings.

Dependency and funeral-related expenses.

Legal basis: COVID-19 Vaccine Claims Scheme Policy 2021.

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Japan – Immunisation Injury Compensation

Japan has maintained a vaccine injury relief framework since 1976.

Compensation for qualifying health damage following vaccination.

Medical expense support.

Disability and survivor-related benefits.

COVID-19 vaccines were incorporated through the temporary vaccination framework.

Legal basis: Immunization Act and related statutory relief provisions.

Women ‘largest minority’, why not give representation without reservation, asks SC

India – Constitutional and statutory remedies

India's framework includes:

Constitutional remedies under Articles 14, 21 and 32.

Civil negligence and product-liability claims.

Consumer remedies where the statutory requirements are satisfied.

AEFI reporting and causality assessment.

The Supreme Court's 2026 direction to formulate a no-fault COVID-19 vaccine injury compensation framework.

Key case: Rachana Gangu v. Union of India, 2026 INSC 218.

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8. Cross-Border Choice of Law

Choice of law determines which country's substantive legal rules govern the compensation claim.

This question is different from jurisdiction: a court in one country may hear a case while applying another country's law.

A. Place of injury principle

Some legal systems give considerable importance to the country where the injury occurred.

For example, if a person is vaccinated in France and suffers an immediate injury there, French law may be relevant to the claim.

B. Habitual residence principle

The claimant's habitual residence may become relevant where the injury is suffered in that country or where the applicable conflict-of-laws rules provide for its use.

C. Manufacturer's principal place of business

Where the claim concerns a manufacturing defect, the manufacturer's establishment may be an important connecting factor.

D. European Union: Rome II Regulation

The Rome II Regulation provides conflict-of-law rules for non-contractual obligations.

Article 4 generally uses the law of the country where direct damage occurs, subject to exceptions including common habitual residence and manifestly closer connection.

For vaccine injury claims, Article 5's special rule for product liability is particularly relevant.

It considers connecting factors including:

The injured person's habitual residence.

The place where the product was acquired.

The place where the damage occurred.

Whether the product was marketed in the relevant country.

The exact applicable law depends on the conditions of Article 5 and its exceptions.

E. Hague Convention on Products Liability, 1973

The Hague Convention of 2 October 1973 on the Law Applicable to Products Liability is an important comparative instrument.

It addresses liability of manufacturers, suppliers, and other participants in the commercial distribution chain.

Its conflict-of-law provisions use connecting factors such as the place of injury, habitual residence, principal place of business, and place of acquisition.

However, its applicability depends on the countries concerned and their treaty status. It is not a universal rule binding every country, including India.

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9. Liability of Vaccine Manufacturers in Cross-Border Claims

Manufacturers may face liability under different legal theories.

A. Manufacturing defect

A vaccine may allegedly contain:

Contaminants.

Incorrect ingredients.

Improperly prepared biological material.

Unacceptable manufacturing variations.

Defects arising from inadequate quality control.

A claimant must establish the applicable legal elements of product liability.

B. Design defect

A claimant may allege that the vaccine's formulation creates an unacceptable safety risk.

However, some jurisdictions provide statutory protections against certain design-defect claims, as demonstrated by Bruesewitz v. Wyeth.

C. Failure to warn

A manufacturer may face allegations that it failed to provide adequate information about:

Serious adverse reactions.

Contraindications.

Known risk factors.

Required monitoring.

Appropriate medical responses.

The relevant standard depends on the law governing the claim.

D. Defective distribution

An importer or distributor may potentially be responsible for:

Temperature-control failures.

Improper transportation.

Storage outside approved conditions.

Counterfeit or improperly labelled products.

Failure to maintain traceability.

E. Corporate-group liability

A multinational pharmaceutical group may operate through separate subsidiaries in different countries.

The parent company is not automatically liable for every act of its subsidiary.

A claimant must establish an applicable basis for liability, such as direct negligence, assumption of responsibility, agency, statutory liability, or another recognised legal doctrine.

10. Government Liability and Constitutional Compensation

Government liability is a separate and important dimension of vaccine injury compensation.

A government may be involved as:

Vaccine purchaser.

Public-health programme administrator.

Regulatory authority.

Distributor of vaccines.

Provider of vaccination services.

Party to indemnity or procurement agreements.

Potential claims may arise from negligent administration, failure to follow statutory duties, unlawful governmental action, or violation of constitutional rights.

Indian constitutional framework

Article 14: Protection against arbitrary and discriminatory governmental action.

Article 21: Protection of life and personal liberty, including the constitutional dimension of health and dignity.

Article 32: Right to approach the Supreme Court for enforcement of fundamental rights.

Article 226: High Court jurisdiction to issue writs for enforcement of fundamental rights and other legal purposes.

Articles 41 and 47 of the Constitution also provide important guidance concerning public assistance, sickness, disability, and public health.

An important qualification is that not every vaccine-related injury establishes a constitutional violation. The claimant must establish the legal basis for the State's responsibility.

The Rachana Gangu judgment is particularly important because it recognises the need for an institutional no-fault remedy without declaring every adverse event to be government negligence.

11. Vaccine Procurement Agreements and Indemnity Clauses

International vaccine procurement agreements create another layer of liability.

A government may enter into a supply agreement with a foreign pharmaceutical manufacturer.

The agreement may contain:

Indemnification clauses.

Liability allocation provisions.

Limitation-of-liability clauses.

Insurance obligations.

Governing-law clauses.

Arbitration clauses.

Jurisdiction clauses.

Confidentiality provisions.

Post-marketing surveillance obligations.

Example

Suppose Country A purchases a vaccine from Manufacturer B, which manufactures the vaccine in Country C.

A patient receives the vaccine in Country A and suffers a serious injury.

Three separate legal relationships may arise:

A particularly important distinction is that a government indemnity agreement does not necessarily extinguish the injured individual's independent legal rights.

The contract may allocate financial responsibility between the government and manufacturer without determining whether the patient has a separate cause of action.

12. Burden of Proof and Medical Evidence

The burden of proof is a central issue in vaccine injury litigation.

A claimant generally needs to establish the following elements, subject to the applicable statutory or compensation scheme:

Proof that the vaccine was administered.

Identification of the vaccine and manufacturer.

Medical diagnosis of the alleged injury.

Evidence of the timing of symptoms.

Evidence connecting the injury to vaccination.

Evidence of financial loss or permanent disability, where relevant.

A. Medical evidence

Useful evidence includes:

Vaccination certificates.

Hospital admission records.

Laboratory investigations.

Imaging reports.

Post-mortem examinations.

Specialist medical opinions.

AEFI investigation reports.

Previous medical history.

Pharmaceutical batch information.

B. Scientific causation

Courts must distinguish between:

Temporal association.

Biological plausibility.

Statistical association.

Medical causation.

Legally established causation.

The W and Others v Sanofi Pasteur judgment is especially important because it permits courts, in appropriate circumstances, to evaluate serious, specific and consistent circumstantial evidence.

C. Cross-border evidentiary difficulties

International cases create additional difficulties:

Medical records may be written in different languages.

Foreign laboratory reports may require authentication.

Experts may disagree about causation.

Vaccine batches may be manufactured in different countries.

Clinical trial information may be held abroad.

Regulatory authorities may apply different causality-assessment methods.

International cooperation between medical regulators, hospitals, and public-health institutions is therefore essential.

13. Compensation: What Damages Can Be Recovered?

The amount and type of compensation depend on the applicable legal framework.

No-fault schemes may use fixed statutory amounts or prescribed compensation formulas. Civil courts may calculate damages differently.

Compensation should also be distinguished from insurance payments, government ex-gratia assistance, and contractual indemnification.

14. Enforcement of Foreign Compensation Judgments

A successful claimant may still face difficulties enforcing a judgment against a foreign manufacturer.

For example, a court in Country A may award compensation against a pharmaceutical company incorporated in Country B.

The claimant may need to seek recognition and enforcement in Country B.

Important legal questions include:

Whether the original court had competent jurisdiction.

Whether the judgment is final and conclusive.

Whether the defendant received proper notice.

Whether the judgment conflicts with public policy.

Whether fraud or procedural unfairness is established.

Whether the relevant country has applicable recognition arrangements.

Indian position

Sections 13 and 14 of the Code of Civil Procedure, 1908, are particularly relevant.

Section 13 establishes the general rules governing conclusiveness of foreign judgments.

Section 14 provides a presumption concerning the competence of the foreign court, subject to the statutory framework.

Section 44A may provide a mechanism for execution of qualifying foreign decrees from reciprocating territories.

A foreign vaccine compensation award does not automatically become executable in India merely because it concerns an Indian resident.

15. Important Indian Statutory Provisions

The following legal provisions may be relevant to vaccine injury compensation in India.

The Consumer Protection Act, 2019 is particularly relevant where the statutory requirements for product liability are satisfied.

However, a claim against a public vaccination programme, a private hospital, and a foreign vaccine manufacturer may involve different legal causes of action.

16. Important Doctrines in Cross-Border Vaccine Injury Compensation

The following doctrines help explain the legal structure of this subject.

1. No-fault compensation doctrine

An injured person may receive compensation without proving negligence, provided the statutory eligibility and causation requirements are satisfied.

2. Product liability doctrine

Manufacturers and other legally responsible participants in the distribution chain may be liable for defective products.

3. Strict liability doctrine

Certain product-liability regimes impose liability without requiring proof of negligence, although defect, causation, and statutory defences remain relevant.

4. State constitutional accountability

The government may have constitutional obligations where serious harm arises in the context of a State-led public-health intervention.

5. Access to justice doctrine

An injured person should have a meaningful opportunity to obtain an effective remedy.

6. Proportionality and public-interest balancing

Courts must consider individual rights alongside legitimate public-health objectives, without treating public benefit as an automatic defence to every injury claim.

7. Double-recovery prevention

The claimant should not obtain duplicate compensation for the same loss through multiple legal mechanisms.

8. Extraterritorial liability

Domestic legal systems may, in appropriate circumstances, exercise jurisdiction over foreign companies or conduct outside their territory.

9. Corporate separateness

A parent corporation and its foreign subsidiaries are generally separate legal persons unless an established legal basis justifies attributing liability.

10. Procedural fairness

The claimant and defendant must receive a fair opportunity to present medical, scientific, and legal evidence.

17. Practical Legal Framework for a Cross-Border Claim

Consider this hypothetical situation:

An Indian citizen travels to Country A, receives a vaccine manufactured in Country B, and subsequently develops a serious neurological injury after returning to India.

The following sequence illustrates how the claim might be investigated.

Cross-border compensation process

Identify the vaccination

Establish the vaccination date, location, manufacturer, vaccine type, and batch number.

Establish medical injury

Obtain medical records, diagnostic reports, and specialist opinions.

Investigate causation

Examine the medical relationship between vaccination and the diagnosed condition.

Identify available compensation schemes

Check whether the vaccination country or a relevant international programme provides compensation.

Determine jurisdiction and applicable law

Examine the residence, vaccination, manufacturing, and corporate-establishment connections.

Identify responsible parties

Consider the manufacturer, importer, distributor, vaccination provider, and government.

Initiate the appropriate proceedings

Consider no-fault compensation, civil litigation, consumer proceedings, or constitutional remedies.

Enforce the award

If necessary, pursue recognition and enforcement in the country where the defendant's assets are located.

18. Major Legal Challenges

Cross-border vaccine injury compensation faces several unresolved problems.

19. Suggested Legal Reforms

An effective international compensation framework should include the following reforms.

A. International vaccine injury compensation agreement

Countries should develop common minimum standards for recognising serious vaccine-related injuries and providing compensation.

B. Mutual recognition of medical evidence

Medical reports and causality assessments should be capable of recognition across participating jurisdictions, subject to safeguards and independent review.

C. Cross-border compensation coordination

A person should not lose compensation rights merely because vaccination, injury, residence, and manufacture occur in different countries.

D. Transparent procurement contracts

Government agreements should clearly identify indemnity arrangements and preserve appropriate access to compensation for injured individuals.

E. Harmonised limitation rules

Progressive injuries should receive fair treatment where the medical condition becomes identifiable or stabilises only after a considerable period.

F. Independent compensation administration

Compensation authorities should have clear eligibility criteria, transparent procedures, review mechanisms, and reasonable decision-making deadlines.

G. International medical evidence cooperation

Countries should improve the exchange of relevant vaccine safety information while protecting patient confidentiality.

H. Effective enforcement arrangements

International agreements should facilitate recognition and enforcement of qualifying compensation awards.

20. Conclusion

Cross-border vaccine injury compensation is an emerging and significant field of international health law. It involves the interaction of pharmaceutical product liability, constitutional rights, public-health administration, international cooperation, and private international law.

The most important legal development for India is the Supreme Court's decision in Rachana Gangu v. Union of India (2026 INSC 218), which directed the Union Government to formulate a no-fault compensation framework for serious adverse events following COVID-19 vaccination.

An important qualification concerning India: The March 2026 judgment is a direction to formulate a framework; it is not itself a complete compensation scheme prescribing eligibility, claim forms, compensation amounts, and an operational claims authority. The available official material also identifies India's continuing AEFI surveillance system. The existence and terms of any subsequently notified compensation policy must therefore be verified separately.

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Internationally, W and Others v Sanofi Pasteur, Bruesewitz v Wyeth, and the COVAX No-Fault Compensation Programme demonstrate three different aspects of the subject: scientific causation, statutory restrictions on manufacturer liability, and international no-fault compensation.

Ultimately, an effective cross-border compensation system must balance three principles:

Protection of individuals suffering serious vaccine-related injuries.

Accountability of manufacturers, governments, and healthcare providers according to applicable law.

Preservation of fair and effective public-health vaccination programmes.

The development of coordinated international compensation rules would significantly improve access to justice for individuals injured by vaccines administered through international vaccination and pharmaceutical supply networks.

21. Important Authorities and Research Materials

For further academic and legal research, the following primary materials are particularly useful:

Rachana Gangu v. Union of India (2026 INSC 218) – Supreme Court judgment.

W and Others v. Sanofi Pasteur MSD (C-621/15) – CJEU judgment.

Bruesewitz v. Wyeth LLC (2011) – US Supreme Court judgment.

WHO – Vaccine Injury Compensation Programmes.

WHO – COVAX No-Fault Compensation Programme.

Hague Convention of 1973 on Products Liability.

United States National Childhood Vaccine Injury Act – Compensation provisions.

India – National AEFI Surveillance and Response Operational Guidelines, 2024.

Academic research focus: The relationship between national no-fault compensation schemes, foreign manufacturer liability, international vaccine procurement indemnities, and the constitutional right to health is a particularly important area for further doctrinal research.