1. Introduction

Cross-Border Trial Approval Conflicts arise when a clinical trial, biomedical research project, pharmaceutical investigation, gene-therapy study, vaccine trial, or biotechnology experiment involves participants, researchers, sponsors, research institutions, or investigational products located in two or more countries, but the participating countries apply different legal requirements for approving, supervising, and monitoring the research.

The central legal problem is that approval granted by one country's regulatory authority does not automatically constitute lawful approval in another country.

For example, a pharmaceutical company may obtain permission from the United States Food and Drug Administration (FDA) to conduct a clinical trial. However, if the trial also recruits participants in India, the sponsor may have to comply independently with Indian clinical-trial legislation, ethics-committee requirements, informed-consent rules, compensation obligations, and regulatory reporting procedures.

These conflicts become particularly significant in:

International multicentre clinical trials.

Cross-border vaccine and pharmaceutical research.

Gene therapy and genome-editing trials.

Stem-cell and regenerative medicine trials.

Artificial intelligence-assisted clinical investigations.

International reproductive and fertility research.

Digital clinical trials and remote patient monitoring.

Trials involving biological samples and genetic information transferred internationally.

The subject involves regulatory jurisdiction, international human rights, research ethics, informed consent, data protection, pharmaceutical safety, administrative law, and international liability.

2. Meaning and Nature of Cross-Border Trial Approval Conflicts

A cross-border trial approval conflict occurs when two or more jurisdictions impose inconsistent, overlapping, or mutually incompatible requirements concerning the authorization of a clinical investigation.

For instance:

Country A permits a clinical trial following approval by a national medicines regulator.

Country B requires separate authorization and local ethics approval.

Country C prohibits the proposed research methodology.

Country D permits the research but requires additional participant compensation and insurance.

The sponsor attempts to operate one international trial protocol across all four jurisdictions.

The resulting legal difficulty concerns which approvals are necessary, which regulatory standards prevail, and whether an approval obtained in one jurisdiction can be recognized elsewhere.

Important distinction

Three different legal concepts must be separated:

Regulatory authorization: Permission from a government medicines or clinical-trial regulator.

Ethical approval: Permission or favourable review from an appropriately constituted research ethics committee.

Institutional authorization: Permission from the hospital, university, laboratory, or research institution where the study takes place.

One does not necessarily substitute for the others.

3. Major Causes of Cross-Border Trial Approval Conflicts

A. Conflicting regulatory approval requirements

Different countries use different procedures for authorizing clinical trials.

For example:

The United States generally operates through FDA investigational-new-drug requirements under 21 CFR Part 312.

The European Union regulates clinical trials through Regulation (EU) No. 536/2014.

India regulates clinical trials primarily through the New Drugs and Clinical Trials Rules, 2019.

Australia uses the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Regulations, and the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes.

A trial authorized in one country may therefore require additional applications, documentation, and regulatory assessment elsewhere.

Legal consequence: A sponsor cannot assume that an authorization from its home country provides a universal licence to conduct research internationally.

B. Conflicting ethical approval standards

Research ethics committees may disagree about:

Acceptability of the research methodology.

Risks and benefits to participants.

Recruitment of vulnerable populations.

Consent procedures.

Use of placebos.

Genetic testing and secondary use of samples.

Long-term monitoring of research participants.

Compensation for research-related injuries.

For example, an ethics committee in one country may approve a placebo-controlled trial, while another country's committee may consider the placebo arrangement unethical because an effective treatment already exists.

This creates a conflict between scientific uniformity and local ethical autonomy.

C. Different informed-consent requirements

Informed consent is one of the most important legal safeguards in international clinical research.

Conflicts arise where one jurisdiction accepts electronic consent, but another requires additional documentation, witness involvement, translation, or specific consent procedures.

Particular difficulties arise in:

Trials involving children.

Research involving persons with impaired decision-making capacity.

Emergency clinical investigations.

Genetic and genomic research.

Indigenous and traditionally vulnerable populations.

Research involving stored biological samples.

A consent form approved in the sponsor's home jurisdiction should not automatically be treated as sufficient in every participating country.

D. Different compensation and insurance obligations

Some jurisdictions impose specific compensation obligations for injury or death resulting from clinical-trial participation.

A multinational sponsor may therefore face different standards regarding:

No-fault compensation.

Negligence-based liability.

Insurance coverage.

Compensation for trial-related disability.

Death benefits.

Medical treatment costs.

Long-term monitoring.

A sponsor's global insurance policy may also exclude certain countries or types of experimental treatment.

E. Conflicting data protection requirements

International trials frequently transfer sensitive information across borders.

Examples include:

Genetic information.

Medical histories.

Electronic health records.

Biomarker information.

Digital twin datasets.

Neurological and physiological measurements.

The EU General Data Protection Regulation (GDPR), India's Digital Personal Data Protection Act, 2023, and other national privacy laws may impose different conditions on international transfers, consent, data processing, retention, and participant rights.

F. Conflicting rules concerning investigational products

A medicine or biological product approved for experimental use in one country may not be importable or usable in another without separate authorization.

This is particularly important for:

Stem-cell products.

Gene therapies.

Genetically modified biological products.

Vaccines.

Experimental cancer medicines.

Personalized cellular therapies.

The sponsor must distinguish permission to conduct the trial from permission to manufacture, import, transport, store, and administer the investigational product.

4. International and National Legal Framework

A. International legal framework

These instruments have different legal statuses. A treaty may create binding obligations for its parties, while declarations and guidelines generally operate as ethical or interpretative standards rather than automatically enforceable domestic legislation.

B. United States

The principal regulatory framework includes:

Federal Food, Drug, and Cosmetic Act.

FDA regulations under 21 CFR Part 312.

21 CFR Part 50 concerning informed consent.

21 CFR Part 56 concerning Institutional Review Boards.

45 CFR Part 46, where applicable, concerning protection of human research subjects.

The FDA's investigational new drug (IND) framework generally requires authorization or satisfaction of applicable IND requirements before an investigational drug is administered to human participants in a regulated clinical investigation.

C. European Union

The principal legislation is Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use.

It establishes a harmonized framework involving:

A single clinical-trial application.

Coordinated assessment by participating Member States.

National assessment responsibilities.

Ethics considerations.

Informed consent.

Safety reporting.

Trial transparency.

Substantial modifications.

Regulatory supervision.

Importantly, a harmonized application does not eliminate every national difference. Member States retain responsibilities in specified areas, including certain ethical and local implementation matters.

D. India

India's main regulatory framework includes:

Drugs and Cosmetics Act, 1940.

New Drugs and Clinical Trials Rules, 2019.

ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

Applicable Good Clinical Practice requirements.

Clinical Trials Registry–India requirements.

The Central Drugs Standard Control Organization (CDSCO) and Central Licensing Authority play important roles in regulatory authorization.

The CDSCO has a dedicated Global Clinical Trial Division for trials conducted as part of drug development in more than one country.

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Important Indian requirements:

Regulatory permission where required.

Approval from the appropriately registered Ethics Committee.

Compliance with approved protocols.

Informed consent.

Serious adverse-event reporting.

Compensation for trial-related injury or death, where applicable.

Registration in the Clinical Trials Registry–India before enrolling the first participant.

India's rules also contain provisions concerning trials involving drugs already approved outside India. Such prior foreign approval does not itself replace Indian authorization.

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E. Australia

The Australian system principally involves:

Therapeutic Goods Act 1989 (Cth).

Therapeutic Goods Regulations.

National Statement on Ethical Conduct in Human Research.

NHMRC ethical oversight requirements.

Clinical Trial Notification (CTN) scheme.

Clinical Trial Approval (CTA) scheme.

Under the CTN scheme, the Human Research Ethics Committee (HREC) reviews and approves the trial, and the sponsor notifies the Therapeutic Goods Administration (TGA) before commencement.

Under the CTA scheme, the TGA evaluates and authorizes the trial.

The CTN scheme should not be misunderstood as a system of automatic international recognition of foreign regulatory approvals.

5. Important Case Laws and Judicial Principles

There is no single universally controlling judgment establishing mutual recognition of all cross-border clinical-trial approvals. Courts have instead developed principles concerning informed consent, regulatory supervision, research liability, participant protection, and governmental accountability. These principles are directly relevant to multinational trials.

Case 1. Swasthya Adhikar Manch, Indore v. Union of India (2014)

Court: Supreme Court of India
Case: Writ Petition (Civil) No. 33 of 2012 and connected matters.

Facts:

The petition challenged irregularities and inadequate safeguards in clinical trials conducted in India, particularly trials involving new chemical entities and global clinical research.

Concerns included:

Deaths and serious adverse events.

Inadequate informed consent.

Insufficient compensation.

Deficiencies in regulatory monitoring.

Risks associated with multinational pharmaceutical research.

Judgment and directions:

The Supreme Court scrutinised the Government's clinical-trial approval procedures and directed attention to three important parameters:

Risk-benefit assessment.

Innovation compared with existing therapeutic options.

Unmet medical need.

The Court also addressed audiovisual recording of the informed-consent process and preservation of the documentation in specified trials.

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Legal principles:

Governmental approval must be supported by meaningful regulatory scrutiny.

Participant protection cannot be sacrificed for commercial or scientific interests.

Informed consent must be demonstrable.

Regulatory authorities must exercise effective supervision over clinical research.

Relevance to cross-border trial approval conflicts:

This case is especially important where multinational pharmaceutical companies obtain approval abroad and subsequently seek to recruit Indian participants.

Foreign authorization cannot justify bypassing Indian safeguards. Indian regulators must independently consider whether the trial is appropriate for Indian participants.

Case 2. Grimes v. Kennedy Krieger Institute, Inc. (2001)

Court: Maryland Court of Appeals, United States
Citation: 366 Md. 29 (2001).

Facts:

Researchers conducted a study involving children living in housing containing lead-based paint. The study examined the effectiveness of different lead-abatement methods.

The litigation concerned potential exposure of children to hazardous lead and whether the parents had received sufficient information about the research risks.

Judgment:

The Court vacated the summary judgments in favour of the research institution and remanded the cases.

It recognized that research relationships may create special duties of care and that informed-consent agreements may, in appropriate circumstances, create contractual obligations.

It also emphasized that parental consent cannot automatically legitimize inherently inappropriate non-therapeutic research involving children.

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Legal principles:

Researchers may owe independent duties of care to participants.

Informed consent must disclose material risks.

Ethics committees must independently protect participants.

Consent does not eliminate all researcher liability.

Vulnerable populations require additional protection.

Relevance:

A multinational research sponsor cannot rely exclusively on a consent form approved in its home country.

If the research creates risks prohibited by the host country's legal or ethical framework, obtaining parental consent or foreign ethics approval will not necessarily cure the problem.

Case 3. Hart v. Brown (1972)

Court: Superior Court of Connecticut
Citation: 29 Conn. Supp. 368; 289 A.2d 386 (1972).

Facts:

The case concerned a proposed kidney transplant between seven-year-old identical twins, with one child acting as donor.

Judgment:

The Court approved the proposed transplant after considering the children's circumstances, medical evidence, parental consent, and the welfare of both children.

Legal significance:

The case is useful for understanding the distinction between therapeutic medical intervention and non-therapeutic experimentation involving minors.

Relevance:

Multinational paediatric trials require careful scrutiny of:

Parental authorization.

The child's assent where appropriate.

Risk-benefit assessment.

The child's best interests.

The legal limits of surrogate consent.

It should not be treated as a direct ruling on international trial authorization.

Case 4. Schloendorff v. Society of New York Hospital (1914)

Court: New York Court of Appeals
Citation: 211 N.Y. 125; 105 N.E. 92 (1914).

Facts:

A patient consented to an examination under anaesthesia but did not consent to the surgical removal of a tumour.

The procedure was nevertheless performed.

Judgment:

The Court articulated the principle that an adult of sound mind has the right to determine what is done to their body.

Legal principle:

Medical intervention generally requires valid consent.

Relevance:

A multinational clinical-trial protocol cannot authorize procedures beyond the scope of a participant's valid consent.

The principle is particularly important when trial sponsors use standardized consent documents across different countries.

Case 5. Salgo v. Leland Stanford Jr. University Board of Trustees (1957)

Court: California Court of Appeal
Citation: 154 Cal. App. 2d 560; 317 P.2d 170 (1957).

Facts:

The case concerned a patient who suffered paralysis following a medical diagnostic procedure.

The dispute involved the physician's duty to disclose material risks.

Judgment:

The Court discussed the physician's duty to disclose material information and the importance of informed consent.

Relevance:

In international research, consent documentation must reflect the risks of the particular trial and the applicable local legal requirements. Merely translating a foreign consent form may be inadequate.

Case 6. Canterbury v. Spence (1972)

Court: United States Court of Appeals, District of Columbia Circuit
Citation: 464 F.2d 772 (D.C. Cir. 1972).

Facts:

A patient suffered serious complications after spinal surgery and alleged that the physician had failed to disclose material risks.

Judgment:

The Court developed an important patient-oriented approach to disclosure, emphasizing material risks that would be significant to a reasonable patient.

Legal principle:

Informed consent should not be reduced to the physician's unilateral assessment of what information is important.

Relevance:

International clinical-trial consent documents should disclose risks, alternatives, uncertainties, and relevant participant rights in a comprehensible manner.

This is particularly important in experimental gene therapies, vaccine studies, and first-in-human trials.

6. Specific Legal Conflicts Between Participating Countries

The following examples demonstrate how approval conflicts arise in practice.

A. Approval in the sponsor's home country

A sponsor may have approval from its domestic regulator but still be prohibited from starting recruitment in another country.

Legal doctrine: Territorial regulatory sovereignty.

Each country retains authority to regulate clinical research conducted within its territory, subject to its international obligations.

B. Conflicting ethics-committee decisions

A multinational study may receive approval from a central ethics committee but rejection from a local committee.

This raises questions about whether the central committee's decision can override the local committee.

As a general rule, central ethical review cannot automatically displace legally required local review.

C. Conflicting clinical-trial protocols

A global sponsor may wish to maintain one uniform protocol.

However, local regulators may require changes involving:

Participant eligibility.

Safety monitoring.

Medical treatment during the trial.

Compensation.

Consent language.

Data collection.

Duration of follow-up.

The sponsor must distinguish between scientifically desirable protocol uniformity and legally mandatory local modifications.

7. Jurisdictional Conflicts and Applicable Law

One of the most difficult issues is determining which country's law governs a dispute arising from a multinational clinical trial.

Consider the following example:

A pharmaceutical company is incorporated in the United States.

Its research laboratory is located in Germany.

Its principal investigator is employed in India.

Indian patients participate in the trial.

Biological samples are transferred to Singapore.

Trial data are processed in Ireland.

If an Indian participant suffers an injury, several legal systems may become relevant.

A. Territorial jurisdiction

The country where participants are recruited and clinical procedures are conducted generally has a substantial regulatory interest.

India can regulate clinical research conducted within its territory, even when the sponsor is incorporated abroad.

B. Personal jurisdiction

Courts may examine whether the foreign sponsor has sufficient legal connections with the forum country to be brought before its courts.

Relevant factors include:

Conduct of business in the jurisdiction.

Recruitment of local participants.

Local contractual arrangements.

Appointment of local representatives.

Activities of subsidiaries and research organizations.

Nature of the alleged wrongdoing.

C. Contractual jurisdiction

Clinical-trial agreements may contain:

Governing-law clauses.

Arbitration clauses.

Dispute-resolution provisions.

Indemnification provisions.

Insurance arrangements.

Allocation of sponsor and investigator responsibilities.

However, contractual provisions cannot necessarily exclude mandatory statutory protections available to participants.

D. Conflict of laws

Courts may need to determine:

Which law governs the participant's consent agreement?

Which law governs negligence?

Which law determines compensation?

Which country's regulatory decision is relevant?

Whether a foreign judgment can be enforced domestically.

Whether the sponsor can rely on a foreign regulatory authorization as a defence.

The answer depends on the relevant national conflict-of-laws rules and the circumstances of the dispute.

8. Liability for Conflicting or Invalid Trial Approvals

Cross-border approval conflicts can create liability for several categories of actors.

A. Sponsor liability

A sponsor may be liable where it:

Starts recruitment without required authorization.

Fails to obtain local ethics approval.

Conceals adverse events.

Uses an unauthorized investigational product.

Fails to arrange legally required compensation.

Implements a protocol that violates local law.

B. Investigator liability

Investigators may incur professional, civil, or statutory liability for:

Departing from approved protocols.

Failing to monitor participants.

Inadequate disclosure.

Improper recruitment.

Failure to report serious adverse events.

C. Institutional liability

Hospitals and research institutions may face liability where they fail to verify approvals, maintain adequate oversight, or protect participants.

D. Regulatory accountability

Government authorities may be subject to judicial review when approval decisions are arbitrary, procedurally defective, discriminatory, or inconsistent with statutory obligations.

However, regulatory approval does not automatically make the regulator liable for every injury suffered by a participant.

9. Special Problems in Advanced Biotechnology Trials

A. Cross-border gene-therapy trials

Gene therapies - Cell and Gene Therapy

ct.catapult.org.uk

Gene therapies create special approval conflicts because different jurisdictions may classify them differently.

For example, a genetically modified cell product may be treated as an advanced therapy medicinal product in the EU and as a biological product under the US regulatory system.

Issues include:

Gene-editing authorization.

Long-term safety monitoring.

Germline versus somatic intervention.

Genetic information disclosure.

Unexpected genomic alterations.

Cross-border adverse-event reporting.

A foreign authorization does not automatically permit administration of the product in another jurisdiction.

B. Stem-cell and regenerative medicine trials

アーティストやアスリートが通う、「老化」を「治療」する最先端再生医療とは | GOETHE

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Stem-cell trials raise conflicts involving:

Classification of cell-based products.

Embryonic material.

Donor consent.

Tissue provenance.

Cross-border biospecimen transport.

Manufacturing standards.

Long-term monitoring.

A treatment described as a clinical trial in one country might be considered an unapproved commercial treatment in another.

C. Artificial intelligence-assisted clinical trials

How AI is Transforming Clinical Trials

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AI-assisted trials create additional approval difficulties.

Examples include:

AI-based patient selection.

Algorithmic diagnosis.

Automated dosage recommendations.

Digital biomarkers.

Remote clinical monitoring.

AI-generated trial endpoints.

A regulator may approve the medicine but not the particular AI system used to determine treatment decisions.

The sponsor must therefore examine whether separate medical-device, software, data-protection, and clinical-investigation requirements apply.

D. Digital and decentralized clinical trials

Remote clinical trials may involve patients participating from several countries without visiting a central research institution.

Legal problems include:

Determining where the trial is legally conducted.

Identifying the applicable professional licensing requirements.

Validating electronic informed consent.

Protecting cross-border health information.

Determining responsibility for remote medical emergencies.

Maintaining appropriate local medical supervision.

The physical absence of a conventional trial site does not necessarily eliminate the jurisdiction of the country where participants reside.

10. Remedies and Legal Mechanisms for Resolving Approval Conflicts

Several mechanisms can help resolve cross-border trial approval disputes.

A. Mutual recognition arrangements

Countries can establish arrangements for recognizing specified regulatory assessments.

However, mutual recognition should not be confused with automatic acceptance of every foreign trial approval.

Recognition may be limited by:

Product category.

Regulatory equivalence.

Inspection standards.

Ethical requirements.

National public-health considerations.

B. Coordinated regulatory assessment

Regulators can coordinate their examination of a common clinical-trial dossier.

This can reduce duplication while preserving national authority over local participant protection.

The EU Clinical Trials Regulation provides an important example of coordinated multinational assessment.

C. Harmonized clinical-trial protocols

Sponsors should prepare a common scientific protocol with jurisdiction-specific annexes.

These annexes can address:

Local consent requirements.

Compensation.

Insurance.

Ethics approvals.

Safety reporting.

Import permissions.

Data transfers.

D. Regulatory cooperation

International cooperation can involve:

FDA.

European Medicines Agency (EMA).

CDSCO.

Therapeutic Goods Administration (TGA).

World Health Organization.

National ethics authorities.

Such cooperation can improve consistency in scientific assessment and safety monitoring without removing national legal requirements.

E. Judicial review and administrative appeals

Where an authority rejects or withdraws an approval, the sponsor may have access to administrative reconsideration, statutory appeals, or judicial review, depending on the applicable legal system.

In India, the New Drugs and Clinical Trials Rules, 2019 provide an appeal mechanism under Rule 32 for specified orders of the Central Licensing Authority.

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F. Compensation and civil litigation

Participants who suffer research-related injuries may pursue remedies under applicable statutory and civil-liability frameworks.

The existence of a foreign approval does not necessarily defeat a local compensation claim.

11. Practical Compliance Framework for Multinational Sponsors

A multinational sponsor should adopt the following approval-management process.

Identify all participating jurisdictions

Identify countries where participants are recruited, research procedures occur, products are administered, and samples or data are transferred.

Conduct a regulatory classification assessment

Determine whether the research involves a medicinal product, medical device, biological product, gene therapy, or another regulated intervention.

Obtain national regulatory authorization

Apply separately to the competent authorities wherever domestic legislation requires it.

Obtain local ethics approval

Verify the registration, independence, and competence of each required ethics committee.

Prepare jurisdiction-specific consent documents

Address language, disclosure, participant rights, privacy, compensation, and withdrawal requirements.

Establish safety and compensation arrangements

Arrange appropriate insurance, medical treatment, adverse-event reporting, and legally required compensation.

Verify investigational product importation

Obtain the necessary manufacturing, import, storage, and distribution permissions.

Register the trial

Complete applicable national and international trial-registration requirements before participant recruitment.

Maintain continuing regulatory oversight

Report safety events, submit protocol amendments, and obtain additional approval where required.

12. Critical Legal Issues and Emerging Doctrines

The following emerging issues are particularly important for advanced biotechnology law research.

Particularly important emerging problem: Regulatory arbitrage

Regulatory arbitrage occurs when sponsors choose jurisdictions with comparatively less restrictive approval requirements to conduct research that would be difficult or prohibited in more protective jurisdictions.

This may create situations involving:

Recruitment of economically disadvantaged participants.

Inadequate consent procedures.

Insufficient post-trial access.

Weak compensation arrangements.

Unacceptable research risks.

Inadequate long-term monitoring.

The legal response should involve effective host-country supervision, sponsor accountability, ethical review, and international regulatory cooperation.

13. Critical Analysis

Cross-border trial approval conflicts reveal a fundamental tension between two competing objectives.

First: International scientific harmonization.

Multinational pharmaceutical companies need consistent research protocols, coordinated regulatory reviews, and predictable authorization procedures.

Second: National protection of human participants.

Every country has legitimate interests in protecting its population against unsafe, unethical, or inadequately supervised research.

Complete harmonization could undermine national ethical standards if it forced countries to accept foreign approvals without meaningful review. Conversely, excessive regulatory duplication could delay beneficial research and increase costs.

The appropriate legal approach is therefore coordinated recognition rather than unconditional mutual recognition.

A foreign regulatory assessment may be considered relevant scientific evidence, but the host country should retain the ability to examine local ethical issues, participant protection, public-health risks, and mandatory domestic requirements.

14. Conclusion

Cross-Border Trial Approval Conflicts represent an important area of international biotechnology and pharmaceutical law.

The principal legal challenge is not simply obtaining approval from multiple countries. It is ensuring that different regulatory systems operate consistently without compromising participant autonomy, human dignity, research ethics, and public-health protection.

The decisions in Swasthya Adhikar Manch v. Union of India, Grimes v. Kennedy Krieger Institute, Hart v. Brown, Schloendorff v. Society of New York Hospital, Salgo v. Leland Stanford Jr. University Board of Trustees, and Canterbury v. Spence establish important principles relevant to research authorization, informed consent, participant safety, and institutional accountability.

Ultimately, an effective international clinical-trial framework must combine:

National regulatory sovereignty.

International scientific cooperation.

Independent ethical review.

Meaningful informed consent.

Transparent safety monitoring.

Cross-border sponsor accountability.

Effective compensation and legal remedies.

The fundamental legal principle is that international scientific cooperation cannot be used to circumvent the domestic legal and ethical protections owed to human research participants.

15. Important Legal Sources for Further Research

Official and research references:

India – New Drugs and Clinical Trials Rules, 2019.

CDSCO – Global Clinical Trial Division.

CDSCO – Ethics Committee requirements.

Clinical Trials Registry – India.

Swasthya Adhikar Manch v. Union of India.

Grimes v. Kennedy Krieger Institute (2001).

Academic note: The cited judicial decisions are relevant supporting authorities, not all direct precedents on conflicts between foreign clinical-trial approvals. The distinction is important when developing a dissertation, research paper, or comparative-law argument.