Pharmaceutical governance system for costly drugs through human rights due diligence

Challenges to increasing access to costly new drugs

Access to drugs is hindered by several different factors, many associated with intellectual property rules.11 These include industry actions to block generic competition,1213 lack of data transparency,514 and the influence of industry funded patient advocacy groups to pressure governments to fund costly drugs.15 Pressure from advocacy groups can hinder evidence informed decisions on access by diverting limited public resources towards costly treatments, instead of broader, equitable coverage, despite lack of reliable evidence. Such pressure can also impede governments from stopping funding drugs or withdrawing drugs from the market even when companies fail to produce requested evidence under conditional approval or coverage schemes, such as adaptive licensing or performance based risk sharing agreements. Adaptive licensing relates to approval of new drugs on limited preapproval data that is accompanied by obligations to gather more detailed real life evidence after approval.16

Price control efforts are further weakened by disagreements over the link between drug prices and research and development costs,1718 particularly compared with marketing costs, public investments, and governmental support.19 Meanwhile, the pharmaceutical industry warns that measures imposing additional costs and reducing profits could harm global competitiveness.20

Public health and commercial interests are often misaligned,21 making it challenging to design policies that promote investment in research and drug development targeting unmet health needs and expand access. This misalignment is reflected in conflicting governmental policies and regulations. A key issue is the lack of recognition of the responsibilities of different actors, particularly governments and corporations.

Role of governments and industry

International human rights law could offer a basis for defining the responsibilities of governments and industry to increase access to costly drugs. International human rights law on the right to health—reflected in international treaties, authoritative interpretations by, in particular, the UN Committee on Economic, Social, and Cultural Rights (CESCR 2000 General Comment 14), and related policy documents5—provides a foundation for arguing that governments should establish governance systems that promote equitable and sustainable development, distribution, and coverage of safe, effective, and affordable drugs. In addition, drug companies should operate under governance frameworks that allow reasonable profits while fulfilling responsibilities aligned with international human rights standards and contributing to the public good.5

A human rights due diligence framework could identify agreed targets for implementing human rights obligations, set access targets, and monitor compliance.

Why use a human rights framework?

First, international human rights law is widely recognised and provides a strong foundation for the right to health. The International Covenant on Economic, Social and Cultural Rights, explicitly affirms the right to “the highest attainable standard of physical and mental health” (article 12) and other health-related social rights.22 Within Europe, other sources of relevant human rights law include the European Convention on Human Rights23 and the European Union Charter of Fundamental Rights.24

Second, human rights hold a special status as high priority norms and must be prioritised over rights under other legal rules related to intellectual property law and other economic rights.2526 Although implementation of the right to health remains inconsistent—due to political, economic, and institutional barriers—there is a growing realisation that intellectual property laws and agreements and the interpretation of their rules must be informed by human rights.2728

Third, although human rights law creates direct legal obligations for governments to hold private actors accountable and promote human rights, it is increasingly recognised that all members of society—including corporations—must also respect and protect these rights.29 Corporations are deemed to have “responsibilities” instead of legal obligations, as international treaties do not directly bind them.

Access to drugs is a “right to health” issue

Access to drugs is a core component of the right to health.30 The UN Committee on Economic, Social and Cultural Rights has introduced the availability, accessibility, acceptability, and quality (AAAQ) framework for the right to health, which provides content to key global obligations.31 These four standards initially targeted health services but are increasingly applied more widely. Availability concerns adequate production and supply of drugs to meet identified needs. Accessibility requires ensuring equitable distribution. Acceptability refers to ethical norms in drug development and distribution. Quality refers to the obligation that drugs be safe and effective. The right to health extends beyond provision and coverage of drugs.5 An important obligation, under the core duty of states to provide essential medicines within the right to health framework, is to ensure reasonable prices and equitable access.32

International human rights law obliges governments to take steps to “progressively realize” the right to health, in line with their “available resources.33 A main challenge to enforcing such a right is that governments can invoke budgetary limitations to refuse coverage of costly drugs. Yet, they remain obligated to mobilise all resources to progressively realise the right to health—particularly to ensure access to essential medicines—including through international cooperation and low cost policy options.32 States must also strengthen pharmaceutical governance through policies on financing drug development, rigorous regulatory review of efficacy and safety, and evidence informed decision making.14 Governments must also target the needs of vulnerable members of society (eg, economically disadvantaged people) and set up systems to monitor realisation and progress.31

A 2008 report by the UN rapporteur on the right to health identified specific human rights responsibilities of drug companies.34 These responsibilities included supporting governments and international organisations in tackling unmet needs, providing reliable information to facilitate rational price determinations, and committing to data transparency. The report encouraged exploration of alternative approaches to promote access to drugs—for example, through collaborations such as the Medicines Patent Pool and industry participation in compulsory licensing initiatives (under TRIPS, governments are allowed to over-ride patents, for example, in public health emergencies).

Human rights due diligence

The 2008 UN report is connected to work by John Ruggie, special representative of the UN secretary general on business and human rights.2935 Ruggie proposed corporate human rights due diligence programmes, inspired by standard corporate due diligence processes. The approach encourages companies to proactively identify the potential effect of their operations on human rights and to prioritise risks to people over economic interests.36 Ruggie identified four core components: the company’s public commitment to respecting human rights; periodic assessments of the effect of company activities on human rights; internal oversight mechanisms; and the tracking and public reporting of performance.29

Such processes have been introduced in several corporate sectors, including through national legislation. For example, the Dutch Child Labour Due Diligence Law 2019 requires companies to assess their global supply chains for child labour.37 The French Duty of Vigilance Act 2017 imposes vigilance plans to prevent severe human rights and environmental harms.38 The German Corporate Due Diligence Obligations in Supply Chains Act 2023 enforces robust due diligence measures to assess, prevent, and address human rights violations and environmental damage.39 Such processes have also been voluntarily adopted in some sectors such as sportswear, textiles, and industrial transportation to assess corporations’ performances in relation to labour standards.

The effectiveness of human rights due diligence programmes is still being evaluated as most such programmes are new. They have been criticised for overemphasising procedure and for the challenges in enforcing voluntary standards by civil society or governments.40 Concern has been raised that human rights due diligence may provide only a cosmetic perception of compliance, which hinders meaningful change.41 Yet, human rights due diligence frameworks can foster collaboration to achieve agreed targets in the context of international human rights. Regular review of such programmes can guide new national, regional, and international regulatory initiatives to promote access to costly drugs.4041

Human rights due diligence offers a structured, rights based alternative to fragmented reforms and voluntary corporate social responsibility. It embeds accountability in international law, and its adoption in national legislation, with independent monitoring mechanisms, could increase transparency and stakeholder engagement. While not a cure-all, given challenges including inconsistent implementation and limited enforcement, human rights due diligence complements tools such as patent pooling and price transparency by aligning corporate conduct with human rights. Effective implementation requires further technical development—for example, sector specific indicators, independent monitoring, and phased rollouts from voluntary to binding commitments. Long term success depends on supportive national laws and international agreements to mandate use, define enforcement, and align corporate obligations with human rights standards. In discussions about intellectual property and drug regulatory reform, human rights due diligence targets can serve as benchmarks for reform.

Recommendations for implementation

The Access to Novel Medicines Platform of the World Health Organization’s Region for Europe could coordinate implementation of human rights due diligence across Europe.42 The platform brings together online governments, industry, and other stakeholders to facilitate the development and implementation of policy solutions and establish pilot projects, building on the work of the Oslo Medicines Initiative.43 Several of the platform’s goals are aligned with those we identify under a right to health framework. The platform has working groups to promote transparency, solidarity, sustainability, and the promotion of new antimicrobials. A new working group for human rights due diligence could set targets and priorities, develop reporting structures, produce reports, and introduce a scorecard system to publicly track progress by governments and corporations.

UN human rights agencies already publish regular reports on the performances of countries with respect to human rights. Public reporting is key to holding governments and corporate actors accountable for meeting human rights due diligence targets.

Recommended actions for states and drug companies

The AAAQ framework provides guidance for stakeholders to develop specific, detailed commitments that need to be targeted under a human rights due diligence framework. States have the most direct obligation to act. To create governance rules for research, production, distribution, and coverage of drugs that promote access to safe, effective, and affordable drugs, and in turn support the human rights due diligence process, states should implement the activities outlined in box 1.

To support the human rights due diligence process, drug companies should also commit to undertaking specific activities to help achieve the objectives and targets set by the human rights due diligence working group. Similar frameworks have been introduced in other sectors through laws such as France’s Duty of Vigilance Act and Germany’s Supply Chain Act. These have been voluntarily adopted in industries such as textiles and transportation, although their effectiveness is still being assessed, and concerns about cosmetic compliance remain. In the drug industry, feasibility may lie in phased implementation, starting with voluntary commitments, sector specific indicators, and independent monitoring, and progressing to binding obligations under national and international law. WHO’s Access to Novel Medicines Platform could coordinate pilot schemes and reporting. Incentives for industry include reputational gains, alignment with emerging legal norms, and potential preferential access to public funding and procurement.373839Box 2 lists the responsibilities of drug companies, gathered from previous international human rights reports,2934 under the AAAQ framework.

The commitments require supportive legal frameworks, including transparency mandates, price control mechanisms, and due diligence obligations embedded in national law and aligned with international trade and human rights agreements. Meanwhile, under the obligations in box 1, governments must implement evidence based reforms aimed at better coordinating regulatory systems, enacting appropriate price controls, streamlining drug and device regulations, and ensuring coverage for drugs. However, challenges remain, such as industry resistance, limited regulatory capacity, and political pressure from trade partners. To tackle these challenges, governments could adopt phased implementation strategies, starting with transparency mandates and public procurement reforms, supported by international technical assistance.

Drug companies, in turn, must justify their prices through full cost disclosure, and avoid regulatory manipulation—such as evergreening (extending patent life through minor modifications) or pay-for-delay tactics (paying generic manufacturers to postpone market entry)13—by committing to independent audits and public reporting. They must work with full transparency with governments and civil society to keep the prices of these products affordable. Embedding these practices in national law and linking them to international trade and human rights agreements could help ensure compliance and sustainability.

The framing of these obligations and responsibilities as based on international human rights identifies them as high priority norms that should be respected and promoted by governments and corporations. International human rights reports on the progress of individual countries often spur governments into action. The explicit commitment of corporations to human rights, combined with reporting obligations under a human rights due diligence framework, can be used by civil society and governments to hold corporations accountable. Corporations could be rated on specific responsibilities—for example, their respect for transparency of pricing components and data from clinical trials; their provision of access to drugs for clinical trial participants; and other access to medicines initiatives such as participation in voluntary licensing or technology transfer schemes. Emphasis on the human rights components of access to new drugs should help inform ongoing and future discussions on reform of global intellectual property rights.