Promoting international agreements can enhance regulatory cooperation over public health.
The current COVID-19 pandemic has generated a heated debate about the risks of globalization and the effectiveness of international and regional organizations in handling global crises. Public health governance and regulatory foundations are being tested and questioned. International cooperation has taken a back seat to the pursuit of national self-interest. There is a growing chasm between the need for cooperation and the willingness of countries to cooperate.
In this politically charged atmosphere, some public officials dismiss current multilateral and regional institutions and their approaches as outdated, slow, and unable to rise effectively and efficiently to global challenges.
In a recently published report, a committee of the U.S. National Academies of Sciences, Engineering, and Medicine provides insight and useful recommendations for regulatory cooperation during a global health crisis. The National Academies’ report examines international cooperation mechanisms for pharmaceutical regulation and shows why mutual reliance practices need to be strengthened, not torn down. No national regulator can realistically cope with the enormity of the global regulatory oversight task alone, especially during a global pandemic.
In its report, the committee describes how the development, production, and marketing of medicine has become a global business. Pharmaceutical companies rely on intricate supply chains to source ingredients. They carry out trials in many different countries, and they market their products globally.
Given the prevalence of globalization, regulators face enormous challenges in their efforts to ensure the safety, quality, and efficacy of medicine. The burdens of inspection have become increasingly heavy as supply chains have become global. Pharmaceutical firms in the European Union (EU) and the United States import most of their active pharmaceutical ingredients either from China or India, increasing the need for inspections of facilities in those countries. The rapid pace of technological developments and the introduction of new therapies also present challenges to effective regulation.
To manage a burgeoning workload, regulators need to rely on trusted counterparts. Over the past few decades, domestic regulators have made considerable progress building reliance relationships based on trust with their counterparts in other countries.
Relationships of reliance take many forms, including informal collaboration as well as legally binding, mutual recognition agreements (MRAs). The EU, for example, began to develop MRAs with countries such as the United States and Japan in the late 1990s, recognizing the partner countries’ compliance with good manufacturing practices. The mutual recognition of acceptable manufacturing practices reflected in these agreements eliminated the EU’s need to inspect manufacturing sites in partner countries.
By eliminating redundant inspections, MRAs allow pharmaceutical regulators to conserve resources that can then be redirected, for example, into medicines review and approvals, reducing the time needed to get essential medicine to the market. Similar public health benefits accrue when regulators share unredacted assessments with less well-resourced regulators. Information-sharing through confidentiality agreements expedites access to safe medicines that would otherwise have needed considerable time and resources to bring to local markets.
The National Academies’ committee concludes its report by emphasizing that regulatory cooperation and reliance are essential if national regulators are to ensure the safety, quality, and effectiveness of medicine in a globalized market. One way to strengthen cooperation is to expand the scope of current MRAs to cover a broader range of drugs and to go beyond mutual recognition of inspections of manufacturing premises to recognize clinical trials and post-market surveillance in other countries. In addition, regulatory authorities could share unredacted information with one another, facilitating valuable communication.
This message of collaboration and reliance is needed now in the current cacophony of voices alleging the ineffectiveness of global public health institutions and calling for new approaches that serve solely national interests.
In response to these calls, it is important to emphasize that in today’s globalized environment, it is difficult to imagine any workable, sustainable solution to a public health issue that does not involve some form of international regulatory cooperation. Such cooperation rests on a foundation of trust, transparency, and adaptability—essential elements in any new solutions for today’s public health crisis.
Regulatory cooperation requires trust between regulators, buttressed by political support at the highest levels. It is a long-haul exercise. Building trust takes time. Trust is easily broken but often difficult to repair. Even in the field of medicine, where regulators have similar standards as well as similar legal and institutional frameworks, it has taken many years to establish the mutual confidence and understanding necessary for fruitful regulatory cooperation.
For example, within the EU system, regulatory authorities from more than 30 countries work together, with a common set of pharmaceutical rules and requirements. The system works because national pharmaceutical regulators are confident that their counterparts respect these standards and implement laws effectively. The system took many years to mature, with the development of public health laws at the EU level and the creation of institutions such as the European Medicines Agency being relatively recent.
The EU’s MRA with the United States, while signed in 1998, only came fully into force in 2019. The conditions for successful implementation, which importantly must include trust and confidence in each other’s systems, were not present at the outset of this agreement nor for many years afterwards.
Trust and transparency go hand in hand. Sharing full, unredacted information can expedite the approval of essential vaccines and medicines, help prevent the sale of falsified medicines, and lead to more rapid and effective resource mobilization in times of crisis. Regulators also need to keep the public informed. Importantly, regulators need to be held to account for and show results of their international cooperation efforts—for instance, through more and better ex post evaluations—to gain and keep public trust.
To respond to the current global public health crisis, regulatory authorities must be adaptable and agile. In the EU, the pandemic has exposed globalization’s impact on public health in an open, borderless economic space. Although the pharmaceutical industry is global, and infectious diseases do not respect national boundaries, health remains a national responsibility. The pandemic calls for the EU member states to examine new ways to balance national sovereignty with the daunting, supranational challenges that public health crises pose. There is a need to assess how well the EU is equipped to handle global public health crises and to make necessary adjustments to its priorities, procedures and funding. One small step would be for the EU’s regulatory authorities to design and develop medicine-related MRAs that clearly prioritize public health rather than trade.
Finally, the EU should accelerate ongoing cooperation efforts. Existing pharmaceutical MRAs could be extended to cover vaccines and blood plasma products as well as innovative medicines and therapeutics. The EU and its MRA partners must join forces and share their inspection workload in other countries, providing all concerned parties with information collected. Regulators could put more effort into sharing information with less well-resourced regulators in Africa and Asia to enable them to better meet their public health objectives.
The EU and United States are currently engaged in discussions about a proposed agreement that would provide for mutual recognition of conformity assessment procedures for manufactured goods, including medical devices and personal protective equipment. The coronavirus crisis has clearly shown the need for such cooperation to ensure the quality and improve the availability of these goods.
Enormous gains can be made when regulators work together to ensure that their citizens have timely access to high-quality, safe, and effective medicine. The conclusions and recommendations in the National Academies’ committee report can provide a springboard for enhanced regulatory cooperation in the current crisis.
This essay is part of an ongoing series, entitled Comparing Nations’ Responses to COVID-19.
