By Ana Ayala*, Anthony Brown, Emanuele Cesta, Katherine Ginsbach, Sam Halabi, Dawn Mapatano*
In a public health emergency, pharmaceutical manufacturers’ liability concerns can slow the deployment of urgently needed vaccines and other medical countermeasures (MCMs).
Products used during public health emergencies raise unique issues either because of their novelty, scale and type of proposed use, or regulatory pathway. These products may be categorized as follows:
- Registered products previously used on a large scale with a known safety profile (e.g., existing stocks of vaccines);
- Newly registered products not previously used on a large scale (i.e., with no phase IV clinical trials);
- Registered products for off label use (e.g., Hydroxychloroquine) and;
- Products which have not obtained full licensure prior to their use (i.e., products under conditional marketing authorization or approved for Emergency Use Listing, such as monoclonal antibodies).
Accordingly, pharmaceutical manufacturers will request liability protections, initiating a negotiation process that can be complicated and time consuming.
During H1N1, negotiations over liability delayed global access to pandemic vaccines by at least four months. Initial refusals to accept responsibility for injuries caused by experimental treatments similarly resulted in complicated negotiations for trial sites and liability coverage during the Ebola epidemic.
The COVID-19 pandemic has amplified this legal challenge and highlighted the need to treat liability as a key legal preparedness issue. Addressing liability before and between emergencies (and not during them) can allow all parties to benefit by placing them in an equal and transparent playing field.
Widespread international health emergencies, and particularly pandemics, can lead to a major imbalance of negotiating power between manufacturers and governments.
The capability to develop and manufacture vaccines on a global scale largely sits with pharmaceutical companies, which are subject to investor pressures, market discipline, and government regulations. Profit and loss considerations are a major factor in companies’ decisions to participate in the emergency response, which in turn can impact the availability and accessibility of products needed to stem the crisis.
Manufacturers’ fear of significant financial loss tied to liability concerns, and specifically claims from individuals who have suffered serious adverse events due to use of the MCMs, has been a critical factor in pandemic planning since at least 2005. In that year, the International Federation of Pharmaceutical Manufacturers & Associations, a global pharmaceutical lobbying organization, issued a statement that in order to participate in global pandemic response (at that point, H5N1), it would need assurances against potential legal liabilities. The demand for liability protections reemerged in 2009 during H1N1, in attenuated form during the 2014-15 West Africa Ebola public health emergency, and, prominently, during COVID-19.
A lack of legal preparedness in addressing companies’ demands for protections against loss can exacerbate inequity, especially health equity, at all levels (domestically, regionally, and globally), as it can obstruct access to MCMs particularly for low- and middle-income countries that generally lack adequate or efficient national health systems. Governments may face difficult policy decisions in their attempts to expeditiously control the spread of disease.
These challenges call for a greater understanding about the importance of developing legal tools and building capacity to help guide countries and manufacturers to find sustainable solutions based on appropriate risk sharing and equity as part of public health emergency preparedness.
Solutions
Under a legal preparedness framework, discussions on managing liability risk of MCMs while maximizing equitable access to these products can lead to long-term and balanced solutions that can be systematically integrated into countries’ legal systems and private sector partners’ practices, in order to save as many lives as possible during health emergencies and ensure protection and restoration of patients’ interests.
Essentially, the more these challenges and factors are addressed with legislation, model clauses for MCM procurement contracts, and legal preparedness plans, the more rapidly vaccines and MCMs may be distributed and administered in an equitable manner and where they are needed most.
Considering the complexities of addressing liability and balancing the need for global equitable access to MCMs during widespread international emergencies like COVID-19 and now monkeypox, the Global Health Security Agenda (GHSA) Legal Preparedness Action Package (LP AP) brought together key experts in February 2022 to establish the working group on liability risk management to generate awareness about the issue and the importance of applying a legal preparedness approach to advance the liability debate and develop technical guidance for stakeholders.
The guidance shall cover the following areas: legislation that may be enacted to facilitate expeditious procurement of MCMs; procurement agreement contractual clauses to provide countries with a starting point for negotiations with manufacturers during an emergency and to promote consistency in contractual terms across countries and blocs of countries; indemnity planning and budgeting in the event that funding is required to guarantee a contractual indemnity provision; and no-fault compensation systems to mitigate against the risk of claims by compensating individuals for serious adverse events.
Conclusion
The inefficiencies observed in negotiating procurement agreements between countries and manufacturers during COVID-19 could have been attenuated with greater legal preparedness. The LP AP sees the need to address such inefficiencies by increasing awareness of the issues and developing guidance to help expedite access to MCMs during a public health emergency.
Ana Ayala, Anthony Brown, Emanuele Cesta, Katherine Ginsbach, Sam Halabi, and Dawn Mapatano are members of the Global Health Security Agenda (GHSA) Legal Preparedness Action Package (LP AP). Established in 2014, GHSA has brought together over 70 members from around the world and across sectors to address major challenges to global health security through technical work driven by its Action Packages and coordinated political action. The LP AP is GHSA’s newest Action Package, led by Argentina, Georgetown University’s O’Neill Institute for National and Global Health Law, and the United States. Since its establishment in September 2021, the Action Package has already brought together a multidisciplinary coalition of over 20 members (countries, multilateral organizations, and civil society organizations).
To learn more about the GHSA Legal Preparedness Action Package, or to ask questions, please contact ghsalpap@georgetown.edu
* All views expressed are solely the authors’ own and do not necessarily reflect those of the U.S. Government, the U.S. Department of Health and Human Services, or the Office of Global Affairs.
