Challenges to EU Regulation of Vaccines for Pandemic and Epidemic Diseases
This post sketches the themes of the article “Vaccines for Pandemic and Epidemic Diseases: Towards Defining the Space of EU Public Health between Security Policy and a Transnational Market” (accessible free of charge until 10 January 2018), just published in the European Journal of Risk Regulation. The paper was originally presented at the workshop “Germs, Terrorism and Chemical Attacks” sponsored by CERiM (Brussels, 21-22 November 2016).
Pandemic and epidemic diseases (PEDs) are a frightful feature of human history, which have left indelible marks on societies across the globe and inspired countless horror stories and cautionary tales. In recent years the topic has recaptured international attention with cross-border outbreaks of Swine Flu, Avian Flu, Ebola and Zika. The EU has developed over time a number of policies and regulations geared towards both prevention and reaction. In particular, the Health Threats Decision (HTD) 1082/2013/EU provides a comprehensive policy framework to strengthen preparedness, improve management, enable medical countermeasures and enhance cooperation in the face of cross-border threats to public health. Yet there are insufficient regulatory tools for the prompt development of vaccines for PEDs beyond the quintessentially “Western” disease that is influenza. Besides, the field is experiencing a struggle between, on one hand, a progressive securitization of EU health-threats prevention and management (in accordance with international trends), and on the other hand a pervasive regulatory influence of the private sector inspired by the competing goal of product marketability. In this context, it is essential that free-standing public health considerations do not become subordinate.
Public health emergencies are transnational in nature, and so is their response framework. As such, the EU’s governance of health threats is the product of a complex juxtaposition of policy, regulatory and decision-making levels. We identify three main levels affecting the regulatory framework of vaccines approval:
1. A public international level where the World Health Organization (WHO) is tasked with providing basic definitions of epidemics and pandemics, and setting the parameters to declare a state of emergency. Within a PED situation, WHO provides overarching guidance to affected countries in the form of the International Health Regulations (IHR 2005) and, in parallel, a Research & Development Blueprint for the prevention of epidemics.
2. A transnational hybrid level where regulatory networks, such as the International Council on Harmonization (ICH), are tasked with the development of safety, quality and efficacy standards, as well as emergency governance guidelines including marketing authorization standards, negotiated by regulators and representatives of the industry as peers. The major impact of such guidelines on domestic regulatory frameworks raises serious questions of accountability, as in such a technical field standard-setting often amounts to policy choice.
3. A public domestic level establishing public health priorities and prevention/response mechanisms, where international and transnational guidelines are merged with domestic policy.
The principal interest in this multi-layered structure is that each level is influenced by different drivers. WHO is moved first and foremost by global health goals, and to this end it increasingly relies on readiness-and-response biosecurity strategies. Transnationally, the main driver is on the other hand market efficiency, the principal concern of ICH being the removal of unnecessary duplications and obstacles to the marketing of new products across jurisdictions, with public health considerations used to delimit a broad perimeter of action. Finally, in the domestic arena public authorities must attempt to synthetize the three factors (public health, biosecurity and market efficiency).
This regulatory pyramid is challenged by the increasing menace of “tropical” diseases (such as hemorrhagic fevers like Ebola or Lassa, or the Zika virus). These pose a concrete threat to public health globally in a world of increasing individual mobility, yet are not reflected in emergency vaccine development procedures. Major initiatives such as the Global Action Plan for Influenza Vaccines (GAP) internationally, as well as EU domestic rules contained in Regulation (EC) 1234/2008, are exclusively focused on the fast approval of vaccines for influenza. While biosecurity mechanisms developed internationally in the IHR 2005, and in the EU through the adoption of the HTD, have a wide focus on rapid exchange of information and assessments, containment strategies and hygienic preventive behaviours, vaccine development as such remains disease-specific (which so far means influenza-focused). It is no surprise that in the EU the HTD finds its legal basis in Art. 168 TFEU, while fast-track approval of vaccines is an internal market issue (based on Art. 114). Internationally, this impasse has prompted WHO to promote the Emergency Use Assessment and Listing Procedure (EUAL) for situations in which communities are ready to tolerate a lesser degree of safety and efficacy of products in light of the potential consequences of the disease. This scheme is currently being tested in Guinea to face an ongoing outbreak of Lassa fever, but scarcity of funding for clinical trials is slowing down the process, defeating the goal of speediness. While international collaborative schemes are in place, a significant gap exists between developed and developing worlds’ public health priorities when it comes to the development of costly vaccines.
A strong biosecurity narrative on one hand, market-based considerations in product R&D on the other. Defining and protecting the space of public health considerations in the development of vaccines in the face of PEDs requires confronting these divergent forces, and further academic research will be paramount to this end.
Dr Marco Rizzi is the former Head of the Department of Law at the University of Seychelles, and as of 15 March 2018 Senior Lecturer (Private Law) at the University of Western Australia (currently on parental leave). His main research interest is the increasing pre-eminence of transnational health products regulations and their interaction with national civil remedies (in particular tort law). He is currently completing a monograph for Cambridge University Press titled “Transnational Pharmaceutical Regulation in the Courts: Closed System, Hard Looks”.