The EU is continuously developing strategies, policies and regulations to confront pandemic and epidemic diseases. The actions of the EU in this field do not happen in a vacuum but are instead embedded in a complex international and transnational network. This article suggests the existence of a tension between public health policy and a twofold set of competing considerations: growing security concerns and market pressures. To structure the argument the article examines three distinct but related aspects: first, it clarifies the different levels of decision-making impacting on the EU’s policy and regulation of vaccines for PEDs: these levels are described as international, transnational and domestic, and the key players involved at each level are also identified; second, it analyses levels of responsiveness to and preparedness for outbreaks and analyses how past experiences have oriented the policy debate; third, it discusses issues of accountability of vaccine developers, authorising authorities and rule-makers involved in preparedness and response to emerging PEDs.

Socioeconomic disadvantages are amplified by the COVID-19 pandemic all over the world. Public actions and omissions severely affect the poor, alongside their precarious living, health and working conditions. As we slowly prepare for the aftermath of the pandemic, thanks to the progression of vaccination, especially in developed countries, certain measures taken in this context, more specifically the “vaccination certificates”, are likely particularly to affect the poor, who usually also belong to other vulnerable groups such as ethnic minorities or single parents, and could eventually constitute for them a state of permanent quarantine. In this contribution, I argue that COVID-19 vaccination certificates are a slippery slope towards exclusion and stigmatisation of the poor through a bureaucratic system based on privileges that raises important questions in light of the fundamental rights of the people who reside at society’s margins, struggling to conform to the “phantom of normalcy”.

This article analyses how emergency legislation has affected law-making and regulatory quality principles (RQPs) before, during and after the COVID-19 pandemic (2019–2021) from stakeholders’ perspectives. It takes Slovakia as a case study, as this country was considered a high performer in the adoption of RQPs before the crisis, while empirical findings suggest a subsequent decline in their use. We argue that formal RQPs are not deeply embedded and are vulnerable to crises. In doing so, we conceptually distinguish between standard (fully following the RQPs), emergency (modified to accommodate crisis) and non-standard law-making (violating formal rules and the RQPs). In the transition from a crisis to a post-crisis context, the deployment of both emergency and non-standard law-making has become relatively permanent without proper justification having been provided. This reinforces the notion that RQPs and governance legitimacy became less important for the executive than in the pre-crisis period and emergency and non-standard regulatory law-making became institutionalised as new norms of swift law-making. All of these factors prevent stakeholders from being informed and from engaging in deliberation, which jeopardises the legitimacy of post-crisis law-making governance.

Grand challenges are shaping twenty-first-century politics. Threats connected to health, climate, demographics and welfare are increasingly intruding on the lives of citizens. Still, governments are often found off-guard, and policymakers need strategies grounded in longer-term perspectives. Strategic foresight (SF) helps us to design and shape policies to prepare to withstand shocks, anticipating and adapting to changes. However, as governments work towards embedding SF into their policymaking processes, the empirical evidence suggests that applications are still piecemeal and predominantly limited to the agenda-settings and policy formulation stages. In this article, we argue that to drive anticipatory governance, foresight needs to be applied at all stages of the policy cycle, including in evaluating policies to draw lessons for future interventions. We maintain that considering SF systemically throughout the policymaking cycle, from agenda setting to evaluation, strengthens anticipatory governance.

This article further develops the concept of algorithmic vulnerability. The analysis is built on empirical evidence of the Chinese Health Code System (HCS), compared to similar plans for the “COVID-19 Certificate” in the European Union (EU). Implementing the HCS has shown two-sided regulatory implications: improving social protection (a national strategy, a common mutual-recognition standard, scaled-up public–private cooperation) and increasing risks of social exclusion (non-digital and digital forms of vulnerability). This article argues that algorithmic vulnerability is caused by mismatches between biased databases, unfairly pre-designed algorithms and dynamically changed risk groups in reality in the context of COVID-19 vaccination. It contributes a framework for deploying plans for digital certificates in the EU concerning minimising the social risks associated with algorithmic vulnerability. The framework consists of (1) reinforcing existing vulnerability inherited from non-digital society (eg caused by intersectional factors of race/ethnicity, gender, age and health) and (2) introducing new forms of vulnerability generated by algorithm design and implementation (eg excluding the risk groups of individuals who are un/mis/overrepresented in the databases, such as those defined by nationality plus COVID-19 status).

This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

The dialectic between the technically (or scientifically) possible and the legally possible, which is implied in decision-making in conditions of uncertainty, raises crucial issues from a constitutional perspective. In particular, the emergence of a new factor of legitimacy – which could be envisaged as a form of “scientific legitimacy” – can be detected and needs to be integrated within the constitutional discourse.

Through an overview of the case law of the Italian Constitutional court, the paper aims at highlighting the possible approaches to the need of a deeper integration of technical and scientific knowledge within the public decision-making processes, in an attempt to strike a balance capable of avoiding the two extremes of scientifically weak decisions on one hand, and of “technical deference” to experts on the other.

On 14 November 2018, Poland’s Ministry for Agriculture and Rural Development notified the European Commission (hereinafter, Commission) of its intention to introduce mandatory country of origin labelling (hereinafter, COOL) for potatoes on the basis of a Draft Regulation of the Minister for Agriculture and Rural Development amending the Regulation on the labelling of certain foodstuffs (hereinafter, Draft Regulation).1 Poland’s notification is the most recent example of the continuously increasing number of EU Member States’ measures on COOL for foodstuffs. While the EU already provides COOL requirements for fruits and vegetables in Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors2 (hereinafter, Regulation (EU) No 543/2011), they do not apply to fresh potatoes.

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

The technical, natural science-based approach, with a focus on the likelihood of possible consequences and damage potential, has been adapted to deal with risks, such as genetically modified organisms, or newly synthesised materials, which cannot be managed merely by existing technocratic procedures. For a number of years already, professional risk assessment and management communities have advocated for a change, claiming that major controversies, crises and scandals around food, environmental health and technological innovations have necessitated a reshaping of traditional risk regulation towards a more integrative risk governance.1 In this approach risk experts, policy-makers, stakeholders and civil society organisations (CSOs) are working together towards identifying risks, generating and evaluating options, and coming to a strategy. This is reflected, for example, in the analytic-deliberative approach embodied in the modified IRGC Risk Governance Framework2 that includes concern assessment in parallel with the more conventional risk assessment. Decision-makers need to understand the nature and strengths of societal concerns and consider them alongside more technical recommendations for action. The ideas by the IRGC have a social science basis, but more or less at the same time in the natural science oriented risk assessment community comparable ideas and concepts have been developed. From the 1990s onwards, the US-based National Research Council (NRC) published several reports on how risk assessments should remain credible and authoritative in times of scientific uncertainty and strong competing interests.3 In 2005, the “European” International Risk Governance Council published their white paper, which addressed similar challenges. In this article we focus on the IRGC risk governance framework.4

Despite the popularity of risk governance frameworks amongst scholars and policy-makers, there has been little research done that shows how major institutes for risk research and assessment try to implement the underlying risk governance principles. This is surprising, since such institutes are necessary actors in this process. New technologies show opportunities, but also raise a number of risk-related social, economic and political issues. The governance of these risks is a challenge: the stakeholders and public involved hold vested positions; values are at stake; and the science is complex, uncertain or even incomplete. Yet, the expectations of policy-makers that institutes for risk research and assessment can adequately deal with these risks are often high. On the one hand, it is acknowledged that these risks can be complex, uncertain or ambiguous and need approaches in line with risk governance principles; on the other hand these institutes are also expected to deliver clear and unambiguous answers.5 Operating within this precarious field of tension, the Dutch National Institute for Public Health and the Environment (RIVM) has become an important actor in the implementation of risk governance principles in the Netherlands. The institute has an open attitude towards risk governance principles and new approaches, and has been at the forefront in supporting the Dutch government in developing its national risk governance strategy.6 Moreover, RIVM has its own strategic research budget, from which projects can be funded in which risk researchers and staff members can experiment in ways to translate risk governance principles into practice.

In this article, we want to shed more light on the process of applying risk governance principles in an institutional setting like the RIVM. The importance of the institutional context has already been addressed by Renn and Walker,7 but only in conceptual terms. Boholm, Corvellec, and Karlsson8 have given a more descriptive perspective on day-to-day risk governance in institutional settings. In a similar way, we investigate actual dealings with risk issues as they unfold in the RIVM context.

Most European countries’ constitutional obligations guarantee and protect public security and fundamental rights. One aspect and often a prerequisite for the protection of public security and individual rights is the protection of critical infrastructure (CIP). CIP is of great importance in Switzerland, which is inevitable in an economically and technologically sophisticated and densely populated country.

The global obesity epidemic was in focus at the 7th Summer Academy on Global Food Law and Policy in Gexco/Bilbao in July 2015. It approached this accelerating public health concern from the angle of risk regulations as linked to processing, trade, marketing and choice/consumption of foodstuffs, addressing also risks of negative impacts on public health at the consumer end. A wealth of expertise enlightened participants about current developments regarding EU and US legislation on risk assessments and risk management.

The EU institutions and agencies have become increasingly involved in enforcing EU law directly vis-à-vis private actors. A number of such EU entities have also acquired the so-called emergency powers, which allow interference with the legal position of a private party. Given the lack of research in this area, the question that this article addresses is whether relevant safeguards have been introduced to ensure the rule of law in such situations to prevent the abuse of executive discretion by public authorities. What are the relevant safeguards in the emergency in the EU in the first place? Having analysed relevant EU legislation and case law, the article offers a complete overview of all the existing EU entities with the emergency powers and shows a great diversity in the extent to which the EU legislator has regulated procedural safeguards in relevant law. The article discusses what safeguards need to be ensured in an emergency and argues for clarity of legislative frameworks in this respect.

District Court of The Hague, 24 June 2015, The Urgenda Foundation v. The Netherlands, ECLI:NL:RBDHA:2015:7145

The Dutch State has to ensure that the Dutch emissions in the year 2020 will be at least 25% lower than those in 1990.

The parties agree that the severity and scope of the climate problem make it necessary to take measures to reduce greenhouse gas emissions. Based on the State's current policy, the Netherlands will achieve a reduction of 17% at most in 2020, which is below the norm of 25% to 40% for developed countries deemed necessary in climate science and international climate policy.

With this order, the court has not entered the domain of politics. The court must provide legal protection, also in cases against the government, while respecting the government's scope for policymaking. For these reasons, the court should exercise restraint and has limited therefore the reduction order to 25%, the lower limit of the 25%-40% norm.

In times of low economic growth and post-Copenhagen climate talks, a number of reasons for regulatory competition and cooperation between the United States and the European Union coexist. This paper discusses the role of Impact Assessment between the US and the EU on responses to the economic downturn and climate change. It is argued that, in the future, IAs will be an instrument through which it will be possible to read the level of cooperation and competition between the US and the EU, particularly on economic trade and environmental regulation.