This report examines what has come to be known as “vaccine nationalism” through the lens of the early experience with the COVID-19 vaccination process. After explaining the meaning of the term, this report investigates how this phenomenon has manifested during the COVID-19 pandemic, identifying its epidemiological, economical, ethical and legal aspects. It also looks at the different international

Amidst a growing interest from European Union (EU) Member States, the European Commission recently announced that it would put forward a legislative proposal for the adoption of a harmonised and mandatory front-of-pack nutrition labelling scheme at the EU level. The present contribution discusses the implications of such an adoption, taking a behavioural, legal and policy angle. It introduces first

COVID-19 has demonstrated the fragility of EU free movement rules when we are faced with an unknown virus of such magnitude and strength that it threatens our lives, health systems, economies and society. The aim of this text is to show the dynamics between the threat of COVID-19 and the rules imposed as a response to the pandemic, which have impacted the functioning of the EU internal market and the

For some time, pressure was placed on the European Food Safety Authority concerning the manner in which it conducted risk assessments in relation to food safety. This pressure culminated in the introduction of Regulation (EU) No. 2019/1381 as the upshot to the European Citizens’ Initiative on glyphosate. Concerns were expressed in the initiative regarding the transparency of the scientific studies

In a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible

This contribution evaluates whether European Union State aid policy could play a role in achieving deeper and more solidary integration in the area of public health. According to Article 107 TFEU, the powers of Member States to grant aid to help their economies are seriously limited. Exceptions to the general prohibition to grant State aid are authorised by the European Commission, which enjoys wide

The marketing of tobacco, alcohol, unhealthy food and gambling services is harmful to public health, the European economy and sustainability. If the European Union (EU) has embraced the regulation of cross-border marketing for tobacco products for over two decades, it has consistently resisted evidence-driven calls to regulate the marketing of other harmful commodities, preferring instead to rely on

Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions

Evolving consumer tastes and competing food trends have made the modern foodscape ever more complex for food and beverage companies to navigate. Not only must food companies deliver products that are safe to consume, but they must also be wary of consumer perceptions of risk, which can undermine new foods and established brands. Risk communication refers to the collection and analysis of real-time

Since 1974, the UK has followed a risk-based approach to safety that, in the event of an incident, is enforced through the courts. The legislation is intentionally non-prescriptive and thus requires duty holders and the courts to decide what control measures were reasonable in the circumstances from ex ante and ex post positions. This has proved challenging for all parties involved. This paper describes

It is a striking feature of European Union (EU) health law and policy that it has developed in a relative lack of awareness from the general public. This situation can be partly explained by the existence of only a limited competence in the field and the recourse to other legal bases to enact public health measures, particularly Article 114 TFEU. The use of internal market powers to conduct EU health

In response to the SARS-CoV-2 pandemic, European Union (EU) Member States adopted technological solutions aimed at mitigating the effects of the virus, as well as enforcing newly adopted public health measures. Examples include apps for disseminating information, performing self-diagnosis, enforcing home quarantine orders and aiding contact tracing. This extensive use of technology for tracking and

There is no time more opportune to review the workings of the International Health Regulations (IHR) than the present COVID-19 crisis. This article analyses the theoretical and practical aspects of international public health law (IPHL), particularly the IHR, to argue that it is woefully unprepared to protect human rights in times of a global public health crisis. To rectify this, the article argues

COVID-19 emerged as a cross-cutting problem across governance sectors and levels, urging the creation of a European Health Union. There are already a number of integrated European governance strategies – such as the European Energy Union (2015) and the European Green Deal (2019) – adopted for overcoming problems of governance fragmentation and inadequacy of fragmented policy responses to cross-cutting

In the wake of the outbreak of the COVID-19 crisis, the Swedish and Swiss governments adopted a similar policy approach. They enacted mostly non-binding measures to contain the epidemic, relying on the high level of interpersonal trust and trust in political institutions that exist in both of these (broadly comparable) countries to ensure compliance. However, unlike Sweden’s strategy, the Swiss policy

This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Vaccines being the universally recognised prime method of prevention, immunisation campaigns and vaccine research and development (R&D) could reasonably be expected to feature prominently in any policy and/or strategic document

Based on a mix of conceptual insights and findings from cases, this paper discusses three ways in which the effectiveness of regulation in the areas of competition, data and consumer protection can be improved by tailoring substantive protections and enforcement mechanisms to the extent of market power held by firms. First, it is analysed how market power can be integrated into the substantive scope

This article proposes and discusses the text of a Framework Convention on Alcohol Control, which would serve public health and welfare interests. The history of alcohol’s omission from current drug treaties is briefly discussed. The paper spells out what should be covered in the treaty, using text adapted primarily from the Framework Convention on Tobacco Control, but for the control of trade from

This article addresses the question of how the World Health Organization (WHO) Global Strategy to Reduce the Harmful Use of Alcohol (Global Strategy) and its Framework Convention on Tobacco Control (FCTC) have been used in the context of discussions about alcohol and tobacco measures, respectively, in the World Trade Organization (WTO) Committee on Technical Barriers to Trade. The article finds considerable

In 2014, the European Joint Procurement Agreement (JPA) was introduced as an innovative instrument to organise the procurement of vaccines and medications in preparation for pandemics. An overriding purpose of the JPA is to secure equitable and cost-effective access to medical supplies for participating EU Member States during serious health crises. This article aims to understand the current use of

Health Union raises bioethical questions ranging from resource allocation and risk balancing to respect for specific bioethical prohibitions, as an analysis of the European Parliament’s proposal for such a union shows. To date, European Union (EU) health law has succeeded in avoiding or circumscribing such questions, leading to the limited and inconsistent patchwork of EU bioethical provisions we currently

The shortcomings in the handling of COVID-19 highlighted the salience of health and safety at work and fuelled discussions surrounding the desirability of a European Health Union. This article conceptualises occupational health and safety at the European Union (EU) level as a key driver for the creation of a European Health Union. Through recourse to the area’s roots and its relevance to the tackling

On 23 October 2019 the European Union enacted the Whistleblower Protection Directive. The directive introduces important common standards of protection for whistleblowers reporting on breaches of EU law and significantly increases the level of protection afforded to whistleblowers in many EU Member States. Many of the features of the directive go further than pre-existing national whistleblower protection

The financial crisis in 2008 and the COVID-19 pandemic today have made it clear that both financial and medical crises spread pervasively across borders. The financial crisis proved that the health of the entire European banking system stands and falls with the health of a single systemically important bank. As such, in the past decade, European Union (EU)-wide cooperation and regulation have been

The digital health ecosystem is rife with opportunities to improve healthcare through data-driven services in the European Union (EU). The value of health data, in the multiple forms in which they come (from health records to lifestyle data collected by smartphones or wearables), can truly emerge when they are allowed to flow in the ecosystem within a governance framework supported by all relevant

Alcohol use has been identified in major United Nations (UN) initiatives, such as the Sustainable Development Goals and the Non-Communicable Disease Action Plan, as a major contributor to the global burden of disease. As a result, levels of alcohol use serve as an official indicator of progress towards these UN-set goals. Given current trends, UN targets for reduced alcohol consumption are unlikely

COVID-19 is a zoonosis, a disease transmitted by an animal to humans. The diffusion of the outbreak is therefore born of an unsuitable, insufficient, excessively permissive food safety system. Hence, the regulation of food safety plays a central role in the protection of health and has done so on a global scale. The overall regulation of food safety therefore requires an increase in the level of health

Personalised nutrition, the tailoring of nutrition products, services or advice to individual characteristics such as genetics, phenotype, nutritional intake and/or exercise routine, is increasingly attracting the interest of industry, consumers and researchers. This article provides an overview of the current European Union (EU) regulatory framework as applying to personalised nutrition and draws

What could a European Union (EU) response mechanism to health emergencies look like in the context of a more integrated Health Union? Despite an increased EU role in the preparedness, monitoring and coordination of health emergencies over the past two decades, Member States’ responses to the first wave of COVID-19 were surprisingly uncoordinated. In light of calls to improve cooperation regarding future

While, historically, alcohol production and sale were local matters, commercialised and industrialised alcohol has supervened, globalised initially through European empires, transforming alcohol’s place in everyday life. But alcohol was not included in the current international drug control system, initiated in 1912. In the current “UN system” of 35 intergovernmental agencies, alcohol has been a recurrent

Occupying the dual space of psychoactive substances and food, alcohol has to date escaped the international labelling standards required of either category. Following growing consumer concern focused on ingredient and energy labelling, the issue of alcohol labelling has been brought to the Codex Committee on Food Labelling (CCFL). Russia led the development of a discussion paper on the labelling of

Since the adoption of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) in 2003, public health professionals have debated similar conventions covering other health risks, including potentially a Framework Convention on Alcohol Control. Much of this debate has focused on the merits of binding versus non-binding instruments in terms of commitments at the international

Calls for a European Health Union apparently challenge long-standing beliefs that national healthcare system organisation is a Member State competence. Interaction between Member State and European Union (EU) levels therefore fundamentally requires reflection in the design, overall structure and legal basis of any European Health Union. Article 168(7) Treaty on the Functioning of the European Union

Alcohol is the sole major psychoactive substance with a huge negative public health and social impact without some form of international control grounded in a binding treaty. While existing rules of international law, in particular in the economic field, favour liberalisation and may hinder strong national alcohol control measures, we may be witnessing a turning of the tide due to the growing mobilisation

Some understandings of European Union health law are based on a presumption of law as a static and closed system. This approach to the Union as a legal entity has important ramifications. The Union is a political system created by and subject to the rule of law. Its successes (and failures) are attributable to the legalisation of solving externalities and ensuring Member State solidarity to gain benefits

This article analyses the administrative measures and, more specifically, the administrative strategy implemented in the immediacy of the emergency by the Italian government in order to determine whether it was effective in managing the COVID-19 pandemic throughout the country. In analysing the administrative strategy, the article emphasises the role that the current system of constitutional separation

This contribution will draw on the literature that has accumulated on how the Court of Justice of the European Union (CJEU) has responded to the European Banking Union, which was established in similar crisis circumstances that now face the European Union (EU) in the age of COVID-19, to illustrate the legal issues on which the CJEU’s input will be particularly important in the shaping of any future

This article discusses the role of European Union (EU) State aid law in the COVID-19 crisis. It contends that different Treaty derogations have played unique roles in addressing the core determinants of the economic risk linked to the pandemic (ie the “exposure” to lockdown measures and the “vulnerability” of certain sectors to them), and in increasing the resilience of national economies. Moreover

Administrative Tribunal of Guadeloupe 28 March 2020, case n° 2000295 (Judge for interim relief);French Council of State 4 April 2020, cases n° 439904, 439905 (Judge for interim relief)Based on the precautionary principle and to protect the right to life under Article L 521-2 of the French Code of Administrative Justice, the Administrative Tribunal of Guadeloupe (Judge for interim relief) ordered the

For the protection of biodiversity, the German Federal Environmental Agency (UBA) pursues the goal of establishing compensation areas to balance unavoidable indirect effects on nature and the environment caused by the application of plant protection products. Whether there is a legal basis for this within either European Union or national law is one of the most debated and pressing issues currently

More than 40 years after Cassis de Dijon, the mutual recognition in the field of goods is still a failure. The promise of this principle for ensuring both market access and regulatory diversity has not been kept. Therefore, today, businesses rarely rely on mutual recognition to sell their products in another Member State. In an attempt to stimulate this procedure further, the European Union legislator

Alcohol control has long been recognised as a public health concern. Recent years have also seen increased recognition of the relationship between alcohol control and the human rights agenda. However, fragmentation exists in key global governance instruments over the role alcohol control plays as a human rights priority. The relative success of tobacco control illustrates how utilisation of agendas

Contemporary risk regulation requires an interdisciplinary approach that integrates science, law and socio-political discourses. This calls for new tools in the risk regulation process that enable regulators to adapt to a constantly changing technological realm and help overcome the interdisciplinarity dilemma. In the field of nanotechnologies, tools proposed in the literature include “by design” approaches

Pharmaceutical science has provided humans with better and cheaper treatments However, with improved access to medicines, the amount of pharmaceutical waste also grows Pharmaceutical waste is regularly mismanaged by households, which is considerably and unnecessarily adding to the “pharmaceuticals in the environment” problem Redesigning existing pharmaceutical takeback schemes and their regulation

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase

On 17 March 2020, the President of the European Council, Charles Michel, and the President of the European Commission (hereinafter, Commission), Ursula von der Leyen, announced further European Union (EU) actions in response to the COVID-19 outbreak. Since the pandemic reached Europe, the EU has adopted a number of trade-related measures, including the issuance of guidelines for national border management

Governing globalisation through law implies building the rule of law without a world State, and therefore rethinking the tool that law, traditionally identified with the State, represents in the face of the interdependencies born of globalisation and the challenges they generate Economic and financial crises, social crises, global terrorism;the humanitarian disaster of migrations, the climate crisis

Due to its borderless nature, COVID-19 has been a matter of common European interest since its very first detection on the continent. Yet this pandemic outbreak has largely been handled as an essentially national matter. Member States adopted their own different, uncoordinated and at times competing national responses according to their distinctive risk analysis frameworks, with little regard1 for

Amid the outbreak of the SARS-CoV-2 pandemic, there has been a call to use innovative digital tools for the purpose of protecting public health. There are a number of proposals to embed digital solutions into the regulatory strategies adopted by public authorities to control the spread of the coronavirus more effectively. They range from algorithms to detect population movements by using telecommunications

The COVID-19 outbreak is not the first nor last series of recent real or potential catastrophes - be they natural disasters, terrorist attacks or pandemics - that have taken by surprise governments, globalised firms and the citizenry. 1Yet, due to its near-unprecedented impact on the highly interconnected but vulnerable systems that define the modern world, this pandemic has been testing our ability

Draghi’s short sentence appeased the financial markets and by and large the Member States followed the credo and established the Banking Union 3 The crisis to be managed had a limited focus – monetary and fiscal policy – with broad implications for the economy and society in the European Union (EU) and the Member States, however In the potential euphoria surrounding new perspectives, it should not

This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine

The world economy is sliding yet into another recession (having arguably barely recovered from the previous economic downturn) due to the worldwide pressures and tensions created by the COVID-19 pandemic.1 With most countries in the world under lockdown (or in similar situations), almost all food is now consumed in the household. Arguably, agricultural producers and the retail industry appear to be

COVID-19 hits all of the cognitive triggers for how the lay public misjudges risk. Robust findings from the field of risk perception have identified unique characteristics of a risk that allow for greater attribution of frequency and probability than is likely to be aligned with the base-rate statistics of the risk. COVID-19 embodies these features. It is unfamiliar, invisible, dreaded, potentially

To combat COVID-19, unlike its Member States, the Union may act “only within the limits of the competences conferred upon it by the Member States in the Treati

The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the

The COVID-19 pandemic is changing the face of Europe. Member States’ divergent responses to this crisis reveal a lack of unity in the face of a humanitarian catastrophe. At best, this undermines the effectiveness of health protection within the European Union (EU). At worst, it risks breaking up the Union altogether. Divergent national responses to COVID-19 reflect different national preferences and

The exceptional circumstances brought about by the COVID-19 pandemic have affected the traditional organisation of healthcare resources allocation in the United Kingdom. Since its inception the NHS has aimed to regulate risks of ill health in the population by providing an equal and universal provision of health care services to residents based on their health status rather than their ability to pay

Since the very start of 2020, international business actors have become increasingly concerned with the “viral exceptionalism”1 caused by the various governmental pandemic-mitigation restrictions (PMRs) enacted in response to COVID-19.2 The governmental action was deemed necessary as a consequence of coronavirus’ distinctive epidemiological characteristics. First, by replicating in large quantity during