key: cord-0793591-3kv6wu8d
authors: Greer, Scott; de Ruijter, Anniek
title: EU health law and policy in and after the COVID-19 crisis
date: 2020-08-24
journal: Eur J Public Health
DOI: 10.1093/eurpub/ckaa088
sha: f3c4aebf572b1a0243d08ab374030d38004f7e30
doc_id: 793591
cord_uid: 3kv6wu8d

nan

The very first shock of COVID-19 might beover, but the crisis continues. We have already learned much about what the European Union can and cannot do to help its Member States and peoples manage the crisis-and what it might be able to do better. 1 The EU's contribution to fighting COVID-19 was initially limited because member states wanted it so. From a treaty article on public health that carefully limits EU competencies, to legislation that avoids authorizing forceful EU action, to a budget that puts little money into health and has no health emergencies line at all, the EU's member states have made it clear that they want the EU to be a limited actor. It can meet zoonoses with forceful action, but once they become human diseases the EU is hamstrung. 2 Public health is a strange place to rein in European integration, for everything we know about the movement of diseases, animals and people show that there already is European public health.

COVID-19 exposes the tension between tight social, economic and political integration and deliberately weak EU health powers. The Member States must collectively manage a long and difficult shared crisis. What can they do with each other through the EU?

We focus on policy ideas that are within broad EU health policy, though social and economic policy responses will be crucial to managing the pandemic and its effects. Our ideas use existing EU legal bases (Article 168 TFEU) and administrative forms that can be quickly adapted to this crisis.

First, and most urgently, the EU needs better surveillance and testing capacities from top to bottom. At the top, the ECDC needs to become more than a network hub for data and guidance. Surveillance across the EU, and indeed within Member States, is still slow, inconsistent and patchy. 3 The ECDC can provide common methodologies for information gathering, but it has no way to ensure that Member States indeed provide information in the prescribed manner. To make information flows more integrated and useful, the EU could direct resources and create obligations for Member States to improve surveillance and reporting (e.g. by reducing the time it takes for data to get from a lab to capitals to the ECDC).

Article 168 TFEU allows for the EU to adopt 'incentive measures' regarding the coordination of cross-border health threats. This would also be the basis, bottom-up, for the EU to supply resources for testing and surveillance coupled with standards for performance. Truly improving testing and surveillance entails health systems strengthening, moving from supporting capital investment to supporting local health care capabilities. The funds could come from existing EU money (e.g. cohesion funds) and should be coupled with measures to ensure they are not diverted to prop up authoritarian regimes. These measures will enable a 'test, test, test' model that helps escape future rolling lockdowns and outbreaks. 4 Second, data protection and privacy are substantially EU competencies. The kinds of SARS-CoV-2 control models that appear to work in, e.g. South Korea and Taiwan, depend on intensive tracing via mobile phones as well as big data techniques. 5 Current EU data protection legislation allows for far-reaching infringements of rights to privacy and data protection to safeguard population health. But a state of exception is not a good basis for key public health and health care measures that fundamentally depend on trust. New legislation resting on existing legal bases could allow new health technologies used for surveillance and contact tracing and for the use of large data sets and AI. All of these technologies are showing their uses, and challenges, in the pandemic, and the viability of both EU privacy law and public health policy depends on finding a technically viable and politically legitimate legal balance. 6 Third, the current Decision 1089/2013/EU and the Joint Procurement Agreement that was adopted on this basis, create the possibility to jointly procure medicinal counter measures for large scale disease outbreaks. 7 This system came into existence in the wake of the influenza H1N1 outbreak, when some Member States prepurchased all the vaccines before any other country could get their hands on them, while pharmaceutical companies played member states off against each other. That experience taught governments about the virtues of working together in cutthroat global markets. The current system of voluntary procurement works as a procedural framework for adopting a multilateral contract and allocation criteria are decided separately for each purchase.

In a crisis, this system is flawed. Member States that are currently participating in the public procurement processes can simultaneously negotiate bilateral contracts with manufacturers for pandemic counter measures (Article 1(5) Joint Procurement Agreement). Nor does joint procurement mean re-distribution to those countries that are hit hardest. It is a buyers' club rather than a shared resource.

To address this and future crises, the EU needs a mandatory obligation of solidarity in this area. That would mean that Member States commit to jointly procure medical counter measures in case of a crisis, with a specifically allocated part of the health budgets that does not allow for bilateral processes that undermine the EU process and a central authority at EU level to allocate and distribute based on need through guidance of the ECDC. 8 It is ambitious in its demands on EU solidarity and political foresight, but it is a potentially big win for the EU and a way to show all of its citizens its value while increasing the efficiency of its preparedness measures by fully exploiting the huge size of the 446 million person European market for health products.

Fourth, there is a case for strengthening the EU civil protection system. There is no dedicated EU health emergencies budget. RescEU, the improved civil protection scheme that launched in 2019, is essentially a matchmaker between Member States with spare resources and Member States with needs. Strengthening it would require an ability to call on pledged member state resources regardless of whether it is convenient for the member state. That would mean EU supplies in EU warehouses, something that only began on 19 March; and staff and planning so that resources are based on risk assessment rather than what Member States are willing to donate or what issues were recently fashionable.

The EU should not and realistically cannot stumble through COVID-19 half on lockdown, half fatalistic and all fractious. Its governments and people will need credible, real-time health information across the continent and the capacity to control hot spots. Even after COVID-19 has passed, global heating, antimicrobial resistance and globalization ensure that there will be more such needs for public health action.

It is a truism that European public health, and European integration, grow through crises. 9 EU public health, like the EU, has 'failed forward' several times. 10 COVID-19, by far the biggest public health crisis of the EU's history, could prompt the biggest and most valuable steps yet.

Conflicts of interest: S.L.G. is Senior Expert Advisor to the European Observatory on Health Systems and Policies.

These days we see the first assessments on the EU's role as crisis manager. Commentators differ in their view whether the EU has failed, been late or has finally come to a substantial response. 1, 2 We should bear in mind that there is a limited EU role in crisis response specifically and for Public Health in general. With regard to the first, Member States (MS) and even sub-national levels are the first and key crisis managers addressing the responses to the pandemic. Moreover, despite some responsibilities and institutions for supporting the immediate crisis response (e.g. ECDC, Early Warning & Response System, Health Security Committee, Decision on serious cross-border threats), the EU role is with coordination, sharing information and building supporting structures for MS to be prepared better for an emergency response. With regard to Public Health in general, the EU has a narrow mandate 3 with limited law-making powers. There is a strong reluctance by MS to hand over responsibilities, because health(care) is close to their citizens.

It is tempting to assume that the COVID-19 crisis could lead to major shifts of authority to the EU to address deficiencies in the national responses. This could only be realistically envisaged if there is an added value and greater efficiency to organize responses jointly. 3 Part of the COVID-19 crisis and its characteristics and responses might call for better coordinated European responses with the virus crossing borders, need for highly specialized treatment facilities in intensive care units (ICU) or harmonized surveillance and social distancing guidelines. Moreover, Public Health crises such as infections disease outbreaks have in the past triggered the expansion of the EU powers and institutions. Responses to BSE/CJD, SARS and H1N1 have created some of the EU institutions and mechanisms in Public Health 4 that are currently used and tested by the COVID-19 outbreak.

However, there are good reasons why we may not expect major transfers of health responsibilities to the EU but rather institutional innovations in the form of layering or other mechanisms of incremental institutional change. 5 First, one can argue that the best role for Europe is to provide what it already does. Many institutions and procedures at EU level are in principle established to support the crisis management of MS. A prime example is the ECDC Fellowship Program (previously EPIET training) which after 25 years has the effect that in all MS highly trained communicable disease staff is available. 6 Hence, it rather calls for adding certain tasks to existing work, serving new goals with existing structures or change of impact due to the new COVID-19 environment. 5 Second, the red lines for national governments have become clear in the past with no infectious disease 'management' for ECDC and have become apparent in some of the crisis measures taken unilateral by national governments. However, this does not need to be problematic, because a more decentralized approach can take care of regional variances much better than a one size fits all approach. Furthermore, a European Intervention Task Force coordinated by Brussels would just not work due to language and cultural differences, nor would it help to build up capacities in affected countries. Finally, in the current political mood with major Euro scepticism and reservations towards what the EU is doing, a major reformulations of the EU mandate seem not plausible in the near future.

In the following, a few preliminary suggestions are made for incremental innovations that could be initiated at EU level to

COVID-19 exposes weaknesses in European response to outbreaks