Has the European Union failed its citizens in respect to the handling of the Corona pandemic? The jury is still out.

Legal framework

When the EU asked in an opinion survey during the pandemic, a great majority (69 percent) of Europeans said they wanted the Union to take a stronger role and have more powers in fighting the corona crisis. 60 percent of EU citizens are dissatisfied with the way member states have cooperated. The survey showed that 74 percent of Europeans have heard about EU measures, yet only 42 percent are satisfied.

Whole the EU has the ambition to create a European Health Union, at present, it does not legally have many competences in the field of health. Its existing powers are described in two founding treaties, the Treaty on the European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU). Beyond that, Brussels can only act if and when given additional powers by the member states (Art. 5(2) TEU).

The Treaty on the Functioning of the European Union provides in Article 6 (a) that health is a complementary competence in support of member states and can only extend, according to Article 168 TFEU, to a shared competence. This article outlines the competences the EU has in the area of public health.

Article 168 TFEU

  1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.

Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health.   […]

  1. The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas.

[…] The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, […]. The European Parliament shall be kept fully informed.

  1. The Union and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.
  2. […] the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;

(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.

  1. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.
  2. […]
  3. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. […]

This article has given rise to different interpretations.

Strict interpretation: The EU has a general responsibility to help member states cooperate and strive to achieve a high standard of health in the EU as a secondary actor to the MS and in complement of their actions in time of a pandemic.

Wider interpretation: The EU has a role in health policy and must ensure through its institutions that member states don’t fall behind on the standard of health. More than coordinating national actions, the EU has a responsibility to organize the health system and more specifically to prevent and fight pandemics by researching the causes, transmission and prevention of major health scourges. The EU’s role is to inform and educate its member states and the wider population on the pandemic, monitor its evolution and even be in charge of border control.

The European Parliament and the Council can adopt standards of health in three instances, namely in the case of common safety concerns such as a pandemic, in the veterinary field, and in order to regulate medicine products (European Medicines Agency).

The EU institutions therefore have the competence to choose a vaccine. European Parliament and Council can also adopt incentive measures to fight an epidemic, monitor and combat cross-border threats.

The EU may, however, not pursue any harmonization of laws and regulations applicable in member states. Therefore, no standard, even minimum, can be established in legally binding instruments if it does not address common safety concerns.

The situation of the pandemic and results of the survey appear to show the possibility for the EU to use Article 168 (5) as a basis to adopt legal measures against the pandemic.

A European Health Union?

The Commission has asserted that the EU can adopt health legislation under Article 168 TFEU and has done it in a few sectors including:

  • Patients’ rights in cross-border healthcare
  • Medical devices and pharmaceuticals
  • Cross-border health threats

The Commission can also issue recommendations to member states.

Moreover, there are instruments for co-financing the fight against Covid-19:

  • Health Programme: Ensures health security and information
  • Horizon 2020 Research Programme: Funds research in biotechnology and medical tech
  • EU cohesion policy: proposes investment in member states
  • European Fund for Strategic Investments

On 11 November 2020, Commission proposed a regulation in response to the serious cross-border threats to health.

  • EU cross-border action legal proposition is improved: Reg 1082/2013/EU on serious cross-border health threats: more cooperation, EU emergency situation that triggers coordination and development, stockpiling and procurement of products “allowed vaccinations” coordinated by the Health Security Committee
  • Detection of the threat (outbreak or crisis) with risk assessment to enhance the Union Civil Protection Mechanism proposal
  • ECDC and EMA will be reinforced (see below)

European Medicines Agency (EMA) 

The EMA is the most important health-related agency of the EU. It was established in 1995 and is located in Amsterdam. Its role is to authorize and monitor medicines in the EU that do not fall within the competence of the member states.

The approval process is as follows: Company applies for single marketing authorization -> EMA examines the file and issues a recommendation -> Authorisation is issued by the Commission -> The drug can be sold in the EU

The EMA has a 36-member management board, with members appointed in the public interest and not representing any government. It has seven scientific committees and thousands of experts from Europe.

The EMA does not evaluate the initial authorization applications for all medicines in the EU, nor for clinical trials. It also doesn’t evaluate medical devices or develop drugs or vaccines itself. EMA cannot develop laws on medicines or issue marketing authorisations (the latter is within the purview of the Commission). The EMA was the agency that has so far authorized two Covid-19 vaccines. It will continue examining vaccines and monitoring any secondary effects.

Main competences of EMA

  • Monitoring and mitigating the risk of shortages of critical medicines and medical devices
  • Providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises
  • Coordinating studies to monitor the effectiveness and safety of vaccines
  • Coordinating clinical trials


European Centre for Disease Prevention and Control (ECDC)

The ECDC was established by the Regulation 851/2004 of 21 of April 2004. Articles 5 to 7 establish an independent agency without any regulatory powers which has for objective to “identify, assess and communicate current and emerging threats to human health from communicable diseases”.

The ECDC provides information and risk assessment for the corona virus for the European Union. The agency emits weekly bulletins to provide information on threats monitored, the number of cases and deaths in each member state, etc.

The ECDC has reinforced:

  • Epidemiological surveillance via integrated systems enabling real-time surveillance
  • Preparedness and response planning, reporting and auditing
  • Provision of non-binding recommendations and options for risk management
  • Capacity to mobilise and deploy EU Outbreak Assistance Teams to assist local response in Member States
  • Building a network of EU reference laboratories and a network for substances of human origin

To ensure a high level of health standard, the EU verifies the quality, safety and efficacity of medicines. It has done so through pharmaceutical legislation since the 1950s.

This table shows the centralised or decentralised procedures to accept a medication to be sold in the EU. The EU has written lots of legislation on the requirements for medicines.

Covid-19 vaccination in the EU

The European Commission was tasked by the 27 member states to lead negotiations with the pharmaceutical companies regarding Covid-19 vaccines. There has been a lot of criticism recently about the effectiveness of that strategy.

Already approved and on the market:

  • Pfizer-BioNTech’s vaccine (600 million doses) was approved by the Commission after the green light of EMA on 21 December 2020
  • Moderna  was approved on 6 January 2021 (160 million doses)
  • AstraZeneca-Oxford was approved on 12 January 2021; 400 million doses are expected). In January, the company said it could not honour its promised deliveries for the first quarter of 2021 and would cut back deliveries by 60 percent, but hoped to make up for the shortfall in the second and third quarters

Pre-agreements have also been concluded with

  • Johnson & Johnson (contract signed in October 2020, approval still pending)
    Sanofi-GSK (contract signed in September 2020, development on-going)

At the stage of exploration

  • Novavax (currently at the end phase of the clinical trials, signed in September
    Valneva (second phase of the trials)

In total, the EU is planning to purchase up a total of up to 2.3 billion doses. This is around three times the amount needed to vaccinate the entire EU population. It is planned that surplus doses will be given to third countries.

By the end of February 2021, according to Commission President Ursula von der Leyen, 50 million doses were delivered to the EU-27 – theoretically enough to inocculate at least an eight of the EU’s adult population.

What could the EU have done better?

However, the Commission has come under some heavy fire in some of the member states.

Critics have argued that the EU:

… should have stepped up earlier to coordinate the response to the pandemic (some states having made their own deals with potential vaccine producers early on)

… took too long in approving new vaccines (in particular compared with the UK, the US and Israel) and did not spend enough money for the construction of production plants in Europe

… was not transparent enough in its dealings with the pharmaceutical firms

… haggled for too long over prices and liability issues instead of fast-tracking the vaccination programme, thus causing an uneccessary delay

… did not negotiate precise enough the terms of the contracts (notably on delivery schedules)

… did not ensure that EU countries would get deliveries as a matter of priority

… should have enacted immediately the Lisbon Treaty solidarity clause (Article 222) which would have allowed a joint response to an event such as a terrorist attack, natural disaster, or man-made disaster. That could include a pandemic. So far, the clause has never been invoked.

… should have established common lockdown rules as well as testing and travel regulations

… could have used its powers better to come up with more coordinated responses to the pandemic, including by taking action against diverging member states

… communicated more and synchronized member states’ actions.

More cooperation?

In its meeting on 25 and 26 February 2021, the European Council adopted a statement on the way forward.

In it, the heads of government of the 27 EU member states declared that “our vaccine strategy has ensured that all member states have access to vaccines. Even so, we need to urgently accelerate the
authorisation, production and distribution of vaccines, as well as vaccination. We also need to
enhance our surveillance and detection capacity in order to identify variants as early as
possible so as to control their spread.”

The European Council also resolved to work to improve EU coordination to “ensure better prevention, preparedness for and response to future health emergencies.”

Work was needed for the EU to “have the means to secure enough vaccines and critical supplies” and to make best use of big data and digital technologies for medical research and healthcare.

The Council invited the Commission “to present a report by June 2021 on the lessons learned from the COVID-19 pandemic so far. The report should also address information-sharing, coordination, communication and joint public procurement, as well as how to ensure adequate production capacity in the EU and build up strategic reserves while supporting the diversification and resilience of global medical supply chains.”

Authors: Michael Thaidigsmann / Hélorie Duval