Transparency as a strength – the EU administration’s role in health policy

By Emily O’Reilly, European Ombudsman

The EU has a somewhat limited role in health policy – a fact often repeated at the start of the COVID-19 pandemic. However, the first lesson of the pandemic was that the intricacies of the EU division of powers matter neither to the border-crossing virus nor to citizens. In times of crisis, people simply want to know that public administrations are dealing efficiently and transparently with the problem before them.

The second lesson of the pandemic was that a lot of health-related decision making is – or at least can be – done at the EU level, involving the EU institutions and Member States together. In addition to decisions on the safety of vaccines; there were decisions on vaccine and personal protective equipment procurement, as well as on a major EU recovery fund.

From the outset, it was clear that a transnational crisis of this scale would severely test the capacity of the EU institutions. It was also clear that transparency and accountability would have to be the bedrock of any response in order to ensure public trust.

It is of course hard for the public to understand why vaccine contracts with global pharmaceutical companies – one of which had a damaging public dispute with the Commission – were not proactively published last year. It is also difficult to explain the reluctance to name the seven Member States involved in negotiating the contracts alongside the Commission. This led to the Commission alone being criticised about vaccine procurement in the EU – while the role of national governments in shaping and approving the contracts was rarely mentioned. This is not just about attributing responsibility, it is also about avoiding creating doubt among already anxious citizens about what kind of decisions are being taken.

The EU has two frontline agencies for public health issues: the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). My office examined the work of both in 2020 as both as part of general monitoring of how key EU institutions dealt with COVID-19. In reply, EMA, which has had a centre-stage role in the EU’s response to the crisis, explained it would maintain the accountability procedures it has in place in ‘normal’ times – essentially ensuring that the vaccine approval process is as independent and objective as possible.

My proactive work in this area reflects the fact that agencies working in areas related to health have to do the utmost to prevent any perception that they are not working in the public interest.

It is not enough for EU bodies – particularly those working in highly sensitive areas – to have internal rules on ethics, they must be seen to be implementing them. And I welcome the positive steps in terms of transparency by EMA.

My inquiry into the ECDC – set up in 2004 in the aftermath of the SARS outbreak to help to co-ordinate the EU response to a future and much more serious epidemic – was broader. This reflected reasonable expectations, given its title and mandate, that it would have a major role in any response to the pandemic. The reality was quite different however.

The agency – small in terms of staff and budget – has little capacity to act independently and is entirely reliant on the good will of national authorities to get the data it needs to properly do its task of assessing and monitoring any disease.

This structural weakness came to the fore in 2020 when the ECDC was unable to properly carry out its mandate because it did not have access to the data it needed. All three of its main sources for information – an early warning system and a surveillance system to which national authorities provide data, and surveys carried out by the ECDC itself – proved to be inadequate.

A survey in spring 2020 on laboratory shortages, for example, resulted in only 9 of 30 national authorities responding. Similarly, there were large discrepancies between the number of COVID-19 cases reported to the surveillance database and the much higher numbers revealed by the ECDC’s own epidemic intelligence screening. The inquiry also revealed other shortcomings related to how the ECDC presented the data it received – early on in the pandemic advice on wearing facemasks was changed with little explanation as to why, while certain surveys of member state capacity to deal with the crisis were published while others were not. Meanwhile, despite the pandemic being an issue of overwhelming importance to people, the agency’s communication with the outside world tended to be geared only towards health experts and not the general public.

While the ECDC can make some improvements by itself – such as being more transparent and enabling greater public scrutiny of its data and assessments – ultimately it is up to EU legislators to reflect on its mandate.

Without specific new powers to ensure the completeness and quality of the data it receives from national authorities, the ECDC cannot effectively fulfil its role of pan-European disease prevention and control.

Crises bring unprecedented levels of public scrutiny to governments and institutions. Decisions that may previously have been routine take on a new significance – in health crises they can have life and death consequences. The COVID-19 pandemic has been called the crisis of the century, and continues to have profound social, economic and financial consequences across the globe. In the EU it has prompted debate on creating a ‘health union’. Whatever changes are made to the EU‘s role in health policy, the ability of EU institutions and agencies to act effectively will only ever be as strong as the trust the public accords them.