EU Ombudsman investigating European Medicines Agency ‘fast tracking’ procedure

Emily O’Reilly told MEPs that the EMA had been required to make recommendations on vaccines for COVID-19 in “record time” and has been working with a “fast-track procedure.”
Emily O'Reilly: European Parliament Audiovisual

By Martin Banks

Martin Banks is a senior reporter at the Parliament Magazine

15 Mar 2021

The spotlight has been firmly on the European Medicines Agency (EMA) in recent weeks following what has been the perceived poor performance of the EU’s coronavirus vaccination programme.

Some, including MEPs, have said the EMA has been too slow for approving new vaccines, particularly with similar regulatory bodies in countries like the UK, US and Israel.

The full efficacy of vaccines has again been called into question after Denmark, Norway and Iceland suspended the use of the Oxford/AstraZeneca vaccine last week.

This comes after reports of blood clots. Austria also stopped using doses from one batch after a 49-year-old nurse died of “severe blood coagulation problems” days after receiving an anti-Covid shot.

There is no established link between the vaccine and side-effects of blood clots.

Current question marks against the effectiveness of the vaccines and any possible side effects has also led to questions being asked about the speed with which some Coronavirus vaccines have been approved by national bodies.

The Irish-born Ombudsman, who was appearing before Parliament last week to discuss her activities, touched only relatively briefly on the EMA and vaccines issue.

“Question marks against the effectiveness of the vaccines and any possible side effects has also led to questions being asked about the speed with which some Coronavirus vaccines have been approved by national bodies”

Emily O’Reilly, European Ombudsman

Instead, she focused on the issue of council transparency.

She said that two cases in particular demonstrate how the absence of such transparency has “important real-life consequences.”

One, she told deputies, relates to the Council’s refusal to increase the transparency around the way in which national Ministers negotiate the annual EU fishing quotas.

She said, “The all-night negotiations are legendary and that, and their secrecy, have long been taken for granted, but the world has never before been as acutely conscious of fish stocks and sustainability and the EU never before as ambitious about the protection of our fragile environment.”

“A new approach, in my view, is therefore imperative. Some advances in transparency have been made by the Commission last year, but more needs to be done by Council.”

Another case concerned the lack of transparency around the positions of national authorities on the risk assessment of the effect of pesticides on bees, she told the committee.

This involved guidance given by EFSA as far back as 2013 and which, she noted,  “has yet to be acted on.”

“Never more so than in challenging times, are the highest standards of good administration and transparency required to reassure the public that decisions taken are correct, proportionate, and transparent, and that measures will be implemented properly and fairly” Emily O’Reilly, European Ombudsman

She added, “The lack of transparency allows this vital advice simply to sit there with no capacity for the public to influence a change because they are not allowed to know who is blocking the adoption of this guidance. I fully appreciate the need for space to deliberate but not, as in this case, apparently indefinitely.”

She cited another case which gave rise to concern, dating back to 2019, and the way which the then Commission Secretary General was appointed.

“Despite an initial negative response to my recommendations, within a few months, the Commission did conduct a specific appointment procedure for a new Secretary General to serve under the new President, President Von der Leyen.”

O’Reilly said the case demonstrated a “notable” feature of work, adding, “Sometimes a result can be achieved immediately, at other times it takes time for a recommendation to be fully realised especially if it involves a change in a cultural mindset or a different approach by a different administration.”

The two Council cases, she said, were “cases in point.”

She told the committee, “Given the pressure for greater transparency - encouraged by the pandemic - and given the EU’s climate ambitions, I predict a different result should similar cases arise in the future.”

She said the “devastating pandemic” had taught  “many lessons, including the critical importance of trust in institutions, of being open and honest with the public in a time of crisis, of how everyone benefits from collaboration and of how central, public administrations remain in the resolution of major crises.”

She told the plenary, “Never more so than in challenging times, are the highest standards of good administration and transparency required to reassure the public that decisions taken are correct, proportionate, and transparent, and that measures will be implemented properly and fairly.”

“In the absence of that, public trust will decline and the challenges faced by administrations in encouraging the public to take certain actions to beat the pandemic may be hindered.”

In 2019, O’Reilly, who was re-elected for a second term in December 2019, said that over 2,000 people submitted complaints to her.

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