Finnegan's Take

Amid resignations, political spats and question marks over its budget, there’s a new broom at the EU’s powerful medicines authority

Pity Guido Rasi. Not for his €200 salary, the generous perks or the swanky Canary Wharf offices, but for the unenviable task of turning around the ailing European Medicines Agency.

He takes the helm at a powerful organisation after a torrid two years in which top scientists have quit, the European Parliament has refused to sign off on the EMA’s budget, and the Agency has had to defend itself against a barrage of criticism from doctors and politicians over its independence and transparency.

The farcical tale of Mr Rasi’s own appointment offers some insight into the behind-the-scenes chaos at Europe’s medicines watchdog.

Back in 2010, Rasi’s predecessor, Thomas Lonngren was preparing to step down after two five-year stints as Executive Director. The post was advertised but had to be withdrawn due to supposed translation errors. A second ad was published only for the European Commission to dispute the pay grade on offer, stalling the recruitment process for several months while Brussels pushed to downgrade the job.

After many months of wrangling, the Commission eventually relented, allowing the EMA board (headed up by Pat O’Mahony, Chief Executive of the Irish Medical Board) to offer a highly attractive package to interested candidates.

Still, this deal came too late. Mr Lonngren departed on schedule in December 2010 leaving a vacuum at the head of the medicines regulator for the bones of a year. Andreas Pott, the Agency’s head of administration, served as Acting Executive Director until Mr Rasi took over before Christmas 2011.

Pott’s luck

Mr Pott’s first headache was to deal with reports that Mr Lonngren was providing advisory services to pharmaceutical companies – the kind of firms who might be expected to seek EMA approval for medicines.

Lonngren said he had cleared all of this with Mr O’Mahony, but that claim only exacerbated the political outcry. Amid accusations of conflicting interests, the EMA board launched an investigation which cleared Lonngren of any wrongdoing.

However, it ultimately enforced ‘limitations’ on his activities, preventing him from interacting with the Agency for two years, and introduced a raft of new guidelines on conflicts of interests for its staff, experts and board members. The horse, of course, had bolted but it’s better late than never.

The Financial Times reported that Mr O’Mahony had himself been seen as a frontrunner to replace Lonngren but failed to muster enough support when it came to the crunch last summer, opening the way for Mr Rasi (a former Director-General of the Italian Medicines Agency). Mr O’Mahony had been elected EMA chairman for three-year terms in 2007 and 2010 but opted to step down in 2011 shortly after the board voted to appoint Mr Rasi.

‘Axe the expert?’

Before Mr Rasi could take up his position, there was plenty more incoming fire for the seat-warming Mr Pott to fend off. His first opponent was French MEP Gérard Bapt who wrote to the EU Health Commissioner John Dalli suggesting that an EMA expert be fired. A bitter row ensued.

Mr Bapt’s gripe was with Dr Xavier Kurz, a Belgian scientist and EMA advisor. Back in 1994 when Dr Kurz worked at a university and provided part-time advice to the Belgian authorities, he wrote a report on the safety of an appetite suppressant. The drug would later be taken off the market in due to concerns over cardiac side effects. According to the French MEP, the report by Kurz “minimised and contested” the risks associated with the medication.

Pott was having none of it. He wrote to Mr Bapt defending the 1994 report which he said had added to the scientific understanding of the class of medicines in question.

“I would like to reiterate my absolute confidence in Dr Kurz’s scientific and personal integrity,” he added, refusing point-blank to censure the EMA expert.

The EMA’s relationship with the European Parliament, at best be described as strained, has sunk to a new low in recent times. The Parliament’s Budget Control Committee has also lashed out at the Agency’s supposed transparency deficit when it comes to recruiting staff and it has criticised the way it manages public procurement contracts.

In a fit of pique, MEPs delayed signing off on the EMA’s budget, citing the lack of “proper guarantee of the independence of experts hired to carry out scientific evaluations of human medicines”. A thinly-veiled reference to the Kurz affair perhaps?

Transparency plans

The problems didn’t stop there. With the Agency launching a five-year transparency plan, it was discouraging to read an exchange of terse letters between Mr Pott and the Nordic Cochrane Centre in Denmark. To be fair, the Danes started it.

The Cochrane group wrote a damning critique the BMJ accusing the medicines regulator of refusing to publish clinical data which doctors could use to make informed decisions before writing prescriptions.

The Danes and others had been trying, through various routes including the EU Ombudsman, to force the EMA to release more clinical information. The Agency had been deeply reluctant to do so given the commercially sensitive nature of the data but, Mr Pott noted in a rebuttal published by the BMJ, the regulator has launched a new clinical trials register and is sharing as much information as it reasonably can.

Shock departure

With the dust settling on a series of public rows, there was some relief when Mr Rasi arrived, new broom in hand. But no sooner was he installed than another crisis erupted.

This time, it was the shock resignation of one of the Agency’s most influential figures. Dr Eric Adabie, chair of the key EMA committee which assesses human medicines, abruptly quit with immediate effect.

This has little to do with the Mr Rasi or his predecessors but rather was the latest twist in a complex regulatory scandal gripping the French medical establishment. Following serious criticism by politicians and the media in France, the French medicines regulator has been undergoing a major restructuring which saw Dr Adabie’s contract terminated.

Dr Adabie’s work at the EMA was unpaid (he drew his salary from the French authorities) and his attempt to secure direct payment from the European agency in light of his departure from the regulator in France was rebuffed. So he cleared his desk.

New broom

To this string of calamities you can add the usual criticism of medicines regulators: it takes an age to secure approval for new medicines, leaving patients waiting too long for the latest treatments.

The answer to much of this criticism is more transparency. More transparency helps explain why decisions take so long; how decisions are taken and by whom; how money is spent and how contracts are awarded.

Despite its considerable influence over Europeans’ health, the regulator has often specialised in keeping a low profile. Its technical public statements frequently translate as “Don’t look over here – honestly, we’re really boring.”

All of that, says Mr Rasi, is soon to change. Greater transparency is promised on clinical data, on funding for patient groups and on the role of experts. The EMA has begun publishing meeting agendas and more detailed minutes.

Some of this work had been initiated long before Mr Rasi became Executive Director, having been set in train by previous directors and the EMA board when it was led by Pat O’Mahony.

A fundamental shift in organisational ethos is what is required. With a new man at the helm, potentially for the next decade, the time for renewal is nigh. Failure to change will undermine public confidence in the safety of medicines at a time when faith in authorities is under pressure.

[This post is based on a forthcoming feature in Irish Medical News]

 

The European Medicines Agency

What does it do?

The European Medicines Agency (EMA) is a London-based EU body which assesses medicines to make sure they work and are safe.

Pharmaceutical companies can apply for permission to sell human medicines and veterinary products across Europe, although negotiating prices is chiefly a matter for national authorities and insurers.

The Agency also monitors the safety of medicines sold in Europe through an extensive pharmacovigilance network and from time to time withdraws or updates drug marketing licenses on foot of new evidence of adverse reactions.

It has six scientific committees and a network of over 4,500 experts who help to assess medicines.

What does it not do?

The EMA does not evaluate all medicines used in the Europe. Companies can apply to national authorities to sell their medicines in an individual EU member state rather than pursue a single European marketing authorisation from the EMA.

The EMA does not conduct its own laboratory research or clinical trials – that task falls to those applying for marketing licenses. It does not set prices or judge what medicines should be reimbursed by governments. Nor does it decide what kinds of clinical research should be given ethical approval.

At present, the Agency does not regulate medical devices – such as pacemakers, hip replacements or breast implants. However, innovations such as drug-eluting stents continue to blur the line between medicines and devices.

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