A model way to regulate new drugs that stands up to industry scrutiny

An EU agency in the heart of London has won the approval of the pharmaceutical industry and public alike, writes Magnus Grimond
Click to follow
The Independent Online
Amid all the hue and cry over Europe and its creeping federalist tendencies, few outside the pharmaceuticals industry have noticed the growing role of that unloved body in approving new drugs. Now around two years' old, the cumbersomely titled European Agency for the Evaluation of Medicinal Products, or EMEA for short, is starting to prove itself as one of the quiet success stories of the European Union. It is perhaps ironic that it also happens to be based in London, the centre of some of the most vehement Euro-scepticism.

The EMEA emerged from the 1980s debates in the run up to the single European market in 1992. While the consummation of that project did nothing to create a unified EU market for medicines, some replacement for the individual applications to each of the 15 national drug approval authorities was recognised as an important first step. For a pharmaceuticals group which had already spent millions of pounds on development costs, the typical four to six-year timetable adopted by the authorities took a significant chunk out of a 20-year patent life which, after clinical trials, was probably already half way through its term when an application for approval was made. At the same time, drugs were becoming an emotive issue amongst the public at large as AIDs hit the headlines and consumers demanded that new treatments be made available more quickly to treat a disease which was taking on the proportions of medieval plague in some sections of the media.

EMEA was therefore launched at a propitious moment, when both industry and consumers were calling for speedier, more efficient approval processes. It was a challenge relished by Fernand Sauer, the French pharmacist and veteran of the European Commission chosen to be the first executive head of the new body. Proud of what he sees as the reputation for speed and efficiency which the EMEA has won since starting its work in early 1995, he is already comparing the new European organisation with the powerful Food and Drug Administration (FDA) in the US.

Implicit in Mr Sauer's thoughts is that the Europeans have come up with a better model than the Americans and one which might usefully be adopted elsewhere in the EU.

"We could be in the centre of controversies about federalism and so on, but we are not....We have managed to develop a model of co-operation where rather than opposing member states we use their resources and they use our services. So it's really a partnership."

It took two years to negotiate, but "in terms of all these resources brought together, we are the equivalent of the Food and Drug Administration," he says, although "rather than a centralised, federal, agency we are a 'virtual FDA' ".

The bald statistics certainly suggest a model of efficiency. At its magnificently sited, but rather lonely headquarters facing a bend in the Thames at the west end of London's Canary Wharf development, the EMEA employs just 113 people. On top of that, it can call on 2,000 experts from hospitals, universities and research laboratories around Europe to provide expert input to its deliberations over new drugs. This compares with some 4,000 directly employed by the FDA on pharmaceutical matters, out of a total staff of over 12,000.

But the new body's main claim is its speed. It aims to have completed all its own approval processes within 210 days. Add on a further 90 days for its recommendation to be ratified by Brussels and member states to have their say, and most drugs should be cleared or rejected in under a year. Its latest audit report shows it is hitting the target most of the time, with the main delays being caused by what it says are company requests that the clock be stopped while they supply more information.

Appropriately perhaps, notable successes have been in the AIDs field. Norvir, the combination treatment developed by the US group Abbott Laboratories, was cleared in a record 69 days last year, while Glaxo Wellcome's Epivir took just 150 days.

At the moment, all biotech products must be submitted to the EMEA and in other areas pharmaceuticals companies have a choice. But Mr Sauer reckons it is already winning a large majority of the new drugs being launched. In its first 15 months, the agency has approved 44 cases, which Mr Sauer estimates is around two-thirds of the total.

"It seems industry has confidence in the system, industry is using the system and is rather satisfied with it. They can judge the performance against the performance indicators which are published all the time", he says.

So far, that assessment is broadly supported by the feedback from the industry, although some British companies are keener than others. SmithKline Beecham, which has had four products approved centrally, says it has a very good relationship with the European body. Zeneca, yet to submit anything, is more wary, saying the old national route still has its place.

Consumers' groups also seem happy with the new agency and its attempts to open up its affairs to public scrutiny seem popular: the agency's Internet "home page" was looked at 1.3 million times last year.

The tempo will increase next year, when the option of having drugs approved by individual member states is removed. Thereafter, non-biotech companies will have to choose whether to go the EMEA route or use the so-called decentralised system, whereby a lead authority, typically the UK, Germany or France, does the work and other countries largely accept their findings.

In 10 years, Mr Sauer expects EMEA to have 40 to 50 per cent of the whole market, including regular safety checks on drugs, an important area where it is not involved as yet. Beyond that, the agency could prove a role model for regulators in emerging drugs markets. Mr Sauer can perhaps take some quiet satisfaction from the fact that a Frenchman is using a British-based European bureaucracy to show the rest of the world a thing or two about efficient regulation.

Comments