European regulatory vote skates close to PMA system

If the mark of a true compromise is that it leaves both parties dissatisfied, the European parliament can congratulate itself on a job well done. The vote it took yesterday came much closer than expected to ushering in a centralised PMA-style procedure for medical devices, thereby alarming industry, but stopped short of the across-the-board approval process that patient groups had called for.

Both sides are united, however, in the belief that it will now take longer to bring high-risk medical devices to market. Fortunately for device makers, yesterday’s vote was merely one step in a months-long legislative process, and much wrangling will yet occur before the laws are finalised.

Behemoth

Rather than replacing the current system of notified bodies – agencies empowered by national governments to award the CE mark – with an overarching FDA-style organisation, the parliament has envisioned a structure under which devices must be submitted first to one, then to the other.

If the proposals voted for yesterday by the parliament’s environmental committee stand, some notified bodies will be specially designated by the EMA as able to certify the more complex and high-risk devices. An entirely new body, composed of around 600 medical personnel divided into 21 committees, will also be formed. Overseen by the European Commission, these committees will scrutinise some approval applications, as decided case by case, adding another layer of regulatory assessment.

Eucomed's spokesperson, Ingmar de Gooijer, told EP Vantage that under the new plan, “some devices will need to go to specialised notified bodies which automatically have to give the device’s file to one of 21 committees, and within a specific number of days these committees will decide to scrutinise it or allow it to go through the normal process. If they do want to look at it, it goes through what is pretty much a PMA procedure.”

The group said the situation would delay device approvals and mean that taxpayers would pay twice for the same procedure, equipping both the beefed-up notified bodies and the new expert body which will simply duplicate the notified bodies’ assessments. Eucomed contends that this “bureaucratic behemoth” will cost between €10bn and €25bn.

A very long process

BEUC, a European consumer group that had campaigned for a full central premarket authorisation system, says that this is all worthwhile. In an email to EP Vantage, BEUC spokesperson Pauline Constant said “the administrative burden and the costs of the new set-up would be outweighed by increased safety, reduced recalls and less expensive care following adverse events.”

The organisation questions whether producing evidence of safety and efficacy as a prerequisite to marketing constitutes an “unnecessary delay”.

European Commission rapporteur Dagmar Roth-Behrendt, who masterminded the initial proposals for full centralised approvals, said after the vote that the Commission hopes “that the improvements we have achieved will not be diluted later in the legislative process”.

Eucomed is hoping precisely the opposite. “This is just one part in a very long process,” Mr de Gooijer said, pointing out that draft laws now go to the plenary of the European parliament, which will vote on the proposal on October 22.

After that, the voted act will be submitted to the European Council to seek its approval. Then there will be further discussion between the parliament and the Council. When they reach a common position the final act will be adopted, becoming a law to be enforced by the individual EU member states.

That gives three distinct opportunities for the proposals to be tinkered with. The law that is eventually passed could match the current draft exactly, but with the European Commission, the European Council, the European parliament and its plenary committee – to say nothing of industry lobbyists and patient groups – all determined to have their say, this seems doubtful.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter