The EU regulatory and reimbursement process is becoming unnecessarily complex. That is the view of Professor Bernard de Cannière, professor at the Universite Libre de Bruxelles in Belgium and entrepreneur.

Speaking at Eucomed’s Medtech Forum on October 8, Prof de Cannière indicated this sector is becoming too complex for relatively small players.

The consequences of over-regulation, he warned, “will be to kill initiative and innovation”.

Worse still, this kind of complex environment can push companies to operate “at the border of legality”, he said.

Referring to a complex organisational chart of the French Health Ministry that was shown at the meeting, the speaker said that small companies find it difficult to understand how countries act.

Even when companies manage to achieve CE marking, they still have considerable hurdles to overcome when navigating around the national reimbursement process. This is particularly challenging for innovative products for which a a precedent has not yetbeen set.

Where there is no reimbursement structure or policy for a new device, small companies are then faced with a huge machinery that is complex to understand, and they toften have to try and deal with authorities who speak another European language.

Dr Neal Fearnot, vice-president at the Cook Group, described the EU regulatory system as “the best system in the world today”. He said it was the hallmark in terms of safety, timeliness and efficiency and that the average time to market in the EU of some two years, was way ahead of the US and Japan, where it could sometimes take 10 years.

He alluded to the fact that there are serious efforts underway to reform the systems and warned that increasing the regulatory burden could have “unintended consequences” and so should be approached with caution.

For example, he said patients are going to suffer if the regulations become so onerous that it is no longer viable for companies to develop products for patients with rare diseases.

He also advised the meeting that there are many US companies that have settled in Europe because of the more rapid regulatory process here, but that an increased regulatory burden may make them go elsewhere.

“Some improvements may be warranted, but let’s make sure that the systems are flexible and nimble,” he said, adding that it is vital to evaluate those systems in other parts of the world which are more burdensome, less competitive, and which fail to yield devices that are either safer ormore efficient.

Killed in infancy?

There also was evidence that the current system is crushing the lifeblood out of the EU medical devices industry.

“A huge amount of innovation has come out of Europe in the area of medical devices,”Fred Hrkac, president, EMEA, at Boston Scientific told the meeting.

But the growth of smaller companies is being stunted by the increasingly hostile regulatory environment. These companies may be good domestically but they do not have the resources to grow and export.

They are becoming dependent on partnering or being bought out by the US multinationals who are over here to have access to the necessary resources to navigate the highly complex local systems.

Patients wanting less regulation?

Dr Mary Baker of the European Federation of Neurological Associations also blamed over-regulation for preventing patients having access to innovative treatments that could make the difference between life and death for them.

“There needs to be a more efficient, better management of benefit and risk,” Dr Baker said, and this needs to come from listening to patients”.