EU medical devices regulation set for December adoption; industry stews over lost opportunities

EC health commissioner (DG SANTE) Vytenis Andrukaitis told a pre-event gathering last night at the European Parliament that regulation adoption could occur by year's end as proposed changes enter final 'trilogue' discussions in the EU.

The AESGP (Association of the European Self-Medication Industry) thinks 'substance-based medical devices' that encompass non-prescription, supplement-like products including probiotics for vaginal ailments or cranberry products for urinary tract infection (UTI) don’t require increased regulation, especially in the absence of serious adverse events.

The self-care industry accepts some regulatory change is necessary to reflect a changing market, but expressing widespread industry sentiment, Medical Brands CEO Maikel Hendriks wondered why such drastic regulatory reform was necessary “when there are so few adverse events.”​

“Consumers love these products,”​ Hendriks said of the multi-billion euro category in the EU. In Germany alone, the market for substance-based medical devices is worth around €1bn, according to Dr Angela Graf from the German Medicines Manufacturers’ Association (BAH), an AESGP member.

Hendriks said the substance-based medical devices market had doubled in the Netherlands in two years and was outgrowing the pharma market there.

Risk?​

Aurelian Perez, policy officer at DG SANTE at the European Commission, agreed there were few adverse events for substance-based medical devices but said that was no reason to halt necessary legislative reform.

“We need a much more sustainable system. What we have today is not sustainable for all. We take risks for patients and consumers,”​ Perez said.

“We need something, the wording is to be debated but I am sure the Parliament and the Council will do the right thing. We need clarity to reduce borderline issues. We need Rule 21. We need specific rules to address them otherwise it will be a mess.” ​

He added: “I don’t know if there are incidents or not but we want to improve legislation. And I am not sure reporting of incidents is reliable.”​

Rule 21​

Rule 21 defines what a substance-based medical device can be. It has been the hottest point of contention and highlighted the difficult in classifying a range of products as broad as nasal sprays, eye drops, topical creams and traditional pills and supplements.

There are several categories of risk within the medical devices legislation, and it is likely the amendments as they stand would push many products into the highest classification (class 3), or see them removed from market altogether as is the fear with topical probiotic vaginal products.

As the debate moves into the trilogue phase between the European Council, Commission and Parliament, industry says the current Rule 21 definition will result in more borderline cases, drive costs up and reduce consumer choice.

For the self-care sector, the opportunity to offer safe products that can keep people out of the medical system for ‘minor ailments’ is being compromised – a medical system that is proving vastly expensive for many societies.

European Parliament vice president Mairead McGuinness said the will to push the regulation through to completion quickly was strong after the first trilogue meetings this week, but said no specific progress had been regarding Rule 21, rather "just a discussion of different opinions".​

She told the gathering there was sensitivity among trilogue partners about how substance-based medical devices may be affected under the proposals and in particular "burdening your particular sector with higher classifications."​

"Maybe this is not most complex issue in the file but it is a challenging one,"​ she acknowledged.

One study showed public healthcare cost savings of about €16bn in one year across 25 EU countries if just 5% of minor ailment sufferers self-medicated rather than visiting a medical professional.

But the level of complexity and confusion around medical devices was highlighted when in answering a question about potential product classifications, Matthias Neumann from the German Ministry of Health admitted "I am not sure I even understand what Rule 21 means."​

Proportionality

AESGP medical devices committee member Andrew Wilson told the congress the proposed amendments to the 1993 medical devices regulation had shifted significantly since the serious review process began among EU stakeholders in 2008 amid concerns about safety, efficacy and interaction with food and medicines law.

“We are talking about proportionate regulation versus risk. There has been a shift so that many products would be classified in the highest risk category,”​ Wilson said.

“If there is a real concern about a product, call it out and deal with it case-by-case. Is a lot of this to deal with a real as opposed to a perceived risk?”​

Notifying bodies​

For Ilaria Passarani, head of food and health at the European Consumer Organisation (BEUC), the opportunity for reform that had been accelerated by a breast implant scandal in France in 2013 [also a medical device], could be seized even more zealously.

“We would like to see more ambition from the Parliament and Commission in restoring consumer trust,”​ she said, highlighting an issue of quality and consistency among ‘notifying bodies’ – the private agencies responsible for approving medical devices on behalf of national medical authorities [competent authorities].

Some of these have been questioned as being a soft touch, with Passarani saying notifying bodies in the Czech Republic and Slovakia had placed industry interests over patient and consumer health.

“Some [medical device manufacturers] can shop around for the most flexible ones [notifying bodies].”​

“We need more evidence,”​ she said, referring to the debate over how much mode-of-action data is enough. “We need the right people to look at evidence.”​

BEUC had called for an independent agency to do the job; “A body with a clear and well defined public health mandate” ​but given this is not foreseen, has expressed satisfaction that audits of notifying bodies and better expert education are an improvement. Indeed audits, or the threat of them, had seen some notifying bodies close shop.

There will be a 5-year transition once the regulation goes live although John Wilkinson, director of medical devices at the UK MHRA (Medicines and Healthcare products Regulatory Authority) noted many applications would address the regulation immediately once it entered EU lawbooks.

But he noted a large number of regulatory step that needed to be dealt with before the regulation was fully implemented - about 50 so-called 'implementing acts'.

Wilkinson said the regulation should not stop market-entry for "products with a well-demonstrated history of use"​ and said he was open to the idea of exemptions from the regulation's requirements if such data existed.