The current review of the European Medical Devices Directives to decide the future regulatory regime for medical devices and technologies is about to reach a critical point. With the European elections now just a few months away, there is all to play for during the closing negotiations of the legislation in order for the industry to ensure a robust and safe regulatory environment, effective and speedy access to important technology for patients and the maintenance of innovation.
But, as the legislation currently stands, the industry could be facing a FDA- style regulatory system that achieves none of these objectives. And patient safety and access to devices could be put at risk.
To understand why the industry faces this challenge it is important to remember why an initially benign review of outdated legislation became so politically explosive. In 2010/11 some well-documented assumed failures in the European regulatory system for medical devices which, in the case of the fraudulent PIP breast implants, caused significant patient harm, put the robustness of the existing regulatory environment in the media spotlight. Regulators felt the need to act more strongly against a disparate Member State CE mark regulatory environment which unscrupulous manufacturers felt able to exploit.
So what should the 25,000 medical technology manufacturers – 95 per cent of which are SMEs – be watching for as the legislation enters the crucial end stage? Following a vote by the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee on September 25, if you are a manufacturer who produces ‘high-risk’ products, you will be concerned that your technology will ever reach patients, with industry estimating 3-5 year access delays under the current proposals.
Complicated and burdensome bureaucracy is the future, as technologies face two scrutiny procedures: the creation of special notified bodies managed by the European Medicines Agency (EMA), supported by a second assessment through a highly complex, technology-specific pre-market authorisation committee system that involves clinical experts, the European Commission and the European Medicines Agency.
Other areas of the proposed legislation are cause for concern. In the future all medical devices, including syringes, could, by default, be reusable. That has huge implications for patient safety, with a lack of European-wide convergence on healthcare acquired infections. The call for a general ban on hazardous substances in medical devices may cause significant safety issues for certain products and alarm bells have been ringing about proposals to make randomised controlled trials the gold standard for all devices.
What next? By the time you read this, the full European Parliament will have voted on the current text of the legislation. If you had a crystal ball, you wouldn’t be confident of a positive outcome for industry and patients: most MEPs are unclear what they are voting about, given its technical nature, so will have simply followed political lines unheeded by understanding the full implications. With the conclusion of that vote, the European Parliament and Council (the body made up of 28 Member States), will be in a position to start their dialogue. This is critical: Member State governments have the opportunity to negotiate and shape the legislation that they will be derogated to implement. Industry will be seeking to demonstrate the potential impact significant new hurdles of uncertainty, delay and red tape will have on innovation and patient access to technology if the proposals, as they stand, are not changed.
In the future all medical devices could, by default, be reusable – that has huge implications for safety
The industry trade bodies have been working hard to ensure a successful outcome to negotiations but there is still, of course, the likelihood of a vastly different regulatory system come 2015/16 when the legislation will be implemented.
If the negotiations fail then industry will need to start saving; a Eucomed commissioned survey foresees additional annual costs for a SME of bringing a Class III product to market of €17.5m annually. Expect significant and potentially costly legal challenges as the new system is negotiated and trialled. Difficult customer conversations may need to be had. And, finally, expect a whole group of frustrated patients, no longer able to access the new knees, hips and heart valves that they once did.
