Medical devices directive may lead to lower patient safety

The European parliament's vote on the medical devices directive shows an imbalance in the approach towards patients, argues John Bowis.

By John Bowis

04 Oct 2013

The vote in the European parliament's environment, public health and food safety committee (ENVI) on 25 September highlighted the conflicting views between EU policymakers on how best to protect patients in health systems.

The current compromise, which represents quite a large shift away from the European commission's proposal, aims to protect patients better, by implementing a new approval system for medical devices in Europe.

Ironically, however, the ultimate outcome may not be greater safety, but less. Reducing rapid access to medical technologies, while increasing costs to research and development for new technologies, ultimately harms patients rather than protects them.

Time and again patients' organisations have said to me: 'Without risk there can be no progress to new cures and treatments. We want risk minimised and monitored; we do not want no risk.'

In February 2013, Health First Europe called on EU policymakers to take a balanced approach for patients to the proposal for a medical devices directive. We outlined the need for safety and transparency for medical technologies, while also acknowledging that both safety and transparency could be achieved without compromising access for patients.

Yet I have to say the current compromise text agreed by the ENVI committee raises critical questions about the balance of these key issues for patients. With the new approval system proposed, patients are wondering how much longer this means they have to wait for new technologies to improve treatment of diabetes and other life threatening chronic conditions.

They are also asking what the cost implications for patients, insurers and health systems for the establishment of new structures for approval are. And finally, they want to know how the new system will impact the thousands of small and medium-sized enterprises that are often the creators of technologies to support our treatment.

"This proposal will fundamentally shape the provision of healthcare for the next 20 years and we must ensure that we get it right for patients"

As a former policymaker and a very current patient, I believe these are crucial questions that need to be addressed and answered before any legislation is adopted.

This proposal will fundamentally shape the provision of healthcare for the next 20 years and we must ensure that we get it right for patients. We really need an impact assessment so that decisions about the future safety and health of EU citizens can be fully understood before moving forward.

I have no doubt that a balanced compromise can be achieved that takes account of safety without sacrificing accessibility for patients. A regulatory framework for medical technology in Europe that supports what we want, and need, as citizens and users of our health systems, is possible.