Reform of medical device approval process not straight-forward
The latter exerts pressure on health systems to fund technologies while striving for value for money, as well as ensuring patient safety. As a result, health technologies (including pharmaceutical products, medical devices, etc.) need to be examined for efficacy and effectiveness (including cost-effectiveness) to get market access and reimbursement approval.
Over the past two decades, regulations, license approval processes, and methods for establishing cost-effectiveness, to inform adoption and reimbursement decisions, have developed and are now well-established for capital projects and pharmaceutical products. However, for medical devices, it is only recently coming to the attention of European decision-makers, such as the European Parliament.
For example, the Parliament’s Committee for Environment, Public Health and Food Safetylast week voted in favour of a new process for granting market approval for medical devices. What is more, the same processes and methods cannot be readily applied to medical devices owing to their unique challenges. These include the lack of formal processes for adoption, difficulties with conducting randomised control trials, the learning curve and innovative nature of devices which result in evolving evidence, the suitability of genericisation, and flexible price changes.
While pharmaceutical products have rigorous regulations regarding licensing and randomised control trials, to date medical devices only required a CE Mark. So, for example, a particular heart valve device was subject to the same consideration as a toaster to get a CE mark required for market access. As a result, devices for which there may be outstanding concerns get to market in Europe approximately four years earlier than the US, where devices are subject to strict analysis by the Food and Drug Administration.
If a technology is falsely rejected patients are denied access to life-saving or enhancing technologies. Alternatively, if a technology is falsely accepted, patients are exposed to risk of injury, further illness, and possibly death.
The consideration of introducing more rigorous approval processes by the European Parliament is welcomed. However, in developing such processes the features and challenges associated with medical devices should be considered. The new process for pre-market authorisation (PMA) will be centralised, similar to the FDA. According to Eucomed, the European medical technology industry association, the processes approved by ENVI are too bureaucratic, could stifle innovation and be damaging to Europe’s innovative medical technology SME ecosystem, delaying market access and increasing the financial burden on manufacturers. Eucomed argues it is duplicative and expensive and do not expect it to improve patient safety. However, in light of the recent crises with hip replacements and breast implants, the need for changes to Europe’s regulatory framework for medical devices is clear.
Once market access is granted to medical devices, they quickly diffuse and become part of routine clinical practice for many patients in different settings. Over time, users become more experienced, incremental innovations in the devices are seen, and more patients get access to the device. As a result, the outcomes associated with the device can change, for better or worse. Additional evidence is invaluable; it can reinforce earlier positive reimbursement decisions or indicate that the wrong decision was made.
However, once a device gets to market collecting further information can be difficult as there is little incentive on manufacturers to collect further evidence. There are recruitment difficulties and ethical concerns surrounding randomisation of patients between technologies where the technology under review is widely available outside the study. There may also be difficulty sourcing finance for further research once a coverage decision has been made.
Thus, while the rigour and more formal approach of the new proposed PMA process is welcomed and overdue it does not go far enough in addressing all concerns with health technologies. Reforming processes such as this provides the rare opportunity to improve how decisions are made. Incentivising continued evidence collection and incorporating a reassessment stage into the process would further improve patient safety and efforts for achieving value for money in ensuring only safe, effective and cost effective devices are on the market.
Frameworks and schemes for balancing access and the collection of further evidence exist and could be readily employed at European level. Such schemes grant conditional coverage for a specified period during which additional evidence can be collected and decisions can be reviewed. They have been successfully implemented in Australia, the US, and the UK.
So while the ENVI and European Parliament should be commended for their efforts to reform market access regulation for medical devices, there is still more to do. Health systems are facing rising costs and the rapid pace of development and change in medical technologies places further pressure on scarce resources. Thus, ensuring patients have access to safe, effective and cost effective technologies is the optimal treatment for preventing further crises with faulty devices and rising costs.
