Lately I hear and read a lot of people asking for a Pre-Market Authorisation process for medical technology in Europe, or PMA process as it’s known, similar to the one in the US. Even the European Parliament voted (narrowly) for a resolution in which they call for a PMA approach. And that made me think, hold on a second, don’t we already have an approval system in Europe for high risk products? Didn’t I spend 10 years in a previous life doing exactly this for a notified body under the full and in-depth scrutiny of the Irish health authority? I even re-read the recital to the original legislation, Directive 93/42/EEC, where on page four it states:
…whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;
Device approval approach in Europe a deliberate choice not an oversight
One has to remember here that Europe’s use of the government appointed notified bodies as an approval mechanism over government itself was and is a deliberate choice for medical technology, not an oversight. It was chosen to make sure that people have the fastest access possible to safe medical devices that save lives. Of course there is an economic angle as well for Europe Inc.: making sure that innovation stays in Europe. But this is of second tier importance if compared to patient safety. However, the current system has proven that both these aspects can be successfully married.
Delegated competence with strong authority oversight
We must always bear in mind that unlike medicinal products, which represent one branch of science, medical devices represent a vast range of sciences and technologies. Atomic Physics, anatomy, bioengineering, mathematics, engineering, materials science, radiology, fluid dynamics, thermodynamics, acoustics, computer science, electronics, micro-electronics. It goes on and on - the list is only limited by doctors and scientists capacity to invent and innovate.
The collaborative inventiveness and innovation of doctor and engineer, applying science and technology to solve health problems, led authorities and law-makers to conclude that a pharma-like PMA approach to medical devices simply could not work. Each European government would need to employ hundreds of doctors, scientists and engineers, whom, having left practicing medicine, academia or industry, would be unaware or unable to pass judgement on the latest in scientific development.
A delegated competence would therefore be a better solution with strong authority oversight and monitoring of continued competence, safety, and public health aspects. In this way governments could secure authority involvement with the highest in technical and scientific competence.
A centralised approach delays patient access with 2-3 years
A centralised approach does not work for medical technology. While health systems purchase nearly 16,000 medicines, they require over thirty times that amount of medical devices. Approximately half a million different products are supplied to the healthcare system from a global industry, most of whom, 80%, are SMEs. A central approach would be completely overwhelmed with work and grind to a halt.
And this is even before we think of the economics. In this economic environment, no one could even countenance justifying the cost of creating the behemoth that would be a central European device authority that, like pharmaceuticals, would require beefing up national agencies to be fully technically and scientifically competent - especially when there is a functioning system that costs the exchequer nothing.
This would be the same phenomena that the US FDA system is struggling with today. The same products – and hence with the same safety profile – take on average 2-3 more years to get through the US system than the EU. Furthermore, the US FDA struggles to audit manufacturers outside of the US, whereas the European system guarantees worldwide regular auditing of facilities including the ability to carry out spot-checks. This is why other countries such as Australia and Canada also use the European system of notified bodies to carry out auditing and, in Australia’s case, the checking of safety files.
A decentralised approach as solution
Europe deliberately chose an alternative to the centralised approach. An approach that made sure that the safety, science and technology was sound and that health authorities had a firm grip on the reins should public health or safety be at risk.
This is why Europe has a decentralised approval system with authorities controlling the public health and safety aspects and notified bodies supplying the clinical, scientific and engineering expertise to check the technologies.
Reasons for PMA just don’t stack up
So, by law, in Europe we already have a mechanism for approval before a product gets to market. But because it’s done indirectly by government, by a body chosen and monitored in its work by authorities, the famous so-called ‘notified bodies’, rather than directly by government, the terms ‘certification’ or ‘approval’ are the correct legal and technical terms used.
So if we have authorities involved, they decide who can do the approvals and then oversee and monitor the approvals given, why are there voices calling for PMA?
The PIP scandal obviously plays a part. We need to examine the system thoroughly because of the PIP fraud. But PMA will do nothing to prevent a fraud. Fraud by definition is a criminal intent to circumvent any approval or oversight. No pre- or even post-market checks, no matter who’s doing it, either government or government appointed bodies, or how thoroughly they do it, is immune to fraud. So while I can understand the reaction to call for PMA, once you analyse it as a fraud deterrent, it doesn’t stack up against the facts and is therefore not a plausible reaction to prevent another PIP incident.
Others would like to see a PMA as a parallelism with pharmaceuticals. This again I somewhat understand but it doesn’t stack up either. Once you look at what medical technology is, you realise similar approaches cannot be applied.
Medical technologies are the mechanical and electrical tools and equipment used in everyday life to deliver health. They range from everyday products in health such as tongue depressors, wheel chairs and continence care products through to surgical equipment and implants which range from simple pins, nails and staples, through to sophisticated active implants that sustain life. And these technologies can only work if you have the skilled doctors and nurses who know how to use them. Once you realise this, that technology needs to be analysed on a case by case, technology neutral, basis and that the health professional and health delivery setting plays a significant role in the eventual outcome, you can see that medical technology, although often used in the same health setting as pharmaceuticals, are in fact light years away from pharmaceuticals in terms of their nature and how best to ensure their safety and availability to the doctors, nurses and patients that need them.
Their very nature is completely different, their role in healthcare is completely different, how they are bought and paid for is completely different and the safety concerns and hence safety solutions are completely different. Because there is no parallel to pharmaceuticals a system fit for medical technology is required, not a system fit for pharmaceuticals. So again the PMA argument falls.
But of course the device system has to change and improve upon itself to remain relevant in todays’ societies and address valid concerns arising from PIP and other market issues. Improvements in notified bodies, vigilance and transparency rank high on the agenda.
Improving the decentralised approach
And we are set to improve on that successful system. The weaknesses are known and once legally strengthened we will continue to have a system that is ahead of the world in guaranteeing safety, low costs to the exchequer, effectiveness and efficiency to health authorities, involvement of patients and doctors, transparency and innovation in the EU.
There should be no doubts about the competence and the job done by notified bodies. They must stand up and be transparent to scrutiny. We need a coordination mechanism among authorities and the European Commission to make sure that every notified body in Europe is of the same high standard. And if some are not, they should be delisted.
We need the vigilance system to be bolstered to ensure that, if events occur, there is swift and coordinated action across the full 27 member states, based on a common and scientific risk assessment.
We need an improved engagement in the development of standards and guidelines, one that brings in all stakeholders including patients and doctors.
We need more transparency, including the most basic of tools: a single EU database of products that are on the market.
We need legal, administrative and scientific support from the Commission to help the system function as intended, supporting the coordination of Member States and playing a key role in ensuring that the notified bodies are all of the same high level.
All these changes mentioned here above can be found in our position paper and are expected to be part of the European Commission’s proposal of the Revision of the Medical Devices Directive.
Combining safety and fast access
With the proposed changes and tight implementation Europe could again lead the way in terms of health and technology. Smart implementation along the lines foreseen could bring value-based innovation, faster availability to patients and doctors of products that they want and bring a competitive advantage to the European economy.
I understand the current concerns. And I understand the familiarity with the pharma system. But it is important to also take the time to examine and understand the medical technology system - to understand why it works. To understand how it addresses the concerns of today, and how the improvements foreseen will take care of concerns for the future.
Our system is the envy of other jurisdictions. Much misunderstood, it is also the focal point of criticism. Once understood it is held up as an example of safety and efficiency, delivering both safety and faster access for patients and doctors. We must not forget the importance of this. It’s not a ‘choice’ between safety and fast access – you cannot choose access over safety - it is about ‘combining’ safety and fast access. And this we have done, and hopefully will continue to do successfully in Europe.
Director Regulatory and Technical Affairs