If there is one thing that the medical devices industry agrees on it is that the new proposals for medical devices and IVD regulations are welcome and necessary evolution of regulation. What the industry also agrees on is that although it generally supports the new proposals, it is not certain at all that the proposed scrutiny procedure will achieve the intended goals.
It is undisputed that the CE marking system as we currently know it has brought the EU a lot of advantages in terms of innovation for patients. To me, however, it is unclear why the EU would want to sacrifice this advantage if more proportional and effective measures can be taken. Some voices in the European Parliament want to move to a more pharmaceuticals-like system for market access of medical devices. The assumption behind this is that a more frontloaded market access procedure by necessity only admits safe products to the market.
My contention is that this pre-market authorisation thinking will lead to the creation of an ineffective regulatory dinosaur. Why? “Big brother” pharma is now proposing to say goodbye this T-Rex of regulation, because the underlying assumptions turn out to be incorrect. Indeed, the pharma market access procedure is failing to deliver innovative medicine at the rate we would like because the market access procedure itself is becoming a barrier to entry. A specific case in point is the EU procedure for advanced therapy medicinal products. This procedure is supposed to facilitate an industry characterised by many innovative SMEs with very diverse products (much like the devices industry) but it hasn’t been successful.
The European Medicines Agency (EMA) is now testing the water for ‘adaptive licensing’, an approach based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation in its Roadmap to 2015. But not only EMA is testing this: many other drug agencies around the globe are doing the same, and for the same reasons. EMA expects adaptive licensing to allow approval to align more closely with patient needs for timely access to new medicines and for data to inform medical decisions. It relies on more proportional and risk-based market access procedures that focus more on collection of additional evidence in the post-market phase by relying on beefed up post marketing clinical follow up and/or increased monitoring of its safety/performance ratio for some time after market access. In this respect, EMA says in its Roadmap to 2015 that “[s]trategies on the best way to increase the knowledge of a medicine in the post-authorisation phase need to be set up at the moment of licensing, and subsequently reviewed when new information emerges.”
The new EMA approach sounds a surprising lot like the medical devices system currently in place that uses a clinical evaluation cycle that relies heavily on post-market experience gained with the device in real life. The EMA further states that “[u]nder the current licensing scenario, the treatment experience of most non-trial patients does not contribute significantly to evidence generation for the majority of drugs. Under AL [adaptive licensing], learning about a drug’s benefits and risks, and changing its regulatory status in a planned manner based on that new knowledge, is a more continuous process that informs repeated rounds of assessment, making fuller use of all sources of information.” This fits together very well with the medical devices industry’s findings that non-trial information is very important, because for many devices it is simply not possible to use placebos.
The new pharmacovigilance package for medicinal products is likewise designed to accommodate more post-market monitoring. Mirroring this system would solve all the problems that the scrutiny procedure for medical devices is supposed to fix. For example the transparency and labelling requirements subjecting certain products to additional post-market monitoring would have been well-suited for transplantation to the medical devices field. The possibility to require post-authorisation safety and effectiveness studies would work very well in the devices system.
Say what? All of this is already possible under the post market clinical follow up procedure in the medical devices regulation proposals? That saves a lot of work then. The system could perhaps be tweaked to allow the Medical Device Coordinating Group (the Commission has proposed to create this new MDCG which is comprised of representatives from each Competent Authority and chaired by the European Commission) to pick products for scrutinising the post-market clinical follow-up plan rather than exercising pre-market control, if the MDCG must be involved in the process for political reasons.
Looking at things this way it seems to me that the EU is proposing to evolve the devices system backwards by referring to obsolete regulatory state of the art as a justification to implement pre-market access controls. Why would the Parliament and the Member States want an obsolete solution? The only explanation I can come up with is that they are aiming for a cosmetic solution that will fly politically.
It is of course easier to look at a file only once at the beginning than to monitor a product over time and it saves you the embarrassment of having missed something later because you weren’t paying attention. However, it is precisely this method that prompted new pharmacovigilance rules and licensing procedures for medicinal products because the legacy dinosaur method has proved (1) ineffective for increasing continued long-term safety of products and (2) to not be conducive to innovation.
We already have adaptive licensing in medical devices – why sacrifice that for a regulatory dinosaur? If the EU legislator wants to mirror medicinal products market access rules, it should at least mirror the state of the art. Don’t try to reinvent the wheel with solutions that have proven not to be effective in that field and are currently being abandoned.
– Erik Vollebregt, Life Sciences and IP lawyer
Founding Partner Axon lawyers