UK Legalist’s Perspective On Medical Devices Regulatory Reform Post-PIP

In short

UK law firm Bristows has waded into the debate about regulatory reform in the light of the PIP breast implant scandal. In an article, published on its pages, the London-based firm concludes that no regulatory system, however robust, can guarantee against a further incident of this nature occurring when there is deliberate intent to circumvent the law. Dev Kumar, an associate in the firm, calls for reform to be proportionate and ensure that the medical device industry is not disincentivised such that patients are denied access to innovative technologies.


The full opinion piece can be found here. While it doesn’t bring anything too radical or indeed new to the debate, it is interesting to  read the perspective of the medico-legal profession on these matters. The author, Dev Kumar, is an associate at Bristows and advises on EU and UK regulatory law.

According to Kumar, the timing of the PIP scandal is likely to prove useful to the European Commission as it formulates its final proposals for the recasting of the Medical Devices Directive. Kumar argues that the starting point for the reforms may well now appear to be one of the need for comprehensive reform rather than fine-tuning.

Currently, proposals for reforms include improvements and strengthening of the regulatory framework through the introduction of measures for more pre-market testing and post-marketing surveillance, two measure which we at medlatest have supported. Looking beyond the tempting target of PIP-type situations, to the more realistic targets of problems where companies, regulators and patients all have an incentive to “regulate it right”, for instance the metal-on-metal knee disaster, we happen to believe that reforms should make the process more inclusive at all key development stages and beyond launch. Internal documents claiming that the company has satisfied itself shouldn’t be enough on their own. Notified bodies need greater specialisation and expertise, otherwise their role will be impossible. reassuringly this is part of the plan as it stands. An Orthopaedic notified body should be specialised to deal with the kind of orthopaedic challenges and language that will be trotted out by the people they’re regulating, surely.

Do we want a “European FDA”?

Many commentators on the subject have questioned the current set-up. The peculiarity of the notified body system, as we have said on numerous occasions, is that these “regulatory bodies” are in fact paid-for private companies who need the business of the very companies they are policing.

Kumar states that industry is concerned that the PIP case will result in the Commission endorsing a shift from a decentralised system to centralised accreditation and monitoring with a raft of wholesale changes to the MDD in preference to fixing the bits that aren’t working, while building on the bits that are. The result of centralisation being something akin to a “European FDA”.

Kumar deals at some length with the regulatory demands placed on breast implant manufacturers, but the conclusion of his exhaustive description of the process seems to be that whatever measures a company has undertaken to get to market, the problem, as evidenced by PIP, is that once at market it is too easy to change the practices, for whatever reason.

The knee-jerk response to the PIP debacle might take many forms, but the only one that looks directly at the PIP problem of deliberately dodging the rules, is the introduction of spot checks, or rather the reinforcement of this practice as we understand they are already permitted.

The article concludes with the assertion that despite the huge number of devices on the market there is a tiny number of “incidents of this nature”, which we take to mean deliberate deceptions. Kumar believes these may not be catchable using regulatory tools, so is presumably saying regulatory changes should not try to achieve something they never will. He therefore advocates proportionate reforms which would not disincentivise device companies and ensure a continued flow of innovative technologies which will ultimately benefit patients.

While we’re hugely sympathetic and understanding of the position adopted by victims of medical device disasters, we’re on the same page as Dev Kumar. The answer doesn’t lie in a draconian regulatory regime, but in sensible evolutionary changes coupled with a shift towards greater post-marketing surveillance.

Source: Bristows