The Pip resolution, drafted by the Environment and Public Health (ENVI) Committee of the European Parliament and unanimously passed on 25 April, is a mixed bag, according to Eucomed. The pan-European association applauds many of the measures, including greater oversight of Notified Bodies, more robust vigilance reporting, the introduction of unannounced audits of manufacturers and the establishment of networked registers for implants.
Eucomed, however, was puzzled, to say the least, by the resolution’s call for a preauthorisation system for implantable and Class III devices. “Europe currently has a de facto approval system for these devices,” the association notes in a press release.
Eucomed also expressed consternation that “some of the adopted positions are not fact-based,” notably a reference to the metal-on-metal hip implant controversy as proof that the EU regulatory system is failing. “This is inaccurate as these devices were also granted access in other large markets such as the United States,” notes Eucomed, which also points out that the UK regulatory body MHRA was the first in the world to issue guidance.
The resolution also falls into the traditional trap of confusing drugs and devices by calling for a premarket authorisation system and clinical data requirements that mimic the regulatory framework of pharmaceuticals. This is impractical for two very important reasons, notes Eucomed:
- Many devices cannot be evaluated by means of randomised clinical trials—how would you implant a placebo hip?
- Device efficacy and safety is affected to a large degree by clinician training and experience, patient selection and the care delivery system. This varies by doctor, hospital, region and country, notes Eucomed, and is impossible to predict with any precision.
How will this all play out in the context of the revision of the medical device directives that is currently underway? It sends a clear signal to the European Commission, says Erik Vollebregt on his medicaldeviceslegal blog.
“The [European] Commission is not obliged to take all of this on board in its [revision] proposal at this stage,” writes Vollebregt, “but this is a clear shot across the bow from Parliament telling the Commission what it wants to see in the proposal if it is to have a chance to make it through Parliament. Parliament can make life difficult on the Commission by killing or crippling its proposal with amendments the Commission won’t stand for or by not even agreeing with it,” writes Vollebregt.
Vollebregt is a founding partner of Amsterdam-based Axon Lawyers, a boutique law firm that focuses entirely on the life sciences industry.
It is somewhat ironic that the Pip breast implant scandal, which was caused by fraudulent behaviour that could not have been prevented by regulations, is leading to changes in the rules, observes Vollebregt. “Everyone is blaming Europe, whereas the problem really is a lack of decentralised follow-up and lack of commitment from member states. This cannot be fixed except with the member states stepping up and committing more resources, whether or not in a centralised fashion,” writes Vollebregt.
The European Commission plans to introduce the revision of the medical device directives by the end of Q2 2012. Stay tuned.Norbert Sparrow