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How should the EU regulatory framework change because of the PIP incidents?

Since the French authorities made their announcement just prior to Christmas, the PIP case has generated a large amount of press and political attention. Quite rightly, the main focus is on the women affected and on governments providing the right health advice and appropriate follow-up. As I am writing this posting a couple of days after we released our first statement, I understand that the European Commission is to seek an independent scientific opinion on the human health risks of silicone breast implants.

Much of the media coverage and debate also focuses on the European regulatory system itself and how it must be improved. This attention is to be welcomed since medical technology, and the benefits it brings to people and society, are of such high importance that the underlying regulatory framework behind that must be of the highest calibre and well regarded as such.

Amongst the articles in the media and in public discussions, there are many mixed reactions and unfortunately quite a few errors of fact. But overall there is one clear message: we need a new system that readily addresses some fundamental issues.  The current system is constrained by an excessive level of confidentiality, a lack of effective central coordination and the perceived lack of clinical data and involvement of authorities in high risk devices.  It does protect safety but struggles to justify itself to those who are unfamiliar with its elements and it does not meet the demands of a modern, transparent and information driven age.

Fortunately we are getting a new system. In spring 2012 the European Commission will propose to repeal the current legal framework and replace it with new regulations on medical devices which should address the key concerns being expressed by people and politicians today. A series of new measures are being developed that, if implemented, will help ‘prevent’ similar cases in the future.

I say ‘prevent’ in inverted commas, as one has to remember that the PIP case is one of alleged fraud . No system can ever fully guard against deliberate criminal activity. This is true whether we refer to food, pharmaceutical or cosmetic legislation. So when something goes wrong it does not mean that the whole system is wrong. In food, for example, we had the Italian wine scandal in 1986; in pharmaceuticals, we had the ‘Vioxx’ case in 2004 and the ‘Mediator’ scandal in 2011 – but we didn’t throw out the working parts of the food or pharmaceutical regulatory frameworks.  Policymakers and stakeholders worked to fix what was broken.

With a new legal system for devices on the way, an important aspect is perspective. Patient safety is and remains paramount and may never be compromised. But keep in mind that unlike drugs, which are numbered in the tens of thousands, there are approximately 500,000 medical technologies currently available to healthcare professionals, carers and consumers. These range from simple and everyday consumer products such as spectacles, dentures and sticking-plasters, to incontinence and ostomy care products, syringes and bandages, to hip implants, MRI and X-Ray equipment, and pacemakers.  The technologies concerned also extend far beyond those of pharmaceuticals to include materials science, bioengineering, engineering, electronics, software, information and communication technology, nuclear, aerospace, plastics technology, surface technology and many more which are applied across all areas of clinical practice and homecare.

These technologies assist the elderly, prevent illness, heal the sick and save lives every day.  Rapid access to these technologies is critical to patient care and health system quality and productivity. In Europe, despite the complexity and volume of the technologies to be regulated, key elements of the current system ensure that we have the fastest access for patients, doctors and carers while being as safe as other regions around the world. We must recognise that elements of the current system have worked very well for the wellbeing of EU citizens and health systems. But we need to improve the regulatory system.

So what should the new system bring? Centrally coordinated oversight with the active involvement of national health authorities, and proper information and traceability are paramount. The proposed new system is set to deliver this and Eucomed has made the following suggestions:

  1. Tight authority control on notified bodies and the current market access and approval process;
  2. Centrally coordinated market surveillance by authorities;
  3. Central reporting of incidents into a central monitoring database open to public;
  4. Traceability through unique device identification technology (UDI);
  5. Centrally developed requirements for clinical evidence;
  6. Transparency, including to the public;
  7. A central registration database open to public;
  8. The European Commission’s independent scientific policy advice body Joint Research Centre should provide the necessary resources and variety of independent scientific networks needed to carry out ‘Horizon Scanning’ and support solid independent scientific policy advice to the European Commission and Member States.

There are other suggestions which we have outlined in our position paper.

One element of the current media coverage that needs clarifying is the confusion with pharmaceuticals which centres on the difference in availability of clinical evidence for pharmaceuticals and medical devices, including (inaccurate) claims that no clinical data exists for medical devices.

To clarify: an appropriate clinical evaluation of clinical data is required for all medical devices before they are marketed. In particular, for both implantable devices and devices in Class III, the clinical evaluation must be based on data obtained from clinical investigations unless it is justified to rely on existing clinical data. Fact.

When it comes to requiring the same type of clinical data for devices as for drugs, it is worth highlighting that for pharmaceuticals randomized control trials are relatively straight-forward to perform, and efficacy and relative safety can be statistically demonstrated in support of obtaining a marketing authorization provided that the clinical trials are sufficiently powered (depends on the number of patients). For medical devices, randomized clinical trials are difficult to perform (it is difficult to implant a placebo hip for example). Unlike in pharmaceuticals, randomized clinical trials are not the ‘gold standard’ on how to assess effectiveness and safety in medical devices because:

  • Most devices cannot be evaluated with randomized clinical trials as it is hard to blind and randomize due to strong ethical and practical issues in the choice of the ‘comparator’ (e.g. what would have been a comparator for an implantable cardiac defibrillator?  How would one implant a placebo hip?).
  • Device impact depends on clinician training and experience, patient selection and the care delivery setting. This varies per doctor, hospital and country and is thus nearly impossible to predict with any precision. We therefore believe that ‘real world’ data from observational studies performed under routine conditions are equally important (structured post market surveillance).

In summary, medical technologies are part of the whole healthcare delivery system and their efficacy relies on the skills and experience of the physician, the quality of the hospital, and many other factors (contrary to pharmaceuticals).

Apologies for the long blog posting, but with so much going on it is hard to be brief. But if I had to state the one takeaway thought I would say that patient safety is and remains paramount and may never be comprised; a new European regulatory system is on the way that will tackle the critical issues; and as an industry we remain fully engaged and continue to work closely with authorities to make the best system possible for Europe and its citizens.

John Brennan
Director Regulatory and Technical Affairs Eucomed

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