There has been so much media and political focus on the medical device legislation in Europe in the first four months of 2012 that one could be forgiven for losing track of what's exactly going on and where we are exactly in the process.
Especially as we now have Commissioner Dalli’s joint action plan with Member States in reaction to the PIP breast implant case, the European Parliament’s Resolution on PIP and national authorities voicing their desire to move to a ‘Heads of Agencies’ approach to managing harmonised implementation.
How do these relate or affect the Revision of the Medical Device Directive (MDD)? Is the debate heating up or is it in fact all over and positions now set?
Here’s how I see it: the debate isn’t either at the beginning or at the end, it is merely moving from one stage to the next and the end is most likely in early 2014.
Or after that.
Let me start explaining what’s going on right now.
The Joint Action Plan
The Commissioner’s joint action plan with Member States is aimed at preventing a reoccurrence of a PIP-like event. While it is an action under the current legislation, it includes ‘new’ elements that go beyond the current legal framework. Hence the logical conclusion is that these ‘new’ elements are expected to be included in the MDD Revision text, especially in the areas of notified bodies, vigilance and transparency. As such it is very much supported by Eucomed and reflects many of the improvements we have called for in our position paper.
In effect, the joint action can be viewed as a practical approach by Member States on how to improve the effectiveness of the current European regulatory framework for medical devices. The knowledge gained during the roll-out of the joint action will be fed into the legislative debate, which begins when the Commission turns over its proposal to the Council (Member States) and European Parliament for debate in September 2012.
The PIP Resolution
The European Parliament Resolution on PIP is a call from the Parliament on the Commission and the Council to seek ways to prevent a PIP-like event (a resolution is an instrument of the European Parliament to express its view on topics of their interest - it is a non-binding tool that is addressed to the European Commission and the Council for their consideration). We have to keep in mind that working to a tight annual calendar of work, and with 753 Members of the European Parliament (MEP), only some of whom are specialists in health and only another sub-set of those expert in medical devices, the PIP case came at a time where MEPs were beginning to appraise themselves of the expected medical device legislation. As such and acting in a cross party initiative to show a strong denouncing of the PIP case, the Resolution contains calls for the use of every possible legislative tool to prevent a PIP-like case. It contains even tools which, MEPs already familiar with medical devices legislation know, would not prevent a PIP case, such as the pre-market authorisation amendment.
To wrap it up, the PIP resolution should be viewed as a collection of ideas from all Parliamentarians and not a definitive list of what all Parliamentarians think must be in the final legal text. That will only come when the MEPs examine the definite Commission proposal. Once the text is in their hands MEPs will look closely into the details including the supporting arguments from the Commission and measure those against their concerns.
Not the European Medicines Agency
Most people are seeking an answer to the question: will the European Medicines Agency (EMA) be the coordinating body? And before answering this I think it’s worth pointing out that there are many other important improvements already signalled by the Commission as far back as March 2011.
In a document sent to industry and other stakeholders the Commission pointed to measures to improve:
- Designation and Monitoring of Notified Bodies
- Device Specific Requirements
- Monitoring of Conformity Assessment Procedures (stronger review of high risk/innovative products)
- Borderline and Classification
- Day to Day enquiries
- Clinical Investigations
- Post-market Clinical Follow-up and Market Surveillance
- Registration and UDI (Unique Device Identification)
- Global Medical Device Nomenclature (GMDN)
- Scientific opinions
- Training and Public Information
- International Cooperation and Involvement of Commission, Member States, Industry, Notified Bodies, Healthcare Professionals, Patients and others
Eucomed sees great value in improvements in all these measures to bring a smart and efficient legislative framework that is consistently implemented across the EU and guarantees high quality healthcare, patient safety and rapid access to the latest value-based medical technologies.
On the EMA question I can be brief and clear: the Commission has stated that it will not be turning to EMA as there is a closer, better and more cost-effective alternative that provides the required level of safety. Looking to the actual problem or gap to be filled and mindful of managing constrained EU budgets, the Commission has indicated that it will turn to itself and bring the resources needed to coordinate implementation from within the Commission, namely within DG SANCO with the scientific policy support of the Commission’s Joint Research Centre, JRC. EMA, and indeed national medicines authorities, will of course be involved as they are today in so-called drug-device combination products, which, incidentally, by Eucomed’s calculations only account for 0.2% of the more than half million products on the market.
Member States too have been quite clear and have announced their intention to beef-up their management and coordination of the system. Presumably with a view to dovetail into the Commission’s planned resources they intend to organise the medical device authorities along the lines of the ‘Heads of Medicines Agencies’ model by creating a ‘Heads of Medical Technologies’ model presumably at the same level as the heads of veterinary and medicines. A kind of Health Products Regulatory Network one can imagine where senior involvement can guarantee resources and commitment to decisions. It is not clear if food and cosmetics would be added.
So rather than revolution it seems we have evolution with the two pillars of the current system being strengthened, the Commission and Member States.
So Where Are We Now?
First expected in June 2012 the Commission has extended its estimated publication date for a proposal to the Council and European Parliament until September 2012. This is primarily to allow examination and a stress-test of envisaged proposals against the facts of the PIP case.
While some see September as the end it is in fact only the beginning of the legislative process.
The Council and European Parliament will then discuss the proposal and no doubt bring amendments in order to agree upon a common text. This process is called the ‘Ordinary Legislative Procedure’ in EU law-making.
This process can either be quite quick if there is agreement in what’s called the ‘first reading’. As short as six months is possible. Eighteen months to two years could be said to be more typical. In certain cases, where there are difficulties reaching agreements on amendments either within or between the Council and European Parliament, second readings are necessary and ultimately a conciliation process kicks in. Conciliation is happily a rare occurrence and most balanced law-makers seek to avoid a stalemate or indeed even a second reading.
So this means that we might see an agreed new revised framework for medical devices in either 2013 or early 2014. But there’s a subtlety about 2014 that might stretch things even longer – even if there is broad agreement. In 2014 we have the European Parliamentary elections. This will either mean that Parliament and Council will try to clear the legislative decks before the end of 2013 or, depending on the state of progress or will to continue, leave the debate for a new Parliament. This adds yet another six months to a year at least if it happens.
Once published, and we are expecting Regulations, not Directives, the law will be immediately applicable in all Member States. However, given the nature of certain aspects some provisions will have transition timelines associated to allow authorities, notified bodies and manufacturers to shift to the new rules.
So, while a lot is known today, better clarity will only come when we see the exact text of the Commission’s proposal in September.
In my next blog I’ll elaborate on a topic for which I receive many questions: pre-market authorisation. If you’re interested, watch this space!
Director Regulatory and Technical Affairs