Last week we finally had some new interesting developments (sorry for the boring silence on this blog but there was really nothing to report): the new Commission has completed and we are getting some first glances into how the new Commission sees EU medical devices policy going forward. With the unveiling of the new #teamjunkcer of Commissioners, it transpired that as part of the inevitable reshuffling that is part of a political process, the unit responsible for medical devices policy (together with medicinal products policy and the whole EMA organization) moves (back) to DG Enterprise.
It started with internal market legislation
I think this is significant news because the regulatory system for medical devices, CE marking, is originally an internal market oriented system that started out in DG Enterprise as part of the New Approach that created the CE marking legislative technique that helped complete the EU internal market in time for the political deadlines on the table in the early nineties of the last century. It was only moved to DG SANCO in 2010 when the last Commission started its term.
EU rules on market authorization for medicinal products are historically intended to primarily reduce regulatory burden of having to go to each member state separately, while ensuring safety and performance by means of the essential requirements, medical device specific conformity assessment procedures. And no, this does not mean that medical devices are regulated as toasters. If the people that said that would only take a look at how the medical devices directives work in the flowcharts of the unfortunately abandoned annex 8 of the old Blue Guide…
In the mean time the Lisbon Treaty entered into force which contains quite clear restrictions on the EU to legislate in healthcare (article 168 (4) TFEU)
“[The EU] shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:
(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.”
provided that (article 168 (7) TFEU)
“7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. […]”
These restrictions cause practical problems in situations where the EU does more than take common action with a view to meeting safety concerns in the medical devices field (yes indeed, for example the Joint Immediate Action Plan) or arrange for a common market access and post market surveillance mechanism (that sounds a lot like the three medical devices directives and their implementing measures).
Sometimes this level of involvement works (when member states are defending their national healthcare reimbursement systems) and sometimes it doesn’t (for example when the European Parliament tries to outstep for the In Vitro Diagnostics Regulation proposal with its genetic testing devices proposal, see for background here).
The Cross-Border Patient Rights Directive and the eHealth measures based on it are a good example of some of the tightrope exercises the EU is doing when trying to regulate things it perhaps is not completely allowed to regulate in healthcare.
Re-orientation on internal market
So to me the move looks like a re-orientation on the internal market aspects of medical products.
The consequences – I think – will be an EU policy that is more about integration and harmonization with a view to a more efficient and innovative market than careful but active intervention in the delivery and development as such as of healthcare as a matter of EU policy, which is exactly what the EU is supposed to do.
This will likely have have consequences for the developing mobile health market, which is all about how healthcare is delivered to individuals. It will be more about bottom up harmonization than the Commission proposing top-down interoperability standards and patient rights in relation to cross-border mHealth.
Also, SANCO has not been able to get the EMA to make regulation and market access of ATMPs a success, which has deprived innovative biotech SMEs of opportunities in the European market. In my professional activities I see SMEs run into the ground at the EMA with innovative ATMPs all the time. The consequence is that many SME have given up seeing their products through to market access and instead hope to be acquired on a proof of concept before their money runs out.
More in general SANCO has been less than innovation friendly in its regulatory policy so far putting NOs in innovation with a perhaps overly cautious approach, for example with the eLabeling regulation that requires paper labeling of apps.
Maybe this will also be fixed under the new Commission. A lot of ifs and buts remain of course while the political dust settles, but from where we are now, this is how it looks to me. Those who claim the moral high ground in health policy will say this is bad and innovative industry will say this is good.
So what will this mean
for the MDR and IVDR in the legislative process? The Commission is still an important voice in the process and takes an important role in the trialogue to bring the Council and Parliament closer together. With this reshuffling the Parliament could perceive the Commission as more biased towards the internal market and on the side of the member states that are no fans of the Parliament’s proposal – even if they have formally not even looked at that yet. The ENVI committee has not formally appointed a new rapporteur for the MDR with Dagmar Roth Behrend, famous for polarizing this dossier, on the way out. And it’s unclear still if the rapporteur for the mostly ignored IVDR (Peter Liese) will change as he is still member of ENVI.
It is safe to say that DG Enterprise will stick strongly to the internal market aspects in the MDR and IVDR proposals that come from Regulation 765/2008 and Decision 768/2008, which basically shape CE regulation and market surveillance on the markets thus regulated that comes after the Goods Package in 2008 (e.g. the supply chain rules in them).
Conclusion: no definitive answers yet unfortunately, as there are too many things that still have to become clear. But, with the new Commission’s plans we have a first idea of where things might be going.