European Commissioner for Health & Consumers, John Dalli, confirmed the pressing need for Europe to introduce policies and concrete programmes to promote innovation in medical technology and services if Europe is to meet the systemic health challenges ahead.
He did so during a High Level Conference organised by the European Commission in Brussels on 22 March entitled “Exploring Innovative Healthcare – The Role of the Medical Technology Innovation and Regulation”. This is the first time that the Commission organises such an event focused specifically on medical technology. It is hoped that this conference is the beginning of a series of such events centred on medical technology.
Commissioner Dalli framed his ideas on what action would be needed in a series of conclusions which are now set to be taken forward to the Council of Health Ministers by the Hungarian Presidency to the EU for confirmation and development of a strong action plan.
Chairing this one day conference on the joint themes of “Innovation” and “Regulation” of medical technology and with an invited audience of national Health Ministers, MEPs, including EU Parliament Vice-President Dagmar Roth-Behrndt, senior EU Research officials, senior national health ministry officials and other stakeholders including Eucomed, Commissioner Dalli oversaw what was a well- attended, balanced and strategic discussion.
During the morning session, Eucomed Vice-Chairman, Alain Coudray of Medtronic, received the opportunity to give an industry address on the value of technology which widely echoed the positive view of medical technology in the room. In particular, some Member States such as the United Kingdom, the Netherlands and Denmark, emphasised the gains to be had if the right policy decisions are made, reflecting their initiatives in this area. The point of not making the same policy errors that irreparably damaged European research and innovation in the area of medicines was also well made.
At what was widely acknowledged as a very successful and pivotal event, Commissioner Dalli’s conclusions focussed on the need to:
- Promote more patient-centred and cost-effective innovation if systemic challenges are to be met;
- Augment current initiatives in this area and develop more focussed and better mechanisms to both promote and fund this innovation;
He also emphasised the crucial and particular role of SMEs in this sector and the need to increase support to help gain more productivity within health systems, reiterating that SMEs are the backbone of the needed innovation in the products, processes and services, A specific need mentioned was access to appropriate expertise in what is a very complex sector and that this needs to be facilitated by the EU.
Bookending his Chairing of the morning session, and with an eye to the subject of the afternoon session, Europe’s chosen regulatory framework was seen as a key success factor in needed innovation in medical technology. The currently planned update of the framework needs to keep all the characteristics and benefits that it has produced to date and be designed to accommodate future needs, for instance homecare, integration of e- and m-health and interoperability across Europe.
The afternoon session was Chaired by the Director General of the Directorate for Health and Consumers, Paola Testori Coggi, and focussed on the upcoming revision, or ‘recast’, of the legal framework for medical devices in Europe.
Here again, echoing the morning session, there was a strong, broad support for keeping and enhancing the current legal framework. Both the Commission and Member States saw no reason to alter the way medical technology is regulated in Europe, supporting a technology specific approach and the European CE marking system.
Instead policymakers focussed on improving the system’s known weaknesses and making it even stronger in encouraging the development of innovative technology, ensuring safety and reinforcing confidence. Member States also pointed to the need to examine the sustainability of the current funding of the system.
There was no new emerging preference given by the Commission on any one of the four different choices of enhanced management of the system being considered:
- Member States’ Committee
- The Commission supported by its Joint Research Centre or similar Commission structure;
- A new stand-alone Medical Technology Agency;
- Or a separate function within a renamed and restructured European Medicines Agency.
But there was a clear acknowledgement in the room that any choice should fully align with the political discussions of the morning with a certain resonance of the point of not making the same policy errors that irreparably damaged needed research and innovation in the area of medicines.
As a next step, Eucomed looks forward to the action plan that the Hungarian Presidency will put forward and to collaborating with the Commission and the presidency to carry it out.
For further information contact John Brennan (john.brennan@eucomed.org), Director Regulatory & Technical Affairs, Eucomed
