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Eucomed MTF 2011: EU Commission right behind industry - Dalli, Minor, Kroes and Madelin signpost medtech future

This article was originally published in Clinica

Executive Summary

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No less than four high-level representatives of the European Commission, including health and consumer policy commissioner John Dalli, gave presentations at the just-concluded Eucomed Medtech Forum – more than ever before at a publicly accessible medtech meeting.

Their presence in such a number at the event, which took place in Brussels during 12-14 October, gave a clear sign to the industry of the vital role it is expected to play in terms of the delivery of innovative solutions, particularly in e-health, to ensure the sustainability of Europe’s healthcare systems in contributing to the future health of EU citizens.

The message from the meeting was that it is an exciting environment with good potential rewards ahead, but that industry must accept some significant challenges as well as the need to change its culture and to work more closely with other stakeholders to contribute to integrated care delivery.

It must also work hard to provide convincing evidence to argue its quality and value case.

And it needs to make a paradigm shift to work in collaboration with other players in the health sector since, delegates were told, e-health offers the greatest potential when seen in the context of healthcare as a whole, and not just the medtech segment.

Commissioner Dalli: innovation and integrated care

John Dalli, the European commissioner for health and consumer policy, spoke on the first day of how medtech innovation must be part of the solution to keep people healthy and active as society ages, against a backdrop of economic fragility and uncertainty.

John Dalli, the European Commissioner for Health and Consumer Policy Photo: david plas photography

Though ageing could be responsible for an increase in total healthcare spending of 1.5-2% of GDP by 2060, age does not have to be such a drain on our resources, he suggested. It is time to “sever the link between old age and ill health” and work towards healthy ageing, he told the meeting.

His vision, he explained, is to keep people out of hospital beds as much as possible for their quality of life and for the sake of sustainability our EU health systems.

The aim of the European Innovation Partnership on Active and Healthy Ageing is to increase the average healthy lifespan of Europeans by two years by 2020.

The hope is that with medical innovation, patients can become co-producers of their own health, receive more tailor-made healthcare, and stay at home, living actively and independently for a longer period of time.

The medtech industry will be a vital facilitator in achieving these goals; but to achieve these aims, industry must explore solutions for more efficient patient pathways in healthcare.

It is time for innovation to look beyond traditional product offerings and include the whole healthcare chain – from hospitals, carers and health insurers, to health systems themselves – in their product and service concepts, Mr Dalli said.

Integrated care, for example, which often includes remote monitoring of patients and involves the whole chain, will be a key feature of future healthcare delivery and is an area where industry is needed to play a key role in design of essential, often e-health, tools.

With the aim of keeping people healthier and more independent for longer, Mr Dalli said, three goals have been identified:

  • innovation in awareness, prevention and early diagnosis;
  • innovation in care and cure; and
  • innovation in environments for active and independent ageing.

He talked of how medtech can help in this respect, including by bridging the gap between hospital, ambulatory and community care of the future.

Innovation, he said, must help to not only increase the efficiency of healthcare systems, but also ensure economic growth.

But it will not be innovation for innovation’s sake.

Mr Dalli spoke of how health technology assessment will help produce safe, effective health policies that are patient-focused and seek to achieve best value – smart investment coupled with smart innovation.

“We need to promote more effective used of new technologies,” he said, adding that the appropriate regulatory environment is crucial to improving access to innovative devices.

With the proposed draft recast of the medical device directives – due to be published next April –industry does not need to fear any far-reaching impact from the recent EU/US spat over the relative value of their two systems, since Dalli stated that there is no evidence that one regulatory system is “safer” than the other.

He referred to the need to provide administrative and technical support to member states at EU level, but said that the debate surrounding where to locate a centralised management agency was more a matter of organisation than of substance.

The Commission is committed to a continued dialogue with industry and other stakeholders in the future, and Mr Dalli announced that he strongly supported a second Commission-led, high-level medtech meeting in 2012, similar to the one held in March 2011.

The last meeting served as a basis for the European Council conclusions on innovation in the medical device sector (www.clinica.co.uk, 7 June 2011 ).

Mr Dalli invited industry to come up with topic proposals for the next meeting.

Robert Madelin: digitisation of health

Robert Madelin, director general of the DG for the information society and media at the European Commission, brought a practical and dynamic dimension to discussions, by introducing the subject of digitisation of health.

Robert Madelin (right), Director General of the DG for the Information Society and Media Photo: david plas photography

He believes that digital solutions are key to all citizens taking greater responsibility for their own health, posing a to the industry to design innovative digital medical products so patients can better control their own healthcare.

If everyone were actively engaging with new media, then this would transform the market for medical applications of apps and gadgets, and begin the digitisation of health, he said.

At present, only one in five citizens look for self-care products on the internet, he said, but 75% who found products there said what they had found had improved their health or condition.

“Everybody has to go digital,” he said, recognising that partnerships are needed to really drive the digital future, and adding that more patient-centred trials are needed to validate medical apps.

With tens of thousands of apps on the iPhone, how many are linked to medtech products, he challenged? There are still questions over the regulation of the digitisation of healthcare, he noted, adding that we need to avoid iPhones themselves with medical apps becoming regulated as devices.

Mr Madelin recognised the challenges ahead and advised manufacturers to design for resilience.

He also added that issues need to be addressed, such as how to manage when electronic systems go down – collapses of the Blackberry network internationally during the days preceding the Eucomed meeting were a stark reminder of the potential risks that the digitised age pose.

It is important to help citizens become more acquainted with the digitised world, he concluded, to transform economics for industry as a whole.

Neelie Kroes: fully understanding the needs of users

Meanwhile, Neelie Kroes, vice-president of the European Commission and commissioner for the European digital agenda, described the ICT sector as an open field waiting for new ideas to be planted in health and social care. Addressing the meeting via video presentation, she predicted a good harvest.

Too often there is a gap between technological capability and practice, she said, a gap which must be addressed to ensure that quality care remains available to all and to help bring about self-determination in health.

The reasons for this gap vary – sometimes solutions are not deployed because of costs, sometimes because of legal issues, or because of inertia caused by ingrained cultures, habits or business models, a recurrent theme at the meeting.

But part of the reason that technological solutions are not found quickly enough is down to a lack of sufficient understanding of user needs, was another key theme.

How do we come to understand fully the needs and barriers of end users whether patients, the elderly, care givers or the practitioners?, she challenged industry. It is in attempting to answer this question that the Commission created the European Partnership on Active and Health Ageing, to bring together these main actors.

This partnership is key to unlocking Europe’s innovation potential, she said, addressing barriers to ensuring that systems are inter-operable and that efforts are not replicated. Within its context, co-operation is key between different health and social care sectors, public and private.

“The partnership is a chance to work together with a wide variety of stakeholders towards new viable solutions,” she said. “The best thing about ICT sector is not what it has achieved, but what it has to potentially achieve.”

She raised the question of whether there needs to be more regulation, and more standards in the area of e-health and whether it will be necessary to clarify the responsibility of players in this area.

Jacqueline Minor: regulatory framework and sustainability

Last but not least, Jacqueline Minor, director of consumer affairs at DG Sanco spoke of how the European Commission, in reviewing the regulatory framework, has been focused – as well as on patient safety – on ensuring the long-term sustainability of healthcare systems in the EU and on increasing the competitivity of the EU industry on the global market.

Jacqueline Minor, Director of Consumer Affairs at DG Sanco Photo: david plas photography

The Commission has been trying to make the system as cost-effective as possible, she said.

Communication with industry has played a vital role in informing the Commission; its March high-level conference, which was followed by the Council conclusions in June, gave the Commission a strong mandate to review the regulatory framework to enhance predictability and transparency, and so decision-making, at a rate commensurate to stimulate innovation.

She sees the recast as more a case of evolution than revolution.

“We hope to preserve all that is good in terms of patient safety,” she said, adding that the hope is that the revised requirements will enable innovative business to save money on the administrative burdens, so that money can be reinvested in further R&D aimed at bringing further innovation.

All the studies published in the last 12 months or so indicate that the EU is getting it right and has not sacrificed patient safety in having innovation reach the market, she said.

But she issued a word of warning: it would only take one incident to result in calls for changes to the medtech regulations.

While detailing brief details of changes anticipated in the recast, Mrs Minor referred in particular to the medtech centralised management committee issue, which has been the subject of considerable controversy across the industry.

She said that the medtech regulators will need to co-ordinate with the European Medicines Agency (EMA) over the regulation of the growing number of combination products, and this was one of the arguments for having any centralised management committee based at the EMA.

However, she also recognised that the medtech industry does not wish to be brought closer to the pharma model, for fear it might bring some changes to the medtech regulatory culture.

Digitisation of the Eucomed meeting itself

The meeting itself was a demonstration of just how technology can revolutionise an environment.

These statements were made against a backdrop of two screens at the meeting which allowed 400 or so delegates to engage directly with all those in the room. The first was a rolling screen of tweets as they came in, which even allowed twitterati at the meeting to dialogue together, discussing issues as they arose; the second was a rolling screen of questions and observations to the speakers which could be accessed via a Eucomed app available free on the Apple iStore.

Delegates were actively engaging with the rest of the audience and the speakers via these two screens and, over the days of the meeting, the processes became highly interactive, as questions raised on the questions and observations board were answered by the twitterati and, in turn, twitter followers re-tweeted our tweets to the outside world.

As testimony to Ms Kroes’ commitment to digitisation, her office was heavily involved in making use of twitter and retweets during and after the meeting, thus engaging with the sector.

Mr Dalli’s speech is available at:

http://ec.europa.eu/commission_2010-2014/dalli/docs/speech_12102011_eucomed_en.pdf

Ms Kroes speech is available at:

http://www.youtube.com/watch?v=xWvrVkAtQsQ

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