Innovation is in for EU's Healthcare System

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-05-01-2011, Volume 20, Issue 5

Europe aism to increase jobs and growth through its "Europe 2020" strategy.

It will come as little consolation to those already struggling to keep up with change to learn that more change is already on the way. Innovation is in, in Europe—again. And not just in the recast of the EU's clinical trials rules currently brewing within the bureaucrats' offices in Brussels. The entire healthcare system in Europe is under profound review, squeezed between rapid advances in technology and increasingly difficult public finances.

Peter O'Donnell

The spring brought with it a major conference in Brussels on innovation in healthcare, which spelled out both these challenges in detail—more below. This was no more than an aftershock in the wake of seismic convulsions in the European economy, further gloomy predictions about the aging of Europe's population, and ambitious declarations of intent about a better future that only served to highlight some glaring shortfalls in the capacity of healthcare providers to pay for innovative healthcare options.

It is not the role of this column to comment—and still less to report-on the grave financial and economic difficulties that Europe and countries within the European single currency are facing. No one around the world can open a newspaper or watch a television newscast without learning of yet another setback in attempts to emerge from the train wreck of the last two years. Inevitably, with austerity the order of the day in nearly every European Union member state, public funding of healthcare is being hit—along with programs on education, housing, defence, or the dozens of other areas that European governments are finding it harder and harder to fund.

Catchphrases

In the face of these difficulties, the European Union is displaying its customary resourcefulness in creating catchphrases, slogans, and programs to promote recovery (it is hard, even for those profoundly sympathetic to the concept of "Europe," to resist the reflection that Europe would be more successful if as much resourcefulness were shown in policy formation and implementation as in creating slogans). So the aim is to catalyse jobs and growth through a strategy boldly entitled "Europe 2020." This strategy is itself bolstered by a series of "flagship" components (apparently no one in the Brussels slogan factory is aware of the meaning of "flagship"), most of which are also flavored with a strong dash of "innovation."

"With an aging population and strong competitive pressures from globalization, Europe's future economic growth and jobs will increasingly have to come from innovation in products, services, and business models. This is why innovation has been placed at the heart of the Europe 2020 strategy," it says.

One of the "flagship" initiatives, the "Innovation Union," contains over thirty "action points," which range from "delivering the European Research Area" and "focusing EU funding instruments on Innovation Union priorities" to "promoting the European Institute of Innovation and Technology as a model of innovation governance," "reforming research and innovation systems," or "enhancing access to finance for innovative companies."

Healthy aging

One of them is a "European Innovation Partnership" on active and healthy aging, which aims to add an average of two years of healthy life for everyone in Europe. This has a suitably pompous genesis in the conclusions of a summit of EU leaders in February: "Innovation contributes to tackling the most critical societal challenges we are facing. Europe's expertise and resources must be mobilized in a coherent manner and synergies between the EU and the member states must be fostered in order to ensure that innovations with a societal benefit get to the market quicker. Joint programming should be developed. The launch of the pilot Innovation Partnership on active and healthy aging is an important step in that context."

The active and healthy aging agenda is intended to help EU citizens to lead healthy, active, and independent lives while aging, to improve the sustainability and efficiency of social and healthcare systems, and to improve the competitiveness of the markets for innovative products and services so as to create new opportunities for businesses. The hoped-for result will be conditions that are more conducive to the uptake of innovation, leveraged financing, investment in innovation, and closer coordination and coherence between funding for research and innovation at all levels in Europe. Altogether, predicts the EU, this will foster innovation in products; processes; and services, at the same time as reducing the time to market for innovative solutions.

That's not all. The Innovation Union introduces the strategic use of public procurement budgets to finance innovation, a comprehensive "Innovation Scoreboard" based on 25 indicators, a "European knowledge market" for patents and licensing, and measures to reinforce initiatives like "the risk sharing finance facility," which has so far levered 15 times the EU's direct of over a billion euro.

Other "flagships" sailing into view include "an industrial policy for the globalization era" (which claims to put industry "center stage," and to boost growth and jobs by supporting "a strong, diversified, and competitive industrial base in Europe," while a parallel bid is underway to ensure that 3 percent of the EU's GDP is invested in R&D and innovation.

All stirring stuff in terms of ambition. Some of it is starting to come through in terms of innovation, too.

Responding to challenges

So what about the healthcare and innovation conference, against this background? This was the cumulative effort by the EU to find a way through the challenges in the spirit of the age, as it were, by moving forward, through innovation, rather than backward, through simple limitation on expenditure.

"Fostering innovation in healthcare is a particularly difficult, expensive, and long process that includes clinical evaluation and regulatory approval," intoned a background paper for the meeting. Citing industry figures of average costs of €1 billion and a timetable of "10-15, sometimes 20 years" to turn an idea into "a viable, marketable, and profitable pharmaceutical product," with numerous "prerequisites and conditions to ensure good knowledge creation and transfer."

That, it continued, is why the EU has organized the conference, aiming to "define concrete solutions to foster innovation in the European healthcare sector." It aimed to "deepen the research-to-market aspects," and to "explore how the healthcare system will cope with new delivery models becoming available to clinicians and patients."

European Health Commissioner John Dalli set much of the tone of the conference: "I have made innovation in health a priority," Dalli claimed, going on to emphasize that "innovation must look beyond traditional 'products.'" He spoke of the need "to find better ways to deliver high quality healthcare to patients, while keeping down costs and maintaining the efficiency and sustainability of health systems. Innovation in health must be about organization, management, financial planning, and control, coordination between services, economies of scale," he said. "Rather than spending more, we need to spend better. The time has come to create more efficient models of healthcare and find innovative solutions."

Dalli praised health technology assessment as "a valuable tool for decision-makers when considering taking up new health technologies or phasing out obsolete technologies," and urged that EU member states "have much to gain from greater cooperation on health technology assessment."

Some industry participants were dismayed at the focus on cutting costs, on finding new ways of assessing the merit of healthcare innovations. The shadow of health technology assessment lies long over the pharmaceutical industry in Europe. There is a growing fear that the current preoccupation with austerity is giving health authorities a pretext for refusing reimbursement to new products because they are not immediately better than currently available alternatives—disregarding the intrinsic challenges of drug development and the inevitably gradual establishment of the clinical relevance of a product. Some pharmaceutical industry speakers timidly cautioned against over-simplified recourse to health technology assessment, suggesting that over-hasty establishment of a standardized approach across Europe might fail to take account of the complexities of evaluating relative efficacy. They were not entirely reassured when Giulia Del Brenna, a senior EU official responsible for biotechnology, also urged greater coordination at European level, including on health technology assessment.

While Europe's "large and varied innovative health industry" was lauded as "one of the major strengths in tackling the growing healthcare challenge" by Andrzej Rys, the Director for Health Systems and Products in the European Commission, there were, he said, good examples of how healthcare systems in Europe can change to meet the challenges.

Some seized on the opportunity with glee. The medical devices industry was particularly conspicuous at the meeting. Eucomed, the industry association representing European medical technology, trumpeted its members' "power and capability to rapidly innovate and bring solutions for the challenges that Europe is facing, not only by improving people's lives, but also by delivering the changes needed to help build new models of healthcare delivery." Its chairman, Dr. Guy Lebeau, claimed that "a medical technology patent is registered every 38 minutes, accounting for 12 percent of all patents registered... to help people, governments, and healthcare systems." Its Chief Executive, John Wilkinson, highlighted the need for "a European environment conducive to innovation and change."

But the challenges facing medical devices are still rather different to those that medicines must confront, and there were fewer cheers heard from pharmaceutical industry participants at the meeting. They left the conference—and are facing the summer—in a rather thoughtful mood.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.