Perfect harmony

15 April 2011 John Wilkinson



Global harmonisation keeps patients safe and makes technology cheaper, but getting new technology out quickly for the world's ageing populations remains a major challenge to European and international regulators. John Wilkinson, chief executive of Eucomed, tells Ellie Broughton about the possibilities for medical technology under a global regulatory framework, and the challenges of legislative collaboration for a regulator-led Global Harmonisation Task Force.


In the advanced economies of North America, Europe, Japan and Australia, our health is better than ever, better than we anticipated, and many people are living for longer than their pensions can provide for them. Every new generation has a greater chance of reaching their 100th birthday but with longevity comes the revelation that we'll have to work longer and harder to pay for retirement.

Medical devices have already improved quality of life for young and old, but the particular problem of demographic change means that innovation must accelerate in order to optimise the contribution of technology to the European population over the next 50 years. In 2005, the UN reported that the national median age was rising in all but 18 countries, with Japan the worst hit. In 2000, the UN suggested that, to maintain its retiree-to-worker ratio, the country needed to admit 1 million immigrants a year until 2050 or raise the retirement age to 77.

This phenomenon has been widely accepted and discussed across OECD countries and regions, not least in Europe. A study by the European Commission and the Economic Policy Committee in 2006 found that demographic changes could seriously threaten its economic capacity.

Medical devices will play a big part in the economic future of the European Union; if the Union can enable the ageing population to live fuller lives for longer, it may also be able to improve the economic outlook for its member states and keep its medical device industry at the top of the game.

There's a clear need to ensure that Notified Bodies operate on a more consistent basis. Processes need to be more harmonised so that member states can learn from one another.

Healthcare efficiency

John Wilkinson is the chief executive of Eucomed, an association which represents the medical technology industry in Europe; he sees two major areas where medical technology is important. "Medical technology has transformed lives and allowed many to return to active lifestyles when previously they would not have been able to do so," he says. "Everyone can think of an example of how medical technology has contributed to the quality of their lives.

"But another aspect is the general efficiency of the healthcare system, especially productivity in hospitals. Stay times in most European hospitals have dropped around 50% in the last 20 years, which is down to the use of treatments such as minimally-invasive surgery."

Eucomed represents around 4,500 designers, manufacturers and suppliers in the medical device industry in Europe, a sector currently valued at €95bn a year. At the moment, 24 national medical technology associations and 62 medical technology companies are members.

The organisation was one of the contributors to the consultation on the pilot European Innovation Partnership on Active and Healthy Ageing, an initiative launched by the European Commission (EC) to investigate the perspectives of public and private organisations, companies and citizens on innovations that could handle the challenge of an ageing population. The consultation period closed at the end of January 2011.

Innovation for the elderly

Between 2010 and 2030, the number of Europeans aged over 65 will rise by nearly 40%, which creates opportunities and difficulties for the economy. This year the EC launches its European Innovation Partnership (EIP) as a first step towards improving the quality of life amongst the older population, making health and social care systems more sustainable and fostering competition amongst European businesses operating in this field.

When the consultation was launched, the European Commissioner for health and consumer policy John Dalli said: "Europe needs to prepare for the future ageing of its society and the use of innovation shall be one of the tools at our disposal. This is why I am very pleased that the very first of the partnerships is on active and healthy ageing - it will imply a close cooperation across different policies covering public health, research, digital and industrial policy."

"We were very encouraged to see the Commission take it on," Wilkinson says. "It's the challenge of an ageing population." When the consultation was announced, Eucomed identified over 40 promising project areas that might have an important bearing on healthy ageing. It plans to research common themes relating to the role of medical device development to the subject.

The European regulatory system is currently being reviewed as part of the recast of Medical Device Directives. Wilkinson explains that most of Eucomed's stakeholders agree on three substantive areas: the EU's Notified Bodies - its accredited device regulators - post-market processes and transparency: "There's a clear need to ensure that Notified Bodies operate on a more consistent basis. Processes need to be more effectively harmonised so that member states can learn from one another and incidents in one area can be quickly responded to across the whole of Europe.

"More generally, when we compare the European regulatory system to that of the US, there's a lot to learn regarding transparency. We expect media interest in our industry to increase as the volume of treatments and technologies increases and medical devices inevitably step more into the public eye than before."

Progress in harmonisation

Wilkinson takes a positive view of global harmonisation in the medical device industry. When he first joined the industry in Europe, every country had its own regulator and manufacturers had to file each product to them individually, meeting different demands every time. Progress has gradually swept much of the paperwork into the bin, and reconciled many legislative demands with a framework suggested by a more general perspective.

The introduction of the Medical Device Directive (MDD) in 1993 reduced the burden of activity for manufacturers and European governments alike. Wilkinson recalls: "The Medical Device Directive had a huge impact in terms of the efficiency and cost of regulating the market in Europe, and I would argue it introduced a much greater level of consistency and patient safety to the industry."

After 18 years, the MDD is due for a recast and is expected to be adopted from 2012 onwards, and while he won't be drawn in to predictions, Wilkinson hopes that the Commission, member states, patients and other stakeholders can work together to create the right balance of risk and reward that safeguards patients' safety. Extended to the global stage, Wilkinson says, the more similar that regulatory regimes are around the world then the less demanding and expensive it is for the industry to satisfy them effectively. Ultimately, a more universal regulatory system translates into a lower cost of goods supplied through the efficiencies of a simpler process. "If we club together on what's required and create demanding criteria for judging performance, everyone benefits," he adds.

Nor does Wilkinson feel that harmonisation endangers patient safety: "Medical device companies are very rigorous about getting an effective regulatory process; it's key to risk management. Global standards make life easier without any dilution of aspects relating to safety."

GHTF leads the charge

While international standards are an important frontier for the medical device industry, there's no doubt that the founders of the Global Harmonisation Task Force (GHTF) - and Europe in particular - still lead the charge for standardisation. "Historically the GHTF is entirely built around the European regulatory model and the initiative to global harmonisation. We had experienced it first hand when we created a pan-European system, and Europeans know a lot about collaborative work in a more general sense," he notes.

"It is essential that this legacy is preserved and built upon in the future and expertise from the developers of medical technology is critical to that process."

Harmonisation in Europe is part of a wider scheme of standardisation, overseen by the GHTF, a voluntary group of representatives from medical device regulatory authorities, founded by the EU, US, Canada, Japan and Australia in 1992. The regulators within GHTF decided in March 2010 to reform the body of the GHTF without its trade group members - such as Eucomed - as a regulator-only forum. After news of GHTF's cessation emerged, Eucomed recognised that it was timely to restructure the organisation but, along with other industry associations from Europe, Australia, Japan and Canada, regretted that the regulators diminished the value of its contributions under the Task Force's new arrangements. Wilkinson remarks: "The legacy of GHTF is indeed something to be proud of and is the result of a huge shared effort by experts from the industry and regulators over many years. The result is already a high degree of harmonisation which reduces the cost of taking products to market whilst enhancing safety.

"It is essential that this legacy is preserved and built upon in the future and expertise from the developers of medical technology is critical to that process." While Eucomed's main task is to emphasise the economic benefits of European and international collaboration, he acknowledges that in the end technological progress is a trickle-down benefit for countries, hospitals and individual patients.

"Every national health service has a moral responsibility to provide the best possible care from its inevitably limited resources," he concludes, "and in that context if medical technologies improve, the lot of patients will improve. They have a strong obligation to look at every opportunity they can to use technology to its best advantage."



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