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HDA UK Media And Political Bulletin – 4 September 2017

Medical devices regulations need action to begin relay race

Politico, Sarah Wheaton, 4 September 2017

 

Even though the implementation deadline for the medical devices regulations isn’t until mid-2020 or mid-2022, depending on the type of product, the industry and its regulators are racing to comply. Industry officials warn that foot-dragging by the Commission could start a chain reaction of missed targets and hurt the availability of products ranging from syringes to defibrillators when the new rules take effect. This is partly due to the fact that one link in the supply chain must reach a certain point before the next can really start.

 

The launch of the Life Sciences Industrial Strategy is an important milestone for the industry

ABPI, Mike Thompson, 1 September 2017

ABPI’s CEO Mike Thompson shared his thoughts on the launch of the Life Sciences Industrial Strategy last week. Mr. Thompson commented especially on the success of the Strategy in balancing and representing the views of all players across this diverse and complex sector. He added that if the recommendations from the Strategy were all delivered, this would not only be a success in terms of patient outcomes but also good news for scientists, doctors, business leaders and investors. In line with other industry commentators, he applauded the central role of the NHS in the Strategy and welcomed the ambition to fully explore the organisation’s potential.

 

 

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Medical devices regulations need action to begin relay race

Politico, Sarah Wheaton, 4 September 2017

 

Leaking breast implants and shoddy metal hips prompted 336 pages of new medical device regulations for the European Union.

 

Action this fall is key for meeting implementation deadlines that are still years away, especially on rules related to assessing whether devices are safe. Industry officials warn that foot-dragging by the Commission could start a chain reaction of missed targets and hurt the availability of products ranging from syringes to defibrillators when the new rules take effect.

 

The sweeping changes add new responsibilities and standards for virtually every player in the medtech sector. Even though the final implementation deadline isn’t until mid-2020 or mid-2022, depending on the type of product, the industry and its regulators are racing to comply.

 

It’s more like a relay race, they say, because one link in the supply chain must reach a certain point before the next can really start. A significant delay at any stage could ultimately mean medical devices and diagnostic tools, which pinpoint diseases and drive treatment decisions, get pulled from the shelves. Later runners are already getting impatient with the earliest players, particularly the European Commission.

 

It will take between 14 and 80 pieces of supplemental legislation to actually implement the regulation, and “the European Commission has been particularly unforthcoming as to the priorities of those implementing and delegating acts,” said Phil Brown, technical and regulatory director of the Association of British Healthcare Industries. “We don’t know which ones are going to be implemented when.”

 

These issues are especially pressing for Brown’s membership: Brexit will be official in 2019, midway through the compliance period, likely prompting a regulatory gray zone.

 

But the 25,000 manufacturers around the Continent are wary of the deadline too: New rules for medical devices will take effect three years after their May 5, 2017 publication in the EU’s Official Journal. In vitro diagnostics — items like pregnancy tests and laboratory tools that may never touch a patient’s body, and have generally been less subject to regulation in the past — have five years.

 

All of these products must have an official evaluation of their quality and safety based on the new standards, even if they’ve long been on the market.

 

Evaluating the evaluators

 

Before those products can be evaluated for safety, the evaluators have to go through their own appraisal to show they are indeed qualified to make these judgments. That’s the next big milestone this autumn: The so-called notified bodies that assess safety can formally submit applications starting November 26 to national regulators.

 

The scrutiny of notified bodies is one of the first concrete outcomes of 2011’s PIP breast implant scandal, when silicon meant for industry, not medicine, ruptured inside women. As European patients clamored for someone to take responsibility, they realized not all of the Continent’s 56 notified bodies — mostly private companies — met the same standards. But since they all had equal power to grant a CE mark, and thus Continent-wide market access, ill-intentioned devicemakers could shop for a notified body more likely to let sloppiness slide.

The new device regulations clarify liability when something goes wrong for notified bodies and the national regulators that allow them to operate. There’ll also be a new system to track devices once they’re on the market, and a database for experts and the general public alike to monitor medtech.

 

But for now, to show they’re living up to the more stringent standards, notified bodies must reapply to continue operating. They wanted Brussels to publish implementing legislation, including application forms, earlier in the summer. After all, even the most well-prepared application is likely to take at least 10 months to evaluate, said Françoise Schlemmer, head of Team-NB, the association of notified bodies in Europe. That leaves even less time available to review 500,000 types of medical devices.

 

“If we are not submitting our applications very soon, it is clear that the whole sector will be missing availability to get the certificates. That is why we are in a hurry,” Schlemmer said.

 

Waiting for the road map

 

National authorities and the Commission are moving deliberately for a reason, said Niall MacAleenan of Ireland’s Health Products Regulatory Authority.

 

“One of the most difficult things which could happen would be that every member state’s authority starts to go off in different directions and implement the regulation in a slightly different way,” MacAleenan said. Unlike the previous EU directive on medical devices, the new regulations don’t need to be translated into national laws, but there’s still room for differing interpretations, he said.

 

The main forum for alignment is a network of national-level regulators, the Competent Authorities for Medical Devices (CAMD). With the Commission, it released a draft road map in March outlining how they’ll break down the overhaul into incremental parts and what sort of guidance they’ll provide. Since then, CAMD has “digested” feedback from industry, manufacturers and interested parties.

 

The Commission is planning an October meeting to discuss the final version with CAMD and industry.

 

That final version won’t have “any significant shifts” from the draft, said MacAleenan, a member of the CAMD’s management arm, just “more detail in the latest versions on the specific topics that are underlined, and then more granular detail about timelines.”

 

That’s likely to assuage the industry, which expected the final version in June.

 

Manufacturers are especially concerned about new clinical requirements and making sure there’s support for all the new documentation devicemakers will have to supply, said Oliver Bisazza, who joined the industry’s EU lobby, MedTech Europe, as regulatory affairs director in August.

 

The road map section on IVDs also will require special scrutiny. “We want to make sure that all of their specificities are being taken care of, and they’re not just relegated to a little afterthought or a small group of experts to work on them,” Bisazza said.

 

While most conventional medical devices need to be re-evaluated, some 85 percent of the 40,000 IVDs will have to pass muster with a notified body for the first time.

 

The launch of the Life Sciences Industrial Strategy is an important milestone for the industry

ABPI, Mike Thompson, 1 September 2017

 

The Life Sciences Industrial Strategy was launched, and received, with much enthusiasm this week at the Institute of Translational Medicine. It was a fitting venue: a world-class clinical research facility in Birmingham that helps progress scientific research into the latest treatments for NHS patients.

 

​​​​Sir John Bell has done an excellent job. After working closely with Sir John and his team as the Strategy has developed, the final version is an impressive document that provides a blueprint for a successful UK Life Sciences sector in a post-Brexit world.

 

The Strategy succeeds in balancing and representing the views of all players across this diverse and complex sector and shows the value of Life Sciences partners, academia, charities and Government, all working in partnership together and with the NHS to deliver health and economic benefits to the UK.

 

At the launch, Jeremy Hunt challenged us to be ambitious – the pace of change in our sector is so momentous that there’s a real prize on offer for the UK.

 

He focussed on the benefits to patients and as part of that endorsed the need for early access and uptake of new medicines. We know that this is an area that, collectively, we have not yet delivered, but we are ready to go again to find solutions to make this a reality. For his part, he committed to a Government response to the Accelerated Access Review – which will help progress this – by the end of October and I very much look forward to seeing this.

 

If the recommendations in the Strategy itself are fully implemented, I believe its ambition and vision – that all of us in Life Sciences share with Jeremy Hunt – can be met. This won’t just be good news for patients; it will be good news for scientists, doctors, business leaders and investors.

 

The Strategy offers ambitious challenges, Science, Growth, NHS, Data, and Skills – all areas where the UK can get ahead of the competition.

 

Sir John Bell was right when he said the Industry and NHS relationships are vital. He called for even closer collaboration and I absolutely echo this.

 

The NHS needs to be at the heart of this Strategy. Our health service holds a unique offer for healthcare innovators to use real-world health data. Making the best use of data and digital tools to support research and better patient care – and opening up further opportunities for collaboration, shows the rest of the world that the UK is serious about becoming one of the best places in the world to research, develop and use new medicines and health technologies.

 

If we get this right, the UK can open itself up to be at the forefront of cutting-edge clinical research; NHS hospitals will reap the benefits of global clinical trials and the financial rewards they bring; doctors can prescribe the very latest treatments and patients – our families and friends – will get the very best standard of care. This ecosystem can deliver for everyone.

 

With the willingness demonstrated by everyone on Wednesday morning, I see no reason why the NHS cannot realise this potential, embracing the new ways the industry develops and delivers the latest medical breakthroughs to facilitate more sustainable and better care.

 

As a case in point, this week’s momentous decision taken by the US Food and Drug Administration to approve the use of Kymriah – a gene therapy that engineers a patient’s own immune system to attack cancer – is an exciting glimpse into tomorrow, today. And with a great number of similar advances on the horizon, but no established global centre of expertise, countries around the world are preparing to compete to attract investment. The UK must act quickly and decisively – and this Strategy could not come at a better time.

 

Many of building blocks are already in place. Leveraging the UK’s world leading position in science and technology, and making the most of the fiscal certainty to invest in new medicines provided through the current – and future – Pharmaceutical Price Regulation Scheme (PPRS), Britain can become the global leader in developing and delivering the cutting-edge, high-quality medicine of the future.

 

We now need to push on and build on this, working with Government to ensure that we can attract long-term investment from global pharmaceutical companies, who between them are central to a thriving Life Sciences sector. Biopharmaceuticals is a £30billion industry and critical to the UK’s economic success, both in terms of inward investment and from the employment generated across the whole UK. Securing and building on its future will be especially important as we leave the European Union and will send a clear signal to global boardrooms that post-Brexit Britain is an attractive place to invest.

 

As Sir John pointed out in Birmingham, a successful Life Sciences sector is a big win for the UK economy and it is a UK wide endeavour. This is not about London, or Cambridge, or Manchester or any single city; it’s about a whole range of companies and organisations, small and large, spread across many towns throughout the UK. As the global Life Sciences market continues to grow, we must seize the chance for Britain to become the industry’s partner of choice, bringing huge benefits to the patients and employees in towns and cities across the country.

 

Opportunities like this don’t come along often, and I look forward to working with Life Science partners and Government on a sector deal which will be crucial in bringing this impressive Strategy to life.​

HDA UK Media And Political Bulletin – 4 September 2017

From Factory to Pharmacy

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