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.

 

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

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.​

Hard Brexit could deprive Ireland of key medicines

The Times, Ellen Coyne, 31 August 2017

 

Pharmaceutical body, Medicines for Ireland, which represents the country’s largest drug suppliers, warned that Irish patients could face drug shortages after Brexit and costs could rise while drugs with a short shelf life could be at risk of expiring if they were delayed by border checks. Stakeholders have been invited to examine the impact on the sector of Britain’s decision to leave the EU at a Health Products Regulatory Authority event today. Ireland has been able to share batches of medicines with Britain but could in the future face problems accessing drugs because the country’s population is too small to buy in bulk.

 

The warning was also covered by The Irish Times.

 

Life Sciences Industrial Strategy Report

UK Government, 30 August 2017

 

The strategy report set outs a plan for the British medical industry to become a global powerhouse after Brexit. A pre-announcement released overnight heralds £160 million of funding across basic science, clinical and technology research and collaboration with the NHS. Only £14 million of this appears to be new funding, with the remaining £146 million coming from an industrial challenges fund announced at the start of the year.

 

There are five priorities: science, infrastructure, the NHS, data and skills, according to the independent panel headed by Professor Sir John Bell that put together the strategy. It confirms the Accelerated Access Review proposal, to fast-track treatments from the lab to patients, will be adopted. A handful of hubs will be set up to share medical data, and tax rules altered to aid private investment. The strategy will also set out plans to ensure “the U.K. has the talent and skills to underpin future life sciences success,” the government said. The first UK Life Sciences Strategy since 2011, the report signals a continued favourable focus of the UK Government on the sector.

 

The ABPI welcomed the publication of the Strategy commenting: “Today’s Life Sciences Industrial Strategy is an impressive document which captures the importance of our sector to a successful post-Brexit Britain.”  ABPI CEO Mike Thompson stated: “The NHS is rightly at the heart of the strategy: If it can build on its unique capability to use health data in research and development and address the UK’s long-standing challenge of adopting new treatments, it will create a virtuous circle for all and deliver massive health and economic benefits to the UK.”. The full statement is available here.

 

The strategy was largely covered in national and specialist media outlets including BBC NewsThe GuardianThe Daily TelegraphReutersCity AMPharma Times and pharmaphorum. Media coverage picked up on the NHS being a central theme of the report with references to the role that technology should play in transforming healthcare for patients and shaping a completely new industry. While The Guardian focused on the potential privacy issues that surround the extensive use of data, Reuters emphasised the pharmaceutical sector’s focus on ensuring that the UK remains “open for innovation as it prepares to exit the EU”.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Hard Brexit could deprive Ireland of key medicines

The Times, Ellen Coyne, 31 August 2017

 

Irish patients could face drug shortages after a hard Brexit, a pharmaceutical body has warned.

 

Medicines for Ireland, which represents the country’s largest drug suppliers, said that costs could rise while drugs with a short shelf life could be at risk of expiring if they were delayed by border checks.

The group will set out a series of negative consequences that Irish patients could face at a Health Products Regulatory Authority event today. Stakeholders have been invited to examine the impact on the sector of Britain’s decision to leave the EU.

 

Sandra Gannon, general manager of Teva Pharmaceuticals Ireland and chairwoman of the group, said that Britain leaving the customs union and single market would be the “worst case scenario” for patients and manufacturers because there was no reason to think that the present regulatory structures would remain in place.

 

“In fact, it would signal strongly an intention for the UK to apply its own standards and regulatory requirements,” she said.

 

Ireland has been able to share batches of medicines with Britain but could in the future face problems accessing drugs because the country’s population is too small to buy in bulk.

 

“The issue of medicine shortages is another concern. Already, 140 medicines are out of stock and we are at risk of further shortages due to Ireland’s dependence on the much larger British market,” Ms Gannon said.

 

“Without the ability to batch-share, the small size of the Irish market may make it commercially unsustainable for manufacturers to supply to Ireland. That would seriously damage Ireland’s interests both in terms of patient access to medicines and the inevitable rise in cost which would occur.”

 

The British government said that it wanted a hard Brexit but has not set out in detail what kind of customs and border arrangements it was considering.

 

Medicines for Ireland said that every hour of a customs delay in the event of a hard border would increase the cost of drugs, which would have an impact on the health service and patients.

UK life sciences report calls for high-risk research programme

Financial Times, Clive Cookson, 30 August 2017

 

Following the launch of the UK Government’s industrial strategy green paper in January, John Bell, professor of medicine at Oxford university, will present the plan in the first of five sector reports for UK life sciences. As well as investing in high-risk life sciences “moon shot” projects in the hope of creating “two or three entirely new industries over the next 10 years”, the report also proposes the creation of a Health Advanced Research Programme (Harp), a body to bridge the gap between government and industry funding. John Bell, professor of medicine at Oxford university, presenting the plan stated: “What is missing in conventional government funding is a bolder approach that would take risks with the science but could bring huge rewards. If we use the resources of the NHS well, Britain would be the best place in the world to carry out these projects.”

 

The Department for Business, Energy & Industrial Strategy’s press release is available here.

 

UK regulator releases guide to EU medtech regulations

Politico, Sarah Wheaton, 29 August 2017

 

The U.K.’s Medical and Healthcare Products Regulatory Agency today published an interactive guide to the EU’s new medical device regulations. The guide is intended to help manufacturers of medical devices and in-vitro diagnostics (IVDs) navigate sweeping new rules, which must be fully implemented by May 2020 for devices and May 2022 for IVDs. The guide does not cover what the impact of Brexit may be for manufacturers.

Media Summary

Life Sciences at heart of UK’s new Industrial Strategy

Pharmaphorum, Andrew McConaghie, 23 January 2017

Yesterday, Theresa May lay out plans for Britain’s new industrial strategy. Brexit negotiations will bring compromise as well as opportunity, and May has made it clear that she supports globalisation, free trade and strong industry. Life sciences, moreover, is a key sector in the strategy. Sir John Bell – a name well known in the UK pharma industry – is leading the plans; among the 10 strategic pillars, ‘investing in science, research and innovation’ is a highly anticipated and appreciated feature. A £10 million investment in a regional life sciences cluster has already been announced. The UK life sciences will push for the government to realise its newly-outlined commitments. Pressure on the NHS will be a particular test, as will changes in regulation after Brexit.

Parliamentary Coverage

House of Commons, Written Answers, Department of Health, 23 January 2017

NHS: Drugs

Stephen Timms: What assessment he has made of the potential for (a) flexible pricing and (b) indication-specific pricing for drug purchase by the NHS.

Nicola Blackwood: Flexible pricing is an option for companies within the 2014 Pharmaceutical Price Regulation Scheme (PPRS). To date, no applications have been received under the flexible pricing provisions since their introduction under the 2009 PPRS.

The PPRS pricing flexibility provisions make clear that the Government is unlikely to support proposals for pricing approaches that would result in indication-specific pricing. This is because initial assessments indicate that such approaches would have significant long-term financial and operational implications for the National Health Service.

Full Coverage

Life Sciences at heart of UK’s new Industrial Strategy

Pharmaphorum, Andrew McConaghie, 23 January 2017

Prime Minister Theresa May has unveiled a new ‘modern Industrial Strategy’ aimed at creating world-leading UK sectors via more government-led co-ordination and planning.

The industrial strategy is one of Theresa May’s big ideas for her government, and is intended to stand apart from the coming Brexit negotiations.

But it is inevitably being seen as a blueprint for a post-Brexit Britain, as it could try to exploit advantages of leaving the EU – if any emerge.

Prime Minister Theresa May said: “The modern Industrial Strategy will back Britain for the long-term: creating the conditions where successful businesses can emerge and grow, and backing them to invest in the long-term future of our country.”

Interventionist industrial policies have not been in vogue for decades in the UK, but May believes this is the time to introduce a modern version of the approach.  On the continent, France’s ‘dirigisme’  helped it grow strongly after the second world war, typified by investment in infrastructure and key (state-owned) industries.

Of course May is not proposing taking back industries into public ownership, but does want to take a more direct role in promoting excellence and addressing weak points.

The prime minister said it would mean the government “not just stepping back but stepping up to a new, active role that backs business and ensures more people in all corners of the country share in the benefits of its success.”

However the strategy will still depend on a healthy and growing economy – something which Brexit could put at risk over the next few years.

The new strategy emerges just as the newly inaugurated President Trump has promised to put ‘America First’,  protectionism which may include ripping up existing free trade agreements and introducing new tariffs.

May has made it clear that she is an advocate of globalisation and free trade, however; something she will undoubtedly discuss when she travels to Washington to meet Trump on Friday.

Life Sciences

Among the UK industries highlighted as existing world leading sectors are life sciences, and early work on creating a new industrial strategy has already begun.  Sir John Bell, already very familiar to UK pharma and biotech – most recently from the Accelerated Access Review – is leading the new strategy, which the government hopes to have set out by March or April.

Among the 10 strategic pillars for its pan-industrial strategy is ‘investing in science, research and innovation’, something that UK pharma association the ABPI and biotech sector organisation the BIA will hope the government sees through.

A new green paper published today sets out technologies where Britain has strengths in research and development. These stand to gain from a new Industrial Strategy Challenge Fund, and will include: smart energy technologies; robotics and artificial intelligence and 5G mobile network technology. This fund is part of £4.7 billion of additional R&D funding announced in November, a bigger increase than in any Parliament since 1979.

Among a number of new projects announced today to accompany the strategy was a new £10 million investment in a regional life sciences cluster.

The Greater Manchester and Cheshire Life Sciences Fund will provide capital to local small and medium businesses to drive the growth of innovative young life sciences businesses

NHS funding

But the greatest test for any UK life sciences industrial strategy will be investment in the NHS and its uptake of new medicines, medical devices and other new technologies.

Just as the new life sciences strategy is being launched, the NHS is experiencing unprecedented pressure, as funding per patient declines amid ever-growing demand.

This is directly affecting spending on new medicines. Most notably, NHS England is set to introduce a new ‘affordability test’ into the NICE process which could see use of more new medicines blocked or delayed.

UK pharma leaders have told pharmaphorum that any life sciences industrial strategy which doesn’t address this question – and see the NHS as potential engine for growth – will fall far short.

The green paper says the new strategy is “an offer to businesses to strike new sector deals, driven by the interests of firms and the people they employ, to address sector-specific challenges and opportunities.”

The Prime Minister’s office says it will be prepared to offer a range of support, including addressing regulatory barriers to innovation and growth, looking at how trade and investment deals can be used to increase exports.

It adds that new institutions could be created to provide leadership, support innovation or boost skills. While this is an attractive proposition for life sciences, Brexit raises some more pressing questions about existing regulations.

Following her speech last week in which she signalled that the UK would exit the single market, it now looks increasingly likely that the UK will have to go it alone in terms of drug regulation, and not be aligned with European Medicines Agency.

Finding a solution to this – probably involving the UK’s regulator the MHRA taking over as sole regulator – will be of utmost in importance between today and when Brexit occurs in 2019.

The UK life sciences sector will try to pin the government down to real commitments in talks around the new strategy. But much like the UK government in its own Brexit negotiations with the EU, UK pharma and biotech will find it is not they who have the final decision on the agreement.On 23rd December 2016, the Government published the level of payment due from members of the Pharmaceutical Price Regulation Scheme (PPRS) in 2017 to keep health service spend on branded medicines within the levels agreed under the Scheme.

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