HDA UK MEDIA AND POLITICAL BULLETIN – 25 August 2017

MEDIA SUMMARY 

Drugs sector first to get industrial strategy boost with plan launch next week
The Daily Telegraph, Iain Withers, 24 August 2017

The government will revive its industrial strategy next week with a launch event for the first report on how the Government can boost the 220,000 strong drugs sector in the UK. The report will apparently focus on attracting investment and cutting red tape. The pharmaceutical sector is one of five that are the focus of the Industrial Strategy, which also includes an emphasis on robotics and low-emission vehicles. Pharmaceutical industry leaders have been invited to the unveiling next Wednesday, at Birmingham’s Institute of Translational Medicine. It is though Business Secretary Greg Clark will be the minister in attendance. The head of the report, Sir John Bell, is said to focus on proposals to boost R&D, manufacturing and skills, start-ups and suggestions to improve the relationship between the drug industry and the NHS. The Department of Business, Energy and Industrial Strategy declined to comment on the timing of the announcement, but said “the Government is prepared to work with any sector that organises behind strong leadership, and offers a clear and compelling case for partnership”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

Drugs sector first to get industrial strategy boost with plan launch next week
The Daily Telegraph, Iain Withers, 24 August 2017~

The Government will revive its industrial strategy next week with a launch event for the first report on how the Conservatives plan to stimulate Britain’s economy ahead of Brexit, with the £60bn life sciences sector first under the microscope.

The report, authored by Canadian–British immunologist and geneticist Sir John Bell, will lay out recommendations to boost the 220,000-strong UK drugs sector through new investment and cutting red tape.

The Daily Telegraph has learned pharmaceutical industry leaders have been invited to the unveiling next Wednesday at Birmingham’s Institute of Translational Medicine, a clinical research facility opened two years ago.

It is expected to be hosted by Sir John and a government minister, with Business Secretary Greg Clark thought to be the most likely candidate.

The Conservatives will hope the revival of its industrial strategy will help it reset its relationship with business, after an election campaign roundly panned for being anti-enterprise.

Life sciences was one of five ‘winners’ picked by Theresa May under her industrial strategy launched in January, alongside low emission vehicles, industrial digitalisation, nuclear and the creative industries.

Sir John’s report is expected to contain proposals to boost R&D, manufacturing and skills, start-ups and suggestions to improve the fractious relationship between the drugs industry and the NHS.

Each report will be followed up by a “sector deal” from the Government providing concrete spending commitments and policies, with the life sciences deal expected this autumn.

A spokesman for the Department for Business, Energy and Industrial Strategy declined to comment on the timing of the announcement, but said: “As the Business Secretary has made clear, through our Industrial Strategy the Government is prepared to work with any sector which self-organizes behind strong leadership, offers a clear and compelling case for a partnership with Government, with clear proposals for boosting the productivity of their sector.

“We look forward to continuing our engagement with the sector and discussing with industry their specific proposals when they are published.”

Media Summary

Brexit Could Put The UK ‘Second Rank’ For Access To New Medicines

Huffington Post UK, Martha Gill, 24 January 2017

Health Secretary Jeremy Hunt told MPs this week that patients could face significant delays for new medicines as a result of Brexit. Saying that Britain would leave the European Medicines Agency (EMA), Hunt confirmed that this could leave it ‘second rank’ in terms of accessing new drugs, lagging behind the EU and the US. The EMA offers a quick route for marketing medicines across the EU, allowing major drug companies to bypass regulators in individual member states. MPs opposed the Health Secretary for ceding membership of the EMA so quickly. Hunt said he would fight for the ‘closest possible equivalence’ to the UK’s existing relationship with the EMA in Brexit negotiations, where there will be a number of organisations and agencies to navigate. Theresa May, too, has pledged to champion the UK’s pharmaceutical industry, saying in July that it was ‘hard to think of an industry of greater strategic importance to Britain that its pharmaceutical industry’.

Life Sciences Leaders Welcome UKs Industrial Strategy

Pharma Times, Selina McKee, 24 January 2017

Life sciences leaders have welcomed the government’s new industrial strategy, which places science and innovation at the centre of plans for post-Brexit Britain. Prime minister Theresa May said that the new strategy supports ‘creating the conditions where  successful businesses can emerge and grow, and backing them to invest in the long-term future of Britain’. Additionally, the government will invest £4.7 billion by 2020/21 in R&D funding – a bigger increase than in any Parliament since 1979. Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, welcomed the plan, with the appraisal that ‘[o]ur sector is worth £60bn a year to our economy, employing more than 220,000 highly skilled people across the UK. If we play to our strengths, we can go even further and create one of the world’s pre-eminent hubs for life sciences research and investment’.

2016 GMP Symposium

MHRA Inspectorate, Michelle Rowson, 24 January 2017

The 2016 MHRA Symposium put a spotlight on good manufacturing practice. Updating delegates on current activities, it also reassured that no routine activities have been put on hold because of Brexit. Planned updates to the EU GMP were outlined and international coalition initiatives were discussed, such as the International Coalition of Medicines Regulatory Agencies (ICMRA) and the EU/USA Mutual Reliance Initiative (MRI). The MRI is a strategic collaboration between EU regulatory authorities and the US-FDA to evaluate whether there are comparable regulatory frameworks for inspections of manufacturers of human medicines. Current plans are for the initiative to enter into operation later in 2017. The Symposium closed with Richard Andrews reminding delegates of the key themes of the day:

  • Organisations need to maintain awareness of GMP requirements and ensure there are systems in place to identify new requirements and implement the required changes within the pharmaceutical quality system.
  • Organisations need to consider the impact of company culture and management behaviour – the data integrity, IAG/CMT, deficiency data and investigation of anomalies presentations all identified company culture as being a key factor in improving GMP compliance
  • MHRA has, and plans to maintain a key role in EU and International initiatives.

Parliamentary Coverage

There is no Parliamentary coverage.

Full Coverage

Brexit Could Put The UK ‘Second Rank’ For Access To New Medicines

Huffington Post UK, Martha Gill, 24 January 2017

Patients could face a delay of up to a year for new medicines as a result of Brexit, the Heath Secretary told MPs on Tuesday.

Jeremy Hunt said Britain would leave the European Medicines Agency (EMA), a regulator, and confirmed this could reduce it to “second rank” in terms of access to new drugs, behind the EU and the US.

Major drugs companies, including those for cancer, use the EMA as a quick route to marketing medicines across the EU, as they can then bypass regulators in individual member states.

Hunt told the Health Select Committee it was also “likely” the regulator’s headquarters would move out of the UK, where it employs 890 people.

MPs slammed the Health Secretary for giving up membership of the EMA “without a fight”.

“It’s vital for the whole of the functioning of our medicines industry… We seem to be giving up this one without a fight,” Labour’s former health minister Ben Bradshaw said. Theresa May has pledged to champion the UK’s role in drug research and development. In July she said it was “hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.”

The EMA has been based in London for two decades, cementing the UK’s place in Europe’s drugs industry.

But on Tuesday Hunt told MPs he did “not expect” to remain within the EMA, although he was “very hopeful” to keep working “very very closely” with the regulator. He agreed with warnings from SNP MP and former surgeon Philippa Whitford that the UK might move into the “second rank” for access to drugs if it couldn’t maintain its relationship with the EMA.

“We might move into the second rank for drugs being launched, in that Canada and Australia get access to new drugs six months to a year behind the EU and the US, and that’s just market size”, Whitfield said.

“That is precisely why I would like to have the closest possible relationship, and would also say that I think the EU has as much to gain as we do from having that close relationship because of the scientific expertise within this country”, Hunt said in reply.

But MPs criticised Hunt for not trying harder to retain membership of the EMA. “I have real concerns… that pharma are simply going to see the UK as a hostile market. It’s not just that we’ll be down there with Canada and Australia, six months to a year behind, we could slide further down”, Whitford said.

“We don’t want research that is done here that eventually becomes a drug, doesn’t become available.” “We’ve just had a meeting with one of your colleagues who says the UK will retain membership of the European Patent Office. There are all sorts of agencies and organisations that are vital for us to remain a member of”, Bradshaw said.

“We seem to have given up on this one.” Hunt said he would be arguing for the “closest possible equivalence” to the UK’s existing relationship with the EMA the upcoming Brexit negotiations.

The Department of Health and the Association of the British Pharmaceutical Industry have agreed in principle to amend Chapter 6 of the 2014 PPRS in accordance with paragraph 3.4 of the scheme in order that the scheme continues to deliver its agreed objectives of predictability and stability to Government and industry, and ensuring that the cost of branded medicines to the NHS stays within affordable limits. The effect of the changes is that the payment percentage for 2017 is to be set at 4.75% for 2017, and the 2018 PPRS payment percentage will be determined by reference to the existing PPRS payment mechanism, provided that the resulting percentage falls within the lower and upper limits of 2.38% and 7.80%. The Government recognises the additional contribution being made by the pharmaceutical industry in acknowledgement of the financial challenges facing the NHS.

The Department has published a document setting out further details entitled “Pharmaceutical Price Regulation Scheme (PPRS) 2014: revised payment percentages at December 2016”. A copy is attached.

Life Sciences Leaders Welcome UKs Industrial Strategy

Pharma Times, Selina McKee, 24 January 2017

Life sciences leaders have welcomed the government’s new industrial strategy, which gives science and innovation a prominent role in plans for post-Brexit Britain. According to prime minister Theresa May, the new strategy is designed to help “deliver a stronger economy and a fairer society”, “creating the conditions where successful businesses can emerge and grow, and backing them to invest in the long-term future of Britain”.

“Our action will help ensure young people develop the skills they need to do the high-paid, high-skilled jobs of the future. That means boosting technical education and ensuring we extend the same opportunity and respect we give university graduates to those people who pursue technical routes,” she said.

The green paper outlines proposals to further encourage pupils to study STEM (Science, Technology, Engineering, Maths) subjects and explore options to incentivise growth in the number of STEM graduates, as well as a commitment for more apprenticeships and PhD funding. Also, as previously announced, the government will invest an additional £4.7 billion by 2020/21 in R&D funding, a bigger increase than in any Parliament since 1979, to help bring the UK’s spend in the area more in line with European peers.

There is now consultation on how to invest this funding, setting out options ranging from investment in local science and innovation strengths, and increased support for commercialisation, to investing in future research talent, May noted. Chris Stirling, KPMG’s global lead for life sciences, said he expects that this funding and support “will focus on encouraging companies, particularly smaller businesses, to be more innovative and to make better use of technology developments including artificial intelligence and robotics”.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, has welcomed the plans. A successful industrial strategy “will help deliver a strong pharmaceutical industry for the UK economy and improve healthcare for patients,” he said. “Our sector is worth £60bn a year to our economy, employing more than 220,000 highly skilled people across the UK. If we play to our strengths, we can go even further and create one of the world’s pre-eminent hubs for life sciences research and investment”.

Also responding to the paper’s launch, Steve Bates, chief executive of the BioIndustry Association, said: “It’s great to see life sciences at the heart of the government consultation on Industrial Strategy. They are right to focus on investing in science research and innovation, developing skills, supporting business to start and grow, and cultivating world leading UK sectors like biotech”.

“The Industrial Strategy should capitalise on the UK’s strong fundamentals that underpin our vision and help attract investment to the UK, stimulate the growth of our domestic industry, deliver effective and efficient healthcare for future generations, seize the opportunity of the UK’s lead in efficient and effective regulation of new technologies and demonstrate that the UK is open for business.”

Brexit uncertainty
However, Stirling stressed that since the Brexit vote, there remains “plenty of uncertainty” in the industry.

“UK participation in EU research and development programmes is at risk, and scientists and other skilled workers from the EU are considering returning to their home countries. The regulatory environment is also likely to be significantly more complex as, currently, the UK relies significantly on the European Medicines Authority (likely to be moving out of London).

“These issues are still very real for the industry, but its businesses will hope [the] commitment by May will soften the potential blow.”

 

2016 GMP Symposium

MHRA Inspectorate, Michelle Rowson, 24 January 2017

It was a case of “lights, camera, action!” for the GMP days of the 2016 MHRA Symposium, with speakers making use of video clips, music, and pictures in order to deliver key messages.

As the GMDP Operations Manager with overall responsibility for planning and delivery of the event, I am pleased to be able to share with you some of the highlights of what was a professional and well received event.

The Inspectorate have taken to heart one of the MHRA’s priorities of supporting innovation and applied this to ensure the symposium was keeping up to date with emerging technologies. As well as a number of new presenters taking to the stage this year, the event made use of the MHRA Event App for the first time. The app enabled delegates to access presentation materials and to participate in the interactive sessions using their own electronic device.

The GMP day started with an opening presentation by Richard Andrews (Unit Manager Inspectorate Operations GMP and PV), who provided an update on applicable Agency, International and Inspectorate activities. This included confirmation that the 2017 editions of both the Orange Guide and Green Guide are on track to be published in January 2017 and also confirmation that no routine activities have been put on hold as a result of Brexit. George Collins (GMDP Inspector) then took to the stage to provide a regulatory update, which covered recent changes now in effect, and on-going and planned updates to EU GMP, Q&As and guidance for industry. George played the role of anchor man in delivering the regulatory news and was supported by video pop-ups from subject matter experts, who provided more detailed update reports. The following diagram provides a timeline of past and future changes in the pipeline.

The take home message was that the structure of GMP is changing. The EU Commission has taken a new approach to publication of specialist guidance. Organisations that manufacture a

combination of authorised products, IMPs and ATMPs will need to implement a quality system which accommodates the requirements of separate GMP guidances.

Mark Birse (Group Manager Inspectorate) then provided an update on current international coalition initiatives, which included updates on the various Pharmaceutical Inspection Co-operation Scheme (PIC/S) activities MHRA is leading and supporting, the International Coalition of Medicines Regulatory Agencies (ICMRA) and the EU/USA Mutual Reliance Initiative (MRI).

Mark explained that the ICMRA project aims to determine if it is feasible to take a risk-based approach to international inspections, placing reliance on data provided by the site and by their national regulator to carry out desktop assessments rather than inspecting the site.  The phase 1 implementation has now been completed and phase 2  will be starting in Jan 2017 to expand the number of countries involved. The proposal longer-term is for the operational phase to be transferred to PIC/S.

The MRI is a strategic collaboration between EU regulatory authorities and the US-FDA to evaluate whether we have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines so that we can rely on each other’s information. The FDA is continuing to assess each EU regulator.  The UK assessment has been finalised and the decision is now awaiting ratification.  The current proposal is that the initiative will be ‘signed off’ in January 2017, and enter into operation later in 2017 on a voluntary basis for inspections carried out in member territories, with a view to making it a permanent requirement in 2019.

The agenda then moved to an interactive session taking another look at data integrity, and explored why we are still seeing stories in the media relating to data governance and data integrity failures at manufacturing sites, despite the publication of MHRA and international guidance for industry. This thought provoking session was presented by Graham Carroll (GMDP Inspector) and David Churchward (Expert GMDP Inspector), who concluded that effective implementation of data governance requires understanding of organisational behaviour, business process, data lifecycle, data risk, and critical thinking.

The next session provided an overview of the processes and possible outcomes of the Inspection Action Group (IAG) and Compliance Management Team (CMT) activities. Alan Moon (GMDP Inspector) and Andrew Hopkins (Expert GMDP Inspector) presented the session, which emphasised that the primary function of the two escalation processes is to protect the patient. An interactive poll of delegates revealed that over 70% were unaware of the CMT, which is a non-statutory process managed within the Inspectorate by Senior and Expert Inspectors, Operations and Unit Managers. The process was introduced by the GMP Inspectorate in late 2013/early 2014, with the aim to help direct companies back into a state of acceptable compliance, maintain supply of medicines, and avoid regulatory action.

Vivian Rowland (GMDP Inspector) then provided an update on deficiency data trending for 2015 and 2016 and presented examples from the most cited deficiency topic areas. To highlight one area of international collaboration the Inspectorate is involved with, Vivian provided some background to the work of the PIC/S working Group on Harmonisation of Classification of Deficiencies and the development of a tool for Inspectorates to improve harmonised risk classification of GMP deficiencies. It was reassuring to see that of the top ten most cited deficiencies across PIC/S countries, eight of the ten were the same as those within MHRA’s top ten of most citied deficiencies.

Quality Systems was the number one most cited deficiency by both MHRA and PIC/S countries, with a particular weakness noted in the investigation and reporting of quality incidents,

deviations, customer complaints, out of specification investigations. It was therefore very timely that the next session on the agenda focused on the investigation of anomalies. Delegates were given the opportunity to benefit from some “tricks of the trade”, as Ewan Norton (GMDP Inspector) demonstrated some excellent practical tips on how to improve the effectiveness of investigations, to identify common causes of error and ensure effective CAPA is implemented.

This year’s event also featured two Q&A sessions which gave the audience the opportunity to pose Q&As to the MHRA panel. Delegates were invited to submit questions to the panel throughout the day using the MHRA Events App, and a wide range of questions were answered by the panel of Expert and Senior Inspectors. The Inspectorate commit to providing a written response to all questions submitted and the Q&As will be collated and made available to delegates in the New Year.

The event was drawn to a close by Richard Andrews who reminded delegates of the key themes of the day and take home messages which were:

  • Organisations need to maintain awareness of GMP requirements and ensure there are systems in place to identify new requirements and implement the required changes within the pharmaceutical quality system
  • Organisations need to consider the impact of company culture and management behaviour – the data integrity, IAG/CMT, deficiency data and investigation of anomalies presentations all identified company culture as being a key factor in improving GMP compliance
  • MHRA has, and plans to maintain a key role in EU and International initiatives

As with the use of new technologies this year, we are keen to continue evolving the format and content of the symposium to enhance stakeholder engagement. We are interested in receiving post evaluation feedback from delegates, and in response to this blog, to help us plan for next year’s event. 2016 was the third year we have held a four day joint GMP and GDP event, and we would be interested to hear your thoughts on how the joint back to back event format works for you.

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.

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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