HDA UK MEDIA AND POLITICAL BULLETIN – 11 July 2017

MEDIA SUMMARY 

UK drugs groups seek court block on NHS price limits
Financial Times, Sarah Neville, 11 July 2017

The UK drug industry has entered legal proceedings in an attempt to stop the NHS from imposing new price limits. This was prompted by a recent crackdown in April that means medicines will no longer automatically be funded if they are set to cost more than £20 million a year. This means that manufacturers will have to cut separate deals for each approval of a drug over the £20 million limit. Manufacturers claim that this will deprive patients of cutting edge pharmaceuticals, and that they have thus ‘reluctantly’ applied for a judicial review. However, legal action has divided the industry, with GSK stating that it was “not supportive of this action”. AstraZeneca also made it clear it head reservations, although it did not publically oppose the application. The NHS only devotes 10 percent of its funding to medicines, but many observers claim the NHS is in the middle of a funding crisis.

Westminster Health Forum Keynote Seminar; Next steps for delivering the new models of care and vanguard sites
Westminster Forums, 11 July, 2017

The Westminster Forum Project is excited to invite guests to its conference on delivering new models of care, October 25, 2017. Following on from a very successful conference in 2016, delegates will be able to further assess the NHS New Model of Care targets for 2020. Chaired by the Lord Warner, former Minister of State for Health, issues relating to service delivery, integration and redesign will be at the heart of this forum, and will involve stakeholders from across the health sector. The agenda can be found here.

2017 International Pharmaceutical Distribution Conference
HDA, 11 July 2017

For the fourth year in a row, healthcare distribution associations from around the world will gather in Geneva, Switzerland for the annual Pharmaceutical Distribution Conference. The conference will feature expert-led sessions on the political and policy landscape, product traceability, value-based outcomes and the global financial outlook. To register, go to the HDA website. For inquiries, call the HDA Conference Department at (703) 885-0278 or for information regarding the conference programming, contact Anne Nevel, Senior Director, Industry Education, at (703) 885-0283.

Pharmacies have been marginalised by Sustainability and Transformation Plans claim pharmacy bodies
Pharmacy Business, Neil Trainis, 11 July 2017

Despite the fact that Sustainability and Transformation Plans (STPs) were designed to “fuse health and social care in local areas by getting healthcare providers including pharmacists working together effectively”, a survey has shown that community pharmacies feel marginalized and have struggled to engage with those leading STPs. 50% of local pharmacies said they had no input into their local STPs. The NHS Confederation Chief has also called the STPs “extremely challenging”. They have been accused of focusing too much on organizational changes, and not enough on improving system performance.

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Pharmacies have been marginalised by Sustainability and Transformation Plans claim pharmacy bodies
Pharmacy Business, Neil Trainis, 11 July 2017

A survey carried out by leading pharmacy organisations has found that community pharmacies across England have been marginalised as they try to involve themselves in Sustainability and Transformation Plans (STPs).

The government’s attempt to alleviate pressure on hospitals and A&E by moving care into the community, thus closing the £22 billion NHS funding gap, culminated in STPs which were supposed to fuse health and social care in local areas by getting healthcare providers including pharmacists working together effectively.

Investigations launched last December however into the extent to which community pharmacies are part of STPs by the PSNC, Royal Pharmaceutical Society and Pharmacy Voice, which has since folded, revealed pharmacists and their teams have struggled to engage with those leading STPs and new care models.

Just 10% of Local Pharmaceutical Committees (LPCs) rated community pharmacy involvement in STPs as four or five out of five and 50% of LPCs claimed community pharmacy has no involvement in plans for health and social care devolution.

“Looking across the 44 evolving Sustainability and Transformation Partnerships (STPs) it is clear that in many areas the potential contribution of the community pharmacy sector has not been considered or explored in detail, or fully understood,” a report based on the survey said.

“This reflects anecdotal feedback received by the pharmacy organisations during 2016 which suggested that fruitful relationships between community pharmacy representatives and those leading STPs and New Care Models were far from widespread, with significant differences in levels of engagement by region.”

Only 6% of LPCs rated involvement in vanguards, 50 of which were selected to lead on the development of new care models between January and September 2015, as a four or five out of five and 55% said they had no involvement in the £50 million GP Access Fund.

Concerns raised by the survey coincided with an assertion by NHS Confederation chief executive Niall Dickson that STPs “have proved extremely challenging.”

“In part, this is because they require leaders to set aside organisational interests in favour of the system as a whole,” he told Confed17.

“That is much easier to promise than to deliver. And it is made more difficult because the regulatory and accountability mechanisms that govern providers and commissioners are not always aligned. They continue in law, and too often in practice, to be focused on organisational rather than system performance.”

Brexit casts shadow over sector’s future

P3 Pharmacy, 7 June 2017

 

P3 Pharmacy reports on a survey conducted by CIG Research that finds pharmacists are feeling “gloomy” about the sector’s future in post-Brexit Britain. Immediate fears include medicine shortages, rising drug prices and business costs. Looking at healthcare more widely, survey respondents anticipated reduced investment in UK pharma, an NHS staffing crisis, and a negative impact on regulation and standards as the UK falls outside the remit of the European Medicines Agency.

 

Jeremy Hunt remains health secretary in post-election reshuffle

Health Service Journal, Allison Coggan and Nick Carding, 11 June 2017

 

Jeremy Hunt has been confirmed as Health Secretary in Theresa May’s new cabinet, a post he has held since 2012. He will be joined by two new ministers at the Department of Health after previous incumbents Nicola Blackwood and David Mowat both lost their seats. It is not yet known who will replace Mr. Mowat or Mrs. Blackwood, or when appointments will be made.

 

BREAKING: Pharmacy minister David Mowat MP loses seat

Chemist & Druggist, Grace Lewis, 9 June 2017

 

Pharmacy minister David Mowat MP lost his seat in his constituency of Warrington South in last week’s vote. Despite no longer being an MP, Mr. Mowat will officially retain his pharmacy brief until a new minister is appointed, according to a PSNC statement. Mr. Mowat was first elected in 2010 and again in 2015, and gained the pharmacy minister role in July 2016 after Alistair Burt’s shock resignation. Reactions on Twitter were yet another indication of the continued debate around the controversial implementation of pharmacy funding cuts.

 

P3 Pharmacy also reported on David Mowat losing his parliamentary seat. Chemist & Druggist compiled winners and losers amongst “pharmacy’s parliamentary champions”. The ABPI’s full response to the confirmed result of the UK General Election 2017 is available here and its reaction to the formation of a minority government is available here.  

 

Sustainability and transformation plans: working together is not going to be easy

The Pharmaceutical Journal, Editorial, 9 June 2017

 

With nearly 55 million people living in England, the 44 STPs aim to improve collaboration across local health and care organisations to help boost the health of the nation. STPs are moving away from a competitive model, introduced in 1990 by the NHS and Community Care Act, and require NHS and local government leaders to collaborate to improve care based on local needs. The Pharmaceutical Journal comments: “To address the financial challenges of the NHS, it is only right that there should be more collaboration between organisations.”

 

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Brexit casts shadow over sector’s future

P3 Pharmacy, 7 June 2017

 

With less than a day to go to the general election, pharmacists are feeling pessimistic about the future of community pharmacy in post-Brexit Britain, envisaging working life as more complicated and even harder in financial terms.

 

Immediate fears include medicine shortages, and rising drug prices and business costs. The prospects for healthcare on a wider basis are equally bleak, with pharmacists anticipating reduced investment in UK pharma, an NHS staffing crisis, and a negative impact on regulation and standards as the UK falls outside the remit of the European Medicines Agency.

 

The gloomy outlook stems from a survey conducted by CIG Research, a division of Communications International Group, completed by 214 pharmacy staff – the vast majority identifying themselves as pharmacists, proprietors and managers – in May. The findings are perhaps to be expected given that over half the respondents stated that they voted to stay in the EU, though when asked how they would choose if the referendum were to be repeated, the Remain figure jumped to over 62 per cent.

 

Given that the Leave figure was more or less consistent at around 21 per cent, it suggests that those who were undecided last June feel much more strongly on the subject a year on.

 

One of the areas in which Brexit seems likely to have a significant impact on pharmacy concerns staffing. More than half of those polled said they employ non-UK nationals in their pharmacy, six in ten of whom are EU passport holders.

 

While the majority said they expected the employment of these individuals to not be affected by Brexit – or said they hadn’t given the matter any thought – a substantial minority believed work visas would become a requirement and a small number anticipated replacing non-UK EU workers with British passport holders. Of the 179 pharmacies involved in the survey who have non-UK staff, four in ten said that these individuals were worried about their future employment status.

 

Many survey participants said they had already noticed changes to their business that they attribute to Brexit. Chief among these is an increase in medicine purchase prices – this was felt more strongly by independents than multiples, which is unsurprising given the bargaining power of the big players – but also striking has been a rise in problems accessing EU products and services, and a downturn in sales.

 

All of these are predicted by respondents to become even more marked once the UK exits Europe, with an accompanying increase in paperwork and decline in quality control in relation to medicines.

 

The majority of respondents see Brexit as having a negative effect on nearly all aspects of their work, from declining consumer confidence, spending and profitability, to an escalation in the price of medicines, and staffing and running costs. Even medicines safety and innovation in pharmacy practice are viewed as being in peril, and there are real concerns about the UK becoming marginalised once it is outside the EU.

 

Jeremy Hunt remains health secretary in post-election reshuffle

Health Service Journal, Allison Coggan and Nick Carding, 11 June 2017

 

Jeremy Hunt will remain the health secretary as part of Theresa May’s new cabinet, it has been confirmed.

 

Mr Hunt arrived at Number Ten at 4.15pm, smiling at the assembled media and wearing his NHS pin on his lapel.

 

Shortly after 5pm, a statement from Downing Street confirmed Mr Hunt would remain in the post he has held since 2012.

 

It means Mr Hunt, who saw his majority cut from 28,500 in 2015 to 21,600 (a drop of 4.1 per cent) in Surrey South West seat, will reach five years as health secretary in September.

 

However he will be joined by two new ministers at the Department of Health after previous incumbents Nicola Blackwood and David Mowat both lost their seats.

 

Parliamentary undersecretary of state Mr Mowat lost his Warrington South seat to Labour’s Faisal Rashid, who won with a majority of 2,549. Mr Mowat came second, polling 27,445 votes.

 

Public health minister Ms Blackwood lost the Oxford West and Abingdon seat to Liberal Democrat Layla Moran by 816 votes.

 

It is not yet known who will replace Mr Mowat or Ms Blackwood, or when appointments will be made.

 

Prior to polling day there had been speculation that Mr Hunt might have been replaced by another former health minister, Ben Gummer, but Mr Gummer lost his Ipswich seat to Labour’s Sandy Martin in one of the shock results of the election.

 

The Conservatives won 318 seats overall, with Labour second after winning 261 seats.

 

Sustainability and transformation plans: working together is not going to be easy

The Pharmaceutical Journal, Editorial, 9 June 2017

 

It is vital that pharmacy engages with sustainability and transformation plans now to avoid being left behind.

 

The new sustainability and transformation plans (STPs) — five-year plans for the future of health and care services in local areas — are going to reshape local health and social care in England.

 

With nearly 55 million people living in England, the 44 STPs aim to improve collaboration across local health and care organisations to help boost the health of the nation. For instance, from our reading of the plans, STPs could help reduce the incidence of stroke by ensuring patients with atrial fibrillation are prescribed anticoagulants, help reconfigure specialist cardiac services, improve asthma outcomes and lead to better management of long-term conditions.

 

Different way of working

 

The NHS has operated in a competitive environment since 1990 when the NHS and Community Care Act introduced the concept of the internal market. Now, STPs require NHS and local government leaders to collaborate to improve care based on local needs. This will dramatically change everyone’s way of thinking and working.

 

Some leaders are working together and talking through challenging issues, for instance, asking how they are going to integrate services for older people. But it will not be enough for leaders to hold business meetings. Frequent contacts, developing trust and looking at longer term change are required. The nature of the dialogue should be examined because, if it is an environment where leaders of organisations compete for a transaction, then they will not share useful information with others.

 

To address the financial challenges of the NHS, it is only right that there should be more collaboration between organisations. With the rise in chronic conditions, which cannot be treated with a single fix, patients will need care from a range of bodies, including pharmacy, which is also on the frontline but often relegated to the margins of any large reshaping of the NHS landscape.

 

When leaders meet, they need to develop a shared purpose: a high-level vision where all people can live better and longer lives that can be cascaded back to their organisation to increase engagement among staff.

 

Collaboration

 

In health, with advances in technology, people are thinking through how they can shift resources to offer more care in the community to prevent hospital admissions. It will be a challenge for the different organisations to collaborate in STPs. Many of the bodies with a healthcare function are already engaged with each other in the STPs, but not so with other groups such as local authorities, which are important because they provide services, too, such as rehabilitation for stroke sufferers.

 

STPs’ relationship with local councils has been patchy. In some areas, STP leads have been keen to share their plans with local councils, but this is not always the case.

 

Getting a foot in the door

 

Pharmacy owners, pharmacists and locums need to read the plans in their area, make frequent contact with the people and organisations involved in the STPs to ensure that pharmacy and pharmacists are on the radar. They need to make sure that any long-term plans firmly include the benefits to patients of pharmacy involvement. Sometimes it is going to be difficult to enter dialogue with STPs and it will be hard to identify the right people to engage with.

 

STPs will have different priorities in different regions, so it cannot be expected that they will treat pharmacy services the same. Some may want minor ailment services, others may not be interested in smoking cessation services, for instance. But not being involved means citizens with health challenges over the next five years may not reap the benefits of pharmacy services.

Media Summary

Care Quality Commission advises people to take care when using online primary care services
The Care Quality Commission, 3 March 2017

With a new report, the Care Quality Commission (CQC) is calling on people to act with caution when considering buying medicines online. In a joint statement, four regulatory bodies – CQC, the General Medical Council, the General Pharmaceutical Council, and the Medicines and Healthcare products Regulatory Agency – have reminded providers and healthcare professionals that they must provide safe and effective care. The statement notes the opportunities that come with technological advances but emphasises their commitment to safeguards and sharing intelligence, endorsing the guidance set out by the General Medical Council.

Buying medications online ‘can put health at risk’
BBC News, Dr Faye Kirkland, 3 March 2017

After an investigation into online medicine purchasing, the Quality Care Commission (CQC) says it will visit providers and shut any which put patients at risk. Prof Steve Field, the CQC’s chief inspector of general practice, said there was “little clinical oversight” in the way many websites sold medications. The CQC has now published set guidelines to address the issue, including verifying the patient and providing proper information. Two websites are being urgently inspected: Treated.com and MD Direct.

NHS ‘overcharged’ by drug makers’ non-compete deal, says CMA
BBC News, 3 March 2017

The Competition and Markets Authority (CMA) has said that two pharmaceutical companies have pushed up the price of a lifesaving NHS drug. By striking a deal not to compete with each other, the companies allowed a pack of tablets almost to double in price for the NHS, according to provisional findings.

Pharmaceutical industry and patient group collaboration ‘absolutely appropriate’, says ABPI
ABPI, 1 March 2017

Responding to a BBC News story, the APBI has issued a statement supporting the pharmaceutical industry’s working with patient groups to support common goals. Underscoring the strict rules governing the relationship between pharmaceutical companies and patient groups, the ABPI advocated its partnership with National Voice to produce a guide to collaboration between charities and pharmaceutical companies in the UK based on the four key principles of clarity of purpose, integrity, independence and transparency.

NHS sustainability plans unlikely to work without greater government commitment, warns expert
Rochdale Online, 3 March 2017

Kieran Walshe, Professor of health policy and management at the University of Manchester, argues that STPs face crucial barriers to success. At a time of huge financial pressure in the NHS, Walshe warns that they lack enough government engagement and statutory force. To offset this, he voiced support of the recommendations of the Barker commission for a single system of funding to commission health and social care.

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The Care Quality Commission, 3 March 2017

Our inspections of some companies providing online primary care have found significant concerns about patient safety.
Well-run services can offer a convenient and effective form of treatment, but inspectors found services that were putting patients at risk of harm by selling medicines without doing enough to check they were appropriate. We are publishing reports from two urgent inspections today – in both cases the providers have stopped providing services in England.

Professor Steve Field, Chief Inspector of General Practice, said: “As with conventional GP surgeries, online companies and pharmacies are required to provide safe, high-quality and compassionate care and must adhere to exactly the same standards. They must not cut corners.”

Following a review of all online services registered with us we have brought forward our inspection programme. We have prioritised inspections of services we think may present a significant risk to patients.

Today we have:

Published advice for people considering using an online doctor.

Issued a joint statement with the General Medical Council, the General Pharmaceutical Council, and the Medicines and Healthcare products Regulatory Agency to remind clinicians and service providers that they must continue to follow professional guidelines.

Published information on how we inspect and regulate digital primary care providers.

“The NHS and its leaders have done what they can to map out a sustainable future health and social care system for England. But without a much greater commitment from government, it seems very unlikely that these plans will work,” he concludes.

Buying medications online ‘can put health at risk’
BBC News, Dr Faye Kirkland, 3 March 2017

People should be wary of buying medications on the internet after an investigation found “widespread failings” at some online providers, the Care Quality Commission (CQC) has said.

The watchdog inspected 11 internet prescription services in England, finding some “potentially presenting a significant risk to patients”.

The regulator said while some providers were well-run, others “cut corners”.

The CQC says it will visit providers and shut any putting patients at risk.

It follows a BBC Radio 5 Live investigation into online pharmacies selling antibiotics.

The CQC has published reports on urgent inspections of two websites: Treated.com, run by HR Healthcare, and MD Direct, which traded through Assetchemist.co.uk.

Prof Steve Field, the CQC’s chief inspector of general practice, said there was “little clinical oversight” in the way many websites sold medications.

“Some of these websites prescribed unlicensed medicines and – even more worryingly – medicines for diabetes, Parkinson’s disease, heart disease and Lithium for bipolar disorder,” he told BBC’s Radio 5 Live.

“Patients can go online, self-diagnose their condition, order their own medicine and obtain a prescription from the online doctor service, with minimal checks,” he said.

‘Making improvements’

The CQC has now published a clear set of standards for online pharmacies, saying they must:
verify that patients match their photo ID, such as through a Skype check, get a comprehensive and up-to-date medical history, ensure patients truly understand what medicines they are being given and seek permission to contact a patient’s GP.

Treated.com was the focus of the 5 Live investigation in October. The CQC suspended the website two months later and began an inspection of its operations.

Riaz Vali, responsible for Treated.com, told the BBC it was making improvements to its processes and systems.

NHS ‘overcharged’ by drug makers’ non-compete deal, says CMA
BBC News, 3 March 2017

Two pharmaceutical firms have been accused of pushing up the price of a “lifesaving” NHS drug by striking a deal not to compete with each other.

The Competition and Markets Authority (CMA) said in provisional findings that Actavis and Concordia fixed the market for hydrocortisone tablets.

Hydrocortisone treats life-threatening conditions such as Addison’s disease.

A pack of the tablets almost doubled in price for the NHS to £88 while the deal was in place, the CMA said.

“Anti-competitive agreements can cost the NHS, and ultimately the taxpayer, by stopping competition bringing down the cost of lifesaving drugs like hydrocortisone tablets,” said Andrew Groves of the CMA.

“We allege these agreements were intended to keep Actavis UK as the sole supplier of a drug relied on by thousands of patients – and in a position which could allow it to dictate and prolong high prices.”

However, Mr Groves added that the findings were provisional and that the regulator would consider any arguments from the companies before deciding “if the law has been infringed”.

Hydrocortisone tablets are used by patients whose adrenal glands do not produce enough hormones and in many cases helps them to live an active life.

The CMA accused the firms of agreeing between January 2013 and June 2016 that Concordia would not launch its own version of the drug, leaving Actavis as the sole supplier to the NHS for much of that time.

Pharmaceutical firm Teva confirmed Actavis UK was the subject of “allegations of anti-competitive conduct” from the CMA.

The company declined to comment further. The BBC has contacted Concordia for comment.
It is the latest case where the CMA has accused drug makers of overcharging the NHS.

The regulator accused Actavis in December of raising the price for 10mg hydrocortisone tablets by 12,000% in eight years, from 70p to £88.

Earlier that month, Pfizer and Flynn Pharma were fined nearly £90m for raising the price of an anti-epilepsy treatment, although both firms said they would appeal.

Pharmaceutical industry and patient group collaboration ‘absolutely appropriate’, says ABPI
ABPI, 1 March 2017

Following a BBC news story [Wednesday 1 March] reporting that the Hepatitis C Trust took funding from the pharmaceutical industry, the ABPI has responded by highlighting guidance produced in partnership with National Voices, as well as the ABPI Code of Practice.

​​​​​​​In 2015, the ABPI and National Voices jointly produced ‘Working together, delivering​ for patients‘ aiming to promote transparency and accountability in collaborative working and to serve as a practical ‘how to’ guide for all parties.
In response to today’s BBC News story, ABPI have issued the following statement:

“It is absolutely appropriate for the pharmaceutical industry to work with and support patient groups to achieve common objectives such as enhancing patient information, raising awareness of clinical research or improving access to medicines.

This is why in partnership with National Voices we produced a guide to collaboration between charities and pharmaceutical companies in the UK based on the four key principles of clarity of purpose, integrity, independence and transparency, to ensure that collaborations work well for both parties and, ultimately, for patients.

In addition to this, there are strict rules that govern the relationship between pharmaceutical companies and patient groups, and this is central to the ABPI Code of Practice, administered by the arm’s length regulator – the Prescription Medicines Code of Practice Authority (PMCPA). The Code requires that all grants and donations to patient organisations are publicly disclosed by the company, including the purpose of the support.”

NHS sustainability plans unlikely to work without greater government commitment, warns expert
Rochdale Online, 3 March 2017

Local sustainability and transformation plans (STPs) – designed to transform the way health and social care services are organised, delivered, and used across England – are unlikely to work without a much greater commitment from government, warns an expert in The BMJ.

Kieran Walshe, Professor of health policy and management at the University of Manchester, argues that while STPs aim to keep people well and help them to care for themselves, and use health and care services more appropriately, there are four main problems, which if not resolved make it unlikely that these plans will work.

First, he warns that they are being launched at a time of huge, unprecedented levels of financial constraint and challenge in the NHS, which will require considerable investment.

Second, he argues that the plans have been written in a rush, and professional and public consultation and engagement have been largely neglected, resulting in “suspicion and opposition” from the medical profession, the public, and the media.

Third, he says these plans have no statutory force or authority, adding that the Health and Social Care Act 2012 “contains a host of provisions on competition and market access that make these changes open to legal challenge and difficult to implement.”

Finally, these plans are founded on the sound idea that we should bring health and social care services together – but he points out that “social care services are funded separately by local authorities, whose funding has been cut by 37% in real terms over the last six years.”Fixing these problems and giving STPs a real chance to succeed requires action from government, writes Walshe..

He therefore calls for government action to provide realistic transitional funding for the changes and to give political backing to the changes and allow for proper consultation at a national and a local level.

He also calls for legislation to remove the competition and market access provisions of the Health and Social Care Act and to allow for statutory bodies to be created to lead STPs.

Finally, he suggests the government tackle the health and social care divide by implementing the recommendations of the Barker commission for a single system of funding to commission health and social care.

Media Summary 

Private firms warn Stevens over end of purchaser-provider split
HSJ, Ben Clover, 1 March 2017

David Hare, chief executive of the NHS Partners Network, has warned Simon Stevens that STPs must act within competition laws. He was responding to the NHS England chief executive’s comments to MPs that some sustainability and transformation plans will “effectively end the purchaser-provider split for first time since 1990”. Competition has become a less critical force in NHS policy circles; however, there have been recent competition challenges by providers in London, Kent and Yorkshire. NHS England is understood to be in discussion with several STP areas regarding the Five Year Forward View “delivery plan” published next month.

Deal paves the way for outcomes-based drug pricing
Science Business, 2 March 2017

An agreement between the pharmaceutical industry and healthcare providers in Manchester will collect real-world data on the value of drugs. The aim is to consider fixing drug prices based on how effective they prove to be in everyday use. The deal, supported by 14 pharmaceutical countries, is also seen as a route to making the region a hub for health research and clinical studies, and a means of creating cost-effective medicines for patients in Greater Manchester and throughout the UK.

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Private firms warn Stevens over end of purchaser-provider split
HSJ, Ben Clover, 1 March 2017

The head of the body representing private providers of NHS work has warned Simon Stevens that STPs must act within competition laws.

David Hare, chief executive of the NHS Partners Network, was responding to the NHS England chief executive’s comments to MPs that some sustainability and transformation plans will “effectively end the purchaser-provider split for first time since 1990”.

Mr Stevens told the Commons public accounts committee that six to 10 STPs were set to become “accountable care organisations or systems… bringing about integrated funding and delivery for a given geographical population”. The Health and Social Care Act 2012 made several earlier regulations on choice and competition in an area into law.

In response to Mr Stevens’ comments, Mr Hare told HSJ: “It is important that with the implementation of STPs and the development of new care models there is not a move towards inflexible monopoly provision of health services and that the legal principles of patient choice, fair treatment of provider and a diversity of healthcare provision are upheld.

“Any changes to the way in which services are planned and secured must act within existing legal frameworks, be in line with the principles of patient choice and plurality of provision, applied consistently across the NHS and based upon strong evidence of improved patient care.”

Competition has become a less powerful force in NHS policy circles since Jeremy Hunt replaced Andrew Lansley as health secretary in September 2012. However, there have been recent competition challenges by providers in London, Kent and Yorkshire.

HSJ reported earlier this week that NHS England is understood to be in discussion with several STP areas with a view to them being listed in the Five Year Forward View “delivery plan” to be published next month. These are thought to include Frimley, Lancashire and South Yorkshire.

Deal paves the way for outcomes-based drug pricing
Science Business, 2 March 2017

An agreement between the pharma industry and health care providers in Manchester will collect real-world data on the value of drugs. The aim is to open the door to fixing drug prices based on how effective they are in everyday use.

A newly established partnership between healthcare providers and the pharma industry in Manchester will use patient data to monitor the safety and effectiveness of medicines, helping to extract more value from the region’s £1 billion drug budget.

The deal, which has the support of 14 pharma countries, is also seen as a route to making the region a hub for health research and clinical studies.

“We want to be able to improve people’s health, get the very best value for money from our medicines budget and continue to raise Greater Manchester’s profile as a global hub for investment in research and development,” said Jon Rouse, Chief Officer of Greater Manchester Health and Social Care Partnership.

The agreement has benefits for companies, which are promised access to patient data and faster uptake of drugs that are shown to be effective in real world use. Signatories to the Memorandum of Understanding have committed to explore, “the potential of multi-year, multi-agency budgets to enable outcome-based models.”

This will open the door to developing “outcome-based pricing methods and test other incentive models,” with successful pilots becoming standard care within two years.

New risk-sharing models of care delivery will be tested as part of the new arrangement. A group including members from the health service and pharma companies is now developing a plan to scale up successful proof-of-concept projects that demonstrate the value of drugs, reduce inequalities and variation in outcomes.

Several ‘quick win’ projects are already in the pipeline for the first year of the partnership. Those that work well will be adopted within three years.

Real-world value

Health chiefs and industry leaders have highlighted the need to rethink healthcare funding models to improve the value for taxpayers and outcome for patients.

“The industry recognises the challenges faced by the NHS and we are committed to supporting improvements in the use of medicines that can enhance the care and wellbeing of people in the area,” said Mike Thomson, CEO of the Association of the British Pharmaceutical Industry.

He cited the Salford Lung Study as an example of how the NHS can embrace innovation to help improve health outcomes.

That project, funded by GlaxoSmithKline (GSK) and conducted in Salford and South Manchester, was the world’s first randomised controlled trial to test a drug in a real world setting, using a single electronic medical record linking primary care, secondary care and pharmacy data. It found that patients taking a new GSK drugs to treat chronic obstructive pulmonary disease (COPD) were less likely to suffer exacerbations than those taking standard therapies.

On the back of its linked electronic health records and the experience of the Salford Lung Study, greater Manchester has the infrastructure to create one of the world’s pre-eminent hubs for life sciences research and investment from global companies, according to Thomson.“We can see from initiatives like the Salford Lung Study how the NHS can embrace innovation to help improve health outcomes,” he said.

“By working together with the NHS to improve how to use and learn from real time health data in hospitals and communities we have the best chance of creating the most appropriate and cost-effective medicines for patients in Greater Manchester and throughout the UK,” Thomson said.

Rowena Burns, chair of Health Innovation Manchester said the agreement is a first step towards increasing the number of real-world clinical trials in Greater Manchester. “Our goal is to improve the health of greater Manchester citizens by working more effectively with industry,” she said.

Media Summary

‘Woefully short’ NHS will miss Forward View targets, report warns

Chemist and Druggist, James Illman, 23 February 2017

New research suggests that the NHS will not meet its Forward View targets. The report finds that no STPs provide analysis of workforce productivity. Lord Carter says that progress is being made but “urgent” action is needed to build on this. Kingsley Manning’s report raises deep and unnerving questions about the NHS’s long-term sustainability. Alongside a lack of attention to productivity, digital is another area where progress is falling short, with Manning saying: “the inevitable digital revolution in healthcare will happen beyond the boundaries of the NHS, with potentially profound implications for its future role”.

Bidding war over lucrative Brexit spoil

Politico, Giulia Paravicini and Carme Paun, 23 February 2017

There is a fear that a large proportion of the European Medicines Agency staff may leave when the agency moves away from London. More than a dozen cities, including Milan, Copenhagen, Dublin, Lille, Stockholm and Warsaw are bidding to be the new home of the EMA. Officials in Brussels say that from a purely practical perspective, Sweden, Denmark, the Netherlands and Germany have the strongest cases – in terms of facilities and urban infrastructure. Health Minister Jeremy Hunt has spoken about the UK mirroring the EMA’s regulations, but this is complex in itself. Morale at the EMA has plummeted since Brexit and is getting “worse and worse,” according to its Executive Director, Guido Rasi. Language considerations, good connections to other EU cities and a top-quality airport are among the priorities for the EMA relocation negotiations.

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Bidding war over lucrative Brexit spoil

Politico, Giulia Paravicini and Carme Paun, 23 February 2017

Where there are drugs, there’s money.

That makes the London-based European Medicines Agency one of the biggest spoils of Brexit. And nearly every other country in the EU is actively courting the EU’s drug regulator to move to their shores once the U.K. leaves the bloc.

Untangling the U.K. from the EU is expected to drag on for years, but the new host of the EMA could be declared as early as June. The Commission already has a draft set of criteria obtained by POLITICO that encompass everything from how smooth a transition would be — since Brussels wants to keep the regulator on its drug-approval schedule — to access to hotels, airports, schools, child care and high-quality health care.

Though the health of 500 million Europeans is at stake, the bidding war is likely to be anything but orderly or even focused on public health needs.

It’s expected to come down to political considerations, regional sensitivities and even the interplay of other topics that end up on the agenda of the European Council meeting where the decision will be made — like the burden of refugee flows, for example — according to officials from member countries, the EMA and the Commission interviewed for this article.

“In the end, it will turn into a souk,” said a senior Commission official with knowledge of the issue, invoking the image of bargaining at a bustling Middle Eastern bazaar.

Lobbying to win the agency is already at the highest diplomatic levels, with heads of governments, health ministers and diplomats in Brussels and in the capitals making their public and private cases. In recent weeks, Italian Prime Minister Paolo Gentiloni pitched Milan’s candidacy directly to European Council President Donald Tusk. Croatian Prime Minister Andrej Plenković wrote to Tusk and Commission President Jean-Claude Juncker to make the case for his country, according to the local media. Others, including the health ministers of Ireland and Hungary, have pressed Vytenis Andriukaitis, European commissioner for health and food safety, as well.

“These decisions are political, absolutely, they’re made in the European Council,” acknowledged Ireland’s Health Minister Simon Harris, speaking to reporters during a recent trip to Brussels to lobby for the EMA. “But it is important, I believe as a European health minister, that criteria is set down, because this is a very important agency, and if the agency was to be located in the wrong place, then its work would go backwards.”

There is also hope, however distant, to keep the agency in the U.K., too: No law explicitly states the agency can’t sit outside the union and London has a solid case. If the risk to public health through a mass exodus of EMA staff — causing severe delays in pipeline drug approvals and stalling major projects like building the anti-counterfeit tracing system — is so great, the concerns could sway EU leaders to keep the regulator right where it is.

For the U.K. to win the hearts and minds of EU leaders, many of whom have called for a deal that punishes Britain for giving up on the EU project, the U.K. will have to show some humility — and some cash.

“Politically it would be quite hard to do,” said Mike Galsworthy, research associate at University College London and co-founder of the campaign group Scientists for EU. “EU leaders will question, ‘Why should Britain benefit from Brexit when it’s giving up on the EU?’”

The EMA is no small prize. Its crucial role in assessing the safety and efficacy of new drugs puts it at the center of the European pharmaceutical market. In 2016, the agency gave the green light to 81 medicines for treating cancer, cardiovascular diseases and infections, among others. To do this,

the EMA brings 40,000 people each year to its 6-floor, 23,500-square-meter headquarters in London’s Canary Wharf. It needs 350 hotel rooms per night, five days a week, the agency’s Executive Director Guido Rasi said last year. The EMA has a budget of €322 million for 2017.

So the list of volunteers to adopt this economic powerhouse keeps growing. More than a dozen cities, including Milan, Copenhagen, Dublin, Lille, Stockholm and Warsaw are in the race.

Officials in Brussels say that from a purely practical perspective, Sweden, Denmark, the Netherlands and Germany have the strongest cases. They have large enough facilities to hold 900 EMA employees, plus the necessary infrastructure for housing and transportation. They offer a high enough quality of life to woo those specialists, who may be reluctant to leave cosmopolitan London.

Some EU officials may want to avoid past mistakes of meting out EU agencies to cities that couldn’t support them. But with the imperative to evenly distribute institutions — and reward the EU’s most enthusiastic members amid resurgent skepticism — all the same temptations are still there.

Only considering convenience, however, puts the EU in a political bind.

Longstanding tensions among member states — East vs West, rich vs poor, isolated vs well-connected — will frame the debate about the EMA’s home.

Among the 16 countries that have joined the race, Denmark, Ireland, Italy and Sweden have the most advanced candidacies. The four countries have launched their campaigns in Brussels with task forces, websites or even an appointed special envoy dedicated to snagging the agency. All have a recurring argument in their bid: They want to minimize the impact of staff relocation and the unavoidable loss of expertise that will come with it.

“What we are pushing very hard for, now, is a list of very clear and comprehensive criteria that should be fulfilled by the host country” — Christer Asp, former Swedish ambassador

Sweden claims it has one of Europe’s top national medicines’ agencies, a great record on innovation and high quality of life. It also has experience hosting a European agency because Stockholm is home to the European Centre for Disease Prevention and Control.

“We see quite an important synergy by having both located geographically at the same place. They both deal with antimicrobial resistance and these are issues that will grow in importance with time,” said Christer Asp, a former Swedish ambassador who is now coordinating the Swedish health ministry task force on the EMA.

Denmark’s selling points are that its capital is “well-connected and easy to reach,” thanks to the Copenhagen airport, and, like Sweden, the Danes list their experience in hosting international organizations, including several United Nations bodies.

Ireland and Italy have slightly different pitches. The former argues that the country will suffer the most from Brexit, and getting the EMA would serve as a sort of compensation. During a recent visit to Brussels to promote the country’s candidacy, Ireland’s Harris also pointed to Dublin’s status as an anglophone city that’s physically and culturally close to London.

Italy, which already houses the European Food Safety Authority in Parma, came up with a new concept, saying cooperation between the two agencies would benefit patients and boost expertise.

“EFSA and EMA work already together for several issues and we believe in a ‘one-health approach’ which would mean a synergistic cooperation between the two agencies,” said Giovanni Pugliese, Italy’s ambassador for Coreper I.

However, some member states say an argument like that should be disqualifying. The EU leadership needs to show it is ready to move some of the bloc’s center of gravity towards the East if it is to remain united, according to one national diplomat in Brussels. “Countries which already host EU agencies should have not even gotten in the race,” the diplomat added.

By moving early, countries hope to shape the rules of the contest in their favor.

Deciding by June could be critical. Morale at the EMA has plummeted since Brexit and is getting “worse and worse,” according to its boss, Rasi. The agency has lost an unprecedented number of high-level staff, with six senior executives quitting since the June Brexit referendum, he said. That’s more than the number who left in the last decade.

Good connections to other EU cities and a top-quality airport will be among the priorities.

The majority of EMA employees come from overseas; only 7 percent are U.K. citizens. However, the agency’s move is expected to upend their families’ lives and cause disruption, since many likely want to stay in London.

Making a decision fast about the new seat of the agency will help end the uncertainty for the EMA employees, according to Sweden’s Asp. Once that decision is made, he estimated the relocation would take up to two years to complete.

An EU document from 2010 says that “the decision on the seat of an agency is currently a political one for which no detailed justification is provided.”

It goes on to explain that the EU heads of states and government decided in December 2003 to give priority to new EU member countries when distributing future agencies. The countries that don’t already host an EU office should go to the front of the line, according to the document.

That’s music to the ears of Eastern countries including Croatia, Hungary and even Bulgaria, who have also joined the race, some more formally than others.

“We don’t know that much about the decision-making process,” Sweden’s Asp said. “What we are pushing very hard for, now, is a list of very clear and comprehensive criteria that should be fulfilled by the host country, and the decision-making process will start by the member states agreeing on such criteria,” he said.

The Commission is writing a checklist of ideal qualities of the next EMA that will land on the desks of Michel Barnier’s Brexit task force and Tusk. Here’s what’s not in the draft copy obtained by POLITICO: the quality of the city’s existing community of local scientists, whether the EMA should go to a member country that does not already have an EU agency, or other issues likely to be part of the political debate. The criteria focus exclusively on infrastructure and quality of life.

In any case, this checklist is likely to be ignored, officials in member states and the Commission privately acknowledge. At the same time, the Commission has learned the hard way about the pitfalls of dropping agencies into unprepared cities.

“What is sure is that they will not want to repeat the mistake of [the European Food Safety Authority] in Parma, where [former Italian Prime Minister Silvio] Berlusconi managed to get the agency claiming the Finns had no clue about prosciutto crudo and Parmesan,” the senior Commission official said.

The local cuisine is tasty, but it’s difficult to connect with the rest of the world or bring in experts: There’s only one flight a week — to Sicily. For the EMA, good connections to other EU cities and a top-quality airport will be among the priorities, the official added.

Another example of what not to do when allocating an EU agency is the European Union Agency for Network and Information Security (ENISA) which was set up in 2004, in Heraklion, Crete’s largest city. Because of its remote location, a second office had to be opened in Athens, turning it into one of the most expensive agencies in the EU.

“Experience shows that agencies located in very remote places face severe difficulties to attract and retain staff from the rest of Europe,” the 2010 EU document said.

Media Summary

February Concessionary Prices Updated

Chemist and Druggist, Thomas Cox, 21 February 2017

The Department of Health and National Assembly for Wales have agreed further concessionary prices for the following items for February 2017 prescriptions, as follows:

Drug Strength Form Price
Buspirone 5mg tablets (30) £17.50
Leflunomide 10mg tablets (30) £7.79
Leflunomide 20mg tablets (30) £9.03
Valsartan 40mg capsules (28) £4.72
Valsartan 80mg capsules (28) £5.55

Initial concessionary prices were announced earlier this month.

Delivering sustainability and transformation plans

The King’s Fund, Chris Ham, Hugh Alderwick, Phoebe Dunn, Helen McKenna, 21 February 2017

The King’s Fund has published its report examining the content of the 44 sustainability and transformation plans (STPs) which constitute the main vehicle for transforming health and care services in England, in line with the NHS five year forward view. The report looks at challenges and opportunities that come with implementing STPs. In terms of policy, the proposals in STPs now need to be developed into credible plans, with clarity about the priorities in each footprint. Changes to the law are also needed to amend aspects of the Health and Social Care Act 2012 that are not aligned with the Forward View, particularly in relation to market regulation.

Parliamentary Coverage

Lords Second Reading – European Union (Notification of Withdrawal) Bill (Day 1)

HDA briefed the Lib Dem Health Spokesperson after the Financial Times letter from Martin Sawer. An extract from Baroness Walmsley’s speech can be found below.

Baroness Walmsley (LD):

As your Lordships will be aware, I speak for these Benches on health and social care. There are three main healthcare reasons why I believe the Bill should be amended. They boil down to: people, healthcare and Donald Trump. There are tens of thousands of EU citizens working in our health and care system and the Government are using their future, and the future of those they care for, as a pawn in a misguided game of cat and mouse with the other 27 countries. Without them, the staff shortages we are already experiencing will be a lot worse and patients will suffer. 1 am pleased there has been a cross-party outcry from your Lordships about this, so I hope all will vote for an end to that foolishness.

Secondly, the businesses which provide the drugs, medical devices and treatments that British people need will be badly affected by a hard Brexit. That is why I support access to the single market rather than just waving a white flag and not even trying. The pharmaceutical products most of us depend on are developed by research by networks of scientists working together across Europe. These networks are already suffering and the massive EU funding from which they benefit is being put at risk. Clinical trials taking place here in the UK are at risk. UK patients get access to new and cutting-edge treatments because of them. The UK has played an enormous role in the regulation and licensing of medicines for the whole EU. Indeed, much of the expertise is here. It makes no sense to develop our own system. We could lose a lot of that expertise.

Companies will always develop products for big markets where the profits are. Why would they want to develop a product to satisfy the regulations in a market of 68 million people when they could sell to a market of 400 million? Medicine distributors warn of cost increases, decreased access and even shortages. Harmonised regulation is not a burden. It gives us the freedom to sell and the confidence to buy. Why throw it away? Medcare products frequently cross borders in the course of their manufacture, packaging and labelling. Having tariffs imposed on them will increase their costs and decrease their competitiveness. So, for the sake of UK patients and their access to affordable and cutting-edge medicines and treatments, I will be supporting an amendment to give us continued access to the single market and the customs union.

Then there is Donald Trump. Our NHS is probably our most valuable asset. Already a lot of American healthcare companies are sniffing around to see what they can pick up. We all heard what Trump said about trade deals putting America first—America first, not the UK first. So anyone who thinks a trade deal with the USA will not result in a lot of our health services being run by American companies must be completely mad.

Finally, I will be supporting an amendment to ensure the approval of the British people for the deal put before them by the Government. All those who are most affected should have a say, including those who were denied one in the last referendum with its gerrymandered electorate, such as: citizens of other EU countries who live here; British citizens who have lived for many years in other EU countries; and 16 to 18 year-olds whose future study and work opportunities will be damaged by Brexit.

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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