News

Media And Political Bulletin – 07 January 2019

Media and Political Bulletin

07 January 2019

Media Summary

Note: The full version of the NHS’ 10-Year-Plan will be published today at midday.

UK – NHS Long-Term Plan coming today

Politico, Sarah Wheaton, 07 January 2019

Politico reports that the government is debuting the National Health Service’s long-term plan today — to be bankrolled by the £20.5 billion infusion by 2023-24 that Prime Minister Theresa May cast as the “Brexit dividend.”

Long term plan features new model for A&Es

Health Service Journal, James Illman, 07 January 2019

Health Service Journal reports that the NHS long-term plan, being launched today, has pledged to save “almost half a million more lives” by reducing premature mortality. It will also propose new access targets for mental health and a big expansion of personal health budgets, according to announcements by the Prime Minister Theresa May over the weekend.

A new “same day” model for emergency departments and a further cash boost for primary and community services are also to be set out in the plan.

Pharmaceutical Chief: We Must Avoid No-Deal Brexit At All Costs

LBC Radio, Nick Ferrari, 07 January 2019

LBC Radio reports that Chief Executive of the Association of the British Pharmaceutical Industry Mike Thompson has told LBC a no-deal Brexit “should be avoided at all costs.” He says the building of stocks for a no-deal scenario is the “biggest logistical challenge” the industry has ever faced.

Speaking to Nick Ferrari on LBC, he urged MPs to prevent leaving the EU without an agreement.

Sophy Ridge on Sunday Interview with Matt Hancock MP Health Secretary

Sky News, Sophy Ridge, 06 January 2019

Sophy Ridge interviewed Health Secretary Matt Hancock on Sunday. They discussed the upcoming 10-year plan, issues the NHS is currently facing, and medicine supply concerns resulting from a potential no-deal Brexit scenario.

Prime Minister reveals NHS long term plan top priorities

Health Service Journal, Rebecca Thomas, 05 January 2019

Health Service Journal reports that the Prime Minister has confirmed headline priorities of the new NHS long term plan, including new “comprehensive” access targets for mental health, and a big expansion of personal health budgets.

A Number 10 announcement on Saturday identified the priorities of the long term plan as: maternity, older people – including integration and personalised care, outcomes for major conditions, “increasing the NHS workforce”, digital access to services, and cutting waste – including “back office savings of more than £700m”.

MHRA announces EU exit no-deal legislative proposals

European Pharmaceutical Review, Nikki Withers, 04 January 2019

European Pharmaceutical Review reports that pharma companies will be able to amend packaging and leaflets for a product already on the market until the end of 2021, according to the Medicines and Healthcare products Regulatory Agency (MHRA) in response to an EU exit no-deal legislative proposals consultation.

The MHRA consulted on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario and published their key arrangements on 3 January 2019.

64% of contractors unprepared for FMD, while no-deal doubts confirmed

Chemist+Druggist, Vincent Forrester, 04 January 2019

Chemist+Druggist reports that two thirds of contractors were unprepared for the EU’s scanning law at the end of 2018, while the MHRA has since confirmed a no-deal Brexit would kill the directive.

Of the 53 contractors who responded to the C+D Salary Survey 2018 in October – 88% of whom were based in England – 64% said they were unprepared for the Falsified Medicines Directive (FMD), which will require all pharmacies to scan barcodes on medicines packaging at the point of dispensing from February 9. In addition, 77% of contractors said they had not yet bought the scanners required to comply with the FMD.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

UK – NHS Long-Term Plan coming today

Politico, Sarah Wheaton, 07 January 2019

After six months of learning on the job, U.K. Health Secretary Matt Hancock’s moment of truth has arrived. The government is debuting the National Health Service’s long-term plan today — to be bankrolled by the £20.5 billion infusion by 2023-24 that Prime Minister Theresa May cast (highly disputably) as the “Brexit dividend.” It’ll be up to Hancock to sell the new 10-year plan as a way to fix the beloved but troubled system in crisis from chronic underfunding and an exodus of EU employees scared off by Brexit.

Focus on prevention: While a formal announcement is slated for midday, there were a few sneak previews over the weekend. “We need to see a big shift in the way that health services are delivered so that essentially we focus on prevention as much as we do on cure,” Hancock told Sky News’ Sophy Ridge on Sunday. “The focus needs to be on making sure that we support people in the community … and that we ask people, as well as giving them rights for free care … we also ask them to take responsibility to keep the pressure off the NHS and make sure it’s there for people who really need it.”

As part of that, the NHS outlined details Saturday about new programs to help people kick addictions to cigarettes and alcohol. In the latter case, so-called Alcohol Care Teams will be rolled out in areas with the most alcohol-related hospital admissions, which have grown by 17 percent over the last decade, according to the NHS. Initiatives on obesity and diabetes are also coming. The Guardian has a roundup of other details already previewed.

The staffing issue: Ridge reminded Hancock of a nagging deficit: “The 10-year plan isn’t going to work if you haven’t got the people to implement it,” she said, as she cited some stats: 100,000 vacancies, including 41,000 nursing posts, 6,000 GPs slots and 3,000 midwife openings.

“We need to recruit more, we need to train more and also we need to retain the people in the NHS who are working so hard now. Taking the pressure off them actually is one of the important things we can do to retain [staff],” he replied.

Brexit reassurances (sort of): “We are confident that if everybody does what they need to do then we’ll have an unhindered supply of medicines,” Hancock said. “A lot of this relies on the pharmaceutical companies and others so it isn’t entirely in the gift of the government,” he continued, adding that he’s “very pleased with the response of the pharmaceutical industry who obviously take this incredibly seriously and frankly a hospital should get their supply of drugs in exactly the same way as they do now.”

Also on the way: Hancock said a “green paper” with the government’s plan for shoring up social care in the community will be introduced “in the coming weeks.”

Long term plan features new model for A&Es

Health Service Journal, James Illman, 07 January 2019

A new “same day” model for emergency departments and a further cash boost for primary and community services are to be set out in the NHS long-term plan, being launched today.

The long awaited plan, which NHS England also pledged would save “almost half a million more lives” by reducing premature mortality, will also propose new access targets for mental health and a big expansion of personal health budgets, according to announcements by the Prime Minister Theresa May over the weekend.

The government also confirmed that a workforce strategy – previously slated for publication alongside the NHS plan – will not be ready until “later this year”.

And Ms May declined during a BBC interview to repeat a pledge she made in June that the £20bn funding boost would ensure the NHS gets back to meeting its statutory targets.

The national commissioner also said ahead of the plan that one of the major short term priorities would be a new target to “ensure every hospital with a major A&E department has ‘same day emergency care’ in place”. It is understood this amounts to setting up new ambulatory care units.

NHS England said these would mean “patients can be treated and discharged with the right package of support, without needing an overnight stay”. Its statement indicated the proposals on accident and emergency would be targeted for the first or second year of the plan.

Meanwhile, Health and Social Care Secretary Matt Hancock told Sky News the plan would commit £4.5bn real terms growth to primary medical and community services over five years – £1bn more than the £3.5bn of funding originally announced for the sectors in November. This will see funding for those services grow faster than the NHS overall. NHS England said it would fund “a new service model”.

On personalised care, the Department of Health and Social Care told HSJ the “comprehensive model for personalised care” – which includes social prescribing, personal health/care budgets, and care planning – would be extended to 2.5 million people over five years. This will include 500,000 personal health budgets – up from fewer than 40,000 currently.

NHS England said its primary care plans, and new treatments, “coupled with early detection and a renewed focus on prevention [would] stop an estimated 85,000 premature deaths each year”.

This will include stopping 150,000 heart attacks, strokes and dementia cases “while more than three million people will benefit from new and improved stroke, respiratory and cardiac services over the next decade”.

“Patients will benefit from services ranging from improved neonatal care for new parents and babies to life changing stroke therapy and integrated support to keep older people out of hospital, living longer and more independent lives,” it added.

It also confirmed its commitment that mental health funding would rise by “at least £2.3bn a year by 2023-24”, which should see it rise slightly as a share of NHS spend.

The plan follows ministers announcing last year the NHS would receive a 3.4 per cent five year NHS funding settlement.

NHSE also said in its statement it had been “realistic about inevitable continuing demand growth from our growing and ageing population, increasing concern about areas of longstanding unmet need [and] the practical realities of phased workforce expansion”.

NHS Providers said the “NHS frontline wanted an ambitious plan” but warned: “We must avoid an undeliverable wish list that makes too many promises as over promising sets the NHS up to fail.”

The Nuffield Trust said “the goals of this ambitious plan look right” but warned that the biggest barrier to achieving them would be resolving the workforce crisis, which was tied up with the UK’s exit from the European Union and its ability to retain and recruit foreign workers.

Pharmaceutical Chief: We Must Avoid No-Deal Brexit At All Costs

LBC Radio, Nick Ferrari, 07 January 2019

The Chief Executive of the Association of the British Pharmaceutical Industry has told LBC a no-deal Brexit “should be avoided at all costs.”

Mike Thompson’s revealed the Government has plans to airlift medicines into the UK, if there’s major disruption as a result of extra border checks.

He says the building of stocks for a no-deal scenario is the “biggest logistical challenge” the industry has ever faced.

And speaking to Nick Ferrari on LBC, he urged MPs to prevent leaving the EU without an agreement.

When asked if stories of medicine stockpiling are true, Mr Thompson said: “Yes it is. Absolutely. Every member is doing that.

“That’s why patients can be reassured that we are doing everything in our power to ensure we can get our medicines to them even though this is the biggest logistical challenge we are facing.

“Our message is, when parliamentarians come to think about the options in front of them, no-deal is something which they should avoid at all costs because of the challenges it will give everybody.

“I don’t want to get involved into the politics of all of this. I’m just saying that no-deal creates significant challenges for us.

“We are as prepared as we can be, but undoubtedly things will go wrong.

“There are over 12,000 medicines which are licensed to be used in the UK. It is a massive challenge for us. On average, there is normally about 50 medicines which have some shortage problem, so we’re used to dealing with shortages.

“But clearly when we’re talking about the challenges were facing here, there will be unexpected issues we have to deal with. It’s better that we avoid those and that’s our message.”

Sophy Ridge on Sunday Interview with Matt Hancock MP Health Secretary

Sky News, Sophy Ridge, 06 January 2019

SOPHY RIDGE: Last year the NHS turned 70 and enjoyed a £20 billion birthday present from the Prime Minister. Now they have to work out what they are going to do with it because many believe the NHS needs some radical change if it’s to deliver world-leading healthcare into the next decade. The government is about to publish its 10 Year Plan for the NHS so we’re joined now by the Health and Social Care Secretary, live from the West Suffolk Hospital. Matt Hancock, thank you for being with us today.

MATT HANCOCK: Good morning, how are you?

SOPHY RIDGE: Not too bad, I hope you’re well as well. So tell us, what is in this plan?

MATT HANCOCK: Well as you say, the £20 billion extra that we’re putting into the NHS over the next five years is there to make sure it is sustainable for the long-term but money alone is not enough. We need to see a big shift in the way that health services are delivered so that essentially we focus on prevention as much as we do on cure. Of course, hospitals like this do an amazing job in helping people to get better when they’re ill but increasingly over the last generation, the focus needs to be on making sure that we support people in the community, that we support people for instance through GPs and that we ask people, as well as giving them rights for free care, free at the point of use, we also ask them to take responsibility to keep the pressure off the NHS and make sure it’s there for people who really need it.

SR: Some people in the Conservative party will think this sounds a bit like the nanny state.

MATT HANCOCK: Oh I don’t think so at all. Asking people to take responsibility is the very opposite of that. We then need to empower them to do so, so for instance the ability to go and see your GP or have support in the community, even for somebody who is very frail, to be given the money to be able to make say improvements to your home so that you don’t trip, so that you don’t end up in this emergency department which is very expensive for the NHS as well as obviously very bad for the patient; making sure that we can help people to stay healthy is at the core of what a National Health Service should be doing and the focus just on what happens in hospitals means that we don’t spend enough thought, effort and resources – both government resources but also asking people to take responsibility themselves – to keep people healthy. The whole purpose of the NHS over the next ten years needs to shift towards helping people to stay healthy as much as curing them when they’re ill.

SR: You’ve got a bit of a problem though haven’t you and that’s about staff because currently there is 100,000 vacancies in the NHS. I am just going to talk you though some of the numbers because I’ll be honest, I was pretty shocked when I was doing the research for this interview. 41,000 unfilled nursing posts, 6,000 GPs short of the number that we need, 3000 midwives short – the 10 Year Plan isn’t going to work if you haven’t got the people to implement it.

MATT HANCOCK: Well of course when you put £20 billion into something we are going to need the people to deliver, absolutely right and the plan has a detailed workforce chapter and then there is going to be further working on making sure we have the people that we need. We need to recruit more, we need to train more and also we need to retain the people in the NHS who are working so hard now. Taking the pressure off them actually is one of the important things we can do to retain …

SR: But how can you do that?

MATT HANCOCK: Well let’s take the nurses figure that you gave, 41,000 vacancies you mentioned. Actually 30,000 of those vacancies are currently filled but they are filled through people working through for instance agencies rather than full time. That can be fixed. We also have got to have more because that still doesn’t bring us up to the full complement and so we are expanding training, we’ve got an expansion of the training budget, we’re going to make sure that we also recruit better and we have also got to make sure that, as I say, we retain those who are currently working in the NHS and a lot of that means taking the pressure off.

SR: You sound as if it is all under control but actually on the ground if you talk to people you get a very different picture. I was speaking to someone who works in a rural GP practitioner and they were saying in the last year they advertised for a nurse practitioner, a practice nurse and a GP and received zero applicants and that is not an isolated case. I mean this is a crisis isn’t it? A crisis where you haven’t got enough people who are working in the health service.

MATT HANCOCK: Well this is why we’ve got a long term plan and in fact we said before we thought of the 20 billion, £3.5 billion needed to go to primary care and community care. In fact we are going to be putting £4.5 billion extra into primary care and community care and yes, that means we are going to need a lot more community nurses, we’re going to need more GPs as you say, we’ve got a target for more GPs and this is all part of the plan, to make sure we have people. You know, there’s a big picture here. If you step back we have a population that is ageing and also getting wealthier and as populations get wealthier and as they age, they need more healthcare and that means we need more people focused on healthcare and keeping people healthy, so that requires training, it also requires recruitment and part of the plan is to solve exactly the sorts of issues that you are talking about and exactly the sorts of shortages that you mentioned from talking to the people who you did.

SR: You’re talking about the challenges of an ageing population and of course one of the big challenges facing the NHS is social care but I haven’t found anything on social care in this plan, in the brief that we’ve been given, so can you tell me when the Green Paper is going to be finally published on it?

MATT HANCOCK: Yes, we’re going to have a Green Paper on social care soon. The plan does actually cover the very important links between health and social care because the link between making sure you can get people out of hospital when they don’t need to be in hospital and they do need care, that’s critical and…

SR: So when will the plan be published?

MATT HANCOCK: In the coming weeks. Clearly there is a big focus on one other big subject as well in Parliament at the moment but the plan is, the Green Paper is well developed and it fits with and goes alongside this long-term plan for the NHS.

SR: Part of the plan which I know you are very passionate about is technology and you are talking about targeting people with unhealthy habits, for example people who enjoy smoking, enjoy drinking, for example, with targeted adverts, a bit like politicians do during election campaigns. Does that mean that medical data will become available to private companies?

MATT HANCOCK: No, it doesn’t mean that at all. What we propose there is that as part of this approach to try to support people to stay healthy, in the past public health messages have tended just to go to the population as a whole. We all know the mantra that you should eat five a day, that is a public health message and normally we give the same message right across the population. Increasingly a with new technology actually you can better target those messages so instead of saying to everybody the same thing, you can say for instance, if you are a smoker, that is very bad for your health but if you are a smoker and you’re pregnant, that’s not only bad for your health but seriously bad for your baby’s health and we can target messages to people to try to make sure that they maintain healthier lifestyles instead of, and what I don’t like in this area is punishing the masses for problems that only a minority has. Take alcohol for example, a fifth of people drink a third of all the alcohol … Sorry, 5% of people drink a third of all the alcohol in the country, 5% and yet many of us like a nice pint and it’s perfectly healthy, so I think instead of things like minimum unit pricing that some people suggest, we should target measures so that if somebody has a serious drinking problem that leads them to end up using the NHS in a hospital like this, then they should get much more active intervention and counselling to try to support them so that we’re not stopping most people from having a perfectly healthy drink or punishing them and instead we’re tackling the problem where it really is serious.

SR: Now Brexit of course affects all government departments at the minute and a lot of people are very worried that if there is no deal there will be shortages of medicine so can you as Health Secretary guarantee now that even if there is a deal, if no deal can be reached, people will be able to get the medicine that they need?

MATT HANCOCK: Yes, we are confident that if everybody does what they need to do then we’ll have an unhindered supply of medicines. Obviously this is very, very important. In all Brexit scenarios, no matter what happens in those negotiations, people should be able to get their supplies and there is an awful lot of work going on to ensure that that’s the case and we’re confident that so long as everybody does what they need to do, because a lot of this relies on the pharmaceutical companies and others so it isn’t entirely in the gift of the government, but we need to do what we need to do and the pharmaceutical industry, so far that work has been progressing very well, I’ve been very pleased with the response of the pharmaceutical industry who obviously take this incredibly seriously and frankly a hospital should get their supply of drugs in exactly the same way as they do now, they shouldn’t notice any difference because the unhindered supply should be done in the pharmaceutical supply chain and we’ve got plans underway to make sure that that can happen.

SR: Being confident that something will happen isn’t the same as a guarantee though is it?

MATT HANCOCK: Well the truth is that in medical supplies, there are these sorts of shortages all the time. In the autumn there was a shortage of EpiPens because of a problem with supply at the factory in America where they were made, so actually the NHS and the Department deal with these sorts of issues all of the time so that is why I use the language that I do, because there is always all sorts of problems. Frankly, one of the jobs of the Health Secretary is to prepare for all sorts of things that you don’t want to happen but do happen. We have people at the moment out in the Democratic Republic of Congo dealing with Ebola, I don’t want Ebola to be a problem but I am absolutely happy to ensure that we put resources into stopping it. So this sort of planning happens all of the time and we are clear that we are not going to over-promise but we are confident that the plans are in place and so long as everybody does what they need to do, then there will be an unhindered supply of medicines in whatever the Brexit scenario.

SR: Okay, now it was reported in November that you told Cabinet that you couldn’t guarantee that people wouldn’t die as a result of a no deal Brexit. Now I’m not asking you to go into confidential Cabinet discussions, I know you don’t want to do that but can you guarantee that people’s lives will be safe?

MATT HANCOCK: I am confident that we will have the unhindered supply of medicines so long as the plans that we have in place are properly enacted. I didn’t actually say what you reported to Cabinet and I am really very clear on the position here which is that there is a lot of work to do to make sure that we get to that position. Some of it is for government and are doing that, I now have a whole floor of my department working on this and we’ve put money behind it already, as has been widely reported, making sure that there are facilities so that we have got the stockpiles of drugs that we need but I am also not going to over-promise. I am doing everything that we need to and everything that we can to make sure there is the unhindered supply no matter what happens.

SR: Okay and very briefly, the Prime Minister is going to be putting her Brexit deal back to a Parliamentary vote shortly, we believe in the next fortnight or so. Do you think anyone has changed their minds over Christmas?

MATT HANCOCK: Well I certainly hope that the chances of the deal going through have improved. If people have gone back to their constituencies, as I have, and talked to normal people, then they will have found an overwhelming sense of just please can we get on with it. The plan on the table is the best plan, it will get rid of all the problems that we’ve just been talking about in terms of no deal. It will also mean that we have both a close economic relationship with the EU in the future and deliver on the referendum result. I think it is overwhelmingly the best way forward compared to even no deal or a second referendum which will be divisive, hugely divisive, but it wouldn’t be decisive because people would say well why not have the best of three? So I’m very confident that the plan is the best way forward and I hope that on listening to constituents and taking a bit of time to consider the questions over Christmas, people can back the plan that gets on and delivers Brexit and delivers Brexit in a way that means that our economy can thrive and we can then support our public services like the NHS and there’s a great bright future out there for this country and we need to get on with building it.

SR: Okay, Matt Hancock, thank you very much.

Prime Minister reveals NHS long term plan top priorities

Health Service Journal, Rebecca Thomas, 05 January 2019

The Prime Minister has confirmed headline priorities of the new NHS long term plan, including new “comprehensive” access targets for mental health, and a big expansion of personal health budgets.

The plan itself is due to be published on Monday, launched by Theresa May and NHS England Chief Executive Simon Stevens.

A Number 10 announcement today identifies the priorities of the long term plan as: maternity, older people – including integration and personalised care, outcomes for major conditions, “increasing the NHS workforce”, digital access to services, and cutting waste – including “back office savings of more than £700m”.

Mental health is also singled out by Ms May, saying the sector will receive £2.3bn real terms funding growth over the next five years. This is more than a £2bn figure issued by government in October, but could still be insufficient to ensure mental health’s share of the total NHS pot grows. The Royal College of Psychiatrists has previously estimated this would require at least £2.5bn real terms growth.

Today’s announcement said 350,000 more children and young people would have access to mental health services, though the baseline for this target is not clear. The 2015 Forward View for Mental Health promised access for “at least 70,000” more.

Number 10 also said the NHS would “for the first time ever… test and introduce comprehensive access standards for mental health”, though no more details have been given.

Priority services for expansion include 24-hour mental health crisis care, and specialist services for new and expectant mothers and for adults aged 18-25, who can face a “cliff edge” when they leave services for children only.

The government’s announcement also confirms there will be no major workforce plan issued alongside the NHS plan on Monday, as had initially been proposed. It says: “We are improving access to mental health, primary care and community services, with tens of thousands more doctors, nurses and other health professionals – a full workforce plan is expected later this year.”

Mr Stevens said in November the plan would not “definitively” deal with workforce, public health and capital issues, as these budgets depend on the government spending review later this year.

No detail has been given on the promise to make £700m in back office savings, although it is understood it does not include abolishing NHS Improvement. In November clinical commissioning groups were told to cut their admin spend by a fifth to save “more than £320m a year”; while NHS England and NHS Improvement are restructuring to cut costs classified as admin by 15 per cent.

On the expansion of personal health budgets, an ambitious new five year target will be set, aiming to take the current number of about 30,000 up to around 200,000.

The long term plan will set specific priorities for the NHS for the next five years and some improvement ambitions over a decade, responding to the government’s announcement in the summer of a five year funding settlement for the NHS England budget.

Ms May said the plan “marks an historic step to secure [the NHS’s] future and offers a vision for the service for the next ten years, with a focus on ensuring that every pound is spent in a way that will most benefit patients”.

MHRA announces EU exit no-deal legislative proposals

European Pharmaceutical Review, Nikki Withers, 04 January 2019

Pharma companies will be able to amend packaging and leaflets for a product already on the market until the end of 2021, according to the Medicines and Healthcare products Regulatory Agency (MHRA) in response to an EU exit no-deal legislative proposals consultation.

There will also be free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs) if there is no Brexit deal.

The MHRA consulted on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario and published their key arrangements on 3 January 2019.

Dr Ian Hudson, Chief Executive Officer at the MHRA said: “We are committed to giving businesses and individuals as much certainty as possible, as soon as possible to make sure the UK continues to be at the forefront of regulatory innovation and processes.”

Key arrangements include a targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion, full accelerated assessment for new active substances and conversion of Centrally Authorised Products (CAPs) to UK Marketing Authorisations (Mas).

“The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles, that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health,” says Dr Hudson.

For medical devices the key arrangements include, for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market and an expansion of the MHRA’s registration system to all classes of medical device.

For clinical trials, the key arrangements include continuing to recognise existing approvals so there will be no need to re-apply, requiring the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list which would initially include EU or EEA countries and aligning, where possible, with the EU Clinical Trials Regulation when it applies.

“The responses to our consultation have helped us prepare a robust plan to make sure our regulatory processes for medicines, clinical trials and medical devices are fit for purpose on exit day,” concludes Dr Hudson.

The MHRA notes that these proposals are still subject to parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.

Further detailed guidance is available in the Further guidance note on the regulation of medicines, medical devices and clinical trials if there is a no Brexit deal.

64% of contractors unprepared for FMD, while no-deal doubts confirmed

Chemist+Druggist, Vincent Forrester, 04 January 2019

Two thirds of contractors were unprepared for the EU’s scanning law at the end of 2018, while the MHRA has since confirmed a no-deal Brexit would kill the directive.

Of the 53 contractors who responded to the C+D Salary Survey 2018 in October – 88% of whom were based in England – 64% said they were unprepared for the Falsified Medicines Directive (FMD), which will require all pharmacies to scan barcodes on medicines packaging at the point of dispensing from February 9.

In addition, 77% of contractors said they had not yet bought the scanners required to comply with the FMD.

Over half (52%) of 42 respondents to a separate question said they had spent less than £100 per pharmacy on preparations, while 21% had spent between £100 and £500, and 17% had invested more than £1,000.

Several respondents said the price of the equipment was prohibitive. Describing it as “so expensive”, one contractor said they were “trying to see if any colleagues get better deals so I can negotiate the same”.

Uncertainty surrounding Brexit was cited by two contractors as a factor in their unwillingness to invest in preparations. One respondent said they were “waiting for more guidance and Brexit information”, while another said they were “still deciding”.

MHRA: No-deal Brexit will void FMD

In its response to a consultation on the implementation of the FMD, published last week (December 24), the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that in the case of a no-deal Brexit, UK “stakeholders” – including pharmacies – will not be able to participate in the system after the country is scheduled to leave the EU on March 29.

Following a no-deal Brexit, the UK “would not have access to the [EU’s] central data hub”, resulting in pharmacies being “unable to upload, verify and decommission the unique identifier on packs of medicines”, the MHRA said.

The medicines watchdog also said that under certain circumstances it will allow some healthcare institutions to be exempt from FMD compliance.

However, the MHRA told C+D that “there is no flexibility…for a community pharmacy to be exempt from the requirement to decommission”.

In October, government officials suggested pharmacies should prepare for the FMD regardless of a no-deal Brexit, as any UK-focused scheme would be based on a similar system.

Media And Political Bulletin – 07 January 2019

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.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?