HDA UK Media and Political Bulletin – 10 May 2024

Media Coverage

More than 90% of pharmacies say medicines shortages have got worse over the past year
The Pharmaceutical Journal, Saša Janković, 9 May 2024

The Pharmaceutical Journal reports on Community Pharmacy England’s national Pharmacy Pressures Survey 2024: Medicines Supply Report which found that 94% of pharmacy owners spend more time sourcing medicines now than at the same point in 2023. 84% of respondents reported spending longer than ever sourcing medicines.

Janet Morrison, Chief Executive of Community Pharmacy England, described the current medicine supply challenge as “beyond critical” and said the report makes “distressing reading” and “should be ringing alarm bells”.

William Pett, Head of Policy and Research at Healthwatch England, called for “a review of the medicine supply chain to ensure safety and resilience, and for pharmacy teams to be given flexibility…to make changes to medicines they dispense in collaboration with patients”.

This report was also reported on by P3pharmacyDispensing Doctors’ Association and ITV News.

Parliamentary Coverage

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence
Medicines and Healthcare products Regulatory Agency, 9 May 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched AI Airlock, a new regulatory sandbox to help with the safe development and deployment of AI medical devices (AIaMD) by addressing novel regulatory challenges.

Dr Paul Campbell, Head of Software and AI at the MHRA, welcomed the tool’s launch noting that the Agency is “currently seeing a marked increase in innovative AIaMD products entering the UK market” and reinforced the Agency’s aim to “balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products”.

Carbamazepine
Catherine West MP (Labour, Hornsey and Wood Green): To ask the Secretary of State for Health and Social Care, whether she has had recent discussions with Novartis on the adequacy of supply of the epilepsy medication Tegretol.

Andrew Stephenson MP (Conservative, Pendle): The Department has been working intensively to address issues with the supply of some epilepsy medications, and as a result we have helped to resolve issues with Tegretol 200 milligram and 400 milligram prolonged release tablets, and Tegretol 100 milligram immediate release tablets. We are aware of a shortage of Tegretol 100 milligram/5 millilitre liquid, but have been advised that resupplies are expected this month. We are continuing to work closely with manufacturers, including Novartis, to help ensure the continued supply of these medicines for patients in the United Kingdom, for example by asking suppliers to expedite deliveries.

Whilst we can’t always prevent supply issues, we have a range of well-established tools and processes to mitigate risks to patients. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols, and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals, so they can advise and support their patients.

Pharmacy: Drugs
Catherine West MP (Labour, Hornsey and Wood Green): To ask the Secretary of State for Health and Social Care, what steps she is taking to help tackle shortages of medicines in pharmacies.

Andrew Stephenson MP (Conservative, Pendle): The Department has a responsibility to work with United Kingdom medicine license holders, to help ensure continuity of supply. We monitor and manage medicine supply at a national level, so that stocks remain available to meet regional and local demand. There are approximately 14,000 medicines licensed for supply in the UK, and the overwhelming majority are in good supply. The medicine supply chain is complex, global, and highly regulated, and supply issues can be caused by a range of factors. For example, suppliers can encounter manufacturing problems, difficulty accessing raw materials, and surges in demand. These are commonly cited as the drivers of recent supply issues, which have affected many countries, not just the UK.

Whilst we can’t always prevent supply issues, we have a range of well-established tools and processes to mitigate risks to patients at a national level. These include close and regular engagement with suppliers, use of alternative strengths or forms of a medicine to allow patients to remain on the same product, expediting regulatory procedures, sourcing unlicensed imports from abroad, adding products to the restricted exports and hoarding list, use of Serious Shortage Protocols, and issuing National Health Service communications to provide management advice and information on the issue to healthcare professionals including pharmacists, so they can advise and support their patients.

Full Coverage

More than 90% of pharmacies say medicines shortages have got worse over the past year
The Pharmaceutical Journal, Saša Janković, 9 May 2024

The vast majority of community pharmacy owners have said that medicines shortages have got worse over the past year, a survey by Community Pharmacy England (CPE) has revealed.

The survey of more than 2,000 community staff members and the owners of more than 6,000 pharmacy premises, results of which were published on 9 May 2024, also revealed that medicines supply problems were affecting 99% of community pharmacies at least weekly, with 72% experiencing multiple shortages each day.

CPE’s ‘Pharmacy pressures survey: medicines supply report‘ also reported that 94% of pharmacy owners said their teams now spent more time sourcing medicines compared with the same point in 2023, while 84% said they were spending longer than ever before sourcing medicines.

The survey also revealed that 79% of pharmacy staff said that patient health was being put at risk owing to medicine supply issues, with 84% of team members experiencing aggression from patients as a result.

The report’s authors concluded that medicines across a range of clinical and therapeutic areas were being affected by supply disruptions at different times, with issues in 2024 affecting “in particular medicines used for the treatment of diabetes, ADHD, and epilepsy”, while there were “availability issues with HRT, adrenalines and antibiotics” in 2023.

Fin McCaul, managing director of Prestwich Pharmacy in Manchester, told The Pharmaceutical Journal: “This is the longest period of continuous disruption that I’ve ever experienced and it’s a constant issue. In the past, shortages were confined to one molecule but now they change from product to product to product in every disease area across the board, from cardiology and diabetes, to respiratory, pain, ADHD, mental health medicines.”

Anil Sharma, pharmacist and director of Medicines4U in Huntingdon, Cambridgeshire, told The Pharmaceutical Journal: “Sometimes up to 10% of things we place on order are coming up as out of stock and it’s costing us one to two hours a day of extra staffing time to resolve, even though these are really common drugs.

“We will try to order the drug two or three times but if we can’t get it by the third day we will ask the patient’s surgery for an alternative, but sometimes there is no clinically suitable alternative product, and this can end up being a matter of life or death for many patients.”

Describing the medicine supply challenges being faced by community pharmacies and their patients as “beyond critical”, Janet Morrison, chief executive of CPE, said the survey results “make distressing reading, and they should be ringing alarm bells for anybody interested in protecting the health and wellbeing of local communities and the public”.

“We’ve been warning for some time that these issues must be resolved, and this evidence provides yet another stark warning which must not be ignored,” she added.

In March 2024, The Pharmaceutical Journal revealed that manufacturers reported medicines shortages to the Department of Health and Social Care an average of 137 times per month in 2023, compared with 82 times per month in 2021.

Patient mouthpiece Healthwatch published research on medicines shortages in April 2024, which showed that 24% of patients had experienced their pharmacy not having stock of their medicines in the past year.

Responding to the results of CPE’s survey, William Pett, head of policy and research at Healthwatch England, said: “Healthwatch England hears about how shortages can lead to rationing and desperate instances of ‘pharmacy bingo’, where patients must travel from pharmacy to pharmacy looking for stock.

“We are calling for a review of the medicine supply chain to ensure safety and resilience, and for pharmacy teams to be given flexibility, where it is safe to do so, to make changes to medicines they dispense in collaboration with patients.”

A spokesperson for the Department of Health and Social Care said: “There are around 14,000 licensed medicines and the overwhelming majority are in good supply. Supply issues can arise for a wide range of reasons and are not specific to the UK.
“Our priority is to mitigate risks posed by those issues and to help ensure that patients continue to get the treatments they need. Thankfully, most issues can be managed with minimal impact to patients.

“We recognise the vital role pharmacies play in our healthcare system and that’s why they are backed by £2.6bn a year in government funding.”

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence
Medicines and Healthcare products Regulatory Agency, 9 May 2024

Last month, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government. This pilot project is a key part of that approach. It will help the Agency to identify and address the challenges for regulating standalone AI medical devices (AIaMD), initially seeking out and supporting 4-6 virtual or real-world projects through simulation. This will allow us to test a range of regulatory issues for these devices when they are used for direct clinical purposes within the NHS.

The regulatory sandbox model is a recognised mechanism to help address novel regulatory challenges across sectors. The AI Airlock is a world-leading version in healthcare, designed to assist in safe development and deployment of AIaMDs, and this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.

The MHRA’s regulatory AI Airlock takes into account evidence-based work produced by other bodies with a similar focus and we will work collaboratively with the NHS AI Lab and the Department of Health and Social Care (DHSC). AIaMD products are deployed via NHS infrastructure, making the Devolved Nations crucial to regulatory discussions around deployment and post-market surveillance.

The findings from this partnership between government, regulators and industry will inform future AI Airlock projects and influence future UK and international AIaMD guidance, including how we work with UK Approved Bodies on UKCA marking and with trusted regulatory partners on international recognition of medical devices.

Dr Paul Campbell, MHRA Head of Software and AI, said:

We are currently seeing a marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionise the healthcare landscape and provide improved ways to address patient and public needs.

As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation.

The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.

This fact-finding approach is key to safeguarding patients as we learn about the full potential of this technology. Where AI Airlock can enhance the relationship between developers and manufacturers with the MHRA as a regulatory body, in the future, it may also serve to support confidence in patient engagement and the safe use of AIaMD products.

MHRA’s regulatory sandbox is an expanding offering in the healthcare technology space, and investment in innovative solutions is underway to position the NHS as an industry leader by 2030.

Media Coverage

There was no media coverage today.

Parliamentary Coverage

Atorvastatin: Shortages
Justin Madders MP (Labour, Ellesmere Port and Neston): To ask the Secretary of State for Health and Social Care, what discussions she has had with stakeholders on tackling shortages of atorvastatin.

Andrew Stephenson MP (Conservative, Pendle): There have been supply issues with atorvastatin, but as a result of our work to manage those issues, including engaging with alternative suppliers to cover supply gaps in order to meet demand, they have now been resolved.

The medicine supply chain is highly regulated, complex, and global. Supply disruption is an issue which affects the United Kingdom, as well as other countries around the world. There can be a variety of causes, including manufacturing issues, problems with access to raw ingredients, and sudden spikes in demand.

Whilst we can’t always prevent supply issues, the Department has well-established tools and processes to manage them, in order to mitigate risks to patients. We work closely with the pharmaceutical industry, NHS England, the Medicines and Healthcare products Regulatory Agency, and others operating in the supply chain to help ensure patients continue to have access to suitable medicines when supply is disrupted.

Ezetimibe: Shortages
Justin Madders MP (Labour, Ellesmere Port and Neston): To ask the Secretary of State for Health and Social Care, what discussions she has had with relevant stakeholders on tackling shortages of Ezetimibe.

Andrew Stephenson MP (Conservative, Pendle): The Department is aware of supply issues affecting several Ezetimibe suppliers. We are engaging with these suppliers to address the issues, and are working with alternative suppliers to ensure supplies remain available.

The medicine supply chain is highly regulated, complex, and global. Supply disruption is an issue which affects the United Kingdom, as well as other countries around the world. There can be a variety of causes, including manufacturing issues, problems with access to raw ingredients, and sudden spikes in demand.

Whilst we can’t always prevent supply issues, the Department has well-established tools and processes to manage them, in order to mitigate risks to patients. We work closely with the pharmaceutical industry, NHS England, the Medicines and Healthcare products Regulatory Agency, and others operating in the supply chain to help ensure patients continue to have access to suitable medicines when supply is disrupted.

Pharmacy: Finance
Grahame Morris MP (Labour, Easington): To ask the Secretary of State for Health and Social Care, what assessment she has made of the adequacy of the medication reimbursement mechanism for community pharmacists.

Andrew Stephenson MP (Conservative, Pendle): Through the medicine margin survey, the Department assesses whether the reimbursement arrangements pay pharmacy contractors as agreed as part of the community pharmacy contractual framework (CPCF). The medicine margin survey considers what pharmacies paid for medicines by looking at their invoices compared to the amount reimbursed by the National Health Service. Where the survey finds that they have been underpaid, we increase the pharmacy contractors’ payments, and where they have been overpaid, we decrease payments.

Furthermore, where pharmacies cannot purchase products at or below the Drug Tariff NHS reimbursement price, Community Pharmacy England can request that the Department reassesses the reimbursement price. If a new reimbursement price is issued, this is known as a concessionary price.

Dear member,

Please find below the GIRP Press Review for 06/07/2023 – 13/07/2023

Press Review 06.07.2023 – 13.07.2023

The HDA Secretariat

Dear member,

Please find below the GIRP Press Review for 23/06/2023 – 29/06/2023

Press Review 16.06.2023 – 22.06.2023

The HDA Secretariat

Media Coverage

‘A global outlier’: how drug firms are fighting back against UK tax increases
Pharmaceutical Journal, Anna Sayburn, 13 April 2023

The Pharmaceutical Journal reports that the sharp rise in the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) to 26.5% in 2023 led to a series of warnings from the Association of the British Pharmaceutical Industry (ABPI) and British Generic Manufacturers Association (BGMA) that drug companies might be forced to move their manufacturing and research out of the UK. Such a move would be hugely impactful on medicine supply in the UK and result in NHS patients having delayed access to new treatments and facing a potential reduction in the supply of existing medicines.

The potential risk of a reduction in medicine supply is highlighted by Jessamy Baird, Chief Executive of Sanofi UK, who argued the heightened VPAS rate could lead to a “reduction of suppliers of some classes of medicines”.

The potential withdrawal of several manufacturers from the UK also comes at a time when the UK’s supply chain is already lacking in resilience with Mike Dent, Director of Pharmacy Funding at the Pharmaceutical Services Negotiating Committee (PSNC) warning that pharmacists are “reporting problems obtaining more and more drugs”.

Community pharmacies spending twice as much time managing medicines shortages as last year
Pharmaceutical Journal, Corrine Burns, 13 April 2023

The Pharmaceutical Journal reports that pharmacy staff have spent an average of 11 hours a week on procurement in 2023, double the amount of time spent in 2022 according to the 2023 Pharmacy Pressures Survey published by the Pharmaceutical Services Negotiating Committee (PSNC).

The survey also found that 92% of pharmacy teams have experienced daily supply issues in 2023, an increase from just 67% in 2022. This is alongside 97% facing significant increases in wholesaler and medicine supply issues which 71% stating that this has led to a delay in prescriptions being issued.

Janet Morrison, Chief Executive of the PSNC said the survey highlights that “funding is needed, without delay, to maintain patient access to the medicines and pharmacy services they need”. A spokesperson for the Department of Health and Social Care responded to the survey results by saying that the Department has “well-established processes in place to manage or mitigate” medicine supply issues.

Parliamentary Coverage

There was no parliamentary coverage today. 

Full Coverage

‘A global outlier’: how drug firms are fighting back against UK tax increases
Pharmaceutical Journal, Anna Sayburn, 13 April 2023

The past three months have seen the rhetoric heat up around the UK government’s levy imposed on medicine manufacturers.

When the ‘Voluntary Scheme for Branded Medicines Pricing and Access’ (VPAS) was initially agreed in 2019, manufacturers were asked to pay the government 9.6% of their net income from sales of branded medicines to the NHS in exchange for various incentives to support innovation.

The aim was to limit the growth in NHS spending on medicines to 2% each year by adjusting the payment percentage accordingly. However, the levy rose sharply to 26.5% in 2023, largely the result of increased sales growth in 2021 and 2022, as a result of the COVID-19 pandemic.

This led to increasingly aggressive warnings from the Association of the British Pharmaceutical Industry (ABPI) and British Generic Manufacturers Association (BGMA) that the increasing rates could result in drug companies taking their research and manufacturing outside of the UK, which would ultimately cause delays to accessing new treatments for NHS patients and reduce supply of existing medicines.

Pulling out of the UK

Manufacturers themselves have also said they will take action, pouring millions of pounds into manufacturing and research overseas. In 2022, manufacturers AbbVie and Eli Lilly spent €460m on developing manufacturing facilities in Ireland, with both companies later announcing their withdrawal from the VPAS in January 2023, instead opting to pay an increased levy of 27.5% under the statutory scheme instead.

The ABPI said at the time that the companies’ move stemmed from increasing difficulties in justifying the voluntary scheme to global boardrooms, explaining that it is “easier to justify a statutory scheme, which is applied through direct legal imposition”. The statutory scheme, as set out in the Branded Health Service Medicines (Costs) Regulations 2018, applies to all manufacturers unless they choose to join VPAS instead, which offers additional incentives to support innovation.

At the time, Laura Steele, president and general manager for Northern Europe at Eli Lilly and Company, said: “Getting the VPAS right is a win for patients, taxpayers and industry, so government must act urgently to rescue our partnership.

“The current scheme has harmed innovation, with costs spiralling out of control and the UK falling behind other major countries to be left as a global outlier.”

Of the companies that remain enrolled in VPAS, such as Takeda and MSD some have confirmed to The Pharmaceutical Journal that UK-based clinical trials — which are already in decline — would suffer further under the soaring levy.

“The current VPAS rebate rate leaves the UK as an outlier compared to the lower rates in other countries. This is a real risk to inward investment, the UK’s place as a life science destination, and, importantly, threatens our ability to get the latest medicines to UK patients,” says Véronique Walsh, general manager at Gilead Sciences UK and Ireland, which is still enrolled in the VPAS.

“If innovation is not established in a country, it becomes more difficult to bring the next generation of therapies into trials, and therefore patients will wait longer for new treatments.”

According to research published in October 2022 by the ABPI, as of 2020, patients were already waiting increasing lengths of time for a medicine after a clinical trial.

“Between 2018 and 2020, the median time between a clinical trial in the UK applying for regulatory approval and that trial delivering its first dose to a participant rose by 25 days to 247 days,” the research found, resulting in the number of industry clinical trials initiated in the UK per year falling by 41% between 2017 and 2021.

Jessamy Baird, chief executive of Sanofi UK, says: “I would argue that [when VPAS rates were] around 6–7% in the UK, new decisions around early R&D [research and development] investment were not linked to VPAS. That situation has changed.

“When you are looking at a revenue tax of 27% it does bring up difficult questions, at a time when there is an existing decline in clinical trials.

“You are not going to do trials in therapy areas where you don’t think you can get the medicine reimbursed. Why would you trial a medicine in a country where you might not ultimately gain access for those drugs? It’s not ethical to do [trials] if you don’t think you can get reimbursement in that country,” she says, highlighting a need for a “healthy market” in branded medicines in all therapy areas.

“What [VPAS] could lead to is a reduction of suppliers of some classes of medicines. We have some originator off-patent medicines where we could end up being the single supplier — and if we have quality problems you’ve lost all the resilience. It’s not a position we want to be in.”

Existing supply chain issues

This would come at a time when the UK’s medicine supply chain already lacks resilience, with Mike Dent, director of pharmacy funding at the Pharmaceutical Services Negotiating Committee, warning in early 2022 that pharmacy contracters were “reporting problems obtaining more and more drugs”.

Later that year, 54% of respondents to The Pharmaceutical Journal’s annual salary and job satisfaction survey said that medicine shortages were putting patient safety at risk.

However, Haran Maheson, commercial lead for oncology at pharmaceutical company Daiichi-Sankyo, told The Pharmaceutical Journal in March 2023 that the threat from VPAS rates is mainly to “future products because the ecosystem is becoming more cost-prohibitive in many ways”.

“This time [in 2022] I’d have said [VPAS] was one of many things — National Institute for Health and Care Excellence (NICE) technical appraisals, methodology, the regulatory environment (which tends to be slow in the UK). However, that was a year ago. VPAS has become a clear and present challenge,” he says.

“NICE appraisal is quite challenging in itself. With VPAS added on, the whole ecosystem is becoming more punitive. It could mean discussions and decisions about not launching in the UK, just providing [new medicines] privately and with free of charge programmes if there is unmet need.

“There are different options on the table. All decisions will be on a case-by-case basis,” he continues, adding that the company was “watching and waiting” before making decisions.

survey of ABPI members, carried out by consultancy firm WPI Strategy and published in February 2023, revealed “the higher the payment rate, the greater the negative impact on research and development (R&D) investment”.

The report predicted that only a rate below 10% would see R&D spending rise, while companies said their UK R&D investment would fall 20% from 2023 levels by 2028, under the current rates of 20–30%. Extrapolating from these figures, the report said this could represent a loss of £1.9bn in 2028.
And these losses will not be quickly recouped if the VPAS rate is lowered. “The clawback rates in the UK mean that we having to take difficult decisions about our UK operations,” says a spokesperson for Bayer UK.

“Many of these business decisions, including on personnel and our commercial footprint in the UK, cannot be easily or quickly reversed … If high payment rates continue, there is the very real risk of further disinvestment in the sector, which will be very difficult to unwind.”

Renegotiations

However, health economists are sceptical about the timing of the pharmaceutical industry’s rally against the VPAS.

“The timing of the pushback by industry is quite suspicious, since it’s happening in the run-up to the renegotiations,” says Olivier Wouters, assistant professor of health policy at the London School of Economics.

“A few firms have already said that they’re pulling out of the voluntary scheme, but that just means they’ll end up paying more under the statutory scheme. These actions seem like threats heading into renegotiations.”

The VPAS in its current form is set to expire at the end of 2023, with the ABPI and Department of Health and Social Care (DHSC) due to enter negotiations for a new scheme between spring and autumn 2023.

“They are recouping those costs globally so there is not much evidence to support their stance. I’m a bit sceptical. The link between domestic pricing policy and where companies hold clinical trials and site manufacturing capacity is not clear,” Wouters says.

He says that the clawback system is a vital one. “It is really important for the government to have a safety valve to protect NHS spending in case of a spike in spending. A lot of other European countries have similar mechanisms in place to relieve pressure on budgets in such cases — it’s not restricted to the UK.”

Mark Sculpher, professor of health economics at the University of York’s Centre for Health Economics, says: “[It is] ironic that, for many years, Ireland has been a popular place to manufacture pharmaceuticals, but its approach to drug pricing and reimbursement is no more generous than that of the NHS.

“It’s more to do with incentives, in particular corporation tax,” he adds.

In 2021, Ireland’s corporation tax was 12.5%, compared with 19% in the UK. However, in 2023, Ireland’s rate rose to 15% and the UK rate increased to 25%.

Instead, Sculpher says the controversy over VPAS is a sign of other failures.

“The real problem at the heart of this is that VPAS is really a backstop for a NICE approval process that doesn’t work as it should. If you had a NICE approval process that worked better, decisions would be made about new products that focus not just on clinical effectiveness but also cost-effectiveness and respected other valuable uses of the NHS budget,” he says.

“Research has shown that the cost-effectiveness threshold used by NICE is too high because the NHS can produce better outcomes from other activities at the same additional cost.”

NICE’s routine threshold requires each additional quality-adjusted life-year (QALY) generated by a new drug to cost no more than £30,000, “but [the] research shows that the NHS more generally can generate an additional QALY at approximately £15,000”, Sculpher explains.

“Rebates therefore become essential to limit expenditure on branded pharmaceuticals crowding out more productive funding elsewhere in the NHS.”

Pharmaceutical companies, by contrast, tend to believe the NICE cost-effectiveness threshold is too low. “Companies can’t have it all ways. They fought tooth and nail against reductions in the cost-effectiveness thresholds for drugs,” says Sculpher, leading to an increase in cost-effectiveness thresholds for some products, such as those for rare diseases and products used in end-of-life care.
However, Sculpher continues, an increase in cost-effectiveness threshold means the costs of these drugs to the NHS rises. Pharmaceutical companies then “also fight tooth and nail” against a blanket cap on profits such as VPAS.

David Watson, director of patient access at the ABPI, comments: “The UK spends considerably less per person on medicines than other comparable countries, using a number of mechanisms to negotiate and control pricing, including the cost/benefit determinations overseen by NICE.

“While we would like to see reform of the NICE appraisal system, since the pandemic, it is the voluntary and statutory schemes [that] have spiralled out of control and risk costing the UK economy far more than they save through lost investment, jobs and tax revenue.”

Watson adds the ABPI is “urging the government to agree to an ambitious new deal with the industry that can reverse this decline and puts us on a par with our global competitors”.

In March 2023, the ABPI proposed a fixed levy of 6.9% on profits made from selling medicines to the NHS; however, this was dismissed as “completely unaffordable” by the DHSC.

Following a request for comment from The Pharmaceutical Journal, a spokesperson for the DHSC, said: “The VPAS improves taxpayer value for money, and provides investment in patient access to medicines and wider NHS services.”

Negotiations on a new voluntary scheme, to be led by chief negotiations adviser Hugh Taylor, are expected to conclude by autumn 2023.

Nevertheless, Baird warns that the need for an agreement on VPAS is becoming urgent.

“Decisions for 2024 to 2025 are being taken in global boardrooms now and we need more than rhetoric to know we are being heard. We are hoping for that before the summer because those decisions will be locked in from June and July,” she says.

“VPAS has propelled the UK into global board room conversations, but not for the right reasons. Given where we are, what would our reasons be for us deciding to place our trials in the UK?”

Community pharmacies spending twice as much time managing medicines shortages as last year
Pharmaceutical Journal, Corrine Burns, 13 April 2023

The 2023 ‘Pharmacy Pressures Survey‘ has found the majority (93%) of pharmacy owners in England say their staff are spending much longer on medicines procurement, and that patient health is being put at risk by supply shortages.

The survey, which received responses from more than 900 pharmacy owners and 2,000 pharmacy team members in England, found that pharmacy staff spent an average of 11 hours per week on medicines procurement, up from 5.3 hours in the 2022 survey.

Results of the survey, published by the Pharmaceutical Services Negotiating Committee (PSNC) on 13 April 2023, found that 92% of pharmacy teams were experiencing daily supply issues in 2023: up from 67% in the 2022 survey. Some 84% of pharmacy teams said they had experienced aggression from patients owing to these medicine supply issues.

Almost all respondents (97%) said they had seen significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued. Some 87% of pharmacy team members said that patient health is being put at risk owing to medicines supply issues.

Community pharmacies have repeatedly flagged medicines supply issues in recent months. In December 2022, the government agreed to 198 product price concessions — the highest ever reported in the UK. And data from the Office for National Statistics showed that, last year, the proportion of people struggling to buy the medicines they needed had doubled since the previous year.

As well as highlighting the extent of medicines supply issues, the survey found that 96% of pharmacy owners were facing significantly higher costs in 2023, up from 80% in the 2022 survey. 78% of pharmacy owners said they were extremely concerned about their business finances, and almost half (48%) said their pharmacies were operating understaffed owing to insufficient funding.

More than three-quarters (78%) of pharmacy staff said that their work was having a negative impact on their mental health and wellbeing, with 31% of these saying they were barely coping. Just 7% of respondents said their work had a positive impact on their mental health.

On 14 March 2023, the PSNC said that community pharmacies in England should be able to permanently reduce their core opening hours by 30% to help contractors manage “unrelenting financial and operational challenges”.

Janet Morrison, chief executive of the PSNC, said the survey “paints a devastating picture of staff under unbearable pressures, and businesses struggling to cope. Whilst we strongly suspected to uncover a stark situation, the results are still distressing”.

She added that the PSNC would be using the results in discussions ahead of the next community pharmacy contractual framework negotiations and in its discussions with parliamentarians.

“Funding is needed, without delay, to maintain patient access to the medicines and pharmacy services that they need,” Morrison said.

“PSNC has been pressing for a fully-funded national ‘Pharmacy First’ service to be included in the upcoming ‘Primary Care Recovery Plan’ as we strongly believe this is the best chance for getting significant additional funds into community pharmacies.”

Commenting on the survey results, a spokesperson for the Department of Health and Social Care said: “We know how frustrating medicine supply issues can be and have well-established processes in place to manage or mitigate them when they occur.

“Community pharmacies play a vital role in supporting the NHS. We back them with £2.6bn a year and are also rapidly increasing the numbers of GP appointments available.”

Dear member,

Please find below the GIRP Press Review for 09/12/22 – 15/12/22

Press Review 09.12.2022-15.12.22

Best,

The HDA Secretariat

 

Media Summary

UK watchdog investigates rise in antibiotics prices amid strep A outbreak
Andrew Gregory, The Guardian, 14 December 2022
 
The Guardian reports that the Competition and Markets Authority (CMA) said on Wednesday it had started an inquiry and is collecting evidence after antibiotics prices soared over the past few weeks.

A spokesperson for the CMA commented: “We are working to establish the facts of what is currently happening in the market and welcome new information as part of our work.”

“People have got real concerns about the price of antibiotics used to treat strep A, and we want companies to be clear about their obligations under the law. There should be no doubt that it is illegal for a dominant company to charge excessive prices, or for any companies to collude to drive up prices.” they added.

This was also reported in: Sky News Daily Mail , The Financial Times The ExpressThe Evening Standard Pharmacy BusinessP3 PharmacyCity AM, The Independent Pharmacist

DH bans wholesalers from exporting or ‘hoarding’ strep A antibiotics
The Chemist and Druggist, Eliza Loukou, 14 December 2022

The Chemist and Druggist reports that from the 14 December, wholesale dealer licence holders cannot “hoard” or export certain antibiotics – including amoxicillin and phenoxymethylpenicillin – from the UK.

The Department of Health and Social Care (DHSC) defined the “hoarding” of medicines as “when wholesale dealers withhold a medicine when it’s in short supply”.

The Healthcare Distribution Association (HDA) said soaring antibiotics prices “directly reflect the increase in prices” they are having to pay manufacturers.

Antibiotic supply gone from bad to worse, say pharmacists
BBC News, Philippa Roxby, 14 December 2022

BBC News reports on comments by pharmacists saying that supplies to treat strep A have “gone from bad to worse” in the past week.

Martin Sawer, Executive Director of the HDA, said one national wholesaler had told him that demand for the medicines had risen by 400-500% on last December.

“We are prioritising all the antibiotics amid huge demand for them, particularly liquid solutions,” he said.

Antibiotic supply and pricing issues: Steps taken this week
PSNC, Editorial Staff, 14 December 2022

The Pharmaceutical Services Negotiating Committee (PSNC) reports on recent developments in the  antibiotic supply and pricing.

The PSNC issues a warning to the Department of Health and Social Care (DHSC) about the serious impact the shortage of strep A antibiotics is having on pharmacies. The PSNC further reports on the HDA’s position on the availability of strep A treatments.

The HDA stated: “As regards to pricing, the prices charged to pharmacies by HDA wholesale distributors will directly reflect the increase in prices wholesalers are having to pay for these medicines from manufacturers at the moment, in order to be able to continue supplying these medicines to pharmacies. This will be the case until supply and demand are more in sync.”

NI government acknowledges ‘tireless’ work of pharmacies, wholesalers in antibiotic supply
Pharmacy Business, Swati Rana, 14 December 2022

Pharmacy Business reports that The Department of Health in Northern Ireland has acknowledged the efforts of community pharmacies, wholesalers, and procurement teams in securing supply of antibiotics for the treatment of strep A.

A spokesperson for the Department of Health in Northern Ireland  said: “While demand is well in excess of what is usual for this time of year, the system has been working hard to replenish stocks as quickly as possible, as such wholesalers are still receiving and making deliveries, with more scheduled over the coming days.”

The Chief Pharmaceutical Officer in Northern Ireland asked that pharmacy teams work with prescribers to understand local antibiotic availability and refrain from ordering excessive quantities to avoid putting the supply chain under additional pressure.

Parliamentary Coverage

There was no parliamentary coverage today

Full Coverage

UK watchdog investigates rise in antibiotics prices amid strep A outbreak
Andrew Gregory, The Guardian, 14 December 2022

A watchdog has launched an investigation into the sharp rise in prices of antibiotics after a surge in the number of children falling ill with strep A.

The Competition and Markets Authority (CMA) said on Wednesday it had started an inquiry and was gathering evidence after prices soared over the past fortnight.

Drug companies have been accused of increasing prices, with some pharmacists saying they are being charged up to £19 for a box of drugs that normally costs about £2.
Pharmacies say they are losing thousands of pounds a week because they can recoup only a fraction of what drugs truly cost from the NHS.

“We are working to establish the facts of what is currently happening in the market and welcome new information as part of our work,” the CMA said in a statement. “We stand ready to take action if there is evidence of anti-competitive behaviour that breaks the law.

“People have got real concerns about the price of antibiotics used to treat strep A, and we want companies to be clear about their obligations under the law. There should be no doubt that it is illegal for a dominant company to charge excessive prices, or for any companies to collude to drive up prices.”

Group A strep bacteria can cause many different infections, ranging from minor illnesses to deadly diseases. While the vast majority of infections are mild, sometimes the bacteria cause a life-threatening illness called invasive group A streptococcal disease.

At least 16 children across the UK have died from invasive strep A infection and there has been a huge jump in cases of scarlet fever.

The UK Health Security Agency has said there is no evidence that a new strain is circulating and the rise in cases is most likely due to high amounts of circulating bacteria and increased social mixing.

As well as the sudden price increases, pharmacies are also reporting struggling to get hold of antibiotics, with parents forced to go from pharmacy to pharmacy trying to find drugs for sick children.

The Association of Independent Multiple Pharmacies has said the problem is now getting worse and urged the government to take action.

Steve Barclay, the health secretary, said there was no shortage of antibiotics and stock could be moved around if areas were experiencing problems with supply.

However, on Monday the Department of Health and Social Care (DHSC), which Barclay oversees, issued a supply warning for antibiotics for the treatment of strep A.

“Supplies of antibiotics for the treatment of group A strep have seen a surge in demand and may be temporarily in limited supply at certain wholesalers and pharmacies,” the alert said. “Supplies are available with manufacturers, and deliveries into wholesalers and pharmacies are being expedited and are expected in the coming days.”

Reena Barai, of the National Pharmacy Association, said earlier this week that the medicines supply chain in the UK was “broken”.

A DHSC spokesperson said: “Manufacturers currently have supplies of antibiotics available to treat strep A.

“We continue to work urgently with manufacturers and wholesalers to expedite deliveries, bring forward stock they have to help ensure it gets to where it’s needed and boost supply to meet demand as quickly as possible and support access to these vital medicines.”

DH bans wholesalers from exporting or ‘hoarding’ strep A antibiotics
The Chemist and Druggist, Eliza Loukou, 14 December 2022

As of today (December 14), wholesale dealer licence holders cannot “hoard” or export certain antibiotics – including amoxicillin and phenoxymethylpenicillin – from the UK.

The DH added the medications to its regularly updated ‘list of medicines that cannot be exported from the UK or hoarded’, which it uses to identify products that “are needed for UK patients”.

It defined the “hoarding” of medicines as “when wholesale dealers withhold a medicine when it’s in short supply”.

The list also includes ceftazidime, cefuroxime, levofloxacin, linezolid, piperacillin + tazobactam and vancomycin.

Continued sourcing pressures

The Association in Independent Multiple pharmacies CEO Leyla Hannbeck suggested that the move contradicts the DH’s claims last week that there are no antibiotic supply issues.

The DH should have been “open with people from the beginning that there is a problem”, Dr Hannbeck told C+D.

However, the DH reiterated to C+D earlier this week that “there is no supplier shortage” of antibiotics used to treat strep A infections.

“We sometimes have surges for products and increased demand means some pharmacies are having difficulties obtaining certain antibiotics,” a spokesperson said.

This comes after pharmacists raised concerns over difficulties sourcing antibiotics, while England’s chief pharmaceutical officer David Webb warned pharmacy teams last week that they may face “a temporary interruption of supply” of “some relevant” antibiotics.

Dr Hannbeck also urged the DH to make sure its supply of antibiotics – “wherever they have” them – is delivered to pharmacies “as soon as possible, so that patients don’t have to go from one pharmacy to another pharmacy or wait long”.

Pharmacists are still facing difficulties getting hold of the products, she explained.
“[Stock is] very, very sporadic,” Dr Hannbeck added, with patients buying the antibiotics almost as soon they’re restocked in pharmacies.

RPS welcomes move following pharmacy “challenges”

Chair of the Royal Pharmaceutical Society (RPS) English pharmacy board Thorrun Govind welcomed the DH’s move to restrict the export of antibiotics, “given the challenges pharmacies in the UK are facing”.

The DH prohibits the export of a medicine if it determines that the drug is in short supply or at the “risk of being in shortage” and that its export might “contribute to a shortage or risk of shortage of that medicine in the UK”, its guidance explained.

Wholesalers found to be hoarding or exporting a medicine on the list could face regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA), which “could include immediate suspension of the wholesaler dealer licence”, it said.

Earlier this week, a DH spokesperson told C+D that “there is no supplier shortage” of antibiotics used to treat strep A infections.

“We sometimes have surges for products and increased demand means some pharmacies are having difficulties obtaining certain antibiotics,” they said.

Meanwhile, the Healthcare Distribution Association (HDA) said soaring antibiotics prices“directly reflect the increase in prices” they are having to pay manufacturers, following pharmacists’ complaints that they have been left out of pocket.

It previously stressed that “there is not a shortage” of antibiotics commonly used to treat invasive group A strep, but a “huge” surge in demand.

Antibiotic supply gone from bad to worse, say pharmacists
BBC News, Philippa Roxby, 14 December 2022

Pharmacists say supplies of key antibiotics to treat strep A have “gone from bad to worse” in the past week.

The Association of Independent Multiple Pharmacies (AIMP) said the situation was “unacceptable” and it was time for the government to get a plan in place.

Four antibiotics, which treat different conditions, have been added to a list of products that the UK cannot export.

The UK government says it is working urgently with manufacturers and wholesalers to speed up deliveries.
However, Leyla Hannbeck, chief executive of the AIMP, which represents 4,000 pharmacies in the UK, said the supply of antibiotics to treat bacterial infections including strep A and scarlet fever was “very poor”.

‘Too little too late’

She said the problem had been highlighted a week ago, but it was now getting worse, making it very difficult to get hold of any antibiotics.

“People are having to go from one pharmacy to another – it’s chaos,” she said.

“Supplies are not coming through to us and it feels like no-one cares.”

Dr Hannbeck said putting four antibiotics – three of which are go-to treatments for strep A – on the banned UK export list because of high demand was “too little too late”.

Amoxicillin, phenoxymethylpenicillin (penicillin V), azithromycin oral suspension and cefalexin are used to treat a large range of bacterial infections, including throat, chest and skin infections.

Her message to worried parents is that pharmacists are working very hard to find alternatives, and also changing formulations from solid pills to liquid medicines.
But even the alternatives are running short, Dr Hannbeck says.

A spokesperson from the Department of Health and Social Care said manufacturers currently have supplies of antibiotics to treat strep A and they are trying to get that stock to pharmacies.

“We continue to work urgently with manufacturers and wholesalers to expedite deliveries, bring forward stock they have to help ensure it gets to where it’s needed and boost supply to meet demand as quickly as possible, and support access to these vital medicines,” they said.

GPs have been advised to prescribe antibiotics for children who may have worsening symptoms linked to strep A, a bacterial infection which can lead to scarlet fever and, very rarely, a serious and fatal invasive infection called iGAS.

Antibiotic supply and pricing issues: Steps taken this week
PSNC, 14 December 2022

Following on from our update about antibiotic supply and pricing issues on Friday 9th December, we wanted to share some recent developments.

HDA statement

The Healthcare Distribution Association (HDA), whose member companies distribute over 90% of prescription medicines on behalf of the NHS, has issued a lengthy statement regarding the availability of Strep A treatments.

According to the HDA, the sudden spike in demand for antibiotics used for the treatment of Strep A has meant that there is not enough of these medicines in the supply chain currently to meet this increased demand. As a result, wholesalers are working extremely hard with manufacturers to increase the supply of antibiotics.
The HDA goes on to say:

“As regards pricing, the prices charged to pharmacies by HDA wholesale distributors will directly reflect the increase in prices wholesalers are having to pay for these medicines from manufacturers at the moment, in order to be able to continue supplying these medicines to pharmacies. This will be the case until supply and demand are more in sync.”

In their statement, the HDA has also requested that NHS England and the Department of Health and Social Care (DHSC) issue urgent communications requesting that all those involved in medicines supply do not hoard, stockpile or over-prescribe Strep A antibiotics.

Managing supply

To help ensure the continued supply of medicines to meet the needs of UK patients, DHSC has now added the following products to its list of medicines which must not be parallel exported from the UK:
·       Amoxicillin;
·       Cefalexin;
·       Phenoxymethylpenicillin (Penicillin V); and
·       Azithromycin oral suspension.

Hoarding or exporting a medicine on the list is considered a breach of regulation 43(2) of the Human Medicines Regulations 2012 and a contravention of the wholesale dealer licence and may lead to regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA), which could include immediate suspension of the wholesale dealer licence.

Antibiotic pricing

PSNC continues to hear from contractors who are paying inflated prices for antibiotics used for the treatment of Strep A and who are rightly concerned about the lack of certainty around the final reimbursement prices for these medicines.

With this in mind, we welcome the news being reported today that the Competition and Markets Authority (CMA) is investigating the price of antibiotics.

PSNC’s view

Whilst the above measures are steps in the right direction, PSNC continues to warn DHSC about the very serious impact the shortage of Strep A antibiotics is having on pharmacies and to press them to think broadly about what measures could help to manage the current crisis, such as allowing pharmacists more freedom to change strengths or formulations without prescriber approval (outside of Serious Shortage Protocols (SSPs)).

We have also been clear that more communications are needed to reassure patients and to protect pharmacy staff from the abuse that they are reporting.

The DHSC is considering our applications for price concessions this month and we are continuing to stress the urgency of this.

Pharmacy Business, Swati Rana, 14 December 2022

The Department of Health in Northern Ireland has acknowledged the efforts of community pharmacies, wholesalers and procurement teams in securing supply of antibiotics for the treatment of Group A Streptococcus(Group A Strep) infection in Northern Ireland.

“Locally community pharmacies, wholesalers and procurement teams have been working tirelessly to secure stock deliveries into Northern Ireland. The Department acknowledges the immense efforts from all involved,” it said.

“To put this in context, it is estimated that around one month’s worth of stock based on normal demand was exhausted in less than 48 hours last week.”

“While demand is well in excess of what is usual for this time of year, the system has been working hard to replenish stocks as quickly as possible, as such wholesalers are still receiving and making deliveries, with more scheduled over the coming days.”

The government department, which has lead responsibility for continuity of medicines supply on a UK-wide basis, is working closely with manufacturers and wholesalers to expedite resupply deliveries to secure continuity of supply.

It said: “The Chief Pharmaceutical Officer has updated pharmacy teams on the current situation and to ask that pharmacy teams work with prescribers to understand local antibiotic availability and refrain from ordering excessive quantities to avoid putting the supply chain under additional pressure.”

“The Chief Pharmaceutical Officer and Department of Health colleagues will continue to liaise closely with the Department of Health and Social Care with regard to the UK-wide supply chain, ensuring that Northern Ireland’s supply needs are fully understood.”

COVID-19 Update – 29 April 2020

 

HDA Statement regarding the availability of Public Health England-supplied PPE for community pharmacy

The Healthcare Distribution Association would like the community pharmacy sector to be aware that the stocks of Public Health England (PHE) PPE masks recently supplied by the Association’s member wholesalers to pharmacies, for staff use only, have now almost completely run out.  HDA member companies are awaiting a new sale event to be announced by Public Health England.

In the meantime, the Department of Health & Social Care has told HDA:

“We have extended our PPE supply route to Local Resilience Forums (LRFs) to help distribute stock to organisations outside of the NHS supply chain who have the highest need clinically and other services that would have a high priority need for PPE including Pharmacists.

Over 7 million more items of PPE have been delivered over the last week to the LRFs identified as being in the highest need of resupply. We will continue to make drops of PPE for distribution by the LRFs to meet some priority need until the new e-commerce solution is operational.

We will continue to make releases to wholesalers when stocks permit.

If providers are unable to access PPE through these routes and have an urgent need, they should contact the National Supply Disruption Response (NSDR) helpline to request emergency support. The 24/7 freephone number is 0800 915 9964.”

This statement about PHE-supplied PPE masks excludes the fact that individual HDA wholesalers may be able to obtain some supplies of appropriately certified PPE masks from their own sources.

Dear HDA Members,

On behalf of the Healthcare Distribution Association, we would like to thank all our members for your continuing dedicated efforts and hard work through these challenging and unprecedented times.  Now more than ever, your work is crucial to the health of millions of UK citizens up and down  the country, with hospitals, community pharmacies and dispensing doctors relying on wholesalers to provide vital medicines.  This critical role has been recognised across Government, and by others in the medicines supply chain.   You all have been classified as Key Workers in our joint fight against Covid-19; for this we say ‘Thank You’.

The safety of wholesaling and distribution colleagues is one of our top priorities.  With this aim, the HDA is working closely with the UK Government and our members, to ensure that distribution staff’s day-to-day work is as safe and secure as possible.  As always, our mission remains to maintain the efficiency of our supply chain and get medicines to those who need it the most at the right time.

The HDA is very proud of the work you are doing to support the country’s healthcare system at such a critical time.  We hope our members, and all respective families are keeping well.

Once again, on behalf of all at the Healthcare Distribution Association, we thank you.

Yours sincerely,

Martin Sawer, Executive Director and Jeremy Main, Chair

The Healthcare Distribution Association (HDA) has been working closely with its members and supply chain partners during the COVID-19 pandemic to help ensure patients continue to receive the right medicine, in the right place, at the right time.

The demand for medicines has increased dramatically, both from primary and secondary care, leading to a substantial uplift in the volumes of medicines flowing through the supply chain. Such increased volumes would place strains on healthcare distributors in more normal circumstances but has done so to an even greater extent in recent weeks, as some wholesaling staff have been self-isolating.

As an Association, we have been working with partners such as the Department for Health and Social Care; NHS England; NHS Improvement; the Medicines and Healthcare products Regulatory Agency; and pharmacy and pharmaceutical manufacturing trade bodies to identify and mitigate possible impediments to the safe and secure distribution of increased volumes of medicines.

Examples of such measures include:

  • Exceptional Good Distribution Practice (GDP) flexibilities from the MHRA that minimise business burden during the pandemic.
  • The recognition by Government of wholesaling staff as key workers; providing greater access to schooling and eventually COVID-19 antigen and antibody testing.
  • Formal government recognition of the crucial role being played by healthcare distributors in tackling the COVID-19 pandemic.
  • An NHS England Standard Operating Procedure for out of hours and weekend access to emergency orders from wholesalers for NHS Trusts.

The priority of the HDA remains the safe and secure distribution of medicines to primary and secondary care, which in itself is predicated on the safety of wholesaling staff. The Association will continue to work with all its supply chain partners during and after the COVID-19 pandemic to achieve these twin aims.

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

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