HDA Call to Action
Ensuring the Future: 8 Policies to Reset the Healthcare Distribution Sector
After extensive engagement with relevant stakeholders and our members, the Healthcare Distribution Association (HDA) the representative body for wholesale distributors of medicinal products, distributing 95% of all NHS medicines, has developed a call-to-action outlining steps the new Labour Government can take to support the efficient and effective distribution of medicines to patients in the UK. This call-to-action outlines some ‘quick fixes’ which can be implemented within the first 100 days of Government to support the industry as well as some longer term, more institutional changes which will foster longer lasting and more impactful change.
HDA and its member companies believe that the current medicines supply chain is fit for purpose, having withstood COVID-19 shocks, and provides great service and delivers excellent value for patients, healthcare professionals and the UK taxpayer on a daily basis. Every year HDA members deliver 2.1bn packs of medicines to healthcare professionals across the UK, delivering twice per day on average.
A key issue for the sector is that of medicine availability and HDA member companies already dedicate significant systems and resources, working with government, regulators and other supply chain actors to identify, prevent and mitigate such challenges, whether caused by supply disruption, demand increases, or a combination of factors.
The First 100 Days for Action
The HDA urges the new Labour Government to implement measures under five categories within the first 100 days of Government to alleviate some of the most pressing issues facing the medicines distribution sector. The industry faces significant challenges including growing financial issues in community pharmacy, workforce pressures, and a transition to net zero.
Addressing these issues within the first 100 days is essential for ensuring the healthcare distribution industry’s continued resilience, efficiency, and viability.
- Digital First Regulation – Ensure Parliamentary time to allow debate and endorsement of paperless invoicing throughout the medicines supply chain (by laying appropriate Statutory Instruments). This will create a safer, more efficient and environmentally sustainable record of transactions.
- A Strong Medicines Supply Chain – Greater financial support for the sector should be considered, including long-term, sustained and appropriate funding for community pharmacies. Incentives for global manufacturers to supply the UK are also critical in ensuring that our sector has enough medicines to distribute to an ever-increasing number of patients. NHS Hospitals should be mandated to pay for medicines in a timely manner.
- Accelerating The Transition to Net Zero – Re-evaluate regulatory requirements regarding the temperature control of ambient medicines during transportation, balancing patient safety with the imperative to reduce energy consumption.
- Immediate action to unlock Controlled Drug regulation – healthcare distributors are currently experiencing significant delays to the Controlled Drug licensing process, potentially putting the supply of critical treatments to patients at risk.
- Business Rates – Companies responsible for medicines distribution should be treated as a special case during any reforms of business rates and not conflated with other warehouse-based sectors, who do not provide life-saving treatments for high-street pharmacies, patients and the NHS. HDA members support the retail sector rather than compete with it.
Institutional Actions for Longer-Term Change
Alongside the above ‘quick fix’ actions, longer-term, more sustained change is essential to secure and maintain a robust and effective pharmaceutical supply chain. The measures outlined below list the actions that HDA believes the Government should consider in order to foster long lasting and impactful change within the industry.
- An Adaptive and Risk-Based Approach to Regulation – Regulators to place an enhanced focus on a risk-based approach to regulating the sector which is consistently compliant with regulations, including a greater focus on businesses and organisations with higher-risk operating models.
- Funding The Transition to Net Zero – Consider incentives and financial support for healthcare distributors, as they transition on behalf of the NHS, to practices and operations which enable the move to Net Zero, in particular the electrification of delivery fleets. More specifically, an intensive and frequent medicines distribution network, operating across the four countries of the UK, urgently requires robust electric vehicle charging infrastructure.
- Staffing and Workforce– Consider additional funding, incentives and support for regulation-mandated training to underpin the upskilling of medicines supply chain staff, to match rising demand and increase training-related requirements.
These immediate and sustained actions are crucial to revitalising the medicines distribution sector and ensuring that the UK retains its resilient, efficient, and sustainable healthcare system.
The Healthcare Distribution Association (HDA) represents businesses who supply medicines, medical devices and healthcare services to patients, pharmacies, hospitals, dispensing doctors, and the pharmaceutical industry.
HDA members operate across the four nations of the United Kingdom, enabling a safe, efficient and high-quality supply chain for the healthcare sector, delivering 95% of the NHS’s medicines.
As the trade body representing all leading companies that provide pharmaceutical wholesaling services across the UK, the HDA has always supported proportionate regulation to ensure the resilience of the UK’s healthcare supply sector while promoting innovation and adaptability.
Further Questions
If you have further questions about the HDA’s ‘Ensuring the Future: 8 Policies to Reset the Healthcare Distribution Sector’ please contact our Executive Director Martin Sawer, at msawer@hdauk.co.uk.
Media Contact
For all media inquiries, please contact secretariat@hdauk.co.uk
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 P3pharmacy, Dispensing 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 22/03/2024 – 28/03/2024
GIRP Press Review 22.03.2024 -28.03.2024
The HDA Secretariat
London, 25 October 2023: The HDA has signed a joint letter to Health Secretary Steve Barclay MP calling on the Department of Health and Social Care, the UK Health Security Agency and NHS England to begin planning the 2024/2025 winter vaccination programme as soon as possible in order to ensure that plans are well established ahead of the 2024/2024 flu season.
The letter was also signed by the Royal Pharmaceutical Society, vaccine manufacturer CSL Seqirus, NHS Confederation Primary Care Network, and the Dispensing Doctors’ Association.
Alastair Buxton, Director of NHS Services at Community Pharmacy England, said:
“Community pharmacy teams always plan their winter vaccination provision many months before the autumn. This year their efforts were hampered in August when NHS England moved the goalposts on the flu vaccination service start date, only to change its mind again a couple of weeks later. This was a shambolic start to the vaccination programme and caused unnecessary work and hassle for pharmacy owners and their teams. This sort of policy to-ing and fro-ing must not be repeated and we hope to begin constructive conversations with NHS and the Government very soon to help next year’s programme run more smoothly for all.”
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.
A 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.”
