HDA UK Media and Political Bulletin – 30 September 2021

Media Coverage

Fuel shortage raises concerns over continuance of health services, medicine deliveries

Pharmacy Business, Shilpa Sharma, 29 September 2021

Pharmacy Business reports that due to the shortage of fuel supply, concerns have been raised about the continuation of health-related services and medicine deliveries across the UK.

The National Pharmacy Association (NPA) has requested the Petrol Retailers Association (PRA) to ensure fuel access for critical health care workers, including community pharmacy staff. The NPA highlighted that this is necessary to maintain the supply of medicines to NHS patients, to housebound patients and workplaces.

The Pharmacists’ Defence Association has also written to the Prime Minister, to highlight the need for fuel supply to be prioritised for pharmacists.

The letter states that “We are therefore calling on you as Prime Minister to ensure that the government prioritises fuel provision for healthcare workers to include pharmacists, and for those delivering supplies of medicines and clinical equipment.”

The HDA is also engaged in talks with the government on the fuel supply issue, noting that members are experiencing challenges in accessing fuel and that some normal delivery schedules for medicines would be disrupted for most of this week.

The PRA says that there are early signs of the pressure easing, and the government is preparing 150 military tanker drivers to deliver fuel with another 150 personnel on standby.

 

NHSE extends COVID home delivery service

Dispensing Doctor’s Association, Ailsa Colquhoun, 30 September 2021

The Dispensing Doctor’s Association reports that the NHS has extended the COVID medicines delivery service in England to people who have been notified of the need to self-isolate, until 31 March 2022.

The service is available to people during their 10-day isolation period if they are not able to get medicines picked up on their behalf.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Fuel shortage raises concerns over continuance of health services, medicine deliveries

Pharmacy Business, Shilpa Sharma, 29 September 2021

As the country struggles to match fuel supply with demand, serious concerns have been raised about the continuation of health-related services and medicine deliveries across the UK.

In anticipation of disruption to healthcare services amid reports of fuel shortages, dearth of HGV drivers and impact of Covid-19, the National Pharmacy Association (NPA) has requested the Petrol Retailers Association (PRA) to ensure fuel access for critical health care workers including all community pharmacy staff.

“We want their members (forecourt operators) to recognise community pharmacists and their teams as a critical part of the health care workforce,” NPA said.

Besides supplying essential medicines, pharmacies now also provide a range of critical NHS services such as vaccinations for Covid and flu, it pointed out.

The association highlighted that pharmacy staff needs fuel to maintain the supply of medicines to NHS patients, to deliver vital medicines to housebound patients and to reach workplaces.

Following concerns expressed by members, the Pharmacists’ Defence Association has also written to the prime minister Boris Johnson, asking him to ensure that fuel supply is prioritised for pharmacists.

In a letter addressed to the prime minister, PDA highlighted pharmacists’ concerns about the consequences of current fuel panic buying and asked him to ensure they, their teams and supplies of medicine reach the pharmacy.

The letter stated: “We are therefore calling on you as prime minister to ensure that the government prioritises fuel provision for healthcare workers to include pharmacists, and for those delivering supplies of medicines and clinical equipment.”

Separately, the Healthcare Distribution Association (HDA) is also engaged in urgent talks with the government on the fuel supply issue.

It noted in a statement that its member companies are experiencing challenges in accessing fuel like many other critical sectors across the UK.

The association said some normal delivery schedules for medicines could be disrupted for most of this week due to fuel supply shortage.

Meanwhile, the PRA, which represents nearly 5,500 of the UK’s 8,000 filling stations, has said there are “early signs” the pressure is starting to ease at the pumps.

After a fourth day of long queues and pump closures in the UK, the government is now preparing about 150 military tanker drivers to deliver fuel and has kept another 150 personnel on standby to support them.

 

NHSE extends COVID home delivery service

Dispensing Doctor’s Association, Ailsa Colquhoun, 30 September 2021

NHS England has extended the COVID medicines delivery service in England to people who have been notified of the need to self-isolate by NHS Test and Trace. The service will be extended from 1 October 2021 to 31 March 2022 (inclusive).

This service is only available to people during their 10-day self-isolation period and where they are unable to arrange for medicines to be picked up on their behalf. Service users should provide their NHS Test and Trace Account ID.

Payment for dispensing doctors is via a form which must be submitted by the fifth of the following month.

Payment for the mandatory element of the Pandemic Delivery Service will be made automatically.

Read the NHSE letter.  

Media Coverage

Fuel shortages: Medicines wholesalers ‘severely tested’
Pharmacy Magazine, 27 September 2021

Pharmacy Magazine reports that according to the Healthcare Distribution Association (HDA), the UK’s medicines supply chain is being “severely tested” by fuel shortages.

HDA Executive Director Martin Sawer said that while wholesalers have business continuity plans to maintain medicine deliveries “these arrangements are currently being severely tested, as fuel supplies are not as available as we would like from normal sources”.

Additionally, “HDA knows that some normal delivery schedules for medicines could be disrupted for most of this week, but every effort will be made to fulfil orders. HDA members are grateful for the patience and understanding being displayed by their customers.”

The article highlights that according to Mr Sawer, transport fleets should be given priority access to fuel “principally at petrol stations” to maintain an effective supply chain. He added that HDA “is in urgent talks with the UK Government on this specific issue” and another “critical” issue is maintaining regular deliveries of medicines to wholesaler warehouses.

Royal Pharmaceutical Society President Claire Anderson said: “As normal, pharmacists are working with patients to ensure they get the medicines they need. We’re not aware that the problems with fuel supplies are stopping patients getting their medicines.”

A spokesperson for AAH said it was not experiencing any issues with medicines supply as AAH does not rely on forecourts to supply fuel for its medicines distribution system.

Northern Ireland could face medicine shortages after Brexit grace period ends next year, report claims
iNews, David Parsley, 27 September 2021

iNews reports that a leading pharmaceutical research firm has revealed that some drug firms will withdraw up to 90% of their products from Northern Ireland as protocol hits exports.

Informa Pharma Intelligence said that the withdrawals are due to the uncertain and high-cost imposition of new quality-check procedures as the Brexit grace period ends. The extra costs of implementing new regulatory procedures for batch testing drugs could threatens the ability of UK manufacturers to export low-cost generic drugs to Northern Ireland.

The firm suggested that statins and diabetes drugs are among the medicines threatened with shortages in Northern Ireland at the beginning of next year. The firm’s report suggested that the concern among drug manufacturers was due to the lack of a clear political solution, putting pressure on policymakers ahead of the deadline on 1st January 2022.

In line with the Northern Ireland Protocol, from 2022 companies that want to export from Great Britain to Northern Ireland will have to establish specific batch control and release facilities in Northern Ireland that meet EU standards.

The Government asserted that its indefinite extension of the Brexit grace period earlier this month includes the import of medicines into Northern Ireland. A spokesman for the Department of Health and Social Care (DHSC) said: “Under the standstill all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines.”

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

Fuel shortages: Medicines wholesalers ‘severely tested’
Pharmacy Magazine, 27 September 2021

The UK’s medicines supply chain is being “severely tested” by fuel shortages according to a trade body representing drugs distributors.

The UK has faced an acute shortage of goods drivers for some time, with fuel supply issues – which may be driven to some extent by consumer panic – also receiving widespread coverage in recent days.

Concerns have been raised around how the UK’s medicines supply chain may be affected, with the National Pharmacy Association’s Gareth Jones commenting that “deliveries to some pharmacies have been reduced” with NPA members “working hard to ensure the impact on patients’ access to treatment is currently limited”.

Royal Pharmaceutical Society president Claire Anderson said: “As normal, pharmacists are working with patients to ensure they get the medicines they need. We’re not aware that the problems with fuel supplies are stopping patients getting their medicines.”

Commenting on the present difficulties, Healthcare Distribution Association chief executive Martin Sawer said that while wholesalers have business continuity plans to maintain medicine deliveries “these arrangements are currently being severely tested, as fuel supplies are not as available as we would like from normal sources”.

“HDA knows that some normal delivery schedules for medicines could be disrupted for most of this week, but every effort will be made to fulfil orders. HDA members are grateful for the patience and understanding being displayed by their customers.”

Mr Sawer said that to maintain an effective supply chain distributors’ transport fleets should be given priority access to fuel “principally at petrol stations”, adding that the HDA “is in urgent talks with the UK Government on this specific issue”.

Another “critical” issue is maintaining regular deliveries of medicines to wholesaler warehouses, Mr Sawer said.

AAH ‘not facing any issues’

Despite Mr Sawer’s warning a spokesperson for AAH told Pharmacy Network News it was not experiencing any difficulties: “AAH does not rely on forecourts to supply fuel for our medicines distribution system, so we are unaffected by current consumer buying patterns.

“In line with the current national picture for most logistics organisations, we do face challenges with driver recruitment. However, AAH is not currently facing any issues with medicines supply to our customers.”

Alliance: Fuel supply a ‘challenge’

Meanwhile, Alliance Healthcare told PNN it was “striving for business-as-usual service,” saying that despite driver shortages “we are seeing success from our continued recruitment drive”.

“The national fuel supply challenge, along with continued driver shortages, is a current challenge within the UK and we are working with all stakeholders on various initiatives to mitigate any potential impact to our normal operating schedule,” an Alliance spokesperson said.

“We continue to inform our customers proactively on this on-going situation and thank them for their patience and understanding at this time.”

Phoenix Healthcare Distribution did not respond to requests for comment.

Northern Ireland could face medicine shortages after Brexit grace period ends next year, report claims
INews, David Parsley, 27 September 2021

Leading pharmaceutical research firm finds some drug firms will withdraw up to 90 per cent of their products from Northern Ireland as protocol hits exports

Statins and diabetes drugs are among the medicines threatened with shortages in Northern Ireland at the beginning of next year, a leading medical research group has claimed.

Informa Pharma Intelligence warns some pharmaceutical companies may withdraw up to 90 per cent of their products from the Northern Ireland market due to the uncertain and high-cost imposition of new quality-check procedures as the Brexit grace period ends.

The analysis focuses on the uncertain regulatory position of Northern Ireland, which is governed by the protocol that binds it to European Union single market practices and regulations, yet is still part of the UK.

The report highlights that the additional costs of implementing new regulatory procedures after the end of the grace period for batch testing drugs, which ends at the start of 2022, could threaten the ability of manufacturers of low-cost generic drugs to export to Northern Ireland from within the UK.

It presents a stark warning for policymakers ahead of the 1 January deadline. Much of the concern among drug manufacturers was due to the lack of a clear political solution, the report says.

While the EU has signalled its solution, Informa believes the UK is unlikely to accept any resolution that ties its Medicines and Healthcare products Regulatory Agency (MHRA) too closely to the European Medicines Agency (EMA).

Shortages of critical drugs to treat conditions ranging from high blood pressure to cancer would be an additional consequence for Northern Ireland, which has already suffered from food shortages and empty supermarket shelves since the UK left the EU at the beginning of last year.

Ian Schofield, executive editor of Pharma Insights at Informa, said: “The Brexit vote, and the UK’s stance on leaving the single market, forced a separation between the UK’s MHRA and the EMA.

“Whilst the separation itself is a lengthy process that requires a re-evaluation of each detail of the UK’s drug approval processes, the impact of the Northern Ireland protocol remains an ongoing area of tension with potentially significant impacts on the availability of generic drugs to Northern Irish citizens.

“Worryingly, an easy solution to this is not forthcoming even with the deadline fast approaching.”

The EU granted the UK a grace period at the end of the Brexit transition whereby the current regulations for quality-checking medicines in Great Britain before release to the Northern Ireland market remain in place and batch release can be authorised by UK agencies.

The grace period has been unilaterally extended for an indefinite period – but this does not apply to the pharmaceutical drugs market, according to Informa.

From 2022 companies that want to export from Great Britain to Northern Ireland will have to establish specific batch control and release facilities in Northern Ireland that meet EU standards.

This is to ensure adherence to the Northern Ireland Protocol and to assure the EU that any drugs that are placed on the Northern Ireland market follow the same regulatory processes that are in place across the EU single market.

Mr Schofield added: “Adherence to these rules is likely to be expensive, particularly for generics companies with high-volume, low turnover products, as they will need to foot the cost of compliance.

“Some companies say they may have to withdraw up to 90 per cent of their medicines from the Northern Ireland market as EMA standards add an extra quality control burden and cost.

“This could threaten the access of these companies to the Northern Ireland market, and more importantly the ability of Northern Irish citizens to purchase generic drugs.”

The Government claimed its indefinite extension of the Brexit grace period earlier this month would cover the import of medicine into Northern Ireland.

A spokesman for the Department of Health and Social Care said: “Under the standstill all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines.

“Though there are different original end dates for the grace periods, the extension applies to all of them.”

However, Mr Schofield disagrees with the Government’s interpretation of the extended grace period.

He said: “This is a different grace period relating to the imposition of customs checks on trade in agrifood products. They were supposed to take effect earlier this year but their introduction was deferred in March and then again in June.

“The grace period for pharmaceutical batch testing and release is a separate issue.”

Simon Sutcliffe, a customs expert at tax and advisory firm Blick Rothenberg also said the Government’s claim that the grace period extension covered pharmaceutical drugs was wrong.

He added: “It is a separate issue, as although pharma is indeed part of the Northern Ireland Protocol and is part of the Command Paper extension attempt from Lord Frost – in which he tried to include pharma – there has been no real response from the EU on the issue.

“Pharma is part of a separate legislative framework for approving and licensing medicines that it seems could only be extended if pharma was removed from the Protocol – and that is why it seems a grace period cannot cover it as it does with customs controls on other items.

“The whole grace period extension does not cover pharma, and because at the moment Northern Ireland health is under the care of Great Britain for most of its medicine approvals and supply, that will and must change.

“Medicines are already being notified for withdrawal from Northern Ireland because six months month notice is required to withdraw them.”

Informa is an independent medical market insights company that works in over 175 countries and with 20,000 pharmaceutical companies that manage more than 348,000 clinical trials for over 1,400 diseases.

Media Coverage

UK pharmacies in dark about ministers’ plan to maintain drug supplies
The Guardian, Ben Quinn, 26 September 2021

The Guardian reports that UK pharmacists are waiting for government information on what measures are in place to tackle the delays to drug supply deliveries as a result of van driver shortages.

Some pharmacists have suggested that a “serious shortage protocol” would be used if the situation continues. This would allow pharmacists to supply alternate forms and strengths of medicines without the need to contact the prescriber. The government initiated this as a solution to hard Brexit concerns and supply problems.

The National Pharmacists Association (NPA) said that it was aware that deliveries to some pharmacies had been reduced and that its members worked together and with local GPs to get medicines that were needed when problems occurred.

A spokesperson for the NPA said: “A resilient medicines supply chain is obviously vital to the health of the nation, so it’s important this isn’t allowed to escalate into a widespread problem that impacts patient care.”

Leyla Hannbeck, Chief Executive Officer of the Association of Independent Multiple Pharmacies, raised concerns about what measures were in place to ensure that supply lines were not disrupted. She said: “We do everything we can to make sure that we are prepared for any eventuality so that people are not left without medicines.”

This weekend pharmacies were quoted saying that some orders were either arriving late or not at all, though customers were still being served. Pharmacists who travel to do home visits are affected by the fuel shortages caused by the supply chain crisis.

This was also reported by LBC and The Express.

Patients face delays on prescriptions as van driver shortage hits pharmacies
The Telegraph, Daniel Capurro, 25 September 2021

The Telegraph reports that patients are experiencing delays to their prescriptions and shortages of over-the-counter drugs because of a lack of van drivers. Pharmacists expect that this will get worse as demand rises over the winter with an increase in demand for medications owing to more widespread respiratory illnesses such as common colds and flu.

Pharmacies have reported that orders are either arriving late or not at all, without any warning and that at least one major supplier of medications had to suspend deliveries for a week because of distribution problems.

The article suggests that the shortage of van drivers is a result of the wider scarcity of labour in the economy, and of drivers having to self-isolate because of Covid-19 and a recent change in the rules on freelancing.

A National Pharmacy Association (NPA) spokesman said: “We are aware that deliveries to some pharmacies have been reduced, but this is not generally affecting patients’ access to treatment at this stage. Whenever supply problems occur, pharmacists work together, with each other and local GPs, to get people the medicines they need, when and where they need them.”

Additionally, the disruption has affected supplies of over-the-counter medications, one supplier has suspended delivery of all over-the-counter medicines for several weeks.

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

UK pharmacies in dark about ministers’ plan to maintain drug supplies
The Guardian, Ben Quinn, 26 September 2021

Pharmacists are waiting for details from the government about what measures are in place to deal with any delays to deliveries of drug supplies as a result of van driver shortages.

If the situation worsens, pharmacists have suggested that one fall-back could involve the use of a “serious shortage protocol”, which the government had originally prepared, against the backdrop of hard Brexit concerns, to cater for drugs with known supply problems. This would enable pharmacists to supply alternate forms and strengths of medicines without the need to contact the prescriber.

The National Pharmacists Association (NPA) said on Sunday that it was aware that deliveries to some pharmacies had been reduced and that its members worked together and with local GPs to get medicines that were needed when problems occurred.

“A resilient medicines supply chain is obviously vital to the health of the nation, so it’s important this isn’t allowed to escalate into a widespread problem that impacts patient care,” added the spokesperson for the NPA, which acts as the trade association for independent community pharmacy professionals in the UK.

Leyla Hannbeck, chief executive officer of the Association of Independent Multiple Pharmacies, told the Guardian that she had raised the question of what measures were in place to ensure that supply lines were not disrupted. “It was a question I asked at a round table with government representatives, so hopefully we will get some reassurance,” said Hannbeck, whose association represents more than 2,000 independent pharmacies around the UK.

“We do everything we can to make sure that we are prepared for any eventuality so that people are not left without medicines.”

Pharmacists are eager to ensure that the panic buying seen at the outset of the pandemic last year does not happen again, especially at a time when Covid-19 booster vaccinations and flu jabs are being administered.

Pharmacies that spoke to the Sunday Telegraph were quoted as saying that some orders were either arriving late or not at all, though customers were still being catered for. However, pharmacists who do home visits are among the healthcare staff who are experiencing problems as a result of fuel shortages caused by the supply chain crisis.

“At the moment I have about a quarter tank of petrol left and it is a concern,” said Claude Pereira, a pharmacist in London who carries out essential blood testing for people who are at risk of blood clotting.

While ambulance fleets will, in theory, have stocks of fuel, Pereira pointed out that the crisis was having an impact on workers such as pharmacists upon whom some housebound members of the public rely.

“We rely on our cars to get us to those places, and if we can’t use them, then it’s an issue. I went out at 5.30 [on Sunday morning] and went around a number of petrol stations in an attempt to get fuel, but I couldn’t. I’m crossing my fingers that things will calm down in the coming days.”

The NHS, Department of Health and Department for Business, Energy and Industrial Strategy have been approached for comment.

Patients face delays on prescriptions as van driver shortage hits pharmacies
The Telegraph, Daniel Capurro, 25 September 2021

Patients are facing delays to their prescriptions and shortages of over-the-counter drugs because of a lack of van drivers, and the problem is expected to get worse as winter drives up demand, pharmacists have warned.

Multiple pharmacies have told The Telegraph that orders are either arriving late or not at all, without any warning and that at least one major supplier of medications had to suspend deliveries for a week because of distribution problems.

The shortage of van drivers is being caused by a combination of factors, including the wider scarcity of labour in the economy, drivers having to self-isolate because of Covid-19 and a recent change in the rules on freelancing.

Martin Hewitson runs an independent pharmacy in Dorset and is a former board member of the National Pharmacy Association (NPA). He told The Telegraph: “It’s not happening every day, but once, twice, three times a week we’re having disruption to wholesale deliveries. Medicines which we were expecting end up not arriving, often with no explanation.”

Negative impact of winter

Winter is expected to worsen the problem, with pharmacists warning that the colder months usually bring an increase in demand for medications owing to more widespread respiratory illnesses such as common colds and flu.

An NPA spokesman told The Telegraph: “We are aware that deliveries to some pharmacies have been reduced, but this is not generally affecting patients’ access to treatment at this stage. Whenever supply problems occur, pharmacists work together, with each other and local GPs, to get people the medicines they need, when and where they need them.”

Steve Anderson, the UK mnaging director of Phoenix Medical, one of the UK’s big three suppliers, admitted there was disruption to deliveries, but said the problem was affecting the whole sector and was part of wider disruption to the UK economy.

‘The whole thing is a shambles’

Pharmacies rarely hold large stocks of drugs, with thousands of different possible medicines needing to be ordered and customers often requiring a variety of dosages and formulations.

“Pharmacies are a classic just-in-time supply chain,” said Mr Hewitson. “There’s never huge amounts of surplus stock in the supply chain”.

Dimple Bhatia, who runs the Tollesbury pharmacy in rural east Essex, said the disruption was hitting patients and costing pharmacies money.

He said: “We don’t know if we’re getting stock or not. We’ve got urgent medicines to give to patients so we reorder it and then we get two lots in, with one turning up three days late. It’s an admin burden having to return it and if we return too much we get penalised. The whole thing is a shambles, really.”

Impact of remote GP appointments

Pharmacists said they weren’t turning patients away but we’re instead having to phone around other local pharmacies asking if they could help or asking GPs to write alternative prescriptions.

“It can damage our reputation because people don’t understand the bigger picture,” said Mr Bhatia.

Pharmacies were already under intense pressure, having taken on extra burdens due to the pandemic. Mr Bhatia added: “We’re providing flu jabs, distributing lateral flow tests, we’ll be starting Covid booster shots next month and we’re providing advice because GP surgeries still haven’t got their doors open and so people are turning to their pharmacies for everything.”

Customers in tears due to medicine shortage

Mr Hewitson told The Telegraph: “It’s worrying [patients], if nothing else. I’ve had a woman in tears this morning who couldn’t get her medicine from her regular pharmacy. We were able to help her out.”

The disruption has also affected supplies of over-the-counter medications, with one supplier said to have suspended delivery of all over-the-counter medicines for several weeks.

One reason for the shortage of drivers is the generally tight labour market, with workers less willing to put up with long hours and low pay. This has been exacerbated by remaining drivers being asked to work longer and more frequent shifts.

Another factor is thought to be recent changes to IR35 freelancing rules. The Government has taken action on companies treating full-time employees as freelancers. However, this has forced some drivers who want to retain their freelance status to work for multiple companies at once, leaving individual businesses without guaranteed service.

Asked about the lack of van drivers, a spokesman from the Unite union told The Telegraph: “The casualisation of van driving work, with drivers being forced to be either bogusly self-employed or self-employed, coupled with long hours and poor rates of pay is leading to van drivers leaving the sector.”

Media Coverage

Cabinet reshuffle: DH confirms Maria Caulfield as new pharmacy minister
Chemist and Druggist, Valeria Fiore, 23 September 2021

The Chemist and Druggist reports that Maria Caulfield has been appointed the minister with responsibility for patient safety and primary care, including pharmacy as Maggie Throup’s brief changes to cover vaccines and public health.

Ms Caulfield was previously a nurse and is the MP for Lewes, East Sussex..

Pharmaceutical Services Negotiating Committee outgoing CEO Simon Dukes congratulated the minister and welcomed her to her role.

He said: “We look forward to meeting with her at the earliest opportunity and to continuing to work collaboratively with both her and the DH to ensure that community pharmacies can contribute to the government’s health ambitions.

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

Cabinet reshuffle: DH confirms Maria Caulfield as new pharmacy minister
Chemist and Druggist, Valeria Fiore, 23 September 2021

Maria Caulfield has been appointed the minister with responsibility for patient safety and primary care, as Maggie Throup’s brief changes to cover vaccines and public health.

Ms Throup was appointed parliamentary under-secretary of state at the Department of Health and Social Care (DH) last week (September 16), with responsibility for prevention, public health and primary care.

However, the DH told C+D last week that, as the cabinet reshuffle was still ongoing, ministers’ responsibilities and job titles could change.

As of today (September 23), Ms Caulfield is now the health minister responsible for patient safety and primary care, which includes pharmacy, a DH spokesperson confirmed to C+D.

C+D understands that, excluding further reshuffles, Ms Caufield’s brief is unlikely to change soon.

Her role will include overseeing the following policy areas:

primary care
community health
major diseases, rare diseases and long-COVID
patient safety
maternity care
inquiries
patient experience
cosmetic regulation
gender identify services
blood transplants and organ donation
fertility and embryology.

An NHS nurse by background, Ms Caulfield is the MP for Lewes, East Sussex – a position she has held since May 2015.

She was previously assistant government whip, starting that position in 2019, and was vice-chair of the Conservative Party in 2018. She also served on the women and equalities committee from July 2015 to May 2017.

Views on pharmacy

Ms Caulfield was among 305 MPs who voted in favour of the pharmacy funding cuts in England in 2016. Only one Conservative MP voted against the cuts.

Speaking during the parliamentary debate on cutting the budget for community pharmacies in 2016, Ms Caulfield said she believed that the “money that is saved through these changes must go to community pharmacies and away from big business”.

She said she feared “that the role of the pharmacist is not properly understood”.

“As a practising nurse, I see at first hand every day the role that pharmacists play in safeguarding patients. Doctors often make out prescriptions that are wrong or do not take into account current medications a patient is on. That is where the pharmacist comes in. Thinking that pharmacists simply stand at a counter, pick a box off a shelf and put a sticker on it is misguided; they do a huge amount more,” Ms Caulfield said at the time.

Support for pharmacists’ skills

Last year, Ms Caulfield showed her support for the Community Pharmacist Consultation Service (CPCS) on her website.

In January – a few months after the CPCS was launched on October 29, 2019 – Ms Caulfield said in a statement on her website that “the role of pharmacists is an important part of the NHS long-term plan”.

“Pharmacists are highly skilled health professionals who have five years of training, giving them expert knowledge on how to use medicines to support patients,” she said.

Pharmaceutical Services Negotiating Committee outgoing CEO Simon Dukes congratulated the minister and welcomed her to her role.

“We look forward to meeting with her at the earliest opportunity and to continuing to work collaboratively with both her and the DH to ensure that community pharmacies can contribute to the government’s health ambitions.

“There is much that pharmacy can – and is – doing to support the pandemic recovery and we will ensure that Ms Caulfield is fully briefed on both the challenges ahead for community pharmacies and the vital and valuable roles they play in their local communities.”

Media Coverage

Government pledges to reduce overprescribing of medicines in healthcare centres
Pharmacy Business, Shilpa Sharma, 22 September 2021

Pharmacy Business reports that the UK Government has announced that it will take measures to limit overprescribing of medicines in primary healthcare centres.

This decision follows a government-commissioned review led by Dr Keith Ridge, Chief Pharmaceutical Officer for England. The review revealed that 10% of the volume of prescription items dispensed through primary care are either unsuitable for that patients’ circumstances or could be better served with alternative treatments.

Additionally, it found that around 6.5% of total hospital admissions are caused by the adverse effects of medicines and a higher consumption of medicines increases the chances of harmful side effects.

Dr Ridge said: “Medicines do people a lot of good and the practical measures set out in this report will help clinicians ensure people are getting the right type and amount of medication, which is better for patients and also benefits taxpayers, by preventing unnecessary spending on prescriptions.”

The article highlights that the report provides six key recommendations, including the introduction of a new national clinical director for prescribing to lead a 3-year programme, covering research and training for effective prescribing.

The report suggested system-wide changes to improve patient records and training for general practices (GPs) to improve prescribing processes. Furthermore, the report recommended waste reduction in healthcare to help deliver NHS’s net zero carbon emissions.

The Government has accepted all recommendations and reforms to pharmacist training.

Health Secretary Sajid Javid said: “With 15 per cent of people taking 5 or more medicines a day, in some cases to deal with the side effects of another medicine, more needs to be done to listen to patients and help clinical teams tackle overprescribing.”

Royal Pharmaceutical Society England Chair Thorrun Govind suggested the review would “ensure more effective use of medicines.”

Dr Leyla Hannbeck, Chief Executive at Association of Independent Multiple Pharmacies (AIMp), said: “Community pharmacy should be centre stage to these reforms. Any changes are likely to impact on the sector and concentrate disproportionately on cost and will thus have a complex and uneven impact on the network. It is therefore crucial that the sector is engaged with in this journey and be a key influencer in driving the patients’ and public’s expectations.”

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

Government pledges to reduce overprescribing of medicines in healthcare centres
Pharmacy Business, Shilpa Sharma, 22 September 2021

The UK government has decided to take action against unnecessary and overprescribing of medicines in primary healthcare centres.

The decision follows a government-commissioned review led by Dr Keith Ridge, the chief pharmaceutical officer for England.

The review found that 10 per cent of the volume of prescription items dispensed through primary care are either inappropriate for that patients’ circumstances, or could be better served with alternative treatments.

Around 6.5 per cent of total hospital admissions are caused by the adverse effects of medicines, it said.

The study added that higher consumption of medicines increases the chances of harmful side effects. Even a blood pressure controlling medicine can increase the risk of falls amongst the frail and elderly.

It described overprescribing as a situation where potential harm outweighs the benefit of the medication. It can happen when a better alternative is available but not prescribed.

Dr Ridge said: “Medicines do people a lot of good and the practical measures set out in this report will help clinicians ensure people are getting the right type and amount of medication, which is better for patients and also benefits taxpayers, by preventing unnecessary spending on prescriptions.”

The report has given six key recommendations, including introduction of a new national clinical director for prescribing to lead a 3-year programme, covering research and training for effective prescribing.

It further suggested system-wide changes to improve patient records and training for general practices (GPs) to improve prescribing processes.

It recommended safe withdrawal of inappropriate medication, and called for cultural changes to reduce a reliance on medicines and support for shared decision-making between clinicians and patients.

The report also insisted on waste reduction in healthcare to help deliver NHS’s net zero carbon emissions.

The government has accepted all recommendations and reforms to pharmacist training is already underway.

Calling it a significant step towards benefiting patients, health minister Syed Kamall said: “Whether it’s helping to change a culture of demand for medicines that are not needed, providing better alternatives and preventing ill-health in the first place, we will take a range of steps to act on this review.”

“This is an incredibly important review which will have a lasting impact on people’s lives and improve the way medicines are prescribed,” said health secretary Sajid Javid.

“With 15 per cent of people taking 5 or more medicines a day, in some cases to deal with the side effects of another medicine, more needs to be done to listen to patients and help clinical teams tackle overprescribing,” he added.

Pharmacy reaction

Royal Pharmaceutical Society England chair Thorrun Govind lauded the review saying it will “ensure more effective use of medicines.”

“For too long the healthcare system has focused on the positive effects of adding medicines to a prescription, rather than acknowledging that this can also increase the risk of side effects and interactions between medicines, leading to poor health and costly unnecessary admissions to hospital.

“We need to focus on putting shared decision making between the prescriber and patient at the heart of prescribing, and look at the individual needs and circumstances of each person.”

She added the report not only explores several issues that pharmacists have been highlighting, but also gives a range of solutions to them.

“Pharmacists across the country will be eager to play an active role, working alongside the patients and communities they serve, to reduce the harm that medicines can cause when over prescribed.”

RPS representative on the report’s working group, Lelly Oboh FRPharmS, said it is important to consider a person’s social, physical and mental health needs while prescribing medicines.

She added: “This report will change how we start, stop, monitor and review people’s medicines, with a greater emphasis on having person-centred conversations”.

Association of Independent Multiple Pharmacies (AIMp) has also welcomed the report, but highlighted some complexities in the suggested solutions.

Dr Leyla Hannbeck, chief executive at AIMp, said: “Community pharmacy should be centre stage to these reforms. Any changes are likely to impact on the sector and concentrate disproportionately on cost and will thus have a complex and uneven impact on the network. It is therefore crucial that the sector is engaged with in this journey and be a key influencer in driving the patients’ and public’s expectations.”

She added: “Education, social responsibility, personal accountability and sweeping national cultural changes are necessary.”

Welcoming the report, Nick Kaye, vice chair at the National Pharmacy Association, highlighted the role that pharmacists can play to tackle the overprescribing of medication.

He said: “Community pharmacists could play an increasingly important role in ensuring effective prescribing, for example through Structured Medication Reviews and as independent prescribers. That will improve patients’ access to advice and deploy the expertise of pharmacists to good effect.

“On the flip side of overprescribing is the matter of helping patients get the most from their medicines once dispensed, which is the bread and butter of community pharmacy.  New services like the Discharge Medicines Service and the extended New Medicine Service build on this role significantly.”

Media Coverage

UK to enter into ‘serious discussions’ with EU to remove medicines from NI Brexit deal
The Chemist and Druggist, Valeria Fiore, 21 September 2021

The Chemist and Druggist reports that the UK Government will discuss its proposal to remove medicines from the Northern Ireland Brexit deal with the European Commission. This was confirmed by a DHSC representative.

Martin Sawer, Executive Director at the Healthcare Distribution Association (HDA), spoke at a webinar on the Northern Ireland protocol this week hosted by Sigma Pharmaceuticals, the Ethical Medicines Industry Group, and the Pharmaceutical Industry Network Group.

Mr Sawer highlighted some of the challenges arising from the protocol, including the responsibility for manufacturers based in Great Britain to manufacture medicine for Northern Ireland in compliance with EU regulations. The Northern Ireland market only constitutes 3% of the UK medicines market therefore there are no “market incentives” for them to do so.

He stated: “HDA member companies believe that, without fundamental mitigation measures being introduced, there could be a significant reduction in the range of medicines available to NHS patients in Northern Ireland”.

Antonia Jeans, Head of Northern Ireland Regulatory Policy and Devices Trade at the Department of Health and Social Care (DHSC), who was also invited to speak at the webinar, discussed the UK Government’s measures to solve the tensions caused by the protocol. She also confirmed that the EU does not intend to take legal action following the UK’s decision to extend the grace period.

Ms Jeans added: “We’ve got talks with the Commission underway at the moment and we are thinking to negotiate significant changes to how the protocol works for medicines. We think this will give us the opportunity to find a long-term solution.”

Ms Jeans also asked manufacturers to consider their plans to discontinue medicines as it helps the DHSC understand which medicines are most at risk of supply shortages. She said: “We know the EU is intending to pass legislation by the end of the year on those areas, so the picture is looking much more positive than it was”.

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

UK to enter into ‘serious discussions’ with EU to remove medicines from NI Brexit deal
The Chemist and Druggist, Valeria Fiore, 21 September 2021

Sigma Pharmaceuticals, the Ethical Medicines Industry Group, and the Pharmaceutical Industry Network Group jointly hosted a webinar on the Northern Ireland protocol, yesterday (September 20).

Currently, the protocol means that Northern Ireland has remained in the EU’s single market for goods. Since January 2021, the protocol has mandated that Northern Ireland must follow EU medicine regulations, although there is currently a grace period in place until the end of the year – which the UK extended unilaterally earlier this month (September 6).

Antonia Jeans, head of Northern Ireland Regulatory Policy and Devices Trade at the Department of Health and Social Care (DH) – who was invited to speak at the webinar – gave an overview of the actions the UK government is adopting to tackle the “significant disruption” caused by the protocol.

Ms Jeans told delegates about the UK government’s proposal – set out in a document referred to as a “command paper” – for medicines to be removed from the protocol, which would avoid having “two different regimes across one territory, which is the UK”.

“We are working with the commission to enter into serious discussions on the command paper position,” Ms Jeans said.

UK’s unilateral extension to grace period

Martin Sawer, executive director at the Healthcare Distribution Association (HDA) – who also spoke at the webinar – said that some of the challenges arising from the protocol include the responsibility for manufacturers based in Great Britain to manufacture separate medicine packs for Northern Ireland to comply with EU regulations.

But there are no “market incentives” for them to do so, as the Northern Ireland market only constitutes 3% of the UK medicines market, Mr Sawer explained.

While the extension to the grace period has given manufacturers “breathing space”, Mr Sawer said that “HDA member companies believe that, without fundamental mitigation measures being introduced, there could be a significant reduction in the range of medicines available to NHS patients in Northern Ireland”.

C+D reported last week that manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total in Northern Ireland.

Manufacturers urged to rethink discontinuation intentions

Ms Jeans confirmed that the EU does not intend to take legal action following the UK’s decision to extend the grace period and that the DH is “confident that [that] provides the breathing space that industries need”.

“We’ve got talks with the Commission underway at the moment and we are thinking to negotiate significant changes to how the protocol works for medicines. We think this will give us the opportunity to find a long-term solution,” Ms Jeans added.

She asked manufacturers to consider whether they have “sufficient certainty to not make plans to discontinue”.

“It really helps with our prioritisation in terms of understanding which medicines are most at risk of supply shortages. There’s a team of pharmacists who have a very difficult job at the DH, who basically have to review every medicine that is at risk of discontinuation to try and find alternatives for patients.

“If there’s any positive sentiment that you have about being able to continue because you feel certainty from what you’ve heard today, then I would urge you to withdraw the discontinuations,” Ms Jeans added.

She said that the DH has already seen some companies stepping back from their intentions to discontinue medicines in Northern Ireland. While she warned that she cannot offer commercial advice on this issue, she said: “We know the EU is intending to pass legislation by the end of the year on those areas, so the picture is looking much more positive than it was”.

“The commission doesn’t want any discontinuation of medicines for patients in Northern Ireland, that’s not their objective and it’s the same for us. We’re working for the same goals,” Ms Jeans added.

Media Coverage

Roll out of Covid boosters and teenage jabs could be delayed by CO2 shortage
iNews, David Parsley, 20 September 2021

iNews reports that the rollout of the Covid vaccine to teenagers and those receiving booster jabs will be disrupted due to the shortage of CO2 gas.

The Pfizer vaccine requires storage and transportation at ultra-cold temperatures requiring  large amounts of CO2.

The article suggests that officials are monitoring supplies of the gas, however, they are unable to guarantee that the vaccine rollout will not be interrupted by the shortage of products such as dry ice, made from CO2.

A senior scientific adviser to the Government claimed that in order to protect the vaccine rollout, the new Parliamentary Under-Secretary of State for Covid-19 Vaccine Deployment, Maggie Throup, must redistribute CO2 from other sectors of the economy. However, this could result in shortages in other areas including in hospitals.

Additionally, the advisor said that unless the Government could “lay it hands on enough CO2 for the vaccines” it could be forced to move to Plan B.

A Government spokesperson stated: “We are confident the COVID-19 vaccination programme will not be impacted by this issue.”

Additionally, the spokesperson said the government is continuing to monitor supplies across critical sectors and is in regular contact with health and care sectors on their CO2 supplies.

Q&A: The NI Protocol medicines issue explained
BBC News NI, John Campbell, 18 September 2021

Following the recent criticism from the British Generic Manufacturers Association (BGMA), BBC News NI has published an explainer article on on the supply of medicines from Great Britain to Northern Ireland under the Northern Ireland Protocol.

The article highlights that some firms intend to stop supplying some medicines to Northern Ireland because of the expensive new regulatory processes. By the end of August, the health department had been notified that 910 medicines were due to be withdrawn, with a further 2,400 at risk.

Many off-patent generic drugs are manufactured in the UK and cannot be sourced in the single market to avoid the additional quality control process.

In July, the EU published a paper which stated: “Adapting supply chains to the new situation is still particularly challenging, in particular for suppliers of generics.”

European Commission Vice President Maroš Šefčovič said it was his top priority that people in Northern Ireland continue to get the medicines they need.

The British Generic Manufacturers Association (BGMA) said: “In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

In its July command paper, the UK government said that given “the range and depth” of the challenges around this issue, “the simplest way forward may be to remove all medicines from the scope of the protocol entirely”.

This was also reported by P3 Pharmacy.

 

Parliamentary Coverage

 Lord Kamall has been appointed as the new Parliamentary Under Secretary of State (Minister for Innovation), replacing Lord Bethell.

 

Full Coverage

Roll out of Covid boosters and teenage jabs could be delayed by CO2 shortage
iNews, David Parsley, 20 September 2021

The Government has refused to rule out that the rollout of the Pfizer Covid vaccine to teenagers and those receiving booster jabs will be disrupted due to the shortage of CO2 gas.

Officials are monitoring supplies of the gas “across critical sectors” but, despite several request to do so, they failed to guarantee the vaccine rollout would not be delayed by the shortage of crucial cooling products such as dry ice, which is made from CO2.

The Pfizer vaccine, which is due to be given to 12- to 15-year-olds and those receiving boosters from this week, requires storage and transportation at ultra-cold temperatures that requires large amounts of CO2.

One senior scientific adviser to the Government told I that in order to prevent a collapse of the jab rollout the new Parliamentary Under-Secretary of State for Covid-19 Vaccine Deployment, Maggie Throup, will have to divert as much CO2 as it she from every other sector of the economy.

This could, in turn, lead to shortages in hospitals and right across the economy with food, drink and hospitality businesses losing out if the Government prioritises the vaccine rollout. Energy supplies are also under pressure.

The scientist added that unless the Government could “lay it hands on enough CO2 for the vaccines” then its Plan A for the winter, which relies on the vaccination programme, would be “blown out of the water” and it could be forced to move to Plan B immediately.

It would result in measures such compulsory face masks inside public areas and on transport, social distancing and working from home, for those who can, being enforced.

The government has begun distributing the Pfizer vaccine across the country to jab around three million teens at school pop-up centres with an initial 1.5 million people making appointments for their third jab.

However, the vaccine needs to be kept at -70 degrees centigrade, but there is growing concern that there will not be enough CO2 to produce the dry ice to maintain such a low temperature in trucks due to deliver millions of vaccine vials across the UK.

The latest vaccine rollout is the primary defence against Covid in Boris Johnson’s Winter Plan to keep the NHS from being overwhelmed by the pandemic and other traditional cold weather illnesses.

In May, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorised the storage of undiluted, thawed vials of the Pfizer vaccine for up to one month at refrigerator temperatures, but if CO2 shortages continue the delivery and storage of the required amounts of vaccine from manufacturing plants across Europe to complete the vaccination of young teens and booster recipients could be threatened.

The UK Government has order 135 million Pfizer doses since the pandemic began, but the vast majority of these are yet to be delivered.

In order to vaccinate teenagers and give the initial third booster jabs to older, more vulnerable people, the Government requires 4.5 millions doses. In order to provide all over 50s with a booster the Government will require a further 20 million Pfizer vaccines to be delivered into the country.

A Government spokesperson said: “We are confident the COVID-19 vaccination programme will not be impacted by this issue.

“We continue to monitor supplies across critical sectors and are in regular contact with industry, food and health and care sectors on their CO2 supplies.”

Q&A: The NI Protocol medicines issue explained
BBC News, John Campbell, 18 September 2021

A body representing some UK pharmaceutical firms has warned that an EU plan to guarantee the supply of medicines from Great Britain to Northern Ireland is unworkable.

BBC News NI has examined what is behind the matter.

Why is the supply of medicines an issue?

It is a consequence of the protocol, the Northern Ireland Brexit deal agreed by the UK and EU.

It leaves Northern Ireland in the EU’s single market for goods, a market which includes medicines.

The protocol means that goods can flow freely between the Republic of Ireland and Northern Ireland but goods arriving into Northern Ireland from the rest of the UK are subject to controls and checks to ensure they comply with EU standards.

‘Patients at risk’ if medicines withdrawn from NI

What next for the Northern Ireland Protocol?

Northern Ireland gets most of its medicines from distributors and manufacturers in GB but, due to a “grace period”, controls have not yet been imposed on the movement of those products.

That grace period was due to expire in January, but the UK government has indefinitely extended it.

Nonetheless, some firms had notified Stormont’s Department of Health that they intended to stop supplying some medicines to Northern Ireland at the end of the grace period because they would have had to comply with expensive new regulatory processes to put GB-sourced products on the market in Northern Ireland.

By the end of August, the health department had been notified that 910 medicines were due to be withdrawn, with a further 2,400 at risk.

What was due to happen at the end of the grace period?
A fundamental part of the EU’s medicines regulation is that products being imported to the single market undergo quality control or “batch testing” at a facility inside the single market.

In practical terms, this would mean most products entering from GB would have to undergo batch testing at laboratories in Northern Ireland, a new and significant expense.

Additionally, anyone responsible for placing those products on the market in Northern Ireland, primarily wholesalers, would need to obtain what is known as an EU “manufacturing authorisation”.

This also requires the oversight of what is known as a “qualified person”.

Finally, medicines to be distributed in Northern Ireland would have different regulatory labelling requirements from those for sale in GB.

All this adds up to a separate quality control, distribution and labelling system for Northern Ireland.

Why not just get the medicines direct from the EU?
The EU did intend the grace period to be used for supply lines to change in this way.

A senior UK official told the BBC that some firms have been planning for this, but that it is only an option for a limited number of products, specifically branded on-patent medicines.

Many of these medicines are manufactured in the EU, particularly Belgium, France and Germany.

The products could be shipped directly to Ireland and on to Northern Ireland, never entering GB, so no additional quality control processes would be required.

Additionally, the manufacturers would ask: “Do we already have EU-compliant English language packaging for these drugs?” If they are sold in Ireland the answer is “yes” so there would be no requirement to create Northern Ireland-specific packaging.

This would, however, mean that some products or pack sizes would not be available if they were not already sold in Ireland.

But the real problem concerns off-patent generic drugs, which are very widely used in the UK health service.

Many of these products are manufactured in the UK with no option to source them in the single market and so avoid the additional quality control process.

Furthermore, Ireland makes much less use of generics so there would be a bigger requirement to have Northern Ireland-specific packaging.

Generic medicine is a lower profit margin business so the companies are not keen on taking on the extra cost of supplying a very small market like Northern Ireland.

It is no surprise, therefore, that generics manufacturers have been most concerned about the protocol.

What has the EU proposed?

In July, the EU publicly acknowledged there was a problem, publishing a paper which stated: “Adapting supply chains to the new situation is still particularly challenging, in particular for suppliers of generics.”

Its big idea is that rather than having those regulatory processes like batch testing happening in Northern Ireland they can happen in GB, at the manufacturer’s labs.

This would require a change to EU law, with draft legislation expected to be published within the next few weeks.

This would be subject to certain conditions, including EU-compliant labelling for Northern Ireland products and “enhanced enforcement” in the Northern Ireland market.

European Commission vice president Maroš Šefčovič briefed Northern Ireland party leaders on the plan during his recent visit and said it was his top priority that people in Northern Ireland continue to get the medicines they need.

Problem solved?

The generics manufacturers do not agree.

They say that “it hammers home” the need for a separate and specialised Northern Ireland product distinct from a GB one so the additional complexity and cost remains.

The British Generic Manufacturers Association said: “In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

A senior UK official also pointed to the fact that companies were continuing to notify Stormont of the intent to discontinue products in Northern Ireland well after the EU had published its proposal, suggesting industry is not confident it will work.

What does the UK propose?

In its July command paper, the government said that given “the range and depth” of the challenges around this issue, “the simplest way forward may be to remove all medicines from the scope of the protocol entirely”.

Media Coverage

‘Terrible’: 2.4k medicines at risk of withdrawal in Northern Ireland
The Chemist and Druggist, Valeria Fiore, 16 September 2021

The Chemist and Druggist reports that British Generic Manufacturers Association (BGMA) CEO Mark Samuels disclosed in an interview with BBC Today that 910 medicines have been discontinued in Northern Ireland, with many more on track to be withdrawn.

In the interview Mark Samuels said that manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total and the medicines that have been withdrawn or are at risk of withdrawal are generics.

In addition, he stated: “We have never seen medicines withdrawal on this scale and already to have almost 1,000 medicines withdrawn, it’s terrible.”

A Northern Ireland Department of Health spokesperson suggested that the Government is aware of “a large number of confirmed and potential discontinuations of medicines to Northern Ireland” that have been formally notified to the Department of Health and Social care (DHSC). The spokesperson asserted that there is no immediate risk to medicines supplies in Northern Ireland and patients do not need to take any action.

The DoH proposed that the issues causing the discontinuations need to be addressed as a matter of urgency to avoid a negative impact on patients. However, pharmacies and patients do not need to stockpile medicines, and prescribers should not issue longer prescriptions.

 

Parliamentary Coverage

MHRA launches public consultation on future of medical device regulation
Medicines and Healthcare products Regulatory Agency and The Rt Hon Sajid Javid MP16 September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week consultation to give the public an opportunity to contribute to the improvement of the regulatory framework and patient safety.

The MHRA is the regulator for medical devices used in the UK. The MHRA want to draw on views across the medical devices and healthcare sectors, including, medical practitioners, patients and the wider public, to inform the future approach. The MHRA are interested in gaining insights from those who research, manufacture, supply and use medical devices.

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA now has the opportunity to create a world-leading regime that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices.

The consultation is comprehensive, covering a broad range of regulatory issues, including how devices are assessed before being placed on the market, importer and distributor obligations, transparency, and the role of patients.

Dr June Raine, MHRA Chief Executive said: “The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart.”

“This is your chance to make a difference to people’s experiences with devices by helping shape the regulations around medical devices – from how much scrutiny they face before they reach the market, to how they are tracked and monitored, and what actions are taken if problems with a device arise.”

Health and Social Care Secretary Sajid Javid said: “This consultation will allow us to revolutionise the regulation of medical devices, making sure our pioneering life sciences sector can continue to lead the world and safeguard the health of our nation.”

The consultation will close at 11.45pm on 25th November 2021.

 

Full Coverage

‘Terrible’: 2.4k medicines at risk of withdrawal in Northern Ireland
The Chemist and Druggist, Valeria Fiore, 16 September 2021

More than 900 medicines are no longer “readily available” in Northern Ireland, with many more on track to be withdrawn, British Generic Manufacturers Association (BGMA) CEO Mark Samuels has revealed.

In an interview with BBC Today yesterday (September 15), Mr Samuels revealed that 910 medicines have already been discontinued in Northern Ireland, while manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total.

“It takes six months, so for medicines to be withdrawn in January, that notification needed to have begun by now, which is why we know the figures in advance,” Mr Samuels added.

The medicines that have been withdrawn or are at risk of withdrawal are generics, Mr Samuels specified.

“We have never seen medicines withdrawal on this scale and already to have almost 1,000 medicines withdrawn, it’s terrible,” he added.

“No immediate risk to medicine supplies”

A Northern Ireland Department of Health (DoH) spokesperson told C+D yesterday that the government is aware of “a large number of confirmed and potential discontinuations of medicines to Northern Ireland” that have been formally notified to the Department of Health and Social care (DH).

“I want to reassure the public that there is no immediate risk to medicines supplies in Northern Ireland and there is no need for patients to do anything differently with regard to ordering or taking their prescribed medication,” they said.

The DoH argued that the “underlying issues” that have triggered the discontinuations need to be addressed with urgency to avoid a negative impact on patient health.

However, neither pharmacies nor patients need to stockpile medicines, and prescribers should not issue longer prescriptions, it advised.

C+D has asked for a list of the affected medicines, but the DoH spokesperson said that the information on confirmed or potential discontinuations is provided confidentially to the DH, which is therefore not at liberty to share information it receives from the suppliers.

“Phased process” and Northern Ireland Protocol

Before the UK left the European Union on January 31 last year, it reached a Brexit agreement with the EU, known as the Northern Ireland Protocol, which means Northern Ireland has remained in the EU’s single market for goods.

The government announced in November last year that the UK and EU had agreed on a “phased process” for the implementation of medicines regulations in Northern Ireland.

This means that until December 31, Great Britain can continue to supply medicines to Northern Ireland “with a pragmatic approach to applying EU rules on importation and unique identifier requirements”.

In June, Prime Minister Boris Johnson reportedly said that 30 medicines were no longer available in Northern Ireland because of the way regulations that were being phased in around the border were affecting the movement of goods, according to the Sunday Times.

In a document on the Northern Ireland Protocol published in July, the UK government acknowledged that the “current arrangements are creating considerable challenges with medicine supply to patients in Northern Ireland being put at risk for a number of products from the end of 2021”.

It suggested that the “simplest way forward may be to remove all medicines from the scope of the Protocol entirely”.

Media Coverage

Brexit: EU medicine supply plans for Northern Ireland ‘unworkable’
BBC News, John Campbell, 15 September 2021

BBC News reports on a statement by the British Generic Manufactures Association (BGMA) regarding the Northern Ireland protocol and its subsequent impact on medicines supply to the region.

Specifically, the BGMA takes issue with the requirement that medicines entering Northern Ireland would be subject to separate regulatory standards than those supplied to Great Britain.

In its statement responding to the European Commission’s July non-paper, the BGMA said: “The proposed EU solution fails to recognise the added complexity its additional measures would bring… The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Brexit: EU medicine supply plans for Northern Ireland ‘unworkable’
BBC News, John Campbell, 15 September 2021 

A pharmaceutical trade association has warned that EU proposals for guaranteeing the supply of medicines to Northern Ireland are “unworkable”.

The Northern Ireland Protocol means Northern Ireland remains in the EU’s pharmaceutical regulatory system.

The EU is preparing to change some of its laws to help maintain GB-to-Northern Ireland medicines exports.

But the British Generic Manufacturers Association believes the EU’s plan is misconceived.

There is currently no risk to supplies as movement of medicines from Great Britain to Northern Ireland is covered by a grace period.

Last week that grace period was indefinitely extended by the UK government.

The issue concerns the strict regulatory and quality control requirements for batch testing and labelling of medicines.

Under the terms of the protocol, medicines would need to be batch tested in Northern Ireland or the EU, which would need duplicate warehousing, laboratory testing and technical specialists.

This would increase costs and complexity so, in response, some Great Britain distributors have said they intend to stop selling some products in Northern Ireland.

Northern Ireland’s Department of Health has said it had been notified that 910 medicines were due to be withdrawn with a further 2,400 at risk.

In response, the EU has proposed that the batch testing of medicines due to be shipped to Northern Ireland could continue to happen in Great Britain, with certain safeguards.

Those safeguards include separate licences for Northern Ireland and placing Northern Ireland-specific labels on packs.

But the BGMA said the problem remained the separate regulatory treatment of Northern Ireland medicines.

“The EU’s proposal would make trade in medicines, and supplying Northern Ireland, even harder since it hammers home the need for a separate and specialised Northern Ireland product (distinct from a GB one),” it said.

“The proposed EU solution fails to recognise the added complexity its additional measures would bring.

“In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

Overall the EU has proposed “a set of measures that we believe are unworkable”, it said.

Last week, European Commission Vice President Maros Sefcovic said he would do “whatever it takes” to guarantee the supply of medicines.

The UK government has proposed that medicines should be entirely removed from the scope of the protocol.

Media Coverage

Pharmacies and GPs could deliver Covid vaccines with annual flu jabs
P3 Pharmacy, Pharmacy Magazine, 14 September 2021

P3 Pharmacy reports that the Government is considering giving patients in England an annual Covid vaccine at the same time as their flu jab in general practices and pharmacies, according to Vaccine Minister Nadhim Zahawi.

Health Secretary Sajid Javid confirmed today that the Covid phase three booster programme will begin next week, and the Joint Committee on Vaccination and Immunisation (JCVI) said that around 30 million people will be eligible for a Covid booster jab.

The JCVI recommended in the interim advice that the most vulnerable are given booster vaccines for the flu, as well as for Covid.

Nadhim Zahawi said: “Where possible we will try and co-administer – with one caveat – with flu. GPs and pharmacies, which are the backbone of the vaccination programme, can rapidly vaccinate lots of people.”

Nadhim Zahawi also suggested that delivering Covid and flu vaccines at the same time is “probably the last piece of the jigsaw to allow us to transition this virus from pandemic to endemic.” He also said that he hopes by next year Covid can be dealt with like the flu.

The article highlights that the plan to allow pharmacies to administer Covid vaccines with yearly flu jabs could pose problems given reports in recent years that some GPs have discouraged patients from getting their flu jab in pharmacies.

The Pharmaceutical Services Negotiating Committee (PSNC)’s Director of NHS services Alastair Buxton said: “This year more than ever, GPs and pharmacies should be working together to help provide the biggest ever flu vaccination programme.”

A National Pharmacy Association spokesperson said: “We need to examine the details of how the flu and Covid vaccination programmes will run alongside each other, but pharmacies have proven themselves more than capable in relation to both.”

Furthermore, Leyla Hannbeck, Chief Executive of the Association of Independent Multiple Pharmacies, said: “With GPs already struggling to cope and busy A&E departments, pharmacies should be used to the maximum this winter because we can help take the pressure off the NHS.”

 

Parliamentary Coverage

Prime Minister sets out autumn and winter Covid plan
Prime Minister’s Office, 10 Downing Street and The Rt Hon Boris Johnson MP, 14 September 2021

The Prime Minister set out the government’s plan to manage Covid throughout autumn and winter.

Data shows the success of vaccination programme, with a decline in cases, hospitalisations and deaths. The number of Covid hospital admissions in England has remained relatively stable over the past month.

Throughout autumn and winter, the government aims to sustain this progress through: Pharmaceutical interventions, identifying and isolating positive cases to limit transmission, supporting the NHS and social care, advising people on how to protect themselves and others and pursuing an international approach.

Vaccines will continue to be of utmost importance line of defence and those vaccinated during Phase 1 of the vaccine programme will be offered booster jabs from this month.

The Test, Trace and Isolate programme will continue symptomatic PCR testing over the autumn and winter.

Additionally, lateral flow tests will remain free of charge but at a later stage, as the response to the virus changes, individuals and businesses will be expected to cover the cost.

The legal obligation to self-isolate for those who test positive and their unvaccinated contacts will continue, and the financial support payment for those self-isolating on certain benefits will continue in its current format until the end of March.

The NHS will continue to be supported, with an extra £5.4 billion recently announced for the next 6 months solely for the Covid response.

As well as this, there are ‘Plan B’ measures are kept under review to help control transmission of the virus while limiting economic and social damage. These measures include: Implementing vaccine only Covid certification in certain settings, legally mandating face coverings in certain settings and work from home advice .

Ministers would only implement ‘Plan B’ measures if necessary and if the NHS is at risk of becoming overwhelmed.

 

Full Coverage

Pharmacies and GPs could deliver Covid vaccines with annual flu jabs
P3 Pharmacy, Pharmacy Magazine, 14 September 2021

Vaccines minister Nadhim Zahawi has said the Government is considering giving patients in England an annual Covid vaccine at the same time as their flu jab in general practices and pharmacies.

His comments came as health secretary Sajid Javid confirmed today that the Covid phase three booster programme will begin next week, with the Joint Committee on Vaccination and Immunisation saying that 30 million or so people will be eligible for a Covid booster jab including the over-50s, young adults with health conditions and frontline health and social care staff.

The JCVI had already recommended a third Covid jab for people living in care homes, 16 to 49-year-olds with underlying health conditions and adult household contacts of individuals who are immunosuppressed.

“The JCVI recommended in the interim advice that we look at boosting the most vulnerable to Covid and of course flu as well,” Mr Zahawi told BBC Radio 4 Today.

“Where possible we will try and co-administer – with one caveat – with flu. GPs and pharmacies, which are the backbone of the vaccination programme, can rapidly vaccinate lots of people.

“If we are using the mNRA vaccines, Pfizer/BioNTech or Moderna, there is a 15-minute observation period for the Covid boost. But, wherever possible, we will try and co-administer.”

Mr Zahawi said delivering Covid and flu vaccines at the same time is “probably the last piece of the jigsaw to allow us to transition this virus from pandemic to endemic.”

“I hope by next year we will be in a position to deal with this virus with an annual inoculation programme as we do flu,” he said.

Calum Semple, who sits on the Scientific Advisory Group for Emergencies, told BBC Breakfast “it’s not just going to be coronavirus that’s causing us trouble” over the next few months. The government is concerned that protection offered by the Covid vaccine may wane to some extent a few months after the second dose, especially in the most vulnerable groups.

However, the plan to allow pharmacies to administer Covid vaccines with yearly flu jabs could pose problems given reports in recent years that some GPs have discouraged patients from getting their flu jab in pharmacies.

One pharmacist recently said a GP surgery used scare tactics to persuade its patients not to go elsewhere for their flu vaccinations ahead of the start of the Covid booster programme.

The PSNC’s director of NHS services Alastair Buxton told Independent Community Pharmacist it was important that “this year more than ever, GPs and pharmacies should be working together to help provide the biggest ever flu vaccination programme.”

He added: “That is why shared incentives for community pharmacy and general practice have been agreed for a second year running. The JCVI have advised the rollout of C-19 boosters should be similar to the original phasing used for the primary vaccination course; many patients are also now eligible for a flu vaccination and it is important that they get this as soon as possible.”

A National Pharmacy Association spokesperson said: “We need to examine the details of how the flu and Covid vaccination programmes will run alongside each other, but pharmacies have proven themselves more than capable in relation to both.”

“People should not delay getting protected against flu, whatever the advice about vaccinating people for flu and Covid in the same visit.”

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies, said community pharmacies “must be called upon” in the booster campaign.

“With GPs already struggling to cope and busy A&E departments, pharmacies should be used to the maximum this winter because we can help take the pressure off the NHS,” said Ms Hannbeck.

“Last year we smashed flu vaccination records and delivered nearly 3 million flu jabs. Community pharmacy teams have also been working at many Covid vaccination sites and the feedback from patients has been overwhelmingly positive.”

From Factory to Pharmacy

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

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