Media And Political Bulletin – 02 April 2020

Media and Political Bulletin

02 April 2020

Media Summary

Emergency funding for COVID-19 not enough to prevent pharmacy closures, trade body warns

The Pharmaceutical Journal, Carolyn Wickware, 01 April 2020

The Pharmaceutical Journal reports that pharmacy bodies have said that emergency COVID-19 funding for community pharmacies may not be enough to prevent closures after the government promised £300m in advance, but not extra, payments for pharmacies.

Pharmacies were told that the sector will receive a £200m advanced payment on or shortly after 1 April 2020, with a further £100m expected at the end of month or in early May 2020. But announcing this on its website, the PSNC said the payments would need to be paid back at a later date.

Malcolm Harrison, chief executive of the Company Chemists’ Association, said he was “disappointed” with the level of funding, “and the fact that pharmacies will ultimately have to pay it back.” Claire Anderson, chair of Royal Pharmaceutical Society England Pharmacy Board, said the announcement “is a welcome step … but should have come from new money”.

This was also reported in C+D and Pharmacy Business.

COVID-19 update: coronavirus and the pharmaceutical supply chain

European Pharmaceutical Review, Hannah Balfour, 01 April 2020

With the COVID-19 pandemic affecting industries across the globe, European Pharmaceutical Review’s Hannah Balfour explored the latest reports on medicine availability during the global pandemic, and spoke to James P. Duffy, a Reed Smith Partner, to assess how the outbreak is affecting the global pharmaceutical supply chain. He explores the impact of China and India, logistics and distribution concerns, and future changes to manufacturing practices, amongst others.

While he observes that drug shortages due to COVID-19 are so far limited and expected to remain this way in the short term, James Duffy says that if the pandemic continues then stockpiles of pharmaceuticals, APIs and other chemicals may decrease, resulting in shortages. He adds that a further effect is the added complications for distribution, particularly with population movement restrictions across Europe.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Emergency funding for COVID-19 not enough to prevent pharmacy closures, trade body warns

The Pharmaceutical Journal, Carolyn Wickware, 01 April 2020

Although the government has promised an advance payment of £300m to the community pharmacy sector, the amount is too little to cover the full expense pharmacies are incurring, pharmacists have said.

Emergency COVID-19 funding for community pharmacies may not be enough to prevent closures, pharmacy bodies have said, after the government promised £300m in advance, but not extra, payments for pharmacies.

Pharmacies were told that the sector will receive a £200m advanced payment on or shortly after 1 April 2020, with a further £100m expected at the end of month or in early May 2020. But announcing the funding in a statement on its website, the Pharmaceutical Services Negotiating Committee said the payments totalling £300m would need to be paid back at a later date.

Malcolm Harrison, chief executive of the Company Chemists’ Association, said he was “disappointed” with the level of funding, “and the fact that pharmacies will ultimately have to pay it back,” adding that the initial £200m payment “will only just cover half of the estimated uplift in prescription items seen [in April 2020]”.

“In addition to the increased cost of purchasing medicines, pharmacies are having to pay for additional staff and overtime, additional cleaning and guarding, as well as providing protective equipment — such as screens and visors — to protect their teams, so that they can stay open for the public,” he said.

“We have grave concerns that pharmacy businesses, large and small, will not be able to continue to cope in this unprecedented situation without adequate additional support and may be forced to close permanently.”

Claire Anderson, chair of Royal Pharmaceutical Society England Pharmacy Board, said the announcement “is a welcome step … but should have come from new money”.

“With rising costs, this will not yet be enough to support those pharmacy teams working hard on the frontline during the COVID-19 pandemic,” she said.

“As we await further details on the proposed medicines delivery service, we must also see fair funding in the longer-term to help pharmacies keep their doors open to the public.”

Local pharmaceutical committee (LPC) leaders have also suggested the funding is insufficient.

Nick Hunter, chief officer of Nottinghamshire, Rotherham and Doncaster LPCs, told The Pharmaceutical Journal that although the advanced payments are “very welcome and essential to keep the sector running” during the pandemic, they are “a sticking plaster” with further negotiations needed.

Raj Matharu, chair of Pharmacy London — a representative body for London’s LPCs — said the lack of new funding will “[cause] pain later on”.

NHS England and NHS Improvement “do not value the fantastic response from the community pharmacy sector,” he said, adding that community pharmacy is “the only healthcare profession out there in the community still seeing people and patients face to face”.

“[We are], literally, putting our mental and physical health on the line and we can’t attract new funding after that. What else do we have to do?” he said.

Meanwhile, pharmacies in Scotland have also been promised advanced payments to help manage cash flow issues, although details have yet to be finalised.

Matt Barclay, director of operations at Community Pharmacy Scotland (CPS), said in a video update on 31 March 2020 that an agreement with the Scottish government on advance payments is “to be made at the end of April [2020]”.

“These will be three times the value of the net amount paid at the end of December 2019,” he said, and added that the CPS was “still working with Scottish government on new monies and how that could happen”.

Keith Ridge, chief pharmaceutical officer for England, also announced, on 31 March 2020, that pharmacies will be given £300 to pay for screens or other “physical barriers” to be installed to maintain social distancing in pharmacies.

Jawad Merali, pharmacist at Fairview Pharmacy in Edgware, told The Pharmaceutical Journal that putting up a screen at his pharmacy had “made a big difference” to staff morale, but that it cost £1,500 to install at short notice.

“There will be an equivalent, probably three quarters of the cost [of installation], to take it away,” he added, as it required drilling to the floor.

The advance payments come as some community pharmacies in England are expected to receive an uplift in their transitional payments from 1 April 2020, depending on their dispensing volume.

Under the agreed dispensing volume bands, pharmacies that dispense between 2,501 and 5,000 items will now receive £1,168, compared with £700 in 2019/2020.

Pharmacies dispensing between 5,001 and 12,500 will get £1,475, while those dispensing between 12,501 and 19,167 items will receive £1,598 monthly. Previously all pharmacies dispensing between 5,001 and 19,167 received £780.

Lastly, those dispensing more than 19,168 items will get £1,660 each month — nearly twice as much as the £833 monthly payment they received in 2019/2020.

This was also reported in C+D and Pharmacy Business.

COVID-19 update: coronavirus and the pharmaceutical supply chain

European Pharmaceutical Review, Hannah Balfour, 01 April 2020

With concerns rising about medicine availability during the global COVID-19 coronavirus pandemic, European Pharmaceutical Review explores how the pharmaceutical supply chain is faring.

With the COVID-19 pandemic affecting industries across the globe, European Pharmaceutical Review’s Hannah Balfour explored the latest reports and spoke to J.P. Duffy, a Reed Smith Partner, to assess how the outbreak is affecting the global pharmaceutical supply chain.

Supplying the supply chain

The impact of China and India

Among the problems for pharmaceutical supply chains during this pandemic are the restrictions and impact of COVID-19 on two of the largest global producers of active pharmaceutical ingredients (APIs) and generics: China and India.

Since the outbreak started in China and lockdowns were imposed, ­supply from their manufacturing facilities has reduced. The true extent has been difficult to quantify as limited numbers of the typical workforce have been able to return to work. A recent letter sent by Medicines for Europe revealed that the Chinese powers expect large manufacturing facilities to be fully operational soon, although smaller producers may continue to struggle for some time.

Duffy stated that “most companies feel that they are relatively well positioned to weather short-term disruption. This is because many publicly traded companies have six months to a year of stockpiles; however, if restrictions continue for an extended period of time, especially if people in China cannot get back into the factories to work, eventually supply chain shortages will start to disrupt everyone.”

Reports suggest a range of possible effects, including:

  • generic drug producers who source APIs from China are likely to face supply chain issues if the outbreak continues
  • short-term scarcities affecting certain products – one such shortage has already been announced by the US Food and Drug Administration (FDA)1
  • manufacturers of branded pharmaceuticals may see a shift in their demand, both as antiviral use rises and as other chronic conditions are left untreated by patients due to concerns over exposure to COVID-19.

A second roadblock for some pharmaceutical manufacturers is that “India has restricted the export of 26 active pharmaceutical ingredients… which represents about 10 percent of their export capacity,” according to FDA Commissioner Stephen Hahn. As the contributors of 20 percent of the global generics supply, the decision to restrict exports due to fears of internal supply shortages has far-reaching impacts, particularly on supplies of paracetamol, several antibiotics such as tinidazole and erythromycin, the hormone progesterone and vitamin B12.2

According to reports, the restrictions were imposed because India’s manufacturers rely heavily on imports of their APIs from China. As a result of the lockdowns and closures, slowed production of APIs by the latter resulted in less availability and higher costs for the materials required for generics production. Duffy said the primary reason behind the export restrictions was to prevent domestic shortages in India in the long-term.

When speaking with EPR, Duffy highlighted that: “The US is the largest consumer of pharmaceutical products, accounting for somewhere between 45 and 50 percent of the market. We import more than half of our APIs and finished products. Therefore, it seems logical to think that if disruption in India and China goes on for an extended period of time, it will have to impact the US, as it will the rest of the world.”

Logistics and distribution concerns

Duffy explained that while manufacturing of the products is complicated by COVID-19, a further concern is disruption in product delivery: “This is not just pharmaceuticals, it is everything. The huge restrictions on population movements in Europe make distribution and shipping a problem. Let us look at an example: say you start with the manufacturing of an API in one country that then has to be moved to another jurisdiction to be manufactured into a finished product or go through several other production stages. You also need pill casings that are made somewhere else. All these elements have to be brought together to manufacture the finished product and then be moved by logistics companies, who, despite their best efforts to keep up with all this, have movement restrictions and worker illnesses placed upon them.

“What I would suspect is that there are going to be several disruptions within the supply chain, such that companies start declaring force majeure, as it becomes a commercial reality that people cannot perform under contracts.”

Force majeure clauses in contracts essentially state conditions under which the performance of a company can be excused or suspended. They can also state that a company is not liable for failing to meet the terms a contract. Force majeure typically applies while the event, such as a pandemic, is impacting the ability of the company to perform; however, Duffy explained: “there is no one standard force majeure clause that is in every contract. Therefore, the scope of what is entitled, what companies can claim and the scope of what your excuse for non-performance might be varies from contract to contract.”

What can pharma do to limit the impact on the supply chain?

Duffy suggested that because of the “incredibly fluid situation… companies need to constantly monitor these issues and assess their possible impact for the immediate future, as well as the more medium- and longer-term impacts. Companies must think around corners and anticipate problems before they become larger immediate issues”.

What can companies actively do aside from monitoring?

Duffy presented two suggestions; first, every company should review their contracts: “look at the global contracts and suss out which ones are going to be impacted by cross-border issues and determine what the force majeure provisions say, both in terms of what you can claim and what others can claim against you. I think the biggest and most important exercise now is to get a grip on what the potential issues are and what the potential exposure is.”

The second is to look at the indemnity provisions, which require a party to compensate another company for a loss suffered in which they have some role or in which they have accepted some form of legal responsibility. These could include the provision of financial or legal aid, so Duffy said: “companies need to be looking at those as part of this same exercise, because if someone claims either force majeure or indemnity provisions against them, the business against whom it was claimed might not be able to perform or offer services to another enterprise higher up in the supply chain.”

As a result, Duffy suggests pharma needs to be careful of both the direct supply shortages and the legal situations that COVID-19 could place them in.

Future changes to manufacturing practices

While the effects of coronavirus are overwhelmingly negative, Duffy suggested there could be one positive as a result of COVID-19: that companies may begin to spread production across different markets, limiting the effects of future disruptions: “I think the next six months are going to be extremely interesting because companies are going to have to look at shifting manufacturing from impacted markets to less impacted markets. A few pharmaceutical companies have already released statements saying they are trying to shift manufacturing or compensate for market disruptions by increasing manufacturing elsewhere.”

He suggested this could be problematic in the short-term, as an increasing number of markets are impacted by COVID-19 and the process to establish pharmaceutical manufacturing facilities is lengthy due to the tight regulations and the need for precise capabilities. In order to do this Duffy said that pharma companies will have to use and expand production at existing facilities in other markets. However, “in the long-term enterprises are going to have to diversify out their manufacturing capacity across a number of markets. Where manufacturing is highly concentrated right now, such as in China or India, that is probably not going to be the case in five years.”

Duffy concluded: “I think over the long term, businesses across several markets are going to be looking at whether it makes sense to have lots of factories in any one market or if they should be attempting to diversify by building factories elsewhere.”

Conclusion

While drug shortages due to COVID-19 are so far limited and expected to remain this way in the short term, if the pandemic continues then stockpiles of pharmaceuticals, APIs and other chemicals may decrease, resulting in shortages. A further effect is the added complications for distribution, particularly with population movement restrictions across Europe.

Duffy advises pharmaceutical companies to monitor the evolving situation and ensure enterprises are aware of the clauses of their contracts that may become problematic in the longer term.

Media and Political Bulletin

01 April 2020

Media Summary

Guidance: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

MHRA, 01 April 2020

Understanding that disruption to the supply chain has given rise to difficulties for wholesalers in applying the safeguards in GDP to meet supply needs, the MHRA has published guidance for industry on flexible approaches they are taking on good distribution practices.

The list of temporary regulatory flexibilities that will be allowed address the current exceptional circumstances. The challenges arising from to COVID-19 are likely to change. As more information becomes available the MHRA may periodically review previous decisions to ensure they are still valid. They are being regularly reviewed and may be updated at any time.

Wholesalers using these flexibilities should record the decision using existing local procedures for recording unexpected events, with a brief explanation of why this was necessary. It must also be reported to MHRA at Covid19.GMDP@mhra.gov.uk.

UK medicines watchdog warns over unsafe coronavirus tests

Financial Times, Camilla Hodgson, 01 April 2020

This article is subject to copyright terms and conditions. Please access full article here.

India likely to soon ease some drug export curbs after U.S. pressure – sources

Reuters, Neha Dasgupta, 01 April 2020

Two Indian government officials have told Reuters India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge.

An easing of the restrictions will probably come within two days and will likely include Paracetamol, a common pain reliever also known as acetaminophen, the government officials in New Delhi said.

The restrictions will be lifted for all countries, the officials said, but it was not immediately clear exactly how many drugs formulations would be exempted.

March/April supply issues update published

Dispensing Doctors’ Association, Ailsa Colquhoun, 01 April 2020

Dispensing Doctors’ Association reports that the Department of Health and Social Care (DHSC) Medicine Supply Team has published its March/April supply issues update. DDA members can view the full details of the notifications of new and ongoing issues by visiting the supply shortages library.

A summary of the new issues are included in the full transcript of the article further down.

COVID-19: English pharmacies to receive £300m in “advance funding”

C+D, Eliza Slawther, 31 March 2020

C+D reports that the PSNC has announced that community pharmacies in England will receive £300 million in “advance funding” over the next two months to alleviate cashflow issues caused by COVID-19. The total sum will be “paid as uplifts to contractors’ January and February payments” – payable in April and May.

The £300m is not new money for the sector and will have to be “reconciled at a later date”, the PSNC announced yesterday. The advance funding is “recognition of the significant cashflow pressures facing the sector at this point in the COVID-19 pandemic”, it said. There will be two cash injections, with the first payment of £200m made on or around April 1. The second payment, of £100m, will be made at the end of April or early May, the PSNC added.

Although the organisation “welcomes” the intention of the forward payment, the “funding gesture alone is not enough”, PSNC chief executive Simon Dukes commented.

This was also reported in The Pharmaceutical JournalP3 Pharmacy, and Pharmacy Business.

EMA warns consumers about falsified COVID-19 drugs from online pharmacies

European Pharmaceutical Review, Hannah Balfour, 31 March 2020

European Pharmaceutical Review reports that the EMA has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications, urging the public not to buy medicines from unauthorised online pharmacy websites and vendors. They state that any claim a product can treat or prevent COVID-19 is unfounded, as there are no approved therapeutics or vaccines as of yet.

They also stated that if a legitimate medicine that is otherwise in short supply is listed on an online pharmacy it is likely to be falsified, ie, a fake being passed off as the authorised product.

The EMA is advising consumers to buy products from local pharmacies or retailers and if using online pharmacies, ensure that it they are registered with the national competent authorities.

BMA speaks out as healthcare workers still waiting for protective gear

Metro, Harriet Line, 31 March 2020

Metro reports that the British Medical Association has said healthcare workers treating coronavirus patients should not have to risk their lives because they do not have adequate personal protection equipment. The BMA called on ministers to ‘clarify’ what medics should be expected to do after concerns about PPE shortages, with nurses on some Covid-19 wards without vital masks and gowns.

Communities secretary Robert Jenrick has said the government ‘cannot and should not ask people to be on the front line without the right protective equipment’.

Deputy chief medical officer Dr Jenny Harries has apologised, admitting distribution had been ‘tricky at times’.

This was also reported in the Financial Times.

GIRP Secretary-General discusses the challenges of medical supplies distribution

New Europe, 31 March 2020

As part of New Europe’s COVID-19 Livestream series, Monika Derecque-Pois, Secretary-General of GIRP, discussed the current challenges of distributing medical supplies across Europe.

“Before and shortly after the lockdown, we have seen a surge in demand with [some] having tripled the normal volume [of orders],” Derecque-Pois said. “We have worked around the clock doing night shifts and weekend shifts to bring the medicines due to the surge of demands in pharmacies. Everybody tried to fill their prescriptions or to stock up on self-medication to not go out as often and there was a real peak [as a result].”

Some of the distribution challenges faced by GIRP have involved the harder access of drivers to countries going through a lockdown and increase border control security. GIRP is in constant talks with government officials to expedite the delivery to countries in need.

 

 

Parliamentary Coverage

 

There was no parliamentary coverage today.

 

Full Coverage

Guidance: Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

MHRA, 01 April 2020

We understand that disruption to the supply chain has given rise to difficulties for wholesalers in applying the safeguards in GDP to meet supply needs.

The following list of temporary regulatory flexibilities that will be allowed address the current exceptional circumstances. The challenges arising from to COVID-19 are likely to change. As more information becomes available we may periodically review previous decisions to ensure they are still valid.

They are being regularly reviewed and may be updated at any time.

Supply chain

  • Periodic supplier and customer requalification may be deferred. Interim reliance may be placed upon regular review of our notifications of suspended wholesale dealer authorisations (WDA(H)) and any General Pharmaceutical Council registration updates
  • Medicines may be returned to saleable stock if returned from the wholesale distribution chain within 10 days

Transportation

  • Non-temperature-controlled transport may be used when the ambient temperature is less than 20°C
  • ‘Do not refrigerate’ products should be identified and shipped appropriately when the ambient temperature is less than 8°C. A risk assessment should be in place for products transported under these conditions, with mitigating measures implemented where necessary
  • Products may be held for up to 96 hours at a transit hub without a WDA(H) to assist in transportation. A risk assessment in respect of storage conditions and security should be in place, with mitigating measures implemented where necessary
  • Alternative arrangements to show proof of delivery will be permitted

Responsible Persons (RP)

Responsible Persons may act as RP for another company within the same group of companies without variation, provided they have an RP registration number issued by MHRA

Facilities and equipment

Storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible. This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possible

Small changes in various elements of the quality system will be permitted to provide more RP resource and enable focus on supply

  • Management of deviations – following assessment by the RP to determine the impact of a deviation or non-conformance, investigation of ‘minor’ events may be put on hold. These should be tracked, with investigations initiated in response to an identified trend
  • Post inspection regulatory commitments relating to deficiencies classified as ‘Other’ may be put on hold. These should be recorded in the quality system and corrected after pandemic restrictions are lifted
  • Routine Standard Operating Procedure reviews may be extended
  • Electronic alternatives to wet signatures will be permitted. Distributors should ensure that interim ways of working are designed to accommodate data integrity principles
  • Internal audit (self-inspection) and GDP refresher training may be put on hold. Training new personnel in GDP principles, and training of procedural updates should continue

Flexibilities relating to verification of unique identifier codes required by the Falsified Medicines Directive remain under consideration and will be communicated later.

We recognise that the care of patients is your first priority. We will do everything we can to support you in the decisions you need to make. To do so we need you to ensure that when you make relevant decisions, you have carefully evaluated the risks and you are fully transparent.

Reporting your use of this guidance

Wholesalers using these flexibilities should record the decision using existing local procedures for recording unexpected events, with a brief explanation of why this was necessary.

It must also be reported to MHRA at Covid19.GMDP@mhra.gov.uk.

These reports do not require prior approval to implement. Reporting decisions will assist regulators in monitoring the national situation in real time and take further actions to address common difficulties as situations change.

If these flexibilities do not provide enough scope to enable quick actions to the current logistical challenges, please report this to us as soon as it becomes apparent. Reporting any difficulties will assist us to monitor the national situation in real time and take actions to support critical supply chains while continuing to protect public health.

UK medicines watchdog warns over unsafe coronavirus tests

Financial Times, Camilla Hodgson, 01 April 2020

This article is subject to copyright terms and conditions. Please access full article here.

India likely to soon ease some drug export curbs after U.S. pressure – sources

Reuters, Neha Dasgupta, 01 April 2020

India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge, two Indian government officials told Reuters.

India, which supplies more than a quarter of the world’s generic drugs, last month restricted exports of 26 pharmaceutical ingredients and the medicines made from them. The move was seen as an attempt to secure supplies for its domestic population after the outbreak played havoc with the industry’s supply chain globally.

The restrictions are not complete bans but impede sales of drug and drug ingredients overseas by specifying circumstances for their export and requiring firms to procure a “no objection” certificate from the government.

An easing of those restrictions will probably come within two days and will likely include Paracetamol, a common pain reliever also known as acetaminophen, the government officials in New Delhi said.

“There is so much (U.S.) pressure on the government. For U.S. what matters is Paracetamol, it matters to them significantly,” said one official, adding that India had adequate stock of the drug for domestic use for at least four months.

The restrictions will be lifted for all countries, the officials said, but it was not immediately clear exactly how many drugs formulations would be exempted.

Both officials declined to be identified due to the sensitive nature of the discussions. India’s commerce ministry did not immediately respond to a request for comment.

The U.S. government said in a statement on Tuesday that Secretary of State Mike Pompeo had spoken with India’s foreign minister and sought cooperation in strengthening global pharma manufacturing and supply chains, but gave no further details.

President Donald Trump has warned Americans of a “painful” two weeks ahead in fighting the virus. Nearly 3,900 people have died in the United States, and the total confirmed U.S. cases has risen to 187,000.

Imports from India accounted for 24% of medicines and 31% of medicine ingredients to the United States in 2018, according to the U.S. Food and Drug Administration.

India was, however, unlikely to ease a ban on the export of malaria drug hydroxychloroquine, which came in addition to the restrictions on the 26 drugs and formulations. The drug is being tested to see if it is effective in treating patients with COVID-19.

The United States’ Health and Human Services has listed hydroxychloroquine as a medical resource that was subject to hoarding prevention measures.

March/April supply issues update published

Dispensing Doctors’ Association, Ailsa Colquhoun, 01 April 2020

The Department of Health and Social Care (DHSC) Medicine Supply Team has published its March/April supply issues update. DDA members can view the full details of the notifications of new and ongoing issues by visiting the supply shortages library.

A summary of the new issues are as follows:

Injectables

Diazepam (Diazemuls) 10mg/2ml emulsion for injection

Gadovist preparations

Orals

Calcium Folinate 15mg tablets

Clozapine (Zaponex) 25mg oro-dispersible tablets

Cycloserine 250mg capsules

Diclofenac/Misoprostol (Arthrotec 50) 50mg/200 microgram tablets

Fluoxetine 10mg tablets

Levodopa/carbidopa/entacapone (Stanek) tablets – various strengths

Medroxyprogesterone (Provera) 400mg tablets

Paracetamol tablets

Promazine 25mg/50mg tablets

Valproate semisodium (Depakote) 250mg/500mg tablets

Others

Proctosedyl (cinchocaine 0.5%/hydrocortisone 0.5%) Ointment

Clenil Inhaler Range

Eye drops/treatments

Betamethasone (Vistamethasone) 0.1% eye drops

Fluocinolone Acetonide (Iluvien) 190 mcg Intravitreal implant in applicator

COVID-19: English pharmacies to receive £300m in “advance funding”

C+D, Eliza Slawther, 31 March 2020

Community pharmacies in England will receive £300 million in “advance funding” over the next two months to alleviate cashflow issues caused by COVID-19, the PSNC has announced.

The total sum will be “paid as uplifts to contractors’ January and February payments” – payable in April and May.

The £300m is not new money for the sector and will have to be “reconciled at a later date”, the Pharmaceutical Services Negotiating Committee (PSNC) announced today (March 31).

The advance funding is “recognition of the significant cashflow pressures facing the sector at this point in the COVID-19 pandemic”, it said.

There will be two cash injections, with the first payment of £200m made on or around April 1. The second payment, of £100m, will be made at the end of April or early May, the PSNC added.

The NHS Business Services Authority (NHS BSA) is “working to recalculate payments”, with the intention that the initial £200m will be paid alongside the planned April 1 payment.

The PSNC said it is “in ongoing discussions about the need for more funding for the sector” to help contractors with costs arising from “increasing prescription numbers, staffing costs, one-off costs and rising drugs bills” as a result of the COVID-19 pandemic.

“While this funding injection is a step in the right direction, PSNC has told HM Government that it is not sufficient to cover contractors’ rising costs and to help them to manage the new pressures on their businesses,” the negotiator added.

“Funding gesture is not enough”

Although the organisation “welcomes” the intention of the forward payment, the “funding gesture alone is not enough”, PSNC chief executive Simon Dukes commented.

The negotiator has informed the government that “it simply will not be sufficient to help many contractors to meet the rapidly increasing costs that they are facing as a result of this pandemic”, he said.

“Community pharmacy is at a critical point, with pharmacy teams and businesses under extreme pressure and many pharmacies now not financially viable,” Mr Dukes added.

The PSNC and other pharmacy bodies are trying to “persuade” the government of the “very urgent need for further emergency funding support”, he said.

This was also reported in The Pharmaceutical JournalP3 Pharmacy, and Pharmacy Business.

EMA warns consumers about falsified COVID-19 drugs from online pharmacies

European Pharmaceutical Review, Hannah Balfour, 31 March 2020

The European Medicines Agency (EMA) has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications.

The European Medicines Agency (EMA) is urging the public not to buy medicines from unauthorised online pharmacy websites and vendors. They state that any claim a product can treat or prevent COVID-19 is unfounded, as there are no approved therapeutics or vaccines as of yet.

They also stated that if a legitimate medicine that is otherwise in short supply is listed on an online pharmacy it is likely to be falsified, ie, a fake being passed off as the authorised product. Falsified medicines may contain the wrong or no active pharmaceutical ingredient (API) or the correct API in the wrong dosage. They are often found to also contain harmful substances, unsafe for human consumption.

The EMA is advising consumers to buy products from local pharmacies or retailers and if using online pharmacies, ensure that it they are registered with the national competent authorities.

Online pharmacies registered in Europe carry a common logo with the flag of the European Union country where the pharmacy is registered below it. Clicking on the logo should redirect customers to the website of their national authority and show a list of all legally operating online pharmacies, allowing them to check if the pharmacy they are using is registered before purchase.

Click here for the lists of registered online pharmacies in EU countries.

BMA speaks out as healthcare workers still waiting for protective gear

Metro, Harriet Line, 31 March 2020

Healthcare workers treating coronavirus patients should not have to risk their lives because they do not have adequate personal protection equipment, the British Medical Association has said.

The BMA called on ministers to ‘clarify’ what medics should be expected to do after concerns about PPE shortages, with nurses on some Covid-19 wards without vital masks and gowns.

Communities secretary Robert Jenrick has said the government ‘cannot and should not ask people to be on the front line without the right protective equipment’. And on Monday, 2.5million aprons, 870,000 eye protectors, 218,000 respiratory masks, 1million surgical masks and 11million pairs of gloves were delivered to NHS trusts. But they have yet to reach many hospitals and GP practices.

Deputy chief medical officer Dr Jenny Harries has apologised, admitting distribution had been ‘tricky at times’.

She said the Army had been called in to help. The BMA’s Dr Rob Harwood said: ‘We need clarity from the government on what it is that healthcare staff should do and, particularly, what risks they should not have to take if they do not have adequate PPE.

‘Doctors are placing themselves at significant risk by treating patients on the front line and there are concerns that sometimes this is without adequate PPE.

‘While the government has been letting us know that protection is on the way, there are still doctors and other NHS staff who today, tomorrow and in the coming week, may face the daunting prospect of having to consider treating patients without adequate protection.

‘A lack of adequate protection is not only dangerous, it may be fatal.’

Meanwhile, many care workers are still without masks or hand sanitiser, with just plastic aprons and gloves for protection. Unison’s Christina McAnea said: ‘Care workers are being treated as though their safety doesn’t matter. They feel forgotten about — at the bottom of the pile.’

This was also reported in the Financial Times.

GIRP Secretary-General discusses the challenges of medical supplies distribution

New Europe, 31 March 2020

As part of New Europe’s COVID-19 Livestream series, Monika Derecque-Pois, Secretary-General of the European Health Care Distribution Association (GIRP), discussed the current challenges of distributing medical supplies across Europe.

GIRP is responsible for the yearly wholesale distribution of around 15 billion packs of medicines as well as a wide range of healthcare products to pharmacists in 34 European countries. With the COVID-19 pandemic, GIRP’s works have been more vital than ever in making sure the access to medicine and healthcare products continues amid lockdown measures.

“Before and shortly after the lockdown, we have seen a surge in demand with [some] having tripled the normal volume [of orders],” Derecque-Pois said. “We have worked around the clock doing night shifts and weekend shifts to bring the medicines due to the surge of demands in pharmacies. Everybody tried to fill their prescriptions or to stock up on self-medication to not go out as often and there was a real peak [as a result].”

Some of the distribution challenges faced by GIRP have involved the harder access of drivers to countries going through a lockdown and increase border control security. GIRP is in constant talks with government officials to expedite the delivery to countries in need like Italy. The best advice right now is to be mindful of others and purchase only what you need.

“We should plead for solidarity. People should only purchase or ask for the medicines they really need because other patients need those medicines. So, no hoarding, be reasonable and just take what is actually needed,” Derecque-Pois said.

Media and Political Bulletin

30 March 2020

Media Summary

Small pharmacies facing closure as drug prices rise

The Times, Callum Jones, 30 March 2020

The Times reports that hundreds of community pharmacies face an “imminent risk” of going under without urgent government support, Rishi Sunak has been warned.

Industry leaders called on ministers to act “without delay” and increase funding for chemists to help keep their doors open. Jonathan Cooper of Coopers Chemists said the “massive increase” in demand created by Covid-19 “will be our swansong” unless the sector was thrown a lifeline.

There are more than 12,000 community pharmacies in England and Wales. A surge in demand for prescription medication has exacerbated an existing issue, Mr Cooper said, with the NHS drugs tariff in some cases considerably lower than the prices pharmacies pay suppliers.

The NPA said the country’s network of chemists was “financially extremely fragile”. The PSNC said the “additional challenge” of drug price increases required government intervention.

Coronavirus: Two-thirds of Britons want UK to request Brexit extension to focus on pandemic, poll shows

The Independent, Harry Cockburn, 29 March 2020

The Independent reports that two-thirds of people in the UK want the government to request an extension to the Brexit transition period in order to focus on the coronavirus outbreak, a new opinion poll indicates.

The poll of over 2,000 adults revealed such an extension was supported by all age groups, social grades and UK regions, and also had relatively high support among Conservative and Brexit Party voters. The Focaldata poll was commissioned by cross-party campaign groups Best for Britain and Hope Not Hate.

The call for an extension to the transition period has been echoed by numerous bodies and pressure groups, including the Scottish and Welsh governments.

UK ministers under fire over ventilator delays

Financial Times, Michael Pooler, Laura Hughes and Jim Brunsden, 27 March 2020

This article is subject to copyright terms and conditions. Please access the full article here.

Vital drug for people with lupus running out after unproven Covid-19 link

The Guardian, Sarah Boseley, 27 March 2020

The Guardian reports that a race for an unproven “cure” for Covid-19 is clearing pharmacy shelves of a medicine that is vital for up to 5 million people around the world suffering from lupus, as countries abandon the trials that would show whether hydroxychloroquine works against coronavirus infection.

Both Italy and France have said doctors can now prescribe hydroxychloroquine, even though there is no robust evidence to prove that it is effective against Covid-19. Popular pressure for access to the drug has been ramped up by pronouncements from presidents Donald Trump in the US and Jair Bolsonaro in Brazil, both of whom have claimed it is a cure.

But the drug is already running out for people with lupus, a disorder of the immune system, who rely on it to stay well. Shortages are being reported from the UK to Thailand to France. India, which manufactures the raw ingredient, has banned all exports of the chemical to safeguard its own supplies and recommended all health workers to take the drug to protect themselves from the virus.

UK government calls for increased supply of COVID-19 testing kits

European Pharmaceutical Review, Victoria Rees, 27 March 2020

European Pharmaceutical Review reports that the UK government has made an urgent call to the life sciences sector to help increase the supply of antigen testing kits for the COVID-19 coronavirus.

The requirement is for commercial supply of the following:

  • Full testing packages

Any of the separate components within the testing package

Any alternative tests government should be considering

The specification for a testing kit is included in the full coverage of the article further down. Any organisations that can supply for sale any or all of the above should email covid19testing@dhsc.gov.uk as soon as possible.

Rules on carrying over annual leave to be relaxed to support key industries during COVID-19

Department for Environment, Food & Rural Affairs, Department for Business, Energy & Industrial Strategy, The Rt Hon George Eustice MP, and The Rt Hon Alok Sharma MP, 27 March 2020

Workers who have not taken all of their statutory annual leave entitlement due to COVID-19 will now be able to carry it over into the next 2 leave years, under measures introduced by Business Secretary Alok Sharma on Friday 27 March.

The regulations will allow up to 4 weeks of unused leave to be carried into the next 2 leave years, easing the requirements on business to ensure that workers take statutory amount of annual leave in any one year.

This will mean staff can continue working in the national effort against the coronavirus without losing out on annual leave entitlement.

The changes will also ensure all employers affected by COVID-19 have the flexibility to allow workers to carry over leave at a time when granting annual leave could leave them short-staffed in some of Britain’s key industries, such as food and healthcare.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Small pharmacies facing closure as drug prices rise

The Times, Callum Jones, 30 March 2020

Hundreds of community pharmacies face an “imminent risk” of going under without urgent government support, Rishi Sunak has been warned.

Industry leaders called on ministers to act “without delay” and increase funding for chemists to help keep their doors open. Jonathan Cooper, of Coopers Chemists, an independent chain in Yorkshire, said the “massive increase” in demand created by Covid-19 “will be our swansong” unless the sector was thrown a lifeline.

In a letter to Mr Sunak, the chancellor and his local MP, Mr Cooper wrote: “There is a serious and imminent risk that the NHS will lose a service that is clearly vital to the community and our country. Community pharmacy desperately needs to be properly remunerated for the work we are doing and not left with debts we will never be able to pay off as a result of giving everything to tackle this pandemic.”

There are more than 12,000 community pharmacies in England and Wales. Mr Sunak has spoken of working in his mother’s Southampton chemist when growing up.

A surge in demand for prescription medication has exacerbated an existing issue, Mr Cooper said, with the NHS drugs tariff — which pharmacies receive for selling generic prescription drugs — in some cases considerably lower than the prices pharmacies pay suppliers.

“The increase in demand for generics is creating shortages and the cost prices are rising far faster than the tariff and concession system can react,” he wrote. “We have no time or resources to chase the best prices round the wholesalers to mitigate the significant losses . . . we know we are making.”

A Whitehall source said Mr Sunak had received an “enormous” amount of correspondence and was not familiar with the case.

The National Pharmacy Association said the country’s network of chemists was “financially extremely fragile”.

The Pharmaceutical Services Negotiating Committee, which speaks directly with the government on behalf of chemists, said the “additional challenge” of drug price increases required government intervention. Simon Dukes, its chief executive, said the committee was in discussions with officials regarding “protection for pharmacies against sudden price rises”.

Coronavirus: Two-thirds of Britons want UK to request Brexit extension to focus on pandemic, poll shows

The Independent, Harry Cockburn, 29 March 2020

Two-thirds of people in the UK want the government to request an extension to the Brexit transition period in order to focus on the coronavirus outbreak, a new opinion poll indicates.

The poll of over 2,000 adults revealed such an extension was supported by all age groups, social grades and UK regions, and also had relatively high support among Conservative and Brexit Party voters.

The Focaldata poll was commissioned by cross-party campaign groups Best for Britain and Hope Not Hate.

The call for an extension to the transition period has been echoed by numerous bodies and pressure groups, including the Scottish and Welsh governments.

Two-thirds of respondents (64 per cent) said they agreed with the statement: “The government should request an extension to the transition period in order to focus properly on the coronavirus.” However, just a third (36 per cent) agreed with the statement: “The Brexit transition period must end on 31 December whether a deal has been fixed or not.”

Best for Britain said the responses broke down into predictable support from those who voted for Labour (84 per cent) and the Lib Dems (83 per cent) at the last election, but that the first statement was also supported by nearly half of those who voted Conservative (44 per cent) and a fifth of Brexit Party voters (19 per cent).

An extension was supported by more than 50 per cent of people across all age groups, with 18-24 year olds the most supportive (78 per cent) and 65-plus year olds the least supportive (although still 52 per cent) – meaning there is no generational divide in the country over an extension request.

The SNP has also urged the UK government to “hit pause” on the Brexit negotiations and seek an extension to the transition period while authorities grapple with the coronavirus pandemic.

The party’s Brexit spokeswoman, MP Philippa Whitford, said it would be irresponsible and “an act of economic and social self-harm” to continue “hurtling” towards the transition deadline.

The Focaldata poll also indicated most people would like the government to seek membership of the EU Early Warning and Response System (EWRS) for medical emergencies, after it emerged earlier this month the Department of Health had been unsuccessful in lobbying No 10 to remain a member.

A total of 65 per cent of people in the UK, including 55 per cent of those who voted Conservative at the last election, want the government to seek membership of the EWRS.

The EWRS was set up in 1998 to “allow exchange of information on risk assessment and risk management for more timely, efficient and coordinated public health action”.

The NHS Confederation has identified membership of the EWRS as a priority, arguing that tackling global outbreaks such as coronavirus would become “more difficult if the UK loses access”.

Speaking about the poll, Best for Britain chief executive Naomi Smith said: “It’s simply not reasonable to expect we will have tied up negotiations with the EU by the end of the year while dealing with a warlike emergency. Nor is it desirable.

“By thinking it can complete both challenges at once, the government would be setting itself up for failure with profound economic consequences.

“Most people just want the government to get on with the job at hand so that lives can be saved and normality restored as quickly as possible.”

She added: “The country is simply not in a place to weather two storms at the moment.”

Hope Not Hate chief executive Nick Lowles said: “EU schemes like the Early Warning and Response System and the ventilator procurement programme are critical tools for responding to this urgent public health crisis.

“Healthcare workers are doing a fantastic job, but they cannot fight this disease alone. They need all the help they can get.

“The government must put politics aside and urgently seek participation in these schemes. It would be foolhardy for ideology to get in the way of practical measures to keep people safe.”

The government has recently said it remains “fully committed to the negotiations”, which it said are continuing.

The Independent has contacted Downing Street for comment.

UK ministers under fire over ventilator delays

Financial Times, Michael Pooler, Laura Hughes and Jim Brunsden, 27 March 2020

This article is subject to copyright terms and conditions. Please access the full article here.

Vital drug for people with lupus running out after unproven Covid-19 link

The Guardian, Sarah Boseley, 27 March 2020

A stampede for an unproven “cure” for Covid-19 is clearing the pharmacy shelves of a medicine that is vital for up to 5 million people around the world suffering from lupus, as countries bow to populist pressure and abandon the trials that would show whether hydroxychloroquine works against coronavirus infection.

Both Italy and France have said doctors can now prescribe hydroxychloroquine – a less toxic version of the malaria drug chloroquine – even though there is no robust evidence to prove that it is effective against Covid-19.

Popular pressure for access to the drug has been ramped up by pronouncements from presidents Donald Trump in the US and Jair Bolsonaro in Brazil, both of whom have claimed it is a cure. An Australian businessman, the former politician Clive Palmer, has pledged to fund 1m doses “to ensure all Australians would have access to the drug as soon as possible”.

But the drug is already running out for people with lupus, a disorder of the immune system, who rely on it to stay well. Shortages are being reported from the UK to Thailand to France. India, which manufactures the raw ingredient, has banned all exports of the chemical to safeguard its own supplies and recommended all health workers to take the drug to protect themselves from the virus.

“We are incredibly concerned at the moment,” said Paul Howard of Lupus UK. “We started receiving inquiries from patients across the UK about a week ago. That’s been rapidly increasing – more and more people each day.”

For 90% of the more than 60,000 people in the UK with lupus, hydroxychloroquine is the mainstay of their treatment, preventing their immune system making too many antibodies, which can otherwise attack the body’s organs – mainly the kidneys and the skin, but also the heart, lungs and brain.

“Their local pharmacies don’t have any stocks available on the shelves,” said Howard. “They have no date for when they can expect stocks to arrive.”

There is no good alternative, he said. Other immunosuppressants have toxic side-effects and may put people at greater risk of Covid-19.

A nationalistic scramble is now on around the world to secure supplies of hydroxychloroquine in spite of the absence of rigorous evidence in the treatment of the coronavirus. One small trial in China produced good results, but was far from sufficient to show that it works.

In France, the government caved to pressure from a doctor who ran his own very small and rapid trial of the drug combined with an antibiotic in 26 people, using methodology that has been seriously criticised. Dr Didier Raoult, a professor of infectious diseases who works at La Timone hospital in Marseille, then declared in a video on YouTube that chloroquine was a cure for Covid-19 and should be used immediately.

Raoult walked out of the scientific advisory committee advising the government. A social media frenzy began, with allegations that the government was being influenced by the big pharmaceutical companies which wanted to block hydroxychloroquine because it was cheap, being out of patent. People queued outside Raoult’s hospital to be tested and get the drug, defying the lockdown. Finally, the French government gave way and decreed that hospitals could prescribe it for any Covid-19 patient. They can also give the anti-HIV medicine which is supposed to be in global trials for Covid-19, Kaletra, which is a combination of lopinavir and ritonavir.

Italy has followed suit. The government announced on Friday that chloroquine and hydroxychloroquine could be used to treat all Covid-19 patients and paid for entirely by the Italian national healthcare system. It would also pay for Kaletra.

The impact on the global trials to find out what really works is serious. Nick White, a professor of tropical medicine at Mahidol University in Thailand and at the University of Oxford, says the problem is enormous – not so much for malaria, where the drug is now less used, but for lupus patients and for hopes of finding out what works and sharing it globally.

“From Fauci [US government infectious diseases adviser, Dr Anthony Fauci] to the head of the World Health Organization, everyone says trials. It may be worse than nothing. We don’t know,” he said.

“The nationalistic shuttering down of export and import of drugs is serious. Drugs are manufactured in relatively small numbers of places and have to be moved to other places.

“The indirect harm could be worse than the impact of Covid-19,” he said. “it is not just the drugs that might work. It is all drugs. Italy, for instance, is a major source of drugs for the NHS. This is a very big area. It is getting bigger by the minute. And the opportunity to answer the sensible question – do these things work, yes or no? – is narrowing as countries become more nationalistic in terms of hoarding drugs.”

UK government calls for increased supply of COVID-19 testing kits

European Pharmaceutical Review, Victoria Rees, 27 March 2020

The UK government has reached out to the life sciences sector to ask potential suppliers of COVID-19 testing kits to get in contact.

The UK government has made an urgent call to the life sciences sector to help increase the supply of antigen testing kits for the COVID-19 coronavirus.

The requirement is for commercial supply of the following:

  • Full testing packages

Any of the separate components within the testing package

Any alternative tests government should be considering

The specification for a testing kit is as follows:

1 Swabs:

Nasopharangeal (Floxsynthetic fiber tipped (polyester) or flocked swabs) with polystyrene shafts that are scored at 80mm for a breakpoint

Nasopharyngeal (minitip) are currently preferred

No discoloration on the swab bud (ie, yellowing or brown discoloration)

Sterilised and individually wrapped

No calcium alginate swabs

No swabs with wooden shafts

Nose and throat swabs (Rayon tipped – US Food and Drug Administration (FDA) review in process)

1 Sample vial:

Glass (20.25 +- 0.25 x 47.25+- 0.5) and plastic (TBD)

1 Viral transport medium:

COVID-19 transport medium

1 Alcohol/sanitiser wipes

2 Re-packaging (storage/biohazard packaging)

  • Vial wrap – specification TBD
  • Sealed zip lock bag
  • Second bag (plastic/cushioned)
  • Sealable container – ‘biobottle’
  • Postal ‘biobox’.

In addition, there is also a requirement for swabs for PCR diagnostic testing.

Any organisations that can supply for sale any or all of the above should email covid19testing@dhsc.gov.uk as soon as possible.

Rules on carrying over annual leave to be relaxed to support key industries during COVID-19

Department for Environment, Food & Rural Affairs, Department for Business, Energy & Industrial Strategy, The Rt Hon George Eustice MP, and The Rt Hon Alok Sharma MP, 27 March 2020

Workers who have not taken all of their statutory annual leave entitlement due to COVID-19 will now be able to carry it over into the next 2 leave years.

Workers who have not taken all of their statutory annual leave entitlement due to COVID-19 will now be able to carry it over into the next 2 leave years, under measures introduced by Business Secretary Alok Sharma today (Friday 27 March).

Currently, almost all workers are entitled to 28 days holiday including bank holidays each year. However, most of this entitlement cannot be carried between leave years, meaning workers lose their holiday if they do not take it.

There is also an obligation on employers to ensure their workers take their statutory entitlement in any one year – failure to do so could result in a financial penalty.

The regulations will allow up to 4 weeks of unused leave to be carried into the next 2 leave years, easing the requirements on business to ensure that workers take statutory amount of annual leave in any one year.

This will mean staff can continue working in the national effort against the coronavirus without losing out on annual leave entitlement.

The changes will also ensure all employers affected by COVID-19 have the flexibility to allow workers to carry over leave at a time when granting annual leave could leave them short-staffed in some of Britain’s key industries, such as food and healthcare.

Business Secretary Alok Sharma said:

“Whether it is in our hospitals, or our supermarkets, people are working around the clock to help our country deal with the coronavirus pandemic.

“Today’s changes will mean these valued employees do not lose out on the annual leave they are entitled to as a result of their efforts, and employers are not penalised.”

Environment Secretary George Eustice said:

“From our fields to our supermarkets, we are hugely grateful to the many people working around the clock to keep the nation fed.

“At this crucial time, relaxing laws on statutory leave will help ensure key workers can continue the important work to keep supplies flowing, but without losing the crucial time off they are entitled to.

“We welcome the measures the food industry is already taking to keep shelves stocked and supply chains resilient, and will continue to support them with their response to coronavirus.”

The changes will amend the Working Time Regulations, which apply to almost all workers, including agency workers, those who work irregular hours, and workers on zero-hours contracts.

The change is aimed at allowing businesses under particular pressure from the impacts of COVID-19 the flexibility to better manage their workforce, while protecting workers’ right to paid holiday.

Media and Political Bulletin

16 March 2020

Media Summary

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

The Pharmaceutical Journal reports that pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

Martin Sawer told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said. However, he added that “there are not supply shortages”. Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added “there could be a manufacturing issue around the corner.”

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic. A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

Alliance Healthcare said it had faced similar pressures, while a spokesperson for Phoenix said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Martin McKee (professor of European public health at the London School of Hygiene and Tropical Medicine), Anniek de Ruijter (associate professor at Amsterdam Law School) and Mark Flear (reader in law at Queens University, Belfast) write in the Guardian that Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

Media attention has already highlighted the damage that being outside the EMA will do to the British economy, however the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states.

In addition, they write, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

Cathy Harrison, Chief Pharmaceutical Officer at the Department of Health of Northern Ireland, told ITV News that the Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal, saying stockpiling could ‘disadvantage other patients’.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Last week representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks.”

EFPIA reiterates that the continuity of supply of medicines to patients remains of the highest priority, and that members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

Dispensing Doctors’ Association reports that a Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply. This SSP will run until Friday 12 June.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

C+D reports that hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since. All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

Pharmacy Business reports that the GPhC, along with other healthcare regulators, has launched a new guide to help people access safe and right medicines or treatment online. The guide has a six-point check list for anyone going online for medicines or treatment.

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

 

 

Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

‘Unprecedented demand’ for OTC painkillers as COVID-19 outbreak spreads

The Pharmaceutical Journal, Debbie Andalo, 13 March 2020

Pharmaceutical wholesalers are not ruling out supply issues in the near future as demand for medicine rises amid the outbreak.

The owner of LloydsPharmacy has said there is “unprecedented demand” for over-the-counter painkillers as a result of the COVID-19 pandemic.

A statement released on 12 March 2020 from McKesson said it had put processes in place to “minimise” the impact of shortages of medicines and to continue to be able to provide a “consistent supply of critical products” from its stores.

The statement added: “We are doing everything we can to ensure we provide a consistent supply of medicines. This includes sourcing from multiple providers, and putting commitments in place with manufacturers to secure supply.”

Meanwhile, Martin Sawer, executive director of the Healthcare Distribution Association — the membership organisation for UK wholesalers — told The Pharmaceutical Journal that while there are currently no medicines shortages in the UK, there could be issues “around the corner”.

“The demand level for medicines across the board from community pharmacists, doctors and patients has gone up dramatically compared to what it usually is this time of year,” he said.

However, he added that “there are not supply shortages”.

“There may be cases where deliveries into pharmacies may not be the [entire] amount they ordered because they are ordering a lot more than they would normally, so they are not getting the whole delivery the first time.

“The situation is just like supermarkets — they’ve got enough food but people are taking things off the shelves. We’ve got enough medicines.”

Sawer added that wholesalers were using drugs from the stockpiles created for Brexit, but added: “I wouldn’t say I’m not worried [about the impact of COVID-19]. The situation with the coronavirus changes quite quickly and supplies can change quickly but usually that is down to a manufacturing problem which we didn’t know about.

“We are managing at the moment and I feel confident, but there could be a manufacturing issue around the corner.”

A spokesperson for Phoenix, one of the UK’s largest pharmaceutical wholesalers, said it had seen a “considerable increase” in demand for medicines including paracetamol and Calpol.

“We have put in place some order restrictions for certain products to ensure equitable supply across the UK, but again emphasise that customers should only purchase according to need,” they said.

“Prices for some medicines have increased, but this is beyond the control of medicine distributors like Phoenix”.

Similarly, Alliance Healthcare said it had faced similar pressures.

A spokesperson for the wholesaler said: “There has been a significant increase in the demand for products such as paracetamol and ibuprofen over the last few weeks, which has caused some supply constraints.”

Gordon Hockey, director of operations and support at the Pharmaceutical Services Negotiation Committee (PSNC), said the government had already “approached medicine suppliers to assess the impact that COVID-19 could have on the supply chain”.

“The PSNC is keeping a close eye on the generic medicines, including paracetamol, affected by recent price hikes and is making applications to the Department of Health and Social Care (DHSC) for price concessions in the usual way,” he said.

“The PSNC has also commenced discussions with the DHSC on protection for pharmacies against sudden price rises and launched the Community Pharmacy COVID-19 Forum, providing an opportunity for information sharing with other pharmacy and supply chain bodies, DHSC and NHS England and NHS Improvement.”

Brexit threatens UK’s ability to respond to a future pandemic

The Guardian, Martin McKee, Anniek de Ruijter and Mark Flear, 14 March 2020

Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics.

The coronavirus pandemic could not have come at a worse time for the UK and its citizens. Just as UK government ministers are digging in for the really difficult part of Brexit, the negotiations on future relationships with the EU and the rest of the world, a new virus comes out of China that reminds us of just why international co-operation is so important.

The obvious response, one might think, would be to do everything to safeguard those areas where the UK does collaborate, so as to reduce the threat of infectious disease. Instead, the UK has decided to isolate itself from European systems that have been built up over the past decade, many as a result of problems exposed by the 2009 swine flu pandemic.

The UK’s decision to leave the European Medicines Agency (EMA), an arm of the European Commission, has been discussed at length. The EMA is responsible for overseeing clinical trials for new vaccines and medicines for pandemics, and deciding on marketing authorisations for them that apply across the EU. Media attention has highlighted the damage that being outside the EMA will do to the British economy – both through lost activity among UK researchers and suppliers, and by making the UK a less attractive place for major pharmaceutical companies.

However, the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorisation mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states. To make matters worse, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.

The government could, if it wished, go for a much closer alignment with the EU, a choice made by Norway, Liechtenstein, and Iceland, which form the European Economic Area (EEA). These countries are on the same footing as regulators in EU countries. However, the difference is that these countries are in the single market and have accepted its rules. Even Switzerland, which is outside the EEA, has bespoke arrangements with the EMA based on its alignment to EU rules.

A deal similar to the Ukrainian Association Agreement with the EU is another option. But each of these non-member states is outside the EU’s bulk buying mechanism for vaccines and medicines. In any case, all of these models seem unacceptable to the current UK government.

There other ways that the UK could mitigate the problems that come with being outside the EMA. One would be to copy Singapore, which has decided to automatically recognise EMA marketing authorisations, as well as those issued by the US Food and Drug Administration, subject to a 60-day Verification Route. However, this would be contrary to the UK government’s refusal to be a “rule taker”.

Finally, the UK could also, at least in theory, create its own rapid marketing authorisation mechanism. The slight problem is that this would almost certainly be impossible in the short term, not least because of the need to attract skilled staff. Many staff would have to be recruited internationally, and they may well be put off by the UK’s harsh, and extremely expensive, immigration regime. And even if a new UK mechanism did work, it would not necessarily ensure swift access to medicines as UK standards may diverge from those in the EU, a real threat given the upcoming implementation of the recent EU clinical trials regulation.

Concerns about UK divergence have been exacerbated by health secretary Matt Hancock, commenting that the UK’s medicines regulator could reduce bureaucracy, which signifies an intention to diverge. Clinical trials data and marketing authorisations in the UK, especially when made on the basis of that data, may not satisfy the EMA. Some pharmaceutical companies may therefore opt to base clinical trials in the EU, or in third countries that apply EU-compliant standards, so as to ensure they obtain marketing approval through the EMA for the EU market.

Pharmaceutical companies with UK manufacturing plants, including AstraZeneca, have already established batch control sites and pharmacovigilance teams in EU member states. This is to ensure they can continue to lawfully supply medicines in the EU. Pharmaceutical companies, facing the very large administrative burden involved in obtaining marketing authorisation, are likely to prioritise the EU’s single market over the UK’s far smaller market, as already happens with Switzerland and Canada.

It is a Canada-style trade deal that the UK is now pursuing, although it has not ruled out what it describes as an Australia-style deal, which is in effect code for no deal. Yet this could take upwards of eight years to agree, and EU negotiators are likely to drive a hard bargain. As with any deal with the US, itself very unlikely, this will demand that the UK make choices about who to align with.

For all of these reasons, if, as seems likely, a vaccine is developed against the 2019-nCoV virus, the UK is likely to have to join the queue for access with other countries, and to pay more than it otherwise would as an EU member state.

So while, in one respect, the timing of the pandemic could not have been worse for the UK, in another it could provide an opportunity to reflect on whether an isolationist ideology really is such a good idea. It has taken many years to build up the EU’s systems of defences against infectious disease. In an ever more uncertain and interconnected world, is it really a good idea to withdraw from them?

Martin McKee is professor of European public health at the London School of Hygiene and Tropical Medicine; Anniek de Ruijter is associate professor at Amsterdam Law School; Mark Flear is reader in law at Queens University, Belfast.

This was reported on by The New European, the Independent, the Mirror and the Express.

Covid-19 presenting ‘increasing pressures’ on community pharmacies

ITV News, 14 March 2020

The Covid-19 strain of Coronavirus is presenting ‘increasing pressures’ on community pharmacies, according to the Chief Pharmaceutical Officer.

Cathy Harrison says people needing medication should not stockpile and should continue to take their medication as normal.

It comes as Northern Ireland saw its biggest spike in Coronavirus cases on Friday with 29 people diagnosed with the disease. Three cases came from community transmission.

There have been 90 confirmed cases in the Republic of Ireland.

Retail premises have saw items such as toilet rolls and hygiene products being cleared from shelves.

The Chief Pharmaceutical Officer says stockpiling could ‘disadvantage other patients’.

“People should order prescriptions and take their medicines as normal,” said Harrison.

“Covid-19 is presenting increasing challenges for the dedicated staff working in our community pharmacies,” she continued.

“The Department is working to ensure that everyone continues to have access to their local community pharmacy. It is vital at this busy time that we are mindful of the pressure that community pharmacy staff are under.

“There is no need for you to do anything new or different when ordering or taking your medicines.”

She continued: “People should order prescriptions and take their medicines as normal.

“Extra supplies should not be ordered from your doctor.

“Stockpiling or purchasing medication that you do not need is completely unnecessary and could disadvantage other patients.

“There are no prescription medicine shortages as a result of Covid-19.”

Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines during the COVID-19 pandemic

EFPIA, 13 March 2020

Earlier today representatives from EFPIA joined a call with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič together with representatives from across the medicines and medical devices supply chain, to discuss the potential impact of the coronavirus on the supply of vaccines and medicines.

Speaking after the first of what will become weekly calls, EFPIA Director General Nathalie Moll said: “We welcome the proactive approach from the Commissioners and the opportunity for regular dialogue at this critical time. The biopharmaceutical industry in Europe remains fully committed to global efforts to care for those affected, contain the outbreak and develop resources to tackle future outbreaks; through research into vaccines, diagnostics and treatments for COVID-19, through donations and in-kind support on the ground and by working to ensure the continued supply of medicines and vaccines.”

The continuity of supply of our medicines to patients has been, and remains, of the highest priority. EFPIA members have comprehensive business continuity and contingency plans in place. Companies are constantly monitoring global and market-specific demands for their products and take all inventory decisions carefully because supply disruptions can affect patients globally.

EFPIA is in constant dialogue with its members and authorities. From the latest information received, there is limited immediate risk that COVID-19 would impact manufacturing and supply of branded medicines in Europe in the short term. While supply and demand vary by product, EFPIA members are not aware of any significant near-term impacts on the availability of our medicines and vaccines. Companies have also assessed potential longer-term impacts. The situation is fluid, but at this point EFPIA members do not anticipate impacts to their supply chains unless disruption due to the COVID-19 outbreak is sustained over the next several months. We continue to monitor the situation closely and we will keep an open and constant dialogue with the European Medicines Agency and the European and National Authorities as important information becomes available.

The uncertainty with respect to the length and extent of the pandemic poses a challenge for everyone involved in the fight against COVID-19. We support the Commission in its goals to minimize any impacts to the quality of care for patients in Europe, including access to medicines and vaccines. We look forward to continuing to work in partnership with the Commission and EMA, the Member States, their Competent Authorities and our supply chain colleagues to address challenges as they arise with pragmatic approaches that put patient needs first. At the same time, researchers from across our member companies will continue the quest to find diagnostics, vaccines and treatments to address the crisis.

Fluoxetine 10mg tablet SSP published

Dispensing Doctors’ Association, Ailsa Colquhoun, 13 March 2020

A Serious Shortage Protocol (SSP) has been issued for fluoxetine 10mg tablets. This enables community pharmacists in England, Wales and Northern Ireland to supply patients with fluoxetine 10mg capsules.

Dispensers faced with shortages of fluoxetine 10mg tablets should request that the GP alters the prescription to fluoxetine 10mg capsules to enable the supply.

This SSP will run until Friday 12 June. For more information, visit the NHS Business Services Authority (BSA) website.

This was also reported in C+D.

Current list of products under export ban due to national shortages

C+D, Eliza Slawther, 13 March 2020

Hydroxychloroquine has been added to the list of medicines and products that cannot be exported from the UK as of March 14.

An initial 23 products were listed on October 4 last year, with more added and removed since.

All the products are at “high risk of parallel export”, due to their prices increasing in EU countries, the Department of Health and Social Care (DH) told C+D in October.

By restricting wholesalers from exporting these products, the DH hopes “to tackle ongoing shortages and minimise the impact on patients”, it also said.

The list will be updated with each product that the DH subjects to export restrictions, and applies to all medicines containing the active ingredients, whether generic or branded.

GPhC launches guidance on getting medicines online

Pharmacy Business, Kiran Paul, 13 March 2020

The General Pharmaceutical Council (GPhC), along with other healthcare regulators, today launched a new guide to help people access safe and right medicines or treatment online.

The guide has a six-point check list for anyone going online for medicines or treatment:

  1. Check if the online healthcare service and healthcare professionals working there are registered with UK regulators.
  2. Ask questions about how the service works
  3. Answer questions honestly about your health and medical history
  4. Find out your options for treatment and how to take any medicines you’re prescribed
  5. Expect to be asked for consent for information to be shared with other healthcare professionals involved in your care
  6. Check what after-care you will receive

“Online healthcare services and apps can bring real benefits for people, but there can also be significant risks, particularly if you use online services which are not regulated in the UK,” commented Duncan Rudkin, chief executive of the GPhC.

“We hope this advice will be particularly helpful during the coronavirus outbreak, when more people may be considering going online for medicines and when some unregulated websites may be offering fake medicines or false information”.

The guide also offers supporting information such as methods to check the regulatory status of the services and professionals.

In addition to the GPhC, the online guide is supported by Care Quality Commission, Healthcare Improvement Scotland, Healthcare Inspectorate Wales, General Medical Council, Medicines and Healthcare Products Regulatory Agency, Nursing and Midwifery Council, Pharmaceutical Society of Northern Ireland, Pharmacy Forum NI and the Royal Pharmaceutical Society.

Sandra Gidley, president of the RPS, said: “It is important to recognise there are benefits and risks to buying medicines online. Keeping patients safe is essential as there are many unregulated sites out there which look legitimate.

“The guidance builds on recommendations from across healthcare that will help people to avoid illegal sites and help protect patients from fake medicine or obtaining prescription-only medicines without a prescription.”

Media and Political Bulletin

13 March 2020

Media Summary

Call for pharmacists to be allowed to dispense from original packs during COVID-19 pandemic

The Pharmaceutical Journal, Carolyn Wickware, 12 March 2020

The Pharmaceutical Journal reports that the chief executive of the NPA, Mark Lyonette, has called on the NHS to implement a series of contingency measures after the World Health Organization declared the COVID-19 outbreak a pandemic.

In a statement, the NPA called on the NHS and the government to implement eight contingency measures “to mitigate against the impact of COVID-19 on pharmacy businesses”. The proposed measures include enabling pharmacists to “save time in the dispensing process by moving to original pack dispensing, rather than breaking packs to reach the prescribed number of tablets”, as well as allowing “flexibility in relation to re-packing medicines for sale from a bulk pack”.

The NPA also calls on the government to “suspend obligations for non time-dependent pharmacy tasks,” noting the recent cancellation of the national clinical audit. It said the measures would “help pharmacies maintain continuity of service to patients” in the face of an outbreak.

Coronavirus triggers sharp rise in price of pain relief medication

The Guardian, Zoe Wood and Sarah Butler, 12 March 2020

The Guardian reports that the cost of over-the-counter pain relief medication has jumped in the UK as drugmakers demand price increases on the back of raw material shortages triggered by the coronavirus outbreak.

High street retailers and pharmacies confirmed that the cost of sourcing paracetamol, ibuprofen and aspirin had all risen sharply in recent weeks, in some cases by as much as 30%, as drugs wholesalers sought to pass on higher costs.

Some independent pharmacies are struggling with the wholesale price rises, while big chains have largely been able to use their financial firepower to absorb the costs.

Some suppliers have placed limits on the volume of pain relief products they will provide to retailers and pharmacies, to ensure stock is distributed evenly around the country. In turn, many retailers are limiting the number of boxes of pain relief and children’s medication shoppers can purchase.

This was also reported in the Mirror.

Revealed: 142 pharmacies in England have closed in a year-and-a-half

C+D, Eliza Slawther, 12 March 2020

An exclusive C+D investigation has identified that at least 142 bricks-and-mortar community pharmacies closed across England between May 2018 and October 2019. The new findings add to the 140 pharmacies identified by a 2018 C+D investigation as having closed between November 2016 – the month before the 12% funding cuts came into force – and May 2018.

More than half of closures since May 2018 have been pharmacies owned by CCA members. Commenting on this, CCA chief executive Malcolm Harrison said the level of funding available to community pharmacy “cannot sustain the current scale of the network”.

“We need to find a way to allow the network to restructure to reflect funding levels,” he added.

Mr Harrison said the CCA is calling for NHS England to “work with the sector” to prevent the “gradual erosion of quality and safety of care for patients as funding is continually squeezed”.

 

Parliamentary Coverage

Budget 2020

Transport

  • In a drive to promote air quality improvement, the government announced in its Budget that it will remove the entitlement to use red diesel except for agriculture, fish farming, rail and non-commercial heating.
  • Road transport is responsible for 91% of domestic transport greenhouse gas emissions and is one of the biggest contributors to poor air quality in the UK’s towns and cities. The government has set ambitious targets to increase the number of zero emission vehicles on the road and is currently consulting on bringing forward the phaseout date for the sale of new petrol and diesel cars and vans from 2040.
  • The government will freeze fuel duty for a tenth year in a row

Sector investment

According to the new Budget, public R&D investment, including in the life sciences, will be increased to £22 billion per year by 2024-25. The announcement comes days after the UK government pledged a £46 million investment package to develop a coronavirus vaccine and develop a test for the disease. This additional support brings the UK’s investment into COVID-19 research to £65 million.

House of Lords – Written Answer

Baroness Bennett of Manor Castle (asked on 27 February 2020): Department of Health and Social Care European Medicines Agency Lords HL1980 To ask Her Majesty’s Government whether Brexit has resulted in any changes in the UK’s participation in, and access to, the European Medicines Agency; if so, what assessment they have made of the impact this will have on the UK’s ability to respond to coronavirus; and what steps they intend to take as a result.

Lord Bethell (answered on 12 March 2020): As of 1 January 2020, we are in the transition period during which the United Kingdom will continue to follow European legislation and European Medicines Agency (EMA) processes and decisions until 31 December 2020. We continue to receive public safety information from the EMA and have firm links with the World Health Organization and other key international public health organisations working on this issue. The Government has set out its negotiation approach with the European Union, which includes commitments for cooperation and information sharing to enable regulators to act promptly to safeguard patient safety and public health.

The UK is a world leader in preparing for and managing public health incidents and on 3 March the Government published its action plan to tackle the spread of coronavirus. A copy of Coronavirus: action plan. A guide to what you can expect across the UK is attached.

 

Full Coverage

Call for pharmacists to be allowed to dispense from original packs during COVID-19 pandemic

The Pharmaceutical Journal, Carolyn Wickware, 12 March 2020

The chief executive of the National Pharmacy Association, Mark Lyonette, has called on the NHS to implement a series of contingency measures after the World Health Organization declared the COVID-19 outbreak a pandemic.

Pharmacists should be able to dispense from original packs as a time-saving contingency measure to cope with COVID-19, the National Pharmacy Association (NPA) has said.

In a statement, published on 11 March 2020, the NPA called on the NHS and the government to implement eight contingency measures “to mitigate against the impact of COVID-19 on pharmacy businesses”.

It said the measures would “help pharmacies maintain continuity of service to patients” in the face of an outbreak.

The NPA’s proposed measures include enabling pharmacists to “save time in the dispensing process by moving to original pack dispensing, rather than breaking packs to reach the prescribed number of tablets”, as well as allowing “flexibility in relation to re-packing medicines for sale from a bulk pack”.

It also calls on the government to “suspend obligations for non time-dependent pharmacy tasks,” noting the recent cancellation of the national clinical audit.

Mark Lyonette, chief executive at the NPA, said pharmacists are “meeting requests for advice about preventing coronavirus”, while also fulfilling everyday tasks.

“As always, community pharmacy is playing an invaluable role by diverting routine activity away from other parts of the health service facing extra workload,” he said.

“Therefore, it is very important that pharmacies are supported during this period, to stay operational as businesses and effective as frontline providers of patient care.”

The measures also asked the government to “consider the knock-on impact of limited hospital capacity for palliative care”, suggesting that community pharmacies may help more people in the community at the end of their lives.

The NPA’s call for improved contingency measures comes after the Pharmaceutical Services Negotiating Committee said it was in talks with the NHS and the Department of Health and Social Care about funding arrangements for pharmacies that need to close temporarily and “cash flow solutions” to help pharmacists cope with rising medicine prices.

“Many pharmacies are small businesses with existing cash flow problems,” the NPA statement said.

“Coronavirus could exacerbate this situation, so an NHS scheme may be necessary to brings forward payments to pharmacy businesses and cover shortfalls.”

Pharmacists have already told The Pharmaceutical Journal that they have seen the cost of paracetamol increase drastically following the news that India would cease parallel exporting of the drug.

The World Health Organization declared the COVID-19 outbreak to be a pandemic on 11 March 2020.

Coronavirus triggers sharp rise in price of pain relief medication

The Guardian, Zoe Wood and Sarah Butler, 12 March 2020

The cost of over-the-counter pain relief medication has jumped in the UK as drugmakers demand price increases on the back of raw material shortages triggered by the coronavirus outbreak.

High street retailers and pharmacies confirmed that the cost of sourcing paracetamol, ibuprofen and aspirin had all risen sharply in recent weeks, in some cases by as much as 30%, as drugs wholesalers sought to pass on higher costs.

Some independent pharmacies are struggling with the wholesale price rises – one reported having to push through several successive increases – while big chains have largely been able to use their financial firepower to absorb the costs.

Christian Jakobsson, the managing director of online pharmacy Medino, said its supplier was now charging 85p for 32 capsules of 500mg paracetamol, which was a third – or 21p – more than in February. “We have seen similar price increases for ibuprofen,” he added.

Boots said it was aware of some wholesale price increases, but said: “Customers can be reassured that the cost of their regular brands, including Boots own brand paracetamol, has not and will not go up. The same is true for our antibacterial products.”

It is understood that Aspar Pharmaceuticals, a major supplier of pain relief medicines to chemists and supermarkets, including market leader Tesco, wrote to clients this week asking for a near 20% price increase on its aspirin and paracetamol. Another supplier, Bell’s Healthcare, is also understood to have asked for a similar price rise on ibuprofen.

In its letter to clients, Aspar said it had been forced to put up prices as there was a shortage of raw materials from both China and India, pushing up the cost of its supplies. Aspar declined to comment.

Last week India, the world’s biggest supplier of generic drugs, limited the export of certain medicines, including paracetamol. The Chinese shutdown has fractured the industry’s supply chain as many of India’s drugmakers get their base ingredients there.

Some suppliers have placed limits on the volume of pain relief products they will provide to retailers and pharmacies, to ensure stock is distributed evenly around the country. In turn, many retailers are limiting the number of boxes of pain relief and children’s medication shoppers can purchase.

Boots said it had seen an increase in sales of hand sanitisers and cold, flu and pain relief medication. On Tuesday it imposed a limit of two items per customer on cough and cold medication, pain relief, children’s medicines, thermometers and tissues, in addition to baby sterilising and antibacterial products, hand sanitiser and handwash.

“Given current demand, we are exploring new avenues of supply and alternative brands,” said a Boots spokeswoman. “We will endeavour to price appropriately, to reflect costs within our control.”

Phoenix, the owner of the Rowlands pharmacy chain, said it had seen a considerable increase in demand for medicines such as paracetamol and Calpol. It said it had put order restrictions in place on some products to “ensure equitable supply across the UK”.

Phoenix confirmed that prices for some medicines had increased, but said: “This is beyond the control of medicine distributors like Phoenix.”

McKesson, the pharmaceuticals supplier that owns the Lloyds pharmacy chain, said it had processes in place with suppliers and manufacturers “designed to help minimise the impact of shortages and ensure we are able to provide a consistent supply of critical products”.

A spokesperson said: “We are experiencing an unprecedented demand for over-the-counter pain relief and are doing everything we can to ensure we provide a consistent supply of medicines. This includes sourcing from multiple providers and putting commitments in place with manufacturers to secure supply.”

This was also reported in the Mirror.

Revealed: 142 pharmacies in England have closed in a year-and-a-half

C+D, Eliza Slawther, 12 March 2020

An exclusive C+D investigation has found that 142 pharmacies closed in England between May 2018 and October 2019, adding to the 140 that had already shut since 2016’s funding cuts.

Analysis of Department of Health and Social Care (DH) and NHS Digital data has identified that at least 142 bricks-and-mortar community pharmacies closed across England between May 2018 and October 2019.

The investigation also revealed the location of each of the premises, which can be viewed on C+D’s interactive map below.

The new findings add to the 140 pharmacies identified by a 2018 C+D investigation as having closed between November 2016 – the month before the 12% funding cuts came into force – and May 2018.

Of the 142 identified as closing between May 2018 and October 2019, 99 were owned by multiples, while 43 were independents.

Of the multiples, Lloydspharmacy branches accounted for 51 closures, 26 were owned by Boots, nine by Rowlands, seven by Day Lewis, three by Cohens, two by Well and one by Jhoots.

CCA: Funding “cannot sustain network”

More than half of closures since May 2018 have been pharmacies owned by CCA members.

Commenting on this, CCA chief executive Malcolm Harrison said the level of funding available to community pharmacy “cannot sustain the current scale of the network”.

“We need to find a way to allow the network to restructure to reflect funding levels,” he added.

Mr Harrison said the CCA is calling for NHS England to “work with the sector” to prevent the “gradual erosion of quality and safety of care for patients as funding is continually squeezed”.

Boots: 28 of 200 store closures confirmed

Boots UK’s parent company Walgreen Boots Alliance confirmed earlier this year (January 9) that it had completed 28 of the 200 planned store closures that were announced in June 2019.

The multiple said it currently has “no further details to share”, and did not comment on the 26 locations identified by C+D. The remaining two branches confirmed by Boots as having closed may have closed after October 2019, or not been located in England, and therefore were not included in this investigation.

Lloyds: “Increasing financial pressures”

Lloydspharmacy announced in October 2017 that it would cease trading in 190 “commercially unviable” locations. To date, C+D has identified more than 120 of these.

Commenting on the most recent 51 branch closures, mapped below, a spokesperson for Lloydspharmacy said “good business practice” requires the company to “regularly review” its estate and make “appropriate commercial decisions including buying and selling pharmacies”.

Lloydspharmacy “may decide to close a pharmacy” rather than put “patient safety and colleague wellbeing” at risk if a store is not profitable, it added.

The company cited “increasing financial pressures”, including business rates and changes to pharmacy funding, as contributing to the decision to close branches.

Well: Transferring patients

Well has said it closed the two pharmacy branches in 2018 for reasons including “the current and future profitability of each individual pharmacy, the location of our nearby pharmacies and the local marketplace”.

The company also “considers the funding reductions across the whole of the pharmacy industry”, it added.

When a branch closes, the multiple says it works with patients to “transfer them to another local Well pharmacy, introduce them [to its] digital service if appropriate or discuss other options, including moving to a competitor”.

Rowlands: Funding pressures to blame

Rowlands has put three of its closures down to the funding cuts, which it said rendered the businesses “unsustainable”.

The other six were the result of a “merge and close”, where the pharmacies were merged with nearby branches, it added.

NPA: Government must “direct money” into sector

The National Pharmacy Association (NPA) blames “rising costs and cuts to funding” for the wave of independent pharmacies closing.

“Many independent pharmacies are running on empty and unable to keep their doors open,” NPA CEO Mark Lyonette (pictured above) told C+D in January.

He said the government “must be prepared to direct more money into community pharmacy” to avoid uncontrolled closures and support new services.

Increased funding for community pharmacies can release pressure on NHS resources and “would be a wise investment”, Mr Lyonette added.

Media and Political Bulletin

30 May 2019

Media Summary

Pharmacy is financially ‘on its knees’, PSNC tells government

Chemist+Druggist, Thomas Cox, 28 May 2019

Chemist+Druggist reports that the Pharmaceutical Services Negotiating Committee (PSNC) has told the government that community pharmacy is on its knees financially during funding talks.

“I visit a lot of pharmacies and I’m in no doubt…there is no more money to be squeezed out,” he told C+D last week (May 22) after speaking at the Healthcare Distribution Association conference in London.

It would be “irresponsible” not to tell the DH about these issues, and “irresponsible” for the DH not to listen, he continued. “It’s part of the dialogue that we should rightly have.”

 

MIMS launches drug shortage tracker

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 May 2019

Dispensing Doctors’ Association reports that prescribing and clinical reference tool MIMS has introduced a live MIMS product shortages tracker.

The information is free to GPs and nurses, and to practice pharmacists on email request, but are not exhaustive, MIMS says. Suppliers with an out of stock notification to add to the database are asked to email MIMS.

Supply shortage notifications are also being added to the DDA website. The most recent update is dated 24 May.

 

Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

Pharmacy is financially ‘on its knees’, PSNC tells government

Chemist+Druggist, Thomas Cox, 28 May 2019

Community pharmacy is on its knees financially, the Pharmaceutical Services Negotiating Committee (PSNC) has told the government during funding talks.

PSNC CEO Simon Dukes said the Department of Health and Social Care (DH) “needs to understand what the state of the sector is”.

“I visit a lot of pharmacies and I’m in no doubt…there is no more money to be squeezed out,” he told C+D last week (May 22) after speaking at the Healthcare Distribution Association conference in London.

Mr Dukes has heard about “a number of businesses…either [getting into] debt, using reserves or borrowing money, placing stress on contractors and their families”, he said.

It would be “irresponsible” not to tell the DH about these issues, and “irresponsible” for the DH not to listen, he continued. “It’s part of the dialogue that we should rightly have.”

“Cautious optimism” about negotiations

Mr Dukes has “cautious optimism” about the negotiations for a new pharmacy contract, which officially began last month.

The tone of discussions so far has been “collaborative”, with both the DH and PSNC entering them with a “positive frame of mind”, he said.

Mr Dukes said in an exclusive blog for C+D earlier this month that there are some barriers to trust from both pharmacy and the government.

Read the blog in full to see the big items up for discussion in ongoing funding talks.

 

MIMS launches drug shortage tracker

Dispensing Doctors’ Association, Ailsa Colquhoun, 28 May 2019

Prescribing and clinical reference tool MIMS has introduced a live MIMS product shortages tracker.

The information is free to GPs and nurses, and to practice pharmacists on email request, but are not exhaustive, MIMS says. Suppliers with an out of stock notification to add to the database are asked to email MIMS.

In a survey of 586 GPs conducted by GPonline earlier this year, 31 per cent of GPs reported spending an hour or more each week dealing with the effects of medicines shortages – potentially writing new prescriptions or carrying out follow-up appointments.

More than half of respondents said they had ‘often’ been forced to prescribe second-choice medication over the past year because of drug shortages.

There has been widespread speculation that the increase in medicine shortages is linked to Brexit. However, the Pharmaceutical Services Negotiating Committee (PSNC) has insisted that medicine supplies are ‘unaffected’ by the UK’s departure from the EU and will therefore not improve as a result of the Brexit deadline being extended to 31 October 2019.

The number of drugs on the PSNC’s price concessions list, which gives an indication of which drugs are in short supply, reached a record high in March.

Supply shortage notifications are also being added to the DDA website. The most recent update is dated 24 May.

Media Summary

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

HDA UK Chief Executive Martin Sawer told delegates at the Sigma conference that Brexit will not disrupt plans to implement the EU’s Falsified Medicines Directive. The Directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019. “FMD and medications verification scanning will happen whether the sector is ready or not”, Sawer said. SecurMed UK will appoint an IT provider to deliver the UK’s Medicines Verification System over the coming weeks. With this, systems will need to be tested and pharmacies will need to consider altering the flow of the dispensing process to ensure that efficiency and data protection are safeguarded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has criticised the Government for its ‘complete ignorance about the tremendous value’ community pharmacy delivers. Condemning the funding cuts, Sharpe said that they will particularly hit low volume, urban pharmacies.  “You really need to be prepared for what’s coming down the line.”, she said, focusing on the need to develop relationships with commissioners and establish local links.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

The big pharmaceutical companies were driven into a £250 million bailout to help fill a £500 million gap in the NHS budget; now, with fear over NHS finances Sir Jeremy Heywood has threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money. Opposition MPs say that ministers must come clean on the gap in the NHS budget. Shadow health secretary Jonathan Ashworth said: “Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent”.

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are hoping to benefit from the relocation of the European Medicines Agency (EMA). This week, Portugal joined the competition, with the Portuguese minister of health, Adalberto Campos Fernandes, saying: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines”. In the UK, Hunt has promised that the UK will keep the closest possible regulatory equivalence with the EU. The array of countries courting the EMA voice their commitment to the EU, strong cities, and vibrant medical research industries as points of merit.

Parliamentary Coverage

House of Lords, Written Answers, Department of Health

16 February 2017

Lord Bradshaw: further to the Written Answer by Lord O’Shaughnessy on 19 January (HL4501), whether the Answer also applies to the Automated Repeat Prescription Service offered by some high street pharmacies; and what checks there are to ensure that this does not lead to over-ordering.

Lord O’shaughnessy:

My Written Answer of 19 January applies also to repeatable prescriptions provided through the Electronic Prescription Service.

Any service provided by a pharmacist including ordering prescriptions on behalf of patients, should be carried out in accordance with their professional code of conduct, ethics and performance and the standards for registered pharmacies – both regulated by the General Pharmaceutical Council. This would include obtaining all the information they require to assess a person’s needs in order to give safe and effective treatment and to obtain consent for professional services they provide.

Full Coverage

Murray review of community pharmacy services will ‘direct’ government policy, says health minister

The Pharmaceutical Journal, 15 February 2017

UK health minister David Mowat says that the Murray review into the provision of community pharmacy services will “direct” government policy.

The independent review, published on 14 December 2016 and led by Richard Murray, director of policy at the King’s Fund, looked at clinical services provided by community pharmacy and recommended greater use of repeat dispensing and independent prescribing. It also called for pharmacists to have full read and write access to the patient medical record.

Speaking to delegates at the Sigma conference in Rio de Janeiro on 13 February 2017 via a video recording, Mowat said that the report’s findings are now with England’s chief pharmaceutical officer Keith Ridge, who commissioned the review.

David Mowat told delegates at the Sigma conference in Rio de Janeiro that a “great deal” of the recommendations within the Murray review are worthwhile and will direct government policy.

“I do know that [Keith Ridge] welcomed the review, there was a great deal in there which is very worthwhile and will direct policy,” Mowat said, adding that community pharmacists should become a more “clinically focused” and “services-orientated” profession.

Mowat also pointed out that 50% of pharmacies in England were delivering a minor ailment service and he, along with NHS England, wanted the rest of the country to have the service in place by April 2018.

He told delegates that pharmacists wanted greater integration with the NHS and to contribute more: “I agree with both of those objectives, as we build a seven-day NHS. We frankly don’t have enough GPs, health professionals and it really is a massive opportunity for the pharmacy sector to step up and work with us as we try to get things integrated right across the primary care sector.”

Earlier at the conference, a message was read out to delegates from prime minister Theresa May, who said that government reforms would “ensure we have a modern and efficient community pharmacy sector, properly integrated in primary care and public health, offering better patient choice and easier access”.

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

The UK government has confirmed that Brexit will not put a stop to its plans to implement the EU’s Falsified Medicines Directive, Martin Sawer, executive director of the Healthcare Distribution Association, told delegates at the Sigma conference in Rio de Janeiro on 14 February 2017 via a live video link.

Martin Sawer told delegates at this year’s Sigma conference in Rio de Janeiro that the Falsified Medicines Directive “will happen whether the sector is ready or not”

The directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019.

As part of the directive, measures to verify the authenticity of medicines at certain points in the supply chain will be introduced — for example, 2D barcodes on individual medicines packs to be scanned and checked before dispensing.

“FMD and medications verification scanning will happen whether the sector is ready or not,” Sawer said, adding that implementation will probably have “significant costs and training requirements”.

Also, speaking via live video link, Gareth Jones, head of corporate affairs at the National Pharmacy Association, which represents independent pharmacies, said the pharmacy sector was unlikely to see a “big bang” on launch day but that it should expect to see an increase in the number of packs with barcodes from that date. Pharmacies will likely need to fund software and hardware updates to link with a new medicines database, he added.

SecurMed UK, a not-for-profit organisation set up to deliver the UK’s Medicines Verification System, will appoint an IT provider for the project in the next few weeks, said Sawer. After this, a verification system will be developed and will then need to be tested with UK system suppliers.

Jones said that decisions still have to be made on when pharmacies will need to scan each medicine pack, adding that the fact that medicines cannot be returned into a pharmacy’s stock after ten days “could create a lot of waste”.

“Pharmacies need to consider changing the flow of the dispensing process for efficiency, and data protection needs to be considered,” he concluded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has slammed the Government for making “stupid decisions” about community pharmacy borne of “complete ignorance about the tremendous value it delivers to the NHS and general public”.

The funding cuts were targeting urban pharmacies, she said. “If you’re a low volume pharmacy in an urban area, you need to think really carefully about what the future looks like for you.” Now is the time to focus on developing local services to meet local needs, develop good relationships with commissioners and maybe even merge or join forces with other pharmacies in the locality.

“You need to make sure that local commissioners, GPs and social care think you’re the people they want to deal with.”

Address delegates in a pre-recorded video, she warned that the funding situation for contractors over the next four months would be “very, very difficult” before becoming a little easier. “You really need to be prepared for what’s coming down the line.”

Contractors should aim to get 100 per cent of the new quality payments. “This is going to be a great differentiator between pharmacies in the future. Commissioners may well look at that”.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

Britain’s top civil servant forced the big pharmaceutical companies into a £250 million bailout to help to plug a £500 million hole in the NHS budget.

In the latest sign of panic over NHS finances, Sir Jeremy Heywood, the cabinet secretary, threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money.

The pharmaceutical industry then agreed to cover part of a shortfall in an attempt to win government goodwill in talks over medicines regulation and avoid an “acrimonious” row.

Opposition MPs say that ministers must come clean on the gap in the NHS budget and explain why they were spending money that they had yet to receive. The bailout stems from an

agreement in 2014 which capped NHS spending on branded medicines at about £8 billion, with any costs above that level refunded by drugs companies.

The pharmaceutical industry had hoped that this would free doctors and hospitals from worrying about the cost of medicines and encourage them to change Britain’s traditional reluctance to use new drugs.

However, instead of funnelling rebates back to areas that spent the most, ministers opted to use the money to prop up the central NHS budget. As a result the Department of Health was caught short when rebates were less than predicted, having already allocated the expected refunds to NHS budgets for 2017-18.

At a meeting in November, Sir Jeremy told the industry that the scheme was failing and threatened statutory price cuts to medicines unless they stumped up more money.

The Association of the British Pharmaceutical Industry said that while it “fundamentally disagree[d]” with the government’s approach, it felt that it was best to agree some sort of deal.

“At best even if the government does not end the scheme early, there would be a significantly more acrimonious relationship going into the next negotiations. There would be significant immediate impact on industry ability to influence and shape the UK commercial environment now and in the future,” industry minutes say.

David Watson of the association told The Times that goodwill with ministers was crucial as the industry approached talks on the shape of the economy and how drugs would be approved once Britain left the EU.

“We are aware that we’ve got a new industrial strategy coming along and there is a lot up for grabs about regulation after Brexit that we want to be working on as partners with the government,” he said.

“Having allocated that money in advance, they found there was a gap in their budget for 2017-18 of £400-£500 million. We agreed to meet them halfway.”

Jonathan Ashworth, the shadow health secretary, said: “It’s embarrassing that ministers have had to go cap in hand to big pharmaceutical industry to plug gaps in the NHS finances. Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent.”

Norman Lamb, the Liberal Democrat health spokesman, said: “What these arrangements expose is the government’s appalling financial planning for the NHS. They have scraped around to find ways of claiming that funding for the NHS has been increased, and now resort to these emergency deals which will inevitably raise eyebrows.”

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are seeking to take the headquarters of the European Medicines Agency from the UK once Brexit is complete – and with it 900 highly skilled staff.

Portugal has joined the competition for the EMA this week, which is fiercely sought after because acting as host is likely to have a huge knock-on effect for any country’s medical and pharmaceutical industry. As well as the loss of 900 staff, there is already deep concern in the UK about the ripple effect of the move on the industry.

The EMA’s chief role is to act as the regulatory agency deciding if products are safe for the European single market. Two Portuguese ministers visited its HQ in Canary Wharf on Monday and acknowledged that competition to house the agency is going to be stiff across Europe.

Nationals from every EU industry save Malta and Luxembourg work at the agency. France has 112 employees in the headquarters, and there are 50 British staff. No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision.

Germany is the single largest manufacturer of medical products followed by Italy, and Rome has been arguing that apart from the European Food Safety Authority, it has been given no major EU agency so far. Other countries making bids are the Netherlands, Ireland, Sweden, Austria, Denmark and Spain.

The health secretary, Jeremy Hunt, has acknowledged this month that the EMA would quit Britain as part of Brexit, largely because Theresa May has asserted that the UK would no longer be subject to the decisions of the European court of justice.

The ECJ at present adjudicates appeals against EMA decisions or rulings that require interpretation of pharmaceutical legislation, such as the recent clash between Novartis and Apozyt over the use of the label Avastin.

Hunt has promised the UK would keep the closest possible regulatory equivalence with the EU. Critics claim that this means UK firms would largely have to accept the rules devised in the EU if they are to trade in the single market.

The Portuguese minister of health, Adalberto Campos Fernandes, said before the visit: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines, being one of its major contributors in several roles.”

Lisbon, like almost every candidate city, is touting itself as being committed to the EU, with a cosmopolitan culture and a vibrant medical research industry.

Media Summary

Theresa May: Funding cuts will make pharmacy more efficient

Chemist and Druggist, James Waldron, 15 February 2017

Expressing her support for the Sigma conference in Rio de Janeiro this week, Theresa May said she wants “to see a thriving community pharmacy service”, and added that the government “is committed to achieving this”. Her letter praised this year’s Sigma Retail Pharmacy Conference, voicing confidence that ‘the UK will continue to be a leader in the life sciences sector […], with the Government stepping up to a new, active role that backs the business’.

NHS Improvement admits trusts will miss deficit target

HSJ, Lawrence Dunhill, 15 February 2017

With finances having deteriorated substantially, Chief Executive of NHS Improvement, Jim Mackey, has said that NHS trusts will miss their financial target in 2016-17, after provider forecasts indicated the year-end deficit will be £280m worse than predicted three months ago. Mackey said he is confident the deficit can still be limited to within the £800m. The ability to stick to budget is proving increasingly tough, and Mackey voiced the ‘need to all work as hard as we can to keep the deficit as low as possible’.

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

NHS Improvement admits trusts will miss deficit target

HSJ, Lawrence Dunhill, 15 February 2017

The deteriorating position, revealed through figures obtained directly from trusts by HSJ, suggests a year-end sector deficit around £970m, which would significantly breach the maximum £580m deficit “control total” set by national leaders.

‘We need to all work as hard as we can to keep the deficit as low as possible,’ Jim Mackey said. The numbers were those submitted for quarter three of 2016-17 to NHS Improvement, which is due to publish the sector’s official position next week.

HSJ collected forecast figures from all but five of England’s 237 NHS trusts, via public board reports and direct requests. They suggested the year-end forecast was £280m worse than the previous £690m official deficit forecast published in November.

However, it is understood the regulator has since managed to improve a number of the forecasts following discussions with trust boards. It is not yet clear to what extent the overall forecast has been reduced, or by what means.

Mr Mackey, the NHS Improvement chief executive, told HSJ: “We’ll not hit £580m and I think it’s about containing this to as manageable a number as we can. Ever since quarter two we’ve not really expected to hit that number. We need to all work as hard as we can to keep it as low as possible.”

Trusts’ quarterly forecasts are seen by the NHS’s senior leaders as the most important indicator of whether efforts to reduce the provider sector deficit, such as last July’s “reset”, are proving successful.

The numbers submitted by trusts will likely alarm officials at the Department of Health and Treasury, as they threaten to exceed the £800m of NHS funding that has been set aside as a “risk reserve” in case of trusts overspending.

Mr Mackey said he is confident the deficit can still be limited to within the £800m.

HSJ understands more providers will be placed in financial special measures as a result of deteriorations in their position, once the official figures are published.

Around 40 trusts have reported significant deteriorations compared to their quarter two forecast, with 12 of these each coming to more than £10m.

The largest falls, excluding the impact of lost sustainability and transformation funding, were reported by University Hospitals of North Midlands Trust (£26m deterioration in forecast); Royal Free London Foundation Trust (£25m); King’s College Hospital FT (£17m); and Kettering General Hospital FT (£17m).

HSJ has also identified examples of where trusts have gone through formal protocols to adjust their forecast downwards, but have then revised them back upwards following discussions with NHS Improvement.

For example, in its board papers Royal Liverpool and Broadgreen University Hospitals Trust reported an underlying deterioration of £15m, but then told HSJ the position had been revised back to its planned surplus following subsequent discussions, including with the regulator.

This will be largely achieved via additional income from commissioners, as well as a capital to revenue transfer.

Although improvements secured through additional income will help the provider sector reduce its deficit, it will have the opposite effect on clinical commissioning groups. The projected overspend by CCGs has almost doubled in the last three months.

Extra income for trusts is neutral in terms of the DH’s revenue position as this includes the performance of both trusts and CCGs. The DH is likely to come close to breaching its spending limit again in 2016-17, especially if the provider deficit is larger than £800m.

Responding to HSJ’s research, Richard Murray, policy director at the King’s Fund, said: “There were risks that the better financial performance among NHS providers seen in the first quarters of 2016-17 might slip over the year, and these risks appear to be materialising.

“With performance challenges rising in the NHS in January, trust finances may yet deteriorate further. With the forecast provider deficit rising past the £800m risk reserve top-sliced from commissioners at the start of the year, the ability of the DH to live within its overall budget is once again in question.”

In 2015-16 the provider sector deficit was officially reported as £2.45bn, though various technical accounting measures had been deployed to bring this down from an underlying position of around £3.7bn.

Since then the sector has benefitted from the £1.8bn “sustainability and transformation fund”, as well as a change in the national payment tariff which delivers more income from commissioners.

In July’s financial “reset”, the combined financial plans for NHS trusts set a planned deficit of £580m for 2016-17, after accounting for the £1.8bn STF.

NHS Improvement and NHS England subsequently said actions had been taken to ensure the deficit was “no more” than £580m, but stressed the aim of reducing the deficit to £250m.

Meanwhile, two-year planning guidance issued by the regulators has said a failure to meet the £250m target and enter 2017-18 in “run-rate balance” would require an additional efficiency requirement for trusts next year. The figures collected by HSJ suggest this additional requirement could total around £970m.

Discounting STF, the forecast figures suggest a year-end forecast of £2.77bn. Although this is worse than the £2.45bn reported last year, there may well be further one-off accounting measures and additional income deployed to bring the figure down. This would support this year’s position, but is unlikely to make next year’s challenge any easier.

Lib Dems slam pharmacy cuts and call for cross-party commission

15 November 2016, Pharmacy Business, Neil Trainis

 

A Liberal Democrat MP, Tom Brake, led a public meeting of constituents where he called for a cross-party commission to ensure the NHS is properly funded. Tom Brake made it clear that although the pharmacy funding cuts are designed to generate efficiency savings within the NHS, the cuts will only add to the burden of the health service during the winter period. Dr Brendan Hudson, Chair of Sutton Clinical Commissioning Group, made it clear that he agrees with the rhetoric of Liberal Democrat Health Spokesperson, Norman Lamb who also believes the NHS needs to be stabilised by a cross- party commission to prevent it being used for political gain.

 

UK drug funding framework needs an overhaul to ensure the right areas are being prioritised

15 November 2016, The Pharmaceutical Journal, David Webb & Ken Paterson

 

David Webb, President of the British Pharmaceutical Society and Ken Paterson, Former Chair of the Scottish Medicines Consortium, have expressed their belief that it is time to review the current drug funding framework due to the rising cost of medicines in the pipeline coupled with increasing financial pressure on the NHS. They believe that it is important to include the wider UK public in discussion around the future priorities for the NHS. They warn that with the 20th anniversary of NICE conducting health technology assessments approaching it is time for the UK’s healthcare funding bodies to make a collective and informed decision about which health problems to prioritise based on what the UK population values.

 

November 2016 Price Concessions/NCSO

15 November 2016, PSNC

The Department of Health have granted the following price concessions for November 2016:

Drug Pack size Price concession
Amitriptyline 50mg tablets 28 £3.25
Bumetanide 1mg tablets 28 £1.95
Candesartan 2mg tablets 7 £2.25
Dapsone 50mg tablets 28 £46.19
Desmopressin 10micrograms/dose nasal spray 60 dose £23.49
Exemestane 25mg tablets 30 £9.60
Flecainide 100mg  tablets 60 £10.93
Flecainide 50mg  tablets 60 £10.70
Fludroxycortide 4mcg/sq cm tape 7.5cm 20 £12.49
Leflunomide 20mg tablets 30 £10.99
Lorazepam 1mg tablets 28 £6.05
Lorazepam 2.5mg tablets 28 £12.50
Metronidazole 400mg tablets 21 £7.88
Naratriptan 2.5mg tablets 6 £24.55
Nitrofurantoin 100mg tablets 28 £14.02
Nitrofurantoin 50mg tablets 28 £16.00
Ropinirole 0.25mg tablets 12 £4.50
Ropinirole 0.5mg tablets 28 £14.85
Ropinirole 1mg tablets 84 £56.71
Ropinirole 2mg tablets 28 £31.51
Trospium Chloride 20mg tablets 60 £15.47
Valsartan 160mg capsules 28 £5.30

No endorsements are required as these prices will automatically be applied to this month’s prescriptions.

 

When any NCSO or price concession announcements are made, these appear on the Generic Shortages page (psnc.org.uk/ncso) and are emailed to those subscribed to this mailing list.

 

Parliamentary Coverage

House of Commons Tabled Written Questions, Department of Health, 15 November 2016

Health

 

Crispin Blunt: To ask the Secretary of State for Health, what discussions he has had on enhancing consultation with and involvement of Pharmaceutical Price Regulation in the preparation and conduct of the forthcoming negotiations on the next such Scheme, in particular industry bodies representing companies directly affected through their participation in the Scheme.

 

###

 

Jonathan Ashworth: To ask the Secretary of State for Health, what assessment he has made of the effect of recent currency exchange rate changes on the import costs of (a) medicines and (b) equipment for the NHS.

 

###

 

Jim Shannon: To ask the Secretary of State for Health, how much the NHS spent on branded drugs after the rebate from the Pharmaceutical Price Regulation Scheme as a proportion of total expenditure in (a) 2010-11 and (b) 2015-16.

 

Full Coverage

Lib Dems slam pharmacy cuts and call for cross-party commission

15 November 2016, Pharmacy Business, Neil Trainis

 

The Liberal Democrats added their voice to the growing swell of discontent at the government’s decision to cut community pharmacy’s funding during a public meeting of constituents which produced strong condemnation of the measures.

 

The meeting was led by Tom Brake, the Lib Dem MP for Carshalton and Wallington, who accused the Conservatives of being “happy to cut off their nose to spite their face” over cuts which are designed to generate efficiency savings in the NHS but which the pharmacy profession feels will only add to the burden faced by a health service under extreme pressure.

 

Brake also called for the establishment of a cross-party commission to ensure the NHS is properly funded.

 

Local residents expressed their feelings about the cuts during the meeting which was also attended by Councillor Simon Wales, the deputy leader of Sutton Council, Dr Brendan Hudson, chair of Sutton Clinical Commissioning Group and Renna Barai, an award-winning pharmacist who runs a pharmacy in Sutton.

 

“These changes are nothing more than a backdoor health cut from the government. We must stand up and let the Conservative government know that these pharmacies provide a vital service in our community and we will not allow them to be heartlessly cut,” Brake said.

 

“The cuts are due to be made right at the start of winter, at a time when doctors surgeries will already be feeling the strain. The Conservatives are happy to cut off their nose to spite their face and are showing no regard for the kind of joined-up thinking that our NHS needs.

 

“In fact, the government has not carried out an impact assessment, so the government is ordering funding cuts, without knowing which pharmacies may close, how many patients will be affected or the number of people who will lose their jobs.

 

“I am in agreement with Liberal Democrat Health Spokesperson Norman Lamb when he says that we need a new deal for the NHS. It is time to stop using our health service as a political football and to establish a cross-party commission to ensure the NHS gets the funding it needs.”

 

Barai said: “It won’t be big businesses that feel these cuts the hardest – it will be small businesses in our area; businesses that will no longer be able to afford the same level of highly-skilled staff, or that will have to start finding other ways to cope, which can only mean a reduced service for patients.

 

“Community pharmacies are a local lifeline in the NHS yet the Department of Health has made it clear that they do not see this value.

 

“These plans will increase pressure on already-overburdened NHS services locally and with GP surgeries, doctors and nurses and A&E departments all overstretched, we surely should not be closing our pharmacies but rather using them more than ever.”

 

The cuts, due to start on December 1, could force many community pharmacies, including those in Sutton which contains areas of deprivation, to cut back on their services and staff and even close.

 

UK drug funding framework needs an overhaul to ensure the right areas are being prioritised

15 November 2016, The Pharmaceutical Journal, David Webb & Ken Paterson

 

If the NHS is to get value for money from medicines, it needs to consider what the UK population values and where its priorities lie.

 

The National Institute for Health and Care Excellence (NICE) in England, the Scottish Medicines Consortium (SMC) and the All-Wales Medicines Strategy Group (AWMSG) are each charged with making recommendations on which new medicines to fund in their respective countries. Many experienced pharmacists, doctors and other healthcare professionals are involved in and commit time to these processes. All three bodies are highly regarded internationally for the quality and rigour of their work, and all use similar methods to assess the clinical and economic evidence for a medicine in order to reach a conclusion on its value. Yet when these agencies choose not to recommend funding for a medicine, the decision can be met with widespread dissatisfaction from the pharmaceutical industry, healthcare professionals, patient advocacy groups and even politicians. It is obvious that any decision not to fund a new medicine will be unpopular with those directly affected, but the criticism often implies that the fundamental assessment of value is flawed.

 

This is because the underlying decision-making framework is based on many untested assumptions about what members of society value. It is not the exclusive role of clinical experts to set this framework, it is a collective responsibility as citizens and current or future patients. We need to come together for some difficult conversations.

 

Value for money

 

Although often accused of being focused purely on cost-containment and the affordability of new medicines, NICE, the SMC and the AWMSG are, in fact, primarily interested in value-for-money, as opposed to total costs. They weigh up the clinical benefits of new medicines against their costs, assessing their cost effectiveness to make sure that money is spent wisely and efficiently. These decisions are important because annual budgets in the NHS are limited. Any money spent unwisely or inefficiently will lead to other treatments of proven benefit not being provided, known as the opportunity cost of the use of a new medicine. Of course, if the NHS was allocated more money it would be able to make available more options and treatments, but there will always be a budget limit. It will never be possible to fund every treatment and so there will always be a requirement to use funding to the greatest effect.

 

The opportunity cost becomes more of an issue when the total cost of a new medicine is high. Until recently total cost was rarely an issue for the NHS. However, recent examples of medicines to treat hepatitis C and for pre-exposure prophylaxis of HIV infection have created situations where medicines appear to offer value for money but the NHS cannot always afford to pay for all eligible patients to access them. They are cost-effective interventions that may not be affordable. This throws the question of societal values into sharp relief: we must help the NHS decide how to evaluate and where to incur the opportunity costs. Who do we want to benefit from new medicines, and what health benefits are we willing to sacrifice in order to achieve this?

 

Singling out certain diseases

 

NICE, the SMC and the AWMSG work from the principle that UK society wishes to derive benefits from new medicines equally across the population, with no discrimination in favour of, or against, any group of patients. For example, improved health in older patients is valued as much as in younger patients, prevention of illness is as highly valued as its treatment, and no disease areas are regarded as more or less worthy of treatment than others. Although this approach is highly equitable, and completely defensible, it is the very decisions made within this framework that come in for criticism.

 

The framework itself is rarely formally questioned, but some workarounds have arisen that cast doubt on the underlying principles involved. In 2008, the health secretary John Reid asked NICE to adopt a more generous approach to ‘end-of-life’ medicines, implicitly valuing the health benefits of these medicines more highly than similar benefits from medicines used earlier in the course of a disease [1]. The Cancer Drugs Fund in England makes medicines available that have not met the cost-effectiveness criteria during NICE assessment, potentially displacing treatments that are more cost-effective [2]. As the name suggests, it is restricted to cancer medicines, implying that these are a ‘special case’ and worthy of exceptional funding not available in other diseases, even those, such as heart failure, with similarly poor outcomes. The SMC has a Patient and Clinician Engagement process that is applied to medicines for rare diseases (orphan diseases or equivalent), again making these conditions a ‘special case’ [3]. The possible ‘ethical imperative’ of aiming to provide treatment where there are no other options (sometimes known as the ‘rule of rescue’) may come into play in these situations.

 

However, the justification for singling out certain diseases or clinical situations is often not based on a clear rationale. These processes have generally come about because of external pressures on the assessment organisations resulting from adverse publicity that has been triggered by individual decisions. There has been tacit acceptance that the changes made match the views of UK society, yet there has been no exploration of whether that is, in fact, the case. The limited evidence that there is[4] suggests that the general public do not favour cancer over other diseases, end-of-life treatments over other interventions[5],[6], or place a higher value on medicines for rare diseases, but the issues have barely been defined or discussed. NICE has undertaken some work in this area with its Citizens’ Council, looking at, for instance, the issues surrounding medicines for orphan diseases, but no clear conclusions emerged to inform real-life decision-making [7].

 

Review funding framework

 

Newer and more expensive medicines in the pipeline, coupled with increasing financial pressures within the NHS, mean that it’s the right time to look at the fundamentals of decision-making around funding of new medicines. The clinical specialists who participate in the work of NICE, the SMC and the AWMSG are highly skilled and experienced in assessing the clinical value and cost-effectiveness of medicines, but are not well placed to assess the views of UK society on where and how limited resources should be spent. Their assessment skills and real world insights will remain essential, but the final call will be influenced by the decision-making framework in which they operate, a framework that society needs to develop. If the deliberations of NICE, the SMC and the AWMSG lead to decisions that society believes are wrong, then maligning the bodies themselves, or their individual members, will not lead to different outcomes unless the context for their deliberations is altered.

 

There is a need to involve the wider UK public in discussions around priorities for the healthcare system, especially in the field of new medicines. Wider and more detailed research into the preferences of society is needed, with a view to incorporating the outcomes of that research into revised processes for the assessment bodies based on objective evidence of societal views. Approaches such as discrete choice experiments [8], where members of the public are asked to express a preference between two or more options and do this for multiple sets of options, allow assessment of the decision-making framework of each individual, and can be combined to gauge the view of wider society.

 

Other methodologies can be[9], and have been[10], used but none has yet achieved widespread acceptance and all have, to date, had little influence on the decision-making framework of the medicines assessment agencies. The limited experience of NICE’s Citizens’ Council has shown the difficulties that can arise — whether in achieving consensus or even clarity of opinion — but the present situation is far from ideal so new thinking is urgently needed.

 

Rather than expedient workarounds with no evidence base of their impact or societal preference, we need this detailed assessment of the views of the UK public followed by a rational debate about where NHS medicines expenditure should be focused. These will be difficult discussions involving many stakeholders – current patients, the wider public (who are all ‘future patients’), ethicists, academics in social sciences and health economics, clinicians, those actively involved in medicines assessment and the pharmaceutical industry all have legitimate interests and need to participate. As we look ahead to the 20th anniversary of NICE conducting health technology assessments, we must decide collectively which health problems to prioritise in order to provide an evidence base for future decision-making.

Trump elected president: what now for pharma?
09 November 2016, Pharmaphorum, Richard Staines

The American President Elect, Donald Trump, released a health policy document during his campaign although it contained little information about his future policy on drug pricing. Trump has previously said he wanted to allow cheaper drugs to be imported into the U.S. to reduce medicine costs. He has also made a pledge to repeal the Affordable Care Act in the first days of his administration. In his primary campaign Donal Trump said he would work to introduce legislation that enables Medicare to negotiate lower prescription prices with pharmaceutical companies. Dan DiMicco, Donald Trump’s Trade Advisor has said that the UK will be offered a tree trade deal with the U.S. ahead of the EU.

The PPRS medicines pricing scheme: is it working for both sides?
08 November 2016, Pharmaphorum, Leela Barham

The Pharmaceutical Price Regulation Scheme (PPRS) is the result of an agreement between the UK Government and the Pharmaceutical Industry for the pricing of branded medicines. The updated agreement was launched on 1 January 2014 to implement ta new mechanism top cap the growth of NHS spending per year. Under the scheme when the NHS exceeds the agreed level PPRS members have to make repayments to the Government. The PPRS agreement does not say where this money is spent, although it is split across the devolved nations. It is as yet unknown how the PPRS will evolve after December 2018 as several pharmaceutical companies have expressed disappointment that the promise of a greater uptake of new medicines in the agreement has not been occurred.

NPA lawyer: ‘Serious flaws’ justify legal challenge to cuts
09 November 2016, Chemist & Druggist, Vincent Forrester

A lawyer acting on behalf of the National Pharmacy Association (NPA) has said the legal challenge against the Government’s plans to cut community pharmacy funding is justified. She has said that the flaws in the Government’s justification for the pharmacy cuts is cause for legal action. The NPA has already successfully challenged the Government’s claim that expanding hub-and-spoke dispensing will improve patient safety which resulted in a delayed implementation date. The NPA said last week that it had no option but to challenge the Government’s pharmacy funding cuts in court.
The APPGs plans to investigate the impact of the pharmacy funding cuts has been further reported by The Pharmaceutical Journal

 

Parliamentary Coverage

House of Commons Questions, UK Trade with EU, 09 November 2016

Treasury

 

Jonathan Edwards: What estimate he made of the potential cost to the public purse of subsidising tariffs for access to the single market for the (a) financial services, (b) insurance, (c) professional services, (d) food, beverages and tobacco, (e) machinery, electrical and transport, (f) chemical and pharmaceuticals, (g) metal, plastic and non-metal mineral products, (h) aerospace and (i) automotive sectors.

 

HM Treasury

 

Mr David Gauke:

 

The Government continues to undertake a range of analyses to inform the UK’s position for the upcoming EU exit negotiations, to ensure the best possible deal for the UK. However, this does not extend to assessing the impact on the public purse of tariff subsidisation that would be illegal under international law.

Full Coverage

Trump elected president: what now for pharma?

09 November 2016, Pharmaphorum, Richard Staines

 

The world has woken up to a new era, with Donald Trump elected as US president – a huge victory for a political outsider and the ‘silent majority’ who felt sidelined by the status quo.

 

While a small majority of US voters is celebrating, the country has been badly divided by a bitter election campaign. Many who voted for Hillary Clinton are fearful that Trump will deliver on his many populist promises, including a  ban on all Muslims entering the country, trade wars with China and Mexico, the repeal Obamacare.

 

Like many in big business, the pharma industry had given more backing to Clinton, despite her anti-pharma policies – and now wait to see how the political upheaval will affect them.

 

Hillary Clinton had been making waves with her sharp criticism of drug pricing, and strong campaigning against price gouging by pharma – but the industry may not get an easy ride from Trump, either.

 

In a health policy document, Trump said surprisingly little about drug pricing, although he did say he wanted to allow cheaper drugs to be imported to reduce medicine costs.

 

But Trump did make a clear pledge to repeal the Affordable Care Act, the expansion of health insurance coverage which was one of President Obama’s proudest achievements.

 

However many middle-class citizens had suffered an increase in premiums caused by Obamacare, and Trump has promised to repeal the legislation “on day one” of his administration.

 

But in his primary campaign, Trump said that he would renegotiate prices that the Medicare social insurance programme for older people pays for drugs.

 

Medicare is legally unable to negotiate lower prescription prices with pharma companies, and Trump will likely need a new law to introduce this policy.

 

Trump also highlighted the lobbying powers of drug companies, which is ironic given that the industry traditionally relies on sympathetic politicians from Trump’s Republican party to influence the political process.

 

The Republicans have retained control of both the House of Representatives and the Senate, meaning Trump could have more freedom to implement his policies – if he and the Republican party can stay on friendly terms.

 

The election result could also have ramifications this side of the Atlantic, as the UK prepares for Brexit.

 

Yesterday Donald Trump’s trade adviser, Dan DiMicco, said Britain will be offered a free trade deal before the rest of the European Union ahead of his election victory, offering the possibility of a welcome political and economic boost after this year’s upheavals.

 

Although Trump’s victory sent the dollar sliding on currency exchanges, pharma stocks outside of the US ticked up.

 

GlaxoSmithKline, AstraZeneca and Sanofi all made small gains, suggesting that Trump’s election could be seen as a let-off for the industry.

 

While the ramifications of Trump’s victory are still not certain, there was some clearly good news for pharma in California, where voters decided against Proposition 61.  This would have introduced new powers to negotiate prices direct with the industry at state level, but heavy funding from pharma has helped to persuade voters to reject the idea.

 

Whatever the next four years of a Trump presidency bring, pharma knows its current pricing model is unsustainable.  Ongoing investigations by US authorities into pricing tactics of companies such as Mylan, means the industry is already looking to change to its approach. Whether a Trump administration will support or move against the sector is yet to be seen.

 

The PPRS medicines pricing scheme: is it working for both sides?

08 November 2016, Pharmaphorum, Leela Barham

 

The PPRS is the keystone of the UK’s medicines pricing system, but is the agreement launched in 2014 working for the pharma industry and the government?

 

The Pharmaceutical Price Regulation Scheme (PPRS) is the UK government’s pricing agreement on branded medicines with the pharmaceutical industry, and has been around in one form or another for more than 50 years.

 

However there were some significant changes when the new PPRS agreement was launched on 1 January 2014, most notably a new mechanism to cap the growth of NHS medicines spending in each year of the agreement.

 

The deal was struck at the height of the UK government’s austerity measures, and the planned ‘allowed growth rate’ in medicines spending reflected a squeeze on NHS budgets.

 

There was no permitted growth in the branded medicines bill in 2014 and 2015, with growth then allowed to begin in 2016, 2017 and 2018, but limited to 1.8%, 1.8% and 1.9%, respectively.

 

Moreover, if and when expenditure exceeds these agreed level, PPRS members as a whole have to make repayments – PPRS payments – back to the government.

 

These payments replaced the old system of headline price cuts of previous schemes, and the industry has to date paid back over £1 billion to the government (figure 1).

 

The Association of the British Pharmaceutical Industry (ABPI) agreed to this deal with the Department of Health (DH), in return the 2014 PPRS included key commitments on patient access– a long running concern of industry.

 

As we approach the end of 2016, the deal has reached it half way point, with the agreement to complete its 5 year lifespan on 31 December 2018.

 

So what trends and conclusions can be drawn from the agreement so far?

 

Analysis of the PPRS needs to look widely – as widely as the agreement itself – but one of the clearest guides can be found in the quarterly reports of the PPRS payments.  The latest data was published in September, making it possible to take a look at PPRS payments at the half-way point in the scheme.

 

Unpredictable growth

 

In agreeing the deal in late 2013, neither the Department of Health nor the ABPI could be sure whether actual growth in medicines spending would exceed the annual growth caps or not.

 

Expectations on both sides were informed by forecasts made at the outset of the 2014 PPRS. For example, the DH and ABPI published a Heads of Agreement in December 2013 that included forecasts for the growth rate in measured spend (the 2014 PPRS has some exclusions, so measured spend is not the same as the total spend on branded medicines), the share of new products in that measured spend, as well as the expected annual payment percentages.

 

Growth in measured spend has been much more variable than expected – whilst it was far higher than forecast in 2014 (6% rather than just under 4%), the following year it was far lower, under 1% compared to the predicted 3.5% (figure 2).

 

In turn, payment percentages have been adjusted too, with a higher payment percentage in 2015 than expected in 2013, and now lower in the final years of the scheme (figure 3).

 

The situation may have changed since the revised forecasts in December 2015 as well. According to formal review minutes of a meeting between the ABPI and the DH in March 2016, “growth was now significantly below the original project profile for this stage in the scheme.”

 

Where do the PPRS payment go?

 

While companies have to make quarterly payments to the DH, the PPRS agreement doesn’t say where they go from there. In practice, the DH has agreed a split of PPRS monies across devolved nations. The DH has allocated PPRS payments into the overall allocation to NHS England (NHSE).

 

The Department of Health

 

NHSE then makes its own decisions about how much to allocate to itself for the services that they commission and pay for (such as specialised services for relatively rare and complex healthcare, including drugs used as part of those services) and how much to allocate further out to the Clinical Commissioning Groups (CCGs).

 

Advance PPRS payments factored into allocations to the NHS

 

The DH took the decision to allocate estimated PPRS receipts in advance to NHSE. This has created a novel problem where the DH has actually overpaid NHSE, as PPRS payments have been less than anticipated (figure 4).

 

The ‘shortfall’ is driven in large part by parallel imports and divestments to the Statutory Scheme (the default for those companies who choose not to join the voluntary PPRS). The DH has said that sales of £157m have moved out of the PPRS and into the Statutory Scheme. It’s also driven by the agreement struck to limit the amount paid back on products in the Cancer Drugs Fund (CDF).

 

The shortfall in PPRS payments was made up by the Treasury in 2015/16.

 

It remains unclear whether the PPRS payments will hit the DH’s forecast of £647m for 2016/17.  If not, this could see a repeat of the problem from the previous financial year, as an allocation of £518m has already been made to NHSE.

 

The future?

 

Time will tell how the PPRS will evolve after December 2018.  The successor to the 2014 PPRS could revert to headline price cuts. There’s something appealing about keeping it simple: it would certainly demystify the PPRS, which has become more complex over time. There should be a lot of sympathy for those who struggle to reconcile the PPRS with other headlines on spend on medicines.

 

For example, NHS Digital’s prescribing costs in hospitals and the community in England 2014/15 illustrates a 7.8% increase on spend versus 2013/14. This is not an apple to apple comparison: a financial year, just for England and including generics versus the calendar year, UK wide and for growth in measured spend on branded medicines. Even despite this, the difference between around 8% growth and the revised growth in measured spend of around 1% raises questions about what is really happening in the medicines market.

 

Those questions intensify in light of what different sources seem to suggest. For example, ABPI analysis discussed with the DH in March 2016, highlights that IMS data shows 7.8% growth from 2014 to 2015 at list prices for branded medicines sold by members of the PPRS. PPRS measured spend reported by companies suggests a decline of 0.2% for the same time period. Even parallel imports and other exclusions can’t explain all of the gap between the IMS data and measured spend. Discounting could be it: the DH seem unconvinced, though, about the real gains from discounting, suggesting that it hadn’t led to a saving in the drugs bill.

 

At the same time, many individual pharmaceutical companies have expressed unhappiness with the agreement, saying the promise of greater uptake in new medicines has not materialised.

 

If PPRS payments continue, the DH may decide to be more cautious. They could pass on payments once the sums have been added up for example. That may be financially prudent – avoiding the need to go cap in hand to the Treasury – but it would add (even less) credibility to the idea that underwriting the NHS spend on medicines could improve access to medicines.

 

NPA lawyer: ‘Serious flaws’ justify legal challenge to cuts

09 November 2016, Chemist & Druggist, Vincent Forrester

 

“Very serious flaws” in the government’s justification for the pharmacy cuts is cause for court action, a lawyer acting on behalf of the National Pharmacy Association (NPA) has said.

Andrea James, a partner at LHS Solicitors, which is acting on behalf of the NPA, is confident that the shortcomings in the Department of Health’s (DH) approach to the proposed £113 million cut to funding in England justifies mounting a legal challenge.

 

She pointed out that this year the pharmacy organisation has already successfully challenged the government’s claim that expanding hub-and-spoke dispensing will improve patient safety, and help push the intended implementation date of the cuts back from October to December.

 

The NPA has “explored every possible avenue to help its members”, including negotiations with the government, Ms James told C+D last week (November 4).

 

“The NPA has sought, at all times, to behave reasonably and negotiate sensibly with the DH, so legal action was never considered inevitable right up to the publication of the final [funding] package,” she added.

 

The NPA said last week that it had “no option” but to take its fight against the cuts to court.

 

The DH has been asked to respond to the legal challenge by 4pm today (November 9). The NPA had not received a response at the time of going to press.

 

Cross-party group of MPs launches enquiry into impact of pharmacy funding cuts

09 November 2016, The Pharmaceutical Journal

 

An influential group of cross-party MPs has launched an inquiry into the impact of the government’s decision to cut community pharmacy funding in England.

 

The All-Party Pharmacy Group (APPG) announced the terms of reference for its inquiry on 8 November 2016.

 

The details emerged two weeks after MPs from the APPG met health minister David Mowat; Keith Ridge, chief pharmacist for England; and others from the Department of Health to discuss the cuts.

 

Kevin Barron, Labour MP and chair of APPG, says: “The APPG has previously called for further investment in community pharmacies to allow them to provide more health services and ease the burden on GP surgeries and hospitals.

 

“The Department of Health believes this can be achieved with the new funding package that has been announced. The APPG will therefore scrutinise what is being proposed in detail to better understand what their reforms will mean for community pharmacies, and the patients they serve.”

 

The inquiry, which will begin later in November 2016, follows confirmation by Mowat that the government will slash community pharmacy funding by 12% from December 2016 to March 2017 and by another 3.4% in 2017–2018. It will consider the impact of cuts on pharmacies, staff and services and what the government expects from pharmacists employed by GP practices.

 

The inquiry will also look at how the proposed £42m pharmacy integration fund and the roll out of minor ailments schemes will work.

 

The APPG, which receives financial support from the Pharmaceutical Services Negotiating Committee, the Royal Pharmaceutical Society and Pharmacy Voice, will consider whether the pharmacy access scheme will guarantee the long-term future of premises in remote or deprived areas. It also intends to look at the potential impact of the King’s Fund review of community pharmacy.

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