HDA UK Media and Political Bulletin – 05 January 2021

Media Summary

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

With the UK now having licensed two coronavirus vaccines, the Independent reports that supply shortages have raised concerns over whether the government will be able to meet its vaccination target.

It has been reported that enough of the Oxford vaccine has been produced to provide 4 million doses, but some claim that the UK has not yet secured enough “fill and finish” supplies to scale up the rollout. Indeed, a lack of material such as vials and specialised bungs has hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested. He said: “It’s not so much a manufacturing issue although that’s part of it. Each batch needs to be properly approved and quality controlled.”

MHRA Chief Executive, Dr June Raine, added: “It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

 

Parliamentary Coverage

House of Commons, Written Answer, 24 December

Stephen Farry (Alliance, North Down): To ask the Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, whether the Draft unilateral declarations by the European Union and the United Kingdom of Great Britain and Northern Ireland in the Withdrawal Agreement Joint Committee on human and veterinary medicines cover medical devices.

Penny Mordaunt (Conservative, Portsmouth North): The Unilateral Declaration on Medicines allows for the phased implementation in Northern Ireland of relevant medicines regulation, and in particular the Falsified Medicines Directive. Medical devices are not subject to the Falsified Medicines Directive and are not in scope of the declaration. Businesses and authorities moving medical devices can make use of the Trade Support Service and the UK Trader Scheme. Full guidance on the regulatory requirements for medical devices are set out on gov.uk. Medical devices will be able to be moved smoothly between Great Britain and Northern Ireland from 1 January 2021.

 

Full Coverage

 

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

The UK has now licensed two coronavirus vaccines and has begun administering doses throughout the four nations.

Research has shown that the NHS will need to carry two 2 million vaccinations a week to prevent a third wave of Covid-19, but supply shortages have raised concerns over whether the government will be able to meet this target.

So, how many vaccine doses do we have on the way? And how much is ready to go?

Pre-ordered supplies

The UK’s vaccine taskforce has put together a portfolio of seven different candidates, securing a total of 357 million doses – enough to vaccinate the British population twice over.

So far, two of those seven vaccines have been approved for emergency use by the the Medicines and Healthcare products Regulatory Agency: the Pfizer-BioNTech and Oxford-AstraZeneca jabs. The other candidates remain in development.

Up to 40 million doses of the Pfizer-BioNTech vaccine have been ordered, while 100 million doses of the Oxford jab are set to be delivered to the UK.

Originally, the government said that 10 million doses of the Pfizer vaccine were due by the end of 2020 – a target which was missed.

For the Oxford vaccine, Downing Street said in May of last year that the country would have 30 million doses available by September in preparation for the national rollout.

That figure was later corrected by the vaccine taskforce to 4 million for the end of 2020. However, this target was also not met.

Last week, health secretary Matt Hancock said that the UK had just 530,000 doses of the Oxford for its nationwide rollout on 4 January.

How much vaccine is ready to go?

Pfizer said the number of doses it has now sent to the UK is “in the millions”, while the Department of Health and Social Care said the government had received 22 deliveries of the vaccine as of 25 December.

It is not clear how many doses of the Pfizer-BioNTech candidate are currently available to the population, or how much will be provided in the coming weeks.

Pascal Soriot, the Chief Executive of AstraZeneca, said last Wednesday that the manufacturer was able to produce “1 million doses and beyond” per week of the Oxford vaccine.

Although 530,000 doses are ready for use as of 4 January, the government has said this figure will rise to the “tens of millions” by the end of March.

What’s behind the lack of supplies?

According to reports, enough of the Oxford vaccine has been produced to provide 4 million doses. However, it’s claimed that UK has not yet secured enough “fill and finish” supplies to scale up the rollout.

A lack of material such as vials and specialised bungs has supposedly hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Professor Jonathan Van-Tam, Deputy Chief Medical Officer for England, said last month: “The only thing that is going to slow us down is batches of vaccines becoming available. Many of you know already that it’s not just about vaccine manufacture. It’s about fill and finish, which is a critically short resource across the globe.”

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested.

Ministers have said the NHS has the capacity to deliver 2 million doses a week of the Oxford vaccine once it receives supplies from the manufacturers. But the PM said the issue is not supply or staff, but waiting for batch approval.

He explained: “We have the capacity, the issue is to do with supply of the vaccine.

“It’s not so much a manufacturing issue although that’s part of it.

“Each batch needs to be properly approved and quality controlled.”

The Medicines and Healthcare products Regulatory Agency (MHRA) said it had “scaled up” its review process for each vaccine batch.

“The MHRA is fully scaled up to do the batch testing that’s so important for confidence as the new products come through,” said Dr June Raine, Chief Executive of the agency.

“It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

How many people have been vaccinated so far?

As of 4 January, a total of 944,539 people across the UK had received their first vaccine dose.

The government says this figure will rapidly rise in the coming weeks and months once more batches from the different vaccine manufacturers have been quality checked.

It is hoped that all at-risk groups will have been vaccinated using the Oxford or BioNTech-Pfizer candidate by the end of April, helping to ease the strain on the NHS amid a deluge of hospitalisations driven in part by the new coronavirus variant.

Media and Political Bulletin

11 September 2020

Media Summary

Government in talks to offer drugs manufacturers incentives to diversify supply chains

The Pharmaceutical Journal, Carolyn Wickware, 10 September 2020

The Pharmaceutical Journal reports that the British Generic Manufacturers Association is in talks with the government over incentivising drugs firms to obtain active pharmaceutical ingredients from more than one source to avoid future supply problems.

Warwick Smith, director general of the BGMA, told The Pharmaceutical Journal that the trade body was “intensively” discussing measures with the government that would make it easier for companies to diversify their API production.

“The concentration of API supply over the years is a greater risk to resilience of the generics supply chain than having manufacturing plants in other parts of the world,” he added.

Responding to Smith’s comments, a spokesperson for the Department of Health and Social Care said: “We have robust systems in place to prevent and manage medicine shortages and we are constantly looking at ways to further enhance the resilience of supply chains.”

Parliamentary Coverage

Funding boost to help healthcare suppliers improve cyber security

Department for Digital, Culture, Media & Sport, National Cyber Security Centre, and Matt Warman MP, 10 September 2020

The UK government announced that small and medium-sized businesses in the healthcare sector, such as medical suppliers and primary care providers, can apply for part of the new £500,000 funding to improve their cyber security.

The government will cover all consultancy and certification costs, and it will also offer guidance and support to small and medium-sized businesses in the healthcare sector to get accreditation from the government’s Cyber Essentials certification.

The government support will include training to make sure all phones, tablets, laptops or computers are kept up-to-date, proper firewall usage to secure devices’ internet connections, and user access controls to manage employee access to services.

This comes after the National Cyber Security Centre (NCSC) identified a heightened cyber threat to the UK health sector in relation to the pandemic, with cyber crime groups attempting to steal sensitive intelligence, intellectual property and personal information from pharmaceutical companies and medical research organisations.

Full Coverage

Government in talks to offer drugs manufacturers incentives to diversify supply chains

The Pharmaceutical Journal, Carolyn Wickware, 10 September 2020

Talks are taking place between the British Generic Manufacturers Association and the government over incentivising drugs firms to take action to prevent future shortages.

The British Generic Manufacturers Association (BGMA) is in talks with the government over incentivising drugs firms to obtain active pharmaceutical ingredients (APIs) from more than one source in an effort to avoid future supply problems.

Warwick Smith, director general of the BGMA, told The Pharmaceutical Journal that the trade body was “intensively” discussing measures with the government that would make it easier for companies to diversify their API production.

It comes after critical care medicines — such as atracurium and cisatracurium — faced supply issues in April 2020 because of significantly increased demand from COVID-19 patients, with the Royal College of Anaesthetists forced to issue guidance that provided alternative medicines to those that were out of stock.

Smith said the demand meant that “one company with one product, [sold] what they would normally sell in 12 months in two weeks, and they only manufacture one batch a year”.

“What wasn’t appreciated at the time is that the volumes [of intensive care medicines] that are typically used are quite low,” he said, adding that this means there are “comparatively few suppliers of those medicines”.

Some manufacturers responded by halting production of other medicines to produce those that are more urgently needed, while one company “changed the production from mainland Europe to the UK for one product because that made them respond more flexibly,” he said.

Manufacturer Accord Healthcare told The Pharmaceutical Journal in May 2020 that it had plans to move production of hydroxychloroquine — which was being trialled as a COVID-19 treatment at the time — to the UK from abroad to combat potential shortages.

However, Smith said shoring up supply chains is more “nuanced” than building more factories in the UK.

“In fact, if all the factories were in the UK and the UK had a problem, that will be no use at all. What we need is diversity,” Smith explained.

“The concentration of API supply over the years is a greater risk to resilience of the generics supply chain than having manufacturing plants in other parts of the world,” he added, noting that “around a quarter of all generic medicines used in the UK are made here, but the supply of API is focused in places such as Italy, China and India.”

In August 2019, The Pharmaceutical Journal revealed that half of all safety warnings issued by European and US drug regulators are issued to drug manufacturers in India and China, raising concerns about the fragility of the global supply chain.

When asked whether companies were now looking at diversifying their API production, Smith said the BGMA was “talking to the government quite intensively about trying to get a programme of measures, which would make it easier for companies to do that”.

Smith clarified that these measures “could be government incentives to encourage manufacturers to have more than one API supplier and manufacturing location”.

“Hospitals buy the cheapest product, but it costs money to have more than one API supplier on your licence, so maybe we need to look at procurement and invest more in companies that have got more resilient supply chains,” he said.

“If it’s just about price, you’ll get cheap medicines, but when the excrement hits the air conditioning you might find we’re less able to step up than if we’d had a broader view of value.”

Responding to Smith’s comments, a spokesperson for the Department of Health and Social Care said: “We have robust systems in place to prevent and manage medicine shortages and we are constantly looking at ways to further enhance the resilience of supply chains.”

In July 2020, it was announced that the government had launched ‘Project Defend’, led by the Department for International Trade, “to identify vulnerabilities in global supply chains”.

Media and Political Bulletin

29 July 2020

Media Summary

Medicine supplies stretched and must be boosted ahead of possible second wave of coronavirus, MPs warn

Evening Standard, Sean Morrison, 29 July 2020

The Evening Standard reports that in a report examining the economic impact of Covid-19, the Commons International Trade Committee said the typical six-month “buffer stock” of supplies needs to be increased.

“While UK supply chains for medicines have proved to be resilient, they can only be stretched so far. “The Government must ensure that buffer stock of medicines (which typically only lasts up to six months) is being replenished in case of a further pandemic wave.”

A Government spokeswoman said the Department for International Trade was leading a review, called Project Defend, aimed at strengthening supply chains for critical goods. She added: “Medical supplies are critical to the Government’s response to coronavirus and the department’s global team has worked around the clock to support the continued flow of medical supplies and equipment and other essential goods into the UK.”

Rise in use of illicit benzodiazepines, PHE warns pharmacies

Chemist+Druggist, Eliza Slawther, 28 July 2020

Chemist+Druggist reports that Public Health England (PHE) has told pharmacies to “be alert” after evidence of hospitalisations, seizures and deaths linked to people taking illicit drugs sold as benzodiazepines.

Healthcare professionals who are in contact with people who use illegal drugs should “be alert to the increased possibility of overdose arising from illicit drugs sold as benzodiazepines, raise awareness and be able to recognise possible symptoms of overdose and respond appropriately”, PHE said in a central alerting system alert last week (July 24).

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Medicine supplies stretched and must be boosted ahead of possible second wave of coronavirus, MPs warn

Evening Standard, Sean Morrison, 29 July 2020

Stockpiles of medicines need to be boosted ahead of a possible second wave of coronavirus, MPs have warned.

In a report examining the economic impact of Covid-19, the Commons International Trade Committee said the typical six-month “buffer stock” of supplies needs to be increased.

It found that UK trade in essential goods like pharmaceuticals, medical supplies and food had mainly managed well in the crisis, but more action was needed.

MPs on the committee said: “UK supply chains in these critical sectors have largely held up during the pandemic, despite spikes in demand, disruption to production and freight, and export bans in some countries.

“While UK supply chains for medicines have proved to be resilient, they can only be stretched so far.

“The Government must ensure that buffer stock of medicines (which typically only lasts up to six months) is being replenished in case of a further pandemic wave.”

Committee chairman and SNP MP Angus MacNeil said dealing with the economic impact of coronavirus was a matter of “intimidating complexity”.

He said: “The question now facing trade policymakers is not only how to help economies respond to the damage caused by Covid-19 but also how to better prepare for a similarly dire scenario in the future.

“It is a task of intimidating complexity and seeing it through will require political dexterity.

“Ensuring supply-chain resilience and access to essential goods needs smart solutions that avoid falling into the trap of short-sighted protectionism.

“At the same time, the Department for International Trade must ensure it provides the right support to UK businesses as they rebuild, as well as leading international efforts to respond to this disease through co-ordinated trade policy. Their successes and failures will affect us all.”

The committee also called for the Government to consider adjusting intellectual property provisions to allow for compulsory licensing of therapeutic drugs or vaccines against Covid-19.

MPs said this could be a means of ensuring they can be made available as quickly, widely and cheaply as possible.

The committee called on the Department for International Trade (DIT) to “improve communication” about how it can support exporters to recover from the pandemic.

The report expressed “concern” about the lack of a co-ordinated international trade plan early in the pandemic.

MPs said this was in contrast to what happened in the 2008 financial crisis and called on the Government “to act to ensure that temporary disruptions do not become permanent barriers to trade”.

The MPs also urged transparency, stating: “The committee calls on the Government to be as open as possible about the measures it is considering to address supply chain vulnerabilities.

“It asks for clarity about how the Government will balance national security with its ambition to be a global champion of free trade.

“The report calls on DIT to step up its efforts in helping inward investors.

“The committee also calls on the Government to set out its approach to investment agreements in light of issues raised by the pandemic.

“Following concerns about predatory investors taking advantage of the devaluation of assets in the pandemic, the committee asks the Government to set out how it will strike a balance between screening investment for security concerns and promoting inward investment.”

A Government spokeswoman said the Department for International Trade was leading a review, called Project Defend, aimed at strengthening supply chains for critical goods.

She added: “Medical supplies are critical to the Government’s response to coronavirus and the department’s global team has worked around the clock to support the continued flow of medical supplies and equipment and other essential goods into the UK.

“The Department for Health and Social Care is doing everything possible to prepare for all scenarios and protect NHS patients including building a stockpile of crucial medicines.”

Rise in use of illicit benzodiazepines, PHE warns pharmacies

Chemist+Druggist, Eliza Slawther, 28 July 2020

Public Health England (PHE) has told pharmacies to “be alert” after evidence of hospitalisations, seizures and deaths linked to people taking illicit drugs sold as benzodiazepines.

Healthcare professionals who are in contact with people who use illegal drugs should “be alert to the increased possibility of overdose arising from illicit drugs sold as benzodiazepines, raise awareness and be able to recognise possible symptoms of overdose and respond appropriately”, PHE said in a central alerting system alert last week (July 24).

The alert, which was sent to community pharmacy teams, highlighted “significant evidence from toxicology results of illicit tablets being sold as diazepam, temazepam and alprazolam linked to recent hospitalisations and deaths”.

“This includes tablets known as and or marked with ‘DAN 5620’ (on one side) and ‘10’ (on the other), ‘T-20’, ‘TEM 20’, ‘Bensedin’ and ‘MSJ’ which may contain dangerously potent benzodiazepines or their analogues such as flubromazolam, flualprazolam and etizolam,” it explained.

Harm reduction advice

Most of these tablets are blue, although they also come in other colours and “may stain people’s mouths”, PHE said.

They are often “available in blister packs or pharmacy tubs to make them appear to be genuine medicines”, with the packaging claiming that they feature a “certain dose of diazepam (often referred to as ‘Valium’) or alprazolam (often referred to as ‘Xanax’)”, the alert explained.

In reality, “they may not actually contain any of those substances at all”.

The illicit benzodiazepines can be particularly harmful when used in combination with alcohol and drugs with “a respiratory depressant effect, including gabapentinoids and opioids”, PHE said.

The alert advised people who come into contact with people who have taken the affected drugs to give “harm reduction advice and information”, including administering naloxone if you are competent and able to do so; calling for an ambulance; monitoring for signs of an overdose and giving first aid.

Media and Political Bulletin

23 June 2020

Lord Bethell Thank You Letter to the Healthcare Distribution Sector, 17 June 2020

Please see here for a letter from Lord Bethell, Minister of Innovation at DHSC, thanking all staff in the healthcare distribution sector for their hard work during the COVID-19 pandemic.

Media Summary

‘Medicines supply to pharmacies was severely flexed during COVID-19’

Chemist+Druggist, Martin Sawer, 19 June 2020

Martin Sawer reported in an article for Chemist+Druggist that the medicines supply chain has remained afloat in spite of COVID-19 thanks to the collaboration between wholesalers and pharmacy teams.

The HDA is aligning with the PSNC and NPA, among others, to identify and mitigate potential risk factors. The HDA has also been working very closely with the DHSC, NHS England & Improvement, PHE and the MHRA to have issues formally addressed by government guidance or by the short-term easing of certain less critical regulations.

In many ways, medicines distribution is the hidden player in the supply chain.  The delivery service provided by HDA members often goes unseen. Across all our member companies, there are numerous examples of individuals working selflessly and tirelessly to ensure medicines are delivered safely and on time.

No-deal Brexit would see pharmaceutical exports to EU drop by 22%, peers told

The Herald, Herald Scotland Online, 22 June 2020

The Herald reports that pharmaceutical exports to the EU would slump by more than a fifth if the UK exits the Brexit transition period without a deal, peers have been told.

Dr Louise Gill, head of policy at GlaxoSmithKline, told the Lords EU Goods Sub-Committee that  “Our European Federation for Pharmaceutical Industry and Association is conducting a study where they are looking at the cost estimates in relation to the free trade agreement and introduction of a mutual recognition agreement.

“Preliminary draft data that I can share today is showing that pharma exports are expected to drop by 22.5% in a no deal, 22% in a simple free trade agreement – so, this is one without mutual recognition.”

However, Dr Gill said that if an FTA was coupled with a mutual recognition agreement, exports would decline by 12.6%.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

‘Medicines supply to pharmacies was severely flexed during COVID-19’

Chemist+Druggist, Martin Sawer, 19 June 2020

The medicines supply chain has remained afloat in spite of COVID-19 thanks to the collaboration between wholesalers and pharmacy teams, says HDA executive director Martin Sawer.

As the COVID-19 pandemic has swept the world, the vital roles of certain sectors that have for a long time been under-appreciated have been thrown into sharp relief. A good example of this is pharmacy.

Having long been a pillar of local communities, pharmacies and pharmacy teams sit at the heart of a well-functioning healthcare system. Yet this sector is often taken for granted, especially by those in government – it is underfunded and not given enough recognition.

Suddenly, pharmacy and the associated medicines supply are in the spotlight as key players in the frontline fight against COVID-19. It was therefore vital for those working with community pharmacy to rise to the challenge of providing support during the pandemic.

Understandably, many people are unaware of the number of medicines partners supporting pharmacy. These include the manufacturers of active pharmaceutical ingredients around the globe, the freight providers moving medicines, the vast warehouses containing pre-wholesale products and the network of smaller wholesale depots across all four UK countries. The medicines supply chain before a pack reaches a community pharmacy is long.

But all that matters to patients is whether the pharmacist is able to hand over their medicines when they need them. This task became immeasurably harder in March and April this year due to the COVID-19 outbreak. The rapid and unpredicted increase in demand for drugs dramatically impacted each complex moving component further up the chain.

The challenges

Take the healthcare distributors that the Healthcare Distribution Alliance (HDA) represents. In many ways, they faced a similar challenge to supermarkets. Although patients can’t panic-buy prescription medicines, the increase in prescriptions and number of days they were written for meant an unpredicted, massive volume of medicines had to arrive at pharmacies very quickly.

One HDA member’s warehouse reported distributing one week’s worth of Ventolin inhalers in one day in March, for example. Make no mistake, the government was worried and offered military support – the existing system was severely flexed, but critically, did not fall over.

This is a tribute to a terrific team effort: from pharmacists ordering accurately and on time, to the pre-wholesalers moving vast quantities of medicines, while pharmaceutical manufacturers reacted quickly to changing market dynamics. To accommodate this, HDA members committed millions of pounds to purchasing huge quantities of medicines at very short notice.

The level of detail that has been addressed to ensure the continuity of UK medicines supply has been simply astounding. It is a reminder of just how complex and interdependent the supply chain is.  Every stage must function efficiently for patients to receive their medicines. When every stage is being severely challenged as a result of COVID-19 then the potential for a breakdown is very high.

Thankfully, we have not so far experienced any significant breakdown in the overall continuity of supply – with wholesalers and pharmacies closely collaborating. This is not only at the day-to-day wholesaler to pharmacy level, but also at the more macro policy level.

The HDA is aligning with the Pharmaceutical Services Negotiating Committee (PSNC) and National Pharmacy Association (NPA), among others, to identify and mitigate potential risk factors. The HDA has also been working very closely with the Department of Health and Social Care (DH), NHS England & Improvement, Public Health England (PHE) and the Medicines and Healthcare products Regulatory Agency (MHRA) to have issues formally addressed by government guidance or by the short-term easing of certain less critical regulations.

One in five workers absent

Like pharmacy, wholesalers have faced many new challenges in the day-to-day operation of their businesses during the pandemic. Due to strong personal commitment, staff absences at the latter were thankfully lower than many expected. Nonetheless, normal ways of working had to be flexed or redesigned – especially in late March when absences hit the 20% mark.

Many office staff members have been redeployed to increase capacity in service centres, while extra hours and shifts are being added across our members’ businesses. For example, one company moved to working 24-hour-days seven days a week to serve hospitals in London and south east England.

Following sustained lobbying we were grateful that the government has classified pharmaceutical wholesalers as key workers, allowing our sector’s staff members all the valid recognition and flexibilities this continues to bring.  This has meant more team members can be on the warehouse floor to get pharmacy orders packed and out for delivery.

Like many other sectors, agency staff have had to be taken on to fill gaps left by absences.  Given the technical skills required to safely and securely distribute medicines to the letter of complex regulations, agency staff have required training in a very short space of time.

In many ways, medicines distribution is the hidden player in the supply chain.  The delivery service provided by HDA members often goes unseen. Across all our member companies, there are numerous examples of individuals working selflessly and tirelessly to ensure medicines are delivered safely and on time.

It has been a time of unprecedented challenge, and as with other supply chains, of course not everything has been perfect. However, in the most part the efforts of our member companies, manufacturers and pharmacy teams have underpinned our joint obligation to ensure patients receive their medicines.

In an unprecedented time like this we are all in it together, and we need to continue working collaboratively in the coming weeks and months. Let’s really applaud the efforts of everybody involved in the medicines supply chain, recognise the challenges we all have and work constructively to solve them.

In the meantime, I am signing off with a comment from a colleague working for an HDA member company: “Let us never forget what we do and the difference it makes – this is brought into sharp focus at times of crisis.”

Martin Sawer is executive director of Healthcare Distribution Association, which represents the UK’s largest medicine wholesalers.

No-deal Brexit would see pharmaceutical exports to EU drop by 22%, peers told

The Herald, Herald Scotland Online, 22 June 2020

Pharmaceutical exports to the EU would slump by more than a fifth if the UK exits the Brexit transition period without a deal, peers have been told.

Dr Louise Gill, head of policy at GlaxoSmithKline, told the Lords EU Goods Sub-Committee that if such a scenario played out at the end of the year preliminary data showed a decline in sales to the EU of 22.5%.

She said a simple free trade agreement (FTA) would be almost as bad, with a drop in exports of 22%.

However, Dr Gill said that if an FTA was coupled with a mutual recognition agreement – meaning both parties would allow goods manufacturing inspections and acceptance of batch testing performed either in the UK or the EU – exports would decline by 12.6%.

This would reduce the loss in exports to around two billion euro (£1.8 billion) per year, Dr Gill said.

Prime Minister Boris Johnson has insisted he will not accept the EU’s offer of a transition period extension beyond December 31, despite trade talks making slow progress.

Dr Gill told the committee: “Our European Federation for Pharmaceutical Industry and Association is conducting a study where they are looking at the cost estimates in relation to the free trade agreement and introduction of a mutual recognition agreement.

“Preliminary draft data that I can share today is showing that pharma exports are expected to drop by 22.5% in a no deal, 22% in a simple free trade agreement – so, this is one without mutual recognition.

“But only reduce by 12.6% in a scenario where we have a free trade agreement and a mutual recognition agreement.

“So, having a mutual recognition agreement would reduce the loss of exports by around two billion euro a year for the UK if we can have the free trade agreement and reach a mutual recognition agreement.

“Our biggest impact for our sector is having a mutual recognition agreement that supports good manufacturing inspections and allows the acceptance of batch testing performed either in the UK or the EU.”

Dr Gill said the industry wanted a smooth transfer of products between the UK and the EU.

She said that the option of non-tariff barriers would require duplicate testing and extra processes.

Dr Gill said: “We want to ensure the ease of movement of goods across borders and ensure we have swift access of our products to both patients and consumers, and this is our priority.

“In terms of costs and numbers, the European Federation of Pharmaceutical Industry and Association has noted that every month 45 million patient packs are supplied from the UK into Europe.

“Similarly, there are 37 million packs supplied from Europe into the UK.

“Non-tariff barriers will introduce additional processes into that movement and, of note, is the requirement for duplicate testing.”

Media and Political Bulletin

21 May 2020

Media Summary

Pharmacy minister confirms availability of home testing kits for pharmacy staff, their kin

Pharmacy Business, Pri Mandav, 20 May 2020

Pharmacy Business reports that symptomatic pharmacy staff and members of their household can order home testing kits for coronavirus, pharmacy minister has confirmed.

Jo Churchill said that deliveries of PPE packs were made to around 11,500 community pharmacies in England in March, and that “Further, supplies of PPE have been distributed to wholesalers and distributor networks supplying community pharmacies.”

Churchill said: “We understand the financial pressure of COVID-19 on community pharmacy which is why £300 million in extra advance payments have been made available to alleviate initial cash flow pressures.”

Superdrug antibody test sells out hours after launch

P3 Pharmacy, Pharmacy Network News, 20 May 2020

P3 Pharmacy reports that a coronavirus antibody test launched by Superdrug earlier today is already listed as unavailable on the company’s website due to high demand.

The home testing kit is being sold from Superdrug’s Online Doctor service but is not available in the company’s stores. To obtain the test, patients over 18 are required to fill out a questionnaire on the company’s website. If eligible, they can pay to have a kit mailed to them along with instructions on how to take a pinprick blood sample.

Parliamentary Coverage

The UK Government has released a document on the UK’s approach to the Northern Ireland Protocol.

Brexit: Government confirms new checks on goods entering NI from GB

BBC, John Campbell, 20 May 2020

BBC reports that the government has confirmed there will be new checks on some goods entering Northern Ireland from the rest of the UK as part of the Brexit deal. Speaking in the House of Commons, Mr Gove emphasised that trade from NI to GB would remain “unfettered”.

The government said there would not need to be any new paperwork for almost all GB-NI trade, including what are known exit summary declarations. The EU has previously suggested these declarations will be needed so this could be a point of dispute.

The Protocol does not mention pharmaceuticals, medicines or medicine devices.

Full Coverage

Pharmacy minister confirms availability of home testing kits for pharmacy staff, their kin

Pharmacy Business, Pri Mandav, 20 May 2020

Symptomatic pharmacy staff and members of their household can order home testing kits for coronavirus, pharmacy minister has confirmed.

The confirmation came just as the government announced that anyone with symptoms of coronavirus was eligible to book a test.

Due to the ongoing social distancing measures, members of parliament have resorted to sending written questions to ask ministers for information on the work, policy and activities of government departments. Pharmacy has been featuring prominently in the new world of a virtual House of Commons.

In a reply on Tuesday (May 19) to a written question from Erith and Thamesmead MP Abena Oppong-Asare, Jo Churchill said that testing could now be done through a self-referral online portal via this link.

“Symptomatic pharmacy staff, or symptomatic member(s) of their household, are eligible for testing through the self-referral online portal where they are able to order home delivery testing kits,” she confirmed.

PPE provision for pharmacy

Responding to the provision of personal protective equipment for pharmacy staff, the minister noted that deliveries of PPE packs were made to around 11,500 community pharmacies in England in March.

“Further, supplies of PPE have been distributed to wholesalers and distributor networks supplying community pharmacies,” she added.

“Where there remains an urgent need for additional PPE stock, community pharmacies should contact their Local Resilience Forums (LRFs) who can provide supplies to respond to local spikes in need.

“For those who are critically short of PPE, they should phone the National Supply Distribution Response for an urgent delivery. We will continue to work in ensuring that community pharmacies have access to PPE.”

Additional funding

Earlier, responding to a question from Hyndburn MP Sara Britcliffe on “additional funding to pharmacies,” Churchill said: “We understand the financial pressure of COVID-19 on community pharmacy which is why £300 million in extra advance payments have been made available to alleviate initial cash flow pressures.

“The Government has also provided additional funding to community pharmacy to cover costs associated with Bank Holiday opening at Easter and the Early May Bank Holiday and the new medicine delivery service commissioned for shielded patients, as well as making a contribution towards measures taken by community pharmacy to support social distancing.

“We continue to work with the Pharmaceutical Services Negotiating Committee and NHS England and NHS Improvement to examine what further funding community pharmacy may require to continue to supply medicines and to help their communities stay well.”

This was days before the government announced an increase in Category M drugs reimbursements of £15 million in June.

Superdrug antibody test sells out hours after launch

P3 Pharmacy, Pharmacy Network News, 20 May 2020

A coronavirus antibody test launched by Superdrug earlier today is already listed as unavailable on the company’s website due to high demand.

Superdrug announced this morning it had begun selling Abbott’s Covid-19 antibody test – the second to be approved by the UK Government after one developed by Roche – for £69, making it the first UK multiple to market an antibody test.

The Abbott test is said to have 97.5 per cent sensitivity and 100 per cent specificity, meaning it will not give a positive result if a patient has not previously had coronavirus and developed antibodies for the virus. It is being sold on other websites for £100.

The home testing kit is being sold from Superdrug’s Online Doctor service but is not available in the company’s stores. To obtain the test, patients over 18 are required to fill out a questionnaire on the company’s website. If eligible, they can pay to have a kit mailed to them along with instructions on how to take a pinprick blood sample.

The patient then mails their sample to be assessed. “The results of your test should be ready within two days after our partner lab receives your sample,” the Superdrug website says.

Patients with possible coronavirus symptoms are advised to wait 14 days to allow antibodies to develop before taking the test.

Unavailable due to high demand

However, this afternoon the product was listed as ‘currently unavailable’ just hours after the launch was first announced, with the website explaining this was “due to the high demand of orders”. Individuals wishing to purchase a test can email the chain to be put on a waiting list.

‘Positive result does not confer immunity’

Superdrug doctor ambassador Dr Zoe Williams said: “Now that Public Health England have approved certain antibody tests, it is great that Superdrug are offering the validated test to its customers.

“There are, however, things to consider before taking it. Receiving a positive antibody test result does not confer immunity. And it is important that people understand a positive test result does not mean you can be any more relaxed with the required hygiene and social distancing measures as set out by the government.”

Media and Political Bulletin

18 May 2020

Government guidance published to help ensure workplaces are as safe as possible. The government, in consultation with industry, has published guidance to help employers, employees and the self-employed understand how to work safely during the coronavirus pandemic.

There are 8 guides, including on Factoriesplants and warehouses and on Vehicles.

Media Summary

 

Salazopyrin out of stock until June 1

P3 Pharmacy, Pharmacy Networks News, 13 May 2020

P3 Pharmacy reports that the Pharmaceutical Services Negotiating Committee has informed community pharmacies that Salazopyrin 500mg suppositories are out of stock until the week beginning June 1.

The supply issues were caused by “an increase in demand seen by the sole supplier Pfizer” according to the negotiator. During this period, limited supplies of Salofalk 500mg suppositories will be available from Monday May 18. Additionally, they reported that Pentasa 1g suppositories remain available during this period.

33 more medicines added to export blacklist

Dispensing Doctors’ Association, MHRA, 13 May 2020

Dispensing Doctors’ Association reports that the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have added 33 medicines to the list of medicines which must not be parallel exported from the UK.

The new restrictions cover specified pharmaceutical forms and strengths of medicines, including Ibuprofen. The list will continue to be reviewed on an ongoing basis.

Programme to develop sustainable cold chain delivery for COVID-19 vaccine initiated

European Pharmaceutical Review, Victoria Rees, 12 May 2020

European Pharmaceutical Review reports that researchers and scientists are launching a new research project in India that will help to establish sustainable cold chain delivery systems for a COVID-19 vaccine in resource-poor countries.

Universal vaccine access is a major challenge, particularly in low-income countries – partly due to the lack of robust cold-chains. The Global Alliance for Vaccines and Immunization estimates that only 10 percent of health care facilities in the world’s poorest countries have a reliable electricity supply while in some countries less than 5 percent of health centres have vaccine-qualified refrigerators.

Parliamentary Coverage

 

House of Commons – Written Question, 13 May 2020

Matt Vickers (Stockton South): To ask the Secretary of State for Health and Social Care, what assessment he has made of whether there has been a change in the price of medicines and drugs for the NHS and pharmacists since the start of the covid-19 outbreak.

 

Full Coverage

 

Salazopyrin out of stock until June 1

P3 Pharmacy, Pharmacy Networks News, 13 May 2020

The Pharmaceutical Services Negotiating Committee has informed community pharmacies that Salazopyrin (sulfasalazine) 500mg suppositories are out of stock until the week beginning June 1.

The negotiator said supply issues affecting the medication, which is used to treat rheumatoid arthritis, ulcerative colitis and Crohn’s disease, were caused by “an increase in demand seen by the sole supplier Pfizer.”

PSNC also reported that limited supplies of Salofalk (mesalazine) 500mg suppositories, used to treat inflammatory bowel disease including ulcerative colitis and Crohn’s disease, will be available from Monday May 18 and that Pentasa 1g suppositories remain available during this period.

33 more medicines added to export blacklist

Dispensing Doctors’ Association, MHRA, 13 May 2020

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have added 33 medicines to the list of medicines which must not be parallel exported from the UK.

The new restrictions cover specified pharmaceutical forms and strengths of medicines including:

Atenolol

Azithromycin

Bisoprolol

Buprenorphine

Dexamethasone

Digoxin

Glycopyrronium bromide

Ibuprofen

Lisinopril

Metoprolol

Tiotropium

The list, will continue to be reviewed on an ongoing basis, to include any product that meets the following criteria:

  • the medicine is required to meet the needs of UK patients;
  • the medicine is either being parallel exported or is at threat of being parallel exported; and
  • the export of that medicine is either contributing to, or may contribute to, a shortage of that medicine in the UK.

Programme to develop sustainable cold chain delivery for COVID-19 vaccine initiated

European Pharmaceutical Review, Victoria Rees, 12 May 2020

Scientists are launching a new research project in India that will help to engineer an efficient and sustainable delivery mechanism for the distribution of an eventual COVID-19 vaccine to billions of people around the globe.

Supported by the Shakti Sustainable Energy Foundation in India, experts from the University of Birmingham and Heriot-Watt University, both UK, are joining forces with non-profit, commercial and academic partners to begin investigating the scale of challenge involved in distributing a potentially temperature-sensitive COVID-19 vaccine.

According to the researchers, universal vaccine access is a major challenge, particularly in low-income countries – partly due to the lack of robust cold-chains. The Global Alliance for Vaccines and Immunization estimates that only 10 percent of health care facilities in the world’s poorest countries have a reliable electricity supply while in some countries less than 5 percent of health centres have vaccine-qualified refrigerators.

Toby Peters, Professor of Cold Economy at the University of Birmingham, commented: “Universal vaccine access is already a major challenge. With COVID-19, rapid mass immunisation will probably be required; maintaining a continuous cold chain to rapidly transport and deliver COVID-19 vaccine to all communities, many where electricity supply and cooling infrastructure is often non-existent or unreliable, will be a daunting task. Given most of the technologies deployed today will still be in operation in the next decade, the emergence of sustainable and off-grid cold-chain devices allows us the opportunity to create sustainable solutions for COVID-19 vaccine deployment that also can deliver resilient and sustainable health cold-chain systems as a lasting legacy.”

Shubhashis Dey, Associate Director of Shakti Sustainable Energy Foundation, commented: “COVID-19 related mass immunisation requirements offer us an opportunity to not only increase our vaccine production, but also create a robust logistics cold chain system that can handle the country’s overall vaccine needs… Our effort is designed to help India overcome this massive logistic challenge sustainably and create a model of global adoption.”

Research in India will be led by the Centre for Environment Education and supported by commercial partners such as Zanotti (a part of the Daikin Group), Sure Chill and Nexleaf Analytics. This group will begin by researching a number of questions that will be key to solving the cold-chain conundrum, including which countries have the needed infrastructure, what the the financing requirements to establish an efficient vaccine delivery system and how this can be done sustainably.

Clean cold experts from the University of Birmingham and Heriot-Watt University are working with Indian counterparts Centre for Environment Education and MP Ensystems to explore how integrated ‘Community Cooling Hubs’ can integrate food cold chains with other cold-dependent services such as community health facilities, social facilities and even emergency services.

Professor Phil Greening, from the Centre for Sustainable Road Freight at Heriot-Watt University, commented: “We may have 12-18 months to engineer a robust, efficient distribution system to ensure any vaccine for COVID-19 can reach the world’s population, whether they are in urban or remote rural areas. A radical approach like community cooling hubs could help meet the different communities’ cooling needs in a clean, affordable and sustainable way while helping to safeguard people’s health. There will be many knowns and unknowns in facing the coronavirus challenge, but a vaccine is one of the very few exit strategies around which scientists and government are aligned.”

Researchers at the University of Birmingham and Heriot-Watt University believe that their work in this area will ultimately help to:

  • Develop a short- to medium-term crisis exit solution aimed to deliver COVID-19 vaccine in a safe, efficient and clean manner, while still maintaining routine vaccine deliveries
  • Create a long-term contingency framework through establishment of logistics specifically for medicine, blood, vaccines, that is cost-effective, sustainable and responsive to different levels of challenge – basic needs, natural disasters/ regional epidemics, national pandemics
  • Deliver lasting value by meeting current unmet and future vaccine demand.

Professor Peters added: “Ultimately, we need a global effort to prepare the vaccine and in parallel a global strategy to develop the appropriate sustainable and legacy equitable cold chains and achieve this with minimum environmental impact. Out-of-the-box thinking is needed if we are to define sustainable and inclusive solutions that can be delivered quickly and at scale to beat this pandemic and unlock connections between COVID-19 vaccine deployment, sustainable cold chain and development of clean energy infrastructure.”

 

Media and Political Bulletin

08 April 2020

Media Summary

Limiting shortages: steps for the UK to strengthen drug supply

European Pharmaceutical Review, Dr Sam Roscoe, 08 April 2020

The delivery of pharmaceutical products has been significantly impacted by the COVID-19 coronavirus – especially those medicines that address the condition’s symptoms (e.g., paracetamol, aspirin) and the underlying health conditions that the virus exploits (e.g., diabetes medication, asthma inhalers, heart medication).

As the pharmaceutical supply chain is more global than that of standard grocery staples, it has been more affected by COVID-19’s rapid spread around the globe.

Dr Sam Roscoe gives European Pharmaceutical Review his recommendations for pharmaceutical companies and supermarkets in the UK to limit reliance on deliveries from overseas, to ease the impact of the COVID-19 coronavirus on drug supply chains.

Emerade 300 microgram pens recall

Dispensing Doctors’ Association, MHRA, 07 April 2020

Dispensing Doctors’ Association reports that Emerade 300 microgram pens (Pharmaswiss Česka republika, an affiliate of Bausch & Lomb UK Limited) are being recalled due to a higher risk of activation failure.

The recall follows a previous alert for Emerade 150 microgram auto-injectors from patients. Emerade 500 microgram auto-injectors are not being recalled.

Affected patients and carers should request a new prescription for an alternative brand. Quarantined or returned Emerade 300 microgram auto-injectors should be returned to suppliers.

The alert also contains information for managing requests during the COVID-19 pandemic.

Medical groups warn of serious shortages of hydroxychloroquine

Financial Times, Michael Peel, Stephanie Findlay and Donato Paolo Mancini, 07 April 2020

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

COVID-19: Scottish pharmacies land ‘initial’ £5.5m funding boost

C+D, Valeria Fiore, 07 April 2020

C+D reports that pharmacies in Scotland will receive “an initial package” of £5.5m to help them cover the costs of COVID-19, health secretary Jeane Freeman has announced.

The additional funding “will address [pharmacies’] unparalleled level of activity” in dispensing medicines and providing treatment through the extended Scottish minor ailment service during the crisis, Ms Freeman said at the Scottish Government’s COVID-19 press briefing yesterday. The cash boost will help cover the cost of “equipment, adaptation of premises, additional staffing and locum cover when they have a sickness absence”, Ms Freeman added.

Community Pharmacy Scotland (CPS) clarified that the extra £5.5m comes on top of the advance payments due for the end of April, which were announced at the end of last month.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Limiting shortages: steps for the UK to strengthen drug supply

European Pharmaceutical Review, Dr Sam Roscoe, 08 April 2020

Dr Sam Roscoe explains his recommendations for pharmaceutical companies and supermarkets in the UK to limit reliance on deliveries from overseas, to ease the impact of the COVID-19 coronavirus on drug supply chains.

The delivery of pharmaceutical products has been significantly impacted by the COVID-19 coronavirus – especially those medicines that address the condition’s symptoms (e.g., paracetamol, aspirin) and the underlying health conditions that the virus exploits (e.g., diabetes medication, asthma inhalers, heart medication).

As the pharmaceutical supply chain is more global than that of standard grocery staples, it has been more affected by COVID-19’s rapid spread around the globe. However, placing maximum purchasing regulations in supermarkets on key pharmaceutical products, ensuring that pharma companies reduce their stock lines and encouraging UK producers to significantly increase their production could be vital to guaranteeing medicinal supply to the country and limiting shortages.

Current stresses on the pharma supply chain

Many of the active pharmaceutical ingredients (APIs) that are included in the finished formulation of pharmaceutical products are sourced and manufactured in China and then shipped to India for assemblage and packaging. However, when the virus emerged in China it quickly shut down pharmaceutical manufacturing facilities, directly impacting medicine supply – not just to India but also to the rest of the world.

While much of China’s manufacturing capabilities are now available for use again, contract manufacturing organisations (CMOs) in India are currently being forced to temporarily shut because of the government mandated lockdown, which will further impact production and disrupt trade.

Pharmaceutical supply chains therefore face two major supply disruptions that have occurred within a three-month period.

Medicinal supply is further restricted due to labour shortages in the wholesale and distribution of generics and other pharma products to UK pharmacies, as well as shortages with pharmacy staff.

Finally, panic buying in the UK has led to a spike in demand for medicines directly linked to the symptoms of COVID-19 and the upper respiratory system. Long, globalised supply chains, with an already disrupted supply, will therefore have difficulty in swiftly responding to these spikes in demand.

The one saving grace is that pharma companies tend to hold significant amounts of inventory in the supply chain, often up to six months – meaning that they can fulfil demand if the panic buying situation stabilises in the next few months by utilising their stockpiles.

However, if excessive demand in the UK is coupled with a decreased supply from India, there could be significant shortages of key medicines in the near future.

Ways to handle a rise in demand

The pharmaceutical industry needs to take instruction from the grocery sector on how to avoid stockouts of key medicines such as paracetamol, aspirin, insulin, heart medication and salbutamol. The first way pharmacies and other retailers could combat this situation would be to immediately introduce maximum purchase quantities.

Secondly, pharma companies could reduce the number of product variations they make, as can be seen at Tesco, Asda and Sainsbury’s for certain grocery items. For example, instead of having 100ml, 250ml and 500ml bottles of paracetamol that are regular and extra strength, pharma companies could prioritise the manufacture of a standard size bottle of regular strength paracetamol. By reducing product range now, pharma firms would be able to produce larger volumes by having longer production runs. Moreover, pharmacies will reduce the risk of stockouts because they would hold fewer stock-keeping units in stores and would have higher volumes of a particular product type.

Lastly, pharma companies can begin collaborating with UK-based CMOs to ramp up local production volumes.

Conclusion

Taken together, these steps would greatly reduce the impact of COVID-19 on the pharmaceutical supply chain, while also easing delays at border crossings and the likelihood that overseas governments will restrict the export of medications to their own populations.

Emerade 300 microgram pens recall

Dispensing Doctors’ Association, MHRA, 07 April 2020

Emerade 300 microgram pens (Pharmaswiss Česka republika, an affiliate of Bausch & Lomb UK Limited) are being recalled due to a higher risk of activation failure.

The recall of Emerade 300 microgram auto-injectors from patients follows a previous alert for Emerade 150 microgram auto-injectors from patients. The alert notice provides GPs with a letter for affected patients.

Emerade 500 microgram auto-injectors are not being recalled.

Affected patients and carers should request a new prescription for an alternative brand. Quarantined or returned Emerade 300 microgram auto-injectors should be returned to suppliers.

The alert also contains information for managing requests during the COVID-19 pandemic.

Medical groups warn of serious shortages of hydroxychloroquine

Financial Times, Michael Peel, Stephanie Findlay and Donato Paolo Mancini, 07 April 2020

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

COVID-19: Scottish pharmacies land ‘initial’ £5.5m funding boost

C+D, Valeria Fiore, 07 April 2020

Pharmacies in Scotland will receive “an initial package” of £5.5m to help them cover the costs of COVID-19, health secretary Jeane Freeman has announced.

The additional funding “will address [pharmacies’] unparalleled level of activity” in dispensing medicines and providing treatment through the extended Scottish minor ailment service during the crisis, Ms Freeman said at the Scottish Government’s COVID-19 press briefing today (April 7).

The cash boost will help cover the cost of “equipment, adaptation of premises, additional staffing and locum cover when they have a sickness absence”, Ms Freeman added.

Community Pharmacy Scotland (CPS) clarified that the extra £5.5m comes on top of the advance payments due for the end of April, which were announced at the end of last month.

In a statement published today, CPS said that community pharmacy has been “the real frontline in supporting patients within primary care in recent weeks”.

“We have agreed to continue to engage with Scottish Government colleagues to ensure that this is truly recognised in financial terms, as this pandemic continues, as we know it is in policy terms within Government in Scotland,” the negotiator added.

Opening on Easter bank holidays

In the press briefing, Ms Freeman said pharmacies had responded positively to her request for them to stay open on Good Friday and Easter Monday.

“We will meet in full additional costs incurred by community pharmacies to support the NHS at this time,” she added.

CPS acknowledged that this ask is “one that will be difficult for pharmacy teams anticipating a break after a number of challenging weeks”, but said it shows how important community pharmacy is “up and down the country”.

Pharmacies need your support

Ms Freeman concluded her speech with an appeal to the public to ask them to support community pharmacy during the COVID-19 pandemic.

She said: “Pharmacies are working incredibly hard right now. I understand there are times when we are queuing for our medicines or for advice [when] we can become frustrated by those queues.

“But I would ask everyone to please understand that our community pharmacies and our pharmacists are part of the healthcare workforce that I know you support, and they need your support as much as any other part of it does.”

Following confirmation from the Scottish Government, the story was updated today (April 7) to say that the “initial” funding community pharmacies will receive is £5.5m, not £5.3m as it was originally stated by first minister Nicola Sturgeon and health secretary Jeane Freeman at the Scottish COVID-19 press briefing.

This was reported in a number of publications, including P3 Pharmacy.

Media and Political Bulletin

17 June 2019

Media Summary

Unsafe medicines stolen in Italy ‘entered NHS supply chain’

The Guardian, Mattha Busby, 16 July 2019

The Guardian reports that medical authorities in the UK have launched an internal inquiry after unsafe medicines for common conditions were stolen from Italian hospitals and sold to UK pharmacies.

The article states that criminal gangs linked to the mafia infiltrated the NHS supply chain in 2014, which resulted in prescription medicines for prostate cancer, epilepsy and schizophrenia being imported into the UK.

More than 10,000 units of stolen drugs had arrived in the UK by 2014, according to an investigation by Channel 4 Dispatches, with four types of unsafe medicine sold to pharmacies.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Unsafe medicines stolen in Italy ‘entered NHS supply chain’

The Guardian, Mattha Busby, 16 July 2019

Medical authorities in Britain have launched an internal inquiry after unsafe medicines for common conditions were stolen from Italian hospitals, sold to UK pharmacies and potentially reached patients.

Criminal gangs linked to the mafia infiltrated the NHS supply chain in 2014, which resulted in prescription medicines for prostate cancer, epilepsy and schizophrenia being imported into the UK.

More than 10,000 units of stolen drugs had arrived in the UK by 2014, according to an investigation by Channel 4 Dispatches, with four types of unsafe medicine sold to pharmacies.

The medicines were not counterfeit, but given the time they spent outside of the regulated supply chain they were classed as “falsified”. The Medicines and Healthcare products Regulatory Agency (MHRA), which did not alert the wider public at the time, said it believed the risk to public health was low since they were legitimate medicines.

However, during a review of its 2014 investigation into reports of stolen medicines sold for use in the UK, the regulator found that records concerning the probe were incomplete – prompting an internal review to ensure it was adequately protecting the regulated supply chain.

“In 2014, following reports of medicines being stolen in Italy and sold to the UK, we undertook an investigation and acted to make sure products on the UK market were safe,” said MHRA chief executive Ian Hudson. “We received this information more than a year after the thefts occurred.

“In addition to this case, the MHRA has seized falsified medicines from the regulated supply chain only nine times in the last decade, and there is no evidence any of these medicines made it to patients.”

A well-known high street pharmacy chain said to have stocked and prescribed the medicines is to be named on Monday by Dispatches.

The first indication that the stolen Italian medicines had entered the UK’s supply chain came in March 2014, when a German pharmaceutical wholesaler purchased breast cancer drugs which were found to have been tampered with and had become ineffective.

The Italian regulator investigated a number of major thefts between 2011 and 2014 that saw thousands of critical medicines for serious illnesses go missing, later entering official medical supply chains across Europe.

It is understood that the MHRA wrote to wholesalers and asked them to ensure the affected products did not enter the supply chain, and to quarantine such medicines if necessary and contact those they supplied requesting they do the same.

The MHRA does not hold prescribing data, and has no direct evidence that patients received these medicines. However, it acknowledged that “there is a possibility that some of these medicines reached patient level”.

Former Liberal Democrat health minister Norman Lamb led calls for a review. “People first of all need to be told that they may have received medicines that came through an illegal route,” he said. “And what I find extraordinary is that there hasn’t been openness about this having happened.”

All medicines in the UK have carried a unique barcode since February 2019, which allows their veracity to be authenticated after the MHRA implemented the EU Falsified Medicines Directive.

Media and Political Bulletin

14 February 2018

Media Summary

Joining European coalition will secure cheaper drugs

The Times, Jennifer Bray, 13 February 2018

 

The Times reports that yesterday Simon Harris, the Irish health minister, brought a memo to cabinet proposing to open negotiations with Belgium, the Netherlands, Luxembourg and Austria on drug pricing and supply.

The health minister is thought to have said that securing timely access to new and innovative medicines is a key government priority. He is expected to have outlined how the challenge is not unique to Ireland and that many countries are confronting the same issues.

There have been two years of negotiations between the Department of Health and other European countries to try to access cheaper medicines. Mr. Harris should now receive cabinet approval to issue a “letter of intent” to his counterparts in Belgium, the Netherlands, Luxembourg and Austria signalling Ireland’s interest in joining the collaboration between them, known as the BeNeLuxA Initiative, on drug pricing and supply.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Joining European coalition will secure cheaper drugs

The Times, Jennifer Bray, 13 February 2018

 

Simon Harris will bring a memo to cabinet this morning proposing to open negotiations with Belgium, the Netherlands, Luxembourg and Austria on drug pricing and supply.

The health minister will say that securing timely access to new and innovative medicines is a key government priority. He is expected to outline how the challenge is not unique to Ireland and that many countries are confronting the same issues.

There have been two years of negotiations between the Department of Health and other European countries to try to access cheaper medicines.

Mr Harris will receive cabinet approval to issue a “letter of intent” to his counterparts in Belgium, the Netherlands, Luxembourg and Austria signalling Ireland’s interest in joining the collaboration between them, known as the BeNeLuxA Initiative, on drug pricing and supply. Mr Harris will outline how joining will allow Ireland to explore opportunities to secure sustainable and affordable access for patients to innovative medicines in an era of high pricing by pharmaceutical companies.

Mr Harris will bring a draft bill to allow a referendum on the Eighth Amendment to cabinet next week. If passed, there would be a vote on the state’s constitutional ban on abortion in either late May or early June.

Mr Harris has said that if Ireland votes to repeal the amendment, he plans to pass a law that would allow access to abortion for all women at up to 12 weeks’ gestation. Beyond the first three months, abortion would only be allowed in cases of fatal foetal abnormalities and when the woman’s life or health was at risk.

From Factory to Pharmacy

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

See the Infographic

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