Media and Political Bulletin – 04 August 2020

Media and Political Bulletin

04 August 2020

Media Summary

UK warns drug firms to stockpile in case of Brexit disruption

The Guardian, 04 August 2020

The Department of Health and Social Care (DHSC) has written to medicine suppliers advising them to stockpile six weeks’ worth of drugs to guard against disruption at the end of the Brexit transition period.

The advice comes amid continued uncertainty over whether the UK and the EU will be able to strike an agreement on a future relationship before time runs out. It also comes amid concerns that the Covid-19 crisis has led to a dwindling of some medical stocks and that a disorderly exit without a trade deal could cause significant disruption.

“Holding additional stock in the UK provides a further buffer against some disruption and we believe, where it’s possible, it’s a valuable part of a robust contingency plan,” the letter, signed by Steve Oldfield, Chief Commercial Officer at DHSC, says.

This is also covered in Evening Standard, Express, The Independent, Daily Mail, BBC News, Reuters, The Telegraph, ITV, The New European, Pharmacy Business, Yahoo Finance, The Times, Wales Online, FirstWord Pharma and Medical Xpress.

Parliamentary Coverage

Letter to medicine suppliers: 3 August 2020

Steve Oldfield, Chief Commercial Officer, Department of Health and Social Care

Steve Oldfield wrote to medicine suppliers to share information on the end of the transition period on 31 December 2020, as it relates to the continuity of the supply of medicines and medical products to the UK. This follows the government’s recent confirmation that the transition period will cease as planned on 31 December 2020 and there will be no extension.

You can view the full correspondence here.

DHSC Webinar on the Continuity of Medical Supplies at the End of the Transition Period

The Department of Health & Social Care will be hosting a webinar on 11 August 2020 from 10am-11am UK time, to introduce the plans and preparations of the Department to support the continuity of medical supplies at the end of the transition period (end of December 2020).

This webinar follows from the recent letter from Steve Oldfield, Chief Commercial Officer, at the Department. David Simmons, Director, Supply Resilience at DHSC and Ed Palferman, Head of Engagement and Communications, Continuity of Supply at DHSC, will be presenting. Register here to attend the webinar.

House of Commons, Written Answers – 03 August 2020

Steve McCabe (Birmingham, Selly Oak):

  • To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the (a) effectiveness and (b) safety of using alternatives to Hormone Therapy Replacement patches.
  • To ask the Secretary of State for Health and Social Care, what progress his Department has made on tackling the shortage of Hormone Therapy Replacement patches.

Jo Churchill: We have been working closely with all suppliers of Hormone Replacement Therapy (HRT) preparations to maintain overall supply to patients. Supplies of alternative HRT products continue to remain available and the situation has been improving steadily since the end of February 2020.

The National Institute for Health and Care Excellence has made an assessment of the clinical and cost effectiveness of HRT, including transdermal patches, and has made recommendations on their use in its guideline on menopause: diagnosis and management [NG23].

The safety and efficacy of individual products that are authorised for the relief of oestrogen deficiency symptoms associated with the menopause are assessed at the time each product is licensed and safety is continuously monitored once it is on the market.

Most post-marketing studies examine the safety of HRT products as a group and the safety of HRT products as a class has been kept under continuous review by the Medicines and Healthcare products Regulatory Agency (MHRA) in conjunction with its independent scientific advisory body, the Commission on Human Medicines (CHM) and its Expert Advisory Group on Medicines for Women’s Health. Likewise, the safety of licensed medicines and herbal products that are used as alternatives to HRT are continuously monitored by the MHRA and advice sought from the CHM, as needed, when new safety issues arise.

Full Coverage

UK warns drug firms to stockpile in case of Brexit disruption

The Guardian, 04 August 2020

Pharmaceutical companies should stockpile six weeks’ worth of drugs to guard against disruption at the end of the Brexit transition period, the government has said.

The Department of Health and Social Care (DHSC) has written to medicine suppliers advising them to make boosting their reserves a priority.

The letter, published online on Monday, reiterates that ministers will not be asking for an extension to the transition period past 31 December, despite the coronavirus pandemic.

There are concerns that the Covid-19 crisis has led to a dwindling of some medical stocks and that a disorderly exit without a trade deal could cause significant disruption.

Suppliers were advised all scenarios must be planned for, including reduced traffic flow at short Channel crossings such as between Calais and Dover.

“We recognise that global supply chains are under significant pressure, exacerbated by recent events with Covid-19,” the letter says.

“However, we encourage companies to make stockpiling a key part of contingency plans, and ask industry, where possible, to stockpile to a target level of six weeks’ total stock on UK soil.”

The advice comes amid continued uncertainty over whether the UK and the EU will be able to strike an agreement on a future relationship before time runs out.

Brussels’ chief negotiator, Michel Barnier, said last month that London’s position made the prospects of a deal “at this point unlikely”.

The British Medical Association, the trade union representing doctors, warned the stockpile is “at best a short-term solution”.

Deputy council chairman, Dr David Wrigley, said: “With the transition period only months away and at the height of what will be an undoubtedly difficult winter, this is incredibly concerning.

“The BMA has consistently warned that a no-deal Brexit could have a potentially devastating impact on the NHS and consequently the health of the nation. Now, more than ever, it is absolutely crucial that the government secure a relationship that protects the future health of this country.”

Media and Political Bulletin

20 July 2020

Media Summary

Brexit: Hundreds of health professionals sign open letter demanding protection for NHS in trade deals

The Independent, Andrew Woodcock, 18 July 2020

The Independent reports that more than 400 NHS and public health professionals have signed an open letter demanding legal guarantees in post-Brexit trade legislation currently going through parliament to provide specific protections for the health service in any future negotiations with countries such as the US.

Boris Johnson has repeatedly stated that the NHS is not on the table in trade negotiations with the US, though secret documents revealed last year by Labour showed that American negotiators had made clear their ambition to secure concessions on drug patents and access to health markets.

Former health minister Jackie Doyle-Price elected as chair of All-Party Pharmacy Group

Pharmacy Business, Pri Mandav, 17 July 2020

Pharmacy Business reports that former minister of state for health Jackie Doyle-Price MP has been elected chair of the All-Party Pharmacy Group.

A former civil servant and Conservative Party member, Doyle-Price has served as MP for Thurrock since 2010 and was under-secretary of state for mental health and sucide prevention in Theresa May’s government.

The newly elected group will be exploring how community pharmacy can help relieve pressures on other parts of the health service as the NHS tackles health challenges including Covid-19 and winter pressures.

UK builds up Covid-19 medicines stockpile in case of second wave

Financial Times, Sarah Neville, 16 July 2020

The Financial Times reports that the UK government is building a medicines stockpile worth almost £100 million to boost supplies of vital drugs ahead of a potential second wave of coronavirus. A notice seen by the Financial Times lists 46 different medicines, spanning drugs used in intensive care and for end-of-life patients, as well as antibiotics.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said, it was “quite appropriate”, for the UK Government “to plan for the worst case and introduce additional resilience to the supply of some of the most clinically critical medicines”.

The Department of Health and Social Care said: “As the public would rightly expect, we are doing everything we can to prepare for all scenarios and protect NHS patients. This includes building a stockpile of crucial medicines used to treat Covid-19 patients as a sensible precautionary step, to help ensure there is an uninterrupted supply over the coming months.”

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Brexit: Hundreds of health professionals sign open letter demanding protection for NHS in trade deals

The Independent, Andrew Woodcock, 18 July 2020

More than 400 NHS and public health professionals have signed an open letter demanding legal guarantees in post-Brexit trade legislation currently going through parliament to provide specific protections for the health service in any future negotiations with countries such as the US.

Signatories – who include the president of the Faculty of Public Health, Maggie Rae, and former World Health Organisation director Anthony Costello – warned that without amendments the government’s Trade Bill would put the NHS “on the table in future trade deals”.

Unless explicitly excluded, the NHS will be automatically included in trade negotiations, exposing the UK healthcare system to “unavoidable and irreversible marketisation”, they warned.

Boris Johnson has repeatedly stated that the NHS is not on the table in trade negotiations with the US, though secret documents revealed last year by Labour showed that American negotiators had made clear their ambition to secure concessions on drug patents and access to health markets.

The Trade Bill completes its passage through the House of Commons on Monday, with MPs due to vote on amendments tabled by Labour leader Keir Starmer and SNP trade spokesperson Stewart Hosie to protect the NHS in negotiations, as well as a separate bid by Tory Jonathan Djanogly to give parliament the right to scrutinise and vote on any trade deal before it is signed.

The 400 health workers, who include frontline hospital doctors, nurses and GPs as well as more than 40 professors and the president of the Medical Women’s Federation, Neena Modi, warned that a free trade deal with the US would risk reducing access to medications, compromising the safe storage of NHS data and undermining the National Institute for Clinical Excellence.

Unless MPs pass legal guarantees that the NHS is to be exempted, the UK could be exposed to the Investor-State Dispute Settlement (ISDS) system, which allows a company to sue a government for threatening their profits by imposing barriers to trade, said the letter.

“Protecting the NHS from trade deals has public support,” the signatories said, pointing to recent polls suggesting 84 per cent of voters want the NHS to remain fully public.

“In last year’s elections, all major political parties pledged to protect the NHS. To fulfil their promise, we ask politicians to support amendments to the Trade Bill to mandate adequate scrutiny of all trade deals and to provide explicit protection to the NHS in future trade deals.”

Dr Sarah Walpole, a junior doctor who wrote the letter, said: “In the UK, we take it for granted that we won’t go bankrupt paying for medical treatment. Covid-19 has shown us the importance of healthcare being accessible to all, and the value of our NHS and public health system.

“The Trade Bill in its current form leads the way towards ongoing fragmentation and marketisation of UK health services and higher drug prices, a path which the NHS may not survive. If services are contracted out to private companies through trade deals, this may be irreversible due to international law.

The letter was backed by pro-public ownership pressure group We Own It, whose director Cat Hobbs said: “Boris Johnson’s warm words aren’t enough. We can’t wish away the threat that trade deals pose to our NHS.

“Instead, what we need is concrete protection. To make matters worse, right now we not only don’t have this protection, but parliament isn’t being given the most basic powers of scrutiny on trade deals. That means neither MPs, nor the public will be able to see what is being included, and how our NHS will be affected.

“MPs debating the Trade Bill must listen to the public and stand up for our treasured NHS. At the very least, they must back Jonathan Djanogly’s amendment to allow parliament to scrutinise future trade deals. If they don’t, their constituents won’t forgive, and they won’t forget.”

Former health minister Jackie Doyle-Price elected as chair of All-Party Pharmacy Group

Pharmacy Business, Pri Mandav, 17 July 2020

Former minister of state for health Jackie Doyle-Price MP has been elected chair of the All-Party Pharmacy Group.

A former civil servant and Conservative Party member, Doyle-Price has served as MP for Thurrock since 2010 and was under-secretary of state for mental health and sucide prevention in Theresa May’s government.

The election of Jackie Doyle-Price and eight other officers took place at the APPG’s inaugural meeting on Tuesday (July 14) where attendees also discussed the role of community pharmacy in the next phase of the response to Covid-19.

The newly elected group will be exploring how community pharmacy can help relieve pressures on other parts of the health service as the NHS tackles health challenges including Covid-19 and winter pressures.

It will also be looking at the potential of digital technology in pharmacy as well as the integral role of community pharmacy in supporting people to manage their own health.

“The current challenges caused by Covid-19 have reinforced the critical role that community pharmacies play across the UK as the third pillar of our national health service alongside GPs and A&E,” Doyle-Price said, following her election as chair of the group.

“Beyond just dispensing medicines, pharmacies are many people’s first point of contact with the NHS, providing vital services to keep people healthy.

“In the year ahead, I am looking forward to exploring new opportunities to strengthen the role of pharmacists in the health system, capitalising on their clinical expertise to reduce pressures on GPs and hospitals and support the prevention of ill-health.

“The All-Party Pharmacy Group is preparing a fantastic programme of work and I look forward to working with colleagues across both Houses to support the pharmacy sector at this crucial time for the NHS.”

In a joint statement the national pharmacy organisations that support the APPG said: “We are delighted that the APPG will continue its important work in parliament and we look forward to supporting Jackie Doyle-Price MP and the members of the APPG to broaden the conversation in Parliament of the vital role that pharmacy plays in helping to alleviate pressures on the NHS.

“The NHS has committed to making greater use of pharmacists and we have already seen them taking on greater responsibilities for helping patients and reducing pressures on GPs. Alongside opportunities to support the NHS there are also challenges to explore and overcome, including sustainable funding and embracing new ways of working. We are keen to work with the APPG to facilitate a discussion of how to ensure we capitalise on the value of pharmacy to the benefit of patients and the NHS.”

The APPG is supported with funding from the Association of Independent Multiple Pharmacies, the Company Chemists’ Association, the National Pharmacy Association, the Pharmaceutical Services Negotiating Committee and the Royal Pharmaceutical Society.

Other officers elected to the group were: Sir David Amess MP, Paul Bristow MP, Feryal Clark MP, Jason McCartney MP, Taiwo Owatemi MP, Julian Sturdy MP, Lord Clement-Jone and Baroness Cumberlege.

UK builds up Covid-19 medicines stockpile in case of second wave

Financial Times, Sarah Neville, 16 July 2020

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

Media and Political Bulletin

02 July 2020

Media Summary

Stockpiling drugs likely as countries compete for protection

The Times, 01 July 2020, Rhys Blakely

The Times reports that countries are likely to stockpile drugs that would protect their population from coronavirus. We have witnessed this in recent weeks, with America buying up virtually all of the remdesivir due to be produced over the next three months, and the UK government banning exports of dexamethasone.

However, it would seem that mechanisms have been developed to allow for the equitable distribution of drugs and vaccines. Astrazeneca has said it can produce two billion doses of a candidate Covid-19 jab being developed by Oxford University, and plans to establish several production chains in parallel in different parts of the world to minimise bottlenecks.

Another British vaccines team, based at Imperial College London, have pledged to make their jab available at the lowest possible cost in the developing world; and Gilead has signed agreements to make remdesivir available to poorer countries. But the Times reports that in the short term, bottlenecks, panic buying and what analysts have termed “vaccine nationalism” are probably unavoidable.

Parliamentary Coverage

Northern Ireland Executive – £13.25m funding and commissioning agreement announced for Community

A new £13.25 million funding package for community pharmacy has been announced today by Health Minister Robin Swann.

This funding is being made available up to March 2021 and is in addition to a confirmed recurrent financial envelope of £112.4m for 2020/21. It also adds to a previous investment of £7.5m for the period April to June 2020 which ensured that pharmacies could continue to maintain the supply of essential medicines during the initial stages of the COVID-19 pandemic.

Full Coverage

Stockpiling drugs likely as countries compete for protection

The Times, 01 July 2020, Rhys Blakely

President Trump often sounds like a coronavirus sceptic, but when it comes to stockpiling treatments his approach is unabashedly America first. That his administration has bought up virtually all of the remdesivir due to be produced over the next three months by Gilead, the drugmaker that invented the antiviral medicine, is not surprising. The drug is one of only two that have been shown to help coronavirus patients and supplies are tight.

Britain would probably have done something similar given the chance; last month the UK government banned exports of dexamethasone, a cheap and widely available steroid that is the still the only drug that has been proven to save the lives of Covid patients.

Resources become scarce during pandemics and countries would be foolish to count on the generosity of neighbours during a global outbreak.

However, mechanisms have been developed to allow for the equitable distribution of drugs and vaccines. Astrazeneca, the British drugs company, has pledged to supply the UK with 100 million doses of a candidate Covid-19 jab being developed by Oxford University. It has said that the NHS will have “first dibs” if it works.

This is a small portion of the two billion doses that Astrazeneca has said it can produce in total. The company plans to establish several production chains in parallel in different parts of the world to minimise bottlenecks. It has a partnership, for instance, with the largest vaccine maker in the world, the Serum Institute of India. It has also promised to supply the vaccine without making profits during the pandemic.

Another British vaccines team, based at Imperial College London and led by Professor Robin Shattock, have pledged to make their jab available at the lowest possible cost in the developing world. If it works it would be licensed to outside manufacturers via a “social enterprise” company called VacEquity Global Health (VGH), which would waive royalty payments. VGH is being supported by Imperial and by Morningside Ventures, an investment company run by the billionaire Chan family of Hong Kong.

One key organisation is the Coalition for Epidemic Preparedness, which is funded by the Bill and Melinda Gates Foundation, the Wellcome Trust, the European Commission and seven nations. Founded in 2017, it is backing nine vaccine projects — including Oxford’s and Imperial’s — and has committed itself to making supplies available across the globe as fairly as possible.

There is also a mechanism in place to make remdesivir available to poorer countries. Gilead has signed agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan. They will be allowed to produce the drug for distribution in 127 nations — though that list does not include the UK.

In the short term, however, bottlenecks, panic buying and what analysts have termed “vaccine nationalism” are probably unavoidable. We have seen it before; during the 2009 swine flu epidemic rich countries swooped in to buy up vaccine stocks.

Global relationships may be remade in the months to come. There is a good chance that the first vaccine for Covid-19 could come from China. How Beijing would choose to share it is unknown.

Covid-19 has become notorious among clinicians as an unpredictable disease. The distribution of drugs and vaccines may be just as capricious.

Media and Political Bulletin

15 June 2020

Media Summary

New Chair confirmed for Pharmacy APPG

Pharmacy Business, Radhakrishna NS, 13 June 2020

Pharmacy Business reports that pharmacy trade bodies have confirmed that an MP is set to stand as the new Chair of the All-Party Pharmacy Group (APPG).

National Pharmacy Association said in a statement that they have been “in contact with a number of parliamentarians across both Houses who have expressed a keen interest in getting involved with the APPG, including standing as Officers to help guide the Group.”

The APPG is not currently active as the re-registration of the group could not be done due to the COVID-19 restrictions.

Coronavirus: PPE stocks were in chaos . . . then army got a grip

The Times, Philip Aldrick, 11 June 2020

Philip Aldrick writes how getting PPE supplies to key staff during the pandemic proved a logistical challenge like no other. In his timeline he details how the country got to the stage of having a functioning supply chain in place – from the initial lack of coordination between the Cabinet Office, the DHSC, PHE, the NHS and its own supply chain arm; to the involvement of the army; and more recently the turn to private logistics companies.

Parliamentary Coverage

Government accelerates border planning for the end of the Transition Period

Cabinet Office, 12 June 2020

New border controls and procedures have been confirmed for 2021 as the Chancellor of the Duchy of Lancaster, Michael Gove, formally notified the EU that the UK will neither accept nor seek any extension to the Transition Period.

From 1 January 2021, the UK will have the autonomy to introduce its own approach to goods imported from the EU. Border controls will be introduced in stages to give businesses affected by coronavirus more time to prepare. See here for more details on the different stages.

Full Coverage

New Chair confirmed for Pharmacy APPG

Pharmacy Business, Radhakrishna NS, 13 June 2020

Pharmacy trade bodies have confirmed that an MP is set to stand as the new Chair of the All-Party Pharmacy Group (APPG).

The position is vacant since longstanding Chair Sir Kevin Barron MP has stepped down from parliament last year.

“We are delighted to confirm that an MP with significant experience in health policy has agreed to stand as the new Chair of the APPG in the AGM elections.” the National Pharmacy Association said in a statement.

“We have also been in contact with a number of parliamentarians across both Houses who have expressed a keen interest in getting involved with the APPG, including standing as Officers to help guide the Group.”

The APPG is expected to hold an Annual General Meeting (AGM) soon as the rules that mandated physical presence of at least five MPs in a room has recently changed to allow for virtual meeting.

The APPG is not currently active as the re-registration of the group could not be done due to the COVID-19 restrictions.

Trade bodies that support the APPG – the Association of Independent Multiple Pharmacies, the Company Chemists’ Association, the National Pharmacy Association, the Pharmaceutical Services Negotiating Committee, and the Royal Pharmaceutical Society- said they will continue to work together to inform MPs of the work being done by the community pharmacies during the pandemic, and ensure their support for the sector until AGM elections are held and the APPG is re-registered.

Coronavirus: PPE stocks were in chaos . . . then army got a grip

The Times, Philip Aldrick, 11 June 2020

Tony Mannix, the boss of Clipper Logistics, remembers Sunday March 22 for two reasons. It was Mother’s Day, the eve of the lockdown, and it was the day he received the call that dragged him into the Covid-19 fightback. The call came from an industry contact of his, Neil Ashworth, a civilian working in the British Army’s Engineering and Logistics Staff Corps and a former supply chain director at Tesco.

Mr Mannix had been told that the Ministry of Defence was looking for a company to help distribute personal protective equipment to the health service. By then the provision of PPE was in crisis. Shortages were terrifying health workers and shaming politicians, who were struggling to pull a pandemic response plan together.

The government was in the midst of pivoting from its herd immunity strategy, first flagged on March 11, to lockdown. Modelling by Imperial College London published on March 16 had suggested that herd immunity would cost 250,000 lives and raised the prospect of the NHS being unable to cope.

Ventilator shortages became the immediate focus of attention and, on March 17, the Cabinet Office put out an emergency call to British industry. The other big concern was a lack of PPE and the risk that health service workers might be sent into the coronavirus war without protection — “throwing them to the wolves” as staff would later describe it. By the end of the week the government had moved a long way. Safety was paramount, the herd immunity strategy was ditched and the slogan “Stay home, Protect the NHS, Save lives” had been created.

The army had been drafted in to assist with PPE delivery in late February and soon realised that the supply chain was being overwhelmed. To ease delivery pressures, the directors developed a plan but it needed the political sign-off. With the government struggling to keep up, no decisions were being made.

“Everyone seemed to think it was someone else’s problem,” one source close to the talks said. Between them the Cabinet Office, the Department of Health and Social Care, Public Health England, the NHS and its own supply chain arm could not reach an agreement. Eventually, in frustration, the army took control.

“They are trained for a crisis so they get things done. They made things happen,” one person involved said. Another said: “The army got a grip of stuff.”

It was then that the Ministry of Defence made contact with Mr Ashworth to get the ball rolling.

He recommended Clipper, a fast-growing logistics group that specialises in online retail, to his MoD contacts and they told him to recruit the company.

Clipper, whose workload had fallen because of the lockdown and consequently had some spare capacity, was only too happy to take on the PPE contract. It would work with the army and Unipart, the NHS’s core logistics partner, which was having to handle 220,000 order lines a day — 90,000 more than usual — as calls came in for everything from food, beds, ventilators, syringes and materials for the new Nightingale hospitals.

Winter spikes in demand of about 20 per cent are expected. But the health service supply chain had never before experienced a 70 per cent spike. At the same time, Unipart was losing staff to the virus. At the peak, one in ten on its NHS contract were ill or self-isolating.

Once it was drafted in, Clipper had a warehouse and 70 vehicles up and running within four days.

The protective equipment crisis had begun a month earlier, when the authorities were still claiming to be “extremely well prepared”. In a letter to NHS suppliers on February 11, with Wuhan in lockdown, Steve Oldfield, the Department of Health and Social Care’s chief commercial officer, told suppliers to examine “the requirements in the case of an expanded outbreak in the UK” and to be prepared to ration PPE “in the event of excessive or unusual ordering patterns”.

Within nine days rationing had started as health service trusts started stockpiling in preparation for an outbreak. The problem was obvious. PPE inventory in the core supply chain was typically three weeks’ supply. With more in shipment, there was a maximum of five or six weeks’ worth of stock either in Britain or en route.

But that was for normal levels of demand and demand was exploding.

The first response of Supply Chain Co-ordination Ltd, the private company that oversees the NHS Supply Chain, was to tap the pandemic stockpile, which it manages on behalf of Public Health England and is handled by Movianto, another private logistics group. Technically, the stockpile is only triggered when the World Health Organisation declares a “pandemic influenza” and Covid-19 is not flu. Even the declaration of a pandemic on March 11 was not enough to release the stockpile under the rules, but by then Public Health England had taken matters into its own hands and ordered Movianto into action.

In late February Movianto began moving PPE from the pandemic stockpile into the core supply chain. At one point, it was shipping 800 pallets a day, with each pallet able to hold 120,000 aprons.

The army began shifting packages from the Movianto stockpile to GP surgeries, care homes and dentists. About 200 squaddies were also made available to Unipart to help in the warehouses and loading trucks. By then the supply chain was coming under fierce criticism because PPE was getting where it was not needed and not where it was. “Hospitals were demanding against their fear, not their needs,” one insider said.

The problem was exacerbated by the fact that only half of non-pharmaceutical supplies come through the in-house NHS supply chain. The rest are sourced from private companies, which compete to offer hospitals a better price. As global demand for PPE surged many of the private providers struggled to fulfil orders, pushing more work towards the health service supply chain, which was simply expected to pick up the slack. Sourcing protective equipment was proving increasingly difficult as countries competed for it and supplier nations imposed export restrictions.

Britain has never run out of supplies “but only because a demand limiting function was imposed”, one senior source said. Rationing is hated by supply chain managers as a sign of failure because their job is to deliver what is ordered.

With the help of NHS X, in charge of digital transformation of the health service, allocation is now being run by artificial intelligence. NHS X has recruited a private technology company to build a machine-learning algorithm that anticipates demand using daily hospital situation reports.

The identity of the company is a secret.

With both an AI-led demand control system and Clipper’s parallel dedicated PPE supply chain in place, the worst logistics issues appeared to have been resolved. Sourcing remained fraught, best illustrated by the disastrous order of unfit equipment from Turkey in mid-April, but the stock was getting to where it was needed. Official figures showing that NHS deaths were no higher than their age-related counterparts in the general population suggested that the PPE did get through. But then another crisis struck.

While all the focus was on the health service, the virus was devastating care homes, which now account for more than a quarter of all deaths and where carers are twice as likely to die from the virus as both the general population and NHS staff. The care sector is largely a private operation with more than eight in ten beds owned by for-profit companies for local authorities. It was the care home providers’ responsibility to source PPE.

By early April it was clear they were in big trouble. It was also clear the government did not have a plan to match claims made on March 20 by Jenny Harries, England’s deputy chief medical officer, that there was “a perfectly adequate supply of PPE” and pressures had been “completely resolved”. About 25,000 care homes had received limited supplies from the pandemic stockpile in February, but that was largely it.

When Clipper’s parallel PPE supply chain was set up, it was designed exclusively for the NHS. It was not until the second week of April, with public concerns about care homes at fever pitch, that the government asked it to build a whole new supply chain for the social care sector as well.

The challenge was enormous, expanding Clipper’s logistics network from 233 hospital trusts to 58,000 smaller care homes.

With its experience in online retail logistics, Clipper was well placed to deliver the service but the solution, built with the army, was complex. Ebay was enlisted to create a purchasing portal and a specialised central PPE procurement unit was established to source items. Clipper distributes to the Royal Mail, which delivers to the care home door. It took a week to get the pilot going for a network that Mr Mannix later said would normally take “six weeks to four months” to build. By May 5, it had delivered 400,000 pieces of protective equipment. Sir Nick Carter, chief of the defence staff, said it was the “greatest logistical challenge” in his 40 years of service.

It took almost four months but a functioning supply chain is now in place, albeit one with no pandemic stockpile in reserve. The NHS Supply Chain is said to have 100 new suppliers of PPE from around the world as well as more domestic producers, which are contracted to produce two billion items, more than the 1.6 billion pieces delivered since the pandemic began. “Using our PPE distribution network we will continue to ensure supplies reach the front line quickly and effectively,” a spokesman said.

How the NHS supply chain works

The NHS Supply Chain, the in-house network that supplies healthcare products, services and food but not drugs to the NHS, is a complicated beast.

DHL Life Sciences managed the whole area between 2006 and 2018, when a new structure broke the supply chain into 13 contracts, mostly with private companies. The new system is overseen by Supply Chain Coordination Ltd (SCCL), a company owned by Matt Hancock, the health secretary, on behalf of the Department of Health and Social Care.

Eleven of the 13 contracts are for procurement, with each provider responsible for sourcing a specific set of goods. PPE falls into three of those, two managed by DHL and one run by the Collaborative Procurement Partnership, owned by four NHS trusts.

The twelfth contract is IT, run by DXC Technology, another private company.

The thirteenth and largest of all is the £730 million logistics contract that Unipart took over from DHL in February 2019. Stock levels are jointly decided by SCCL and Unipart and enough to cover three weeks’ demand.

The new system is designed to use the NHS’s massive buying power to drive down prices for the £6 billion spent every year on hospital consumables and save the NHS £2.4 billion by 2023.

The strategy was proving a success when the outbreak struck. But the increased stock was being run through the same seven warehouses as before, with an eighth yet to be built, in Bury St Edmunds. The increase in demand without increasing capacity has raised questions about whether the supply chain was already overstretched. Unipart and NHS Supply Chain reject the suggestion.

Unipart said it had created more capacity by improving the performance of its warehouses. An NHS Supply Chain spokeswoman said: “For stocked deliveries on time, in January on a year-to-date basis, we achieved 99.77 per cent and for delivered service levels, 99.81 per cent. Our customer satisfaction score was consistently at 8.3.”

Media and Political Bulletin

24 March 2020

Media Summary

Coronavirus: pharmacies urge people to stop stockpiling paracetamol

iNews, Paul Gallagher, 23 March 2020

iNews reports that pharmacies have urged people to stop stockpiling drugs. Huge increase in demand for medical items such as paracetamol and thermometers have led to gaps on shelves although there is no overall shortage of prescription medicines, officials have said.

The National Pharmacy Association (NPA) said pharmacies, the Government, the NHS, pharmaceutical wholesalers and manufacturers are all working together and doing “everything they can to keep the supply of medicines flowing.

The article reports that Martin Sawer of the Healthcare Distribution Association said that there is “plenty of paracetamol in the supply chain” but admitted that the demand for it had increased.

This was also reported in the Daily Mail.

Paracetamol sold for more than £50 per tablet on online bidding sites

The Pharmaceutical Journal, Julia Robinson, 23 March 2020

The Pharmaceutical Journal has found that packets of paracetamol are being sold via online bidding sites at increasingly inflated prices amid concerns around shortages resulting from the COVID-19 pandemic.

In one example, on 19 March 2020, 240 tablets of paracetamol (Panadol; GSK) 500mg were being sold on eBay by a vendor in Sri Lanka for £12,500. This is over 500 times the retail price at Boots, which is currently £1.69 for 16 tablets of Panadol Advance.

In another case, bids for 144 tablets of the same brand of paracetamol reached over £250.

Paracetamol price hikes have also been highlighted by customers visiting community pharmacies in the UK.

DH not yet planning to release pandemic stockpile

P3 Pharmacy, Pharmacy Network News, 23 March 2020

Pharmacy Network News (PNN) reveals that a Government scheme to stockpile essential medicines as a ‘buffer’ against national pandemics still exists in some form – but there are no plans to release any stock as yet.

The DH told PNN its Essential Medicines Buffer Stockpile (EMBS), originally established in 2010 in the wake of the swine flu pandemic, lapsed in October 2019 without contracts being formally renewed. However, some manufacturers agreed to extend their contracts on a voluntary basis up to July 2020, and there are currently 142 medicine lines being stockpiled as part of the EMBS, PNN understands.

It is unclear which medicines are currently being kept back. A spokesperson for the DHSC told PNN that the department “continuously reviews the supply situation for all medicines and will consider releases from the EMBS as and when required to manage supply issues and respond to potential increases in demand”.

 

Parliamentary Coverage

House of Commons – Written Answer, 23 March 2020

James Murray (Ealing North): To ask the Secretary of State for Health and Social Care, if he will make it his policy to recognise the marketing authorisation by the European Medicines Agency of any coronavirus (2019-nCoV) vaccine to ensure there is no risk of delay in the UK acquiring the vaccine in comparison to countries in the EU.

Ms Nadine Dorries (answered on 23 March 2020): The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

 

Full Coverage

Coronavirus: pharmacies urge people to stop stockpiling paracetamol

iNews, Paul Gallagher, 23 March 2020

Pharmacies have urged people to stop stockpiling drugs which has led to chemists around the country suffering from “intermittent supplies”.

Huge increase in demand for medical items such as paracetamol and thermometers have led to gaps on shelves although there is no overall shortage of prescription medicines, officials have said.

The National Pharmacy Association (NPA) said pharmacies, the Government, the NHS, pharmaceutical wholesalers and manufacturers are all working together and doing “everything they can to keep the supply of medicines flowing.

Patients are told to only order a repeat prescription when they have between seven and ten days’ worth of medication left. And NHS England guidance says GPs should not give out prescriptions for rolling months.

Boots has warned it could run out of paracetamol by the end of the week. It only has enough of the drug to last until Saturday, according to an urgent memo sent to workers and seen by The Sun on Sunday.

Boots is expected to limit all products that contain paracetamol to just one per person, less than an industry-wide ration of two per customer transaction. The company told staff the decision has been made in order to “help us support as many customers as possible”.

Supermarket shortfall

Supermarket shelves have also been stripped of all paracetamol and ibuprofen in recent days. Martin Sawer, executive director of the Healthcare Distribution Association said that there is “plenty of paracetamol in the supply chain” but admitted that the demand for it had increased.

A spokesman for the NPA said: “There are sufficient medicines flowing through the system to meet the UK’s needs. There’s been a big increase in demand for many types of medicines. In most cases, pharmacies are currently able to meet need in a timely fashion, even if that means limiting the quantity of certain medicines sold to each customer.

“Certain products, for example, hand sanitisers, paracetamol and thermometers, are only intermittently available. Please only buy the medicines you need now for you and your family; this will help to avoid creating difficulties for others, so that everyone in your community gets the medicines they need.

“There is no overall shortage of prescription medicines, but the current exceptionally high demand means that it may take longer than you are used to for pharmacy staff to process prescriptions.”

This was also reported in the Daily Mail.

Paracetamol sold for more than £50 per tablet on online bidding sites

The Pharmaceutical Journal, Julia Robinson, 23 March 2020

Exclusive: Prices for paracetamol tablets online and in independent community pharmacies has jumped considerably since the COVID-19 outbreak.

Packets of paracetamol are being sold via online bidding sites at increasingly inflated prices amid concerns around shortages resulting from the COVID-19 pandemic, The Pharmaceutical Journal has found.

In one example, on 19 March 2020, 240 tablets of paracetamol (Panadol; GSK) 500mg were being sold on eBay by a vendor in Sri Lanka for £12,500.

This is over 500 times the retail price at Boots, which is currently £1.69 for 16 tablets of Panadol Advance.

In another case, bids for 144 tablets of the same brand of paracetamol reached over £250.

Paracetamol price hikes have also been highlighted by customers visiting community pharmacies in the UK.

On 19 March 2020, two Twitter users highlighted that their local pharmacies were charging £9.99 for 32 paracetamol tablets, up substantially from £1.39 the week before. Another Twitter user reported that their local independent pharmacy’s own-brand paracetamol suspensions had doubled in price.

Some branches of Jhoots Pharmacy, an independent community pharmacy chain which owns more than 80 pharmacies, have also been revealed to be one of the pharmacies hiking up paracetamol prices.

In a statement shared on Twitter on 19 March 2020, the West Midlands-based chain said that following an investigation, it had found that the price increases had been made at branch level and that all those affected would be refunded.

“In order to rectify the issue we will make full refunds to our customers affected by this and have taken all appropriate action to ensure that this does not happen again,” it said.

Commenting on the price changes, a spokesperson for the National Pharmacy Association (NPA) said: “It’s important that no-one in the supply chain, including pharmacies, breaches good faith with their customers by introducing unjustifiable mark-ups.

“This kind of story must not be allowed to obscure the fact that pharmacists up and down the land are providing a heroic service on the health service frontline.”

On 20 March 2020, the Competition and Markets Authority (CMA) had launched a COVID-19 taskforce following concerns that businesses might exploit the pandemic to take advantage of people by charging excessive prices or making misleading claims about their products.

The taskforce will scrutinise market developments to identify harmful sales and pricing practices as they emerge and warn firms suspected of exploiting these exceptional circumstances through unjustifiable prices or misleading claims.

The CMA added in a statement released on 20 March 2020 that it had already contacted traders and platforms regarding excessive pricing of hand sanitiser.

“This is obviously a time when we all have to behave responsibly to protect our fellow citizens, and particularly those who are most vulnerable” said Andrea Coscelli, chief executive of the CMA.

“We urge retailers to behave responsibly in the exceptional circumstances of the COVID-19 outbreak.

“But if they do not, our taskforce is monitoring market developments to enable us to intervene as quickly as possible. We have a range of options at our disposal, from warnings to enforcement action to seeking emergency powers.”

On 19 March 2020, the NPA highlighted that while pharmacies are still able to procure prescription only medicine packs of paracetamol, many pharmacies are reporting ongoing shortages of paracetamol 500mg tablets as pharmacy and general sales list packs.

In an interview on BBC Radio 4’s Today programme on 16 March 2020, Simon Dukes, chief executive of the Pharmaceutical Services Negotiating Committee, said that there had been a “300–400% in demand for ibuprofen and paracetamol over the past ten days”.

DH not yet planning to release pandemic stockpile

P3 Pharmacy, 23 March 2020

A Government scheme to stockpile essential medicines as a ‘buffer’ against national pandemics still exists in some form – but there are no plans to release any stock as yet, Pharmacy Network News can reveal.

The Department of Health and Social Care told PNN its Essential Medicines Buffer Stockpile (EMBS), originally established in 2010 in the wake of the swine flu pandemic, lapsed in October 2019 without contracts being formally renewed.

However, some manufacturers agreed to extend their contracts on a voluntary basis up to July 2020, and there are currently 142 medicine lines being stockpiled as part of the EMBS, PNN understands.

It is unclear which medicines are currently being kept back. The original scheme, which saw the Department of Health pay manufacturers £80m over five years to house £176m worth of additional stock, covered 454 essential medicines including drugs for epilepsy and schizophrenia, as well as antibiotics and intravenous fluids.

A spokesperson for the DHSC told PNN that the department “continuously reviews the supply situation for all medicines and will consider releases from the EMBS as and when required to manage supply issues and respond to potential increases in demand”.

Gaps in the EMBS were being identified as late as March 2018, when a tender for peritoneal dialysis fluids was issued, covering a period up to the end of March 2020.

In a statement issued last week on measures to support pharmacies tackling the COVID-19 pandemic, the Pharmaceutical Services Negotiating Committee said: “Medicine suppliers have already been approached by Government to assess the impact that COVID-19 could have on the supply chain.

“In particular, DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto these. We are talking to DHSC about this.”

Previous stockpiling efforts criticized

Government-held buffer stocks have had a chequered history. In 2014 the House of Commons Public Accounts Committee criticised the £560m stockpiling of antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) for use in a flu pandemic on the grounds that there was a lack of consensus over effectiveness.

Some £74m of Tamiflu was written off as a result of poor record keeping by the NHS on how medicines had been stored during the 2009 pandemic.

Supply chain breaches

Dispensing Doctors’ Association, MHRA, 23 March 2020

The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced by HMS Wholesale Limited.

The products appear genuine with legitimate batch numbers. These products are thought to have been stolen from the legitimate supply chain in early 2019 and reintroduced into the supply chain between May and August 2019. This means that the correct transport and storage conditions cannot be guaranteed and while unlikely, could impact their effectiveness.

Only specific batch numbers are within the scope of this alert. If you have received any of these batches after the reintroduction date listed in appendix 1, from HMS Wholesale Limited, please follow the advice below:

  • Please check your stocks of all the listed products for the relevant batches supplied from HMS Wholesale Limited. If any relevant packs are identified, please quarantine and notify the DMRC/MHRA. The products are listed in the section Product description.
  • Please note this alert only requires notification to the MHRA if you have been provided any of the products in the section Product description, directly from HMS Wholesale Limited only.

Media and Political Bulletin

10 March 2020

Media Summary

No respite in challenges for the generics sector

P3 Pharmacy, 28 February 2020

The HDA’s educational infographicFrom factory to pharmacy, was featured in P3 Pharmacy’s article reporting on the independent report by economics consultancy Oxera, commissioned by the BGMA, that highlighted the sector’s capacity to provide sustained and significant savings to the NHS and create greater patient access.

The infographic aims to explain some of the issues behind issues of drug availability and provide helpful information to those involved in dispensing and delivering vital medicines to UK patients.

Communications from SecurMed UK – FMD safety features, 06 March 2020

SecurMed UK has published two communications about:

  • Product not found Alert – Change in procedure
  • Password renewal

These communications can be viewed here.

Community Pharmacy COVID-19 Forum – NHS England preparedness letter, 09 March 2020

Yesterday afternoon, Keith Ridge sent a preparedness letter on COVID 19 to pharmacy colleagues:

See https://www.england.nhs.uk/coronavirus/primary-care/

and https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/preparedness-letter-primary-care-pharmacy-9-march.pdf.

The letter is similar to Dr Nikita Kanani’s letter of 5 March but includes advice specifically for pharmacies.

PSNC has issued an update to pharmacy on the letter and other related developments, and added a news story to their website – see https://psnc.org.uk/.

Coronavirus: stockpiling medicine is unnecessary and may cause its own problems, experts warn

iNews, Ruchira Sharma, 09 March 2020

iNews reports that experts have warned that people should not stockpile medicines as there are no shortages due to Covid-19. Overprescribing or ordering more prescriptions than is necessary could create a problem for others, and goes against the advice issued by the government.

“Patients can be assured that everyone in the supply chain will continue to work together to do all that they can to ensure that they get the medicines they need,” said a spokesperson for the PSNC.

Some pharmacies confirmed that they are seeing an increase in the number of conversations with patients worried about the Covid-19 coronavirus.

But the Government confirmed there was little evidence to suggest supply chains in the UK were affected, the Royal Pharmaceutical Society said. Moreover, the country is prepared thanks to its precautions for a no-deal Brexit, explained Sandra Gidley, president of the RPS.

GPhC could suspend inspections due to coronavirus outbreak

C+D, Valeria Fiore, 09 March 2020

While GPhC inspections will continue as planned for the time being, suspending them could be a “potential option” depending on how the virus develops in the future, the regulator told C+D last week.

The regulator is liaising “with governments, the NHS and other organisations and is preparing appropriately for potential options and scenarios, including in relation to pharmacy inspections”, GPhC CEO Duncan Rudkin explained.

“Our priority is making sure patients and the public continue to receive safe services from pharmacies and pharmacy professionals. We also have an important responsibility to protect the health, safety and wellbeing of our staff and everyone affected by our work,” he said.

Europol notes ‘worrying trend’ in fake medicines

Life Sciences Intellectual Property Review, Rory O’Neill, 09 March 2020

Life Sciences Intellectual Property Review reports that EU authorities seized €7.9 million worth of counterfeit medicines – including fake cancer drugs, antivirals, and erectile dysfunction medicines – as part of an operation carried out last year. According to Europol, nearly 36 million units of counterfeit medicines were seized, accompanying 165 arrests in 12 European countries.

The operation was led principally by the French National Gendarmerie and Finnish customs, and run in conjunction with Europol, the European Union Intellectual Property Office and other national law enforcement agencies. Europol said the operation resulted in the interception of 12 criminal groups, and the recovery of €1.5 million worth of assets.

The drugs were trafficked through both online and offline channels.

 

 

Parliamentary Coverage

House of Commons – Written Answer, 09 March 2020

Ms Harriet Harman (Camberwell and Peckham): To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that women in Camberwell and Peckham constituency have adequate access to Hormone Replacement Therapy (HRT); and if he make an assessment of the adequacy of the medicine supply chain in relation to HRT.

Jo Churchill (answered on 09 March 2020): We are aware of ongoing supply issues with some hormone replacement therapy (HRT) preparations for a variety of reasons.

The National Health Service receives updates on the supply situation and availability of HRT products, and we are continuing to engage with organisations such as the Royal College of Obstetricians and Gynaecologists, the Faculty of Sexual and Reproductive Healthcare and the British Menopausal Society.

We have been working closely with all suppliers to resolve the issues as quickly as possible and maintain overall supply to patients across the United Kingdom, including those living in Camberwell and Peckham. Although some HRT products are still affected by supply issues, alternatives remain available, and the overall supply situation has been improving since February 2020 and will continue to improve over the coming months.

 

Full Coverage

No respite in challenges for the generics sector

P3 Pharmacy, 28 February 2020

A recent independent report by economics consultancy Oxera, commissioned by the British Generic Manufacturers Association (BGMA), has highlighted the sector’s capacity to provide sustained and significant savings to the NHS and create greater patient access. However, will the lack of certainty over the supply of medicines post-Brexit, while the government tries to sort out a longer-term arrangement with the EU, damage the sector and what do those in the know think is in store for the sector this year?

BGMA director general Warwick Smith says these “life-saving, life-enhancing” products need to be “a priority focus” when it comes to UK and EU discussions. “The more the UK’s regulatory regime for medicines diverges from the EU’s, the less likely it is that we can continue to supply the same range of products at the same price, which means there could be fewer new products available,” he says.

This is down to the way the industry operates. New products are launched first in the US and the EU because these are the biggest markets, so it’s economically advantageous for the company that’s putting them out. If we end up with a different regulatory framework in the UK, our products will be brought to market more slowly, which means more expense.

Supply and demand

“The Oxera report found the UK was still an attractive market in Europe because of its low barriers to entry,” says Mr Smith. “But if you need to do more to get through those barriers, it will be less attractive, which means new products will either come at a higher price or they won’t come at all.”

The BGMA has asked Matt Hancock, Secretary of State for Health and Social Care, to urge his colleagues to prioritise medicines supply on their Brexit to-do list. Mr Smith says that Mr Hancock has been very supportive, but nonetheless adds a note of caution. “There is of course a risk in any sort of negotiation that, with dozens of issues on the table, they get linked by negotiators who all want something,” says Mr Smith. “One hopes they all understand the importance for both sides of maintaining a free flow of medicines.”

Mr Smith says the current supply situation is “not far from the mid-range of normal, so although it’s not as good as we’d want it to be, it’s not as bad as we’ve seen it or as good as it has been in the past”.

What we are experiencing – and what seems always to make the news – is a small number of important products such as HRT facing sustained supply issues.

Mr Smith says it’s always difficult to pin down the exact cause in many cases. “We do still have concerns about active pharmaceutical ingredients plants in China being moved from urban centres to more rural areas in order to meet their new environmental criteria, but the Chinese government closed the old plants before opening up a new one, so things have not transitioned as smoothly as they might have.”

The implementation of the EU serialisation rules against falsified medicines has also had an impact on production costs, complexity and capacity. “Manufacturing capacity in Europe is quite tight, due in significant part to FMD, as printing the unique code on each pack reduces production capacity by about 10 per cent, which delays pack runs down the line,” says Mr Smith. “Plus, more strategically, we have seen the supply chain getting thinner and longer. If you face downward pressure on price, you tend to go for lower priced suppliers, so as a result of payors in Europe wanting to pay less for their generics, manufacturers are sourcing more of their needs from further afield, which makes the supply chain longer. This means that if something goes wrong, it takes longer and is harder to put right.”

Misconceptions on pricing

As long as the payors know this, then price fluctuations can be explained, but they have to spread the word down the chain in order to avoid misinformation about pricing snowballing into misconceptions about reimbursement.

“The Oxera report showed that most comparisons done with price look at the reimbursement price, which is very far off the manufacturer’s actual price,” says Mr Smith. “By comparing manufacturers’ actual sale prices, it showed we are the lowest in Europe, which is something we knew, but it’s useful to have an independent report confirming it.”

However, Mr Smith admits that there have been a small number of high-priced products that have caused concern. “In some of these cases, it was necessary to keep getting the product to the patient, but if a company is putting up prices for no good reason then they should be held to account and government should be able to investigate,” he says.

“We all need to understand how the supply chain has changed as result of downward pressure on price, and have a more strategic look at that. For example, we are getting to a stage where more originator products coming off patent are increasingly complex than we’ve seen in the past, so that will put pressure on the traditional generics model as it costs more to develop the products in the first place, which could call into question their sustainability in the long term because of the added complexity for manufacturers and higher costs for payors.

“At the other end of the scale, the sector is doing a lot of work on repurposing medicines where, for a comparatively small investment, we can add a new indication to an old molecule. However, the challenge here is that if one generic company does it, all the others can then market the product for the same new indications, although there are a number of business models that you could use to make this work. For example, the NHS could pay a generics manufacturer to do the work and then recoup that cost as the competition kicked in. It would mean joint working between the generic industry and the NHS in a way that has not been normal thus far, but we are in discussions about how to make it work.”

Comments echoed by manufacturers

Unsurprisingly, manufacturers echo these concerns about future challenges. “Drugs and their development have become more complex and expensive to meet the rising challenge of emerging disease areas,” says Peter Kelly, managing director of Accord Healthcare. “Too much downward pressure on price or a reduction in incentives for dispensers to make margins on generics is likely to reduce competition and therefore suppliers in the market, so it is important that we create a sustainable model for the whole industry where we focus on value and not just pricing. Unless manufacturers are able to see a level of sustainability in the core current generic medicine market, we may see less interest among manufacturers to come to the UK.”

Kim Innes, general manager of Teva UK & Ireland, says that while it’s clear that, overall, the generics sector delivers good value for the country, “margins are tight for the industry”. She says Teva’s strategy is to continue to leverage its portfolio to provide added value for customers, “whether that’s through our e-commerce generics portal or the numerous support programmes we offer for pharmacists. We’re also entering the world of complex generics, which is really exciting for us and creates access to better treatments for patients.”

Luke Hart, managing director of Creo Pharmaceuticals, which was bought by Zentiva in 2019, says: “The generics sector looks bright and, with regard to the UK, we anticipate there will continue to be a healthy level of competition. Recent investments in both in-house and third-party products support our aspirations of a strong growth trajectory. We have a significant launch programme planned in 2020 and beyond for pharmacy-dispensed products, but also within the hospital and speciality sector.”

The importance of safety

Given community pharmacy’s increasing focus on efficiency, but not at the expense of safety, many manufacturers are changing their approach to packaging control in order to differentiate strengths and molecules.

Zentiva has worked closely with the MHRA Patient Information Quality Unit to develop company-specific labelling and packaging solutions to address the issue of molecule and strength differentiation. Its colour schemes take into account pharmacy dispensary storage processes – acknowledging that different pharmacies may stock products alphabetically or by therapy area. Mr Hart says he would welcome patient and dispenser feedback on the new pack designs.

Accord Healthcare has also updated its packaging with new designs, colours and content layouts. “With a growing portfolio of more than 1,000 SKUs, it is difficult to make packs look different from one another using colour alone, so differentiating through different liveries minimises the chances of having lookalikes and signals that no design or colour scheme is specifically associated with any particular product range,” says Mr Kelly. “This encourages healthcare professionals and patients to carefully read product packaging.”

Reassurance on shortages

Patients trust pharmacies to supply them with the correct medicines, but when a product has issues with supply, it can be hard for the pharmacist to explain why. “We have some 20,000 products in the UK with complex supply chains, so every now and again, it’s to be expected that something will go wrong,” says Mr Smith. “It’s frustrating for patients when they are told that this is because of ‘manufacturing issues’. This can sound very vague.”

“More often than not,” he continues, “this is not the pharmacist’s fault, as they haven’t been told the reason themselves. So if, say, they could tell the patient it was because a manufacturer has found a quality issue and has had to recall a batch, I think the patient would probably think the inconvenience made sense. There are, however, some barriers to sorting this out because companies are not keen on telling their competitors what their specific supply problem is. This makes the communications chain to the pharmacist tricky, but it’s something I’m focusing on this year because it’s a service we should be trying to provide for pharmacists and patients.

Mr Smith makes an additional point: “I would also like to stress that so often we hear medicines supply issues all lumped under the label of ‘generic shortages’ when, in fact, of the 78 products on a recent NHS shortages bulletin, only 20 or so were made by generics companies and fewer than 10 were traditional unbranded generics, so this is not all a generics problem,” he says.

Mr Hart agrees. “Every shortage has a story and this needs to be understood,” he says. Ms Innes adds: “As an industry, we can’t forget the real anxiety a shortage can cause patients, and we have to be open with them and explain why medicines go out of stock and the broader challenges the industry faces. At the end of the day, while external factors obviously influence us and the market, what’s most important is understanding the needs of our customers and continuously working on building a close relationship with them. I think if you get that right, then the rest will follow.”

From factory to pharmacy

The Healthcare Distributors Association (HDA UK) has developed an educational infographic that aims to explain some of the issues behind issues of drug availability and provide helpful information to those involved in dispensing and delivering vital medicines to UK patients.

Communications from SecurMed UK – FMD safety features, 06 March 2020

SecurMed UK has published two communications about:

  • Product not found Alert – Change in procedure
  • Password renewal

These communications can be viewed here.

Community Pharmacy COVID-19 Forum – NHS England preparedness letter, 09 March 2020

Yesterday afternoon, Keith Ridge sent a preparedness letter on COVID 19 to pharmacy colleagues:

See https://www.england.nhs.uk/coronavirus/primary-care/

and https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/03/preparedness-letter-primary-care-pharmacy-9-march.pdf.

The letter is similar to Dr Nikita Kanani’s letter of 5 March, a few days ago, but includes advice specifically for pharmacies, including advice on:

  • Relating to guidance from the GPhC to support pharmacists in these challenging times – that guidance includes: We recognise that in highly challenging circumstances, professionals may need to depart from established procedures in order to care for patients and people using health and social care services. Our regulatory standards are designed to be flexible and to provide a framework for decision-making in a wide range of situations. They support professionals by highlighting the key principles which should be followed, including the need to work cooperatively with colleagues to keep people safe, to practise in line with the best available evidence, to recognise and work within the limits of their competence, and to have appropriate indemnity arrangements relevant to their practice.
  • Encouraging pharmacies to check their business continuity plans ensuring collaboration with other pharmacies, practices and the wider healthcare community
  • Online bookings systems may need to be changed to ensure potentially infected patients understand they should not attend the pharmacy
  • No stockpiling of medicines by pharmacies – In general, excess purchasing or stockpiling of medicines can impact adversely on the supply chain and can result in shortages. It remains important therefore for pharmacies not to do this
  • Noting that GPs have been encouraged to use electronic repeat dispensing
  • Cancellation of the national clinical audit for this year (2019/20)

PSNC has issued an update to pharmacy on the letter and other related developments, and has added a news story to their website – see https://psnc.org.uk/.

The first forum meeting is this Thursday this week 10 – 11.30am.

Coronavirus: stockpiling medicine is unnecessary and may cause its own problems, experts warn

iNews, Ruchira Sharma, 09 March 2020

People should not stockpile medicines as there are no shortages because of Covid-19, experts have warned.

Overprescribing or ordering more prescriptions than is necessary could create a problem for others, and goes against the advice issued by the government.

“Patients can be assured that everyone in the supply chain will continue to work together to do all that they can to ensure that they get the medicines they need,” said a spokesperson for Pharmaceutical Services Negotiating Committee (PSNC), a body that promotes and supports the interests of all NHS community pharmacies in England.

Some pharmacies confirmed that they are seeing an increase in the number of conversations with patients worried about the Covid-19 coronavirus.

There are more than 110,000 cases around the world and at least 273 in the UK, according to the latest information from the Department Health and Social Care. Both figures are expected to rise.

Government prepared

In the wake of the outbreak, many of the world’s biggest drug makers in China and India have either shut or cut experts, resulting in global anxiety over supplies.

This is not an issue in the UK however, as the Government confirmed there was little evidence to suggest supply chains in the UK were affected, the Royal Pharmaceutical Society said.

Moreover, the country is prepared thanks to its precautions for a no-deal Brexit, explained Sandra Gidley, president of the Royal Pharmaceutical Society.

Patients particularly anxious over coronavirus have been advised to speak to their local pharmacists.

“As far as individuals are concerned, buying extra medicines when they are not needed is never a good idea as it can contribute towards potential shortages,” said Ms Gidley.

“Talk to your pharmacist if you have any concerns about your medicines. They already manage various medicines shortages on a daily basis and work hard to get patients the medicines they need to keep them well.”

The DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto them in light of the Covid-19 outbreak.

“The Department of Health and Social Care has well-established procedures to deal with medicine shortages and has already approached medicine suppliers to assess the impact that Covid-19 could have on the supply chain,” said a PSNC spokesperson.

The DHSC has asked suppliers who still retain some of their EU exit stockpiles to hold onto them in light of the Covid-19 outbreak.

“There are many details still to be worked out and PSNC will be a part of those discussions, looking at how we can best protect the network of community pharmacies and allow them to continue their crucial work through this crisis,” explained Simon Dukes, PSNC chief executive.

Concerns for pharmacists

Front-line pharmacists are at great risk and must be considered when planning for the Covid-19 outbreak however, experts warned.

“Community pharmacy teams are already putting themselves at risk dealing with this illness, and that will continue to be the case as this situation worsens.

“Pharmacies must be treated as a core part of the NHS in all epidemic planning, and PSNC will ensure that HM Government is aware of the critical part they have to play and the support – including financial – they will need through any epidemic.”

GPhC could suspend inspections due to coronavirus outbreak

C+D, Valeria Fiore, 09 March 2020

The General Pharmaceutical Council (GPhC) could stop inspections if the coronavirus outbreak worsens, it has told C+D.

While GPhC inspections will continue as planned for the time being, suspending them could be a “potential option” depending on how the virus develops in the future, the regulator told C+D last week (March 6).

GPhC CEO Duncan Rudkin added that the regulator is “keeping the situation relating to coronavirus under active review”.

“Safe services”

The regulator is liaising “with governments, the NHS and other organisations and is preparing appropriately for potential options and scenarios, including in relation to pharmacy inspections”, Mr Rudkin explained.

“Our priority is making sure patients and the public continue to receive safe services from pharmacies and pharmacy professionals. We also have an important responsibility to protect the health, safety and wellbeing of our staff and everyone affected by our work,” he said.

Mr Rudkin added that the GPhC “will provide further updates about any action we decide to take in response to the developing situation if and when needed”.

The GPhC said last week it will take coronavirus into account if it receives concerns related to professionals on its register where the virus is a factor.

Meanwhile, NHS England has asked pharmacies to appoint a coronavirus lead and identify a space in the pharmacy where patients suspected to have the virus can be isolated.

As of today (March 9), 319 people had tested positive for coronavirus in the UK. England’s chief medical officer Chris Witty confirmed this afternoon (March 9) that a fourth patient had died due to the virus.

Europol notes ‘worrying trend’ in fake medicines

Life Sciences Intellectual Property Review, Rory O’Neill, 09 March 2020

EU authorities seized €7.9 million ($8.9 million) worth of counterfeit medicines—including fake cancer drugs, antivirals, and erectile dysfunction medicines—as part of an operation carried out last year.

According to Europol, which made the announcement on Friday, March 6, nearly 36 million units of counterfeit medicines were seized, accompanying 165 arrests in 12 European countries.

The operation was led principally by the French National Gendarmerie and Finnish customs, and run in conjunction with Europol (or the European Union Agency for Law Enforcement Cooperation), the European Union Intellectual Property Office and other national law enforcement agencies.

Europol said the operation resulted in the interception of 12 criminal groups, and the recovery of €1.5 million worth of assets.

Also among the counterfeit drugs were pseudoephedrine, antihistamines, anxiolytics, hormone and metabolic regulators, narcotics, painkillers, antiestrogens, hypnotics, and doping substances.

The drugs were trafficked through both online and offline channels.

The seizures indicate a “worrying trend” of trafficked counterfeit medicines entering the EU market, the Europol statement said. Such goods are made and packaged in underground labs, often in the EU, the agency added.

The 165 arrests were made in Belgium, Cyprus, Finland, France, Greece, Hungary, Italy, Portugal, Slovakia, Spain, Ukraine, and the UK.

Pfizer UK ran a social media campaign last year urging people not to be “catfished” by counterfeit drugs.

Neville Broad, manager of the counterfeit lab at Pfizer’s facility in Sandwich, Kent, said his team has found dangerous chemicals such as lead paint, brick dust, floor polish, and boric acid in counterfeit drugs.

“In the worst case they can kill you, in the best case they just won’t work,” Broad said.

The Intellectual Property Office of the Philippines said last year that fake medicines account for a quarter of all counterfeits seized by the country’s officials.

Media and Political Bulletin

31 July 2018

Media Summary

No Deal Brexit: ‘Could UK’s medicine supply be disrupted?’

Channel 4 News, 30 July 2018

HDA was referenced in last night’s Channel 4 news bulletin. The news report considered what would happen to the country’s insulin supplies in the event of a no-deal Brexit. It references the head of the medicines regulator, Sir Michael Rawlins, who recently raised a red flag about the drug, stating that we ‘make no insulin… we import every drop of it.’

Referencing a HDA spokesperson, the program states that ‘the Healthcare Distribution Association told Channel 4 News today that it was aware of government plans for “stockpiling medicines of all types” which the association described as “sensible planning”.

The HDA was also referenced in a Channel 4 write up, read it here.

‘Perfect storm’ behind generics price hikes, PAC hears

Pharmacy Magazine, 30 July 2018

Pharmacy Magazine reports on the recent Public Accounts Committee (PAC) hearing into price increases on generic medicines in 2017. The article reports that the Committee were told that a ‘perfect storm’ of events was behind the price increases on generic medicines in 2017.

An investigation from the National Audit Office said that medicines shortages were a contributing factor to the “unprecedented rise” in spending on generic medicines in 2017-18, with an unexpected rise in wholesaler margins cited as another potential factor.

The article states that speaking before the PAC on July 4, Warwick Smith, director of the British Generic Manufacturers Association, said the shortages were partly due to regulatory action taken against four companies, including “two of our members who were scale manufacturers”.

This was a “perfect storm” of events such as rarely happens, Mr Smith said, adding that he “would be surprised to see this recurring quickly”.

Commenting on how shortages can sometimes come about and how different stakeholders are affected, Mr Smith said: “I think it is important we distinguish between different circumstances that lead to these occurrences… Most shortages… occur because of third party events… without any warning for manufacturers, for anyone, as much as pharmacy or patients”.

Compliance with EU scanning law could be part of pharmacy inspections

Chemist and Druggist, Lilian Anekwe, 30 July 2018

Chemist and Druggist reports that an impact assessment, published alongside the government’s consultation document on FMD legislation, set out the potential risks from its implementation. The impact assessment said that ‘the implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products.’

The article also reports that in its consultation documents, the government proposed ‘legislative changes to provide sanctions to enforce compliance’ of the FMD. One approach that it suggested was ‘the sole use of criminal sanctions for failure to comply,’ in the form og an ‘unlimited fine…or imprisonment for a term not exceeding two years, or both.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

No Deal Brexit: ‘Could UK’s medicine supply be disrupted?’

Channel 4 News, 30 July 2018

Transcript: ‘One very specific but potentially vital issue is what will happen to the country’s supplies of insulin in the event of no deal. There are just over 1 million people in the UK with diabetes who rely on insulin to treat themselves. The head of the medicines regulator, Sir Michael Rawlins, raised a red flag about the drug last week, saying, “we make no insulin in the UK. We import every drop of it.”

Some critics have picked Sir Michael up on the words, “we import every drop of it”. This isn’t quite true. We found one UK company making insulin derived from animals, but only for around 2,000 patients. Insulin from human cells is supplied by three companies, but none of them manufacture the drug in the UK. So more than 99% of insulin used in this country is being imported. However, the Healthcare Distribution Association told Channel 4 News today that it was aware of government plans for “stockpiling medicines of all types” which it described as “sensible planning”.

‘Perfect storm’ behind generics price hikes, PAC hears

Pharmacy Magazine, 30 July 2018

A recent Public Accounts Committee hearing was told that a “perfect storm” of events was behind the dramatic price increases on generic medicines in 2017 that were the basis of a National Audit Office investigation.

The NAO report said that medicines shortages were a contributing factor to the “unprecedented rise” in spending on generic medicines in 2017-18, with an unexpected rise in wholesaler margins cited as another potential factor.

Speaking before the PAC on July 4, Warwick Smith, director of the British Generic Manufacturers Association, said the shortages were partly due to regulatory action taken against four companies, including “two of our members who were scale manufacturers”.

This was a “perfect storm” of events such as rarely happens, Mr Smith said, adding that he “would be surprised to see this recurring quickly”.

Commenting on how shortages can sometimes come about and how different stakeholders are affected, Mr Smith said: “I think it is important we distinguish between different circumstances that lead to these occurrences… Most shortages… occur because of third party events… without any warning for manufacturers, for anyone, as much as pharmacy or patients”.

The current system whereby market competition determines generic medicine prices works well and makes drugs affordable, some witnesses claimed. Sir Chris Wormald, permanent secretary at the Department of Health and Social Care, said: “Our spend on generics in the year of fluctuations went down, not up.”

Pharmacy helped prevent patient harm

Pharmaceutical Services Negotiating Committee regional member for the North East and Cumbria, Mark Burdon, said: “I have not observed and am not hearing reports of patients going without medicines for any length of time, or indeed of patient harm. Much of that is down to the efforts of community pharmacists.”

Mr Burdon agreed with the written evidence provided by Dorset contractor Mike Hewitson, which stated that stock shortages “were sometimes caused by rumours by wholesalers that resulted in a self-fulfilling prophecy, as pharmacists ordered several months’ stock at a time.”

“Not a new problem”

Professor Karim Meeran of Imperial College’s medical education department said shortages and resulting price hikes have been “going on since about 2010 with different drugs” and are “not a new problem.”

Professor Meeran suggested that health bodies should consider whether it is viable to manufacture drugs on the World Health Organization list of essential medicines in the UK, in order to ensure a steady supply of these medicines.

“All of the drugs on that list should be very cheap to make,” Professor Meeran said. “Why don’t we make it in the UK and sell it and use the NHS as a bulk buyer rather than go through wholesalers, because the wholesalers are splitting the NHS?”

However, the BGMA’s Warwick Smith argued that this could come up against ‘commercial realities’: “Overall, the UK is a net exporter of medicines but a net importer of generic medicines, and that is simply because we cannot make them cheaply enough here to compete with prices that come out of the other markets, be they central Europe, India or China. I’m afraid that that is just the commercial reality, unless there is some public policy decision to change that.”

New powers welcomed

Anne Marie Morris MP questioned whether new measures that came into force in July that give the DHSC more power to obtain information about generics prices would be sufficient.

“Even if these new regulations make [information relating to generic medicines] available, it is limited, because it comes in blocks,” Ms Morris said, addressing the BGMA’s Warwick Smith. “Secondly, as far as I can see, to make your members divulge it, there really isn’t much of a penalty.”

Mr Smith countered: “My members, with one or two exceptions, have already been providing the data voluntarily to the Department of Health, which is how they calculate the category M tariff reimbursement price.”

Mr Smith said that while that information currently “flows four times a year,” there are provisions to make this monthly or weekly “if things are happening in the market that make that a more sensible way of behaving”.

He added: “We welcome the new powers, because they will bring into that mix companies that have not been providing the data voluntarily… I think the Department will now be able to track, almost, individual products throughout the supply chain, so they can see what is happening at the different stages. They will be able to see if product is going “missing” within the supply chain, which is important.”

Compliance with EU scanning law could be part of pharmacy inspections

Chemist and Druggist, Lilian Anekwe, 30 July 2018

Ensuring pharmacies have installed a medicines scanner and are checking anti-tampering devices could form part of pharmacy inspections next year, the government has revealed.

Under EU anti-counterfeiting legislation the Falsified Medicines Directive (FMD), every pharmacy in the UK will be required to scan barcodes on medicines and check their anti-tampering device at the point of dispensing from February 9, 2019.

Earlier this month, the government published a consultation document on the legislation, “to identify a solution which results in the lowest burden to UK stakeholders as a whole”.

Ongoing risks

An impact assessment published alongside the document set out the potential risks from implementation, including “that the implementation of safety features will not fully prevent the entry into the legal supply chain of falsified medicinal products”.

One reason for this could be the “failure to decommission products”, which could allow the “unique identifiers” on medicines packaging to be “reused on falsified products”, the government said. It suggested mitigating this risk by using “regulatory inspections” to ensure compliance, as well as introducing “sanctions to enforce” it.

However, when asked by C+D to confirm that monitoring FMD compliance would become part of its pharmacy inspections, the General Pharmaceutical Council (GPhC) said it is “too early to say” what its “respective role” would be.

“We are considering the detail of the consultation document and will respond to any proposals relevant to us as the regulator of registered pharmacy premises,” it said.

Threat of sanctions

In its consultation documents, the government also proposed “legislative changes to provide sanctions to enforce compliance” of the FMD. One approach it suggested was “the sole use of criminal sanctions for failure to comply”, in the form of “an unlimited fine…or imprisonment for a term not exceeding two years, or both”.

However, it also stated it “is minded” to “use a mixture of both criminal and civil sanctions”, which might include “written warnings, stop notices and civil fines”. Under this system, criminal sanctions would only be used for the most serious, “intentionally fraudulent breaches”.

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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