HDA UK Media and Political Bulletin – 20 April 2021

Media Summary

World at One
BBC, World at One, Sarah Montague, 19 April 2021  
The BBC World at One reports on the impact of the Northern Ireland Protocol on the supply of medicine. The Brexit agreement means that companies making non-branded drugs will discontinue supplies to Northern Ireland due to the increase in costs. Four out of every five medicines prescribed on the NHS are non-branded medicines.

Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA) speaking on the World at One said an ‘urgent solution’ is required, or the people of Northern Ireland will feel impact of the medical disruption as soon as January 2022.

Several manufacturing companies have already decided that from January 2022 they will not to launch new products in Northern Ireland, including treatments for epilepsy, cancer and diabetes.

Mark Samuels calls on the UK government to develop a strategy for generics and to work with the European Commission to permit the transit of medication for use in Great Britain into Northern Ireland.

Parliamentary Coverage

There was no parliamentary coverage today.

 

 Full Coverage

Media Summary

Brexit red tape threatens drugs supplies in Northern Ireland
Financial Times, Sarah Neville and Peter Foster, 19 April 2021  

The Financial Times reports that UK-based companies making non-branded drugs have started to withdraw medicines from Northern Ireland because they cannot afford the costs of new post-Brexit red tape.

The disruption in Northern Ireland follows the post-Brexit trade deal which came into force on 1st January 2021. The move threatens to limit the range of treatments available to patients in Northern Ireland from the end of the year and there is increasing pressure for the UK and Brussels to find a solution to the disruption in supply.

The article quotes Martin Sawer, who said “the extra regulatory and operational complications, associated with any segregation of medicine packs specifically for Northern Ireland, could affect the current distribution of medicines into Northern Ireland — the vast majority of which are currently supplied from Great Britain.”

This was also reported by The Telegraph.

Moderna Cuts U.K., Canada Shipments on Supply-Chain Woes
Bloomberg, Suzi Ring and Kait Bolongaro, 16 April 2021  

Bloomberg reports that the supply of the Moderna vaccine will be reduced this month, affecting supply to the UK, Canada and other countries. The reduced supply is due to a shortfall in doses in its European supply chain.

Moderna said in a statement on Friday: “The trajectory of vaccine manufacturing ramp-up is not linear, and despite best efforts, there is a shortfall in previously estimated doses.”

The UK has purchased 17 million doses of the Moderna shot, and shipments to Britain will be reduced starting this month. This announcement comes just days after the Moderna vaccine was rolled out in the UK and will affect the overall number of doses that were expected to be supplied to the UK by the end of June.

This was also reported by The Guardian.

 

Parliamentary Coverage

The NICE strategy 2021 to 2026
NICE, 19 April 2021  

The National Institute for Health and Care Excellence (NICE) has set out its strategic plan and priorities for the next 5 years. The strategy takes into account the lessons learned from the COVID-19 pandemic, which it notes has changed the UK health and care landscape significantly. In particular, the pandemic has highlighted the need to reduce health inequalities and bureaucracy and speed up access to the latest and most effective treatments.

The NICE strategic plan includes the following objectives:

  • Provide independent, world-leading assessments of value for the system and improved access for patients through the use of new and existing technologies.
  • Provide dynamic, living guideline recommendations that are useful, useable and rapidly updated, incorporating the latest evidence and newly recommended technologies to maximise uptake and access for patients.
  • Drive the implementation of guidance, making sure it delivers improvements and contributes to reducing inequalities, with measures to routinely track adoption.
  • Drive the research agenda and developing innovative and data-driven methods. It will use real-world data to resolve issues of uncertainty and improve access to new innovations for patients.
  • Transform the organisation to make sure it has the infrastructure, skills and capacity to deliver its strategy, leveraging technology to maximise efficiency and impact.

Full Coverage

Brexit red tape threatens drugs supplies in Northern Ireland
Financial Times, Sarah Neville and Peter Foster, 19 April 2021  

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

Moderna Cuts U.K., Canada Shipments on Supply-Chain Woes
Bloomberg, Suzi Ring and Kait Bolongaro, 16 April 2021  

Moderna Inc. said it will deliver less COVID-19 vaccine than planned to the U.K., Canada and other countries this quarter due to a shortfall in doses in its European supply chain.

Moderna, which is working with Swiss partner Lonza Group AG to make the shots in Europe, attributed the reduction in deliveries to a slower-than-expected ramp-up of production capacity. Moderna has its own plant in Massachusetts that is making supply for the U.S.

The reduced deliveries to other countries will further constrain global vaccine supplies, with shots from Johnson & Johnson on hold across much of the world due to concerns about a link to rare but dangerous blood clots, an issue that has also prompted restrictions on the use of AstraZeneca Plc’s vaccine in Europe.

“The trajectory of vaccine manufacturing ramp-up is not linear, and despite best efforts, there is a shortfall in previously estimated doses,” Moderna said in a statement Friday. “Vaccine manufacturing is a highly complex process and a number of elements, including human and material resources, have factored into this volatility.”

Shipments to the U.K. will be reduced starting this month, just days after the Moderna vaccine was rolled out in Britain, which will affect the overall number of doses that were expected to be supplied by the end of June.

The U.K.’s immunization program has been a bright spot in Britain’s response to the pandemic, with almost half the population now vaccinated with at least one dose. The pace looks set to slow over the coming weeks, though, after a shipment of the AstraZeneca vaccine from India was delayed, pushing the government to shift focus to delivering second doses.

The U.K. has purchased 17 million doses of the Moderna shot, the smallest contract in its vaccine portfolio.

The company has also told the Canadian government it will nearly halve its expected deliveries of COVID-19 vaccines this month as it struggles to contain a third wave of coronavirus cases, according to Procurement Minister Anita Anand.

Canada will now receive 650,000 doses by the end of April, instead of the originally planned 1.2 million. As many as 2 million more scheduled to arrive by the end of June will arrive by the end of September, Anand said via email.

Lonza did not immediately respond to phone and email messages seeking comment.

Media Summary

Medicine supply chains into NI post-Brexit a ‘high risk area’
BBC Northern IrelandLouise Cullen16 April 2021   

BBC Northern Ireland reports that the Chief Pharmaceutical Officer Cathy Harrison has described the supply of medicines and medical devices into Northern Ireland as a “very high risk area” unless a proactive approach is taken.

Speaking to the Northern Ireland Health Committee about the implications of Brexit and the Northern Ireland Protocol, Ms Harrison acknowledged that “ahead of the overall transition of the UK from the EU, there was a massive amount of work done with the medical supply chains.” However, preparations for a separate supply chain for Northern Ireland now need to be finalised within the current 12-month grace period.

Many medical devices, and about £600m of medicines, are brought into Northern Ireland every year, with around 98% coming from Great Britain. 

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Medicine supply chains into NI post-Brexit a ‘high risk area’
BBC Northern IrelandLouise Cullen, 16 April 2021   

 

The chief pharmaceutical officer has warned that without mitigation, the supply of medicines and medical devices into Northern Ireland would be considered a “very high risk area”. 

Cathy Harrison was speaking to the NI health committee about the implications of Brexit and the NI Protocol for the pharmaceutical industry. 

 

The industry currently has a 12-month grace period to make preparations. Until this year, there has been no separate supply chain for NI. It was treated as part of the UK supply chain. 

 

Ms Harrison told the committee an “enormous amount of work” was being done in the area. 

 

“Without us taking action, and without a very proactive approach being taken, and if we did nothing at all until the end of this year, then there would be a high level of risk and it would be considered a very high risk area,” she said. 

 

“However, there’s an enormous amount of work going on to avoid that. 

 

“Ahead of the overall transition of the UK from the EU, there was a massive amount of work done with the medical supply chains. 

 

“That’s really now standing us in good stead.” 

 

But she acknowledged that costs may rise. 

 

“Essentially, Northern Ireland is now a very small market globally for pharmaceuticals and for medical devices,” she said. 

 

“I have to say, there is a very high level of commitment from the parties I’ve been involved with in the pharmaceutical industry, in terms of working towards a new normal, if you like, for Northern Ireland, but there’s a recognition that in doing that, our costs are likely to increase.” 

 

Many medical devices, and about £600m of medicines, are brought into Northern Ireland every year, with around 98% coming from Great Britain. 

 

‘Disaster’ 

 

The committee also heard that the health minister is to be given options concerning the Cross-Border Healthcare Directive. 

 

The directive stopped after the Brexit transition period ended on 31 December 2020. 

 

It had allowed people in Northern Ireland to pay upfront for treatment in an European Economic Area (EEA) country, then claim reimbursement from the Health and Social Care Board (HSCB). 

 

The committee chairman, Colm Gildernew, described it as a “disaster”. 

 

“Given the fact of the waiting list situation that we have currently, is this not a disaster? Should this not be a priority, to get something to replace that cross-border directive urgently in place?,” he said. 

 

Following the meeting, a Department of Health official said: “The options around the continuation or not of the Cross Border Healthcare Directive in the immediate term are to be provided to the minister imminently and those options will be considered before any announcements are made.” 

Media Summary

How will Medical Devices be regulated following the end of the Brexit Transition Period?

PharmiWeb, PharmiWeb Editor, 14 April 2021

 

This whitepaper by PharmiWeb summarises Medicines and Healthcare products Regulatory Agency (MHRA) guidance on the regulation of medical devices after Brexit. Covering existing legislation, the role of manufacturers and UK-based Responsible Persons, conformity assessments, the placement of products on the UK market, and post-market surveillance, the paper provides a clear list of actions for manufacturers in order to prevent delays and/or blocks to placing products on the UK market. The paper also details the specific regulatory rules for medical devices in Northern Ireland and the European Union respectively.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

How will Medical Devices be regulated following the end of the Brexit Transition Period?

PharmiWeb, PharmiWeb Editor, 14 April 2021

 

From January 1, 2021, the transition period after Brexit ended, and the Medicines and Healthcare products Regulatory Agency (MHRA) took on the role as the UK’s standalone medicines and medical devices regulator.

 

On 1 September 2020, the MHRA published a set of guidance on what the rules will be from 1 January 2021. The guidance on medical devices have been subsequently updated on October 21,  November 4 and December 31.

 

This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance and vigilance that will apply for devices placed on the market in Great Britain (England, Wales and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.

 

Key elements of the MHRA’s guideline

 

Legislation in Great Britain

 

Currently, EU Directives for Active Implantable Medicals Devices (AIMDD), Medical Devices (MDD), and In-Vitro Diagnostic Devices (IVDD) have been enacted in UK law, through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), referred to as ‘UK MDR 2002’ hereafter. The UK MDR 2002 will continue to apply in the UK after January 2021, but it will be amended to include changes required for the new UK status.

 

Because the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) will only fully apply from May 26, 2021 and May 26, 2022 respectively, they will not automatically apply in Great Britain. An independent safety committee recognized the importance of strengthening the current UK regulation in the interest of patient safety. They will consider international standards and global harmonization in the development of the future regulatory system and consult stakeholders from the industry and healthcare sector on the proposed system.

 

Manufacturers

 

In order to place a device on the UK market, the manufacturer will first need to register with the MHRA. Previously, only medical device manufacturers based in the UK or those that had a UK- based Authorised Representative (AR) were required to register with MHRA. Where a manufacturer is not established in the UK, it must designate a UK Responsible Person (UK RP), to register and act on its behalf.

 

Before registering a device and placing it on the market, the manufacturer will need to comply with the UK legislation relevant to its products.

 

UK Responsible Person

 

In order to place a device on the Great Britain Market, non-UK manufacturers will be required to designate a UK Responsible Person, physically based in the UK. The UK RP will act on the behalf of the manufacturer to carry out specific tasks. The responsibilities of the UK RP are similar to those of the EU Authorised Representative under the Directives. The UK RP must ensure that the Declaration of Conformity and the technical documentation have been drawn up and the conformity assessment performed correctly. They are required to keep a copy of the technical documentation and the Declaration of Conformity of the device available for MHRA inspection. They will be the MHRA point of contact regarding requests for information, samples or any preventive or corrective actions to mitigate risks posed by the device. They will need to inform the manufacturer about complaints and incident reports they are aware of. If the manufacturer acts contrary to its obligations, the UK RP must terminate the contract and inform the MHRA and the relevant Notified Body. The UK RP will register the devices and will provide a list of importers to the MHRA.

 

Manufacturers should appoint a UK RP as soon as possible.

 

Conformity Assessment

 

From January 1, 2021, the UK introduced a new product marking that will be used for certain goods including medical devices being placed on the Great Britain market: The UKCA (UK Conformity Assessed). It is voluntary from January 1, 2021 and mandatory for medical devices from July 1, 2023.

 

MHRA will designate UK Approved Bodies to conduct assessments against the relevant requirements (of UK MDR 2002 for medical devices). Existing UK Notified Bodies with designation under MDD, IVDD and AIMDD will be automatically designated as Approved Bodies under UK MDR 2002. These Bodies are: BSI UK (MDD, IVDD and AIMDD), SGS UK (MDD and IVDD) and UL international UK (IVDD). The UK Approved Bodies will be published in a new UK database.

 

Similar to class I devices in the EU, manufacturers of Class I devices and general IVDs will be able to self-certify conformity to UK MDR 2002 before affixing a UKCA mark on their device. Devices that are sterile or with a measuring function will need assessment by an Approved Body.

 

Until June 30, 2023, the MHRA will continue to authorize CE-marked devices to be placed on the Great Britain market. This applies to self-certified devices and to devices with certificates issued by EEA-based Notified Bodies under the MDD, AIMDD, IVDD, MDR and IVDR.

 

If devices have a certificate issued only by a UK Notified Body, the re-designation as a UK Approved Body means that the conformity will be recognized under the UKCA mark, rather than the CE mark.

 

Other economic operators

 

From January 2021, placement of medical devices from the EU on the UK market will be considered as ‘importing’. The current obligations of the importers according to the current UK MDR 2002, includes but are not limited to: ensuring the product is safe; warning patients and users about the potential risks of using the device; monitoring the safety of devices and taking appropriate actions if any safety issues occur. The importer will need to inform the UK RP of their intention to import a device into the UK. Further requirements for importers and distributors may be introduced in the revised UK MDR 2002 (to align with the EU MDR requirements), but they have not been discussed in the latest guidance.

 

Placement of products on the UK market

 

From January 1, 2021, all medical devices, active implantable medical devices, IVDs and custom-made devices will need to be registered with the MHRA prior to being placed on the Great Britain market. This will need to be done by the UK manufacturer or the UK RP if the manufacturer is outside of the UK. As registration cannot start before January 1, 2021, a grace period is allowed for the registrations to be completed; higher risk devices such as Class III, active implantable, Class IIb implantable devices and IVD List A have a grace period of 4 months (they must be registered from May 1, 2021). The remaining Class II devices, IVD List B and self-test IVDs have 8 months (from September 1, 2021) and Class I devices and general IVDs have 12 months to register with MHRA (from January 1, 2022). It will be possible to register devices ahead of the above dates for all classes. Each application will be subject to a fee (£100 per application).

 

From January 2021, medical devices placed on the Great Britain market will need to have either a CE mark or a UKCA mark, with the number of the Notified Body /Approved Body if relevant on their label. However, if the device has a valid CE mark, there is no need to re-label the device with a UKCA mark until July 1, 2023. Dual-labelling (CE and UKCA marks) will be accepted in Great Britain after July 1, 2023. If a product is placed on the market with a UKCA mark, the name and address of the UK RP must be included on the label. There is no need to include the importer’s name and address on the label.

 

Post-market surveillance and vigilance

 

The requirements for the manufacturers to report certain incidents to MHRA will not change. They must also continue to take appropriate safety action and submit and corrective actions to the MHRA when required.

 

Clinical investigations

 

The requirements for clinical investigations will not change. The UK will continue to recognize existing clinical investigation approvals, both for regulatory and ethics approvals and so, there will be no need to re-apply. The Sponsor of a trial should be established in the UK or they will require a UK-based legal representative. UK clinical investigation applications will continue to be authorized by MHRA and Ethics Committees as they are at present. To start any new clinical investigations, MHRA must be informed at least 60 days prior to commencing the study.

 

Regulation of medical devices in Northern Ireland

 

The rules for placing medical devices on the Northern Ireland market will differ from those applicable to Great Britain.

 

Devices will still need to comply to EU regulations and be CE marked before they can be placed on the Northern Ireland market. It means that if a Notified Body assessment is required, it will have to be done by an EEA-based Notified Body. The EU MDR and IVR will apply in Northern Ireland from May 26, 2021 and May 26, 2022 respectively.

 

If the product is intended only for the Northern Ireland market, UK Approved Bodies will be able to carry out an assessment and the device will need to bear a CE UKNI mark that allows the product to be marketed only in Northern Ireland.

 

As for Great Britain, medical devices will need to be registered with MHRA before being placed on the Northern Ireland market. The grace period for registration is the same as the one described for Great Britain. The responsibilities for this registration depend on the location of the manufacturer and device classes:

 

– A manufacturer located in Northern Ireland will register all devices with MHRA themselves;

 

– A manufacturer located in Great Britain will need to designate an EU Authorised Representative. If the AR is in Northern Ireland, they will register all devices with MHRA. If the AR is in another EEA country, they will only need to register Class IIa, IIb, III devices and List A, B and self-test IVDs with the MHRA. The other classes of devices will be registered in the EU member state where the EU AR is located.

 

– A manufacturer located in the EEA will need to designate a UK RP to register all devices except class I medical devices, custom made and general IVDs, which have been registered with an EU Competent Authority.

 

– A manufacturer located outside of the UK and EEA will need to designate a UK RP to register the devices unless their AR is based in Northern Ireland. In this case, the AR will register the devices with MHRA.

 

When devices are registered with MHRA for the purpose of Northern Ireland, they do not need further registration for Great Britain.

 

Any conformity mark held by a NI business that validates the sale on the NI market will be valid for the whole UK market. Devices that are marked CE or CE UKNI by a NI manufacturer will be allowed on the Great Britain market after June 30, 2023.

 

The person importing devices in Northern Ireland will need to inform the NI-based Authorised Representative or the UK Responsible Person.

 

Regarding post-marketing activities, incidents occurring in Northern Ireland will need to be reported to the MHRA.

 

Placing Medical Devices on the EU market

 

From January 1, 2021, EC certificates issued by UK-based Notified Bodies are not recognized in the EU, unless the product was placed on the EU market before the end of 2020.

 

In order to be able to continue marketing devices in the EU, manufacturers with UK-based Notified Bodies needed to get their devices re-assessed by an EEA-based Notified-Body or arrange for the files to be transferred to an EEA-based Notified Body before January 1, 2021.

 

UK manufacturers of self-certified devices can still market these devices after January 1, 2021, but they will need to designate an EEA (or Northern Ireland) based Authorised Representative.

 

Manufacturers based outside the EU who currently have a Great Britain-based Authorised Representative or Great Britain-based manufacturer should have designated an Authorised Representative based in the EEA or Northern Ireland by January 1, 2021 to be able to continue placing devices on the EU market. EU ARs based in Great Britain will no longer be able to operate as EU AR after Brexit.

 

Summary

 

The guidelines published by the MHRA indicate that all economic operators, particularly the manufacturers, must take action in order to continue the placement of their medical device products on the UK and EU markets. If no actions have been taken until now, manufacturers are likely to experience delays and inability to market their products, until all appropriate requirements are met. Therefore, we recommend that you ensure relevant steps are taken to meet these new requirements. Here we have summarised some of the key actions that must be taken:

 

  • If you are a manufacturer not based in the UK, you must designate a UK RP to market your device in the UK.
  • Plan registration with MHRA for the devices marketed in the UK according to MHRA timeline (i.e. 4, 8 or 12 months).
  • If you have a UK-based NB, you are required to transfer to an EEA-based NB (independent or entity of your UK-based NB) to continue marketing the device in the EU. Ensure your products’ labeling are updated appropriately.
  • A new route to market and product marking will be available from January 1, 2021, and mandatory from July 1, 2023 to place devices on the Great Britain market: The UKCA.
  • CE marking and CE certificates issued by EEA-based NB will be valid until June 30, 2023.
  • Further information can be requested via contact@pharmalex.com

 

References

Guidance – Regulating medical devices from January 1, 2021. https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021. Published 1 September 2020, revised October 21, November 4, 2020, and December 31.

The Medical Device Regulation 2002- 002 No. 618 Consumer Protection; June 13, 2002 [http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf]

Media Summary

Mass Covid testing plans in disarray as pharmacies forced to ration supplies

The Telegraph, Lizzie Roberts and Bill Gardner, 13 April 2021

 

The Telegraph reports that caps on the number of Covid-19 tests pharmacies can order threatens to disrupt the Government’s mass testing scheme. Since its launch last Friday, pharmacies have been restricted to ordering one carton of lateral flow tests per day, providing enough tests for 54 people.

 

To manage demand, restrictions have also been placed on the number of tests individuals can collect on their household’s behalf. A source close to the rollout told the Telegraph that these restrictions were to prevent excess supply of unwanted tests while the demand for lateral flow testing is assessed.

 

Parliamentary Coverage

House of Commons – Written Question, 25 February 2021

 

Helen Hayes (Labour, Dulwich and West Norwood): To ask the Secretary of State for Health and Social Care, what assessment he has made of the capacity of local healthcare services to plan their covid-19 vaccine supply in advance to ensure that all second doses are given on time, with reference to the short notice of vaccine deliveries.

 

House of Commons – Written Answer, 13 April 2021

 

Nadhim Zahawi (Conservative, Stratford-on-Avon): COVID-19 vaccine supply is being managed at a national level by NHS England and NHS Improvement and Public Health England to ensure all areas get the supply they need to offer a first vaccine to all registered priority cohorts and to ensure all patients can receive the second dose within 12 weeks of the first. All vaccinations are recorded on the National Immunisation Management Service and individual General Practitioner patient records to enable a second vaccines to be provided in line with national guidance on delivery of the second dose.

 

House of Commons – Written Question, 25 March 2021

 

Kevan Jones (Labour, North Durham): To ask the Secretary of State for Health and Social Care, whether the Government plans to end the use of paper prescriptions.

 

House of Commons – Written Answer, 13 April 2021

 

Jo Churchill (Conservative, Bury St Edmunds): The Government wants to enable as many prescriptions as possible to be sent electronically. However paper prescriptions for those who require them will still be available.

 

In England there has been an unprecedented growth in the use and availability of electronic prescriptions in primary care, and more is being done to expand their use. This builds on work already ongoing throughout the National Health Service, where in January 2021 89% of prescription items were sent via the Electronic Prescription Service.

 

NHS Digital is looking to improve the current functionality of electronic prescribing and extend its use into other care settings.

 

Expansion has been implemented in phases.

Full Coverage

 

Mass Covid testing plans in disarray as pharmacies forced to ration supplies

The Telegraph, Lizzie Roberts and Bill Gardner, 13 April 2021

 

The Government’s mass testing plans are facing disarray less than a week into the rollout after pharmacies were forced to ration supplies.

 

Twice weekly rapid tests were made available for everyone in England on Friday through an online ordering system and a new “Pharmacy Collect” service.

 

Anyone over 18 who is asymptomatic will be able to visit a participating pharmacy and collect a box of seven lateral flow tests to use twice a week at home. But pharmacies have been told they can initially only order enough tests for around 50 people because of supply concerns.

 

Supplies are also being limited for household size, with a maximum of four boxes – enough for four people for one week – being handed out per person.

 

The Pharmaceutical Services Negotiating Committee (PSNC), which represents NHS pharmacy contractors, has issued a warning that sites can initially only order one carton, containing 54 boxes. Each box for an individual person contains around seven test kits. After that initial order, they can only order one carton per day.

 

The PSNC said: “This is to support the equitable distribution of tests to all pharmacies that sign up to provide the service. When supplies can be normalised at up to 12 cartons a week, this will equate to a maximum of 648 boxes of seven tests.”

 

When the scheme launched last week, some pharmacies told The Telegraph they had not received any deliveries yet and did not expect to get any for weeks, while members of the public also reported problems sourcing the tests.

 

A source close to the rollout said the Government and NHS had “pretty much no idea” of the likely demand for lateral flow tests.

 

“It might be that people don’t actually want these things, because a positive result means you have to self-isolate. The idea has been to keep the distribution at one box a day until we know how many people want the tests,” they said.

 

“Pharmacies have limited space, so you don’t want to fill the store cupboards with tests no one wants.”

 

Gareth Jones, the head of corporate affairs at the National Pharmacy Association, said: “The difficulty of assessing initial demand probably helps explain the supply bumps and we are in touch with wholesalers about smoothing distribution of the test kits.”

 

The Department for Health and Social Care is aware some pharmacies had been unable to immediately offer the tests, but is working deliver stock to as many sites as possible.

Media Summary

Supply chain security
Pharma Times Magazine, Raja Sharif, 13 April 2021

Pharma Times reports that one in seven medicines are estimated to be counterfeit globally, and over the last few years, the development of serialisation in the pharmaceutical space has been fundamental in trying to ensure that medical products can be traced throughout the supply chain.

Serialisation has aided regulators in identifying and removing drugs that may be counterfeit, harmful, or even stolen, potentially saving many lives. In February 2016, the European Union’s Falsified Medicines Directive (FMD) was introduced to help protect patients from the potential danger posed by falsified medicines. This was achieved by giving each medicine a unique identification code and allowed for tracking from the manufacturer to pharmacy.

The UK does not have any verification system in place to validate drugs in the supply chain at the moment. This issue of drug supply security and authenticity has only been mentioned in passing as Brexit trade agreements and COVID have dominated the news agenda, yet many experts warn that the UK’s departure from the EU’s FMD has created a huge potential risk.

As such, the UK Government must look for technologies that can modernise the system. By implementing blockchain-based technologies, the UK could become the world’s foremost nation for drug security.

 

All over-50s and high-risk groups in UK offered vaccine ahead of target date

The Guardian, Aubrey Allegretti, 12 April 2021

 

The Guardian reports that Prime Minister Boris Johnson announced that the target for the first phase of the vaccine rollout has been reached.

Despite fears of a supply slowdown after a change in advice on who could get the AstraZeneca jab, PM Johnson welcomed the passing of “another hugely significant milestone”.

All over-50s and high-risk groups in the UK have been offered a coronavirus vaccine a few days before the mid-April deadline set by the Government, and now the second phase of the vaccine rollout can begin.

Sir Simon Stevens, Chief Executive of the NHS in England, included operational managers and pharmacists in his thanks as the UK reached “an incredible milestone”, describing the NHS COVID vaccination programme as “without a doubt the most successful in our history.”

Parliamentary Coverage

House of Commons – Written Question, 25 February 2021

 

Mhairi Black (Scottish National Party, Paisley and Renfrewshire South): To ask the Secretary of State for Health and Social Care, what steps he has taken with Cabinet colleagues to help ensure the importation of medicines into the UK that are manufactured in the EU.

 

House of Commons – Written Answer, 12 April 2021

 

Jo Churchill (Conservative, Bury St Edmunds): We continue to work closely with other Government departments, including the Department for Transport, HM Revenue and Customs and the Cabinet Office’s Transition Task Force, the pharmaceutical industry, the National Health Service and others in the supply chain to deliver the shared goal of continuity of safe patient care under all circumstances.

 

The Department wrote to all suppliers of medicines and medical products coming to the United Kingdom from or via the European Union on 17 November 2020. The letter sets out how we are continuing to work across Government and with suppliers to deliver our multi-layered approach to mitigate any potential disruption to supply of medicines into the UK. The letter is available at the following link:

 

https://www.gov.uk/government/publications/letter-to-medicines-and-medical-products-suppliers-17-november-2020

 

Full Coverage

Supply chain security

Pharma Times Magazine, Raja Sharif, 13 April 2021

 

Globally, one in seven medicines are estimated to be counterfeit, and over the last few years, the development of serialisation in the pharmaceutical space has been pivotal in trying to ensure that every capsule, tablet, strip or vial can be traced throughout the supply chain. It has aided regulators in identifying and removing drugs that may be counterfeit, harmful, or even stolen, potentially saving many lives. In fact, in February 2016, the European Union’s Falsified Medicines Directive (FMD) was introduced to help protect patients from the potential danger posed by falsified medicines. This was achieved by attaching a unique identification code to each medicine and allowed for tracking from the manufacturer to pharmacy.

Whilst much of the industry is still coming to terms with how to fully implement serialisation, one country, notably the UK, as of this moment does not have any verification system in place to validate drugs in the supply chain. It is nearly five years since the UK voted to leave the EU, and after the end of the transition period on January 1, 2021, Securmed, the UK National Medicines Verification Organisation (UKNMVO), said that, apart from Northern Ireland who will remain using the European system – mainland UK will be removed from the database used to track serialised medicine digital barcodes in Europe.

This issue of drug supply security and authenticity has only been mentioned in passing as Brexit trade agreements and COVID have dominated the news agenda, yet many experts warn that the UK’s departure from the EU’s FMD has created a huge potential risk. Concurrent with the significant change we are, of course, also undertaking the world’s largest ever mass immunisation programme for COVID vaccines – at the time of writing AstraZeneca, Moderna and Pfizer vaccines are already being rolled out with several more expected to follow imminently. So the issue of medical verification systems is in the national consciousness more than ever before – as it represents our only means of verifying a vaccine is genuine, and/or any other drug taken for that matter.

Yet we also believe there are still two ways to view this problem, and the glass is not empty, and this should be a moment to think of it simply as glass half full. It’s an ideal moment to re-evaluate our entire medicines supply chain. Serialisation is not perfect by design, and modern blockchain based solutions – which are immutable by definition – were not widely available when FMD came in back in 2016 and can provide far greater visibility and a full custody of medicines. It is a future-proof solution that undoubtably advanced nations will gradually switch to and the UK, with Brexit, has the opportunity to implement the world’s safest medicine supply chain.

As such, we believe the UK government must look ahead, not back, for technologies that can modernise the system and jump ahead of the rest of the world.

In fact, by implementing blockchain-based technologies, the UK would become the world’s foremost nation for drug security, leapfrogging the US – whose Drug Supply Chain Security Act (DSCSA) is widely acknowledged as the current gold standard – and the EU’s current solution. While the FMD is widely seen as a competent solution that ‘does the job’, it is not flawless. Similarly, the European Medicines Verification System (EMVS) provides a very high level of protection against counterfeiting, but only if the products are supplied in compliance with the EU-FMD/EMVS processes.

 

‘The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated’

A further benefit of blockchain based solutions is that they can also prevent critical medicines being diverted away from UK shores – a common pharmaceutical distribution problem – and identify sub-standard drugs quickly for recall, all in real time. This is currently not possible with the EU’s FMD solution. A real-time solution, however, will enable patients and doctors to be reassured, as they will have a transparent digital record of every medicines journey from factory to the pharmacy or surgery. Moreover, it will also empower doctors, innovators and patients with the exact details of shipping and storage conditions, so vital in the transport of sensitive therapies.

To take a recent example currently forming the nadir of global attention. The novel mRNA vaccines developed by both Pfizer and Moderna require extreme temperatures (-20 for Moderna and -70 degrees Celsius in the case of Pfizer) and transportation conditions must be maintained to ensure the integrity of dosages. A blockchain solution utilising essential data would provide valuable control processes from a single dashboard accessible by all authorised entities in real-time. The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated – and would enable a robust distribution system that provided complete supply chain custody.

In October 2020, the Royal Pharmaceutical Society (RPS) wrote to health secretary Matt Hancock, asking for robust plans to be put in place ‘to help authenticate the legitimacy of medicines that move between the EU and the UK’ and how there is ‘legitimate concern around how removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU’. The very fact that even GAVI’s COVAX programme – the vaccine distribution scheme for lower- and middle-income countries – is exploring a robust medicine verification system is good indication of the immediate risk.

 

Taking out the politics of the present, we also have the chance to create a new system fit for purpose in the 21st century and not one that reacts to replace past regulations, but one that is adaptable to the personalised medicines of the future where chain of custody and transport conditions are critical to medical efficacy. It’s a moment in time where if we look at the problem as ‘glass half empty’ we will just replace the old with the old. Yet if we take a ‘glass half full’ view of the world we have the chance to reimagine the supply chain verification process that will be an activate enabler of tomorrow’s medical delivery – from factory to patient and with the scope to build in new approaches like automation of customs documentation and AI-enhanced supply chains with warehouse robotics. In the case of the latter, Amazon is well known to already use this, and we don’t believe it will be too far into the future that pharma and national health providers realise the productivity gains that can be made in drug supply chains.

In our view, dropping out of the FMD is a key inflection point with respect to the UK’s pharma supply chain security. We either run the risk of being exposed to counterfeit drugs or it could be the first Western government to adopt blockchain for supply chain security. Not only would it be used for supply chain security, but it can also be used for the development of new networks in emerging areas like advanced therapies, creating the initial networks that will rapidly spread into mainstream pharma adoption globally – perhaps giving new resonance to the idea of global Britain. A system that regulators like the FDA and EMA may want to take learning from and build into their own future systems.

Adopting blockchain, we can be the ones providing an immutable and secure platform around which new data hubs can be built, with new innovations plugging into to the chain linking the patient, doctor, innovators, devices and records in a way never before possible. It is now on the government to have a moment of Blue Sky thinking and provide the UK with the best possible supply chain security solution or risk being exposed to counterfeits.

 

All over-50s and high-risk groups in UK offered vaccine ahead of target date

The Guardian, Aubrey Allegretti, 12 April 2021

 

All over-50s and high-risk groups in the UK have been offered a coronavirus vaccine a few days before the mid-April deadline set by the government – meaning the second phase of the rollout to younger cohorts can now begin.

 

Despite fears of a supply slowdown and possible knock in confidence after a change in advice on who could get the Oxford/AstraZeneca jab, Boris Johnson hailed the passing of “another hugely significant milestone”.

 

With more than 32 million people now having had a first dose and 7.6 million of those having received their second, the prime minister said “many thousands of lives” had been saved.

The government had promised all those in the first phase of the vaccine rollout in categories one to nine – which included people over 50, care home residents and staff, frontline health workers and the clinically vulnerable – would be offered a vaccine by 15 April.

 

On Monday evening, a few days early, Johnson announced that the target had been reached, and the Joint Committee on Vaccination and Immunisation – which advises which groups should be prioritised for a jab – are to publish their final advice later this week on who should be next in line.

He hinted that their current plan would continue, suggesting those in their late 40s will be offered a vaccine next. The JCVI’s interim plan published at the end of February said the rollout should continue down the age groups – to those over 40 first, then over-30s and finally over-18s.

 

Sir Simon Stevens, chief executive of the NHS in England, said: “Vaccinating 19 out of 20 people aged 50 and over is an incredible milestone. Thanks to our NHS nurses, doctors, pharmacists, operational managers and thousands of other staff and volunteers, the NHS COVID vaccination programme is without a doubt the most successful in our history.”

 

Jonathan Ashworth, Labour’s shadow health secretary, said the news was “hugely welcome progress”, and paid tribute to the NHS. However, he said he wanted to “drill down into the figures” and warned “there are pockets where uptake is lower than average, often in areas of disadvantage”.

He added: “This must be urgently addressed by ministers so no area is left behind. There will be no ‘levelling up’ if COVID remains stubbornly endemic in parts of the country.”

 

There was concern that the government’s next target, to offer all adults a dose by the end of July, could be harder to hit, after the JCVI advised that under-3os be offered an alternative vaccine to AstraZeneca where possible, following concerns over blood clots, of which there may be an extremely small risk.

 

Ministers maintained that there would be no slowdown to the roadmap out of lockdown – the next step of which would allow six people to meet indoors and 30 to gather outside from 17 May at the earliest – and said the next vaccine target would be met.

Matt Hancock, the health secretary, said the “significant impact” of vaccines had seen pressures on hospitals reduced, meaning it should be possible to ease restrictions. He added: “I urge everybody eligible to come forward for their vaccine as soon as possible to protect yourself and your loved ones.”

 

While the number of daily doses administered has remained broadly stable, the seven-day rolling average has recently dipped back down to levels first seen at the start of March. Johnson had tried to set expectations by telling people the number of first doses would likely dip while the rollout focused on making sure those who had their first jab in the winter were fully inoculated with their second.

 

NHS England warned several weeks ago that from the end of March there would be a “significant reduction in weekly supply available from manufacturers … meaning volumes for first doses will be significantly constrained”.

Media Summary

Free PPE provision extended to March 2022
P3 Pharmacy, Pharmacy Magazine, 9 April 2021

According to the latest NHS Primary Care Bulletin (8th April), the government is extending the provision of free Covid-19 PPE to health and social care providers until the end of March 2022 as clinical experts expect that usage will remain high throughout the next financial year.

The article reports that community pharmacists will continue to access COVID-19 PPE via current distribution channels, using the government’s PPE portal.

 

This was also reported by Pharmacy Business.

 

Global Covid vaccine rollout threatened by shortage of vital components

The Guardian, James Tapper, 10 April 2021

The Guardian reports that shortages of vital components such as large plastic growbags in which vaccine cells are grown threaten to delay the vaccine rollout.

 

Manufacturers revealed that some pharmaceutical firms were waiting up to 12 months for the sterile single-use disposable plastic containers, which are used to make medicines of all kinds, including the Pfizer, Moderna and Novavax COVID-19 vaccines.

 

Stan Erck, the chief executive of Novavax and his British partners said they were confident they had enough suppliers to avoid disruption to the supply of Novavax. The vaccine is waiting for approval from the Medicines and Healthcare products Regulatory Agency (MHRA) but the first of 60 million doses ordered by the government are already in production in Teesside.

 

A delivery of 5 million doses of the AstraZeneca vaccine from India was delayed and there was a problem with a batch made in Britain. Following this, the company has been involved in a conflict between the UK and the EU over vaccine exports.

Parliamentary Coverage

 There was no parliamentary coverage today.

 

Full Coverage

Free PPE provision extended to March 2022
P3 Pharmacy, Pharmacy Magazine, 9 April 2021

The government is extending the provision of free Covid-19 PPE to health and social care providers until the end of March 2022.

Following the previous announcement of free PPE provision until the end of June 2021, the scheme is now being extended to the end of March 2022, says the latest NHS Primary Care Bulletin (April 8), as the expectation of clinical experts is that usage will remain high throughout the next financial year.

 

Community pharmacists should continue to access Covid-19 PPE via current distribution channels, using the government’s PPE portal.

 

Global Covid vaccine rollout threatened by shortage of vital components

The Guardian, James Tapper, 10 April 2021

 

Vaccine-makers around the world face shortages of vital components including large plastic growbags, according to the head of the firm that is manufacturing a quarter of the UK’s jab supply.

 

Stan Erck, the chief executive of Novavax – which makes the second vaccine to be grown and bottled entirely in Britain – told the Observer that the shortage of 2,000-litre bags in which the vaccine cells were grown was a significant hurdle for global supply.

 

His warning came as bag manufacturers revealed that some pharmaceutical firms were waiting up to 12 months for the sterile single-use disposable plastic containers, which are used to make medicines of all kinds, including the Pfizer, Moderna and Novavax Covid-19 vaccines.

 

But Erck and his British partners said they were confident they had enough suppliers to avoid disruption to the supply of Novavax. The vaccine is waiting for approval from the Medicines and Healthcare products Regulatory Agency (MHRA) but the first of 60 million doses ordered by the government are already in production in Teesside.

 

The Fujifilm Diosynth Biotechnologies factory began growing the first cells for the Novavax vaccine in Billingham, County Durham this month and in a few weeks they will fill the bioreactor bag, ready to be transported to GlaxoSmithKline’s plant at Barnard Castle to be put into vials for distribution.

 

“The first hurdle is showing it works and we don’t have that hurdle any more,” Erck said.

But he added there were others still to overcome. “There’s the media that the cells have to grow in,” Erck said. “You grow them in these 2,000-litre bags, which are in short supply. Then you pour it out and you have to filter it, and the filters are in short supply. The little things count.”

 

Novavax almost ran out of bags at one of its 20 factories earlier this year, but there had been no delays for the UK operation, according to Martin Meeson, global chief executive of Fujifilm Diosynth.

 

“We started working on our part of the supply chain in summer last year,” he said. “We had to accelerate some of the investment here, but the commitment we made last summer to start manufacturing in February has been fulfilled.”

 

Both Meeson and Erck said the UK’s vaccine taskforce had been helpful in sorting out supply issues so far, but other countries and other medical supplies might be affected.

 

ABEC makes bioreactor bags at two plants in the US and two in Fermoy and Kells in Ireland, and delivered six 4,000-litre bags to the Serum Institute in India last year for its Covid vaccines.

 

Brady Cole, vice-president of equipment solutions at ABEC, said: “We are hearing from our customer base of lead times that are pushing out to nine, 10, even 12 months to get bioreactor bags. We typically run out at 16 weeks to get a custom bioreactor bag out to a customer.” He said ABEC was still managing to fulfil orders at roughly that rate.

 

“The bag manufacturing capacity can’t meet demand right now,” he added. “And on the component side, the tubes and the instruments and so forth that also go into the bag assembly – those lead times are also starting to get stretched as well. But the biggest problem we see is it really is just the ability to get bags in a reasonable amount of time.”

 

ABEC expanded its factories last year and has now started making 6,000-litre bags, which are roughly the size of a minibus. Other firms including MilliporeSigma, part of German company Merck, have also been expanding their manufacturing facilities. American firm Thermo Fisher Scientific expects it will finish doubling its capacity this year.

 

The US government has also blocked exports of bags, filters and other components so it can supply more Pfizer vaccines for Americans. Adar Poonawalla, the chief executive of the Serum Institute of India, said the restrictions were likely to cause serious bottlenecks.

 

Novavax is hoping to avoid delays and “vaccine nationalism” by operating on four continents, with 20 facilities in nine countries.

 

“One year ago, we had exactly zero manufacturing capacity,” Erck said. “We’re self-sufficient. The two main things we need to do are done in the UK. And in the EU we have plants in Spain and the Czech Republic and fill-and-finish in Germany and the Netherlands.”

 

There was no need for vaccines to cross borders to fulfil contracts, he said.

 

The Oxford/AstraZeneca vaccine was hit by a delay to a delivery of 5 million doses from India and a problem with a batch made in Britain, and the company has been dragged into a lengthy row between the UK and the EU over vaccine exports.

Media Summary

NHS ‘evaluating’ threat of fraud in pandemic delivery service

Chemist and Druggist, Valeria Fiore and Grace Lewis, 8 April 2021

The NHS Counter Fraud Authority (NHS CFA) is reviewing potential threats to the pandemic delivery service. The NHS wants to tackle fraud in pharmacies and improve weaknesses in the systems that could allow fraud to take place.

The pandemic delivery service for clinically extremely vulnerable (CEV) patients ended on 31st March, but the service is still available for people who have been notified of the need to self-isolate by NHS Test and Trace.

The Department of Health and Social Care (DH) published a new counter-fraud strategic plan last week, which did not explicitly mention pharmacy fraud. However, the strategy alluded to the DH’s plan of introducing measures to combat certain types of fraud affecting pharmacies, such as prescription fraud. A spokesperson for the NHS CFA confirmed that actions would target fraudulent claims made by contractors and patients alike.

Parliamentary Coverage

 There was no parliamentary coverage today.

 

Full Coverage

NHS ‘evaluating’ threat of fraud in pandemic delivery service

Chemist and Druggist, Valeria Fiore and Grace Lewis, 8 April 2021
The NHS Counter Fraud Authority (NHS CFA) is reviewing “some possible threats and vulnerabilities within the pandemic delivery service”, it has told C+D.

 

The NHS CFA is “aware” of some issues with the service, which was introduced for the first time in April last year, and “remains vigilant in case any additional threats emerge”, the spokesperson added.

 

It considers a “threat” as a “person or group, object or activity” that could commit fraud against the NHS in England, the spokesperson said. Instead, a “vulnerability” is a weakness in the system that “may allow fraud to occur”.

“We remain committed to evaluating the threats and vulnerabilities and finding solutions to mitigate them,” the spokesperson added.

 

The pandemic delivery service for clinically extremely vulnerable (CEV) patients ended on March 31, but the service is still available for people who have been notified of the need to self-isolate by NHS Test and Trace. This is currently commissioned until June 31.

 

In response to a written question in parliament, pharmacy minister Jo Churchill said last month (March 23) that pharmacy contractors and dispensing doctors had claimed for 3,477,259 deliveries to shielded patients between April and December 2020.

 

Tackling fraud in pharmacy “a priority”

 

The Department of Health and Social Care (DH) published a new counter-fraud strategic plan last week (March 30), in which it did not specifically mention pharmacy fraud.

 

However, the strategy alluded to the DH’s plan of introducing “preventative ways of permanently eradicating” certain types of fraud, such as prescription fraud.

 

A spokesperson for the DH told C+D that “tackling fraud within the pharmacy sector remains a priority and the NHS CFA has engaged with pharmacists to understand the types of fraud that take place”.

 

“We are introducing real time exemption checking (RTEC) technology so pharmacists can verify if patients are exempt from prescription charges,” the spokesperson added.

 

An NHS CFA spokesperson told C+D that counter-fraud actions in the pharmacy sector involve fraud committed by both contractors and patients.

 

In 2018, the DH said it would crack down on pharmacy contractor fraud, which it said was “impacting heavily” on the total fraud bill for the NHS.

 

However, a 2019 C+D investigation revealed that only one pharmacy contractor had been sanctioned for fraud against the NHS in a two-year period.

Media Summary

Patients should register with pharmacies says RPS Scotland
P3 Pharmacy, Pharmacy Magazine editoral staff, 7 April 2021

Pharmacy Magazine reports that the Royal Pharmaceutical Society in Scotland has called for patients to be registered with their local community pharmacy in order to ensure continuity of care. This is part of the “transformed” role pharmacists will play in providing patient care by the end of this decade.

According to the report by RPS Scotland, by 2030 pharmacies will be using digital technology to allow patients to access services from any location. It also suggests that patients should also be offered information about safe and effective use of their medicines each time a supply is made.

RPS Scotland’s Pharmacy 2030 vision aims to tackle health inequalities that have been highlighted during the COVID-19 pandemic. Following its publication last week, the report is currently out for consultation and will be followed by separate documents aimed at pharmacists working in other sectors.

Parliamentary Coverage

2021/22 priorities and operational planning guidance
NHS England, 25 March 2021

The 2021/22 priorities and operational planning guidance sets the priorities for the year ahead, against a backdrop of the challenge to restore services, meet new care demands and reduce the care back logs that are a direct consequence of the pandemic, whilst supporting staff recovery and taking further steps to address inequalities in access, experience and outcomes.

Effective partnership working across systems will be at the heart of this and the financial framework arrangements for 2021/22 will therefore continue to support a system-based approach to funding and planning. In this context the priorities for the year ahead are:

A. Supporting the health and wellbeing of staff and taking action on recruitment and retention
B. Delivering the NHS COVID vaccination programme and continuing to meet the needs of patients with COVID-19
C. Building on what we have learned during the pandemic to transform the delivery of services, accelerate the restoration of elective and cancer care and manage the increasing demand on mental health services
D. Expanding primary care capacity to improve access, local health outcomes and address health inequalities
E. Transforming community and urgent and emergency care to prevent inappropriate attendance at emergency departments (ED), improve timely admission to hospital for ED patients and reduce length of stay
F. Working collaboratively across systems to deliver on these priorities.

 

2021/22 priorities and operational planning guidance: Implementation guidance
NHS England, 26 March 2021

The NHS has published implementation guidance, providing further detailed policy and technical information to enable Integrated Care Systems (ICSs) and their constituent organisations to develop and agree operational plans.

Plans should summarise how 2021/22 priorities and operational planning guidance will be operationalised, with a focus on the six months to the end of September 2021 for most areas.

With every part of England now covered by an Integrated Care System, this guidance is aimed at supporting ICSs in delivering their four core purposes of:

• Improving outcomes in population health and healthcare
• Tackling inequalities in outcomes, experience and access
• Enhancing productivity and value for money
• Helping the NHS to support broader social and economic development.

 

Full Coverage

Patients should register with pharmacies says RPS Scotland
P3 Pharmacy, Pharmacy Magazine editoral staff, 7 April 2021

By 2030 patients should be registered with their local community pharmacy to ensure continuity of care, the Royal Pharmaceutical Society in Scotland has said.

In its Pharmacy 2030 document published last week, RPS Scotland outlines its vision for a “transformed” role for pharmacists, who it says will have a greater clinical focus while pharmacy technicians take responsibility for medicines supply.

As well as registering patients, by 2030 pharmacies will be using digital technology to allow patients to access services from any location, according to the professional body’s vision for the coming decade.

The document, for which RPS Scotland sought input from pharmacists working across Scotland, also says patients should be offered a conversation around the safe and effective use of their medicines each time a supply is made.

It emphasises shared decision making and the routine use of clinical examinations and prescribing by pharmacists and explores how the sector can tackle health inequalities.

The 2030 vision is currently out for consultation and will be followed by separate documents aimed at pharmacists working in other sectors.

RPS Scotland director Clare Morrison said: “The Covid pandemic has changed our world and it has changed healthcare. That is why pharmacy needs a new vision. Not because previous strategies weren’t good, but because we need something now that reflects our changed world. Today’s publication is the first step in creating that vision.

“Pharmacy 2030 describes a future where community pharmacies will remain the place rom which people get their medicines, but the pharmacist’s role will be transformed.

“The report explains how pharmacy will tackle health inequalities that have come to the fore during Covid. Importantly, it describes how all of this will be underpinned by better use of data, digital infrastructure and proper workforce development.”

Ian Rudd, director of pharmacy, NHS Highland, said: “I welcome this report from the RPS on its vision for community pharmacy. It highlights many key issues for further discussion across the profession in Scotland. I would encourage all pharmacists to join with the RPS in the conversations that are to follow.”

Scottish pharmacy board chair Jonathan Burton said: “As the only pharmacy organisation with members across all sectors of pharmacy, the RPS is well-placed to engage with the profession and create a single vision for the whole of pharmacy.”

Media Summary

Welsh patients to be first in UK to receive Moderna Covid vaccine

The Guardian, Harry Taylor, 7 April 2021

 

The Guardian reports that Welsh patients will be the first in the United Kingdom to receive doses of the Moderna vaccine outside of clinical trials. The rollout of the third approved vaccine for COVID-19 was described as a “significant” addition to Wales’ vaccination campaign by Welsh Health Minister, Vaughan Gething.

 

Scottish authorities are due to begin administering doses of the same vaccine later this week, having received the first delivery of the circa one million doses ordered through the centralised procurement scheme on Monday. According to Vaccines Minister Nadhim Zahawi rollout in England will begin in “the third week of April”. It is unconfirmed when delivery or administration of the Moderna vaccine will begin in Northern Ireland.

 

The first fallout

PharmaTimes Magazine, Stuart Evans, April 2021

 

Writing in the PharmaTimes Magazine, Stuart Evans explores the rising tensions between the European Commission and AstraZeneca as the first major contractual disagreement in cross-border pharmaceutical trade after Brexit.

 

Evans concludes that, as a vaccines dispute, this particular case benefited from being a high-profile issue requiring a workable solution. Factors for consideration for future cross-border pharmaceutical trade include anticipating potential differences in legal interpretation between countries, and the increasing importance of force majeure clauses and dispute resolution processes.

Parliamentary Coverage

New £20 million fund to grow UK life sciences manufacturing opens for applications

Department for Business, Energy and Industrial Strategy, Office for Life Sciences, Nadhim Zahawi MP, and The Rt Hon Kwasi Kwarteng MP, 7 April 2021

 

Applications are now open for the Medicines and Diagnostics Manufacturing Transformation Fund, a new £20 million fund to boost life science manufacturing across the United Kingdom. This fund will provide capital grant funding for investments related to the manufacture of human medicines, medical diagnostics, and MedTech products.

 

The fund is designed to build national healthcare resilience by improving domestic supply chains and creating high value manufacturing jobs in the sector. The deadline for applications to the fund is 30th June 2021, with any awarded funding to be defrayed by March 2022.

 

Full Coverage

Welsh patients to be first in UK to receive Moderna Covid vaccine

The Guardian, Harry Taylor, 7 April 2021

 

Patients in Wales will from Wednesday become the first in the UK to receive the Moderna vaccine as part of a mass vaccination programme, with the first doses in Scotland set to come later this week.

 

The initial jabs would be given at the West Wales general hospital in Carmarthen, the Welsh government said.

 

It added that 5,000 doses of the Moderna vaccine – the third to be approved for use in the UK – had been sent to centres in the Hywel Dda University Health Board area, covering Ceredigion, Pembrokeshire and Carmarthenshire, on Tuesday.

 

It comes as Scotland received its first delivery on Monday, and a spokesperson told the Guardian that the doses would start to be administered later this week.

 

Scotland is set to get more than a million of the 17m jabs ordered by Westminster, with vaccine procurement centralised rather than devolved.

 

England is yet to receive its first batch for general distribution, with vaccines minister Nadhim Zahawi saying on Tuesday it would be rolled out around “the third week of April”. A spokesperson for the Department of Health and Social Care on Tuesday said it would be rolled out “as soon as possible this month”.

 

The Guardian asked the UK, Welsh and Scottish governments for further details about how the vaccine supply had been divided between the four nations – but none were able to provide details.

 

It has not been confirmed when the jab will be received in Northern Ireland and start to be used to vaccinate people there.

 

The Moderna vaccine was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 8 January, with phase 3 trials showing it had 94.1% efficacy against Covid, and 100% against severe illness. Like the Pfizer/BioNTech and Oxford/AstraZeneca jabs, it requires two doses for full protection, according to tests.

 

The Welsh health minister, Vaughan Gething, said it was a “significant” addition to the country’s vaccination programme.

 

“Every vaccine given to someone in Wales is a small victory against the virus and we would encourage everyone to go for their vaccine when invited.”

 

Ros Jervis, director of public health for Hywel Dda said: “We are incredibly lucky to have a third vaccine in Wales, with a long shelf-life and the ability to be easily transported, to help deliver the vaccination programme to small clinics across our rural communities.”

 

The health secretary, Matt Hancock, said he was “delighted we can start the UK rollout of the Moderna vaccine in west Wales”.

 

He added: “Three out of every five people across the whole UK have received at least one dose, and today we start with the third approved vaccine. Wherever you live, when you get the call, get the jab.”

 

The first fallout

PharmaTimes Magazine, Stuart Evans, April 2021

 

Taking a look at the recent dispute between the EU Commission and AstraZeneca over the ins and outs of its contract, Stuart Evans, commercial litigation expert and partner at law firm BLM, examines what this could represent for EU/UK cross-border pharma relations.

 

Earlier this year we saw reports of the EU commission and AstraZeneca coming to loggerheads over vaccine roll-out across the bloc. Amidst criticism of the speed of the EU’s vaccine roll-out programme, AstraZeneca reported production problems in its Netherlands and Belgium plants, claiming it as a reason for a shortfall in vaccine delivery to the EU.

 

An initial deal was struck in August 2020 for 300 million doses to be delivered into the EU, post-regulatory approval, with the option for an additional 100 million. Come late January, EU projections showed a potential shortfall of around 75 million doses by March.

 

Amongst growing pressure to speed up its vaccine roll-out, production issues at AstraZeneca’s European plants threatened delivery further. As attention turned to the company’s agreement with the bloc, the EU announced AstraZeneca had been instructed to share doses from its UK plants, though AstraZeneca argued its UK contract prevented this.

 

The EU maintained that its own contract meant AstraZeneca was obliged to send UK-produced supplies to account for a shortfall within the EU. Commission President Ursula von der Leyen claimed the company had “explicitly assured us in this contract that no other obligations would prevent the contract from being fulfilled”, subsequently sharing extracts of its contract with the company.

 

At such a critical time for the industry, with all efforts focused on vaccine delivery, does this row represent one of the first major contractual fall-outs in our post-Brexit world, and what could it mean for cross-border pharma going forward?

 

Contractual conundrum

 

Much attention has been paid to whether the wording of the initial contract was open for debate. The 42-page document, of which portions were redacted, endeavoured to deal with a large and complex transaction for the supply of millions of vaccines across multiple countries. There has been particular focus on the contract’s reference to ‘best reasonable efforts’. Whilst this particular contract is governed by Belgian law and is therefore subject of detailed local advice, English law by comparison also wrestles with the concepts of ‘best endeavours’ and ‘reasonable endeavours’, with the former more stringent than the latter.

 

In broad terms, ‘best endeavours’ requires the responsible party to take all available steps to achieve the desired results, whilst “reasonable endeavours” requires the responsible party to act by reference to what a reasonable person, acting prudently and commercially, could do to get such results. The AstraZeneca contract introduces slightly different wording, ‘best reasonable efforts’, in a lengthy definition for each party, which may fall somewhere between the two. What this means in the particular circumstances of this case is a matter for debate, reflecting the possibility that the parties could not agree on something more specific.

 

Ultimately, should this be one of the issues litigated by the parties in the Belgian courts, interpreting what exactly that term means under Belgian law is likely to tax legal minds and generate vast amounts of argument. And that’s just one provision in a 42-page document.

 

‘Vaccine War’

 

As the debate escalated, the EU Justice Commissioner stated the UK was in danger of starting a ‘vaccine war’ between itself and the 27 members of the bloc, claiming that Brexit had made it clear ‘the UK doesn’t want to show solidarity with anyone’. Setting aside how true that assertion is, what is clear is that Brexit may complicate contractual obligations and litigation as a result of any alleged breach of those obligations.

 

Whilst in this instance, this was a dispute between the EU and a Swedish company, this should be a prompt to pharmaceutical companies to look at their commercial contracts in terms of cross-border trade.

 

For example, given the problems caused by the pandemic, firms should look closely at force majeure clauses, whether doing business with an EU or non-EU counterpart. A force majeure clause typically operates to excuse performance of the contract by one or both parties upon the occurrence of certain events. Force majeure clauses may exclude foreseeable events, even if such events would put performance of a contract beyond the control of a party. The logic being that if an event is foreseeable, the contracting party should allow and provide for it, rather than relying on a force majeure clause.

 

In respect of contracts which might be affected by Brexit-related developments (which again could include contracts with non-EU counterparts), parties should also consider expressly providing for situations in which their ability to perform – or their costs of performing – the contract are affected by Brexit. Parties are wise to remember that their business could be affected not only by their inability to perform a contract, but also non-performance (whether driven by Brexit or otherwise) of businesses elsewhere in their supply chain. A force majeure clause or a so called ‘Brexit’ clause may be helpful in forgiving non-performance were this to occur, but protection from litigation is likely to be small comfort if a wider supply chain collapses. This is aside from the need to be on top of EU procurement and public law issues.

 

If litigation with an EU counterpart does become necessary, we currently find ourselves in a legal grey area. The UK and EU are now in a situation where reciprocal arrangements when dealing with jurisdiction, and the recognition of judgments under the Brussels Recast legislation, are no longer applicable for cases begun in 2021. Until there is a replacement regime that can clearly provide which national courts have jurisdiction in cross-border disputes, and depending on the dispute resolution terms agreed by the parties, it is possible that litigation with an EU counterpart may become more costly and time-consuming, both to get it up and running and then to enforce any judgment.

 

What are the EU’s options for future vaccine disruption?

 

After much back and forth once the contract was made public, the EU and AstraZeneca have now come to a resolution. The company agreed to supply an additional nine million doses by March, and the EU sought to distance itself from the possibility of legal action at this stage. The bloc will no doubt be focused on seeking to regularise the supply of vaccines from AstraZeneca and looking at viable contingency plans, rather than taking a lengthy route through the courts.

 

There is a resolution clause in the contract that requires the parties to go through an informal dispute resolution process, and there is now at least a short term solution focused on a programme of delivery that representatives from both sides have signed up to, possibly leaving important but less pressing contractual issues to another day.

 

Whilst this particular row looks to be resolving, it’s clear that the forces of COVID-19 and Brexit could continue to cause complications in cross-border pharma trade. In the particular race to control COVID-19, people ultimately want vaccines, rather than to hear about contractual wrangling by their respective governing bodies and external contractors, so in these situations there will be pressure on the affected parties to reach a workable solution if that is feasible.

 

New £20 million fund to grow UK life sciences manufacturing opens for applications

Department for Business, Energy and Industrial Strategy, Office for Life Sciences, Nadhim Zahawi MP, and The Rt Hon Kwasi Kwarteng MP, 7 April 2021

 

  • Applications open for new £20 million fund to support the manufacture of medicines, diagnostics and MedTech in the UK
  • fund will boost the UK offer in life sciences manufacturing, creating economic opportunities and highly skilled jobs across the country
  • supports the government’s ambitions to build back better, ensuring greater resilience in UK supply chains

 

Announced last November by the Prime Minister and opening for applications today, the Medicines and Diagnostics Manufacturing Transformation Fund is designed to boost the country’s ability to respond to future pandemics and put UK companies ahead of global competitors.

 

With two-thirds of life science manufacturing jobs already outside London and the South East, the new £20 million fund will also open up economic and investment opportunities for manufacturers across the whole of England, Northern Ireland, Scotland and Wales, improving our domestic supply chains and safeguarding and creating hundreds of highly skilled manufacturing jobs.

 

The UK has one of the strongest and most productive health and life sciences industries globally, with a turnover of £80 billion and supporting 256,000 jobs, underpinned by a powerful research landscape and high-quality science base.

 

Business Secretary Kwasi Kwarteng said:

 

This £20 million investment will harness the best in UK manufacturing and fund cutting-edge medical technologies to protect the British public in 2021 and beyond.

 

This will not only boost the UK’s already strong vaccine and medicine portfolio but support top quality, local jobs across the country and put the UK in a formidable position to continue responding to the most pressing global challenges of our time.

 

Life Sciences Minister Nadhim Zahawi said:

 

Our life sciences sector is world leading and its incredible response to COVID-19 has reminded us of the crucial importance of the sector to the UK.

 

I am thrilled to see this fund opening for applications and would encourage companies to make the most of the opportunity to expand their operations and create good jobs as we build back better from the pandemic.

 

The pandemic has shown the importance of having a strong domestic medicines and diagnostics manufacturing industry. This new fund has been established to grow and strengthen the UK’s capabilities, as well as encouraging companies to deploy new technologies, build new factories and harness new advances, including bioprocessing, data and using greener manufacturing processes.

 

To date, the UK government has invested over £300 million into manufacturing a successful vaccine, and through the work of the Vaccine Taskforce, established in April 2020, facilities across the UK are working at pace to supply the world’s most promising vaccines so far as part of the biggest vaccination programme in NHS history.

 

Today’s announcement forms part of the government’s plans to bolster secure and resilient onshore UK manufacturing capacity, ensuring universal and equitable access to safe, efficacious and affordable vaccines, medicines and diagnostics for this and future pandemics, taking advantage of our world-leading genomics expertise.

From Factory to Pharmacy

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

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