HDA UK Media and Political Bulletin – 19 March 2021

Media Summary

EU threat to vaccine exports exposes mutual risks to global supply chain
Financial Times, FT Reporters, 18 March

The Financial Times reports that the EU’s threat to restrict the export of COVID-19 vaccines has exposed the mutual harm that countries could inflict on one another due to the interdependent nature of the global vaccine supply chain.

Ursula von der Leyen, European Commission President, said on Wednesday that Brussels was considering “all options” to ensure Europeans were vaccinated as soon as possible. Her plans, which are likely to be discussed at an EU summit next week, could stop vaccine shipments to countries that did not show “reciprocity” to the EU by allowing supplies to reach the bloc.

Coronavirus vaccine supply chains are intrinsically global. US biotech Moderna produces vaccine ingredients in Switzerland, fills and finishes the doses in Spain and ships from there to all buyers outside the US. Pfizer similarly has all of its non-US production situated inside the bloc. EU facilities are understood to be dependent on imports for their vaccine production, including the lipid nanoparticles needed in mRNA vaccines and the plastic bags used in bioreactors.

For this reason, Jacob Kirkegaard, Senior Fellow at the Peterson Institute for International Economics and the German Marshall Fund, says that protectionist measures would cause significant damage. The EU would be “taking a sledgehammer to something brittle”, risking retaliation and reputational damage for minimal gain, he added. “It’s an altogether bad political idea — and it fails to give Europe a material amount of extra vaccines now.”

Retesting 1.7m vaccines and Indian delay blamed for UK shortage
Financial Times, George Parker, Sarah Neville, Jasmine Cameron-Chileshe & Stephanie Findlay, 18 March

The Financial Times reports that Britain’s vaccine rollout has been knocked off course by the delayed arrival of vaccines from India and a need to check 1.7m doses to ensure their stability. At least 12m people will still receive a second COVID-19 vaccine dose in April but supply will be “tighter than this month” according to Matt Hancock

The Health Secretary confirmed in the House of Commons that there had been a delay to the “scheduled arrival from the Serum Institute of India” of Indian-made doses of the Oxford/AstraZeneca vaccine.

The need to retest a batch of 1.7m doses would also constrain supplies, Hancock said, without providing further detail on the provenance of those vaccines or why they have to be checked. The need for such additional testing was “to be expected” from time to time and showed the “rigour” of UK vaccine safety processes, he added.

Hancock also warned the EU not to impose emergency controls on exports of vaccines — including the Belgium-made Pfizer jab — to Britain. “We fully expect those contracts to be honoured,” he said.

Moderna COVID vaccine expected to arrive in the UK in April, company says
The i, Paul Gallagher, 18 March

The i reports that Moderna is expected to start delivering its order of 17 million COVID vaccine doses to the UK in April, although it is unclear whether their arrival could solve the problem of the expected shortfall of the Oxford/AstraZeneca jabs next month.

The Government signed a deal with the US company last year and said at the time that it expected delivery to arrive in the Spring. Problems over the supply of the AstraZeneca vaccine led scientists to question why officials had yet to name a time when the Moderna doses would arrive, but the US company has said they will be sent from next month. A spokesman said: “Moderna expect to begin deliveries to the UK in April, within the spring delivery window previously communicated. Moderna is on track to meet quarterly contractual commitments.”

The UK Government signed a deal with Moderna for an initial 5 million doses before ordering another 2 million doses in November. It then ordered a further 10 million doses in January. Final clinical results found that the vaccine’s efficacy against COVID-19 was 94.1% and the vaccine’s efficacy against severe COVID-19 was 100%.

 

Parliamentary Coverage

House of Commons – Written Question, 17 March

Julian Sturdy (Conservative, York Outer): To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the potential merits of writing off the repayment of advance funding extended to community pharmacy in 2020 to maintain services during the COVID-19 outbreak.

House of Commons – Written Question, 17 March

Julian Sturdy (Conservative, York Outer): To ask the Secretary of State for Health and Social Care, what assessment his Department has made of whether the performance of community pharmacy during the COVID-19 outbreak necessitates the creation of a new national pharmacy contract.

House of Commons – Written Question, 17 March

Julian Sturdy (Conservative, York Outer): To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of current funding arrangements for community pharmacy.

House of Commons – Written Question, 17 March

Alex Norris (Labour, Nottingham North): To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the COVID-19 outbreak on the cashflows of community pharmacies; what estimate he has made if the number of community pharmacies that (a) have closed in each of the last three financial years and (b) will close in the financial year 2021-22; and if he will make a statement.

Full Coverage

EU threat to vaccine exports exposes mutual risks to global supply chain
Financial Times, FT Reporters, 18 March

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

Retesting 1.7m vaccines and Indian delay blamed for UK shortage
Financial Times, George Parker, Sarah Neville, Jasmine Cameron-Chileshe & Stephanie Findlay, 18 March

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

Moderna Covid vaccine expected to arrive in the UK in April, company says
The i, Paul Gallagher, 18 March

Moderna is expected to start delivering its order of 17 million Covid vaccine doses to the UK in April although it is unclear whether their arrival could solve the problem of the expected shortfall of the Oxford/AstraZeneca jabs next month.

The Government signed a deal with the US company last year and said at the time that it expected delivery to arrive in the Spring. Problems over the supply of the AstraZeneca vaccine led scientists to question why officials had yet to name a time when the Moderna doses would arrive, but the US company has said they will be sent next from month. A spokesman said: “Moderna expect to begin deliveries to the UK in April, within the spring delivery window previously communicated. Moderna is on track to meet quarterly contractual commitments.”

Problems with a shipment of the AstraZeneca jab from India has impacted that supply chain with 5 million doses said to be delayed as a result, meaning people in their 40s are likely to have to wait until May to get their Covid-19 vaccine.

Professor Martin Marshall, chairman of the Royal College of GPs, said news of constraints in supply was “disappointing” and “a bit of a setback”, and the focus in April in England will be on giving second doses to people who were vaccinated earlier in the year.

“The impact of this shortage of supplies will happen on the group that we were hoping to start on in April, which is the people under the age of 50 without any pre-existing conditions, who are now going to have to wait until May,” he told the BBC.

Scientists said issues over the AstraZeneca vaccine supply has made it all the more urgent that the Moderna vaccine will arrive on time.

Lawrence Young, Professor of Molecular Oncology at Warwick Medical School, said: “Vaccine supply was always going to be challenging – particularly at the current rates of daily vaccinations. This highlights the difficulties in manufacturing these complex vaccines along with need for stringent quality control. We are also limited by having just two approved vaccines (Pfizer/BioNTech and AstraZeneca/Oxford) currently in use.

“Millions of doses of the Moderna vaccine, which was approved for use by the UK Medicines regulator (MHRA) in January, were secured for delivery in the spring – where are they? We have also secured 60 million doses of the Novavax vaccine which is currently awaiting regulatory approval.

“We are in a very precarious situation with a significant proportion of the adult population unvaccinated (approximately 21 million in the 18-49 age group) and the continued threat of more transmissible virus variants popping up in different parts of the country. This could mean that we need to revisit the timetable for easing out of lockdown.”

The UK Government signed a deal with Moderna for an initial 5 million doses before ordering another 2 million doses in November. It then ordered a further 10 million doses in January. Final clinical results found the vaccine to be 94.1 per cent effective.

Media Summary

There was no media coverage today.

 

Parliamentary Coverage

Changes to import controls due to be implemented on 1 April and 1 July 2021
Michael Gove, Chancellor for the Duchy of Lancaster and Minister for the Cabinet Office, 11 March

The UK’s departure from the EU’s Single Market and Customs Union on 31 December last year created considerable change for business and citizens, including the introduction of new processes and requirements. But with the first changes coming into force on 1 January 2021, the generalised disruption that many anticipated did not affect supply chains to the levels expected.However, the Government has recognised the scale and significance of the challenges businesses have been facing in adjusting to the new requirements, all while dealing with the impacts of COVID. With the disruption caused by COVID lasting longer and being more extensive than anticipated, the Government has reviewed its timetable for the phased introduction of controls on imports from the EU into Great Britain, giving businesses more time to prepare.

In a statement made yesterday, Michael Gove announced a clear revised timetable for the introduction of controls, as follows:

  • Pre-notification requirements for Products of Animal Origin (POAO), certain animal by-products (ABP), and High Risk Food Not Of Animal Origin (HRFNAO) will not be required until 1 October 2021. Export Health Certificate requirements for POAO and certain ABP will come into force on the same date.
  • Customs import declarations will still be required, but the option to use the deferred declaration scheme, including submitting supplementary declarations up to six months after the goods have been imported, has been extended to 1 January 2022.
  • Safety and Security Declarations for imports will not be required until 1 January 2022.
  • Physical SPS checks for POAO, certain ABP, and HRFNAO will not be required until 1 January 2022. At that point they will take place at Border Control Posts.
  • Physical SPS checks on high risk plants will take place at Border Control Posts, rather than at the place of destination as now, from 1 January 2022.
  • Pre-notification requirements and documentary checks, including phytosanitary certificates will be required for low risk plants and plant products, and will be introduced from 1 January 2022.
  • From March 2022, checks at Border Control Posts will take place on live animals and low risk plants and plant products.

Traders moving controlled goods into Great Britain will continue to be ineligible for the deferred customs declaration approach. They will therefore be required to complete a full customs declaration when the goods enter Great Britain.

You can read the full transcript of Michael Gove’s announcement here.

COVID-19: Community Pharmacies
House of Commons Debate, 11 March

Yesterday, Sir Graham Brady chaired a debate on the effect of the COVID-19 outbreak on community pharmacies. Jackie Doyle-Price MP, Chair of the All-Party Parliamentary Group on Pharmacy, introduced the debate by highlighting the huge contribution made by community pharmacists during the pandemic, and the support and recognition expressed by Members of Parliament.

She drew particular attention to the financial impact of the pandemic on community pharmacists, and the consequences on their personal wellbeing, making a plea that the Government and the NHS fully appreciate their contribution and ensure that they be recompensed adequately for it. She also took this opportunity to highlight the larger role that pharmacists can and should play in primary care.

In line with the observations made by Jackie Doyle-Price MP, Peter Dowd MP outlined four actions which he recommended the Government take to address the situation:

  1. Review the response from pharmacies during the pandemic and re-evaluate a clear vision of what is needed from these undervalued and vital frontline healthcare workers;
  2. Enable pharmacists to do more, by providing additional resources for training and support to the sector;
  3. Reassess the value of pharmacies, to be conducted by finance teams in the Department of Health and Social Care and the NHS; and
  4. Write off the advance payments as an immediate way of providing relief. Additionally, re-evaluate the financial implications of asking pharmacies to pay back the £370 million advance.

Holly Lynch MP backed the proposals, adding that pharmacies had their budgets cut back in 2016, with a reduction from £2.8 billion in 2015-16 to £2.59 billion in 2017-18. She said that austere financial measures had left many pharmacies ill-prepared for the additional requirements posed by the pandemic, flagging a 20% rise in demand for medicines and a 35% increase in required prescriptions.

Taiwo Owatemi MP went on to highlight the important role that these pharmacists play at the heart of communities, referencing her own background as a qualified pharmacist. She also advocated for a review of the sector’s funding, shedding light on the key link it provides between individuals and the wider NHS, and the vital role it can play in plans to address growing health inequalities.

Bob Seely MP noted that independent pharmacies do not gain the discounts given to big multiples, which are often part of a single wholesale and retail chain, and asked the Minister for Health to ensure that independent pharmacies are paid the same and are allowed to make the same profit margins on prescriptions and other services.

You can read a full transcript of the debate here.

Full Coverage

There was no media coverage today.

Media Summary

UK and EU Vaccine Update – 11 March 2021

Tensions have risen between UK and EU leaders this week after European Council President Mr Michel claimed that: “The United Kingdom and the United States have imposed an outright ban on the export of vaccines or vaccine components produced on their territory.”

This latest disagreement follows a high-profile fall-out in January, when the EU briefly attempted to trigger Article 16 of the Brexit withdrawal agreement’s protocol to impose controls on the supply of vaccines into Northern Ireland. Brussels swiftly backtracked and apologised after coming in for heavy criticism over the move. UK-EU relations have run into trouble since then over Downing Street’s decision to unilaterally extend the grace period for fully implementing protocol arrangements contained in the Brexit agreement.

The UK is the biggest recipient of reported EU vaccine exports, securing 9.1m doses under the bloc’s authorisation scheme that came into force on January 30. EU controls were put in place after the bloc struggled to secure adequate volumes of vaccines for member states.

 

UK denies vaccine nationalism

The UK Prime Minister has denied the accusations made by Charles Michel that Britain has introduced an “outright ban” on vaccine exports. “Let me be clear: we have not blocked the export of a single COVID-19 vaccine or vaccine components” Boris Johnson told the House of Commons on Wednesday. Read more in Sky News.

The UK Foreign Office summoned Nicole Mannion, Deputy Ambassador of the EU to the UK and Charge d’affaires at the EU Delegation to the UK, for “further discussions” on the dispute on Wednesday. Read more in the Independent.

EU challenges UK to show vaccine export data

The European Commission has now acknowledged no formal ban is in place, but EU officials noted that Mr Michel was drawing attention to the fact that no vaccines have so far been sent from the UK to the bloc. Mr Michel said on Wednesday that the UK government should disclose data on the number of Coronavirus vaccines Britain ships internationally. Read more in The Express and the Financial Times.

Meanwhile, the EU’s ambassador to the UK denied the bloc is engaging in “vaccine nationalism” but similarly demanded more transparency from Britain as tensions simmer over the export of Coronavirus jabs. “I refute completely the accusation that the EU is protectionist or has engaged in vaccine nationalism,” João Vale de Almeida told British broadcaster ITV’s Robert Peston. The EU has been criticized and at times accused of protectionism over a new vaccine export control mechanism it says is intended to ensure suppliers are fulfilling their contractual obligations. Read more in Politico.

 

Concerns raised over impact of Brexit EU rules on medicines delivery to Northern Ireland

Concerns have been raised about the impact of Brexit on the delivery of medicines at the end of this year. TUV leader Jim Allister sought clarity from Northern Irish Health Minister Robin Swann on the issue and warned it could have serious implications for future vaccine rollout if Northern Ireland is tied to the EU vaccination programme. In response to a written question, Mr Swann said that Northern Ireland was only part of the UK’s vaccine rollout because of a year-long grace period stipulated by the protocol.

Mr Allister said the Health Minister’s response showed that “in simple terms, Northern Ireland is only able to benefit from the UK’s successful vaccine rollout now because of a grace period. But for the grace period, we would be tied to the failed and failing EU policy on vaccination.” Read more in The Irish News.

 

EU set to approve Johnson & Johnson vaccine today

The Johnson & Johnson vaccine is expected to get the green light today from the European Medicines Agency. The one-shot jab has already been approved in the United States and has a 66% efficacy rate. However, despite the European Commission securing a minimum of 200 million doses, Johnson & Johnson has not committed to any shipments until the second quarter of the year — meaning at least a three-week lag between the EU’s approval and Johnson & Johnson’s first deliveries. Read more in Politico.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

UK and EU Vaccine Update – 11 March 2021

Tensions have risen between UK and EU leaders this week after European Council President Mr Michel claimed that: “The United Kingdom and the United States have imposed an outright ban on the export of vaccines or vaccine components produced on their territory.”

This latest disagreement follows a high-profile fall-out in January, when the EU briefly attempted to trigger Article 16 of the Brexit withdrawal agreement’s protocol to impose controls on the supply of vaccines into Northern Ireland. Brussels swiftly backtracked and apologised after coming in for heavy criticism over the move. UK-EU relations have run into trouble since then over Downing Street’s decision to unilaterally extend the grace period for fully implementing protocol arrangements contained in the Brexit agreement.

The UK is the biggest recipient of reported EU vaccine exports, securing 9.1m doses under the bloc’s authorisation scheme that came into force on January 30. EU controls were put in place after the bloc struggled to secure adequate volumes of vaccines for member states.

UK denies vaccine nationalism

The UK Prime Minister has denied the accusations made by Charles Michel that Britain has introduced an “outright ban” on vaccine exports. “Let me be clear: we have not blocked the export of a single COVID-19 vaccine or vaccine components” Boris Johnson told the House of Commons on Wednesday. Read more in Sky News.

The UK Foreign Office summoned Nicole Mannion, Deputy Ambassador of the EU to the UK and Charge d’affaires at the EU Delegation to the UK, for “further discussions” on the dispute on Wednesday. Read more in the Independent.

EU challenges UK to show vaccine export data

The European Commission has now acknowledged no formal ban is in place, but EU officials noted that Mr Michel was drawing attention to the fact that no vaccines have so far been sent from the UK to the bloc. Mr Michel said on Wednesday that the UK government should disclose data on the number of Coronavirus vaccines Britain ships internationally. Read more in The Express and the Financial Times.

Meanwhile, the EU’s ambassador to the UK denied the bloc is engaging in “vaccine nationalism” but similarly demanded more transparency from Britain as tensions simmer over the export of Coronavirus jabs. “I refute completely the accusation that the EU is protectionist or has engaged in vaccine nationalism,” João Vale de Almeida told ITV’s Robert Peston. Read more in Politico.

Concerns raised over impact of Brexit EU rules on medicines delivery to Northern Ireland

Concerns have been raised about the impact of Brexit on the delivery of medicines into Northern Ireland at the end of this year. TUV leader Jim Allister sought clarity from Northern Irish Health Minister Robin Swann on the issue and warned it could have serious implications for future vaccine rollout if Northern Ireland is tied to the EU vaccination programme. In response to a written question, Mr Swann said that Northern Ireland was only part of the UK’s vaccine rollout because of a year-long grace period stipulated by the protocol.

Mr Allister said the Health Minister’s response showed that “in simple terms, Northern Ireland is only able to benefit from the UK’s successful vaccine rollout now because of a grace period. But for the grace period, we would be tied to the failed and failing EU policy on vaccination.” Read more in The Irish News.

EU set to approve Johnson & Johnson vaccine today

The Johnson & Johnson vaccine is expected to get the green light today from the European Medicines Agency. The one-shot jab has already been approved in the United States and has a 66% efficacy rate. However, despite the European Commission securing a minimum of 200 million doses, Johnson & Johnson has not committed to any shipments until the second quarter of the year — meaning at least a three-week lag between the EU’s approval and Johnson & Johnson’s first deliveries. Read more in Politico.

Media Summary

COVID-19: UK rejects ‘completely false’ EU vaccine export ban claim
BBC News, Gavin Stamp, 09 March

BBC News reports that a fresh row has broken out between the UK and the EU after the bloc’s most senior official suggested the UK had banned all COVID-19 vaccine exports.

Charles Michel, the President of the European Council, wrongly claimed the UK had an “outright ban” on exports of vaccines produced on its soil. The BBC understands Foreign Secretary Dominic Raab has written to him to say the claims are “completely false”.

This is the second time since the start of the year that the UK and EU have disagreed over the issue of the production and distribution of Coronavirus vaccines. In January, the EU introduced a new system of controls on vaccine exports amid concerns over availability of supplies on the continent, requiring producers to seek permission from national governments for planned sales.

The move sparked a wider row with the UK about the functioning of post-Brexit trade arrangements relating to Northern Ireland agreed by the two sides last year.

This news was covered by a number of outlets, including The TelegraphFinancial Times and Politico.

 

Parliamentary Coverage

Importing medicines into Northern Ireland before 31 December 2021
Medicines and Healthcare products Regulatory Agency, 09 March

The MHRA has updated its guidance on ‘Importing medicines into Northern Ireland before 31 December 2021’.

This follows the European Union publication of the EU Commission notice updated on 25 January 2021 on the Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period. The notice places a reporting obligation on industry to notify the MHRA for medicines imported into Northern Ireland.

For products approved in the UK before 31 January 2021, the EU Commission Notice means that, for all UK licenced medicines within a company’s portfolio, companies will seek to make use of these flexibilities unless the MHRA is directly informed otherwise. This will be the basis for MHRA enforcement until 31 December 2021.

For products approved in the UK after 31 January 2021 and before 31 December 2021, the EU Commission Notice means that these flexibilities apply to all new products and you only need to notify the MHRA if you do not plan to make use of the flexibilities. This will be the basis for MHRA enforcement until 31 December 2021.

You can read the guidance in full here.

COVID-19 vaccine supply and manufacturing in the UK
Matt Hancock, Secretary of State for Health and Social Care, 09 March

Yesterday Matt Hancock MP, Secretary of State for Health and Social Care, delivered a speech at the Global COVID-19 Vaccine Supply Chain and Manufacturing Summit at Chatham House.

Mr Hancock took this opportunity to detail the success of the UK’s vaccine roll-out, which for him was a result of hard work and diligent planning.

Turning to the global vaccine supply chain, Mr Hancock highlighted the need to broaden access; to remove tariffs where they apply; and to better share data on efficacy and trials. He stressed that this was a global effort, and therefore vaccine protectionism should be opposed.

You can read a full transcript for his speech here.

House of Lords – Written Question, 09 March

Wera Hobhouse (Liberal Democrat, Bath): To ask the Chancellor of the Exchequer, what assessment he has made of the adequacy of levels of funding provided to community pharmacy owners during the COVID-19 outbreak.

House of Commons – Written Answer, 09 March

Sarah Owen (Labour, Luton North): To ask the Secretary of State for Health and Social Care, what plans he has to allocate additional funding to community pharmacies to help them cover costs incurred as a result of the COVID-19 outbreak.

Jo Churchill (Conservative, Bury St Edmunds): Discussions are ongoing with the Pharmaceutical Services Negotiating Committee about additional funding for costs incurred during the COVID-19 pandemic. As well as the increased advance payments, general COVID-19 business support has been accessible to most community pharmacies, including the Retail, Hospitality and Leisure Grant and business rate relief. Additional payments have been made to support opening hours on Bank Holidays, social distancing and the medicine delivery service to shielded patients. Personal protective equipment (PPE) is provided free of charge and pharmacies are reimbursed for PPE already purchased. Non-monetary support provided during the pandemic included the removal of some administrative tasks, flexibility in opening hours and the delayed introduction of new services.

Call for Written Evidence: “Post Brexit and Post COVID Reviews and Consultations-are we going far and fast enough?”
APPG on Access to Medicines and Medical Devices, 08 March

COVID and Brexit have both accelerated change in the access to medicines and medical devices space. The Life Sciences industry, patients and other stakeholders involved in the access agenda have an opportunity to put medicines and medical devices high up on the Government’s agenda to achieve a long-term resilient, sustainable health and care system in which they play a fundamental part.

In parallel, NICE and the MHRA have both been looking at how to improve their own processes, and how these can be streamlined. The APPG is therefore calling for evidence on the changes being proposed as part of this review, at a strategic rather than operational level. Ultimately, the APPG is seeking to answer the following question: ‘Are we going far enough and fast enough to keep pace with the changes in the health and care environment we face post Brexit and post COVID.’

This call for written evidence will therefore be conducted in three parts:

  • Part A: NICE – a three part consultation for change (responses by 24 March 2021)
  • Part B: MHRA – a new role as an international regulator (responses by 12 April 2021)
  • Part C: Government – a White Paper: Integration and Innovation (responses by 10 May 2021)

The APPG is seeking responses to Part A by Wednesday 24 March 2021, and the second and third parts of the call for evidence will follow.

House of Commons – Written Answer, 08 March

Kate Hollern (Labour, Blackburn): To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential merits of waiving the repayment of the £370 million allocated to community pharmacies during the COVID-19 outbreak.

Jo Churchill (Conservative, Bury St Edmunds): Discussions are ongoing with the Pharmaceutical Services Negotiating Committee (PSNC) on additional funding for costs incurred during the COVID-19 pandemic. The PSNC has proposed that the £370 million increased advance payments are not paid back to cover the COVID-19 costs incurred by community pharmacies. That proposal is being looked at as part of the Government’s ongoing assessment of COVID-19 costs incurred by the sector.

Free rapid tests for all businesses for regular workplace testing
Department of Health and Social Care, 06 March

All businesses in England are now able to sign up to the Government’s free COVID-19 workplace testing programme. As part of the Government’s roadmap to cautiously lift restrictions, businesses of all sizes, including those with fewer than 50 employees, can register to order free lateral flow tests for their employees.

An online portal has been launched for businesses to find out more about offering rapid workplace testing. Businesses will be provided with all the information they need to plan and deliver their testing programme, along with promotional materials.

All local authorities in England are now offering rapid lateral flow testing for small businesses if they can’t offer rapid workplace testing. Businesses can find their local test site online.

You can read the full press release here.

 

Full Coverage

COVID-19: UK rejects ‘completely false’ EU vaccine export ban claim
BBC News, Gavin Stamp, 09 March

A fresh row has broken out between the UK and the EU after the bloc’s most senior official suggested the UK had banned all COVID-19 vaccine exports.

Charles Michel, the President of the European Council, wrongly claimed the UK had an “outright ban” on exports of vaccines produced on its soil.

The BBC understands Foreign Secretary Dominic Raab has written to him to say the claims are “completely false”.

An EU representative has been summoned for “further discussions”.

It is the second time since the start of the year that the UK and EU have been at loggerheads over the issue of the production and distribution of coronavirus vaccines.

In January, the EU introduced a new system of controls on vaccine exports amid concerns over availability of supplies on the continent, requiring producers to seek permission from national governments for planned sales.

The move sparked a wider row with the UK about the functioning of post-Brexit trade arrangements relating to Northern Ireland agreed by the two sides last year.

The EU drafted regulations which would have overridden the Northern Ireland Protocol and allowed it to potentially stop vaccines bound for Northern Ireland – although it backed down following widespread criticism.

The bloc’s leaders have been under pressure over the slow rollout of COVID-19 vaccines on the continent, compared with the UK, where 22.5 million people – a third of the adult population – have received their first dose.

Earlier this month, Italy blocked a shipment of 250,000 doses of Oxford-AstraZeneca vaccine to Australia.

In his weekly briefing note, Mr Michel – who represents the bloc’s 27 members – said he was shocked when he heard the EU being accused of “vaccine nationalism” as the bloc had “never stopped exporting”.

“Here again, the facts do not lie,” he wrote.

“The United Kingdom and the United States have imposed an outright ban on the export of vaccines or vaccine components produced on their territory.

“But the European Union, the region with the largest vaccine production capacity in the world, has simply put in place a system for controlling the export of doses produced in the EU.”

In response, the BBC understands Mr Raab has written to Mr Michel to “set the record straight”, expressing concern that the “false claim has been repeated at various levels within the EU and the Commission”.

His letter is understood to say: “The UK government has not blocked the export of a single COVID-19 vaccine or vaccine components. Any references to a UK export ban or any restrictions on vaccines are completely false.”

He added: “We are all facing this pandemic together.”

After news of the row broke, Mr Michel tweeted that there were “different ways of imposing bans or restrictions on vaccines/medicines”.

The EU has faced production problems with three leading vaccines.

The rollout of the Pfizer-BioNTech vaccine was delayed in some countries because of a temporary reduction in deliveries, to enable Pfizer to increase capacity at its processing plant in Belgium.

Distribution of the Moderna jab also ran into problems, with Italy and France both saying they were receiving fewer vaccines than expected.

The Oxford-AstraZeneca vaccine has been in short supply within the EU as well, with production shortfalls at plants in Belgium and the Netherlands.

The UK, which is expected to have a large surplus of vaccines after ordering 400 million doses, has said it will donate most of those left over to poorer countries.

The UK, which left the EU in January 2020, is one of the leading financial backers of the Covax scheme, which aims to ensure vaccines are shared fairly among all nations, rich and poor.

France’s President Emmanuel Macron has said richer countries should send up to 5% of their current vaccine supplies to poorer nations.

Media Summary

Grace period on supermarket agri-food to continue to October

Belfast Telegraph, Michael McHugh, 03 March 2021

The Belfast Telegraph reports that the British Government has unilaterally said the grace period for post-Brexit supermarket agri-food movements from the rest of the UK to Northern Ireland will continue until October. Certification requirements will then be introduced in phases alongside the rollout of a digital assistance scheme, Northern Ireland Secretary Brandon Lewis added.

Businesses in Northern Ireland have been pressing for an extension to avoid a cliff-edge plunge into extra bureaucracy linked to the Northern Ireland Protocol. Mr Lewis said: “These recognise that appropriate time must be provided for businesses to implement new requirements, and support the effective flow of goods between Great Britain and Northern Ireland.”

The first of the grace periods had been due to expire at the end of March. Should the grace period have finished at the end of this month, export health certificates for all shipments of animal products would have been required. Read more in Reuters.

However, according to ITV News, the EU is claiming that extending this grace period without any consultation breaks international law, with European Commission Vice-President Maros Sefcovic saying the UK is in violation of its post-Brexit obligations. Westminster has defended its decision as the minimum step necessary, with Cabinet member Lord David Frost saying the UK’s intervention should allow time for constructive discussions with counterparts in Brussels. Read more on LBC.

 

Pharmacist jailed for selling £1m of controlled drugs on black market

Chemist+Druggist, Aleks Phillips, 03 March 2021

C+D reports that a West Midlands pharmacist who illegally sold “hundreds of thousands” of prescription-only medicines (POMs) on the black market has been sentenced to 12 months in prison.

Balkeet Singh Khaira pleaded guilty to five counts of supplying controlled class C drugs on 09 February at Birmingham Crown Court, where he was sentenced on 02 March.

Following an investigation by the MHRA and West Midlands Police, it was discovered that Mr Khaira had made over £59,000 by illegally selling drugs from his mother’s West Bromwich pharmacy between 2016 and 2017.

Investigators found records at the pharmacy showing that, of hundreds of thousands of doses of diazepam, nitrazepam, tramadol, zolpidem and zopiclone purchased from wholesalers, only a small percentage had been dispensed against prescriptions. This left more than 800,000 pills unaccounted for, which Mr Khaira later admitted he had sold to drug dealers.

 

Parliamentary Coverage

Oral Statement to Parliament: Budget Speech 2021

HM Treasury and The Rt Hon Rishi Sunak MP, 03 March 2021

Yesterday Chancellor Rishi Sunak delivered his Budget 2021 speech. Below you will find some of the key takeaways, and the full transcript of the speech can be accessed here.

Vaccine rollout

A number of measures were announced to further bolster the UK’s vaccine-related capabilities, including:

  • An extra £1.65 billion cash injection to ensure the COVID-19 vaccination rollout in England continues to be a success.
  • £28 million to increase the UK’s capacity for vaccine testing, support for clinical trials, and to improve the UK’s ability to rapidly acquire samples of new variants of COVID-19.
  • £22 million for a world-leading study to test the effectiveness of combinations of different COVID-19 vaccines.

Community pharmacy funding

Ahead of yesterday’s Budget, the PSNC had called on the Chancellor to intervene in the ongoing COVID-19 funding negotiations and ensure that pharmacies do not have to pay back any of the £370 million in emergency loans they received last year.

The Budget being delivered with no mention of the sector, PSNC Chief Executive Simon Dukes said the fact that the Government failed to commit to covering pharmacy’s COVID costs was “exasperating and disappointing”.

Health and social care funding

Many industry stakeholders expressed their disappointed at the lack of extra funding for the NHS given the significant backlog of care. The NHS England budget will in fact be cut in cash terms, by around £9bn in 2021-22. With social care reforms due later this year, no funding was announced for this part of the sector, despite experts highlighting the need for urgent financial support.

Chair of the Health & Social Care Select Committee Jeremy Hunt MP tweeted that there was little hope for the social care sector, which was “bruised and demoralised”. He added that the sector desperately needed to know a plan was coming.

Nuffield Trust Chief Executive Nigel Edwards also responded, saying that the Chancellor will need to go further in his pledge to give the NHS what it needs to deal with the aftermath of the pandemic. He added that structural reform, short-term funding and support were critical for the social care sector.

Richard Sloggett, Founder and Programme Director of Future Health, also commented that the lack of reference to health and social care was disappointing given the level of recovery needed.

Read more in The Financial Times.

Innovation/life sciences funding

The Government will commit £375m to the UK-wide ‘Future Fund: Breakthrough’, which will invest in R&D-intensive industries such as life sciences. The new initiative will involve Government money being matched by private sector venture capital, and targets highly innovative companies that are aiming to raise at least £20 million of funding.

The ABPI noted the recognition awarded to innovative companies in the life sciences industry, and welcomed the measures introduced to attract more cutting-edge investment to the UK.

Northern Ireland

The Chancellor announced that almost half of the £400 million New Deal for Northern Ireland funding has been allocated, subject to business cases, to: new systems for supermarkets and small traders to manage new trading arrangements; building greater resilience in medicine supply chains; promoting Northern Ireland’s goods and services overseas; and supporting skills development.

Freeports

In a bid to boost post-Brexit investment and trade, the Chancellor unveiled the creation of freeports – areas within a country that are legally designated as outside its borders, and as such follow different tax and customs rules. Goods imported into this free trade zone may be exempt from tariffs, unless they subsequently cross the border into the host country.

The creation of eight new freeports, including in Teesside, Humber and Plymouth, has been confirmed. Seven seaports – including Felixstowe, Liverpool, Solent and Thames – and East Midlands airport also won freeport status, with talks continuing over potential sites in Scotland, Wales and Northern Ireland.

Experts have argued that the EU, and in particular its state aid rules, have limited the potential benefits from freeports. Freeports within the EU are seen as much narrower than others globally, such as Singapore. Read more in The Telegraph.

 

Continuation of the Scheme for Temporary Agri-Food Movements to NI for Authorised Traders Moving Agri-Food Goods from GB to NI

Department for Environment, Food & Rural Affairs, 03 March 2021

The UK Department for Environment, Food & Rural Affairs (DEFRA) has issued guidance and correspondence on the continuation of the Scheme for Temporary Agri-food Movements to Northern Ireland (STAMNI) arrangements for Authorised Traders beyond 31 March 2021.

This means Authorised Traders can continue to move products of animal origin, composite products, food and feed of non-animal origin and plants and plant products from Great Britain to Northern Ireland without the need for official certification (such as export health certificates, phytosanitary certificates or marketing standards certification).

The STAMNI arrangements will continue to be in place until at least 01 October 2021, after which there will be a phased introduction of certification requirements for authorised traders.

View DEFRA guidance on the continuation of the STAMNI arrangements for authorised traders moving agri-food goods from Great Britain to Northern Ireland on the HDA website here.

View a letter from Secretary of State for Environment, Food and Rural Affairs, the Rt Hon George Eustice MP, regarding the continuation of the arrangements on the HDA website here.

 

Vaccination plans for community pharmacy COVID vaccination sites for weeks of 8 March to 29 March 2021

Ed Waller, Director for Primary Care Strategy and NHS Contracts, 02 March 2021

In a letter to community pharmacy COVID-19 vaccination sites, Ed Waller describes forthcoming vaccine supply for first doses, providing advanced notification of a substantial increase in the volume of vaccine available, and the need to use it quickly to prevent wastage.

 

Full Coverage

 

Grace period on supermarket agri-food to continue to October

Belfast Telegraph, Michael McHugh, 03 March 2021

The British Government has unilaterally said the grace period for post-Brexit supermarket agri-food movements from the rest of the UK to Northern Ireland “will continue” until October.

Certification requirements will then be introduced in phases alongside the rollout of a digital assistance scheme, Northern Ireland Secretary Brandon Lewis added.

Businesses in Northern Ireland have been pressing for an extension to avoid a cliff-edge plunge into extra bureaucracy linked to the Northern Ireland Protocol.

Mr Lewis said: “As part of the pragmatic and proportionate implementation of the Northern Ireland Protocol, the Government is taking several temporary operational steps to avoid disruptive cliff edges as engagement with the EU continues through the Joint Committee.

“These recognise that appropriate time must be provided for businesses to implement new requirements, and support the effective flow of goods between Great Britain and Northern Ireland.”

Checks on goods at Northern Ireland’s Irish Sea ports were agreed between Northern Ireland and the EU, to avoid a hard border on the island of Ireland and keep the region following the bloc’s trade rules.

That has caused some disruption to Irish Sea trade and prompted a backlash from unionists who fear it threatens Northern Ireland’s place in the UK internal market.

Mr Lewis said: “For supermarkets and their suppliers, as part of the operational plan the UK committed to at the UK-EU Joint Committee on February 24, the current Scheme for Temporary Agri-food Movements to Northern Ireland (STAMNI) will continue until October 1.

“Certification requirements will then be introduced in phases alongside the rollout of the Digital Assistance Scheme.”

He said further guidance will be provided later this week on parcel movements from Great Britain to Northern Ireland, to provide necessary additional time for traders beyond April 1.

“Guidance will also be set out to help address practical problems on soil attached to the movement of plants, seeds, bulbs, vegetables and agricultural machinery.”

The first of the grace periods had been due to expire at the end of March.

Supermarkets would have had to produce Export Health Certificates for all shipments of animal products.

Under the terms of the protocol, which governs the movement of goods in and out of the region post-Brexit, all non-prohibited agri-food goods arriving from GB require an EU export health certificate (EHC) declaring that they pose no risk.

They are a consequence of a Brexit deal that has resulted in Northern Ireland remaining in the EU single market for goods, while the rest of the UK has left that regulatory zone.

There are hundreds of different types of EHCs, with different forms for different products – and some products having multiple certificate versions.

The DUP is aiming to undermine the Northern Ireland Protocol.

The party’s Stormont Agriculture Minister, Gordon Lyons, sparked controversy on Friday night when he announced he had ordered officials to halt work on planned permanent facilities to carry out inspections on goods from Great Britain.

Rival politicians have accused Mr Lyons of stunt politics and have insisted he does not have the authority to act unilaterally on issues considered significant or controversial.

Sinn Fein, the SDLP and Alliance parties have made clear such decisions can only be taken by the Executive as a whole.

 

Pharmacist jailed for selling £1m of controlled drugs on black market

Chemist+Druggist, Aleks Phillips, 03 March 2021

A West Midlands pharmacist who illegally sold “hundreds of thousands” of prescription-only medicines (POMs) on the black market has been sentenced to 12 months in prison.

Balkeet Singh Khaira (registration number 2069004), 37, of Sutton Drive, Sutton Coldfield, pleaded guilty to five counts of supplying controlled class C drugs on February 9 at Birmingham Crown Court, where he was also sentenced yesterday (March 2).

Following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) and West Midlands Police, it was discovered that Mr Khaira had made over £59,000 by illegally selling drugs from his mother’s West Bromwich pharmacy between 2016 and 2017.

His mother was not involved in any of the criminal activity, the MHRA said.

Investigation

Investigators found records at the pharmacy showing that, of hundreds of thousands of doses of diazepam, nitrazepam, tramadol, zolpidem and zopiclone purchased from wholesalers, only a small percentage had been dispensed against prescriptions. This left more than 800,000 pills unaccounted for, which Mr Khaira later admitted he had sold to drug dealers.

Mr Khaira claimed that while he had initially made a voluntary sale to drug dealers, he was subsequently “forced” into selling on more medicines after being “threatened outside of his pharmacy”, the MHRA said.

Previously, when he had been contacted about the investigation by the General Pharmaceutical Council (GPhC), Mr Khaira pretended to be his mother and said he was “shocked and blindsided” by the accusations, according to the MHRA. He then went on to provide falsified evidence, it said. He was suspended from the GPhC register under an interim order while waiting for the case to come to trial.

Grant Powell, Lead MHRA Enforcement Officer for the case, said: “Anyone who sells medicines illegally could be exploiting vulnerable people and clearly has no regard for their health or welfare.

“Prescription only medicines are potent and should only be taken under medical supervision.”

West Midlands Police declined to comment.

Media Summary

The UK’s speedy COVID-19 vaccine rollout: surprise success or planned perfection?
The Conversation, Sarah Schiffling & Liz Breen, 25 February

In an opinion ediotrial, The Conversation reports that the UK is one of the world’s front runners when it comes to vaccine coverage. The article reports that in December it became the first country to start administering a fully trialled and tested COVID-19 vaccine to its citizens. Since then, more than 18 million people in the UK have received a first vaccine dose, with over 600,000 second doses also being administered.

One reason for the success in rolling out the jab, the article suggests, is that British negotiators demonstrated a strong understanding of the medicines supply chain. The UK contract with AstraZeneca, for example, contains a commitment by the pharma firm that the British supply chain “will be appropriate and sufficient” for the supply of the doses the country purchased. If its supply chain were to be insufficient at any point, AstraZeneca would need to cover any shortfall from elsewhere in its global network. The EU contract does not contain an equivalent clause.

However, clever procurement alone does not account for the success of the UK’s vaccine rollout. The Conversation praises the collaborative effort of different organisations and individuals, coming together and using their strengths and existing capabilities to make the rollout as quick and efficient as possible. The UK strategy has been paired with an excellent distribution network, reports the article. The centralised structure of the NHS has offered an ideal platform for planning and coordination; but a varied and localised system of delivery has ensured the rollout has been effective. The diverse network of vaccination sites has made distribution more challenging, with supplies needing to be split among the sites without any one location running out unexpectedly or doses going to waste. Effective planning and stock management have been critical, which, explains the article, is why experienced medicines distributors have been brought in to make sure that supplies can be delivered continually.

 

Parliamentary Coverage

Meeting of the Withdrawal Agreement Joint Committee: 24 February 2021
Michael Gove MP, Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, Written Statement, 25 February

Cabinet Minister Michael Gove has released a written statement, after the European Union and the United Kingdom held the first meeting of the Withdrawal Agreement Joint Committee following the end of the transition period on 24 February.

The statement highlights that the parties welcomed the progress made on citizens’ rights in recent weeks in implementing the rights of UK nationals in the EU and EU citizens in the UK under the Withdrawal Agreement, and reiterated the importance of communication and support to the most vulnerable.

Further to the meeting of the Joint Committee co-chairs on 11 February 2021, the EU and the UK also took stock of the implementation of the Protocol on Ireland and Northern Ireland and of work to find pragmatic solutions. The parties acknowledged the importance of joint action to make the Protocol work for the benefit of everyone in Northern Ireland. In that spirit, the EU and UK reiterated their full commitment to the Good Friday (Belfast) Agreement in all its dimensions, and to the proper implementation of the Protocol. Building on the recent outreach by the Joint Committee co-chairs, there would be further joint engagement with business groups and other stakeholders in Northern Ireland. The UK and the EU underlined their shared commitment to giving effect to those solutions agreed through the Joint Committee on 17 December 2020, without delay. The UK noted that it would provide additional investment in digital solutions for traders in accordance with the Protocol.

Noting the need for ongoing engagement and the shared desire to act at pace, the UK and EU agreed that a further Joint Committee would be held to provide further steers and where appropriate approvals, and would liaise on timings.

You can find the statement here.

 

Full Coverage

The UK’s speedy COVID-19 vaccine rollout: surprise success or planned perfection?
The Conversation, Sarah Schiffling & Liz Breen, 25 February

The UK’s COVID-19 response has been criticised severely. Britain is among the countries with the highest number of recorded COVID-19 cases and deaths. But with its vaccination campaign, its fortunes seem to have turned.

The UK is one of the world’s front runners when it comes to vaccine coverage. On December 8 2020, it became the first country to start administering a fully trialled and tested COVID-19 vaccine to its citizens. Since then, more than 18 million people in the UK have received a first vaccine dose, with over 600,000 second doses also being administered.

The UK government has pledged that all adults will be offered a vaccine before the end of July. This would be a huge achievement less than eight months after vaccinations began. Initially, this deadline was late autumn, which demonstrates the success of Britain’s initiative to date. The speedier rollout of the vaccine raises hopes for a swifter end to restrictions. Unsurprisingly, rollout so far has been termed a “rare pandemic success”. Here’s how it’s been achieved.

Keeping up supply

The UK government’s end-of-July vaccination target looks achievable, and by maintaining an average speed of 2.9 million vaccinations per week – which is what has been achieved so far – the entire UK adult population could receive both doses by late September. Reaching and maintaining this pace requires consistent vaccine supplies, and the key to this lies in the supply chain.

Supply shortages have plagued vaccine rollouts around the world. A prominent example has been the dispute between the EU and AstraZeneca. The manufacturer drastically cut deliveries of its vaccine, citing production issues.

While the UK and the EU signed broadly similar contracts with AstraZeneca, British negotiators demonstrated a better understanding of the supply chain. The UK contract contains a commitment by AstraZeneca that the British supply chain “will be appropriate and sufficient” for the supply of the doses the country purchased. If its supply chain were to be insufficient at any point, AstraZeneca would need to cover any shortfall from elsewhere in its global network. The EU contract does not contain an equivalent clause.

Committing early to contracts with suppliers has been another positive in the UK’s vaccine procurement, as has the willingness to invest. The UK has spent £11.7 billion on purchasing, manufacturing and deploying COVID-19 vaccines as well as on vaccine research. Kate Bingham, the former chair of the UK COVID-19 vaccine task force, has highlighted that her purchasing strategy focused on which vaccines were being developed quickly rather than cost.

The UK now finds itself in the position of having secured access to seven vaccine candidates and potentially many more doses than it needs. It has already ordered enough doses of the vaccines currently authorised to cover its population. As additional vaccines are approved, its supplies will grow further still.

Manufacturing capacity has been the subject of long-term investment from the British government too. As a result, manufacturing infrastructure was already in place at the beginning of the pandemic and could be scaled up quickly, which resulted in three vaccines being made in the UK, giving ready access to supplies. Quickly kickstarting manufacturing also gave Britain the chance to iron out any production glitches early on; the EU has instead had to resolve these more recently, denting its supplies.

Long-term research investment has also helped. The UK, unsurprisingly, was at the front of the queue for the vaccine developed by the University of Oxford with AstraZeneca, and has ordered more of this one than others. Oxford scientists had already been researching a vaccine that could be used against a disease like COVID-19. Ready access to large stocks of a working vaccine is somewhat down to research investment that stretches back years.

Planning the distribution

But early investment and clever procurement alone do not account for the success of the UK’s vaccine rollout. They are paired with an excellent distribution network. The centralised structure of the NHS has offered an ideal platform for planning and coordination; but a varied and localised system of delivery has ensured the rollout has been effective.

In England alone there are more than 1,500 vaccination sites. These consist of GP surgeries and community pharmacies at the smaller end through to hospital hubs and mass vaccination centres established in sports centres, race courses and showgrounds. While the larger vaccination hubs offer speedy inoculations for many, the smaller community-based services ensure that access is broad.

This diverse network of vaccination sites does make distribution more challenging. Supplies need to be split among the sites without any one location running out unexpectedly or doses going to waste. Effective planning and stock management is critical, and for this reason, experienced medicines distributors have been brought in to make sure that supplies can continually be delivered.

Indeed, this is part of a wider effort to bundle together the strengths of different organisations and individuals and using their existing capabilities to make the rollout as quick as possible. For instance, alongside industry experts, military logistics planners and personnel have been drafted in to help with distribution.

The COVID-19 vaccine rollout is an unprecedented logistical effort. The UK is currently handling this challenge better than many other countries, which could well learn from it. However, after the high burden of deaths, illness, repeated lockdowns and economic damage, the pressure on the UK to maintain the speed of its rollout is high. The country is still in lockdown, and hopes for an end to restrictions rest on its vaccination campaign’s success.

Media Summary

Brexit trade delays getting worse at UK border, survey finds
The Guardian, Lisa O’Carroll, 24 February

The Guardian reports that delays importing and exporting goods to and from the EU have worsened since Brexit was introduced at the start of the year and will result in stock shortages and price rises for consumers, according to a report. A survey of 350 supply chain managers found that 66% had experienced delays of “at least two to three days” getting goods into the UK, compared with 38% who reported delays in a similar survey in January.

A 24-page submission to the Scottish Parliament by the Association of the British Pharmaceutical Industry highlighted that “the lack of any transition period is one of the reasons for the practical difficulties,” in addition to the rapidly agreed deal which meant negotiators “ran out of time to address issues fully.”

In a separate submission to the Welsh Affairs Committee in the House of Commons, the ABPI warned of an “unnecessary duplicative requirement” to batch test medicines coming in from the EU from 2022 in Northern Ireland and into Great Britain from 2023. Unless a deal is struck, the current situation could mean delays of up to six weeks to get medicines to patients, the ABPI said.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Brexit trade delays getting worse at UK border, survey finds
The Guardian, Lisa O’Carroll, 24 February

Delays importing and exporting goods to and from the EU have worsened since Brexit was introduced at the start of the year and will result in stock shortages and price rises for consumers, according to a report.

A survey of 350 supply chain managers found that two out of three had experienced delays of “at least two to three days” getting goods into the UK, compared with 38% who reported delays in a similar survey in January.

A third of this group said the delays were “significantly longer” than in January, 28% said “slightly longer” and 15% reported delays of a similar length to January. Just 18% of those surveyed by the Chartered Institute of Procurement & Supply (CIPS) said they experienced no delays or fewer delays.

The situation was only slightly better for exports, with 44% experiencing delays of at least two to three days getting goods into the EU.

The survey comes as one of the UK’s largest chemical producers, BASF, reveals it has experienced “substantial friction” from the new trade barriers caused by withdrawal from the EU.

In a submission to the Scottish parliament ahead of a committee hearing on Brexit on Thursday it said its biopesticide business “has not exported successfully from the UK during January”.

It said product losses had been high and the Department for Environment, Food and Rural Affairs had been unable to answer “standard phytosanitary questions the industry warned of over two years ago” with hold-ups resulting in “damaged and unusable” products reaching the customer.

It reported that drivers were being forced to sleep in their trucks for days at the UK-Irish border and lorry loads were being turned back from their journey to the EU because paperwork and mixed loads “seem to flummox port officials”.

And in an indication that Brexit is not a teething problem, it sad initial optimism about tariffs “has largely disappeared”.

“The lack of any transition period is one of the reasons for the practical difficulties,” in addition to the rapidly agreed deal which meant negotiators “ran out of time to address them [issues] fully,” it said in a 24-page submission by the Association of the British Pharmaceutical Industry.

In a separate submission to the Welsh Affairs Committee in the House of Commons, ABPI warned of an “unnecessary duplicative requirement” to batch test medicines coming in from the EU from 2022 in Northern Ireland and into Great Britain from 2023.

Unless a deal is struck, the current situation could mean delays of up to six weeks to get medicines to patients, the ABPI said.

Dr John Glen, a CIPS Economist and Visiting Fellow at the Cranfield School of Management, said: “We are well into the second month of the new arrangements and the hope that delays at the border would reduce as freight volumes returned to normal and customs systems became used to the new processes has not come to pass.”

He added: “The knock-on impact of these delays will trickle far down the supply chain and ultimately result in stock shortages and inflated prices for consumers.”

Almost half said delays were caused by customs paperwork on both sides of the border.

Glen said business should brace for the delays to continue “for at least the next few months”, with an array of new checks being introduced in the second phase of the UK application of the Brexit deal on 1 April and 1 July.

A government spokesperson said the phased approach to import controls over three stages up until 1 July 2021 would “ensure traders and hauliers have sufficient time to adjust to new processes”.

It added that “the latest available data shows that overall freight volumes between the UK and the EU are back to their normal levels, thanks to the hard work put in by traders and hauliers to prepare for the end of the transition period” and that extensive support was available including a £20m SME Brexit support fund as well as webinars, helplines and guides for tailored information.

Media Summary

Sussex medicines firm takes production line abroad in white van to beat Brexit ban
The Guardian, Lisa O’Carroll, 21 February

The Guardian reports that a Sussex-based pharmaceutical company had to bundle its production line into a van and take it to the Netherlands to beat a Brexit medicines ban. The impromptu move secured the supply of an asthma drug for France, where the company, Mediwin, had a huge order book.

Lisa Cooke, Mediwin’s Finance Director, said the company – specialising in parallel importation and distribution – had been preparing for Brexit since the referendum but had not counted on an overnight block on wholesale distribution from the UK into EU member states. Under the EU single market freedoms known as “parallel distribution”, Mediwin was allowed to buy drugs from one member state and repackage them for another member state at lower prices.

“We had stockpiled supplies, particularly of Ventolin because it was being sold in huge quantities in France and we were getting anxious that we would run out,” she said. “So our production manager hired a van and took five machines – which was essentially one production line – to the Netherlands.”

Cooke added that while she hoped to replace the EU sales with UK custom over time, she had to slash production and work hours for staff in the UK, with the company planning for further financial investment abroad including in Spain and other EU countries.

 

Parliamentary Coverage

Letter from the Secretary of State for Wales, regarding the flow of pharmaceutical products between the UK and EU
Simon Hart MP, Secretary of State for Wales, 19 February

A letter from Simon Hart MP, Secretary of State for Wales, addressed to Stephen Crabb MP, Chair of the Welsh Affairs Committee, has been published. In the letter, Mr Hart addresses questions regarding the flow of pharmaceutical products between the UK and the EU.

The letter reiterates that Mr Hart hosted a roundtable with key Welsh businesses and representative organisations to discuss the UK-EU Trade and Co-operation Agreement (TCA) last December. The potential issue of the TCA not including reciprocal arrangements on medicines regulation was discussed at this meeting. Following this, officials from HM Revenue and Customs and other government departments have liaised closely with companies concerned to seek to resolve a range of issues relating to exporting medicines to the EU.

The letter also notes that the TCA does not include mutual recognition of regulatory regimes in relation to pharmaceuticals and medical devices, except for the mutual recognition of Good Manufacturing Practice certificates. Medicinal products are now regulated in the UK separately from the EU and companies must comply with the relevant requirements for the market in which the product will be sold. The UK has accepted some EU rules on medicines transitionally, for two years after the end of the Transition Period, ensuring continuity in the supply of medicines and to give industry time to adjust. However, companies must meet all EU requirements in full to continue to place medicinal products on the EU market.

You can read the letter in full here.

 

Full Coverage

Sussex medicines firm takes production line abroad in white van to beat Brexit ban
The Guardian, Lisa O’Carroll, 21 February

A Sussex pharmaceutical company has told how it had to bundle a production line into a white van and take it to Amsterdam to beat a Brexit medicines ban.

The impromptu four-wheeled mission to the Netherlands has secured the supply of the asthma drug Ventolin for France, where the company, Mediwin, had a huge order book.

Lisa Cooke, its Finance Director, said the company had been preparing for Brexit since the referendum but had not counted on an overnight block on wholesale distribution from the UK into EU member states.

“It was a bit of a white-knuckle ride a couple of weeks ago. We had stockpiled supplies, particularly of Ventolin because it was being sold in huge quantities in France and we were getting anxious that we would run out,” she said. “So our production manager hired a van and took five machines – which was essentially one production line – to the Netherlands. He got the line up and running. We’ve rented an apartment and got six people working over there now. And so far we’ve hired 15 people in the Netherlands and they want another 10 or 11.”

Under the EU single market freedoms known as “parallel distribution”, Mediwin was allowed to buy drugs for a range of conditions, including type 2 diabetes, glaucoma and atrial fibrillation, from one member state and repackage them for another member state at lower prices.

In a blow to the British company, production lines in Littlehampton are now at near standstill while assembly ramps up in the Netherlands. Further expansion will take place in Spain and other EU countries.

“To put things into context we usually receive around 75 pallets of stock a week – in January we have received two,” Cooke said.

She said while she hoped over time to replace the EU sales with UK custom, it had been heartbreaking to have to slash production and work hours for staff in the UK. “I’ve got about 70 people at the moment who I’ve had to ask to half their hours,” she said. “It has been horrible, absolutely horrible.”

The drastic measures are a reflection of the lack of preparation time pharma firms were given for the new Brexit rules. Other companies have also been hit by sudden trade barriers. Two weeks ago it emerged that a Welsh pharma company producing a cancer drug with a short shelf life had moved its production to Dublin to keep supplies going for patients across the EU.

Ian Price, the Director of the Confederation of British Industry in Wales, said the company, which did not want to be named, had to discard 200 to 300 consignments destined for the EU because of the new Brexit trade barriers.

Cooke said Mediwin was being forced to lay off 45 people in the UK. “We were going to invest in a site in the UK a couple of years ago we we needed to expand. That £2m investment has gone to Spain. We’ve got a fabulous new production facility which will come online in Barcelona, in two or three months time,” she said.

“Once we had the Brexit vote, we knew that we were in significant danger for a number of reasons, so our growth plans for the UK stopped almost immediately. We started investing in Barcelona. We have had to merge our main UK trading company with a Spanish group company to protect licences.”

The company had built up a booming trade in wholesale medicine supply, going from 19 employees 10 years ago, to a workforce of 150 in 2020.

Media Summary

There was no media coverage today.

 

Parliamentary Coverage

House of Commons – Written Answer – 15 February

William Wragg (Conservative, Hazel Grove): To ask the Secretary of State for Health and Social Care, what steps he is taking as a result of new customs arrangements to ensure that (a) the sight-preserving eye drops atropine and (b) other medicines sourced inside the EU are able to reach patients and clinical trial participants in the UK.

Jo Churchill (Conservative, Bury St Edmunds): Our priority is to ensure that patients continue to have access to the medicines and clinical trial supplies they need, including eye medicines such as atropine. We continue to work closely with the pharmaceutical industry, sponsors of clinical trials, 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, including sponsors of clinical trials, 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 with suppliers and sponsors to deliver our multi-layered approach to mitigate any potential disruption to supply of medicines into the UK, including supplies for clinical trials, now that the UK has left the EU Single Market and Customs Union.

The letter is available here.

 

Full Coverage

There was no media coverage today.

Media Summary

Government ‘miscommunicated’ PPE stock levels to pharmacies during first COVID-19 wave, MPs told
Pharmaceutical Journal, Carolyn Wickware, 10 February

Reporting on the Public Accounts Committee’s inquiry into government procurement and supply of PPE during the COVID-19 pandemic, the Pharmaceutical Journal highlights evidence given by the Healthcare Distribution Association. Indeed, the article references the HDA’s statement that centralised PPE stock for community pharmacy during the COVID-19 pandemic “faced considerable challenges”, with the lack of PPE for community pharmacy “overshadowed by the urgent issues faced by secondary care”.

Another key issue highlighted in the HDA’s evidence is that pharmacy staff was led to believe that wholesalers had “dramatically more” PPE in stock than was the case during the first wave of the COVID-19 pandemic. “This is to say, that the centralised PPE procurement for community pharmacy operated by Public Health England faced considerable challenges with low levels of stock availability and miscommunication by PHE [and NHS England and Improvement] that suggested that HDA members had dramatically more PPE stocks available than was actually the case,” the HDA explained.

In its evidence, the HDA also criticised the government’s “lack of transparency” around the early procurement of PPE, stating that “it was impossible for the HDA and members to offer their support in these efforts, as it was unclear what the government’s strategy was. At the beginning of the pandemic when the government signed high value contracts for PPE supply with companies who had little, if any, experience of procuring PPE, engaging healthcare distributors who have long-standing expertise in procuring products from around the world was seemingly not considered.”

 

Parliamentary Coverage

COVID-19: Government procurement and supply of Personal Protective Equipment
Public Accounts Committee, 10 February

The Public Accounts Committee has published its report into Government procurement and supply of Personal Protective Equipment. The report notes that shortages of personal protective equipment at the front-line in the first wave of the pandemic was one of the biggest concerns in March and April 2020. As well as NHS front-line workers there were others  who required high grade PPE – particularly in social care settings, which were mainly private businesses.

The report includes eight key conclusions and recommendations, which suggest that the need to quickly procure PPE opened up significant procurement risks. Government actions and interventions, such as the established ‘high-priority lane,’ were not designed well enough to mitigate against these risks, the report says. The report also notes that the Department of Health and Social Care’s focus on supporting hospitals meant assistance to social care providers was often neglected.

The summary of the report concludes that “the Department of Health and Social Care must develop a better understanding of the needs of both NHS organisations and, crucially, allied health and social care sectors – an issue this and predecessor committees have raised before the pandemic.”

The HDA submitted evidence to the inquiry that informed the final report, which can be found here.

You can read the full report here.

 

Future UK-EU relations: trade in goods
EU Goods Sub-Committee, 08 February

During a session of the EU Goods Sub-Committee on “Future UK-EU relations: trade in goods,” Peers heard from:

  • The Rt Hon Penny Mordaunt MP, Paymaster General, Cabinet Office;
  • Will Hayter, Director, Transition Task Force, Cabinet Office; and
  • Emma Churchill, Director General, Border and Protocol Delivery Group, Cabinet Office.

On the topic of border delays, Conservative Peer Baroness Verma asked about the evidence which showed the disruption at the border where 50% of UK-EU traders faced delays in the last few weeks. Ms Mordaunt said that the flow was similar to, if not exceeding, the figures from last year and this was considerable considering the pressures which businesses faced due to the pandemic. The worst-case scenario was that 30-50% of HGVs would not be ready, but this was not the case, she said.

On trader readiness, Ms Mordaunt said that the most challenging area was infrastructure, but good progress was made on this, and the impact of the pandemic on businesses and their ability to prepare was factored into the planning and this was part of the phased approach taken. Work had been done to understand the needs of businesses and for traders to understand their obligations.

You can watch the session here.

 

Full Coverage

Government ‘miscommunicated’ PPE stock levels to pharmacies during first COVID-19 wave, MPs told
Pharmaceutical Journal, Carolyn Wickware, 10 February

The Healthcare Distribution Association told the Public Accounts Committee that the centralised personal protective equipment stock for community pharmacy during the COVID-19 pandemic “faced considerable challenges”.

The government led pharmacy staff to believe that wholesalers had “dramatically more” personal protective equipment (PPE) in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association (HDA) has said.

In evidence given to the House of Commons Public Accounts Committee (PAC) for its report into the government procurement and supply of PPE during the COVID-19 pandemic, the HDA said the centralised PPE stock for community pharmacy “faced considerable challenges”.

The HDA’s comments follow a survey by the Royal Pharmaceutical Society in April 2020, which found that one in three pharmacists were unable to access continuous supplies of PPE.

The PAC report, published on 10 February 2021, said it had seen similar surveys indicating that “at least 30%” of frontline staff from across health and social care reported having insufficient PPE, with organisations left to buy supplies at “hugely inflated prices”.

“The PPE from central government was sometimes not usable and providers told us that emergency helplines referred them to suppliers which did not have PPE,” the report said.

It added that the government’s focus on supporting PPE provision to hospitals “meant assistance to social care providers was neglected”.

However, evidence submitted to the PAC by the HDA in December 2020 said the lack of PPE for community pharmacy was also “overshadowed by the urgent issues faced by secondary care”.

“This is to say, that the centralised PPE procurement for community pharmacy operated by Public Health England (PHE) faced considerable challenges with low levels of stock availability and miscommunication by PHE [and NHS England and Improvement] that suggested that HDA members had dramatically more PPE stocks available than was actually the case,” it explained.

The HDA had warned in May 2020 that its wholesaler members had “almost completely run out” of the PPE supplied by PHE for distribution to community pharmacies, which they had received the previous month.

Commenting on the report, a spokesperson for the Royal Pharmaceutical Society said it had ”called for pharmacists to have access to free PPE much earlier into the pandemic and they should not have had to fund their own supplies”.

“We’re pleased that community pharmacists are now eligible for free of charge PPE via the PPE Portal and we encourage all to apply. Those who had already paid for supplies themselves should also now be reimbursed.”

In its evidence, the HDA also criticised the government’s “lack of transparency” around the early procurement of PPE, stating that “it was impossible for the HDA and members to offer their support in these efforts, as it was unclear what the government’s strategy was”.

“At the beginning of the pandemic when the government signed high value contracts for PPE supply with companies who had little, if any, experience of procuring PPE, engaging healthcare distributors who have long-standing expertise in procuring products from around the world was seemingly not considered,” it said.

“Even when furnished with a priority cabinet office PPE email address, HDA member companies did not receive replies to their offer of using tried and tested supply capabilities.”

The PAC report found that between February and July 2020, the Department of Health and Social Care spent over £12bn on 32 billion items of PPE.

“Government had permission to procure equipment at pace and without tendering under the law, but acting fast did not give it licence to rip up record keeping on decisions,” said Meg Hillier MP, chair of the PAC.

“It did not publish contracts in time and kept poor records of why some companies won multi-million-pound contracts. The cost of emergency procurement — billions higher than the equivalent a year before — highlights how both its pandemic plan and supply of essential equipment were inadequate.

“Frontline workers were left without adequate supplies, risking their own and their families’ lives to provide treatment and care.”

A spokesperson for the Department of Health and Social Care said: “We have been working tirelessly to procure, produce and deliver PPE to over 58,000 settings, protecting our health and social care staff on the frontline of this pandemic.

“As the Public Accounts Committee recognises, the government faced significant challenges in having to rapidly procure PPE at pace in a competitive international market. Thanks to the combined effort of government, NHS, Armed Forces, civil servants and industry we have delivered over 8.1 billion items of PPE at record speed.

“We have a robust processes in place to ensure PPE meets the strictest safety and quality standards before being distributed to the frontline.”

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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