HDA UK Media and Political Bulletin – 31 March 2021

Media Summary

There was no media coverage today.

 

Parliamentary Coverage

Letter to medicines and medical products suppliers

Steve Oldfield, Chief Commercial Officer, Department of Health and Social Care, 30 March 2021

Steve Oldfield, Chief Commercial Officer at DHSC, has written to industry and the wider supply chain setting out the Government’s latest advice and guidance on supply of medical goods:

  • He said that they had not seen the level of disruption to supply that underpinned planning assumptions, but current levels of preparedness needed to be maintained for some months.
  • He noted the growing third wave in Europe and the likely impact here in the UK, with a “residual risk of COVID-19 impacting global borders”.
  • DHSC has asked NHS Supply Chain to maintain contingency stock in the centralised stock build for the foreseeable future and urged suppliers to continue to hold their UK stockpiles.
  • DHSC has committed to a review of these measures and will report back with recommendations during the summer.
  • The letter urges suppliers to continue preparations to be ready for the introduction of import controls in October 2021 and January 2022.
  • Meanwhile DHSC continues to work with all partners to address the challenges to supply into NI from 1 January 2022.

Challenges and opportunities for UK from new EU pharma policy

European Scrutiny Committee, 30 March 2021

The European Scrutiny Committee has asked the Government for a detailed response to EU plans which could have a significant impact on the way medicines are developed and marketed in the UK. The call for an explanation of the Government’s position comes in the latest regular report by the Committee which scrutinises proposed or new EU legislation that could have an impact on the UK.

The request for information from the Government follows the publishing of the EU’s new, wide-ranging strategy for the future of the pharmaceutical sector, adopted by the European Commission in November 2020. The aim of the strategy is to ensure that EU citizens have access to innovative and affordable medicines, as well as to support the competitiveness, innovative capacity and sustainability of the sector.

The four strands of the EU strategy are:

  • Reviewing and where necessary tailoring incentives, such as patent protections, to satisfy unmet medical needs – for example the need for new antibiotics.
  • Supporting competition and innovation in the sector, by for example simplifying legislation.
  • Focusing on resilience of supply and environmental sustainability.
  • Promoting regulatory convergence and international standards to encourage safe, high quality and affordable treatments globally.

In light of the new EU strategy, and the agreement by the UK and the EU to cooperate in the pharmaceutical sector, the European Scrutiny Committee has written to the Minister of State for Health, Edward Argar MP. The letter said the Committee required from the Minister an outline of the Government’s plans in response to the EU strategy.

The letter also asked:

  • What would be the risks or opportunities for the UK in the event of divergence between UK and EU approaches to pharmaceutical innovation.
  • What opportunities the Government sees for UK-EU research cooperation in the development of pharmaceutical products.
  • Whether the Government sees any benefits for the UK in encouraging other countries to strengthen their regulatory and intellectual property standards.
  • What the Government’s own ideas are for addressing unmet medical needs, ensuring accessibility and affordability of medicines, and promoting innovative, sustainable and patient-oriented pharmaceutical development.

Community pharmacy vaccine service launches

Northern Ireland Executive, 29 March 2021

On Monday Health Minister Robin Swann launched a new community pharmacy COVID-19 vaccination service in Northern Ireland. The new service will see almost 350 community pharmacies throughout Northern Ireland begin to administer the vaccine – at present this applies to those aged 50 years and over. This latest development follows the official opening of the COVID-19 vaccination centre at the SSE arena in Belfast earlier in the day.

Minister Swann said: “Community pharmacy teams have remained dedicated to providing the public with vital health care and support through what have been very challenging times. Pharmacists have a wealth of expertise, skills and experience which makes them very well-placed for delivering the COVID-19 vaccine. The addition of this new service will help speed up the roll-out of the existing programme by increasing capacity and local accessibility to vaccines for the general population, particularly for those who may find it more difficult to travel to one of the mass vaccination centres.”

 

Full Coverage

There was no media coverage today.

Media Summary

Moderna’s COVID vaccine to be rolled out in UK from April

The Financial Times, Jasmine Cameron-Chileshe, 28 March 2021

The Financial Times reports that the Government announced yesterday that Moderna’s Coronavirus vaccine will be rolled out in the UK from next month. Culture Secretary Oliver Dowden confirmed the jab made by the US company was expected to be administered by the NHS from April.

The UK has ordered 17m doses of the two-dose vaccine, which was approved by the MHRA in January and is 95 per cent effective in preventing the disease. It is the third Coronavirus vaccine to be rolled out in the UK after the BioNTech/Pfizer and Oxford/AstraZeneca jabs.

Despite recent concerns over supplies, the Government said it would be able to offer second doses within 12 weeks and remained confident in its ability to inoculate all adults by the end of July, Dowden told the BBC’s The Andrew Marr Show on Sunday.

It is hoped that the introduction of Moderna jabs next month will ease pressure on the supply of vaccines for under-50s, who have been warned that their inoculations could be delayed following delays in the delivery of the Oxford/AstraZeneca vaccine made by the Serum Institute of India.

This was reported in a number of outlets, including The Telegraph and the Evening Standard.

Britain ready to seal COVID vaccine deal with EU

The Times, Oliver Wright and Bruno Waterfield, 28 March 2021

The Times reports that Britain is close to striking a vaccine deal with the European Union under which the EU will remove its threat to ban the export of Pfizer-BioNTech jabs to Britain. In return the Government will agree to forgo some long-term supplies of the Oxford-AstraZeneca vaccine that had been due to be exported from Holland.

A European Commission spokesman said: “The discussions with the UK are ongoing. We do not have any comments to make at the moment on the content of those discussions. But as you know our common aim is to ensure that we have good co-operation in terms of supply chains in terms of producing the vaccine.”

Ministers have insisted that the delivery of second doses in the UK would still be carried out on schedule, even if planned shipments from a plant in the Netherlands were blocked. India has also halted the shipment of about five million Oxford-AstraZeneca doses due in the UK this month, resulting in the Government suspending plans to roll out first doses to under-50s.

This was reported in a number of outlets, including City A.M. and the Evening Standard.

EU medicines regulator approves new vaccine production sites

AP News, Editorial staff, 26 March 2021

AP News reports that the EU’s medicines regulator has approved new manufacturing sites for Coronavirus vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca in the Netherlands, Germany and Switzerland, in a move to boost Europe’s supply of the shots and speed vaccination efforts across the continent. The new approvals come amid the 27-nation bloc’s struggles to ramp up COVID-19 vaccination and repeated delivery delays and manufacturing problems.

The EMA also said it was granting “more flexible storage conditions” to the Pfizer-BioNTech vaccine, which was cleared on the basis that it needed ultra-cold freezer temperatures for storage and delivery. The approval “is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain,” the regulator said.

The approvals come after EU leaders failed to settle a fight about the distribution of COVID-19 shots among member states but pledged to strengthen vaccine export controls and production on EU soil amid a shortage of doses and spikes in new cases.

This was reported in a number of outlets, including Politico and Euronews.

50 to 64-year-olds added to 2021/22 flu programme

P3 Pharmacy, Pharmacy Magazine editorial staff, 26 March 2021

P3 Pharmacy reports that people aged 50 to 64 are expected to be included as an eligible cohort in the 2021/22 flu vaccination programme according to NHS England & Improvement’s latest Primary Care Bulletin. It advises that the flu reimbursement letter is currently being updated to reflect the inclusion and will be republished imminently.

Pharmacy providers are asked to await the updated flu reimbursement letter for more information, before amending their orders for vaccines. The 50-64 age group was included for the first time in the 2020/21 programme as a measure to help reduce the impact of COVID-19.

 

Parliamentary Coverage

House of Commons Question – 26 March 2021

Mr Steve Baker (Conservative, Wycombe): To ask the Secretary of State for Health and Social Care, if he will publish an updated timetable for the estimated (a) regulatory approval and (b) delivery to the NHS of the (i) Novavax and (ii) Johnson & Johnson COVID-19 vaccines; and if he will make a statement.

Nadhim Zahawi (Conservative, Stratford-on-Avon): Reviews are underway by the Medicines and Healthcare products Regulatory Agency (MHRA) to assess the Johnson & Johnson (known by Janssen in Europe) and Novavax vaccines. Any vaccines that are made available will have been authorised because they pass the MHRA’s tests on safety and efficacy. If and when those vaccines are authorised by the MHRA, we expect to receive the doses for both vaccines in the second half of this year.

House of Commons Question – 25 March 2021

Chi Onwurah (Labour, Newcastle upon Tyne Central): To ask the Secretary of State for Health and Social Care, whether he plans to write off the £ 370 million advance payments provided to community pharmacy owners to cover costs incurred during 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 part of its ongoing assessment of COVID-19 costs incurred by the sector, the Government will take account of the £370 million increased advance payments paid to community pharmacies.

The COVID-19 support package for community pharmacy also included general COVID-19 business financial support, funding for Bank Holiday openings, social distancing measures and the medicine delivery service to shielded patients and free personal protective equipment, as well as non-monetary support, including the removal of some administrative tasks, flexibility in opening hours and the delayed introduction of new services.

 

Full Coverage

Moderna’s COVID vaccine to be rolled out in UK from April

The Financial Times, Jasmine Cameron-Chileshe, 28 March 2021

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

This was reported in a number of outlets, including The Telegraph and the Evening Standard.

Britain ready to seal COVID vaccine deal with EU

The Times, Oliver Wright and Bruno Waterfield, 28 March 2021

Britain is close to striking a vaccine deal with the European Union that will remove the threat of the bloc cutting off supplies.

After a week of frantic behind-the-scenes diplomacy the two sides are expected to seal an agreement as soon as this weekend under which the EU will remove its threat to ban the export of Pfizer-BioNTech jabs to Britain. In return the Government will agree to forgo some long-term supplies of the Oxford-AstraZeneca vaccine that had been due to be exported from Holland.

Senior diplomatic sources said the secret talks, which began last Saturday conducted by the former EU Ambassador Sir Tim Barrow, had helped restore trust despite the public rhetoric.

Two sources said the decision to use Barrow rather than Lord Frost, the minister responsible for EU relations, had been key to unlocking a deal.

“For us it was very significant that Johnson did not use Frost but instead went through the Foreign Office,” said one EU diplomat. “It showed that he was really serious about finding a compromise and trying to build trust.”

Barrow was dispatched to Brussels hours after the Government was forced to admit just over a week ago that it would have to delay extending the UK’s vaccination programme to the under-50s because of a shortfall.

On Wednesday the two sides issued a joint statement saying they were working to “ensure a reciprocally beneficial relationship between the UK and EU on COVID-19”.

In a call with President Biden, Boris Johnson is said to have emphasised that “global access to vaccines will be key to defeating the pandemic”.

France’s Foreign Minister claimed yesterday that because of supply shortages, Britain would struggle to source second doses for those who have already had their first. In provocative comments Jean-Yves Le Drian claimed that the UK programme had been over-optimistic about supplies. He suggested on France Info radio that the EU should not help Britain with a problem of its own making. “The UK is proud to have vaccinated many people with the first dose, but they will have a problem with the second dose,” he said.

“We can’t accept any sort of blackmail. The UK is pushing for the first jab, knowing there will be problems with the second one. Europe does not have to pay the price for this policy.”

Ministers have always insisted that the delivery of second doses in the UK would still be carried out on schedule, even if planned shipments from a plant in the Netherlands were blocked.

India has also halted the shipment of about five million Oxford-AstraZeneca doses due in the UK this month. This resulted in the Government suspending plans to roll out first doses to under-50s.

According to the UK Government’s latest data, 55 per cent of adults aged over 18 have received a first jab and 5.3 per cent have had a second dose. Johnson said that the UK had sufficient supplies to ensure that people would be given their second jabs on time. “We will have the second doses that people need within the 12-week window, which means around 12 million people in April,” he said.

A European Commission spokesman said: “The discussions with the UK are ongoing. We do not have any comments to make at the moment on the content of those discussions. But as you know our common aim is to ensure that we have good co-operation in terms of supply chains in terms of producing the vaccine.”

A study of more than 200 healthcare workers has found that people infected with COVID-19 produced six times the immune response after a single dose of the Pfizer vaccine. The research looked at antibodies and T-cells, which can lessen symptoms.

The study, a pre-print version of which is on The Lancet website, was led by Oxford and Sheffield universities and backed by the Department of Health. It suggests that being infected is similar to receiving the first jab in priming the immune system. However, its authors cautioned that people who have had COVID-19 should still get two doses to ensure long-lasting protection.

Over-70s and frontline health and social care workers will start to receive booster jabs from September under plans revealed last night by Nadhim Zahawi, the Vaccines Minister.

This was reported in a number of outlets, including City A.M. and the Evening Standard.

EU medicines regulator approves new vaccine production sites

AP News, Editorial staff, 26 March 2021

The European Union’s medicines regulator on Friday said it has approved new manufacturing sites for Coronavirus vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca, in a move that could significantly boost Europe’s supply of the shots and speed vaccination efforts across the continent.

The European Medicines Agency said in a statement that it had approved sites in the Netherlands, Germany and Switzerland for the COVID-19 vaccines made by the companies.

The new approvals come amid the 27-nation bloc’s struggles to ramp up COVID-19 vaccination and repeated delivery delays and manufacturing problems.

The EMA said it had approved a factory in Leiden, the Netherlands, to make the active substance for AstraZeneca’s vaccine, bringing the number of such licensed sites to four.

The EU regulator said it was also giving the green light to a site in Marburg, Germany, to make both the active substance and completed vaccine developed by BioNTech and Pfizer.

In addition, the EMA said it was granting “more flexible storage conditions” to the Pfizer-BioNTech vaccine – which was cleared on the basis that it needed ultra-cold freezer temperatures for storage and delivery.

That approval “is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain,” the regulator said.

Last week, an expert committee at the EMA recommended new manufacturing lines at a facility in Visp, Switzerland for the Moderna Inc. vaccine.

These changes are “intended to scale up production capacity and increase supply of the vaccine for the EU market,” the regulator said.

All COVID-19 vaccines meant for use in the EU must have their manufacturing sites approved by the EMA after a regulatory evaluation.

On Thursday, EU leaders failed to settle a fight about the distribution of COVID-19 shots among member states but pledged to strengthen vaccine export controls and production on EU soil amid a shortage of doses and spikes in new cases.

At the end of the summit, the bloc’s 27 nations were still locked in a dispute over how an upcoming batch of 10 million doses could be allocated to narrow the vaccine gap between member states, and the leaders decided to push the talks to a future meeting of their ambassadors.

This was reported in a number of outlets, including Politico and Euronews.

50 to 64-year-olds added to 2021/22 flu programme

P3 Pharmacy, Pharmacy Magazine editorial staff, 26 March 2021

People aged 50 to 64 are expected to be included as an eligible cohort in the 2021/22 flu vaccination programme, according to NHS England & Improvement’s latest Primary Care Bulletin (March 24).

It advises that the flu reimbursement letter is currently being updated to reflect the inclusion and will be republished imminently.

Pharmacy providers are asked to await the updated flu reimbursement letter for more information, before amending their orders for vaccines.

The 50-64 age group was included for the first time in the 2020/21 programme as a measure to help reduce the impact of COVID-19.

Media Summary

France may be added to COVID red list regardless of risk to food supply

The Times, Graeme Paton, 25 March 2021

The Times reports that Boris Johnson yesterday confirmed that the Government was considering adding France to its “red list”, severely limiting direct travel from the country. He said the measures may have to be introduced “very soon” to prevent mutant strains of the virus being imported.

The Prime Minister admitted that the move could severely interrupt cross-Channel trade, with particular threats posed to the flow of food and medicines to the UK. Lorry drivers are likely to be exempt but will have to be tested when they enter the UK.

“There is a balance to be struck and what we don’t know is the exact state of the efficacy of the vaccines against the new variants and we have to balance that against the very serious disruption that is entailed by curtailing cross-Channel trade,” Johnson said.

This was reported in a number of outlets, including The Guardian and The Independent.

Coronavirus: EU and UK try to end row with ‘win-win’ on vaccines

BBC News, Editorial staff, 25 March 2021

BBC News reports that the UK and the European Union have said they are working together to improve their relationship, after weeks of tensions over COVID vaccine supplies. In a joint statement, they said they wanted to “create a win-win situation and expand vaccine supply for all”.

The European Commission earlier proposed tougher export controls on vaccines, amid tensions over supplies of the Oxford-AstraZeneca jab. Prime Minister Boris Johnson warned that “blockades” were not “sensible”.

The tougher export controls are most like to affect vaccine-exporting countries that have higher vaccination rates than the EU, such as the UK and US. The key criteria for the proposed regulations are “reciprocity” and “proportionality”.

The BBC’s Europe Editor, Katya Adler, suggests that while the tone of the EU-UK statement was positive, actual progress between the two sides has been described by an insider as “slow, cumbersome and difficult”, on both sides.

This was reported in a number of outlets, including The Financial Times and The Independent.

 

Parliamentary Coverage

Report – Beyond Brexit: food, environment, energy and health

European Union Committee, 23 March 2021

The European Union Lords Select Committee has published its 22nd report of the 2019-2021 session: Beyond Brexit: food, environment, energy and health. In this inquiry, the Committee examined aspects of the EU-UK Trade and Cooperation Agreement (TCA) that fall within the remit of the EU Environment Sub-Committee; exploring the provisions in the TCA, any challenges that arise and how they could be resolved, and where UK-EU relations should go from here.

The Committee recognised that many of the sectors analysed as part of the report – including the healthcare sector – benefit substantially from the tariff-free access to the EU market secured by the TCA, but will be affected in other ways. The report’s chapter dedicated to healthcare looks at a number of issues of relevance to the HDA and its member companies, including continuity of supply, mutual recognition procedures, and inspections:

  • Health Minister Edward Argar MP told the Committee that the TCA “delivers on reciprocal healthcare, delivers continuity of supply, and delivers on health security”.
  • Dr Richard Torbett, Chief Executive of the ABPI, told the Committee: “The fact that we will have a tariff-free flow of trade in medicines and active pharmaceutical ingredients, which are important for manufacturing, is very welcome.” He added, “We were very pleased to see a pharmaceutical annex to the deal that includes provisions for the mutual recognition of good manufacturing standards and inspections.”
  • The BioIndustry Association agreed: “Mutual recognition of GMP reduces the duplication of bureaucracy for medicines manufactured by one party and exported to the other.”
  • Dr Richard Torbett also told the Committee that the Government had unilaterally decided to recognise the EU’s batch testing for two years, but noted, “After that the implication is that we would have to duplicate all those processes.”

Conclusions and recommendations included:

  • It is beneficial for the UK’s pharmaceutical and manufacturing industries that the TCA allows tariff-free export of medicines and medical devices to the EU.
  • While mutual recognition of Good Manufacturing Practices is helpful for the medical industry, it is disappointing that such recognition has not been extended to other regulatory processes such as batch testing. The Committee noted that the EU has reached mutual recognition agreements with other third countries, and urged the Government to seek a similar agreement.
  • The Committee welcomed the grace period that the Government has secured to allow businesses time to adjust their supply routes to accommodate the post-Brexit application of the Falsified Medicines Directive in Northern Ireland. It also welcomed the Government’s continuing engagement with the sector: if disruption once the grace period has elapsed is to be minimised, it will be essential to explore the alternative possibilities mentioned by the Minister, such as bonded warehouses and cabotage.

 

Full Coverage

France may be added to COVID red list regardless of risk to food supply

The Times, Graeme Paton, 25 March 2021

Travel to and from France may be banned to control the spread of the Coronavirus despite the risk of “very serious disruption” to food and medicine supplies, according to Boris Johnson.

The Prime Minister confirmed yesterday that the Government was considering adding France to its “red list”, severely limiting direct travel from the country. He said the measures may have to be introduced “very soon” to prevent mutant strains of the virus being imported.

He admitted that the move could severely interrupt cross-Channel trade, with particular threats posed to the flow of food and medicines to the UK.

The South African and Brazilian variants, which are more resistant to vaccines, account for up to 40 per cent of cases in parts of France.

The Times was told yesterday that the Prime Minister was coming under pressure from Chris Whitty, England’s Chief Medical Officer, to implement tougher border controls.

Ministers have added 35 countries to the red list, which bans direct travel and prevents foreign nationals who have been in the countries in the previous 10 days from entering the UK. Britons can enter the UK from red-list countries — travelling via a third nation — but have to quarantine for 10 days in a hotel.

The measures affect South America, southern Africa and parts of the Middle East but have not applied to Europe since Portugal was removed from the list earlier this month.

Applying the measures to France would pose huge logistical difficulties because of the flow of trade via cross-Channel ferries and through the Channel tunnel. Lorry drivers are likely to be exempt but will have to be tested when they enter the UK.

The move would also pile pressure on Eurostar, which has been crippled by the lockdown on either side of the Channel, leaving the passenger rail service on the brink of collapse.

At the Commons Liaison Committee yesterday, the Labour MP Yvette Cooper said 2,000 to 3,000 cases of the Brazilian and South African variants had been found in France and asked why the country was not on the UK red list. Johnson said it was “something that we will have to look at”.

“There is a balance to be struck and what we don’t know is the exact state of the efficacy of the vaccines against the new variants and we have to balance that against the very serious disruption that is entailed by curtailing cross-Channel trade,” he said.

“We will take a decision, no matter how tough, to interrupt that trade, to interrupt those flows, if we think that it is necessary to protect public health and to stop new variants coming in. It may be that we have to do that very soon.”

The threat of adding France to the red list was made just as the country removed the remaining travel restrictions imposed on the UK. For the past three months lorry drivers have been forced to register a negative COVID test before crossing the Channel from the UK but will no longer need to do so.

Tests will still be required to drive to Denmark, the Netherlands and Germany.

This was reported in a number of publications, including The Guardian and The Independent.

Coronavirus: EU and UK try to end row with ‘win-win’ on vaccines

BBC News, Editorial staff, 25 March 2021

The UK and the European Union have said they are working together to improve their relationship, after weeks of tensions over COVID vaccine supplies.

In a joint statement, they said they wanted to “create a win-win situation and expand vaccine supply for all”.

The European Commission earlier proposed tougher export controls on vaccines, amid tensions over supplies of the Oxford-AstraZeneca jab.

Prime Minister Boris Johnson warned that “blockades” were not “sensible”.

The joint UK-EU statement said that “openness and global co-operation” would be key to tackling the pandemic.

“We are all facing the same pandemic and the third wave makes co-operation between the EU and UK even more important,” it said. “We will continue our discussions.”

But there was little harmony earlier on Wednesday when the Commission announced plans for all vaccine shipments to be assessed on the destination country’s rate of vaccinations and exports. The proposals, which will be put before EU leaders on Thursday, are seen as focused on the UK and US in particular.

Analysis by Katya Adler, Europe Editor

The tone of the EU-UK statement was positive, but actual progress between the two sides was described to me by an EU diplomat as “slow, cumbersome and difficult”. On both sides.

That doesn’t mean impossible, but at their summit on Thursday, some EU leaders – along with the European Commission – will still be pushing for tougher controls on vaccine exports. And they could hit the UK.

EU insiders say they had hoped never to use the controls. They say they want them as a means of exerting pressure on vaccine companies and on countries with vaccine production sites that are not exporting to the EU.

With a third wave of the pandemic hitting much of mainland Europe, EU leaders are coming under increasing pressure to show voters they are taking action to ramp up both the supply of jabs and their vaccine rollout, on both of which they are trailing behind the UK.

EU Health Commissioner Stella Kyriakides rejected a suggestion that the aim was to punish the UK. “We’re dealing with a pandemic and this is not seeking to punish any countries,” she said.

Asked whether the UK might retaliate, Mr Johnson told MPs he did not believe “that blockades of either vaccines or of medicines, of ingredients for vaccines” would be “sensible”. Companies might draw conclusions about future investments “in countries where arbitrary blockades are imposed”, he added.

What is the EU planning?

The tougher export controls are most like to affect vaccine-exporting countries that have higher vaccination rates than the EU, such as the UK and US.

The key criteria for the proposed regulations are “reciprocity” and “proportionality”:

  • The EU says there is no reciprocity if a country importing vaccines from the EU restricts exports itself either by law or other means, so “it may be appropriate to consider whether exports to this country are justified”.
  • Member states and the Commission will also consider the epidemiological situation in that non-EU country, its vaccination rate and existing availability of COVID-19 vaccines.

There will be no outright export bans, which are opposed by countries such as the Netherlands and Belgium.

Vaccine manufacturers would be assessed to see if they were fulfilling their contract with the EU, although no specific algorithm is planned.

Is the UK being targeted?

In an interview with the BBC, the EU’s Internal Market Commissioner Thierry Breton insisted the bloc’s issues were with AstraZeneca and not the UK Government. “I know that there’s some tension… but as long as we have transparency, I think [relations] will be able to be normalised,” he said.

He said if AstraZeneca had provided the agreed 120 million doses to the EU, member states would have been at the same rate of vaccination as the UK: “We have been heavily penalised and we just want to understand why”.

AstraZeneca denies that it is failing to honour its contract with the EU.

A UK Government spokesperson said: “We are all fighting the same pandemic. Vaccines are an international operation; they are produced by collaboration by great scientists around the world. And we will continue to work with our European partners to deliver the vaccine rollout.”

Last week, European Commission President Ursula von der Leyen complained that the EU had exported more than 10 million doses to the UK, but the UK had so far exported none in return.

Her colleagues added that this had to be seen in the context of the EU being both a global COVID hotspot and also the biggest exporter of vaccines. Since the end of January, EU countries have exported 43 million doses of vaccine to 33 countries not subject to export authorisation, they say.

UK sources insist vital components are being sent to the continent, for example for the Pfizer vaccine, and they have emphasised the UK’s role in investing early in vaccine development, BBC correspondent Nick Beake reports.

This was reported in a number of outlets, including The Financial Times and The Independent.

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.

From Factory to Pharmacy

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