HDA UK Media and Political Bulletin – 04 March 2021

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

Spring Budget: What it means for STPs, social care, A&E and devolution

HSJ, Rebecca Thomas, 8 March 2017

Philip Hammond announced in the Spring Budget that funding would be injected into the “most advanced” STPs, upgrading A&E departments and social care. The chancellor announced £325m of new capital funding to support the “strongest” Sustainability and Transformation Plans (STPs). However, some have described this increase as modest, considering the significant capital requirements set out in STP plans. Agreements will soon be laid out for the new London devolution deal, and it is thought that NHS organisations will have no formal influence over how the new social care funding is spent, but that a “tight accountability framework” will be introduced in 2018-19.

BIA CEO Steve Bates responds to the Budget

UK BioIndustry Association, 8 March 2017

Responding to the Spring Budget, BIA CEO Steve Bates praised the focus on investment in biotechnology and skills. He also referenced the BIA’s policy proposals such as Citizens’ Innovation Funds – said to create opportunities for middle-earners to invest in new areas of technology.

New Green guide, MHRA

Dispensing Doctors, Ailsa Colquhoun, 9 March 2017

MHRA ‘orange’ and ‘green’ guides have been revised and updated. The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) contains information and legislation on the manufacture and distribution of human medicines. The tenth edition of the Green Guide includes new sections, such as the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use, matters relating to unlicensed medicines, EU regulation on safety features for medicines, and data integrity.

Parliamentary Coverage

House of Commons, Written Answers, Wednesday 8 March 2017

Mr Jim Cunningham:

What recent assessment he has made of the adequacy of regulation for online doctor services.

Department of Health

Nicola Blackwood, MP:

Online medical services in England are required to register with the Care Quality Commission (CQC) and to meet a set of registration requirements around safety and quality and are further regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) for prescribing purposes.

The MHRA is responsible for the regulation of all medicines available in the United Kingdom. There are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012.

The Department monitors the CQC’s financial and operational performance and risks at a general and strategic level through regular formal accountability meetings.

Full Coverage

Spring Budget: What it means for STPs, social care, A&E and devolution

HSJ, Rebecca Thomas, 8 March 2017

In his first budget as chancellor, Philip Hammond announced funding for the “most advanced” STPs, upgrading A&E departments and social care.

£2bn for social care

Mr Hammond’s budget included a commitment to inject £2bn into adult social care spending over the next three years, with £1bn available in 2017-18.

The chancellor pledged £2bn for social care

HSJ understands NHS organisations will have no formal influence over how the new social care funding is spent in the next financial year, but that a “tight accountability framework” will be introduced in 2018-19.

A very senior NHS source said hospitals needed to be “quite lippy” about what was required to deliver reduced delayed transfers of care, adding that the funds were enough to “free up 2,000 to 3,000 beds”.

Capital for sustainability and transformation plans

The chancellor announced £325m of new capital funding to support the “strongest” STPs.

Mr Hammond said the investment will be spread over three years, with further funding expected to be announced in the autumn budget for more STPs.

However, the increase has been described as “very modest” by experts, considering the significant capital requirements set out in STP documents.

£100m to reform A&E

Capital investment of £100m specifically for accident and emergency departments was also announced.

Luton and Dunstable Hospital NHS Foundation Trust

Trusts will copy Luton and Dunstable’s A&E model

The money is expected to put an urgent treatment centre based on the model of Luton and Dunstable University Hospital Foundation Trust in every A&E in England. HSJ understands equivalents, accounting for local differences, will be permitted.

Mr Hammond said the money “will enable trusts to invest in measures to help manage demand on A&E services”, and he gave the example of “onsite GP facilities”.

New London devolution deal

Details of a second government deal to devolve further health powers in London are to be agreed imminently.

It was announced that a new memorandum of understanding on health in the capital will be agreed next week.

It will “cement progress made to date and support London’s future plans for preventing ill-health”, according to a London devolution agreement published today.

The mayor’s office said the MoU will outline how devolution will “lead to better services that meet the needs of local communities”.

BIA CEO Steve Bates responds to the Budget

UK BioIndustry Association, 8 March 2017

Responding to the Budget announcement by Chancellor Philip Hammond, BIA CEO Steve Bates said:

“The Chancellor is right to focus on keeping the UK at the cutting edge of the global economy by investing in biotechnology and skills. The £270 million to keep the UK at the forefront of disruptive technologies like biotech, gives us a real opportunity to lead the world in new industries such as advanced therapy manufacturing – highly specialised production techniques that allow us to use cells and genes to treat a wide range of diseases from cancer to dementia.

“The Chancellor also announced £90 million for 1,000 PhD places in Science, Engineering, Technology and Maths (STEM) subjects and £200 million to support new fellowships for early and mid-career researchers, in areas identified as important to the industrial strategy (including biotechnology and medicines manufacturing); £50 million of this will be for programmes to attract “top global talent”. Industry must be involved in the design and delivery of training to ensure these investments properly allow the UK to stay at the cutting edge of the global economy.

“The review of R&D tax credits provided an opportunity to enhance the system to put it head and shoulders above other highly-competitive regimes, such as Belgium and France. It’s a shame the government hasn’t taken that opportunity but we are pleased that it listened to the BIA’s call to reduce the admin burden for businesses claiming R&D tax reliefs.”

What else would we liked to have seen

“The BIA has put forward a range of policy proposals that would increase private investment in biotechnology at minimal cost to the public purse, such as Citizens’ Innovation Funds that will open up opportunities for middle-earners to invest in exciting areas of technology.

“The BIA had called for the government to enhance the R&D tax credit scheme to allow companies to claim relief on investments in experimental and manufacturing equipment and the purchase of data for use in R&D. Medical data is as essential to modern drugs research as chemicals and clinical trials so it is a real missed opportunity not to address this discrepancy in the current system.”

New Green guide, MHRA

Dispensing Doctors, Ailsa Colquhoun, 9 March 2017

MHRA ‘orange’ and ‘green’ guides have been revised and updated.

The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors), now in its tenth edition, contains information and legislation relating to the manufacture and distribution of human medicines.

The Green Guide (Rules and Guidance for Pharmaceutical Distributors) reproduces all the elements of the new orange’guide that are relevant to distributors, such as pharmacy owner GPs.

This tenth edition of the green guide includes new sections on:

• the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)

• matters relating to unlicensed medicines

• sourcing and exporting medicinal products – non-EEA countries

• data integrity

• the EU regulation on safety features for medicines

It includes revised sections on:

• qualification of suppliers and customers

• controls on certain medicinal products

• parallel importation and parallel distribution

• the application and inspection process for new licences: “what to expect”

• updated UK legislation

• temperature control and monitoring.

New orange guide content includes:

• qualification of suppliers and customers

• parallel importation and parallel distribution

• temperature control and monitoring

• UK legislation

• unlicensed medicines

New MHRA sections on:

• GMP for excipients

• guidance on revised Annex 16 of GMP

• data Integrity definitions and guidance for industry

New commission guidance on:

• principles and guidelines of GMP for active substances

• principles of GDP of active substances

• setting health based exposure limits

• formalised risk assessment for ascertaining the appropriate GMP for excipients.

Media Summary

Budget 2017: What to look out for in health and care

HSJ, Lawrence Dunhill, Shaun Lintern, 6 March 2017

With the unveiling of the Spring Budget on Wednesday, Philip Hammond has warned that there will be no “spending sprees”. Social care services are expected to receive additional funding; in the spending review in 2015, the government said an extra £1.5bn would be added to the better care fund by 2019-20, with around half of the increase coming in 2018-19. One option could be to bring these increases forward, coming into effect from 2017-18. Significant capital will be needed to fund the 44 STPs. The government may look to cushion the impact of rising business rates for hospitals and trusts, especially as many trusts are now claiming they are eligible for an 80 per cent discount on business rates because they should be classified as charities.

How hub-and-spoke dispensing could work for independents

Chemist and Druggist, Anabelle Collins, 6 March 2017

Numark’s managing director, Mr D’Arcy, spoke to C+D at the Numark conference in Cape Town yesterday on the subject of hub-and-spoke dispensing. He explained that while there is not a “legally workable solution” for independents just yet, an amended hub-and-spoke model could allow pharmacists to provide more “professional services”.

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

Budget 2017: What to look out for in health and care

HSJ, Lawrence Dunhill, Shaun Lintern, 6 March 2017

Chancellor Philip Hammond has warned there will be no “spending sprees” in Wednesday’s budget, but there are several areas in which the government may look to support the NHS.

It will be a surprise if social care services do not receive some additional funding, following months of “crisis” headlines and calls for extra revenue.

In the spending review in 2015, the government said an extra £1.5bn would be added to the better care fund by 2019-20, with around half of the increase coming in 2018-19.

So one option would be to bring these increases forward, to come into effect from 2017-18.

Meanwhile, the use of any additional funds for social care is expected to be overseen by the Care Quality Commission, under measures intended to assure the Treasury that the money will deliver measurable improvements.

Significant capital resources will be needed to fund the 44 sustainability and transformation plans, and an announcement of extra investment would present a major opportunity to dispel the “cuts” narrative that has dominated the process.

However, Simon Stevens has warned not to expect additional capital funding in this budget, suggesting the autumn budget was a more likely juncture.

What we might see instead is what Jim Mackey has described as an “NHS bond”, which would be a new mechanism for allowing providers that want to sell assets to realise some of the capital before the sale goes through.

Proposals from Sir Robert Naylor’s review into the NHS’s estates strategy, which is due to be published soon, could also feature.

NHS trusts are due to be hit by increased business rates from April, following a revaluation process that has proved hugely controversial.

Law firm Gerald Eve has estimated that business rates for hospitals will rise from £328m this year to £418min 2021, with some trusts seeing their rates double.

With the rates increases for many small businesses proving hugely controversial, the government may look to cushion the impact.

Dozens of trusts are also claiming they are eligible for an 80 per cent discount on business rates because they should be classified as charities.

The trusts are seeking a tax rebate relating to the previous six years, which could result in a £1.5bn bill for local authorities. Could Mr Hammond seek to end this dispute?

The government could hand the NHS up to £1bn to cover increased costs from clinical negligence compensation.

Justice secretary Liz Truss has announced plans to end the discount rate used for compensation payments, which means the NHS will face higher payments at the outset of a case being concluded.

The government has said it will compensate the NHS for the increase but will the money go direct to NHS trusts to cover high NHS Litigation Authority premiums or will it go direct to the authority?

Public sector pensions continue to be a significant cost to the Treasury. Particularly as the NHS scheme is an “unfunded” scheme – in other words, paid for out of general tax revenue each year.

NHS employers have been made to increase their contributions to 14.3 per cent and this follows the controversial reforms to the pension scheme in 2012, which transferred staff to career average pensions and increased contributions.

Tax relief is a key area where there could be changes. The government has previously reduced the total lifetime allowance before tax relief ends to £1m, which has hit many NHS staff and added to the early retirement problems among some key groups such as senior leaders, consultant and senior nurses.

A further cut to the allowance could be bad news for staff and for those responsible for workforce planning.

In his autumn statement, Mr Hammond made clear the era of off-payroll senior staff working in the NHS was coming to an end, and new rules are due to be enforced by NHS Improvement along with its crackdown on medical locum costs.

However, costs have not fallen as fast as hoped. Jeremy Hunt has been clear that he wants to see senior pay reduced. Could the chancellor use his budget to reveal tougher measures?

In 2015, George Osborne delivered bad news for NHS staff, making clear that public sector pay restraint would last for at least another four years.

NHS staff on Agenda for Change and medical staff have seen their pay fall substantially in real terms under the coalition and Conservative governments and there are growing calls for Theresa May to lessen the pain.

Changes in pay could help the NHS to tackle workforce shortages, though it’s widely expected Me Hammond will disappoint those calling for an end to pay restraint.

It’s worth noting that the Five Year Forward View made the point that pay restraint needed to come to an end. Nuances within this issue include how the expected 1 per cent pay rise could be used.

The government has previously said it would allow the cash to be pooled and concentrated on staff groups particularly under pressure. This could include junior doctors and nurses, but the chances of this happening look slim. Also watch out for any hint of new contract reform for Agenda for Change staff and consultants.

From Factory to Pharmacy

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