HDA UK Media and Political Bulletin – 23 July 2021

Media Summary

  Which key workers are exempt from self-isolation?
Independent, Clea Skopeliti, 23 July 2021

The Independent reports that the UK Government announced that some critical workers will be exempt from self-isolation.

The announcement comes after 600,000 people were instructed to self-isolate by the NHSCovid-19 app last week and there have been warnings from trade bodies and industry leaders that the ‘pingdemic’ is triggering staff shortages in vital areas, including retail and the NHS.

The article highlights that the exemption will apply to some fully vaccinated workers employed in key industries, including medicines and medical devices.

Employers will need to write to relevant government departments to have applications for exemption signed off and then the government will send out letters to some workplaces approving employees who are exempt.

Government guidance stated the policy “will not cover all or in most cases even the majority of workers in critical sectors”.

Workers who are exempt will be allowed to leave quarantine to travel to work and do their jobs after a negative daily test. If they test positive, they must immediately enter quarantine.

The article says that the policy is expected to be in place until 16th August 2021, when self-isolation rules will be eased for fully vaccinated people to allow them to avoid quarantining after being in contact with Covid-19.

Health Secretary Sajid Javid said critical workers “form the backbone of many of our most vital services and, as we learn to live with this virus, its right we do everything in our power to protect services from disruption by allowing our fully vaccinated critical workers to keep doing their important work.”

This was also reported by Sky News and BBC News.

Northern Ireland set to lose access to 2,000 medicines
Financial Times, Sarah Neville, George Parker and Mehreen Khan, 22 July 2021

The Financial Times reports that about 2,000 medicines currently offered to patients in Northern Ireland are set to be withdrawn due to the post-Brexit red tape.

Members of the British Generic Manufacturers Association (BGMA) told the UK Health Department that they would stop supplying medicines to Northern Ireland because of the increased cost and complexity.

European Commission President Ursula von der Leyen informed UK Prime Minister Boris Johnson that Brussels would not renegotiate the Northern Ireland protocol in his Brexit deal, raising concerns of serious disruption to drug supply.

Under the protocol, Northern Ireland will be treated as part of the EU regulatory system for medicines following a grace period that expires in December. Drugs made in Great Britain will have to be licensed separately and pass safety checks for use in Northern Ireland.

Chief Executive of the BGMA, Mark Samuels, suggested that extra warehousing, laboratory testing and technical specialists would be needed as a result of these regulations. Additionally, he said these new regulations could make “supplying Northern Ireland in many cases unviable in the longer term.”

Mark Samuels said: “With every week that went by, more companies were deciding to remove medicines, I’m not aware we’ve ever had this scale of withdrawal in one go before.”

Downing Street reported that Boris Johnson urged Ursula von der Leyen to “work with the UK” to quickly solve trading problems.

As well as this, the UK Government published a paper calling for most checks to be removed on goods going from Great Britain to Northern Ireland. The European Commission told EU diplomats that it would escalate legal proceedings against the UK if the Government breaks the terms of the protocol and the withdrawal agreement.

 

 Parliamentary Coverage

 

There was no parliamentary coverage today. 

 

Full Coverage

Which key workers are exempt from self-isolation?
Independent, Clea Skopeliti, 23 July 2021

After more than 600,000 people were instructed to self-isolate by the NHSCovid-19 app last week as UK cases soared, the government has created a framework for exemption for some critical workers.

The exemption will only apply to some fully vaccinated workers employed in a number of key industries, as rising infections and the end of lockdown combine to cause disruption in the supply chains of factories, supermarkets and meat processing plants among others.

The government has stressed that it is not a “blanket exemption” for all workers in a sector, but instead only applies to named employees in a specifically approved workplaces who have had their final vaccine dose at least 14 days ago.

Others will have to continue to self-isolate as normal after being identified as a close contact of a person infected with Covid-19.

The sectors include energy, civil nuclear, digital infrastructure, food production and supply, waste, water, veterinary medicines, essential chemicals, essential transport, medicines, medical devices, clinical consumable supplies, emergency services, border control, essential defence outputs, and local government.

Employers will need to write to relevant government departments to have applications for exemption signed off. The government will then send out letters to some workplaces naming employees working in critical areas whose absence would seriously affectedly the delivery of essential services or other “functionings of the state”, including national security.

The government guidance published on Thursday said the policy “will not cover all or in most cases even the majority of workers in critical sectors”.

Workers who are exempt will be allowed to leave quarantine to travel to work and do their jobs after a negative daily test, but must otherwise continue to stay at home. If they test positive, they must immediately enter quarantine.

The policy is expected to be in place until 16 August, when a wider easing of self-isolation rules will be introduced to allow all fully vaccinated people to avoid quarantining after contact with Covid-19.

Sajid Javid, the health secretary, said: “Throughout this global pandemic, critical workers across the country have been doing the extraordinary by delivering vital services – from policing the streets to keeping our transport links open.

“These individuals form the backbone of many of our most vital services and, as we learn to live with this virus, its right we do everything in our power to protect services from disruption by allowing our fully vaccinated critical workers to keep doing their important work.”

Separately, Department for Environment, Food and Rural Affairs (Defra) announced a new testing scheme for food industry workers – allowing staff deemed critical to the supply chain to avoid self-isolation if “pinged”.

Following an emergency meeting with supermarket bosses on Thursday, ministers said sites for daily testing would be set up this week – including at the biggest supermarket distribution centres – to allow staff to keep coming into work if they test negative.

The moves come amid warnings from trade bodies and industry leaders that the ‘pingdemic’, which is accompanying the pandemic, is triggering staff shortages in vital areas include retail and the NHS. The British Retail Consortium (BRC) said on Thursday that the shortages were “putting increasing pressure on retailers’ ability to maintain opening hours and keep shelves stocked”.

Meanwhile the British Meat Processors’ Association (BMPA) has said that 5 per cent to 10 per cent of staff in some plants have been forced to isolate, compounding existing staff shortages caused by factors including Brexit.

Around 70 per cent of adults have now received two vaccine doses.

Northern Ireland set to lose access to 2,000 medicines
Financial Times, Sarah Neville, George Parker and Mehreen Khan, 22 July 2021

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

Media Summary

Parliamentary coverage was also reported by BBC NewsPoliticoReuters and The Guardian.

 

 Parliamentary Coverage

Northern Ireland protocol – next steps
Cabinet Office and Northern Ireland Office, 21 July 2021

This policy paper sets out the details of the UK’s proposed approach on the Northern Ireland Protocol.

The impact of the Protocol has been profound economically, politically, socially, and commercially. Within Northern Ireland it has placed strain on institutions which have already been challenged by COVID-19. Such issues have arisen even before the full effects of the Protocol have taken shape and with mitigations in place to reduce its full impact. The policy paper highlights that it is increasingly clear that the problems cannot be solved by the application of the Protocol in its current form.

The introduction of the policy paper by Lord David Frost (Minister of State) and Brandon Lewis (Secretary of State for Northern Ireland) points to the UK Government’s desire for a new approach based on negotiation and eagerness to find a new and enduring consensus. The UK Government believes working together with the EU is the best means of providing stronger longer-term solutions, which requires significant change to the current Protocol.

The policy paper discusses the circulation of goods within Northern Ireland. Under the current Protocol, supply chains have been disrupted and costs increased. The current arrangements are creating considerable challenges to medicine supply with patients in Northern Ireland being put at risk for a number of products from the end of 2021.

In accordance with the Protocol, Northern Ireland aligns with all relevant EU rules relating to the placing on the market of manufactured goods. The current system underlines the principle that there can be parallel arrangements for different goods in Northern Ireland, underpinned by risk-assessed regulatory checks performed by market surveillance authorities to limit the sale of goods beyond Northern Ireland.

The UK Government proposes that this principle is extended to provide a full dual regulatory regime in Northern Ireland. All goods should be able to circulate within Northern Ireland if they meet either UK or EU rules, as determined by UK or EU regulators, and should be labelled accordingly.

The UK suggests that specific provisions for medicines may be necessary. Arrangements for medicines, for example, are so closely linked to the delivery of national health services, and the associated regulation and control arrangements are so substantial, that the risk of diversion into the Single Market is extremely minimal.

The solution proposed by the EU in June is potentially complex to operate because of its need to work within the broader EU framework for regulating medicines; and furthermore it would not satisfactorily deal with certain medicines (such as new cancer drugs) which must be licensed by the European Medicines Agency. The UK Government recommends that the simplest way forward may be to remove all medicines from the scope of the Protocol entirely.

 

Full Coverage

Parliamentary coverage was also reported by BBC NewsPoliticoReuters and The Guardian.

Media Summary

DHSC sets ambitious targets for winter flu programme
P3 Pharmacy, Pharmacy Magazine, 19 July 2021

P3 Pharmacy reports that the Department of Health and Social Care (DHSC) announced that it aims to reach 85 per cent of people aged 65 and over the coming winter flu vaccination programme.

In a letter published on 16th July 2021, the DHSC says that it aims to exceed the last flu vaccination programme in the September rollout.

The programme aims to reach 75 per cent of people age 50 to 64, who will be vaccinated on the NHS, as well as in the under-65 clinical risk group and pregnant women.

All frontline health and social care workers will be given the opportunity to receive the vaccine, with the hope to vaccinate 85 per cent of these groups.

Additionally, P3 Pharmacy reports that the letter sets out plans to reach more children aged between 2 and 16, with secondary school pupils in years 7 to 11 to be offered a jab.

The UK’s two largest community pharmacy multiples, Boots and LlloydsPharmacy, have reported high levels of early demand for flu jab bookings this year.

The Pharmaceutical Services Negotiating Committee (PSNC) stated that the: “Directions, service specification and Patient Group Direction for the Community Pharmacy Flu Vaccination Advanced Service 2021/22 are expected to be published “in due course.”

 

 Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

DHSC sets ambitious targets for winter flu programme
P3 Pharmacy, Pharmacy Magazine, 19 July 2021

The Department of Health and Social Care has set ambitious targets for the coming winter flu vaccination programme, announcing that it aims to reach 85 per cent of people aged 65 and over.

In a national flu immunisation programme update letter published on Friday (July 16), the DHSC says that after vaccinating 80.9 per cent of over-65s in the last flu season, it hoped to exceed this in the jab programme commencing this September.

As in the previous flu season, the “temporary” measure of vaccinating 50-64-year-olds on the NHS will remain in place. The programme aims to reach 75 per cent of people in this group, as well as in the under-65 clinical risk group and pregnant women.

All frontline health and social care workers will be offered a jab, with the ambition of vaccinating 85 per cent in these groups.

The flu letter also sets out plans to reach more children aged between 2 and 16, with secondary school pupils in years 7 to 11 to be offered a jab.

“Vaccinating children reduces transmission of influenza and JCVI have recommended that expanding into secondary schools would be cost-effective, particularly if Covid-19 is still circulating,” said the DHSC.

The Government says that in order to tackle inequality, no group or community should have a vaccine uptake more than five per cent lower than the national average.

The DHSC letter comes as concerns are raised about the impact that influenza could have this winter, with modelling suggesting that due to lower rates of resistance in the community flu could affect up to 50 per cent more people than usual.

The UK’s two largest community pharmacy multiples, Boots and LlloydsPharmacy, have both reported high levels of early demand for flu jab bookings this year.

“The high ambitions reflect the importance of protecting against flu this winter and should be regarded as a minimum level to achieve,” said the DHSC letter.

“The expanded influenza vaccination programme that we had last year will continue in 2021 to 2022 as part of our wider winter planning when we are likely to see both influenza and Covid-19 in circulation.

The Directions, service specification and Patient Group Direction for the Community Pharmacy Flu Vaccination Advanced Service 2021/22 are expected to be published “in due course,” said the PSNC.

Media Summary

Medical devices industry tests UK plans for post-Brexit divergence
Financial Times, Peter Foster, 18 July 2021

The Financial Times reports that industry experts have suggested that if the UK diverges from EU standards it will have less chance of becoming a global innovation hub for new medical devices post-Brexit.

Following Brexit, the UK chose not to implement the EU’s new Medical Device Regulation (MDR), which places responsibility on companies to prove devices are both safe and beneficial for patients.

The UK is looking to implement a bespoke regulatory system. Minister for Innovation, Lord Bethell, said this month is intended to “grasp the opportunity of innovation now we have left the EU”.

However, academics and leaders from the sector have warned that the UK must mirror the EU system because British companies sell their products in Europe, therefore companies have to comply with MDR regardless of the UK regulation.

Additionally, James Moore, Professor of medical device design at Imperial College London, said a divergent UK regulatory system could limit investment. Others argue that a unique UK system could put further burdens on companies.

The MHRA said that it was aiming to develop a “best-in-class” regulatory environment that would build on international best practice. The article highlights that the UK could become less bureaucratic through better regulation of software in medical devices, including a lighter touch regime for low-risk items and faster interactions with early-stage companies.

The UK Government has agreed to continue recognising the EU’s standard “CE” mark until July 2023, while it develops a new regulatory system.

A consultation will start this summer with secondary legislation clarifying new rules expected in the spring of 2022.

 

 Parliamentary Coverage

 There was no parliamentary coverage today. 

 

Full Coverage

Medical devices industry tests UK plans for post-Brexit divergence
Financial Times, Peter Foster, 18 July 2021

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

Media Summary

Pharmacies able to do 100 jabs a week can now join COVID booster phase
Chemist and Druggist, Valeria Fiore, 14 July 2021

The Chemist and Druggist reports that all community pharmacies in England, including those with a “low-capacity site”, have been invited to express an interest in delivering the COVID-19 booster vaccination programme. Initially, only sites that could deliver 1,000 doses a week and later those who were able to do a minimum of 400 a week were invited to join.

This follows the success of pharmacies participating in Phase 1 and Phase 2 of the programme. Pharmacies who already delivered the first two phases will have to resubmit their interest for the third phase, following the same instructions as the new sites.

Pharmacies will be paid £12.58 for each COVID-19 vaccination they administer. Some pharmacies will be able to claim an extra £10 payment if they give the vaccine to care home staff, residents, or if the patient receives it in that setting.

The Chemist and Druggist highlights that NHSE&I is waiting for official advice from the the Joint Committee on Vaccination and Immunisation (JCVI) on whether the booster COVID-19 vaccination should differ from the first and second doses.

As of 6th July 2021, there are approximately 700 pharmacy-led sites that are participating in the COVID-19 vaccination programme. NHSE&I said pharmacies have until 5pm on 28th July 2021 to show their interest in joining Phase 3.

 

 Parliamentary Coverage

Letter to Community Pharmacy
14 July 2021, Community Pharmacy Local Enhanced Service Specification – Phase 3 COVID-19 vaccination

A letter has been published by Dr Nikki Kanani, Medical Director for Primary Care, and Caroline Temmink, Director of Primary Care Vaccination, announcing the publication of the Local Enhanced Service Specification for Phase 3 of the COVID-19 vaccination programme and guidance on the Community Pharmacy Phase 3 Expression of Interest and Site Designation process.

The letter discusses the implementation of interim advice from the Joint Committee on Vaccination and Immunisation (JCVI) on the potential COVID-19 booster programme. Vaccines will be offered in two stages from September, starting with those most at risk. The flu vaccine should be offered alongside the third, booster dose of the COVID-19 vaccine. The NHS will continue to deliver first and second COVID-19 vaccinations over the summer to all eligible patients.

The letter highlights community pharmacy’s vital role in the COVID-19 vaccination programme. Approaching Phase 3, community pharmacy sites must be able to receive, store, prepare and transport the vaccines which are currently approved, as well as any new vaccines which may be approved.

Pharmacy contractors will be able to opt in to being commissioned to deliver COVID-19 vaccines from a low-capacity site. Pharmacy contractors are permitted to express an interest in administering 100/350/1000 vaccinations per week as agreed with the Commissioner (NHS England) and subject to vaccine supply.

The letter states that there will be a nationally agreed initial Supply Inventory List (SIL) of the equipment that will be required to allow new community pharmacy-led vaccination sites to operate.

In Phase 3, linked vaccine consumables such as syringes will be centrally supplied, but providers will need to purchase non vaccine linked consumables including handwash, waste bags and sharps bins as they would usually do for other vaccination programmes.

Personal protective equipment (PPE) is expected to continue to be available for community pharmacy through the Department of Health and Social Care (DHSC) portal.

The letter reveals that the vaccine ordering model may change to a capped pull vaccine ordering model in Phase 3 to support sites to have greater visibility and influence over the supply of COVID-19 vaccine to designated sites and to support earlier scheduling of clinics. This would allow sites to have the flexibility to request their own vaccines, up to a maximum limit. Sites could also align the COVID-19 vaccine with their flu vaccine supply to support co-administration, where timing of cohort phasing and eligibility of the programmes align.

The Commissioner, NHS England, will distribute available vaccine supply to providers that can contribute to meeting public demand.

Further details will be published on Phase 3 arrangements and on the adult seasonal flu programme, but pharmacy contractors are advised to continue to plan as usual for this year’s flu season.

 

Full Coverage

Pharmacies able to do 100 jabs a week can now join COVID booster phase
Chemist and Druggist, Valeria Fiore, 14 July 2021

All community pharmacies in England, including those with a “low capacity site”, have been invited to express an interest in delivering the COVID-19 booster vaccination programme.

Following a “successful pilot”, NHS England and NHS Improvement (NHSE&I) has decided to allow all pharmacy contractors to apply to join the COVID-19 booster programme in the autumn, it said in a letter to pharmacies this afternoon (July 14).

“Pharmacy contractors can express an interest in administering 100/350/1,000 vaccinations per week, as agreed with the commissioner (NHSE&I) and subject to vaccine supply,” NHSE&I medical director for primary care Nikita Kanani and NHSE&I director of primary care vaccination Caroline Temmink wrote in the letter.

Pharmacies have until 5pm on July 28 to express an interest to join phase 3 – the booster vaccinations – of the national service, NHSE&I said.

Those that are already delivering phase 1 and phase 2 of the programme will have to resubmit their interest in phase 3, following the same instructions as the new sites – which NHSE&I attached to its letter to contractors.

Payment and remuneration for additional costs
Pharmacies will be paid £12.58 for each COVID-19 vaccination they administer.

This is the same payment that pharmacy-led sites were receiving in phase 1 and phase 2 of the programme. Initially, only those sites that could deliver 1,000 doses a week and later those who were able to do a minimum of 400 a week were invited to join.

On top of the fee per vaccination administered, pharmacies will be able to claim a £10 payment if they give the vaccine to care home staff, residents, or if the patient receives it in that setting.

Pharmacists will also be able to claim the additional £10 for each housebound patient they administer the vaccine to.

“Further additional reasonable costs funding will be available to medium and large pharmacy sites delivering COVID-19 vaccinations in phase 3,” Dr Kanani and Ms Temmink wrote.

However, “additional reasonable costs will only be approved for small community pharmacy sites by exception”, they specified.

Flu jabs… and other services?
The letter confirmed NHSE&I’s intention “to put in place arrangements to enable co-administration of flu and COVID-19 vaccines”, following the Joint Committee on Vaccination and Immunisation’s (JCVI) interim advice.

However, NHSE&I awaits the final advice from the JCVI on whether the booster COVID-19 vaccination should be the same or different dose from the first and second doses.

“Community pharmacy sites must therefore be able to receive, store, prepare and transport (where appropriate) the vaccines which are currently approved, as well as any new vaccines which may be approved in future,” Dr Kanani and Ms Temmink added.

Last month, NHSE&I announced it was also hoping that, from this autumn, people dropping into an NHS clinic or pharmacy to receive their flu vaccination or booster dose of COVID-19 jab will also be offered targeted tests, such as blood pressure, heart rhythm, and cholesterol checks.

Community pharmacy “vital” in vaccination programme

Dr Kanani and Ms Temmink acknowledged in the letter that “community pharmacy has been a vital part of this historic programme”, and extended their thanks to “all community pharmacies who have been involved in the delivery of over 67 million COVID-19 vaccinations”.

As of July 6, there are almost 700 pharmacy-led sites that are involved in the COVID-19 vaccination programme.

Earlier this month, NHSE&I revealed its intentions to commission a further 1,000 pharmacy-led COVID-19 vaccination sites in the run-up to September to help deliver booster jabs.

Media Summary

Northern Ireland Protocol agreed with EU by Boris Johnson is ‘not definitive’, says Brexit minister
Independent, Andrew Woodcock, 10 July 2021

The Independent reports that Lord Frost, the Government’s Brexit Minister, has said that the UK Government does not consider the Northern Ireland protocol as “definitive.”

Lord Frost said it was not “reasonable” to regard the protocol as the final arrangements for the border between Northern Ireland and the Republic. He suggested that the protocol was challenging to implement because it only received 50/50 support among the Northern Irish public and “a broader level of consent” was required for effective changes.

The article highlights the impact of the protocol on British exports to Northern Ireland and interruption to supply chains.

Lord Frost said pharmaceutical companies had either begun to withdraw from sales of medicines to Northern Ireland or plan to do so by the end of the year. Industries in the region have raised concerned about how the protocol will operate.

Lord Frost reiterated the UK Government’s warning to suspend the protocol by invoking Article 16, stating that “all options remain on the table.” The Government will set out its position in a statement to parliament before the summer recess begins on  22nd July 2021.

 

 Parliamentary Coverage

Committee for the Executive Office Meeting
Northern Ireland Assembly TV, 9 July 2021

The Committee received a briefing on the current and future workings of the Protocol on Ireland / Northern Ireland from The Rt Hon Lord David Frost CMG, Cabinet Office.

 

Full Coverage

Northern Ireland Protocol agreed with EU by Boris Johnson is ‘not definitive’, says Brexit minister
Independent, Andrew Woodcock, 10 July 2021

The UK government does not regard the Northern Ireland protocol it agreed with the EU as part of Boris Johnson’s withdrawal deal as “definitive”, Brexit minister David Frost has said.

Despite the protocol forming part of an international treaty signed by the UK, Lord Frost said it was not “reasonable” to regard its text as the final word on arrangements for the border between Northern Ireland and the Republic.

In comments that will be seen as deeply ironic in the light of the government’s implementation of Brexit on the back of a 52/48 vote, the PM’s senior negotiator argued that the protocol was difficult to operate because it enjoyed only 50/50 support among the Northern Irish public.

He told the Northern Ireland Assembly that “a broader level of consent” was needed to make such fundamental changes work.

Giving evidence to Stormont’s Executive Office Committee, Lord Frost acknowledged that the deal that he negotiated and Mr Johnson agreed in 2019 has had a “chilling effect” on British exports to Northern Ireland and prompted a shift in supply chains towards the Republic of Ireland.

He said there was evidence that mainland pharmaceutical companies had either begun to withdraw from sales of medicines to Ulster or plan to do so by the end of the year.

Concerns about the operation of the protocol were universal among the province’s businesses, he told MLAs.

Lord Frost again blamed disruption on over-zealous EU implementation of the terms agreed in 2019, and suggested that the text could be amended or re-interpreted in order to improve the flow of trade between the British mainland and Northern Ireland.

“I don’t think it’s right to look at the protocol as a definitive text that was there in October 2019 and there’s nothing more to say,” he said. “It’s very clear, reading the text, that that’s not the case.”

As discussions with the EU remain stalled over Britain’s refusal to accept alignment on veterinary standards, Lord Frost repeated London’s threat to suspend the protocol by invoking Article 16.

“All options remain on the table”, he said, adding that the government will set out its position in a statement to parliament before summer recess begins on 22 July.

Under Article 16, the UK can take action if the protocol gives rise to “serious economic, societal or environmental difficulties” or “diversion of trade”, but risks triggering retaliatory tariffs from Brussels.

Lord Frost came under fire from nationalist members of the Executive Office Committee at Stormont, who told him that the UK government should implement the deal it had agreed.

“It’s your deal,” said the committee’s SDLP chair Colin McGrath. “If your deal is so shoddy, why did you negotiate it?”

And Sinn Fein’s Martina Anderson – an MEP at the time of the Brexit talks – told Lord Frost: “You were Britain’s chief negotiator for Brexit. Your eyes were wide open and your fingerprints are on every page of the protocol.

“The majority of people here in the North rejected Brexit and the majority of parties here in the Assembly, who represent the majority of people, rejected Brexit but support the protocol.

“You were the chief negotiator. You were not asleep. You knew there were going to be trade adjustments. The dogs in the street knew that there were going to be trade adjustments. Even the DUP Brexit cheerleaders knew there were going to be trade adjustments and they felt you threw them under a bus.”

Ms Anderson said that a recent poll had shown just 6 per cent in Northern Ireland trusted the UK government over the protocol.

But Lord Frost responded that another poll had found a 50/50 split in Northern Ireland over whether the protocol was “desirable”.

He said: “If you have a 50/50 division of opinion on something as fundamental as that, it makes it very hard to operate.

“That’s the situation we are in. The protocol depends on a broader level of consent if it is going to work.

“Therefore we’ve got to find a way of ensuring that we can get that consent, and that political problem seems to us to be at the core of the difficulties that we’re trying to solve.”

He blamed Theresa May’s administration for “infelicities” in the protocol that were currently causing disruption and tension in Northern Ireland.

Media Summary

All children in Britain to be offered flu shots this autumn
Reuters, 9 July 2021  

Reuters reports that all children will be offered flu shots in autumn. The rollout will be available to everyone under the age of 16, as well as all over 50’s, and others with health conditions.

Overall, the programme is expected to include over half the population and will be extended to cover all pupils at secondary school.

This was also reported by The Telegraph.

NPA urges Brexit negotiators to allow medicines supply as usual to Northern Ireland
Pharmacy Business, Swati, 8 July 2021

Pharmacy Business reports that the National Pharmacy Association (NPA) appealed to Brexit negotiators on 8th July 2021, calling on them to achieve an agreement that will permit manufacturers and suppliers to continue the usual supply of medicines to Northern Ireland.

NPA board representative for Northern Ireland, Michael Guerin, said: “This situation, if unresolved, will be intolerable for NPA members and patients in Northern Ireland. We are deeply concerned that the additional cost and complexity of getting medicines into Northern Ireland will result in some manufacturers and suppliers not bringing products to the market. This could result in reduced stock being available, leading to medicine shortages and an increase in the procurement costs.”

Guerin urged the EU and UK to address this issue urgently to prevent future disruption and for the benefit patients, carers, pharmacists and GPs.

In addition, Guerin highlighted that the NPA has been working with key stakeholders, including the MHRA, Community Pharmacy Northern Ireland (CPNI) and the Healthcare Distribution Association (HDA), to amplify concerns to all parties in the negotiations.

 

 Parliamentary Coverage

Written Question – House of Lords, 28 June 2021

Lord Dodds of Duncairn: To ask Her Majesty’s Government what process will be followed for Northern Ireland in circumstances where the Medicines and Healthcare products Regulatory Agency approves a licence for a medicine but such approval has not been given by the European Medicines Agency.

Written Answer – House of Lords, 8 July 2021

Lord Bethell (Conservative, Excepted Hereditary): We are committed to maintaining parity of access to medicines across the United Kingdom. In circumstances where the approval dates for products in Great Britain and Northern Ireland differ, doctors can prescribe medicines outside of the label in areas of unmet medical need. The General Medical Council provides clear recommendations to physicians on prescribing medicines which they consider is in the patient’s best interest but may not carry the specific indication. We continue to work with colleagues in Europe to ensure that approval for medicines in Great Britain and Northern Ireland are aligned in the future

Correspondence with the Secretary of State for Health and Social Care on the Health and Care Bill
Health and Social Care Committee, 6 July 2021

The Health and Social Care Committee has published a piece of correspondence from Secretary of State for Health and Social Care Sajid Javid on the Health and Care Bill.

The Health Secretary states that the legislation will promote collaboration, reduce needless bureaucracy, improve accountability and help to improve health outcomes.

Sajid Javid discusses recommendations made in the report by members of the Health and Social Care Committee and how they have informed the drafting of the legislation.

The Committee proposed that Integrated Care Systems (ICSs) should be held accountable for the quality and safety of care through transparent Care Quality Commission (CQC) assessments.

Javid suggested that officials have been working closely with the CQC and National Health Service England (NHSE) to develop proposals to include in the Bill as an amendment.

Javid agreed with the Committee’s recommendation that the Bill should include a framework setting out the roles and responsibilities of both the Integrated Care Board (ICB) and the Integrated Care Partnership (ICP), and of the Chair of the ICP. This will be included in the statutory guidance for both ICBs and ICPs.

Similarly, he agreed with the recommendation that NHSE should provide guidance on how the responsibilities and accountabilities of NHS trusts and foundation trusts align with these.

Following recommendations, the Bill will ensure that ICBs have a duty to consult patients and carers when undertaking their functions.

The Committee made several recommendations in relation to membership of ICBs, including that criteria should be set for appointments to ICBs by the Secretary of State.

The NHSE will now be responsible for the appointment of chairs and chief executives to the ICB, Javid said they are working with them to develop a set of criteria for these appointments.

Furthermore, the Committee also proposed that NHSE and the Department review the training and support provided to board members.

NHSE currently provides a range of training and development opportunities to ICS leads, chairs and nonexecutives. As part of the move to statutory ICSs, this offer will continue to evolve and national guidance will be produced to further help board members, including designate ICS chairs and CEOs.

On procurement, reforms will give commissioners more responsibility over when to use a competitive process to arrange services, with proportionate checks and balances.

Javid highlighted his agreement with the Committee’s position of the need for transparency and scrutiny of the decisions made and the contracts awarded under the proposed new provider selection regime.

In line with the committee’s proposal, the implementation period will consider the different stages that different parts of the country will be at in the process.

At the centre of the Bill is flexibility and to allow local leaders to develop local solutions.

ICSs will be ready to perform core functions from April 2022, subject to the passage of the legislation, and NHSE will prepare to work with systems over the course of the year.

 

Full Coverage

All children in Britain to be offered flu shots this autumn -The Telegraph
Reuters, 9 July 2021  

All children will be offered flu shots this autumn amid fears Britain could be facing one of the worst seasons on record, The Telegraph reported late on Thursday.

The rollout will be extended to everyone under the age of 16, as well as all over 50, and millions of others with common health conditions, The Telegraph reported.

The programme will cover more than half the population and would be expanded this year to cover all pupils at secondary school, the report added, citing sources.

NPA urges Brexit negotiators to allow medicines supply as usual to Northern Ireland
Pharmacy Business, Swati, 8 July 2021

The National Pharmacy Association (NPA) issued a new appeal to Brexit negotiators on Thursday (July 8), urging them to strike an agreement that will allow manufacturers and suppliers to continue supply of medicines to Northern Ireland as usual.

Under the Northern Ireland protocol, part of the Brexit withdrawal agreement, medicines made in the UK have to be licensed separately for use in the country, including separate safety inspections and other checks, before they can be given to the public.

The protocol came into force on January 1 2021, and is now part of international law.

“This situation, if unresolved, will be intolerable for NPA members and patients in Northern Ireland. We are deeply concerned that the additional cost and complexity of getting medicines into Northern Ireland will result in some manufacturers and suppliers not bringing products to the market. This could result in reduced stock being available, leading to medicine shortages and an increase in the procurement costs,” the NPA board representative for Northern Ireland, Michael Guerin, said.

“The medicines supply to Northern Ireland is integrated into the UK market and works on a just in time basis. The close alignment of regulations would help to limit future disruption. We urge the EU and the UK to address this issue urgently and not leave it for patients, carers, pharmacists and GPs to pick up the problem further down the line.”

Guerin informed that on behalf of its members, the NPA has been working with key stakeholders, including the MHRA, Community Pharmacy Northern Ireland (CPNI) and the Healthcare Distribution Association (HDA), to amplify concerns to all parties in the negotiations.

The NPA board discussed this issue during its board meetings on June 28-29 along with other topics, including the community pharmacist consultation service, covid costs, supervision and pharmacy IT.

The board also welcomed the chief executive of Community Pharmacy Scotland, Harry McQuillan, who shared his organisation’s vision of a clinically-based future for the sector.

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 Parliamentary Coverage

Life Sciences Vision
Department for Business, Energy & Industrial Strategy, 6 July 2021
The Life Sciences Vision sets out the Government and the life science sector’s ambitions for the sector over the next decade. It focuses on addressing some of the UK’s most significant healthcare challenges, including cancer, dementia, and obesity and how the UK can become the leading global hub for Life Sciences.

The UK aims to be the global leader for development, testing, access, and uptake of new and innovative treatments, medicines and technologies.

There is a focus on four themes which include, developing strategies to tackle future disease following COVID-19, building the science and clinical research infrastructure, supporting innovative technologies in the NHS and establishing a business environment that promotes company growth.

The Vision outlines proposals for immediate action in NHS England together with an ambition to work closely with NHS Scotland and Wales, and Health and Social Care Northern Ireland.

Following the pandemic, there is an opportunity to focus on developing new modes of administering vaccines and tackling the barriers which prevent the scale-up and commercialisation of those novel vaccine formulation technologies.

Additionally, the UK’s departure from the EU provides an opportunity to develop the regulatory environment, recognising the implications of Brexit regarding Northern Ireland and the importance of equity of patient access across the UK.

The recent structural and organisational changes allow for increased collaboration between Government, the NHS and the Life Sciences Sector.

Over the next few years three areas will be prioritised: Processes, systems and people, secondly, partnership, working and system join-up and lastly, regulation in a global context.

For medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) will work with NHS partners and international regulators deliver the world’s leading regulatory model for Digital Health products, which will be a key driver of innovation in the next decade.

Additionally, the MHRA will draw learnings from COVID-19 to enhance existing regulatory processes and systems. This will include early access to expertise and advice, digitisation, virtual regulatory inspections, integrated systems and use of real-world evidence.
The work of the MHRA will be supported by an integrated, multiagency approach, working alongside NICE, NHS England, NHSX and the NIHR to best support the most innovative new medicines and technologies.

The Health System will ensure that health data can be safely accessed by regulators, to allow evidence and advanced analytical tools to be used most effectively.

The Life Sciences sector supports the Government’s net zero target with a commitment to reduce their environmental footprint. The Greener NHS Initiative is supporting the NHS and its supply chain to reach net zero by 2045.

The Life Sciences Vision will further support net zero targets through aiming to reduce the need for prolonged treatment and frequent visits to healthcare settings, digitisation of the UK’s regulatory system to reduce paper use and supporting the deployment of green manufacturing technologies.

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 Parliamentary Coverage

The Health and Care Bill – The House of Commons
Department of Health and Social Care, 6 July 2021

The Health and Care Bill develops plans for legislative reform set out by NHS England in its Long Term Plan (2019). The Bill aims to strengthen the NHS, benefitting both staff and patients by drawing on insights from the COVID-19 pandemic.

The Bill contains 6 parts with 16 Schedules and makes changes to several existing Acts, including the National Health Service Act 2006 and the Health and Social Care Act 2012.

The Bill will impose statutory Integrated Care Boards (ICBs) and statutory Integrated Care Partnerships (ICPs) in all parts of England. These will be responsible for bringing together local NHS and local government, such as social care, mental health services and public health advice, to deliver joined up care for the local population in the area they cover.

The Bill incorporates the establishment of a new procurement regime informed by public consultation that reduces bureaucracy and the need for competitive tendering where is it invaluable. This will allow patients and communities to receive more effective and efficient NHS services.

The Secretary of State has new powers to manage ICBs and NHS England, including checking that they are carrying out their functions and directing them as to whether they are permitted to exercise a certain power they hold.

The Secretary of State is prohibited from providing directions to the NHS for appointments of individuals or on the use of drugs or treatments that have not be approved by the National Institute for Health and Care Excellence (NICE).

The Bill aims to provide more flexibility and accountability, through focusing on the needs of patients and removing unnecessary bureaucracy.

The Health and Care Bill was officially introduced in the House of Commons on 6th July 2021 and is due to have its second reading in parliament next week.

 

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Media Summary

NHS to add more community pharmacies in Covid-19 booster programme
Pharmacy Business, Shilpasharma, 5 July 2021

Pharmacy Business reports that NHS England and NHS Improvement (NHSE&I) will add 1,000 more community pharmacy sites in the third phase of the Covid-19 vaccination programme scheduled for September.

Adding more community pharmacy sites will help to cover the underserved communities, increase weekend and evening vaccination capacity, and ease workforce pressures across primary care teams.

NHSE&I aims to publish the general practice and community pharmacy service specifications for the third phase in the first half of July. NHSE&I regional teams will work with Local Pharmaceutical Committees (LPC) to explore the interest from contractors to participate in phase three of the vaccination programme.

Alastair Buxton Director of NHS Services at Pharmaceutical Services Negotiating Committee (PSNC) said: “However, the logistical complexities of the programme for the NHS and the availability of vaccines means many pharmacies will not be able to offer C-19 vaccination and co-administration therefore presents a risk that some pharmacies may see a reduction in demand for flu vaccination.”

 

 Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

NHS to add more community pharmacies in Covid-19 booster programme
Pharmacy Business, Shilpasharma, 5 July 2021

Acknowledging their contribution in the first and second phases of vaccination drive, NHS England and NHS Improvement (NHSE&I) has decided to add 1,000 more community pharmacy sites in the third phase.

The decision was taken as the government prepares to launch Covid-19 booster programme in September.

Adding more community pharmacy sites will help to cover the underserved communities, increase weekend and evening vaccination capacity, and ease workforce pressures across primary care teams.

NHSE&I aims to publish the general practice and community pharmacy service specifications for Phase III in the first half of July and enroll the interested contractors towards the month-end.

Last week, the Joint Committee on Vaccination and Immunisation (JCVI) released its advisory about the Covid-19 booster programme, which is expected to be offered in two stages from September.

Over the next few weeks, NHSE&I regional teams will work with Local Pharmaceutical Committees (LPC) to seek expressions of interest from contractors to participate in phase three of the vaccination programme.

It would share further information about the expression of interest with all contractors via their regional teams.

Alastair Buxton, director of NHS Services at Pharmaceutical Services Negotiating Committee (PSNC), said, “PSNC (Pharmaceutical Services Negotiating Committee) believes community pharmacies are ideally placed to play a significant role in the Covid-19 vaccination booster programme, particularly given their incredible track record on flu vaccinations and the work of the 600+ pharmacies already administering Covid-19 vaccines.”

Adding community pharmacies to the programme will allow general practitioners to focus on the backlog of care which has resulted from the pandemic, he said.

“However, the logistical complexities of the programme for the NHS and the availability of vaccines means many pharmacies will not be able to offer C-19 vaccination and co-administration therefore presents a risk that some pharmacies may see a reduction in demand for flu vaccination,” he added.

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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