News

HDA UK Media and Political Bulletin – 23 April 2021

Media Summary

NI protocol ‘already disrupting medicine supply’
P3 Pharmacy, Pharmacy Magazine, 22 April 2021

P3 Pharmacy reports that certain medicines are already becoming unavailable in Northern Ireland as manufacturers feel the impact of the Northern Ireland Protocol regulations which were put into action on 1st January 2021.

Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA) said that manufacturers are “seeing major challenges to supplying medicines to Northern Ireland patients.”

He also revealed that some medicines are already becoming unavailable in Northern Ireland, with some companies not planning to launch medicines there in the future. According to Samuels, “Without a solution immediately, some manufacturers report that up to 90 per cent of medicines could be at risk of being withdrawn.”

Samuels suggested that firms may need to build extra warehousing and hire more staff to ensure medicines comply with both UK and EU regulations.

He called on the European Commission and the Government to work together to solve the disruption to Northern Ireland’s supply chain.

Where does the pharmacy sector stand now on hub-and-spoke?
Chemist and Druggist, Grace Lewis and Chloe Coules, 22 April 2021

The Chemist and Druggist (C+D) reports that the Department of Health and Social Care (DHSC) is working with the community pharmacy sector to inform its hub-and-spoke consultation.

The DHSC can roll out a hub-and-spoke dispensing model across community pharmacy under the Medicines and Medical Devices Act 2021. However, any plans for the model are subject to a “full public consultation.”

Some of the bodies currently involved in these discussions include: the Association of Independent Multiple Pharmacies (AIMp), the Company Chemists’ Association (CCA), the Pharmaceutical Services Negotiating Committee (PSNC), the Pharmacists’ Defence Association (PDA) and the National Pharmacy Association (NPA).

Will there be a Covid pill and when will it be available?
Evening Standard, Tom Ambrose, 22 April 2021

The Evening Standard reports that Prime Minister Boris Johnson announced that by autumn a pill taken at home preventing severe symptoms of COVID could be available.

The pills are being developed particularly for people who are unable to get the vaccine, or for those who have tested positive and need help fighting the virus. Johnson suggested that he hopes the development of pills could help fight an anticipated third wave.

During a press conference, Boris Johnson confirmed the creation of an ‘antivirals task force’ charged with developing early-stage treatments for the disease. The Government is looking at developing and manufacturing at least two different antiviral treatments, which could be given separately or in combination with each other.

The article suggests that the pills could be distributed to patients by posting them via the Royal Mail or making them available for people to collect from pharmacies.

Parliamentary Coverage

There was no parliamentary coverage today.

 Full Coverage

NI protocol ‘already disrupting medicine supply’

P3 Pharmacy, Pharmacy Magazine, 22 April 2021

 

Some medicines are already becoming unavailable in Northern Ireland due to the increased regulatory burden on manufacturers since January 1, an industry spokesperson has said.

 

Mark Samuels, who recently took over as chief executive of the British Generic Manufacturers Association (BGMA), said that since the Northern Ireland Protocol came into effect manufacturers are “seeing major challenges to supplying medicines to Northern Ireland patients”.

 

The terms of the protocol mean that EU medicines regulations apply in Northern Ireland, which Mr Samuels said “threatens to prevent companies from supplying an identical product to Great Britain and Northern Ireland”.

 

The supply chain is already feeling the impact of the protocol, said Mr Samuels: “We are already seeing some medicines become unavailable and are also aware of companies not planning to launch future medicines due to being caught between two regulatory systems.

 

“Without a solution immediately, some manufacturers report that up to 90 per cent of medicines could be at risk of being withdrawn.”

 

‘Unviable’

 

Drug firms may need to build extra warehousing and hire more staff to ensure medicines comply with both UK and EU regulations, Mr Samuels said, adding that “this duplication could make supplying Northern Ireland in many cases unviable in the longer term”.

 

An extended grace period means that until January 1 2022 medicines supplied from Great Britain to Northern Ireland without the need for additional regulatory importation controls. However, after this date controls including batch testing and certification will need to be carried out in Northern Ireland or an EEA state.

 

Mr Samuels said: “Due to the Protocol’s interpretation, the situation has forced our members to review the viability of their ongoing medicines portfolios for Northern Ireland.

 

“Northern Ireland risks becoming a small, self-contained market, similar to Malta or Cyprus, that cannot access the wide range of medicines provided in the rest of the United Kingdom.”

 

He said solutions are “complex” but achievable, “especially if medicines licensed for use in Great Britain were also legal in Northern Ireland without the separate regulatory requirements”.

 

He urged the European Commission and UK Government to come together to prevent severe disruption to Northern Ireland’s supply chain.

 

Where does the pharmacy sector stand now on hub-and-spoke?

Community and Druggist, Grace Lewis and Chloe Coules, 22 April 2021

 

The Department of Health and Social Care (DH) is engaging with the community pharmacy sector as part of preliminary work that will inform its hub-and-spoke consultation.

 

Under the Medicines and Medical Devices Act 2021, the DH has powers to roll out a hub-and-spoke dispensing model across community pharmacy. However, any plans for the model must be subject to a “full public consultation” before they come to fruition.

 

At present, the DH is consulting key pharmacy stakeholders to understand what issues need addressing before a hub-and-spoke model is introduced. The feedback gathered through these engagement sessions will inform the basis of a consultation, a DH spokesperson told C+D last month.

 

The Association of Independent Multiple Pharmacies (AIMp), the Company Chemists’ Association (CCA), the Pharmaceutical Services Negotiating Committee (PSNC), the Pharmacists’ Defence Association (PDA) and the National Pharmacy Association (NPA) are some of the bodies currently participating in those discussions.

 

They told C+D what advantages a hub-and-spoke model could bring to the sector and flagged the potential pitfalls to be addressed before any model for automated dispensing is introduced.

 

AIMp: A “huge cost”

 

AIMp CEO Leyla Hannbeck told C+D that her organisation regularly attends engagement meetings on hub-and-spoke dispensing.

 

However, those meetings are often attended by more than 50 delegates, which make it harder “to put the message across”, she said.

 

One of AIMp’s main concerns with the service is that the introduction of an automated dispensing model might come at a “huge cost, as robotics are expensive and require investment, maintenance and eventual replacement”.

 

The assumption that the model will help pharmacy staff focus on the provision of other services is “OK in principle, but if the services commissioned are not properly remunerated, this will threaten the existence of pharmacy”, Ms Hannbeck said.

 

AIMp is also “extremely concerned” that discussions around the hub delivering directly to patients are “not being brought to this debate”.

 

“If the ‘direct-to-patient hubs’ are given a regulatory advantage over the ‘hubs-to-pharmacy’, they will add this to their industrial economies of scale and create a competitive advantage, allowing them to hoover up prescriptions nationally,” Ms Hannbeck said.

 

The risk is pharmacies might be left with insufficient income for their dispensing activity, which might “result in the collapse of the community pharmacy network,” Ms Hannbeck warned.

 

NPA and PSNC: Not enough evidence

 

Gareth Jones, head of corporate affairs at the NPA, told C+D that the lobbying group has been in “correspondence and in detailed conversation with [DH] officials for several years on this topic”.

“Whatever the next steps are in exploring this concept, the government should weigh the practical experience to date, [both] in the UK and internationally, [rather than] just relying on unproven theories. The real-life experience of hub and spoke clearly shows that it is no panacea and mustn’t be rushed,” Mr Jones added.

 

He said that the NPA is still “sceptical” about some of the claims that have been made about the model, as it is not backed up by “studies of the impact on patient safety of the full end-to-end process”.

 

While the NPA believes it is right to explore how this model could “release time in pharmacies for patient-facing care”, it fears the government might overestimate the benefits of it and use them to “wrongly justify cuts to pharmacy funding”, Mr Jones added.

The NPA’s concerns over the lack of evidence in support of the benefits of a hub-and-spoke model are echoed by PSNC.

 

In a response it submitted during the passage of the Medicines and Medical Devices Bill in June 2020, the English negotiator wrote that “the efficiencies that [the model] may bring are as yet unproven, and there are several patient safety concerns that must be addressed before it can be widely implemented”.

 

PSNC also said that “there is no clear evidence that the model improves the overall efficiency of dispensing as compared with the existing model”.

 

CCA: Multiples found model “invaluable during the pandemic”

 

Several pharmacy chains are currently using hub-and-spoke models within their own branches.

 

CCA CEO Malcolm Harrison told C+D that, based on CCA members’ experience, the model can move workload and “the associated cost” out of pharmacies, allowing pharmacy teams to focus on delivering “more clinical care”.

 

“Our members who use hub-and-spoke models have found it invaluable during the pandemic, by providing business resilience and relieving pressure on frontline teams,” Mr Harrison added.

 

However, he recognises that the model is not a “magic bullet” and “comes with extremely high set-up costs and ongoing operating costs”, he said.

 

“Once a hub-and-spoke model has been embedded in a pharmacy, new clinical services need to be commissioned to allow the pharmacist to utilise the capacity released,” Mr Harrison added.

 

PDA: Not a “silver bullet”

 

PDA director Paul Day told C+D that there are fears that the introduction of greater automation in the dispensing process could results in job cuts, “with potential risk to quality and safety”.

 

Employers taking this approach could “harm the long-term prospects for their own business and the wider sector”, he warned. However, the greater use of automation should instead help the profession move to a “more clinical role”, Mr Day argued.

 

“This would also enable the sector to change how it is often perceived by the public – from a retail supplier of products to consumers, to that of a healthcare professional embedded in the local community and enjoying clinical relationships and increased face-to-face contact with patients,” Mr Day said.

 

But he added that the introduction of this model alone “should not be seen as a silver bullet to increase patient-facing activity in a community pharmacy”.

 

“Pharmacy skill mix and the role of the responsible pharmacist are significant areas that still need to be addressed as part of this conversation,” Mr Day said.

 

In 2016, the government argued that allowing independent pharmacies to legally operate dispensing hubs would “create a level playing field” and give them a greater choice of which business model to operate.

 

But pharmacy organisations – including PSNC – argued at the time that there was no evidence that hub-and-spoke dispensing would save money or improve patient safety.

 

The DH showed renewed interest in a hub-and-spoke model in 2019 when it announced in the five-year funding contract for England that it would explore legislative changes with PSNC to allow all pharmacies to “benefit from more efficient hub-and-spoke dispensing”.

 

Additional reporting by Valeria Fiore

 

Will there be a Covid pill and when will it be available?

Evening Standard, Tom Ambrose, 22 April 2021

 

Boris Johnson announced yesterday that pills taken at home to prevent severe Covid infection could be available by the autumn.

 

It came as the Prime Minister warned that a third wave of cases could hit the UK later this year as restrictions continue to be relaxed.

 

During a press conference last night, he also confirmed the creation of an ‘antivirals task force’ charged with developing early-stage treatments for the disease.

 

The prospect of simple medication which can be taken at home to combat coronavirus would be a major step as the world tries to rebuild – but how realistic is it and when could it happen by?

 

We take a look at some of the key questions below.

 

What did the Prime Minister actually announce?

 

He said he hoped pills or capsules could be developed to help fight an anticipated third wave.

The idea would be to make them available for people – including those unable to get vaccinate – who have tested positive or exposed to someone who has to help fight the virus.

 

He told the press conference: “By focussing on these antivirals we hope to lengthen the UK’s lead in life sciences and to give ever greater confidence to the people of this country that we can continue on our path towards freedom.”

 

When could they be available from?

 

There are concerns about a third wave in the autumn as the country continues to ease lockdown restrictions over the summer.

 

The PM said he hopes this form of medication may start to be used from the “autumn”.

 

What is being done to develop them?

 

The government has set up an ‘antivirals taskforce’ to look at developing and manufacturing treatments for Covid in the coming months.

 

It will aim to find at least two different antiviral treatments, which could be given separately or in combination with each other.

 

How will we be able to get hold of them?

 

Potential ways for distributing the pills to patients include posting them via the Royal Mail or making them available for people to collect from pharmacies.

 

Will it definitely happen?

 

Nobody can be sure, although the Prime Minister appeared characteristically hopeful last night. But it remains very much an aspiration at this stage.

 

The search for at-home treatments for Covid is, Mr Johnson said, part of learning to live with the virus.

HDA UK Media and Political Bulletin – 23 April 2021

From Factory to Pharmacy

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