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HDA UK Media and Political Bulletin – 28 September 2021

Media Coverage

Fuel shortages: Medicines wholesalers ‘severely tested’
Pharmacy Magazine, 27 September 2021

Pharmacy Magazine reports that according to the Healthcare Distribution Association (HDA), the UK’s medicines supply chain is being “severely tested” by fuel shortages.

HDA Executive Director Martin Sawer said that while wholesalers have business continuity plans to maintain medicine deliveries “these arrangements are currently being severely tested, as fuel supplies are not as available as we would like from normal sources”.

Additionally, “HDA knows that some normal delivery schedules for medicines could be disrupted for most of this week, but every effort will be made to fulfil orders. HDA members are grateful for the patience and understanding being displayed by their customers.”

The article highlights that according to Mr Sawer, transport fleets should be given priority access to fuel “principally at petrol stations” to maintain an effective supply chain. He added that HDA “is in urgent talks with the UK Government on this specific issue” and another “critical” issue is maintaining regular deliveries of medicines to wholesaler warehouses.

Royal Pharmaceutical Society President Claire Anderson said: “As normal, pharmacists are working with patients to ensure they get the medicines they need. We’re not aware that the problems with fuel supplies are stopping patients getting their medicines.”

A spokesperson for AAH said it was not experiencing any issues with medicines supply as AAH does not rely on forecourts to supply fuel for its medicines distribution system.

Northern Ireland could face medicine shortages after Brexit grace period ends next year, report claims
iNews, David Parsley, 27 September 2021

iNews reports that a leading pharmaceutical research firm has revealed that some drug firms will withdraw up to 90% of their products from Northern Ireland as protocol hits exports.

Informa Pharma Intelligence said that the withdrawals are due to the uncertain and high-cost imposition of new quality-check procedures as the Brexit grace period ends. The extra costs of implementing new regulatory procedures for batch testing drugs could threatens the ability of UK manufacturers to export low-cost generic drugs to Northern Ireland.

The firm suggested that statins and diabetes drugs are among the medicines threatened with shortages in Northern Ireland at the beginning of next year. The firm’s report suggested that the concern among drug manufacturers was due to the lack of a clear political solution, putting pressure on policymakers ahead of the deadline on 1st January 2022.

In line with the Northern Ireland Protocol, from 2022 companies that want to export from Great Britain to Northern Ireland will have to establish specific batch control and release facilities in Northern Ireland that meet EU standards.

The Government asserted that its indefinite extension of the Brexit grace period earlier this month includes the import of medicines into Northern Ireland. A spokesman for the Department of Health and Social Care (DHSC) said: “Under the standstill all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines.”

 

Parliamentary Coverage

 There were no parliamentary updates today.

 

Full Coverage

Fuel shortages: Medicines wholesalers ‘severely tested’
Pharmacy Magazine, 27 September 2021

The UK’s medicines supply chain is being “severely tested” by fuel shortages according to a trade body representing drugs distributors.

The UK has faced an acute shortage of goods drivers for some time, with fuel supply issues – which may be driven to some extent by consumer panic – also receiving widespread coverage in recent days.

Concerns have been raised around how the UK’s medicines supply chain may be affected, with the National Pharmacy Association’s Gareth Jones commenting that “deliveries to some pharmacies have been reduced” with NPA members “working hard to ensure the impact on patients’ access to treatment is currently limited”.

Royal Pharmaceutical Society president Claire Anderson said: “As normal, pharmacists are working with patients to ensure they get the medicines they need. We’re not aware that the problems with fuel supplies are stopping patients getting their medicines.”

Commenting on the present difficulties, Healthcare Distribution Association chief executive Martin Sawer said that while wholesalers have business continuity plans to maintain medicine deliveries “these arrangements are currently being severely tested, as fuel supplies are not as available as we would like from normal sources”.

“HDA knows that some normal delivery schedules for medicines could be disrupted for most of this week, but every effort will be made to fulfil orders. HDA members are grateful for the patience and understanding being displayed by their customers.”

Mr Sawer said that to maintain an effective supply chain distributors’ transport fleets should be given priority access to fuel “principally at petrol stations”, adding that the HDA “is in urgent talks with the UK Government on this specific issue”.

Another “critical” issue is maintaining regular deliveries of medicines to wholesaler warehouses, Mr Sawer said.

AAH ‘not facing any issues’

Despite Mr Sawer’s warning a spokesperson for AAH told Pharmacy Network News it was not experiencing any difficulties: “AAH does not rely on forecourts to supply fuel for our medicines distribution system, so we are unaffected by current consumer buying patterns.

“In line with the current national picture for most logistics organisations, we do face challenges with driver recruitment. However, AAH is not currently facing any issues with medicines supply to our customers.”

Alliance: Fuel supply a ‘challenge’

Meanwhile, Alliance Healthcare told PNN it was “striving for business-as-usual service,” saying that despite driver shortages “we are seeing success from our continued recruitment drive”.

“The national fuel supply challenge, along with continued driver shortages, is a current challenge within the UK and we are working with all stakeholders on various initiatives to mitigate any potential impact to our normal operating schedule,” an Alliance spokesperson said.

“We continue to inform our customers proactively on this on-going situation and thank them for their patience and understanding at this time.”

Phoenix Healthcare Distribution did not respond to requests for comment.

Northern Ireland could face medicine shortages after Brexit grace period ends next year, report claims
INews, David Parsley, 27 September 2021

Leading pharmaceutical research firm finds some drug firms will withdraw up to 90 per cent of their products from Northern Ireland as protocol hits exports

Statins and diabetes drugs are among the medicines threatened with shortages in Northern Ireland at the beginning of next year, a leading medical research group has claimed.

Informa Pharma Intelligence warns some pharmaceutical companies may withdraw up to 90 per cent of their products from the Northern Ireland market due to the uncertain and high-cost imposition of new quality-check procedures as the Brexit grace period ends.

The analysis focuses on the uncertain regulatory position of Northern Ireland, which is governed by the protocol that binds it to European Union single market practices and regulations, yet is still part of the UK.

The report highlights that the additional costs of implementing new regulatory procedures after the end of the grace period for batch testing drugs, which ends at the start of 2022, could threaten the ability of manufacturers of low-cost generic drugs to export to Northern Ireland from within the UK.

It presents a stark warning for policymakers ahead of the 1 January deadline. Much of the concern among drug manufacturers was due to the lack of a clear political solution, the report says.

While the EU has signalled its solution, Informa believes the UK is unlikely to accept any resolution that ties its Medicines and Healthcare products Regulatory Agency (MHRA) too closely to the European Medicines Agency (EMA).

Shortages of critical drugs to treat conditions ranging from high blood pressure to cancer would be an additional consequence for Northern Ireland, which has already suffered from food shortages and empty supermarket shelves since the UK left the EU at the beginning of last year.

Ian Schofield, executive editor of Pharma Insights at Informa, said: “The Brexit vote, and the UK’s stance on leaving the single market, forced a separation between the UK’s MHRA and the EMA.

“Whilst the separation itself is a lengthy process that requires a re-evaluation of each detail of the UK’s drug approval processes, the impact of the Northern Ireland protocol remains an ongoing area of tension with potentially significant impacts on the availability of generic drugs to Northern Irish citizens.

“Worryingly, an easy solution to this is not forthcoming even with the deadline fast approaching.”

The EU granted the UK a grace period at the end of the Brexit transition whereby the current regulations for quality-checking medicines in Great Britain before release to the Northern Ireland market remain in place and batch release can be authorised by UK agencies.

The grace period has been unilaterally extended for an indefinite period – but this does not apply to the pharmaceutical drugs market, according to Informa.

From 2022 companies that want to export from Great Britain to Northern Ireland will have to establish specific batch control and release facilities in Northern Ireland that meet EU standards.

This is to ensure adherence to the Northern Ireland Protocol and to assure the EU that any drugs that are placed on the Northern Ireland market follow the same regulatory processes that are in place across the EU single market.

Mr Schofield added: “Adherence to these rules is likely to be expensive, particularly for generics companies with high-volume, low turnover products, as they will need to foot the cost of compliance.

“Some companies say they may have to withdraw up to 90 per cent of their medicines from the Northern Ireland market as EMA standards add an extra quality control burden and cost.

“This could threaten the access of these companies to the Northern Ireland market, and more importantly the ability of Northern Irish citizens to purchase generic drugs.”

The Government claimed its indefinite extension of the Brexit grace period earlier this month would cover the import of medicine into Northern Ireland.

A spokesman for the Department of Health and Social Care said: “Under the standstill all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines.

“Though there are different original end dates for the grace periods, the extension applies to all of them.”

However, Mr Schofield disagrees with the Government’s interpretation of the extended grace period.

He said: “This is a different grace period relating to the imposition of customs checks on trade in agrifood products. They were supposed to take effect earlier this year but their introduction was deferred in March and then again in June.

“The grace period for pharmaceutical batch testing and release is a separate issue.”

Simon Sutcliffe, a customs expert at tax and advisory firm Blick Rothenberg also said the Government’s claim that the grace period extension covered pharmaceutical drugs was wrong.

He added: “It is a separate issue, as although pharma is indeed part of the Northern Ireland Protocol and is part of the Command Paper extension attempt from Lord Frost – in which he tried to include pharma – there has been no real response from the EU on the issue.

“Pharma is part of a separate legislative framework for approving and licensing medicines that it seems could only be extended if pharma was removed from the Protocol – and that is why it seems a grace period cannot cover it as it does with customs controls on other items.

“The whole grace period extension does not cover pharma, and because at the moment Northern Ireland health is under the care of Great Britain for most of its medicine approvals and supply, that will and must change.

“Medicines are already being notified for withdrawal from Northern Ireland because six months month notice is required to withdraw them.”

Informa is an independent medical market insights company that works in over 175 countries and with 20,000 pharmaceutical companies that manage more than 348,000 clinical trials for over 1,400 diseases.

HDA UK Media and Political Bulletin – 28 September 2021

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