News

HDA UK Media and Political Bulletin – 21 December 2021

Media Coverage

European Commission proposal guarantees stable supply of medicines in Northern Ireland
Pharmacy Business, Editorial Staff, 20 December 2021

Pharmacy Business reports that the European Commission is prepared to rewrite European Union law on medicines to ensure a stable supply of generic and life-saving medicines in Northern Ireland. This will mean that the same medicines will continue to be available at the same time across the UK.

Helga Mangion, a Policy Manager at the National Pharmacy Association (NPA) said: “We are encouraged by the EU’s statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland.”

The Commission proposes that generic medicines will be authorised under UK procedures, in compliance with EU substantive rules on medicinal products. Patients in Northern Ireland will also continue to have access to novel, innovative life-saving medicines at the same time as their counterparts in other parts of the UK, as part of a “bridging solution”, until the relevant authorisation is also given in the EU.

No manufacturing authorisation or import license will be required for bringing medicines into Northern Ireland from the rest of the UK, and the EU medicine unique identifiers will not need to be removed from prescription medicines that transit through GB to NI for the next three years.

“Record numbers” of lateral flow tests sent to pharmacies amid supply issues
The Pharmaceutical Journal, Carolyn Wickware, 20 December 2021

The Pharmaceutical Journal reports that the UK Health Security Agency (UKHSA) has said that community pharmacies in England received “record numbers” of lateral flow test (LFT) kits during the week of 13 December 2021, despite the supply chain issues.

Contractors offering the “Covid-19 lateral flow device distribution service” reported a surge in the demand for LFT kits following the Prime Ministers address on the threat of the Omicron variant and the announcement that fully vaccinated contacts of people with a positive PCR test were required to take a LFT each day for seven days.

A spokesperson from the UKHSA said that the supply chain issues pharmacies faced “is being resolved and normal service will resume shortly”. They continued that “there is no shortage of free rapid tests and there are a range of ways that people can get them”.

Alastair Buxton, Director of NHS Services at PSNC said on 20 December 2021 that the PSNC had been told by UKHSA “that more LFTs arrived with Alliance [England’s only supplier of LFTs to community pharmacies] over the weekend, with more on the way today, and so these should start to arrive in pharmacies today [on 20 December 2021]’. He added: “This should start to ease supplies … but of course, availability will also depend on whether patient demand for tests continues at inflated rates.”

Parliamentary Coverage

There was no parliamentary coverage today. 


Full Coverage

European Commission proposal guarantees stable supply of medicines in Northern Ireland
Pharmacy Business, Editorial Staff, 20 December 2021

The European Commission is prepared to rewrite European Union law on medicines to ensure stable supply of generic and life-saving medicines in Northern Ireland.

In a press statement issued on Friday (Dec 17), the commission said it put forward a package of measures to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland.

In the context of the Northern Ireland Protocol, this means that the same medicines will continue to be available at the same time across the United Kingdom.

Commenting on the news, policy manager at the National Pharmacy Association (NPA) Helga Mangion said: “We are encouraged by the EU’s statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland.”

She added that the NPA has always been concerned that “additional costs and complexity of getting medicines into Northern Ireland” could dissuade drug firms and suppliers into not bringing products to the market, “leading to medicine shortages and an increase in procurement costs.

“Manufacturers have been informing the government of their intention to withdraw hundreds of medicines from the market in Northern Ireland.”

The commission said the proposed bespoke solution was reached after substantial discussions between former UK cabinet office minister David Frost and European Commission vice-president Maroš Šefčovič, which took into account concerns raised by various stakeholders.

Šefčovič said: “I promised to do whatever it takes to ensure the continued supply of medicines to Northern Ireland, even more so in light of these challenging times of the pandemic… I am convinced that the issue of medicines shows that the EU and the UK can work together for stability and prosperity of all communities in Northern Ireland. It also shows that the Protocol has the flexibility to work on the ground. To strengthen its opportunities, we must now carry this momentum into the other areas of discussion.”

Generic medicines

As per the commission proposals, generic medicines will be authorised under national UK procedures, in compliance with EU substantive rules on medicinal products.

Pharmaceutical companies will have the option of choosing either the UK authorisation process or an EU Member State procedure.

If companies opt for the UK national procedure, the UK regulator will not have to agree the terms of the authorisation with the EU member state authorities and will be solely in charge.

In such a scenario, authorisation by the UK regulator could allow companies located in Great Britain to use a single pack and single leaflet when supplying markets in Great Britain and Northern Ireland. There would be no need for separate packaging.

All regulatory functions will remain wherever they are now in the UK. This means that there is no need to relocate any regulatory functions or testing facilities from Great Britain to Northern Ireland. Batch testing carried out in the EU does not need to be repeated when medicines are brought into Northern Ireland through Great Britain.

Innovative medicines

Patients in Northern Ireland will continue to have access to novel, innovative life-saving medicines at the same time as their counterparts in other parts of the UK.

A ‘bridging solution’ will allow any new medicine authorised in the UK to be supplied to Northern Ireland, until the relevant authorisation is also given in the EU.

Those temporary authorisations should be time limited and cease once a decision on the medicinal product is taken at EU level.

This covers any medicine that may need to undergo assessment by the European Medicines Agency and be authorised by the European Commission.

The ‘bridging solution’ is in addition to the existing compassionate and emergency use early access mechanisms under EU law.

Supply procedures

No manufacturing authorisation or import license will be required for bringing medicines into Northern Ireland from the rest of the United Kingdom.

In addition, EU medicine unique identifiers – that ensure prescription medicines are genuine – will not need to be removed from prescription medicines that transit through Great Britain to Northern Ireland for another three years.

This is a derogation from the rule that unique identifiers must be removed when prescription medicines leave the EU and are exported to a third country. This will avoid the need for affixing a new identifier when those medicines enter Northern Ireland from Great Britain and will allow more time for the industry to adapt.

“Record numbers” of lateral flow tests sent to pharmacies amid supply issues
The Pharmaceutical Journal, Carolyn Wickware, 20 December 2021

The enormous demand for lateral flow tests followed announcements on 13 December 2021, ruling that contacts of people with a positive COVID-19 PCR test should take a lateral flow test each day for one week.

Community pharmacies in England received “record numbers” of lateral flow test (LFT) kits during the week of 13 December 2021, despite supply chain issues, the UK Health Security Agency (UKHSA) has said.

Contractors offering the ‘COVID-19 lateral flow device distribution service’ reported a surge in demand for LFT kits following the prime minister’s televised address on the threat of the Omicron variant on 12 December 2021.

The government announced on the same day that fully vaccinated contacts of people with a positive COVID-19 polymerase chain reaction (PCR) test were required to take a LFT each day for seven days, in lieu of self-isolating.

Then, on 14 December 2021, pharmacy leaders said that they had heard from “numerous contractors” that pharmacy supplies of LFT kits were unable to keep up with public demand.

However, a spokesperson for the UKHSA told The Pharmaceutical Journal on 20 December 2021 that “over 11 million test kits [were] sent to pharmacies across the UK” in the week beginning 13 December 2021 adding that the supply chain issue pharmacies faced “is being resolved and normal service will resume shortly”.

“There is no shortage of free rapid tests and there are a range of ways that people can get them to help combat the spread of COVID-19,” the spokesperson said.

A statement on the Pharmaceutical Services Negotiating Committee (PSNC) website published on 17 December 2021 clarified that the 11 million test kits sent to pharmacies had “doubled” from the previous week.

Alastair Buxton, director of NHS services at PSNC, said on 20 December 2021 that the PSNC had been told by UKHSA “that more LFTs arrived with Alliance [England’s only supplier of LFTs to community pharmacies] over the weekend, with more on the way today, and so these should start to arrive in pharmacies today [on 20 December 2021]’.

“This should start to ease supplies … but of course, availability will also depend on whether patient demand for tests continues at inflated rates.”

On 19 December 2021, a service update from Alliance Healthcare said the “unprecedented demand for lateral flow test kits from people testing due to the Omicron variant, combined with precautionary testing before the Christmas period, continues”.

The ‘COVID-19 lateral flow device distribution service’, also known as ‘Pharmacy Collect’, launched on 29 March 2021 as an advanced service, with LFTs initially distributed by three companies: Phoenix Healthcare Distribution; Sigma Pharmaceuticals; and Alliance Healthcare.

Within the first two and half months of running, pharmacy contractors declared more than 4 million transactions through the Pharmacy Collect scheme to NHS Business Services Authority.

HDA UK Media and Political Bulletin – 21 December 2021

From Factory to Pharmacy

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