News

HDA UK Media and Political Bulletin – 21 September 2021

Media Coverage

Roll out of Covid boosters and teenage jabs could be delayed by CO2 shortage
iNews, David Parsley, 20 September 2021

iNews reports that the rollout of the Covid vaccine to teenagers and those receiving booster jabs will be disrupted due to the shortage of CO2 gas.

The Pfizer vaccine requires storage and transportation at ultra-cold temperatures requiring  large amounts of CO2.

The article suggests that officials are monitoring supplies of the gas, however, they are unable to guarantee that the vaccine rollout will not be interrupted by the shortage of products such as dry ice, made from CO2.

A senior scientific adviser to the Government claimed that in order to protect the vaccine rollout, the new Parliamentary Under-Secretary of State for Covid-19 Vaccine Deployment, Maggie Throup, must redistribute CO2 from other sectors of the economy. However, this could result in shortages in other areas including in hospitals.

Additionally, the advisor said that unless the Government could “lay it hands on enough CO2 for the vaccines” it could be forced to move to Plan B.

A Government spokesperson stated: “We are confident the COVID-19 vaccination programme will not be impacted by this issue.”

Additionally, the spokesperson said the government is continuing to monitor supplies across critical sectors and is in regular contact with health and care sectors on their CO2 supplies.

Q&A: The NI Protocol medicines issue explained
BBC News NI, John Campbell, 18 September 2021

Following the recent criticism from the British Generic Manufacturers Association (BGMA), BBC News NI has published an explainer article on on the supply of medicines from Great Britain to Northern Ireland under the Northern Ireland Protocol.

The article highlights that some firms intend to stop supplying some medicines to Northern Ireland because of the expensive new regulatory processes. By the end of August, the health department had been notified that 910 medicines were due to be withdrawn, with a further 2,400 at risk.

Many off-patent generic drugs are manufactured in the UK and cannot be sourced in the single market to avoid the additional quality control process.

In July, the EU published a paper which stated: “Adapting supply chains to the new situation is still particularly challenging, in particular for suppliers of generics.”

European Commission Vice President Maroš Šefčovič said it was his top priority that people in Northern Ireland continue to get the medicines they need.

The British Generic Manufacturers Association (BGMA) said: “In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

In its July command paper, the UK government said that given “the range and depth” of the challenges around this issue, “the simplest way forward may be to remove all medicines from the scope of the protocol entirely”.

This was also reported by P3 Pharmacy.

 

Parliamentary Coverage

 Lord Kamall has been appointed as the new Parliamentary Under Secretary of State (Minister for Innovation), replacing Lord Bethell.

 

Full Coverage

Roll out of Covid boosters and teenage jabs could be delayed by CO2 shortage
iNews, David Parsley, 20 September 2021

The Government has refused to rule out that the rollout of the Pfizer Covid vaccine to teenagers and those receiving booster jabs will be disrupted due to the shortage of CO2 gas.

Officials are monitoring supplies of the gas “across critical sectors” but, despite several request to do so, they failed to guarantee the vaccine rollout would not be delayed by the shortage of crucial cooling products such as dry ice, which is made from CO2.

The Pfizer vaccine, which is due to be given to 12- to 15-year-olds and those receiving boosters from this week, requires storage and transportation at ultra-cold temperatures that requires large amounts of CO2.

One senior scientific adviser to the Government told I that in order to prevent a collapse of the jab rollout the new Parliamentary Under-Secretary of State for Covid-19 Vaccine Deployment, Maggie Throup, will have to divert as much CO2 as it she from every other sector of the economy.

This could, in turn, lead to shortages in hospitals and right across the economy with food, drink and hospitality businesses losing out if the Government prioritises the vaccine rollout. Energy supplies are also under pressure.

The scientist added that unless the Government could “lay it hands on enough CO2 for the vaccines” then its Plan A for the winter, which relies on the vaccination programme, would be “blown out of the water” and it could be forced to move to Plan B immediately.

It would result in measures such compulsory face masks inside public areas and on transport, social distancing and working from home, for those who can, being enforced.

The government has begun distributing the Pfizer vaccine across the country to jab around three million teens at school pop-up centres with an initial 1.5 million people making appointments for their third jab.

However, the vaccine needs to be kept at -70 degrees centigrade, but there is growing concern that there will not be enough CO2 to produce the dry ice to maintain such a low temperature in trucks due to deliver millions of vaccine vials across the UK.

The latest vaccine rollout is the primary defence against Covid in Boris Johnson’s Winter Plan to keep the NHS from being overwhelmed by the pandemic and other traditional cold weather illnesses.

In May, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorised the storage of undiluted, thawed vials of the Pfizer vaccine for up to one month at refrigerator temperatures, but if CO2 shortages continue the delivery and storage of the required amounts of vaccine from manufacturing plants across Europe to complete the vaccination of young teens and booster recipients could be threatened.

The UK Government has order 135 million Pfizer doses since the pandemic began, but the vast majority of these are yet to be delivered.

In order to vaccinate teenagers and give the initial third booster jabs to older, more vulnerable people, the Government requires 4.5 millions doses. In order to provide all over 50s with a booster the Government will require a further 20 million Pfizer vaccines to be delivered into the country.

A Government spokesperson said: “We are confident the COVID-19 vaccination programme will not be impacted by this issue.

“We continue to monitor supplies across critical sectors and are in regular contact with industry, food and health and care sectors on their CO2 supplies.”

Q&A: The NI Protocol medicines issue explained
BBC News, John Campbell, 18 September 2021

A body representing some UK pharmaceutical firms has warned that an EU plan to guarantee the supply of medicines from Great Britain to Northern Ireland is unworkable.

BBC News NI has examined what is behind the matter.

Why is the supply of medicines an issue?

It is a consequence of the protocol, the Northern Ireland Brexit deal agreed by the UK and EU.

It leaves Northern Ireland in the EU’s single market for goods, a market which includes medicines.

The protocol means that goods can flow freely between the Republic of Ireland and Northern Ireland but goods arriving into Northern Ireland from the rest of the UK are subject to controls and checks to ensure they comply with EU standards.

‘Patients at risk’ if medicines withdrawn from NI

What next for the Northern Ireland Protocol?

Northern Ireland gets most of its medicines from distributors and manufacturers in GB but, due to a “grace period”, controls have not yet been imposed on the movement of those products.

That grace period was due to expire in January, but the UK government has indefinitely extended it.

Nonetheless, some firms had notified Stormont’s Department of Health that they intended to stop supplying some medicines to Northern Ireland at the end of the grace period because they would have had to comply with expensive new regulatory processes to put GB-sourced products on the market in Northern Ireland.

By the end of August, the health department had been notified that 910 medicines were due to be withdrawn, with a further 2,400 at risk.

What was due to happen at the end of the grace period?
A fundamental part of the EU’s medicines regulation is that products being imported to the single market undergo quality control or “batch testing” at a facility inside the single market.

In practical terms, this would mean most products entering from GB would have to undergo batch testing at laboratories in Northern Ireland, a new and significant expense.

Additionally, anyone responsible for placing those products on the market in Northern Ireland, primarily wholesalers, would need to obtain what is known as an EU “manufacturing authorisation”.

This also requires the oversight of what is known as a “qualified person”.

Finally, medicines to be distributed in Northern Ireland would have different regulatory labelling requirements from those for sale in GB.

All this adds up to a separate quality control, distribution and labelling system for Northern Ireland.

Why not just get the medicines direct from the EU?
The EU did intend the grace period to be used for supply lines to change in this way.

A senior UK official told the BBC that some firms have been planning for this, but that it is only an option for a limited number of products, specifically branded on-patent medicines.

Many of these medicines are manufactured in the EU, particularly Belgium, France and Germany.

The products could be shipped directly to Ireland and on to Northern Ireland, never entering GB, so no additional quality control processes would be required.

Additionally, the manufacturers would ask: “Do we already have EU-compliant English language packaging for these drugs?” If they are sold in Ireland the answer is “yes” so there would be no requirement to create Northern Ireland-specific packaging.

This would, however, mean that some products or pack sizes would not be available if they were not already sold in Ireland.

But the real problem concerns off-patent generic drugs, which are very widely used in the UK health service.

Many of these products are manufactured in the UK with no option to source them in the single market and so avoid the additional quality control process.

Furthermore, Ireland makes much less use of generics so there would be a bigger requirement to have Northern Ireland-specific packaging.

Generic medicine is a lower profit margin business so the companies are not keen on taking on the extra cost of supplying a very small market like Northern Ireland.

It is no surprise, therefore, that generics manufacturers have been most concerned about the protocol.

What has the EU proposed?

In July, the EU publicly acknowledged there was a problem, publishing a paper which stated: “Adapting supply chains to the new situation is still particularly challenging, in particular for suppliers of generics.”

Its big idea is that rather than having those regulatory processes like batch testing happening in Northern Ireland they can happen in GB, at the manufacturer’s labs.

This would require a change to EU law, with draft legislation expected to be published within the next few weeks.

This would be subject to certain conditions, including EU-compliant labelling for Northern Ireland products and “enhanced enforcement” in the Northern Ireland market.

European Commission vice president Maroš Šefčovič briefed Northern Ireland party leaders on the plan during his recent visit and said it was his top priority that people in Northern Ireland continue to get the medicines they need.

Problem solved?

The generics manufacturers do not agree.

They say that “it hammers home” the need for a separate and specialised Northern Ireland product distinct from a GB one so the additional complexity and cost remains.

The British Generic Manufacturers Association said: “In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

A senior UK official also pointed to the fact that companies were continuing to notify Stormont of the intent to discontinue products in Northern Ireland well after the EU had published its proposal, suggesting industry is not confident it will work.

What does the UK propose?

In its July command paper, the government said that given “the range and depth” of the challenges around this issue, “the simplest way forward may be to remove all medicines from the scope of the protocol entirely”.

HDA UK Media and Political Bulletin – 21 September 2021

From Factory to Pharmacy

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