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HDA UK Media and Political Bulletin – 6 December 2021

Media Coverage

Brexit stalemate: Frost issued dire warning over Article 16 move
The Express, Aleks Phillips, 5 December 2021

The Express reports that Martin Sawer, Executive Director of the HDA, has told the publication that the UK’s access to medicines manufactured globally would be affected by UK regulations diverging from those of the EU.

Mr Sawer commented that “unilateral approaches” to the issue “might be okay, for medicine supply, but just in the short term.” He continued “but in the longer term – I’m talking in six months or more – the repercussions for medicines access, for the whole of the UK would be affected.”

“… The repercussions of where manufacturers make their medicines, where they might get them licensed, where they might decide to supply will be much more negatively affected by, you know, an Article 16 or a unilateral change in the longer term than an agreement with the EU.”

He stated: “If there’s regulatory simplicity, then it’ll make us have access to more medicines, you know, and more healthcare going forward. And I’m not necessarily talking about medicines we already have, I’m talking about new ones coming on stream in the future.”

Brexit Britain win in sight as deal with EU over medicines ‘nearly there’
The Express, Aleks Phillips, 4 December 2021

The Express reports that Martin Sawer, Executive Director of the HDA told the publication that an agreement on medicines supplies for the Government was “almost their number one priority”.

Mr Sawer said it was the “main concern” of medicine suppliers in Britain to ensure medicines going to Northern Ireland remained consistent with the rest of the UK, as splitting them would cost “millions of pounds”.

He said that an agreement with the EU on medicines was needed to make sure that patients in Northern Ireland continue to get the same range of medicines as the rest of the UK.

He continued “I do know that the UK Government has been engaging with the supply chain really well on this front because I’m part of that engagement; and the UK Government, they have it as almost their number one priority – medicines and healthcare, generally – to make sure that the patients in Northern Ireland are not inconvenienced at all.”

Parliamentary Coverage

There was no parliamentary coverage today. 


Full Coverage

Brexit stalemate: Frost issued dire warning over Article 16 move
The Express, Aleks Phillips, 5 December 2021

Speaking to the Express, Martin Sawer, chief executive of the Healthcare Distribution Association, said that the UK’s access to medicines manufactured globally would be affected by UK regulations diverging from those of the EU. However, in the immediate future, medicine supply to Northern Ireland would remain “business as usual” in an Article 16 scenario.

He commented: “If there’s regulatory simplicity, then it’ll make us have access to more medicines, you know, and more healthcare going forward.”

It comes as medicine is proving to be a key sticking point in renegotiations of the Northern Ireland Protocol, with Brexit Secretary Lord Frost discussing the matter with Maros Sefcovic, European Commission vice president, on Friday.

The UK Government has threatened to trigger Article 16 if negotiations were unable to provide an agreement that would stop EU checks on goods flowing to Northern Ireland from the rest of the UK causing delays.

Mr Sawer commented that “unilateral approaches” to the issue “might be okay, for medicine supply, but just in the short term.”

“But in the longer term – I’m talking in six months or more – the repercussions for medicines access, for the whole of the UK would be affected.”

He explained: “Medicines manufacturer is a global business. The medicines manufacturers are going to be much more interested in 27 countries where they can have one type of license than the old UK, even if Northern Ireland is bolted on to the rest of the UK.

“There’s an economic and regulatory decision here and global manufacturers in whatever sector would rather have harmony in the trade world, if you see what I mean, than discord.”

Mr Sawer cautioned that “the repercussions wouldn’t happen straight away.

“But one, two, 10 years hence the repercussions of where manufacturers make their medicines, where they might get them licensed, where they might decide to supply will be much more negatively affected by, you know, an Article 16 or a unilateral change in the longer term than an agreement with the EU.”

Currently, the medicines available in the UK are largely the same as those in the EU.

Lord Frost has been sympathetic to an equivalence arrangement with the EU when it comes to food safety, in which the bloc recognises the UK as having equivalent food production standards to its own.

And last week, Mark Samuels, chief executive of the British Generic Manufacturers Association, called for a UK-wide license for medicines to avoid “a force nine gale heading Northern Ireland’s way”.

Mr Sawer said that the Medicines and Healthcare products Regulatory Agency (MHRA) would like to “maintain” a link with Europe.

He said: “I think the MHRA and the regulators would like that in principle to continue because it would mean that manufacturers would feel comfortable; they’ll have packs which are UK and the EU, you know, so they can make a pack that’s pretty similar in all respects.

“As soon as we start diverging from that, because we might have triggered Article 16 because of Northern Ireland five years before, means that there’s a longer-term impact that we can’t really foresee yet. But certainly that I know that global manufacturers are concerned about that.”

He stated: “If there’s regulatory simplicity, then it’ll make us have access to more medicines, you know, and more healthcare going forward. And I’m not necessarily talking about medicines we already have, I’m talking about new ones coming on stream in the future.

“You can imagine decisions that might get made if we’re not in agreement and alignment with EU.”
However, he noted that because Article 16 provided that regulatory simplicity in the short term – by maintaining the status quo – the medicines supply chain would remain unhindered.

On the other hand, if EU rules were to come in for Northern Ireland, supply chain distributors, which Mr Sawer represents, would have to split medicines in a regulatory sense, so that ones headed for Northern Ireland complied with EU standards.

This would lead to fewer medicines being available in Northern Ireland – as has already been forecast – as manufacturers would not want to create specific medicine lines for such a small populous.

Mr Sawer added it was the “main concern” of medicine suppliers to ensure medicines going to Northern Ireland remained consistent with the rest of the UK, as splitting them would cost “millions of pounds”.
He commented: “If Article 16 came in, it would keep one pack initially. So we’d be fine with our distribution. “I’m not saying the wider picture for manufacturers is not so great. But for us, that would be business as usual, largely, certainly to start with.

He added: “An agreement with the EU might mean we’ve got to do something different depending on what our agreement means, but we’ve made it very clear that having two separate packs isn’t really an option yet. Operationally and physically and practically, we can’t do that.

“The EU’s understood and accepted that and they’ve said: ‘we’d like to try and keep one pack valid for [Great Britain] and Northern Ireland at the moment’. We don’t know how that’s going to work regulatory wise, and that’s what we’re waiting to see.”

Brexit Britain win in sight as deal with EU over medicines ‘nearly there’
The Express, Aleks Phillips, 4 December 2021

Martin Sawer, chief executive of the Healthcare Distribution Association, told the Express that an agreement on medicine supplies for the Government was “almost their number one priority”. It comes as Brexit Secretary Lord Frost met Maros Sefcovic, European Commission vice president, on Friday to discuss the matter.

So far the free flow of medicines to Northern Ireland from the rest of the UK is proving a sticking point in negotiations.

The Northern Ireland Protocol leaves the country in the single market, allowing goods to flow between it and the rest of the EU without checks.

But, Northern Ireland gets most of its medicines from the rest of the UK, so any checks on the flow of medicines across could lead to shortages in supply.

Mr Sawer explained that only around 30 percent of Northern Ireland’s medicines – the most commonly needed – are stored in the country.

The rest are ferried over twice a day from Scotland to Belfast and would get easily tied up by any border checks or red tape.

Simon Coveney, the Republic of Ireland’s foreign affairs minister, said on Wednesday it had been “difficult to make progress” on the issue.

Mr Sefcovic this week threatened a unilateral move on the part of the EU, ahead of the meeting with Lord Frost.

Mr Sawer said that Lord Frost “publicly is putting pressure on the EU”, but the statements by him and his EU counterparts were mostly “sabre-rattling.

“What the actuality is probably slightly different.

“I think the officials understand the importance of both sides and that alignment is critical. And I think they’re nearly there.”

He added: “Both sides are pushing for an agreement because they feel that that would be the right thing to do at the moment.

“And they are talking, you know, they’re having a lot of talks.”

If EU rules were to come in for Northern Ireland, supply chain distributors, which Mr Sawer represents, would have to split medicines in a regulatory sense, so that ones headed for Northern Ireland complied with EU standards.

This would lead to fewer medicines being available in Northern Ireland – as has already been forecast – as manufacturers would not want to create specific medicine lines for such a small populous.

Mr Sawer added it was the “main concern” of medicine suppliers in Britain to ensure medicines going to Northern Ireland remained consistent with the rest of the UK, as splitting them would cost “millions of pounds”.

It was because of this potential that “we do need some sort of agreement with the EU on medicines, to make sure that patients in Northern Ireland continue to get the same range of medicines that we do in the rest of the UK.

“I do know that the UK Government has been engaging with the supply chain really well on this front because I’m part of that engagement; and the UK Government, they have it as almost their number one priority – medicines and healthcare, generally – to make sure that the patients in Northern Ireland are not inconvenienced at all.

“I think the EU now recognises that and also understands there are complications on the regulatory front, and it is very complicated, that would have meant […] there would have been a no challenges to produce the same range in Northern Ireland because it would just be uneconomic to do so under the regulatory regime of the EU, as applied to Northern Ireland.”

Controls have yet to be imposed on goods flowing into Northern Ireland due to a “grace period” after the UK left the EU.
This period was set to expire in January, but the Government has extended it indefinitely to allow for talks.

During a visit to London earlier this week, Mr Coveney said he believed “some things can be agreed this side of Christmas, hopefully, like giving certainty to people in Northern Ireland in terms of the supply of medicines from Great Britain into Northern Ireland.”

He added: “It’s been difficult to make progress, but I think there has been some progress.”

HDA UK Media and Political Bulletin – 6 December 2021

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