HDA UK Media and Political Bulletin – 25 October 2021

Media Coverage

Boris Johnson will refuse compromise with Brussels over European Court of Justice
The Telegraph, Edward Malnick, James Crisp, Mason Boycott-Owen, 23 October 2021

The Telegraph reports that Boris Johnson will refuse to allow a compromise with Brussels that would give the European Court of Justice (ECJ) a continued role policing the Northern Ireland Protocol. This comes following reports that the UK would back down over Lord Frost’s demands regarding the ECJ’s presence in Northern Ireland.

A negotiation team from the European Commission is due to travel to London on Tuesday for discussions on Northern Ireland. A Government source said: “Whether we’re able to establish that momentum soon will help us determine if we can bridge the gap or if we need to use Article 16 to safeguard the Belfast (Good Friday) Agreement.”

Concern over access to medicines for Northern Ireland continue, with industry officials warning that companies could forgo the Northern Ireland market, which continues to follow EU pharmaceutical rules under the Protocol, as additional costs make it economically unviable.

The European Commission has offered to change EU law so the NHS in Northern Ireland could continue to receive generic drugs from Britain following the end of the grace period and allow for a single UK market authorisation for existing medicines. However, there is no similar concession for new treatments including generic medicines, as well as some medicines such as cancer drugs which must be authorised by the pan-EU European Medicines Agency.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Boris Johnson will refuse compromise with Brussels over European Court of Justice
The Telegraph, Edward Malnick, James Crisp, Mason Boycott-Owen, 23 October 2021

Boris Johnson will refuse to allow a compromise with Brussels that would give the European Court of Justice a continuing role in policing the Northern Ireland protocol, it has emerged.

A Government source denied speculation that the UK could back down over an insistence by Lord Frost, the Cabinet Office minister, that the role of the Luxembourg court should be eliminated altogether from the agreement over the goods trade on the island of Ireland.

The intervention followed claims that Mr Johnson was prepared to accept a limited role for the court in a bid to reach a new deal with the EU over the protocol.

But a Government source said: “There’s been plenty of speculation about governance this week but our position remains unchanged: the role of the European Court of Justice in resolving disputes between the UK and EU must end.”

The source described last week’s talks as “constructive”, but added: “The reality is that we are still far apart on the big issues, especially governance.

“We need to see real progress soon rather than get stuck in a process of endless negotiation because the issues on the ground in Northern Ireland haven’t gone away.”

Lord Frost, the Cabinet Office minister, and his EU counterpart Maros Sefcovic are expected to meet on Friday to discuss whether the talks suggest they will be able to “bridge the gap” between the two sides.

Earlier this week fears were raised over items such as British Christmas crackers which could face burdensome regulations for those wanting to export to Northern Ireland because of Brexit and the Irish Sea border.

A negotiating team from the European Commission is due to travel to London on Tuesday for discussions on Northern Ireland, where substantial gaps remain on some of the fundamental issues of the protocol.

“Whether we’re able to establish that momentum soon will help us determine if we can bridge the gap or if we need to use Article 16 to safeguard the Belfast (Good Friday) Agreement,” a Government source said.

Fears that Northern Ireland could be denied access to new drugs

There are further fears over the Protocol’s effect on medicines, as the province could be denied access to new drugs, despite the EU’s latest offer over the supply of drugs after Brexit.

Northern Ireland continues to follow EU pharmaceutical rules under the protocol, which means new medicines could be approved or rejected there but not in the rest of Britain.

Industry has warned officials that companies could forgo the relatively small Northern Irish market rather than applying for authorisation twice for the same country because additional costs make it economically unviable.

“People in Northern Ireland must have access to the full range of medicines as other parts of the UK. Similarly, the Medicines and Health Care Regulator (MHRA) must be able perform its functions effectively throughout the UK,” a Government spokesperson said.

Earlier this month, the European Commission offered to change EU law so the NHS in Northern Ireland could continue to receive cheap generic drugs from Britain once a grace period in the protocol expires at the end of the year.

The commission’s paper allows a single UK market authorisation for existing medicines, which industry and the Government has welcomed.

But there is no similar concession for new treatments, which can include generic medicines that are cheaper than brand-name drugs but have the same effect.

Some medicines, like new cancer drugs, can only be authorised directly by the pan-EU European Medicines Agency, which is not addressed in the commission paper.

A company which gets approval for a drug in a member state, for example Poland, could then also apply for its approval in Northern Ireland.

The MHRA would have no choice but to approve it for Northern Ireland under this procedure, despite having no access to the data behind the decision.

Media Coverage

NI Protocol: ‘More work needed’ on EU medicine proposals

BBC, John Campbell, 20 October

The BBC reports on statements made by HDA Executive Director, Martin Sawer, at a House of Lords committee hearing on Wednesday.

Mr Sawer was invited to give evidence to the Protocol on Ireland/Northern Ireland Sub-Committee on the implications of the Protocol on medicines supply to the region. He was joined by two other industry representatives: Paul Williams, Senior Director of Corporate Affairs at Teva, and Michelle Riddalls, Chief Executive Officer of PAGB, the consumer healthcare association.

Mr Sawer told the committee that the EU proposals for medicines supply into Northern Ireland “have come a long way”, but that there will still be “major hurdles for some companies” particularly around product labelling.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

NI Protocol: ‘More work needed’ on EU medicine proposals

BBC, John Campbell, 20 October

The EU’s proposals to guarantee the flow of medicines from Great Britain to Northern Ireland represents progress but more work is needed, pharmaceutical industry representatives have said.

The NI Protocol means Northern Ireland is still in the EU’s pharmaceutical regulatory system.

However it continues to get most of its medicines from Great Britain which is outside the EU’s system.

This is creating supply complications with some firms based in Great Britain.

The complications have led to some indicating they will stop supplying products to Northern Ireland.

Last week the EU published proposals to tackle the difficulties, which will include changing EU law.

As it currently stands the protocol would mean most products entering from Great Britain 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 a licence or “marketing authorisation”.

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

The EU’s new proposals acknowledge those requirements are too much of a burden and should be removed, subject to some conditions.

Industry representatives have been giving evidence to a House of Lords committee.

Paul Williams, from pharmaceutical firm Teva, said the original protocol would mean separate marketing authorisations would be needed for medicines being sold in Northern Ireland.

He said this would add so much expense that it would no longer be economically viable to for them to sell around half their 600 lines in Northern Ireland.

However he said the EU’s proposals for Northern Ireland to be covered by a single UK marketing authorisation was a significant move.

“One marketing authorisation for the UK for existing treatments was a big concession by the EU, it was a worthwhile concession,” said Mr Williams

“It exhibited a willingness to move on the part of the European Commission.”

However he said there were other areas which had not been addressed, particularly on the licensing of new products.

Mr Williams said the EU’s proposals would mean that new products would still need separate authorisations for GB and Northern Ireland.

‘Major hurdles’

Michelle Riddalls, from the consumer healthcare association, said the EU proposals goes “some way to address our concerns for over-the-counter medicines”.

But she added that there were still issues to be clarified and worked through.

Ms Riddalls said that some of the import requirements from the EU still look like “an impossibility” for smaller businesses.

Martin Sawer, from the Healthcare Distribution Association, said the EU proposals “have come a long way” but there will still be “major hurdles for some companies” particularly round the issue of labelling.

Media Coverage

Covid: Is the pace of the vaccine booster rollout too slow?
BBC News, Jim Reed, 18 October 2021

BBC News reports that 3.7 million people across the UK have received a third Covid jab under the booster vaccine programme. There are 8.5 million people now eligible for a booster if they want it, leaving 4.8 million who have had their second dose at least six months ago but have not yet received their top up.

Actuary John Roberts from the Covid-19 Actuaries Response Group, who have tracked the vaccine rollout says that the shortfall has been growing by about 800,000 a week as more people become eligible.

He told the BBC’s Today Programme: “If you project that [data] forward, then it’s going to probably take us well into January before we get through those first priority groups”.

It is believed that there are about 20 million doses of Pfizer and Moderna vaccines in UK warehouses, and supply is therefore unlikely to be the problem as it was in the pandemic’s early stages. GPs and pharmacists who are administering the bulk of the booster jab programme are also dealing with the major flu vaccine rollout, combined with a general increase in demand for doctor’s appointments

 

Parliamentary Coverage

House of Commons Question – 18 October 2021

Stephen Farry, MP (Alliance): To ask the Secretary of State for Health and Social Care, with reference to the indefinite extension of the grace period in respect of medicines announced on 6 September 2021, what additional steps are required to ensure that imported medicines used in Northern Ireland after 1 January 2022 are fully recognised as compliant under EU law by the European Commission.

Edward Argar, MP (Conservatives): The Government will continue to operate the Northern Ireland Protocol on its current basis until further notice. The existing arrangements will continue, including the current grace period for medicines which means there are no additional steps after 1 January 2022. The Government will ensure that reasonable notice is provided in the event that any of these arrangements are to change, to enable businesses and citizens to make appropriate preparations.

 

Full Coverage

Covid: Is the pace of the vaccine booster rollout too slow?
BBC News, Jim Reed, 18 October 2021

In September, the government’s scientific advisers recommended that everyone over 50 should be offered a third dose of a Covid vaccine, along with frontline medical staff and younger adults with some underlying health conditions.

At the time, ministers called the programme the “last piece of the jigsaw” as the country transitions to living with the virus. Some though are concerned that the speed of the rollout has not been fast enough to best protect the most vulnerable.

How many have received a booster?

A total of 30 million people across the UK will eventually qualify for a third booster vaccine because they are in one of the nine priority groups most at risk from Covid. Only those who received their second dose at least six months ago are being asked to come forward.

Latest data from the NHS shows 3.7 million people in England have been given a third jab under the programme, offering them the fullest protection against the virus this winter.

According to calculations from the actuary John Roberts, from the Covid-19 Actuaries Response Group, which has been tracking the vaccine rollout, there are 8.5 million people now eligible for a booster if they want it.

That leaves 4.8 million who have had their second dose at least six months ago, but have not yet received that top-up.

He says that shortfall has been growing by about 800,000 a week as more people become eligible.
Mr Roberts says his calculations show 46% of those aged 80 or older have now received a third dose, followed by 30% of those aged between 75 and 79.

He told the BBC’s Today Programme: “If you project that [data] forward, then it’s going to probably take us well into January before we get through those first priority groups.

“At the start of the booster campaign, the health secretary Sajid Javid said: ‘We will protect the most vulnerable through the winter months’. But at the current rate it is going to be well through winter before we get through those first groups.”

Scotland and Wales do not currently publish public data on the number of third booster doses given.

In Northern Ireland, the booster rollout has focused mainly on healthcare workers so far, with 5,291 of 82,911 people aged 80 or older given their third jab.

Why might the speed of the rollout matter?

Some research does suggest that, over time, protection from Covid vaccines may fade – or wane.

A study published in September by Public Health England found that vaccine effectiveness against symptomatic Covid fell from 67% in the early weeks after a second dose of the AstraZeneca vaccine, to 47% after 20 weeks.

Protection against severe disease and hospitalisation appeared to hold up better, decreasing from 95% to 77% over the same timeframe.

The UK got off to a fast start with its vaccine programme – jabbing the most vulnerable with first doses ahead of almost every other country in the world.

But that means the UK has a large number of elderly people who were vaccinated earlier and may now be seeing some of that protection fade.

Mr Roberts said: “The latest data from the UK Health Security Agency shows that, for the over-75 population, we are seeing around 500 deaths a week in people who are are fully vaccinated, because we know that the vaccine is very effective against serious illness and death, but not completely effective.”

Since the first injections in December 2020, vaccines have been very effective at preventing hospitalisations and deaths. England’s Deputy Chief Medical Officer Jonathan Van-Tam said last month that the programme had saved 112,000 lives and prevented 24 million cases of Covid.

More recently, Covid infections have been rising again across the UK, although the number of hospitalisations and deaths has remained well below the levels seen in earlier waves.

Why is the rollout not as fast as some hoped?

Working out how much vaccine is in the country is difficult, as the data is commercially sensitive and tends to be tightly controlled. But it’s thought there are now about 20 million doses of Pfizer and Moderna vaccines in UK warehouses, so supply is unlikely to be the problem it was in the pandemic’s early stages.

GPs and pharmacists, who are administering the bulk of the booster jab programme, are also having to deal with a major flu vaccine rollout this autumn, and there has been an increase in demand for doctor’s appointments more generally.

Government adviser Prof Adam Finn, from the University of Bristol, explained: “The [booster] programme is much more complicated now than before.

“Previously it was a straightforward matter of opening up big centres and getting people in across the age cohorts. Now it’s much more complicated with multiple different groups being offered vaccines.

“The booster programme will focus on the highest risk people first – so will see the most elderly and frontline health workers immunised as a priority.”

survey for the World Economic Forum in September suggested that 82% of UK adults of all ages who had already received two doses of a vaccine would take a booster shot if offered – one of the highest rates in Europe, but still below universal take-up.

An NHS England spokesperson said: “The NHS has delivered more than three million boosters in less than a month and at a faster rate than in December 2020.

“While the NHS continues to deliver first and second doses as well as rolling out the vaccine in schools, millions of people are being invited at least six months on from their second jab, which is in line with independent guidance.”

Media Coverage

EU proposes ‘uninterrupted security of supply of medicines’ in new post-Brexit offer
Chemist and Druggist, Emily Stearn, 15 October 2021

The Chemist and Druggist reports that the European Commission has proposed changes to the Northern Ireland Protocol to ensure the long-term “uninterrupted security of supply of medicines” from Great Britain to Northern Ireland.

The proposal will allow pharmaceutical companies in Great Britain “to keep all their regulatory functions where they are currently located” and continue to act as a hub for the supply of generic medicines to Northern Ireland.

Under the current Protocol, manufactures would need to relocate infrastructure such as testing facilities to Northern Ireland or the EU. Following the extension of a grace period to December 31, which allows Great Britain to continue to supply medicines to Northern Ireland, British Generic Manufacturers Association CEO Mark Samuels revealed that 910 medicines had already been discontinued in Northern Ireland.

A three-week deadline for talks on the Commission’s new proposals is anticipated with Brexit Minister Lord David Frost saying that “I personally believe there comes a decision point probably around early November when we know an agreement can be reached or it cannot and certain consequences flow from that.”

 

Parliamentary Coverage

There was no parliamentary coverage today. 

 

Full Coverage

EU proposes ‘uninterrupted security of supply of medicines’ in new post-Brexit offer
Chemist and Druggist, Emily Stearn, 15 October 2021

The European Commission has proposed some changes to the Northern Ireland protocol to ensure the long-term “uninterrupted security of supply of medicines” from Great Britain to Northern Ireland.

Unveiling its “bespoke arrangements” on Wednesday (October 13), the European Commission published four proposals to tackle trade disruption between Great Britain and Northern Ireland following Brexit.

Its fourth proposal, which looks at the long-term supply of medicines from Great Britain to Northern Ireland, would allow pharmaceutical companies in Great Britain “to keep all their regulatory functions where they are currently located” when supplying the Northern Irish market.

The European Commission’s new proposal would enable Great Britain  to continue acting as a hub for the supply of generic medicines to Northern Ireland from January 2022, even though it is now not a member of the EU.

“In this way, the long-term supply of medicines from Great Britain to Northern Ireland  can be ensured,” it said.

The benefits of the new proposals

Currently, under the terms of the protocol, Northern Ireland has remained in the EU’s single market for goods. Since January 2021, the protocol has mandated that Northern Ireland must follow EU medicine regulations.

Under this protocol, manufacturers based in Great Britain would need to relocate infrastructure – including testing facilities – or regulatory functions to Northern Ireland or the EU. This would no longer be the case under the new proposal for medicines, the European Commission wrote in a document laying out the benefits of its proposals.

The current Northern Ireland protocol has a grace period in place until December 31, allowing Great Britain to continue to supply medicines to Northern Ireland, “with a pragmatic approach to applying EU rules on importation and unique identifier requirements”.

The UK extended that grace period unilaterally last month (September 6). A week later, British Generic Manufacturers Association (BGMA) CEO Mark Samuels revealed that 910 medicines had already been discontinued in Northern Ireland, while manufacturers had “formally begun the withdrawal process” for more than 2,400 drugs in total.

“Proposals are our genuine response”

In a statement published on October 13, European Commission vice-president Maros Šefčovič said that the “proposals are our genuine response to their concerns”.

He added: “We have put a lot of hard work into them to make a tangible change on the ground, in response to the concerns raised by the people and businesses of Northern Ireland. We are looking forward to engaging earnestly and intensively with the UK government, in the interest of all communities in Northern Ireland.”

The UK government said it is now studying the detail of the EU’s proposals. But in an interview with POLITICO yesterday (October 14), Brexit minister Lord David Frost said that while  “the EU has made an effort here, there’s quite a long way to go”.

He is expected to meet with Mr Šefčovič in Brussels later today.

Three-week deadline

A three-week deadline for talks on the commission’s new proposals is anticipated, after Lord Frost said, “we need a short and intensive negotiation, and when I say short, I mean weeks, three weeks”, at a Centre for Brexit Policy event at the Conservative Party Conference (October 4).

He added: “I personally believe there comes a decision point probably around early November when we know an agreement can be reached or it cannot and certain consequences flow from that.”

In its proposal, the commission said it will hold further discussions with the UK and stakeholders before finalising any changes to existing rules. This involves the EU changing its own rules on medicines.

In a document published by the UK government on the Northern Ireland protocol in July, it acknowledged that the “current arrangements are creating considerable challenges with medicine supply to patients in Northern Ireland being put at risk for a number of products from the end of 2021”.

It suggested that the “simplest way forward may be to remove all medicines from the scope of the protocol entirely”.

Media Coverage

EU prepares to curb power of judges under revised Brexit deal
The Times, Bruno Waterfield and Oliver Wright, 14 October 2021

The Times reports that the EU’s chief negotiator yesterday outlined proposals to sweep away the majority of checks on goods crossing from Britain to the province under a revised Northern Ireland Protocol.

The EU proposal on medicines outlines a new regulatory landscape where pharmaceutical companies in Britain, when supplying the Northern Irish market, “can keep all their regulatory functions where they are currently located”. This means that Britain can continue acting as a hub for the supply of generic medicines to Ireland and UK medicines can be prescribed in the province.

The UK has previously suggested that all medicines from the Protocol be removed, and questions remains especially with regards to the provision of new cancer drugs or treatments to individuals that are approved in Britain but face hurdles in Northern Ireland.

This was also reported on BBC News and in the Telegraph.

The full EU proposal on medicines can be read here.

 

Parliamentary Coverage

There was no parliamentary coverage today. 


Full Coverage

EU prepares to curb power of judges under revised Brexit deal
The Times, Bruno Waterfield and Oliver Wright, 14 October 2021

The EU is open to a compromise deal that would limit the role of European judges in Northern Ireland in an effort to remove the last significant hurdle to a new Brexit agreement.

Yesterday the EU’s chief negotiator outlined proposals to sweep away the majority of checks on goods crossing from Britain to the province under a revised Northern Ireland protocol.

The plans were farther reaching than had been anticipated by ministers in London, with government figures describing them as encouraging.

Maros Sefcovic, the EU’s negotiator, said that he hoped they would set the two sides on the “home stretch”.

In an attempt to bridge the remaining gaps, The Times understands that the EU is considering a move to restrict the role of Europe’s highest court from the policing of the agreement.

Disputes would go to an independent arbitration panel, with the European Court of Justice asked to interpret narrow matters of EU law as a last resort after dispute resolution has failed. Under the present agreement the commission rules on disputes and if the government does not comply it refers the case directly to the court as an “infringement”.

Lord Frost, the Brexit minister, has already called for a disputes panel to be set up and the hope is that such a model may prove enough to get the deal over the line, despite London’s insistence that the European Court of Justice have no role at all in policing the protocol.

Face-to-face talks between Frost and Sefcovic are due to begin in Brussels in the coming days. The EU stressed that the new proposal did not amount to a “take it or leave it” offer.

“We have put a lot of hard work into this package, explored every possible angle of the protocol, and at times went beyond current EU law,” Sefcovic said. “In effect we are proposing an alternative model for implementation of the protocol.”

A government source said: “From what we have seen so far it looks encouraging. The proposals so far look fairly hopeful and certainly worthy of discussion.”

Goods moving between Britain and Northern Ireland would be subject to about 50 per cent less paperwork while many of the restrictions and checks on British food sold there would be lifted.

The EU is also proposing lifting restrictions on UK medicines being prescribed in the province and establishing a consultative role for Northern Irish institutions in the implementation of the agreement. However, Sefcovic failed to persuade the commission to lift restrictions on pets travelling to Northern Ireland without a costly animal health certificate. This is likely to be subject to further negotiations.

Micheal Martin, the Irish prime minister, described the EU plans as “the obvious way forward” and said that the commission had demonstrated “imagination, innovation, and a listening ear to the people in Northern Ireland”.

The DUP said that they fell “far short of the fundamental change needed”.

A British government spokesman said: “We will look at the proposal seriously and constructively. The next step should be intensive talks on both our sets of proposals, rapidly conducted, to determine whether there is common ground to find a solution.”

Devil in the detail of attempt to solve Northern Ireland protocol
Since it came into operation almost a year ago, the EU has insisted the Northern Ireland protocol was not open for renegotiation. But yesterday, in four papers, Brussels set out proposals that could alter the arrangements and open the door to solving the most intractable of the Brexit problems. What has the EU proposed, how does it stack up against the UK’s demands and how likely does a compromise look?

Customs formalities
EU proposal:
 The EU’s plan suggests it would “cut in half” the documentation needed to move goods between Britain to Northern Ireland. There would be an “express lane” for lorries entering the province with goods not destined for the Republic of Ireland, with minimal forms to fill in. The UK would commit itself to “providing full and real-time access” to its customs systems as well as undertaking “appropriate monitoring and enforcement measures”.

UK position: It would be the responsibility of UK traders moving goods to Northern Ireland to declare whether they were destined for the North or the Republic. Full customs formalities would be required for goods going to the South and the UK would undertake to enforce them. Other goods would not require customs processes. Ministers say the system would be policed on a “risk-based and intelligence led basis”.

Landing zone: The outcome looks positive.

Food and plants checks
EU proposal:
 The plan would set up “a Northern Ireland-specific solution” to reduce the need for checks on food from the UK. This would allow supermarket lorries to submit one form per load, rather than one per product. Goods must have packaging and labelling indicating they are for “UK only” sale. This will allow sales of “prohibited goods” from countries outside the EU, such as the UK, including sausages and lasagne and also garden plants if they cannot be sourced in the EU or Ireland. The EU says the UK must monitor supply chains to stop imports from South America, Africa or Asia.

UK position: Ministers suggest that food for Northern Ireland should broadly follow the same procedure as goods. The UK would perform the EU food safety checks on goods destined for the EU — and the system would be policed by sharing information between the UK and Ireland.

Landing zone: It could be close. The EU proposals go some way to creating a dual regulatory system for Northern Ireland with goods circulating under both European and British standards.

Medicines
EU proposal:
 The European Commission sees this as the biggest concession. It will mean that pharmaceutical companies in Britain — when supplying the Northern Irish market — “can keep all their regulatory functions where they are currently located”. This means Britain can continue acting as a hub for the supply of generic medicines for Northern Ireland.

UK position: The UK has suggested that the simplest solution is to remove all medicines from the protocol.

Landing zone: The devil will be in the detail, especially on the provision of new cancer drugs or treatments to individuals that are approved in Britain but face hurdles in Northern Ireland.

Pets
EU proposal:
 This was a key area where the EU has refused to make concessions on risk grounds despite Britain not having a case of rabies since 1922. It is demanding that any pet crossing to Northern Ireland have a health certificate issued by a vet at a cost of more than £100.

UK position: The UK says that pets that meet legal requirements such as microchipping should be able to move.

Landing zone: The EU’s lead negotiator, Maros Sefcovic, is frustrated that the concession was not made by the Brussels bureaucracy.

Governance
EU proposal:
 It wants “structured dialogues between Northern Ireland stakeholders and the commission”. People will be “invited to attend some meetings of the specialised committees” that work on the protocol.

UK position: It says it will not agree to any protocol that does not remove the European Court of Justice as final arbiter of laws in the province.

Landing zone: The EU has kept the door open to a solution and the UK has not threatened to strip the court out of the protocol.

Media Coverage

Brexit: EU to offer fewer Northern Ireland border checks on British goods
BBC News, John Campbell, 13 October 2021

BBC News reports that the EU is to set out proposals to address the row about trade in Northern Ireland. This comes in response to UK demands that current rules be changed due to the barriers they impose to the sale of chilled meats and other products.

The EU’s proposals are expected to involve reduced checks on goods and medicines. European Commission Vice-President Maros Šefčovič said that the new proposals for the Protocol would be “very far-reaching”. Among the changes are initiatives to solve the regulatory issues which pose a threat to the supply of medicines to Northern Ireland.

The Irish Republic’s Foreign Minister, Simon Coveney, said the proposals reflected “months of hard work, careful listening across Northern Ireland and will deliver practical solutions to make the Protocol work better”.

The two sides are expected to clash over the continued application of EU law in Northern Ireland through the European Court of Justice.

This was also reported in The IndependentThe Financial Times and Sky News.

Northern Ireland: Brexit chief Lord Frost submits new Protocol to EU but opens door to ‘positive’ negotiations
I News, Arj Singh, 12 October 2021

I News reports that Brexit Minister Lord Frost has opened the door to negotiations to come to an agreement on Northern Ireland promising to engage with EU proposals “seriously, fully and positively”.

In a key speech in Portugal, the Minister tried to reassure the EU that he was not attempting to ramp up tensions. A few turbulent days had followed Lord Frost’s demand that the European Court of Justice’s oversight in Northern Ireland come to an end.

In response to the expected EU proposal, Lord Frost said “What we hear about (the EU proposals) is interesting, we’ll talk about it even though I fear it may not do the job first round.”

Lord Frost has previously argued that the EU’s interpretation of the arrangements is threatening trade, stability, and peace in Northern Ireland.

The full speech is available here.

 

Parliamentary Coverage

House of Lords Question – 12 October 2021

Lord Bourne of Aberystwyth (Conservative): To ask Her Majesty’s Government what assessment they have made of the impact on the delivery of drugs (1) to the NHS, and (2) to patients, of the shortage of HGV drivers in the UK.

Lord Kamall (The Parliamentary Under-Secretary for Health and Social Care, Conservatives): We are not currently seeing the shortage of Heavy Goods Vehicle (HGV) drivers in the United Kingdom impact the delivery of medicines nor are we seeing it impact the delivery of flu vaccinations. The majority of deliveries are still being made to schedule with on-time delivery performance currently at 98%. However, the issue has been raised by a growing number of suppliers, including National Health Service trusts.

The number of National Supply Disruption Responses relating to medicine shortages in August 2021 is similar to the level in March 2021. This has remained stable and is unrelated to HGV driver shortages. Whilst no formal assessment has been made, we are reviewing broad trends are obtained through the Department’s freight desk, through organisations such as NHS Supply Chain, industry and NHS trusts. The Government’s Express Freight Service remains available to support suppliers if their existing supply chains are disrupted.

The Government is aware of concerns and are taking steps to support businesses and stakeholders, including streamlining the process for new HGV drivers, increasing the number of driving tests, improved pay, working conditions and diversity.

 

Full Coverage

Brexit: EU to offer fewer Northern Ireland border checks on British goods
BBC News, John Campbell, 13 October 2021

The EU is to set out proposals later to address the row about trade in Northern Ireland.

The UK wants to change the deal struck as part of the Brexit process to allow goods to circulate more freely between Great Britain and Northern Ireland.

It says the current rules impose too many barriers to the sale of chilled meats and other products.

The EU’s proposals, which it calls far-reaching, are expected to involve reduced checks on goods and medicines.

At the start of the year, a new post-Brexit arrangement – known as the Northern Ireland Protocol – was introduced to help prevent checks along the border between Northern Ireland and the Republic of Ireland.

It involves keeping Northern Ireland in the EU’s single market for goods – but this, in turn, creates a new trade border with Great Britain. Unionists say this undermines their place in the UK.

Both sides seems to agree – though to differing degrees – that the protocol is posing some difficulties for people and businesses in Northern Ireland.

These talks, likely to go on for several weeks, are the first step in trying to reach a better arrangement.

‘Careful listening’

European Commission Vice-President Maros Šefčovič said the new proposals for the protocol would be “very far-reaching” and that he hoped they would be seen as such.

The proposals are understood to include a unique deal around agri-food – which includes agriculture, horticulture, and food and drink processing – aimed at sharply reducing the checks on products moving from Great Britain to Northern Ireland.

There will also be an arrangement to allow the continued sale of chilled meats from Great Britain in Northern Ireland; these products were facing a ban.

The EU has also said it is going to change its laws in an attempt to solve regulatory issues which are posing a threat to the supply of medicines to Northern Ireland.

The Irish Republic’s Foreign Minister, Simon Coveney, said the proposals reflected “months of hard work, careful listening across Northern Ireland and will deliver practical solutions to make the protocol work better”.

“I hope the UK government is serious about moving on in partnership,” he added.

The EU is offering tweaks to the existing protocol and a relaxation of how it’s implemented.

That’s too little for Lord Frost who has tabled an alternative version which would strip out references to the continued application of EU law in Northern Ireland and eliminate the role of the European Court of Justice.

The problem is that’s too much for the EU to stomach.

The two sides will see if they can bridge the difference during a few weeks of intense negotiations. Which means the next crunch point is likely to be in mid-November.

If things go badly that could lead to the UK triggering a clause which allows each side to unilaterally suspend parts of it in an emergency.

That could lead to retaliation by the EU, potentially including new tariffs on British imports. Something you could describe as a trade war.

The protocol seems to be causing genuine problems for trade between Great Britain and Northern Ireland, and within Northern Ireland but the UK government also knows that standing up for the union against the EU is good politics.

On Tuesday, the UK’s Brexit minister Lord Frost proposed plans for an entirely new protocol to replace the existing one.

As part of these plans, the UK government wants to reverse its previous agreement on the oversight role of the European Court of Justice, which is the EU’s highest court.

The agreement states that the ECJ has jurisdiction to rule on matters of EU law in Northern Ireland – so for example, if there was a dispute around complying with applicable EU law, the EU could take the UK to the ECJ.

In a speech to diplomats in Portugal on Tuesday, Lord Frost described his new legal text as “a better way forward”.

He said his proposed text would amend the Northern Ireland Protocol and support the Good Friday Agreement.

“We have a short, but real, opportunity to put in place a new arrangement, to defuse the political crisis that is brewing, both in Northern Ireland and between us,” he said.

However, the EU has repeatedly said the ECJ must have the final say on any matters of EU law in the protocol.

It is expected that the two sides will engage in intense talks during November.

Sir Jeffrey Donaldson, leader of the Democratic Unionist Party – Northern Ireland’s largest unionist party – has warned that it may quit Stormont if its demands over the protocol are not met.

He has claimed pressure from unionists had led the EU to table its new proposals.

DUP MP Sammy Wilson said on Wednesday that central to any EU proposal was that “Northern Ireland is free from being part of the European single market” and that laws governing Northern Ireland should be made in the UK and not Brussels.

“The deal breaker for us will be has sovereignty been fully restored? Are we fully part of the United Kingdom or are we half in the EU and half out of the United Kingdom when it comes to law making and the adjudication on those laws,” he said.

“That’s how we will judge this.”

Declan Kearney, Sinn Féin Northern Ireland assembly member, said the protocol must work and what was needed now was certainty and stability.

He said there had not been any business leaders in Northern Ireland raising issues about the ECJ during Mr Šefčovič’s recent visit to Northern Ireland.

“This is a red herring. It’s a distraction. What we need to do now is listen very carefully to the proposals coming forward from the European Commission,” he said.
 

Northern Ireland: Brexit chief Lord Frost submits new Protocol to EU but opens door to ‘positive’ negotiations
I News, Arj Singh, 12 October 2021

Boris Johnson’s Brexit chief has opened the door to negotiations to “fix” a key deal on Northern Ireland, promising to engage with EU proposals “seriously, fully and positively”.

Brexit Minister Lord Frost described Brussels plans to reimagine the controversial Northern Ireland Protocol he negotiated in 2019 as “interesting”, while acknowledging they may not form the basis of a solution “on the first round” of talks.

In a key speech in Portugal, the peer also tried to reassure the EU that he was not attempting to ramp up tensions for Tory gain, insisting “there is no electoral dividend in endlessly talking about Brexit”.

It came after a turbulent few days in which EU figures reacted furiously to fresh demands from Lord Frost to strip the oversight of the European Court of Justice (ECJ) from the Protocol.

Ireland accused the peer of deliberately trying to engineer a “breakdown in relations” with a demand he knew the EU could not accept as a pretext for unilaterally suspending the Protocol.

The timing ahead of the EU’s own proposals to be published on Wednesday also rankled EU figures, who believe their own plans to end the so-called “sausage war” by easing border checks on food and medicine are significant and should address many UK concerns.

Addressing the audience in Lisbon, Lord Frost revealed he had submitted to the EU his own legal text for a new Protocol, which would mean goods could move around the UK “more or less freely”, and crucially that would replace the ECJ’s role with “international arbitration”.

But the minister also attempted to strike a more conciliatory tone.

“We are now heading to a crucial few weeks,” he said.

“We await the proposals coming tomorrow from Maroš Šefčovič and the European Commission in response to our ideas.

“To be clear, we will be really ready to discuss them – whatever they say – and we will obviously consider them seriously, fully, and positively.

“But – I repeat – if we are going to get to a solution we must, collectively, deliver significant change.”

Answering questions, Lord Frost later said: “What we hear about (the EU proposals) is interesting, we’ll talk about it even though I fear it may not do the job first round.”

The Protocol is designed to avoid a hard border with Ireland and effectively keeps Northern Ireland in the EU’s single market for goods.

The result of this is a trade barrier for products crossing the Irish Sea from Great Britain to Northern Ireland.

But Lord Frost has argued that the EU’s “heavy handed” interpretation of the arrangements is threatening trade, stability and peace in Northern Ireland.
This story has been updated.

 

 

Media Coverage

Pharmacies in England can buy extra flu vaccine stock from DH supply
Chemist and Druggist, Eliza Loukou, 11 October 2021

The Chemist and Druggist reports that the Department of Health and Social Care (DHSC) has detailed how pharmacies can access additional stock of influenza vaccines to top up local supplies.

To achieve an even higher vaccine uptake as compared to last year, the additional supply of influenza vaccines has been secured as a temporary measure.

The DHSC wrote that it “has boosted supply to community pharmacies by working with manufacturers to ensure more stock is available for wholesalers”. Community pharmacies will be able to purchase stock directly through wholesalers, with most of the stock arriving from early November.

 

Parliamentary Coverage

Coronavirus: lessons learned to date report published
12 October 2021

The House of Commons and Science and Technology Committee and Health and Social Care Committee have published “Coronavirus: lessons learned to date”, a report which examines the initial UK response to the COVID-19 pandemic.

The report draws on evidence from 50 witnesses, 400 written submissions and contains 38 recommendations to the Government and public bodies.

The Chair of the Health and Social Care Committee Rt Hon Jeremy Hunt MP and Rt Hon Greg Clark MP, Chair of the Science and Technology Committee said: “The UK response has combined some big achievements with some big mistakes. It is vital to learn from both to ensure that we perform as best as we possibly can during the remainder of the pandemic and in the future.”

Of particular interest in the report was the mention of managing NHS capacity during a health crisis. This included building more resilience into public services rather than running everything to the optimum just-in-time efficiency. Former NHS Chief Executive Officer Sir Simon Stevens in his evidence highlighted the need for a buffer to create resilience which may look wasteful in non-crisis time.

The report further highlighted that NHS Test and Trace was unable to meet demand due to insufficient laboratory capacity, in part because of delays in the delivery of testing equipment and supply chain problems with swabs, screening kits and testing reagents.

The poor access to PPE during the early period of the pandemic was also highlighted, where in March 2020, Sarah Pickup of the Local Government Association called access to PPE “insufficient” and James Bullion of ADASS called the delivery of PPE “extremely erratic and difficult.” The report further stated that this issue was compounded for staff from Black, Asian and minority ethic communities in the NHS and care sector.

Regarding the distribution of vaccines, the report stated that it sprang into large scale operation explosively and impressively. The distribution of vaccines made extensive use of existing NHS resources such as hospitals, GPs and pharmacists and welcomed third party assistance such as volunteer groups.

 

Full Coverage

Pharmacies in England can buy extra flu vaccine stock from DH supply
Chemist and Druggist, Eliza Loukou, 11 October 2021

The Department of Health and Social Care (DH) has detailed how pharmacies in England can access additional stock of influenza vaccines, which it has secured to help top up local supplies.

Following the success of last year’s seasonal flu immunisation programme, which resulted in record numbers of flu vaccine uptake in the UK, the DH hopes to “achieve even higher vaccine uptake rates compared to last year”, it wrote in guidance for pharmacies published last week (October 8).

To achieve this, it has secured additional supplies of influenza vaccines, “as a temporary measure for this year only”, it said.

The “DH has boosted supply to community pharmacies by working with manufacturers to ensure more stock is available for wholesalers”, it wrote.

Pharmacies: Place orders with wholesalers

Community pharmacies are among the NHS providers eligible to receive the centrally secured stock, when they determine they need additional supplies. As with last year, community pharmacies will be able to purchase stock directly through wholesalers, the DH added.

Pharmacies should also contact their wholesalers for details regarding what stock is available, the DH added. It specified in the guidance that it has ordered additional stocks of QIVc, QIVe and QIVr to boost supply.

Most of the stock will arrive from early November onwards and is intended to complement existing flu vaccine supply.

Providers should work with commissioners to ensure stock is prioritised to where uptake is lower, the DH said.

Assess uptake rates

As stock cannot be returned at the end of the flu season, pharmacies must assess whether they need to buy more flu vaccines by analysing “current uptake in eligible cohorts –taking into account booked clinics – and calculating any additional vaccines required”, according to the guidance.

They should purchase vaccines according to the needs of the local population they serve, the DH added.

It wrote that the process for accessing the supplemental flu vaccine stock “has been purposefully designed to limit the impact on business-as-usual vaccinations and supply chains”.

Community pharmacies in England have already administered almost 1.7 million flu jabs as of October 10, according to provisional data collated by the Pharmaceutical Services Negotiating Committee.

Community pharmacies in England administered almost three million influenza vaccines during last year’s flu season, C+D reported in April.

The impact of the flu is predicted to be greater this winter, due to measures imposed during the COVID-19 pandemic, such as mask-wearing and social distancing.

Because of these measures, influenza levels were extremely low globally last year, resulting in a lower level of population immunity this winter, NHS England and NHS Improvement wrote in a letter to contractors this summer.

Media Coverage

EU and UK edge closer to trade war over London’s NI protocol demands
Financial Times, Andy Bounds, Laura Hughes, George Parker and Jude Webber, 10 October 2021

The Financial Times reports that the UK and EU may be edging closer to a trade war after Brussels rejected the UK’s demands to substantially rewrite the Northern Ireland Protocol.

The European Commission reiterated that it would not agree to remove oversight of the Protocol by the European Court of Justice, with European Commission Vice-President Maroš Šefčovič telling a webinar that he did not see how Northern Ireland would keep access to the single market without such oversight.

On Wednesday, the Commission will publish proposals to drop many checks on goods deemed unlikely to leak from Northern Ireland into the EU single market via the Republic of Ireland. This would, however, still leave around half of customs and health checks in place.

Sir Jeffrey Donaldson, the leader of the Democratic Unionist Party said that “we are clear there should be no internal barriers to trade within the United Kingdom and we want to see the removal of barriers to trade between Great Britain and Northern Ireland and that is our bottom line. For us, the Irish Sea border must go.”

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

EU and UK edge closer to trade war over London’s NI protocol demands
Financial Times, Andy Bounds, Laura Hughes, George Parker and Jude Webber, 10 October 2021

This article is subject to copyright terms and conditions. Please access full article here. 

Media Coverage

EU urges UK to drop rhetoric in Northern Ireland Brexit row

The Guardian, Lisa O’Carroll, 07 October 2021

The Guardian reports that the EU will finalise its response to UK demands that the Northern Ireland Protocol be substantially rewritten in the middle of next week, and talks will follow.

The European Commission Vice-President Maroš Šefčovič told a conference in Dublin that Brexit Minister David Frost’s threats to trigger Article 16 had not been helpful. He said that “I believe that the package of practical solutions we are putting on the table would be attractive … and I hope supported by majority of stakeholders in Northern Ireland.”

The counterproposals to Lord Frost’s July command paper are expected to address the UK’s concerns over checks on food crossing the Irish Sea and barriers to medicine supplies between Great Britain and Northern Ireland.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

EU urges UK to drop rhetoric in Northern Ireland Brexit row

The Guardian, Lisa O’Carroll, 07 October 2021

The EU has urged the UK to drop the “political rhetoric” in the row over Brexit negotiations for Northern Ireland, revealing it will make what it described as “far-reaching proposals” to break the impasse next week.

The European Commission vice-president Maroš Šefčovič told a conference in Dublin he had a good relationship with the UK’s Brexit minister, David Frost, but that his threats to pull the plug on the Northern Ireland protocol were “not helpful”.

He confirmed the EU would finalise its response to UK demands that the protocol be substantially rewritten in the “middle of next week” and would then enter intense talks to try to find a solution. “I believe that the package of practical solutions we are putting on the table would be attractive … and I hope supported by majority of stakeholders in Northern Ireland.”

He also said he hoped it would meet the interests of the unionist parties who were vehemently opposed to the protocol.

What the EU was trying to deliver were “the best solutions, which will address the concern of the unionist community”, Šefčovič told the webinar at Ireland’s Institute of International and European Affairs. But he warned that the EU was not going to roll over to renegotiate the entire protocol just because the UK asked for this.

The protocol was the most difficult part of the withdrawal agreement to negotiate and involved “the best minds” on both sides over several years working on a solution to the problems Brexit caused in Northern Ireland. The EU would not negotiate the protocol “as the UK is requesting”, he said.

The commission has been working on counter-proposals to Lord Frost’s July command paper for the past month. Although Šefčovič declined to give details, they are expected to address the UK’s concerns over checks on food crossing the Irish Sea and barriers to medicine supplies between Great Britain and Northern Ireland.

It is unlikely, however, to concede to unionist demands that the role of the European court of justice should disappear. “I would say [they are] very far-reaching proposals and I sincerely hope that it will be seen as such by our UK counterparts and they engage constructively in our discussion, because I think we have to kind of move [away] from the political rhetoric, from the threats,” Šefčovič said.

“You are trying to do your most and what you hear from the other side is ‘it’s not good enough’ … these threats are definitely not helping.”

Šefčovič said the bloc would use all options under the treaties to protect EU interests but that there would not be a hard border if the UK decided to ultimately disapply the protocol.

A UK government spokesperson said it wanted “significant changes” to the protocol and reiterated that “any proposals must be subject to genuine negotiation”.

Earlier this week Frost said he would consider the EU’s proposals in good faith but he would only give the talks three weeks before deciding whether or not to trigger article 16, the mechanism to disapply parts of the protocol.

He warned the UK would act in a “robust” manner if the EU launched a retaliatory trade war in the event of talks collapsing during the article 16 process.

Media Coverage

PSNC discusses with stakeholders impact of fuel crisis on community pharmacy
Pharmacy Business, Shilpa Sharma, 06 October 2021

Pharmacy Business reports that the Pharmaceutical Services Negotiating Committee (PSNC) held a meeting with stakeholders from across the supply chain including the Department of Health and Social Care (DHSC) and NHS England and NHS Improvement (NHSE&I).

The stakeholders agreed that although the situation has started to improve, some areas are still affected by the medicine delivery delays, and the crisis has increased the workload and stress level for everyone across the supply chain. The shortage of HGV drivers has further led to unpredictable deliveries of medicines into warehouses, creating logistic issues for wholesalers.

PSNC’s legal director, Gordon Hockey said: “The continued patient access to medicines throughout the fuel supply issues has been testament to the robustness of the medicines supply chain, as well as the incredible work of pharmacy teams and others across the supply chain to minimise the impact of any disruption.”

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

PSNC discusses with stakeholders impact of fuel crisis on community pharmacy
Pharmacy Business, Shilpa Sharma, 06 October 2021

To discuss the ongoing fuel crisis and its impact on community pharmacy, Pharmaceutical Services Negotiating Committee (PSNC) held a meeting with stakeholders from across the supply chain, including the Department of Health and Social Care (DHSC) and NHS England and NHS Improvement (NHSE&I).

All agreed that the situation has started to improve but acknowledged that some areas still remain affected by delays to deliveries of medicines.

The stakeholders also agreed that fuel crisis has increased the workload and stress levels for everyone across the supply chain and vowed to keep a watch on the evolving situations.

In addition to fuel crisis, the HGV driver shortages led to unpredictable deliveries of medicines into warehouses, creating logistics issues for wholesalers.

Meanwhile, the DHSC confirmed availability of sufficient stock of medicines within the supply chain.

PSNC director, legal, Gordon Hockey said: “The continued patient access to medicines throughout the fuel supply issues has been testament to the robustness of the medicines supply chain, as well as the incredible work of pharmacy teams and others across the supply chain to minimise the impact of any disruption.”

The meeting was also attended by representatives from organisations including the Royal Pharmaceutical Society (RPS), the National Pharmacy Association (NPA), the Association of Independent Multiples (AIMp), the Company Chemists Association (CCA), the General Pharmaceutical Council (GPhC) and the Consumer Healthcare Association (PAGB).

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