HDA UK Media and Political Bulletin – 05 January 2021

Media Summary

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

With the UK now having licensed two coronavirus vaccines, the Independent reports that supply shortages have raised concerns over whether the government will be able to meet its vaccination target.

It has been reported that enough of the Oxford vaccine has been produced to provide 4 million doses, but some claim that the UK has not yet secured enough “fill and finish” supplies to scale up the rollout. Indeed, a lack of material such as vials and specialised bungs has hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested. He said: “It’s not so much a manufacturing issue although that’s part of it. Each batch needs to be properly approved and quality controlled.”

MHRA Chief Executive, Dr June Raine, added: “It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

 

Parliamentary Coverage

House of Commons, Written Answer, 24 December

Stephen Farry (Alliance, North Down): To ask the Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, whether the Draft unilateral declarations by the European Union and the United Kingdom of Great Britain and Northern Ireland in the Withdrawal Agreement Joint Committee on human and veterinary medicines cover medical devices.

Penny Mordaunt (Conservative, Portsmouth North): The Unilateral Declaration on Medicines allows for the phased implementation in Northern Ireland of relevant medicines regulation, and in particular the Falsified Medicines Directive. Medical devices are not subject to the Falsified Medicines Directive and are not in scope of the declaration. Businesses and authorities moving medical devices can make use of the Trade Support Service and the UK Trader Scheme. Full guidance on the regulatory requirements for medical devices are set out on gov.uk. Medical devices will be able to be moved smoothly between Great Britain and Northern Ireland from 1 January 2021.

 

Full Coverage

 

Covid vaccine: How much supply does the UK have and what’s behind the shortage of dosages?

The Independent, Samuel Lovett, 04 January

The UK has now licensed two coronavirus vaccines and has begun administering doses throughout the four nations.

Research has shown that the NHS will need to carry two 2 million vaccinations a week to prevent a third wave of Covid-19, but supply shortages have raised concerns over whether the government will be able to meet this target.

So, how many vaccine doses do we have on the way? And how much is ready to go?

Pre-ordered supplies

The UK’s vaccine taskforce has put together a portfolio of seven different candidates, securing a total of 357 million doses – enough to vaccinate the British population twice over.

So far, two of those seven vaccines have been approved for emergency use by the the Medicines and Healthcare products Regulatory Agency: the Pfizer-BioNTech and Oxford-AstraZeneca jabs. The other candidates remain in development.

Up to 40 million doses of the Pfizer-BioNTech vaccine have been ordered, while 100 million doses of the Oxford jab are set to be delivered to the UK.

Originally, the government said that 10 million doses of the Pfizer vaccine were due by the end of 2020 – a target which was missed.

For the Oxford vaccine, Downing Street said in May of last year that the country would have 30 million doses available by September in preparation for the national rollout.

That figure was later corrected by the vaccine taskforce to 4 million for the end of 2020. However, this target was also not met.

Last week, health secretary Matt Hancock said that the UK had just 530,000 doses of the Oxford for its nationwide rollout on 4 January.

How much vaccine is ready to go?

Pfizer said the number of doses it has now sent to the UK is “in the millions”, while the Department of Health and Social Care said the government had received 22 deliveries of the vaccine as of 25 December.

It is not clear how many doses of the Pfizer-BioNTech candidate are currently available to the population, or how much will be provided in the coming weeks.

Pascal Soriot, the Chief Executive of AstraZeneca, said last Wednesday that the manufacturer was able to produce “1 million doses and beyond” per week of the Oxford vaccine.

Although 530,000 doses are ready for use as of 4 January, the government has said this figure will rise to the “tens of millions” by the end of March.

What’s behind the lack of supplies?

According to reports, enough of the Oxford vaccine has been produced to provide 4 million doses. However, it’s claimed that UK has not yet secured enough “fill and finish” supplies to scale up the rollout.

A lack of material such as vials and specialised bungs has supposedly hampered efforts to get the vaccine bottled up and distributed throughout the four nations.

Professor Jonathan Van-Tam, Deputy Chief Medical Officer for England, said last month: “The only thing that is going to slow us down is batches of vaccines becoming available. Many of you know already that it’s not just about vaccine manufacture. It’s about fill and finish, which is a critically short resource across the globe.”

Prime Minister Boris Johnson has also suggested a limiting factor in expanding the UK’s vaccine rollout is waiting for batches of the jab to be tested.

Ministers have said the NHS has the capacity to deliver 2 million doses a week of the Oxford vaccine once it receives supplies from the manufacturers. But the PM said the issue is not supply or staff, but waiting for batch approval.

He explained: “We have the capacity, the issue is to do with supply of the vaccine.

“It’s not so much a manufacturing issue although that’s part of it.

“Each batch needs to be properly approved and quality controlled.”

The Medicines and Healthcare products Regulatory Agency (MHRA) said it had “scaled up” its review process for each vaccine batch.

“The MHRA is fully scaled up to do the batch testing that’s so important for confidence as the new products come through,” said Dr June Raine, Chief Executive of the agency.

“It’s a supply chain that goes right back from the manufacturer, right through to MHRA, and then on to the clinical bedside or where the vaccines are delivered, so we are a step on the road but our capacity is there, I’m very clear about that.”

How many people have been vaccinated so far?

As of 4 January, a total of 944,539 people across the UK had received their first vaccine dose.

The government says this figure will rapidly rise in the coming weeks and months once more batches from the different vaccine manufacturers have been quality checked.

It is hoped that all at-risk groups will have been vaccinated using the Oxford or BioNTech-Pfizer candidate by the end of April, helping to ease the strain on the NHS amid a deluge of hospitalisations driven in part by the new coronavirus variant.

Media and Political Bulletin

15 July 2019

Media Summary

Health Minister visits Alliance service centre

Pharmacy Business, Lakshmi PS, 12 July 2019

Pharmacy Business reports that Health Minister Stephen Hammond on Thursday visited the Chessington service centre of Alliance Healthcare, calling it a ‘fascinating experience’. Hammond was hosted by Healthcare Distribution Association (HDA) Executive Director Martin Sawer during his visit to the HDA member service centre.

Alliance Healthcare UK Managing Director, Julian Mount, greeted both Sawer and the minister and gave them a service centre tour. The minister witnessed how the centre delivers vital medicines to pharmacies and hospitals, and was given a demonstration of procedures required under the recently introduced Falsified Medicines Directive.

“It is apparent to me that healthcare distributors are pivotal in ensuring that all GP surgeries, pharmacies and hospitals are kept fully stocked with the medicines they need to keep their patients healthy,” Hammond said.

‘No guarantee’ of drugs supply after Brexit

The Times, Kieran Andrews, 15 July 2019

The Times reports that the SNP’s Brexit minister has said the supply of medicines cannot be guaranteed in Scotland if Britain leaves the EU without a deal.

Mike Russell said that arrangements had been in place with the British government to ensure continuity of supplies for the original Brexit date of March 31, but preparations for the new deadline of October 31 had not been finalised. Pushing back the date closer to Christmas has caused problems with finding storage space for stockpiled supplies, and companies are less willing to prepare having already wasted money in the spring.

Asked whether he could guarantee that all necessary medicines would be available in Scotland after a no-deal Brexit, Mr Russell told the BBC’s Sunday Politics Scotland: “You can’t absolutely guarantee that, no.”

Brexit: ‘No guarantee’ of medicines if no EU deal agreed

BBC News, 14 July 2019

BBC News reports that Scottish Brexit Secretary Mike Russell has said he cannot absolutely guarantee the supply of medicine to Scotland in the event of a no-deal Brexit.

He told the Sunday Politics Scotland programme that plans for a no-deal have been disrupted by delays to Brexit and the Conservative leadership race.

Companies will not repeat their March stockpiling efforts, he claimed.

MHRA warns patients about potential failure of Emerade adrenalin auto-injectors

The Pharmaceutical Journal, 12 July 2019

The Pharmaceutical Journal reports that in a class 4 drug alert, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned some Emerade adrenaline auto-injectors may fail to deliver a dose of adrenaline from the syringe owing to a blockage in the needle.

The issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade; however, it was thought that it had the potential to affect just 1.5 in every 10,000 pens and was therefore a “rare event”. Bausch and Lomb, which manufactures Emerade, has now said that the potential occurrence of needle blockage in batches on the market was higher than first estimated and could affect 2.3 in every 1,000 pens.

The alert applies to Emerade devices of all strengths (150 micrograms, 300 micrograms and 500 micrograms), but not to other marketed brands of adrenaline auto-injectors.

This was also reported in Pharmacy Business.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Health Minister visits Alliance service centre

Pharmacy Business, Lakshmi PS, 12 July 2019

Health Minister Stephen Hammond on Thursday visited the Chessington service centre of Alliance Healthcare and called it a ‘fascinating experience’.

Hammond’s visit to the Healthcare Distribution Association (HDA) member service centre was hosted by HDA executive director Martin Sawer.

Alliance Healthcare UK managing director, Julian Mount, greeted both Sawer and the minister and gave them a service centre tour.

The minister, who is an MP from Wimbledon, witnessed how the centre delivers vital medicines to pharmacies and hospitals across the south and south-east of England including his own constituency.

He also observed the semi-automated warehouse in full swing with orders being picked and packed ready for afternoon delivery.

“It was a fascinating experience to see how the operations worked. It is no mean feat for customers to receive two deliveries a day, five days a week and one on Saturday. It is apparent to me that healthcare distributors are pivotal in ensuring that all GP surgeries, pharmacies and hospitals are kept fully stocked with the medicines they need to keep their patients healthy,” Hammond said.

The minister was also given a demonstration of procedures required under the recently introduced falsified medicines directive.

“It was a pleasure to welcome the minister following his keynote address at the recent HDA Annual Conference where he thanked the distribution sector for the vital role it plays in ensuring the safe and consistent supply of healthcare products and medicines to patients across the UK. It is particularly reassuring the Minister continues to recognise the important role our members have played in the complex preparations for a no-deal Brexit,” said Martin Sawer.

‘No guarantee’ of drugs supply after Brexit

The Times, Kieran Andrews, 15 July 2019

The supply of medicines cannot be guaranteed in Scotland if Britain leaves the EU without a deal, the SNP’s Brexit minister has said.

Mike Russell said that arrangements had been in place with the British government to ensure continuity of supplies for the original Brexit date of March 31, but preparations for the new deadline of October 31 had not been finalised.

Pushing back the date closer to Christmas has caused problems with finding storage space for stockpiled supplies, and companies are less willing to prepare having already wasted money in the spring.

Asked whether he could guarantee that all necessary medicines would be available in Scotland after a no-deal Brexit, Mr Russell told the BBC’s Sunday Politics Scotland: “You can’t absolutely guarantee that, no.

“We made arrangements with the UK government in March we felt would last for three to six months, which meant that most things were available and there were substitutes. One of the biggest jobs undertaken was to find substitutes for things that wouldn’t be available and that was a massive job. It was undertaken by both governments and it was by and large successful, we were confident then.

“That work has still to be finalised because it has changed, for example the availability of warehousing has changed. The drug companies themselves are very, very reluctant to be involved in the deep way they were before. They will in the end I think do so, but all companies involved in stockpiling took big losses in March.”

Mr Russell said that leaving the European Union without a deal would be disastrous and repeated his call for another referendum on membership.

The Scottish government has been criticised for failing to pass on funding from a £37 million no-deal package from Westminster to Police Scotland or councils but paying for legal advice on forests. According to the government’s budget revision, it spent only £27 million directly on Brexit-related activities. No money was made available to the police or local authorities but £4.8 million was allocated to pay for more civil servants and £60,000 was given to the Forestry Commission.

The UK Department of Health and Social Care said: “Our priority is for all patients to continue to have access to medicines and medical products when we leave the EU. We are working with industry and other stakeholders to continue robust no-deal contingency planning for supply after October 31.

“We are confident that if everyone does what they need to do, the supply of medicines and medical products should be uninterrupted.”

Brexit: ‘No guarantee’ of medicines if no EU deal agreed

BBC News, 14 July 2019

Scottish Brexit Secretary Mike Russell has said he cannot absolutely guarantee the supply of medicine to Scotland in the event of a no-deal Brexit.

He told the Sunday Politics Scotland programme that plans for a no-deal have been disrupted by delays to Brexit and the Conservative leadership race.

Companies will not repeat their March stockpiling efforts, he claimed.

The UK government said it was “confident” about the supply of medicine and medical products.

Mr Russell said: “The drug companies themselves are very reluctant to be involved in the deep way they were before.

“They will in the end I think do so.

“But all companies involved in stockpiling took big losses in March.”

‘Exit preparedness’

In June, the UK government made a written ministerial statement to parliament which updated on its “EU Exit preparedness”.

Health minister Stephen Hammond made a further written statement in February on plans to ensure the supply of medicines and medical products.

A Department of Health and Social Care spokesperson said: “Our priority is for all patients to continue to have access to medicines and medical products when we leave the EU.

“We are working with industry and other stakeholders to continue robust no deal contingency planning for supply after 31 October.

“We are confident that if everyone does what they need to do, the supply of medicines and medical products should be uninterrupted.”

Cost factor

Mr Russell said he remained concerned about the impact of Brexit on the wider economy.

He believed many businesses were unable to invest in rebuilding stock levels for the second time in a year.

“They’ve been drawing down these stockpiles,” he said.

“I was at an agricultural merchant some months ago where they showed me 200,000 Euros worth of a chemical they had had stockpiled.

“And they simply said they wouldn’t do it again because they couldn’t afford to do it again.”

MHRA warns patients about potential failure of Emerade adrenalin auto-injectors

The Pharmaceutical Journal, 12 July 2019

Some Emerade adrenaline auto-injectors may fail to deliver a dose of adrenaline from the syringe owing to a blockage in the needle, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned in a class 4 drug alert.

The issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade; however, it was thought that it had the potential to affect just 1.5 in every 10,000 pens and was therefore a “rare event”.

Bausch and Lomb, which manufactures Emerade, has now said that the potential occurrence of needle blockage in batches on the market was higher than first estimated and could affect 2.3 in every 1,000 pens.

The alert applies to Emerade devices of all strengths (150 micrograms, 300 micrograms and 500 micrograms), but not to other marketed brands of adrenaline auto-injectors.

Lynne Regent, chief executive of the charity The Anaphylaxis Campaign, said it recognised this as a “very difficult time” for patients who carry Emerade auto-injectors.

“We would like to take this opportunity to remind all individuals who are prescribed an adrenaline auto-injector to always carry two devices at all times,” she said.

The MHRA said that it would not be recalling batches of Emerade and that the manufacturer had conducted “extensive investigations and has implemented corrective actions”.

Emerade manufactured with all the corrective processes is expected to be introduced into the market from mid-July 2019.

This was also reported in Pharmacy Business.

Media and Political Bulletin

30 April 2018

Media Summary

Lords slam government commitment to life sciences strategy

PharmaTimes, Selina McKee, 30 April 2018

PharmaTimes reports that the House of Lords has slammed the government’s commitment to delivering the Life Sciences Industrial Strategy, deeming it “incoherent” and “wholly inadequate”.

An inquiry by the House of Lords Science and Technology Committee has uncovered “complicated arrangements” for the Strategy’s implementation, as well as “a lack of clear authority and accountability”, which, it says, raises questions about the government’s commitment to driving it forward.

In its report, Life Sciences Industrial Strategy: Who’s driving the bus?, the Committee recommends a “sweeping simplification” of the Strategy’s implementation arrangements, and calls for “immediate action” to ensure development and expansion of the sector.

Also reported in The Pharmaceutical Journal.

ABPI response to the House of Lords Science and Technology Committee report

ABPI, 26 April 2018

In response to the House of Lords report on the Government’s Life Sciences Industrial Strategy, the ABPI have published the following statement:

“The Life Sciences Industrial Strategy is the blueprint for the UK’s success in life sciences as we leave the EU. In the short time since the strategy was published, the Government has worked closely with industry – with the first sector deal published only a few months after the report’s publication. We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

 “We want the UK to become a world leader in health data, in clinical trials and in the development as well as adoption of new treatments for patients. Now we have the structures in place, through the implementation of the Life Sciences Industrial Strategy, to work closely with government, academia and health charities, we look to mirror this with the NHS as well. The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI responds to Kings Fund report into the cost of medicines for the NHS

ABPI, 26 April 2018

Last week, the Kings Fund published a new report into the cost of medicines looking at how much the health service spends in total on medicines; both generics and branded medicines.

Dr Richard Torbett, commercial policy director of the ABPI, responded, saying:

“This report provides some very good analysis and insight into UK medicines policy.

“The vast majority of new hospital medicines, including those for Hep C, HIV prevention and new cancer drugs are part of a scheme which caps the amount the NHS spends on medicines, so any suggestion that they are causing an uncontrollable rise is costs is not accurate.  We know with absolute certainty that the spend on these medicines has actually fallen in real terms in the past five years.

“As the report shows, any increase in spending is largely due to the NHS treating more patients with highly effective, older and cheaper medicines, like statins.”

Parliamentary Coverage

House of Commons, Customs and Borders debate, 26 April 2018

Conservative MP Dr Sarah Wollaston was one of several MPs to raise concerns about the impact of Brexit on pharmaceuticals in increased delays, costs, and shortages during a House of Commons debate on customs and borders.

Ms Wollaston said:

“For years, we have taken it for granted that when a prescription is issued, it will be available on the pharmacy shelf.

“I am afraid that we will not be able to take that for granted in the future, because the complex supply chain—from the research lab right through to the pharmacy shelf—will be disrupted by delays at the border, and that will affect costs.”

To read the full debate, please follow this link.

Tabled Written Questions, House of Commons, 26 April 2018

Tom Brake MP: To ask the Secretary of State for Health and Social Care, when he plans to publish the Government’s commissioned analysis by Ernst and Young of the effect of the UK leaving the EU on the medicines supply chain.

Answered by Steve Brine: Due to the large volume of commercial and sensitive information that has been shared by the pharmaceutical industry throughout this work, the Department will be unable to publish the final report. However, we will consider publication of an executive summary of the work.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what progress he has made on negotiations for a new pharmacy contract; and what the timetable is for the interim arrangements published in the Drug Tariff to remain in place.

Answered by Steve Brine: We have agreed interim arrangements for the Community Pharmacy Contractual Framework whilst Ministers consider further their substantive proposals for 2018/19 and beyond. These arrangements published in the Drug Tariff will remain in place until any revised arrangements are determined. Ministers expect negotiations with the Pharmaceutical Services Negotiating Committee to discuss a substantive settlement for community pharmacy will commence shortly.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that stocks of medicines that are in short supply are distributed equitably and proportionately amongst community pharmacies.

Answered by Steve Brine: The Department is unable to directly control how stock is distributed as this is under the control of the individual suppliers or wholesalers. However, in the event of supply issues the Department will work with suppliers and wholesalers to encourage and support them, so where possible, supplies are distributed equitably and proportionally.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the (a) competitiveness and (b) effectiveness of the wholesale pharmaceutical market to provide an affordable supply of medicines for patients.

Answered by Steve Brine: The Department has not made such an assessment.

Luciana Berger MP: To ask the Secretary of State for Health and Social Care, what plans his Department has to support the maintenance of links between regulators, research ethics committees, researchers and the pharmaceutical industry in the UK and the European Medicines Agency after the UK leaves the EU.

Answered by Caroline Dinenage: The Department has always made clear its intention to retain a close working partnership with the European Union, in the interest of ensuring patients continue to have timely access to safe medicines and medical innovations. This includes maintaining a strong working relationship with the European Medicines Agency on all aspects of the life sciences sector.

It is of mutual benefit for the EU to collaborate closely with such a well-developed life sciences market in the United Kingdom. Both sides will always be stronger by working in partnership.

Tim Farron MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 April 2018 to Question 136501, how the Government plans for the UK to participate in the European Medicines Agency during the transition period after the UK leaves the EU.

Answered by Jackie Doyle-Price: From 30 March 2019, the United Kingdom will no longer be a Member of the European Union. However, under the terms of the implementation period agreement regulatory standards and market access for all medicines will continue on current terms.

Both sides agree that for the implementation period to function effectively, the UK will need to remain in step with the EU. In this context, the Withdrawal Agreement will be underpinned by a duty of good faith, with a Joint Committee in place enabling either side to raise issues or concerns. These arrangements will help ensure that the implementation period works properly for both sides.

Common rules will remain in place and the UK may continue to participate in EU agencies and bodies where the presence of the United Kingdom is necessary and is in the interests of the EU, or where the discussion concerns acts addressed to the UK and its citizens. The exact nature of this participation will be a matter for further discussion.

Regarding the future relationship, the Prime Minister’s Mansion House speech outlined that we will also explore the terms on which the UK could remain part of the European Medicines Agency. While it would not be appropriate to pre-judge the outcome of the negotiations, we will discuss with the EU and Member States how best to continue cooperation in medicines regulation.

Luciana Berger MP: To ask the Secretary of State for Health and Social Care, if he will negotiate a deal with the EU to allow mutual recognition agreements on the manufacture and distribution of investigational medicinal products and pharmacovigilance services after the UK leaves the EU.

Answered by Jackie Doyle-Price: From 30 March 2019, the United Kingdom will no longer be a Member of the European Union. However, under the terms of the implementation period agreement regulatory standards and market access for all medicines will continue on current terms.

Regarding the future relationship, the Prime Minister’s Mansion House speech outlined that we will also explore the terms on which the UK could remain part of the European Medicines Agency. While it would not be appropriate to pre-judge the outcome of the negotiations, we will discuss with the EU and Member States how best to continue cooperation in medicines regulation more broadly, including manufacturing and distribution of investigational medicinal products and pharmacovigilance services.

Our overall aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and continued sharing of data.

Full Coverage

Lords slam government commitment to life sciences strategy

PharmaTimes, Selina McKee, 30 April 2018

The House of Lords has slammed the government’s commitment to delivering the Life Sciences Industrial Strategy, deeming it “incoherent” and “wholly inadequate”.

An inquiry by The House of Lords Science and Technology Committee has uncovered “complicated arrangements” for the Strategy’s implementation, as well as “a lack of clear authority and accountability”, which, it says, raises questions about the government’s commitment to driving it forward.

In its report, Life Sciences Industrial Strategy: Who’s driving the bus?, the Committee recommends a “sweeping simplification” of the Strategy’s implementation arrangements, and calls for “immediate action” to ensure development and expansion of the sector.

It also suggests the establishment of a single body that has complete oversight of implementation, called the Life Sciences Governing Body, which must have cross-party support.

“Prompt and vigorous action by the government can save the day. This strategy has already secured the commitment of the business, charity and academic communities. But the central role of the NHS in the life sciences means only the government can take the lead,” it argues.

According to the report, the government has failed to engage the NHS effectively, and so the NHS’ commitment to the strategy has so far been “incoherent, uncoordinated and ineffective”.

The NHS does not have the capacity to rise to the challenge of implementing the strategy, and its current structures “stifle innovation”.

The NHS must give greater priority to the uptake and spread of innovation and to rewarding clinicians and managers who make such adoption successful, the Committee stressed, and called on the government to explore financial incentives for those NHS trusts that do so.

“If implemented correctly the Life Sciences Industrial Strategy will make a major contribution to the future economic prosperity of the UK but what became clear throughout our inquiry is that it stands little chance of success without a detailed plan for implementation and clear lines of authority, responsibility and accountability,” said Chairman of the Committee, Lord Patel.

“The government has an opportunity right now to get ahead of international competition. It can, and must, take bold steps to secure the future growth and expansion of the life sciences sector. This is even more vital as the UK prepares for life outside the European Union.”

But the government said it “does not recognise the Committee’s assessment”.

In a statement emailed to PharmaTimes, a spokesperson noted that the Life Sciences Sector Deal has “committed £500 million of government investment into UK life sciences, backed by investment from 25 organisations across the sector, that will build on the sector’s strengths, secure thousands of jobs and create new innovative medicines and technologies, giving NHS patients access to the best possible treatments.

“The government will continue to work closely with industry to seize the future opportunities in this area and we will respond to the report in due course.”

Sir John Bell also said the government has made “enormous progress” in implementing its recommendations.

“With the help of industry and the charity sector, it has launched the world’s largest genomics programme, is creating digital pathology centres with industry and digital innovation hubs to work with industry. This is in addition to a new set of manufacturing facilities.”

Highlighting that the Strategy is “the blueprint for the UK’s success in life sciences as we leave the EU”, the Association of the British Pharmaceutical Industry ABPI said: “We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

“The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI response to the House of Lords Science and Technology Committee report

ABPI, 26 April 2018

This week, the House of Lords Science and Technology Committee published a report into the Life Sciences Industrial Strategy, asking: “Who’s Driving the Bus?”

26 Apr 2018 Posted in ABPI response By Press Office

In response, the ABPI said:

“The Life Sciences Industrial Strategy is the blueprint for the UK’s success in life sciences as we leave the EU. In the short time since the strategy was published, the Government has worked closely with industry – with the first sector deal published only a few months after the report’s publication. We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

“We want the UK to become a world leader in health data, in clinical trials and in the development as well as adoption of new treatments for patients. Now we have the structures in place, through the implementation of the Life Sciences Industrial Strategy, to work closely with government, academia and health charities, we look to mirror this with the NHS as well. The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI responds to Kings Fund report into the cost of medicines for the NHS

ABPI, 26 April 2018

This week, the Kings Fund published a new report into the cost of medicines looking at how much the health service spends in total on medicines; both generics and branded medicines.

26 Apr 2018 Posted in ABPI response By Press Office

Dr Richard Torbett, commercial policy director of the ABPI, said:

“This report provides some very good analysis and insight into UK medicines policy.

“The vast majority of new hospital medicines, including those for Hep C, HIV prevention and new cancer drugs are part of a scheme which caps the amount the NHS spends on medicines, so any suggestion that they are causing an uncontrollable rise is costs is not accurate.  We know with absolute certainty that the spend on these medicines has actually fallen in real terms in the past five years.

“As the report shows, any increase in spending is largely due to the NHS treating more patients with highly effective, older and cheaper medicines, like statins.”

Media and Political Bulletin

10 January 2018

Media Summary

Brussels warns UK companies of shut-out in event of no-deal Brexit

The Financial Times, Alex Baker, Sarah Gordon and Jim Pickard, 10 January 2018

 

The Financial Times reports that the EU is continuing to warn UK companies of a regulatory chill after Brexit as it seeks to accelerate the private sector’s preparations for a no-deal UK exit, according to recent legal notices reviewed by the publication.

While negotiators neared a breakthrough in Brexit divorce talks, EU regulators issued a series of “be prepared” memos to approximately 15 industries in November and December, ranging from drugmakers, seafarers and mineral water producers to hauliers and airlines that rely on UK operating licences.

These memos call on companies to be ready for the UK to become “a third country” on March 29 2019, with no automatic right to operate in the single market. They also warn that operating licences will automatically lapse after Brexit and that many groups may have to create EU entities for continuity of business.

 

Parliamentary Coverage

Department of Health – NHS Drugs, 9 January 2018

Lord Taylor of Warwick: To ask Her Majesty’s Government what measures they are taking to prevent medicine shortages and disruptions in dealing with public health crises following Brexit.

Lord O’Shaughnessy: Maintaining continuity of medicine supply is a key part of ensuring everyone has continued access to the medicines they need on day one of the European Union exit and thereafter. The United Kingdom is fully committed to continuing the close working relationship with our European partners. As part of our ambition for a broad and dynamic co-operation, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety; including to ensure that cross-border trade with the EU is as frictionless as possible. This will be part of the broader negotiations of the UK’s future relations with the EU.

Full Coverage

Brussels warns UK companies of shut-out in event of no-deal Brexit

The Financial Times, Alex Baker, Sarah Gordon and Jim Pickard, 10 January 2018

 

The EU is systematically warning UK companies of a regulatory chill after Brexit as it seeks to accelerate the private sector’s preparations for a no-deal UK exit, according to recent legal notices reviewed by the Financial Times.

Even as negotiators neared a breakthrough in Brexit divorce talks, EU regulators issued a flurry of “be prepared” memos to about 15 industries in November and December, ranging from drugmakers, seafarers and mineral water producers to hauliers and airlines that rely on UK operating licences.

The documents call on companies to be ready for the UK to become “a third country” on March 29 2019, with no automatic right to operate in the single market. They also warn that operating licences will automatically lapse after Brexit and that many groups may have to create EU entities for continuity of business.

The warnings triggered an angry response from David Davis, the Brexit secretary, who accuses the EU of measures that could jeopardise existing contracts or force British companies to decamp to the continent if the two sides fail to reach a deal.

Mr Davis’s complaints were outlined in a letter sent last month to prime minister Theresa May and leaked to the FT this week.

“We are surprised . . . the UK government is surprised the commission is preparing for a no-deal scenario,” retorted Margaritis Schinas, the commission’s chief spokesperson, on Tuesday.

The flare-up highlights the contrasting approaches to no-deal preparation taken in Westminster and Brussels. While the UK has emphasised government contingency planning, laying aside £3bn to build up regulatory and customs capabilities, the EU is highlighting risks so the private sector makes arrangements for “all circumstances”.

EU negotiators see it as a positive if companies take no chances and trigger comprehensive contingency plans for Brexit, especially if that involves moving business activity from Britain to the continent. A strict approach has also been applied in the awarding of some EU contracts and funding applications.

“We’ve heard pretty concerning reports about negative treatment of UK businesses and universities since the referendum, either on contracts, collaboration or funding,” said Adam Marshall, director-general of the British Chambers of Commerce.

Mrs May’s government sealed a divorce deal with the EU in December and hopes to agree transition arrangements by the end of March.

But although some EU notices made passing references to a possible transition deal after 2019, most of the papers issued by the European Commission did not.

The commission repeats in several notices that “preparing for the withdrawal is not just a matter for union and national authorities, but also for private parties”.

In a speech on Tuesday, Michel Barnier, the EU’s chief negotiator, said the EU and the UK were discussing a transition period of 21 months until December 2020 but added: “The real transition period has already begun.”

The commission notes that UK-issued operating licences for airlines “will no longer be valid” in the EU unless carriers are owned and controlled by EU nationals and “have one’s principal place of business” within the EU. Similarly road transport operators “must have an effective and stable establishment in an EU member state”.

Brussels urges some chemicals groups to apply for approvals for biocidal products, such as disinfectants, from within the remaining 27 EU states so that the process is not affected by Brexit. “Holders of product authorisations must be established within the union,” it notes. Drugmakers are urged to revise product information because any UK representatives mentioned will be “obsolete” after March 2019.

One notice is dedicated to the implications for mineral water sourced in the UK, which can no longer be automatically marketed in the EU because they are “extracted from the ground of a third country”.

Highlighting the breadth of legal issues covered, the commission uses a memo to outline the detailed implications for certificates for slaughtering of animals for fur — a practice outlawed in the UK since 2000.

Only one EU notice to trademark holders explicitly mentions that the EU is “trying to agree solutions for some of the issues that might arise”. But in that case the main problem is for the EU side: the memo notes that legal protections for products such as champagne and parmesan will lapse in the UK after Brexit.

Allie Renison of the Institute of Directors said “the EU could do more to convey its aim to secure a ‘business-as-usual’ period to firms on both sides of the Channel”. But she added it was “essential” for the UK to also “provide further clarity about its objectives for our future trade relationship with the EU — and indeed its own guidance if it finds statements from Brussels misleading”.

Meanwhile Nicola Sturgeon, Scotland’s first minister, reacted with incredulity to Mr Davis’s letter. “A government intent on leaving the EU and continually talking about the prospect of ‘no deal’ moaning about EU preparing to treat the UK as a non-member and for the possibility of ‘no deal’,” she said. “Unbelievable.”

Philip Hammond, the chancellor, and David Davis, the Brexit secretary, issued a joint statement calling on Germany and the UK to work together on a “bespoke solution”. “It makes no sense to either Germany or Britain to put in place unnecessary barriers to trade in goods and services that would only damage businesses and economic growth on both sides of the Channel,” they write in the Frankfurter Allgemeine.

Media and Political Bulletin

17 October 2017

Media Summary

Pharma and medtech industries prepare for hard Brexit

Business Insider, Ben Hirschler, 16 October 2017

 

Business Insider reports that medicine manufacturers and medical devices companies are drawing up plans to protect supply chains in case Britain crashes out of the European Union without a trade deal. The article highlights that some small service businesses are already relocating to stay inside the bloc.

 

The article cites, MeddiQuest, an eight-person consultancy specializing in medical technology regulations, as an example, since the company is in the process of moving from outside Cambridge to Ireland.

 

“A significant part of our business is being an authorized EU representative,” Chief Executive Neil Armstrong told Reuters. “Clearly, if the UK is no longer in the EU, we will be no more in the EU than an American company, so we can’t be an EU authorized rep.”

 

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Pharma and medtech industries prepare for hard Brexit

Business Insider, Ben Hirschler, 16 October 2017

 

Drugmakers and medical devices companies are drawing up plans to protect supply chains in case Britain crashes out of the European Union without a trade deal, and some small service businesses are already relocating to stay inside the bloc.

 

MeddiQuest, an eight-person consultancy specializing in medical technology regulations, is in the process of moving from outside Cambridge to Ireland.

 

“A significant part of our business is being an authorized EU representative,” Chief Executive Neil Armstrong told Reuters. “Clearly, if the UK is no longer in the EU, we will be no more in the EU than an American company, so we can’t be an EU authorized rep.”

 

Armstrong said some rivals were also arranging to set up in Ireland or other EU destinations, including Malta.

 

Fears of a “hard Brexit” have been heightened after EU negotiator Michel Barnier said last week that talks were deadlocked.

 

That has fueled anxieties in a healthcare sector governed by complex regulations and long product development cycles.

 

Drugmakers are already braced for disruption when the European Medicines Agency is uprooted from London, with politicians due to make a decision on the drug watchdog’s new location on Nov. 20.

 

But Brexit also creates other big uncertainties, including the potential need for retesting of UK-manufactured batches of medicines shipped to Europe, as well as the transfer of UK product licenses to European-based entities.

 

“We’re starting to plan for the worst-case scenario,” Alan Morrison, vice president of international regulatory affairs at Merck & Co, told an industry conference last week.

 

“It’s a long-cycle business. If we have to plan for product testing in Europe for drugs that are currently manufactured in the UK, that is going to take some time.”

 

‘RUNNING OUT OF TIME’

 

Britain has a large pharmaceuticals sector and produces many medicines used in Europe and other countries, including big fast-growing markets like China, where shipments are currently also governed by EU trade arrangements.

 

A disorderly exit from the EU in March 2019 with no system in place to ensure drug supplies is not what anyone in the British government wants. Indeed, British ministers declared in July they were aiming for continued co-operation in drug regulation after Brexit.

 

But that requires an agreement on transition terms with the remaining 27 EU countries – something executives across various industries see as far from certain.

 

AstraZeneca CEO Pascal Soriot said in an interview last month he was worried about “the potential for the one thing I didn’t think would happen which is a hard Brexit”.

 

In the absence of a deal, Britain’s trade with the EU would revert to World Trade Organization (WTO) rules, under which industrialized countries generally apply zero tariffs for medicines. However, the WTO’s drugs list has not been updated since 2010, so newer medicines could still be hit.

 

Virginia Acha, head of research, medical and innovation at the Association of the British Pharmaceutical Industry, said companies needed to know imminently whether or not there would be a transition period.

 

Without that information, businesses would start having to put strategies in place to deal with the repercussions of Britain becoming a non-EU “third country”.

 

“We’re running out of time,” she said. “There may be some companies that decide to push the button now just to fix it.”

 

Back at MeddiQuest, Armstrong says his staff are working flat out to help multiple international companies draw up contingency plans.

 

“Everybody is planning and regretting the fact they didn’t start planning earlier.”

From Factory to Pharmacy

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