News

HDA Media And Political Bulletin – 16 November 2018

Media and Political Bulletin

16 November 2018

Media Summary

Theresa May interview on LBC Radio

Theresa May took calls on an LBC radio phone-in this morning.

Highlights include:

At 8:12 she was asked by a patient about the supply of medicines in ‘no deal’ and in the future relationship.

The Prime Minister said DHSC we’re putting plans in place to ensure medicines supply and that this is a topic of particular concern for her: ‘I’m a type-1 diabetic and my insulin is made elsewhere in the European Union’ – in Denmark.

She was asked about Matt Hancock’s comments at Cabinet that ‘no deal’ would be fatal.

She also said they were looking at the UK’s relationship with the EMA to ensure new medicines get to patients in the U.K. as quickly as they do in the EU.

May reveals the insulin she uses to treat her diabetes comes from Denmark as she says she recognises patients’ Brexit medicine fears

Mail Online, Martin Robinson, 16 November 2018

The Mail Online reports that Mrs May today said she faces a personal risk from medicine supplies being unable to get through Britain’s ports.

But Mrs May denied people would die if Britain left the EU with no deal after a disabled caller to LBC said she was worried about getting treatment.

The PM said: ‘This is an issue that I feel personally – as it happens my insulin is produced by a company in the EU, Denmark, so I know this is an issue that’s a matter of importance to people.

‘The Department of Health is ensuring it is making all the steps if we go to no-deal… But I believe we’ve got a good deal.’

Brexit news: Matt Hancock refuses to rule out deaths from medicine shortages if UK crashes out of EU with no-deal

Evening Standard, Nicholas Cecil, 15 November 2018

The Evening Standard reports that yesterday, Health Secretary Matt Hancock publicly refused to rule out that people could die due to medicine shortages if Britain crashes out of the EU with “no deal”.

The Cabinet minister made the alarming admission after health chiefs have been warning for months of the dangers of supplies running out.

Dismay at lack of detail on healthcare in Brexit withdrawal document

The Pharmaceutical Journal, Debbie Andalo, 15 November 2018

The Pharmaceutical Journal reports that the government’s publication of the proposed withdrawal agreement for the UK to leave the EU has been criticised for its lack of detail on the future of healthcare across the continent.

Published on 14 November 2018, the 585-page document does set out some technical details on medicines regulation, but the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it was “extremely concerning that the withdrawal agreement fails to specifically address the health issues important to patients, their safety and the wider public health”.

Prime Minister May defends her Brexit deal as ‘the right one’

Pharmacy Business, Kiran Paul, 15 November 2018

Pharmacy Business reports that Prime Minister Theresa May vowed to fight for her draft divorce deal with the European Union on Thursday after the resignation of her Brexit Secretary and other Ministers put her strategy and her job in peril.

Just over 12 hours after May announced that her Cabinet had agreed to the terms of the deal, Brexit minister Dominic Raab and work and pensions minister Esther McVey resigned.

Eurosceptics in May’s Conservative Party said they had submitted letters calling for a vote of no confidence in her leadership.

Report: Hancock warned Cabinet no-deal Brexit could be fatal

Politico, Jillian Deutsch and Helen Collis, 15 November 2018

Politico reports that, according to leaks, the U.K. Health Secretary Matt Hancock warned Theresa May’s Brexit cabinet meeting that a no-deal Brexit could have dire consequences.

“He told the room that he could not guarantee people would not die as a result of a no-deal Brexit,” The Times reported from leaks of a five-hour Cabinet meeting.

EU and UK pharma lobbies at odds over draft Brexit deal

Politico, Helen Collis, 15 November 2018

Politico reports that Europe’s top drugs lobby criticized Theresa May’s draft Brexit deal for failing to protect patients and public health in any of the articles listed in the 585-page document.

“It is extremely concerning that the Withdrawal Agreement fails to specifically address the health issues important to patients, their safety and the wider public health,” said Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations.

Life science, pharma groups unconvinced by Brexit deal

Politico, Helen Collis, 15 November 2018

Politico reports that the pharmaceutical industry isn’t sold on Theresa May’s draft Brexit deal.

As the U.K. prime minister stood by the Brexit plan in a speech Thursday evening, it appears likely the government could lean heavily on industry to try and convince skeptical MPs and the British public that the deal approved by Cabinet should stick.

But despite broad consensus that the planned implementation period — which includes identical medicines regulations, frictionless trade and continued access to EU science programs — is welcomed, not everyone was convinced on the terms of the transition.

Pharma industry welcomes draft Brexit deal

Pharmacy Business, Kiran Paul, 15 November 2018

Pharmacy Business reports that the Association of the British Pharmaceutical Industry welcomed the draft Brexit agreement approved on Wednesday by Prime Minister Theresa May’s Cabinet.

The withdrawal agreement of a transition period will enable companies to get medicines to patients in March 2019, it said. The Association also commended the approach taken in the declaration on the future UK – EU relationship.

This was also reported on by PharmaField and The Pharma Letter.

EMA Gives Update on Brexit Plans

PharmTech, Pharmaceutical Technology Editors, 15 November 2018

PharmTech reports that the European Medicines Agency published a report on Nov. 13, 2018 of its Sept. 24, 2018 meeting with industry stakeholders to discuss Brexit plans and their impact on agency procedures. The agency stated in a press release that, besides some delays in processing EMA certificates, EMA procedures (such as marketing authorization applications, scientific advice, and orphan designation, etc.) will not be impacted by the agency’s relocation to Amsterdam and throughout 2019. EMA is advising companies to submit applications and requests “as normal”.

FMD deadline ‘not the end’ of serialization process

in-Pharma Technologist, Ben Hargreaves, 15 November 2018

This content is copyright protected and therefore can only be accessed through the link provided.

FMD Safetey Features – Wholesale dealers Guidance

The MHRA has updated its guidance for wholesalers on the FMD.

The FMD error messages and alerts guidance notes and scanning and error messages flowchart can be found here.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Theresa May interview on LBC Radio

Theresa May took calls on an LBC radio phone-in this morning.

Highlights include:

At 8:12 she was asked by a patient about the supply of medicines in ‘no deal’ and in the future relationship.

The Prime Minister said DHSC we’re putting plans in place to ensure medicines supply and that this is a topic of particular concern for her: ‘I’m a type-1 diabetic and my insulin is made elsewhere in the European Union’ – in Denmark.

She was asked about Matt Hancock’s comments at Cabinet that ‘no deal’ would be fatal.

She also said they were looking at the UK’s relationship with the EMA to ensure new medicines get to patients in the U.K. as quickly as they do in the EU.

May reveals the insulin she uses to treat her diabetes comes from Denmark as she says she recognises patients’ Brexit medicine fears

Mail Online, Martin Robinson, 16 November 2018

Theresa May today revealed her own insulin supply from Denmark could be disrupted if there is a no deal Brexit.

The Prime Minister, who has Type 1 diabetes, also admitted her blood sugar levels go up when stressed as she faces a Tory coup over her controversial divorce deal with Brussels.

Mrs May today said she faces a personal risk from medicine supplies being unable to get through Britain’s ports.

But Mrs May denied people would die if Britain left the EU with no deal after a disabled caller to LBC said she was worried about getting treatment.

The PM said: ‘This is an issue that I feel personally – as it happens my insulin is produced by a company in the EU, Denmark, so I know this is an issue that’s a matter of importance to people.

‘The Department of Health is ensuring it is making all the steps if we go to no-deal… But I believe we’ve got a good deal.’

Mrs May told LBC listeners the medicine for her Type 1 diabetes came from Denmark in the EU, so the issue of continuing access to medicines was personal.

When asked whether Health Secretary Matt Hancock was unable to guarantee people would not die in the event of a no-deal Brexit due to problems accessing medicine, she said: ‘I’m not sure that’s exactly what Matt did say’.

Denmark is the world’s largest insulin producer with its main company Novo Nordisk selling £50 billion worth to 75 countries worldwide every year.

They are said to have built up a four month stockpile in the UK in case of the UK.

Theresa May used the LBC show with Nick Ferrari to lay down the gauntlet to Tory Eurosceptics over her Brexit deal today – warning that she is a ‘bloody difficult woman’.

The Prime Minister took a defiant stance despite fears that Michael Gove could become the latest minister to quit and join a massive revolt by Brexiteer MPs.

Mrs May said she had a ‘good conversation’ with Mr Gove this morning – but refused to be drawn on whether he had turned down a move to become the new Brexit Secretary.

In a phone in on LBC Radio, Mrs May admitted she had ‘concerns’ about the Irish border ‘backstop’ – but insisted the overall package was the best thing for the UK.

Theresa May first faced a call to stand down as from a Conservative councillor as she took calls on a LBC radio phone-in.

The man, who identified himself as Daniel from Louth, said he ‘commended’ the PM for trying to strike a Brexit deal with the EU but ‘sadly that has not worked’.

And he asked her: ‘Please Prime Minister, tell me why do you think you should stay on as PM when you have failed – despite your no doubt honourable intentions – to (deliver on) the referendum result?’.

Declaring she is a ‘bloody difficult woman’ she also rejected a suggestion that she was a modern-day Neville Chamberlain, the British leader mocked for claiming he had secured peace with Germany’s Adolf Hitler a year before World War Two broke out.

Some lawmakers in May’s Conservative Party argue that her draft divorce deal with the European Union is a capitulation to the bloc which will leave Britain subject to its rules indefinitely after the country leaves in March 2019.

Asked whether she was a modern-day Chamberlain, May told LBC radio: ‘No I don’t and the reason is this: we are not going to be locked in forever to something that we don’t want.’

Brexit news: Matt Hancock refuses to rule out deaths from medicine shortages if UK crashes out of EU with no-deal

Evening Standard, Nicholas Cecil, 15 November 2018

Health Secretary Matt Hancock today publicly refused to rule out that people could die due to medicine shortages if Britain crashes out of the EU with “no deal”.

The Cabinet minister made the alarming admission after health chiefs have been warning for months of the dangers of supplies running out.

Mr Hancock is reported to have warned the Cabinet that he could not guarantee that people would not die as a result of a “no deal” arrangement.

Asked on BBC Radio 4’s Today programme about this, Mr Hancock did not deny that he said this, adding: “We need to make sure that everybody does what’s necessary if there is no deal to have the unhindered flow of medicines that people need.”

Pressed further on whether there could be fatalities if Brexit is bungled, he continued: “There is a lot of work that we need to do and we are doing. We are spending millions of pounds on this already to make sure that that is put in place.”

Presenter Nick Robinson asked him a third time if the Government got Brexit wrong, then could people pay with their lives?

Mr Hancock responded: “Well, it’s very important that we get it right….’no deal’ is not pretty. It’s very difficult for the economy and for lots of other areas like healthcare.”

Tory MP Dr Sarah Wollaston warned in The Standard on Monday that MPs should not “knowingly inflict harm” on patients with a “no deal” Brexit.

Dismay at lack of detail on healthcare in Brexit withdrawal document

The Pharmaceutical Journal, Debbie Andalo, 15 November 2018

The government’s proposed withdrawal document does not adequately address the future of healthcare after the UK leaves the European Union, critics have said.

The publication of the proposed withdrawal agreement for the UK to leave the EU has been criticised for its lack of detail on the future of healthcare across the continent.

Published on 14 November 2018, the 585-page document does set out some technical details on medicines regulation, but the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it was “extremely concerning that the withdrawal agreement fails to specifically address the health issues important to patients, their safety and the wider public health”.

Nathalie Moll, director general at the EFPIA, said: “While we welcome the commitment to create a ‘free trade area combining deep regulatory and customs cooperation’ referred to in the political declaration, its failure to contain an explicit reference to the importance of securing long-term, extensive cooperation around the regulation of medicines is not in the best interest of patients.”

The publication of the document sparked a number of resignations from Theresa May’s government, and there is no guarantee that Parliament will approve the proposals.

Sarah Wollaston, chair of the House of Commons health and social care select committee, also expressed dismay at the content of the withdrawal agreement.

She wrote on Twitter: “Shockingly, absolutely nothing in the future framework document about health, care, public health or research. Yet this is an area which profoundly touches the lives of every citizen in the UK and across our partner EU nations.”

The Association of the British Pharmaceutical Industry (ABPI) welcomed the confirmation in the document that there will be a transition period following Brexit, assuming the agreement receives political support in Brussels and London.

Although ABPI staff were still analysing details of the document the day after it was published, Mike Thompson, chief executive of the ABPI, said in a statement: “Agreeing a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019.”

Prime Minister May defends her Brexit deal as ‘the right one’

Pharmacy Business, Kiran Paul, 15 November 2018

Prime Minister Theresa May vowed to fight for her draft divorce deal with the European Union on Thursday after the resignation of her Brexit Secretary and other Ministers put her strategy and her job in peril.

Just over 12 hours after May announced that her Cabinet had agreed to the terms of the deal, Brexit minister Dominic Raab and work and pensions minister Esther McVey resigned.

Eurosceptics in May’s Conservative Party said they had submitted letters calling for a vote of no confidence in her leadership.

“Am I going to see this through? Yes,” May told reporters at her Downing Street office.

Two Junior Ministers, two ministerial aides and the Conservatives’ Vice Chairman also quit. Hostility to the deal from government and opposition lawmakers raised the risk that the deal would be rejected and Britain would leave the EU on March 29 without a safety net.

May said she was sorry at the resignations and understood their unhappiness, but believed her deal was the right one.

“I believe with every fibre of my being that the course I have set out is the right one for our country and all our people,” she said.

“I am going to my job of getting the best deal for Britain and I’m going to my job of getting a deal that is in the national interest.”

By seeking to preserve the closest possible ties with the EU, May has upset her party’s many advocates of a clean break, and Northern Ireland’s Democratic Unionist Party (DUP), which props up her minority government.

Meanwhile, proponents of closer relations with the EU in her own party and the Labour opposition say the deal squanders the advantages of membership for little gain.

Both sides say it effectively cedes power to the EU without securing the promised benefits of greater autonomy.

“It is … mathematically impossible to get this deal through the House of Commons. The stark reality is that it was dead on arrival,” said Conservative Brexit-supporting lawmaker Mark Francois.

May will need the backing of about 320 lawmakers in the 650-seat parliament to pass the deal.

The ultimate outcome remains uncertain. Scenarios include May’s deal ultimately winning approval; May losing her job; Britain leaving the bloc with no agreement; or even another referendum.

Report: Hancock warned Cabinet no-deal Brexit could be fatal

Politico, Jillian Deutsch and Helen Collis, 15 November 2018

U.K. Health Secretary Matt Hancock warned Theresa May’s Brexit cabinet meeting that a no-deal Brexit could have dire consequences, according to leaks.

“He told the room that he could not guarantee people would not die as a result of a no-deal Brexit,” The Times reported from leaks of yesterday’s five-hour Cabinet meeting.

Questioned on those remarks this morning on Radio 4’s Today program, he refused to share his comments from the Cabinet, but warned that, “no-deal is not pretty: It is very difficult for the economy and lots of areas like health care that I’ve mentioned.”

“A second referendum would be divisive but would not be decisive,” he told the program, adding that such a move “would be even worse.”

He again dodged the question on whether he told the Cabinet this scenario would be “fatal,” replying: “We are working very hard to ensure people have the unhindered flow and access to medicines that they need,” noting that millions are already being spent on that, but, “there’s a lot of work to do.”

A loyal supporter of May’s Brexit deal, Hancock had a busy schedule of media interviews this morning, appearing on six different shows.

During the transition period, the 585-page draft Withdrawal Agreement, published late on Wednesday, allows sharing drug marketing authorization dossiers, permits medicines’ pending patent applications to apply in the EU, and protects patients with planned cross-border treatment.

EU and UK pharma lobbies at odds over draft Brexit deal

Politico, Helen Collis, 15 November 2018

Europe’s top drugs lobby criticized Theresa May’s draft Brexit deal for failing to protect patients and public health in any of the articles listed in the 585-page document.

“It is extremely concerning that the Withdrawal Agreement fails to specifically address the health issues important to patients, their safety and the wider public health,” said Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations.

“While we welcome the commitment to create a ‘free trade area combining deep regulatory and customs cooperation,’ referred to in the political declaration, its failure to contain an explicit reference to the importance of securing long-term, extensive cooperation around the regulation of medicines is not in the best interest of patients,” she added.

Moll noted that the publication is a “significant milestone” in the Brexit talks, “however, its future is by no means certain.”

She called on all sides to prioritize inclusion of health care issues in the next steps of the deal.

Moll’s comments stand in contrast to her U.K. counterpart’s.

The Association of the British Pharmaceutical Industry this morning got behind their government’s draft Withdrawal Agreement, describing it as an “important step towards securing a Brexit deal.”

Chief Executive Officer Mike Thompson said: “Agreeing a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019.”

He noted that “there’s much to build on,” and there’s “more work to be done,” but added that the ABPI is “committed to working with the U.K. and the EU so that close cooperation on scientific research and medicines regulation are central to a future partnership agreement for the benefit of all.”

Life science, pharma groups unconvinced by Brexit deal

Politico, Helen Collis, 15 November 2018

The pharmaceutical industry isn’t sold on Theresa May’s draft Brexit deal.

As the U.K. prime minister stood by the Brexit plan in a speech Thursday evening, it appears likely the government could lean heavily on industry to try and convince skeptical MPs and the British public that the deal approved by Cabinet should stick.

But despite broad consensus that the planned implementation period — which includes identical medicines regulations, frictionless trade and continued access to EU science programs — is welcomed, not everyone was convinced on the terms of the transition.

Representatives of the U.K. life sciences industry said the country’s loss of powers to influence European medicines regulations during the transition (which, under the terms of the agreement, could be extended for years) raises alarm bells.

This is “a limitation that could have particular implications in the life science sector where decision-making is an ongoing process,” said Jane Summerfield from law firm Hogan Lovells, who leads the company’s life sciences commercial regulatory practice in the U.K.

This could mean no vote on new EU rules, for example, on how to regulate new types of therapies, or changes to patent laws. At the European Medicines Agency, U.K. officials would no longer be able to vote on marketing authorization procedures or evolving methods to speed up the medicines regulatory review process, such as adaptive pathways.

Fellow Hogan Lovells lawyer Alexander Roussanov said it was “surprising” the U.K. would not be permitted to act as a reference country against which to compare new medicines during the transition, given it would be bound by EMA rules.

A lack of clarity over what happens after the transition is also troubling the sector. Pharmaceutical regulation wasn’t mentioned in a seven-page outline of the framework for talks on future relations.

“While we welcome the commitment to create a ‘free trade area combining deep regulatory and customs cooperation,’ referred to in the political declaration, its failure to contain an explicit reference to the importance of securing long-term, extensive cooperation around the regulation of medicines is not in the best interest of patients,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations.

The U.K.’s pharmaceutical industry was the most upbeat on the draft agreement, which it said was an “important step.”

“Agreeing a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019,” said Mike Thompson, CEO of the Association of the British Pharmaceutical Industry.

Taking a cautious line, the U.K.’s BioIndustry Association’s CEO Steve Bates said he would “monitor and inform its members of the political debate that will ensue in the finely balanced U.K. parliament.”

“There remains a long way to go for certainty on Brexit for life sciences businesses but this is a key step on that journey,” Bates added.

Thursday saw a raft of government resignations over the terms of the deal. It must still be approved by the U.K. parliament, and get signoff from EU27 leaders and the European Parliament.

Problems for the NHS

The fall in the value of the pound has already added £1 billion a year to National Health Service costs, said Mike Galsworthy, who runs the campaign groups NHS Against Brexit and Scientists for EU. That includes £100 million to pay for health care of U.K. residents elsewhere in Europe, and an extra £900 million to the cost of imported supplies and equipment.

He said the hard tone of May’s Brexit stance had “chased off” significant numbers of European nurses, doctors and midwives.

Figures released Thursday said NHS staff shortages could reach 350,000 by 2030 if losses continue and the NHS cannot attract skilled workers from abroad, according to analysis by the King’s Fund, the Health Foundation, and the Nuffield Trust.

From a U.K. research perspective, Galsworthy welcomed the fact the text of the deal “protects our role until the end of 2020 in EU science programs,” including the Horizon 2020 research fund and EU structural funds often used to support small businesses.

Niall Dickson, co-chair of the Brexit Health Alliance (BHA) that includes NHS, industry, patient and public health organizations, said the fragile nature of the deal and lack of longer-term clarity had done little to abate serious concerns of crashing out without a deal.

“For now, like many others, we remain deeply concerned about the prospect of ‘no deal’ and we will continue to support the health care sector as it prepares to do everything possible to protect patients should a deal not be reached,” he said.

Pharma industry welcomes draft Brexit deal

Pharmacy Business, Kiran Paul, 15 November 2018

The Association of the British Pharmaceutical Industry welcomed the draft Brexit agreement approved on Wednesday by Prime Minister Theresa May’s Cabinet.

The withdrawal agreement of a transition period will enable companies to get medicines to patients in March 2019, it said. The Association also commended the approach taken in the declaration on the future UK – EU relationship.

“Agreeing a transition period will mean that our members can continue to supply medicines to patients without delay or disruption come March 2019,” said Mike Thompson, CEO of ABPI.

“There’s much to build on. But there’s more work to be done. We are committed to working with the UK and the EU so that close cooperation on scientific research and medicines regulation are central to a future partnership agreement for the benefit of all’.

While significant contingency planning has been put in place by pharmaceutical companies to ensure that patients continue to get medicines in any Brexit scenario, the ABPI has always maintained that this would be challenging in a ‘no deal’ scenario.

The draft divorce deal with the European Union struck on Tuesday would allow the United Kingdom to leave the EU with a deal that avoids a chaotic ‘hard Brexit’ departure.

However, the deal faces an uncertain future as several of her ministers resigned on Thursday and some lawmakers in the UK parliament have vowed to vote it down.

This was also reported on by PharmaField and The Pharma Letter.

EMA Gives Update on Brexit Plans

PharmTech, Pharmaceutical Technology Editors, 15 November 2018

The European Medicines Agency published a report on Nov. 13, 2018 of its Sept. 24, 2018 meeting with industry stakeholders to discuss Brexit plans and their impact on agency procedures. The agency stated in a press release that, besides some delays in processing EMA certificates, EMA procedures (such as marketing authorization applications, scientific advice, and orphan designation, etc.) will not be impacted by the agency’s relocation to Amsterdam and throughout 2019. EMA is advising companies to submit applications and requests “as normal”.

Phase three of EMA’s Brexit preparedness business continuity plan began on Oct. 1, 2018. Some activities were temporarily suspended or reduced such as guideline development and revision. “These steps have been taken to ensure that EMA can focus on its core business of protecting human and animal health and that freed-up resources can be redeployed to allow the Agency to safeguard its core activities related to the evaluation and supervision of medicines,” the agency stated in a press release. The agency anticipates additional temporary suspension or reductions starting Jan. 1, 2019 as part of phase four of its Brexit plan.

FMD deadline ‘not the end’ of serialization process

in-Pharma Technologist, Ben Hargreaves, 15 November 2018

This content is copyright protected and therefore can only be accessed through the link provided.

FMD Safetey Features – Wholesale dealers Guidance

The MHRA has updated its guidance for wholesalers on the FMD.

The FMD error messages and alerts guidance notes and scanning and error messages flowchart can be found here.

HDA Media And Political Bulletin – 16 November 2018

From Factory to Pharmacy

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