News

Media And Political Bulletin – 16 January 2019

Media and Political Bulletin

16 January 2019

Media Summary

EU ‘no deal’ planning advice reminder

Dispensing Doctors’ Association, Ailsa Colquhoun, 16 January 2019

Dispensing Doctors’ Association reminds dispensing practices and other stakeholders in the UK medicines supply chain of  EU Exit Operational Readiness Guidance which will come into effect if the UK leaves the EU without a ratified deal – a ‘no deal’ exit.

The guidance covers seven areas including the supply of medicines and vaccines. They want to ensure organisations are prepared for, and can manage, the risks in such a scenario.

Brexit – Deal Rejected So What Now?

Politico, Helen Collis, 16 January 2019

Politico reports that British MPs rejected Theresa May’s Brexit deal by 432 votes to 202 — a defeat by 230 votes. Labour leader Jeremy Corbyn immediately tabled a motion of no confidence in the government, to be debated today. That’s unlikely to pass the vote this afternoon but today’s events will surely determine what comes next.

Brussels-based drugs lobby EFPIA called on U.K. and EU policymakers to sideline politics and prioritize patients in planning for a “disorderly” Brexit. There are now “very real, tangible and immediate threats to patient safety,” the lobby said.

NHS – Long Term Plan A Tall Order

Politico, Helen Collis, 16 January 2019

Politico reports that British MPs on Tuesday began to scrutinize the detailed plan for the NHS. Funding, primary care changes and the omission of a social care plan were highlighted as key concerns.

The House of Commons’ Health and Social Care Committee was told by think tanks that while the biggest overhauls are foreseen in primary care, there is no clear explanation as to how the plans will be achieved.

Pharmaceutical industry responds to Brexit vote outcome

ABPI, ABPI Press Office, 15 January 2019

The Association of the British Pharmaceutical Industry (ABPI) has responded to the outcome of the meaningful vote on the Withdrawal Agreement and Political Deceleration.

Mike Thompson, Chief Executive of the ABPI, said: “The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. This includes stockpiling and duplicating manufacturing processes here and in Europe. […] But we reiterate that ‘no deal’ would prove to be extremely challenging.”

NPA renews call for shortages powers, as no-deal Brexit risk grows

Chemist+Druggist, Thomas Cox, 15 January 2019

Chemist+Druggist reports that the NPA has stressed that pharmacists must receive the emergency powers proposed by the government to tackle medicines shortages, as the risk of a no-deal Brexit grows.

Ahead of this evening’s vote, the National Pharmacy Association (NPA) told C+D that “major disruption to medicines supplies is something to be avoided at all costs”.

Refrigeration storage for no-deal Brexit medicines stockpiles to cost £1m

The Pharmaceutical Journal, Carolyn Wickware, 15 January 2019

The Pharmaceutical Journal reports that government is expecting to spend around £1m on refrigerated storage for medicine stockpiles in the event of a no-deal Brexit.

In answer to a parliamentary question on cold drug storage, Stephen Hammond, minister of state for health and social care, said contract agreements for storage facilities for stockpiled medicines “have recently been signed or will be signed imminently”.

MHRA confirms it will consider UK version of Falsified Medicines Directive

The Pharmaceutical Journal, no author, 15 January 2019

The Pharmaceutical Journal reports that with less than a month until the Falsified Medicines Directive (FMD) is implemented on 9 February 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that if there is a no-deal Brexit it will consider a UK-only version of the EU law.

In a government response to a 2018 consulation on the implementation of ‘safety features’ under the FMD, the MHRA said that “in the interests of public safety, we will evaluate the options around a future national falsified medicines framework”.

Read the MHRA January drug safety update

Dispensing Doctors’ Association, Ailsa Colquhoun, 15 January 2019

The MHRA has published its January drug safety update.

Clexane supply shortage forecast

Dispensing Doctors’ Association, Ailsa Colquhoun, 15 January 2019

Dispensing Doctors’ Association reports that dispensers are asked to review their stocks of Clexane (enoxaparin) 40mg injection as there is an anticipated supply shortage until Wednesday 23 January for Italian imported (UK licensed) stock and Monday 18 February for further UK Clexane 40mg stock.

If product is required before 23 January, suggested alternatives are included.

 

Parliamentary Coverage

House of Commons Questions

Wes Streeting (Ilford North): What progress his Department has made on contingency planning for the UK leaving the EU without a deal.

The Secretary of State for Health and Social Care (Matt Hancock): We do not want a no-deal scenario in our exit from the European Union, but it incumbent on us to prepare in case. We asked medical suppliers to stockpile a further six-week supply over and above normal levels, and that work is going well. We will continue to work to ensure the unhindered supply of medicines in all Brexit scenarios.

Wes Streeting: The Prime Minister’s threatening of this Parliament and the country with no deal is entirely reckless, irresponsible and unnecessary. It is also causing unnecessary fear and anxiety among a range of clinicians and patients who rely on the consistent supply of life-saving drugs. The Secretary of State says that the Government are stockpiling medicines for up to six weeks. Will he do the right thing and commission an independent assessment of those plans so that patients can be assured? Better still, will he go back to the Cabinet and say that no responsible Health Secretary would allow no deal to take place, no responsible Prime Minister would allow no deal to take place, and this House will not allow no deal to take place?

Matt Hancock: It is incumbent on me as Health Secretary and on my team to ensure that we prepare for all potential scenarios. Of course, because of the overwhelming vote of the House in favour of the withdrawal Bill, no deal is the law of the land unless the House does anything else. If the hon. Gentleman is so worried, the best thing that he and all his friends can do is vote for the deal tonight.

 

Anne Marie Morris (Newton Abbot): To ask the Secretary of State for Health and Social Care, with reference to the Medicines and Healthcare Products Regulatory Agency consultation on EU exit no-deal legislative proposals, published on 4 October 2018, which stakeholders did his Department approach for a response to that consultation.
Stephen Hammond: The Medicines and Healthcare products Regulatory Agency’s (MHRA) public consultation on European Union exit ‘no deal’ legislative proposals ran from 4 October to 1 November 2018 and invited views from the life sciences sector, industry, allied healthcare professionals, medical charities and the public. The MHRA received 168 responses through the online portal and nine responses via email – none of which raised concerns about the consultation process.

The MHRA has now published updated ‘no deal’ guidance, which includes changes based on the responses received to the consultation in October. This can be accessed at the following link: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

 

Anne Marie Morris (Newton Abbot): To ask the Secretary of State for Health and Social Care, with reference to the Medicines and Healthcare Products Regulatory Agency consultation on EU exit no-deal legislative proposals, published on 4 October 2018, how many responses to that consultation raised concern about the consultation process; and if his Department will publish the responses to that consultation.

Stephen Hammond: The Medicines and Healthcare products Regulatory Agency’s (MHRA) public consultation on European Union exit ‘no deal’ legislative proposals ran from 4 October to 1 November 2018 and invited views from the life sciences sector, industry, allied healthcare professionals, medical charities and the public. The MHRA received 168 responses through the online portal and nine responses via email – none of which raised concerns about the consultation process.

The MHRA has now published updated ‘no deal’ guidance, which includes changes based on the responses received to the consultation in October. This can be accessed at the following link: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal.

 

Luciana Berger (Liverpool, Wavertree): To ask the Secretary of State for Health and Social Care, what assessment he has made of how medicines flown to the UK from Maastricht in preparation for the UK leaving the EU without a deal will reach distributors.

Stephen Hammond: On 23 August 2018, the Department wrote to all pharmaceutical companies that supply prescription only medicines and pharmacy medicines to the United Kingdom that come from, or via, the European Union or European Economic Area (EEA) asking them to ensure a minimum of six weeks’ additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019.

We recognise, however, that certain medicines with short shelf lives, including medical radioisotopes, cannot be reasonably stockpiled. Where these medicines are imported from the EU or EEA, we have asked that suppliers prepare plans to air freight these medicines from the EU, that can be implemented in the event of a ‘no deal’ exit.

Since then we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ exit. We recognise that information received from companies about medicines and supply chains is commercially sensitive; therefore, it is not appropriate to release this information publicly.

We expect supply chains for air-freighted medicines from the EU/EEA to the UK to operate as they do now.

 

Full Coverage

EU ‘no deal’ planning advice reminder

Dispensing Doctors’ Association, Ailsa Colquhoun, 16 January 2019

Dispensing practices and other stakeholders in the UK medicines supply chain are reminded of  EU Exit Operational Readiness Guidance which will come into effect if the UK leaves the EU without a ratified deal – a ‘no deal’ exit. This will ensure organisations are prepared for, and can manage, the risks in such a scenario.

The guidance covers seven areas including the supply of medicines and vaccines. This states:

  • UK health providers should not stockpile additional medicines beyond their business as usual stock levels. There is also no need for clinicians to write longer NHS prescriptions and the public should be discouraged from stockpiling. The responsible person is charged with ensuring compliance with this guidance; over-ordering of medicines or unnecessary export of medicines will be investigated.
  • The Department is putting in place a “serious shortage protocol”. This will involve changes to medicines legislation that will allow flexibility in primary care dispensing of medicines. Robust safeguards will be put in place to ensure this is operationalised safely, including making authoritative clinical advice available.
  • Public Health England (PHE) will ensure the continuity of supply for centrally-procured vaccines and other products that are distributed to the NHS for the UK National Immunisation Programme or used for urgent public health use.

Other areas covered by the guidance include

  • supply of medical devices and clinical consumables
  • supply of non-clinical consumables, goods and services;
  • workforce
  • reciprocal healthcare
  • research and clinical trials
  • data sharing, processing and access.

Commenting on last night’s vote in the Commons, DDA chief executive Matthew Isom said: “Maintaining the supply of medicines to UK patients and GP dispensaries must be a priority whatever the eventual approach to Brexit and we are pleased that dialogue on this has already been happening. The DDA, in common with all community pharmacy representatives, has been working closely with the Department of Health and Social Care (DHSC) to plan for all potential scenarios, including a no-deal Brexit.

“Given the ongoing uncertainty this work is now more critical than ever and the DDA will deploy all necessary resources to ensure arrangements are rural-proofed. While we hope that Parliament will, in time, be able to reach consensus on the approach to Brexit, our focus will remain on contingency planning with DHSC to ensure that patients can continue to access the medicines they need, when they need them, and that the impact on GP dispensaries is minimised.

The diversion of Government resource to Brexit planning has already pushed back negotiations on dispensing GP reimbursement. This is not an exclusive problem to dispensing practice but we are concerned that this delay is now likely to continue.”

Brexit – Deal Rejected So What Now?

Politico, Helen Collis, 16 January 2019

British MPs rejected Theresa May’s Brexit deal by 432 votes to 202 — a defeat by 230 votes. Labour leader Jeremy Corbyn immediately tabled a motion of no confidence in the government, to be debated today. That’s unlikely to pass the vote this afternoon but today’s events will surely determine what comes next.

Loyal Hancock: Speaking immediately after the result, Health Secretary Matt Hancock said Theresa May would not resign because “she’s clearly the best person to lead this country to find a way through this difficult impasse,” arguing that MPs “clearly voted against the deal but not against the prime minister.”

Hancock said May would now engage with senior parliamentarians and “listen.” If there is a “majority in the House [of Commons] against no deal, it must therefore be possible to find a majority on a deal,” he said.

May must present that plan to the Commons on Monday.

Efficient negotiators: Hancock also ruled out May seeking an extension on Article 50 “because the EU is very good at negotiating down to the wire,” he said, “when circumstances demand it.”

When presented with the EU’s statement that no talks would be tabled for this weekend, he argued this was simply a starting position of the EU. He said that “it would be worth explaining to our [EU] colleagues that no deal would be damaging to them, as well our ourselves.”

Speaking of no-deal damage: Brussels-based drugs lobby EFPIA called on U.K. and EU policymakers to sideline politics and prioritize patients in planning for a “disorderly” Brexit. There are now “very real, tangible and immediate threats to patient safety,” the lobby said. Mike Thompson, head of the U.K. drugs lobby ABPI warned that despite the sector’s medicines stockpiling and duplicating manufacturing processes, “no deal would prove to be extremely challenging.”

Dr Chaand Nagpaul, council chair of the British Medical Association called for a second public vote — something Hancock said had “no prospect” of happening.

NHS – Long Term Plan A Tall Order

Politico, Helen Collis, 16 January 2019

Politico reports that British MPs on Tuesday began to scrutinize the detailed plan for the NHS, and funding, primary care changes and the omission of a social care plan were highlighted as key concerns. The House of Commons’ health and social care committee was told by think tanks that while the biggest overhauls are foreseen in primary care, there is no clear explanation as to how the plans will be achieved.

Shift to the community: “Primary care networks are all over this document,” said Richard Murray, CEO of the King’s Fund. They are key to delivering greater primary and community services, yet “they do not exist,” he said. “The contract that establishes them … hasn’t been finalized yet,” he said. Investment in local care was “the right thing to do,” said Nigel Edwards of the Nuffield Trust, but he cautioned there was a “very long to do list” in primary and community care. “An awful lot is expected of this so it’s very important that investment that is promised is delivered,” he said.

Speaking of costs: The NHS could be short £2 billion annually after a no-deal Brexit, according to one estimate.

Pharmaceutical industry responds to Brexit vote outcome

ABPI, ABPI Press Office, 15 January 2019

The Association of the British Pharmaceutical Industry (ABPI) – the trade group representing the branded pharmaceutical industry in the UK – has responded to the outcome of the meaningful vote on the Withdrawal Agreement and Political Deceleration.

Mike Thompson, Chief Executive of the ABPI, said:

“The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. This includes stockpiling and duplicating manufacturing processes here and in Europe. We continue to work as closely as possible with Government on no deal planning.

“But we reiterate that ‘no deal’ would prove to be extremely challenging. With time running out we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

NPA renews call for shortages powers, as no-deal Brexit risk grows

Chemist+Druggist, Thomas Cox, 15 January 2019

Pharmacists must receive the emergency powers proposed by the government to tackle medicines shortages, the NPA has stressed, as the risk of a no-deal Brexit grows.

MPs rejected the Prime Minister’s proposed deal on Britain leaving the EU this evening (January 15) by 230 votes. The default option if no new agreement is reached before March 29 is for the UK to leave the EU without a deal, although many MPs have stressed they will not allow this to happen.

Ahead of this evening’s vote, the National Pharmacy Association (NPA) told C+D that “major disruption to medicines supplies is something to be avoided at all costs”.

“What may seem like parliamentary games are in fact very serious matters for our members and their patients,” head of corporate affairs Gareth Jones said.

The Department of Health and Social Care (DH) has proposed a “serious shortages protocol” – due to go before parliament later this month – which would amend the Human Medicines Regulations 2012 to enable pharmacists to dispense an alternative medicine in accordance with the protocol, rather than the prescription, and without having to contact a GP.

The DH told C+D last month that the amendments “will come into force before March, regardless of the situation with Brexit”, and later said the proposals had been “prompted by the preparations for the UK’s exit from the EU”.

The NPA’s Mr Jones said the shortages legislation is “something we and other pharmacy bodies lobbied for and is a sensible contingency”.

However, “more needs to be done” by the government, as pharmacies “should be able to share medicines with each other”.

“Brexit is bringing to a head a number of issues that should have been grappled with years ago. Medicines shortages have been a growing problem for months, so while Brexit appears to be exacerbating the situation, it is not the root cause,” Mr Jones said.

“By now it’s plain that there are structural faults in the medicines supply chain that too often leave patients waiting and pharmacists taking the rap for a situation beyond their control.”

CCA working with DH

The Company Chemists’ Association (CCA) – which represents the UK’s largest multiples and supermarket pharmacies – told C+D: “Regardless of the outcome of the vote, the CCA’s priority remains the safe supply of medicines to patients.”

Chief Executive Malcolm Harrison added that the organisation will continue working with the DH to deliver this.

ABPI: We need to be prepared for all eventualities

When asked about the impact of parliament rejecting Ms May’s deal, Association of the British Pharmaceutical Industry (ABPI) president Erik Nordkamp said: “We need to be prepared for all eventualities in all scenarios.

“Within those scenarios, we’ve always communicated publicly that a no-deal [Brexit] should be avoided.”

The Pharmaceutical Services Negotiating Committee told C+D it would issue a statement after the vote has occurred.

Refrigeration storage for no-deal Brexit medicines stockpiles to cost £1m

The Pharmaceutical Journal, Carolyn Wickware, 15 January 2019

The cold-chain storage warehouses required should the UK leave the EU without a deal in place are expected to cost the UK £1m.

The government is expecting to spend around £1m on refrigerated storage for medicine stockpiles in the event of a no-deal Brexit.

In answer to a parliamentary question on cold drug storage, Stephen Hammond, minister of state for health and social care, said contract agreements for storage facilities for stockpiled medicines “have recently been signed or will be signed imminently”.

The contract, which was put out to tender in October 2018, will provide capacity for “53,000 pallets of ambient storage, 5,000 pallets of refrigerated storage and 850 pallets of controlled-drug storage” from the beginning of February 2019 for 12–18 months, he said.

Hammond added: “This is expected to cost the government in the low tens of millions of pounds with the refrigerated storage expected to cost circa £1m.”

The Department of Health and Social Care (DHSC) previously told The Pharmaceutical Journal in December 2018 that drugs companies were being asked to maintain a rolling six-week stockpile for six months if the UK left the EU without a deal.

In his parliamentary answer, Hammond also admitted that that the DHSC would still have to pay for “some capital costs already incurred by the contractors in the event of a deal being approved by parliament”.

He said: “In that scenario, warehouse providers are required to decommission the additional capacity.

“The department has also put in place measures to minimise precommitted expenditure in the event of a deal being achieved.”

MHRA confirms it will consider UK version of Falsified Medicines Directive

The Pharmaceutical Journal, no author, 15 January 2019

With less than a month until the Falsified Medicines Directive (FMD) is implemented on 9 February 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that if there is a no-deal Brexit it will consider a UK-only version of the EU law.

In a government response to a 2018 consulation on the implementation of ‘safety features’ under the FMD, the MHRA said that “in the interests of public safety, we will evaluate the options around a future national falsified medicines framework”.

The statement, published on 24 December 2018, supports what Claymore Richardson, senior policy manager at the Department of Health and Social Care, told delegates at the Pharmacy Show in October 2018. Richardson told delegates that it would be “common sense” to build on work already done to create a UK version of FMD legislation in the case of a no-deal Brexit.

If the UK leaves the EU without a deal, access to the EU database — including the European Medicines Verification System (EMVS), which is the heart of FMD compliance — will be revoked. The MHRA had previously said that since FMD compliance is impossible without access to the EMVS, legal obligation to adhere to FMD regulations “would be removed for actors in the UK supply chain” in the event of a no-deal departure.

Some pharmacies in the UK are already FMD compliant: on 11 November 2018, a pack of insulin was thought to be the first medicine to be decommissioned under FMD procedures at Aintree University Hospital NHS Foundation Trust. Shortly afterwards, Market Pharmacy in Bolton was thought to be the first UK community pharmacy to decommission a medicine.

The National Pharmacy Association has advised pharmacists to prepare themselves for FMD but to “avoid signing long-term contracts” with FMD solution providers.

Read the MHRA January drug safety update

Dispensing Doctors’ Association, Ailsa Colquhoun, 15 January 2019

The MHRA has published its January drug safety update.

This includes the following articles:

  • Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
  • Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
  • Yellow Card App: download the updated App to receive the latest MHRA safety news and report suspected side effects, including in pregnancy

Clexane supply shortage forecast

Dispensing Doctors’ Association, Ailsa Colquhoun, 15 January 2019

Dispensers are asked to review their stocks of Clexane (enoxaparin) 40mg injection as there is an anticipated supply shortage until Wednesday 23 January for Italian imported (UK licensed) stock and Monday 18 February for further UK Clexane 40mg stock.

If product is required before 23 January, suggested alternatives include:

Inhixa 4,000 IU (40mg) in 0.4ml solution for injection pre-filled syringe (supplied by Techdow). Use instructions are available online.

Arovi 4,000 IU (40mg) in 0.4ml pre-filled syringe (supplied by Rovi Biotech). Use instructions online.

Dispensers are asked to continue to order all other strengths in line with historical demands, and are reminded that ordering will be monitored during this period.

Sanofi advises that there is a difference in the needle guard device between the Italian and UK preparations of Clexane.

Media And Political Bulletin – 16 January 2019

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