News

Media And Political Bulletin – 07 March 2019

Media and Political Bulletin

07 March 2019

Media Summary

Brexit: Warehouse space arranged to stockpile NHS products

BBC News (Wales), James Williams, 07 March 2019

BBC News (Wales) reports that more warehouse capacity is being arranged by the Welsh Government to stockpile NHS products. The space, in south east Wales, will be used to hold medical supplies such as syringes, bandages and rubber gloves.

Six weeks’ additional stock has been arranged in case a no-deal Brexit leads to a disruption in supplies. The Welsh NHS has also identified “alternative providers” of these day-to-day items as part of its Brexit preparations.

Some are concerned if the UK leaves the EU without a deal then extra checks at ports could lead to a backlog of lorries carrying essential items from Europe to the UK.

Delays to cancer testing and treatment ‘inevitable’ after Brexit

PharmaTimes, Anna Smith, 07 March 2019

PharmaTimes reports that, according to a BBC Newsnight report, The Royal College of Radiologists (RCR) has told doctors to prepare for possible delays for some drugs used to detect cancer, regardless of the outcome of Brexit.

Dr Richard Graham, of the RCR, told the programme: “Of course now there will inevitably be delays to treatment as a result of the Brexit process because we need to start booking our lists for the post-Brexit date.

Clinicians have been urged to reduce their workload in the days after 29 March, when the UK is due to leave the European Union.

Epilepsy expert issues warning over vital medication

BBC News (Scotland), 07 March 2019

BBC News (Scotland) reports that Prof John Paul Leach, a top neurologist, has warned patients are being “left in the dark” about access to medicines after Brexit, and that patients are already reporting shortages in some vital epilepsy drugs.

Specialists in palliative care also say they have concerns about the impact of Brexit.

The UK government has said uninterrupted supply of medicines will be a priority in the event of a no-deal Brexit. Advice issued by Whitehall states that “if everyone does what they need to do” (including suppliers, hauliers and the NHS) then the UK government is confident medicine supplies will be uninterrupted.

Preparing for a no-deal Brexit

European Pharmaceutical Review, Nikki Withers, 06 March 2019

The pharmaceutical industry has increasingly voiced its concerns about the possibility of a no-deal Brexit and its impact on supplies and access to medicines. The European Pharmaceutical Review reports on the European Medicines Agency’s (EMA) last-minute advice to pharma companies ahead of March 2019, on the following topics:

  • Do you have any advice for pharma companies to ensure they are prepared?
  • Will the EMA’s move to Amsterdam impact pharma companies in any way?
  • Are there still concerns around centrally authorised medicinal products?

Manufacturers body: The FMD will cause generics prices to rise

C+D, Thomas Cox, 06 March 2019

C+D reports that BGMA director Warwick Smith has warned that financial pressures of the FMD are being felt across the supply chain, and this will be reflected in the price of medicines. “The cost is already in the market, even if the packs are not,” he told C+D at the Sigma conference in Muscat, Oman, last month.

The FMD has already cost the pharmaceutical industry “hundreds of billions of pounds” in production costs of adding 2D barcodes, Mr Smith claimed. On top of this cost, manufacturers paid £9 million to register with SecurMed – the UK group tasked with implementing the FMD, he claimed.

Mr Smith acknowledged that Brexit is having a “small” effect on medicines prices, but “it will get bigger”.

 

 

Parliamentary Coverage

House of Commons Questions – 06 March 2019

Royston Smith (Southampton, Itchen):

  • To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 9 January 2019 to Question 205406 on Naproxen, what progress has been made on securing additional deliveries of naproxen.
  • To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 16 January 2019 to Question 209362, what further discussions his Department has had with the health sector on the supply of Naproxen.
  • To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the availability of naproxen on the NHS.
  • To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of stocks of naproxen held by the NHS in the event that the UK leaves the EU.

Stephen Hammond: The Department is aware that supplies of naproxen tablets were limited during January and early February due to a manufacturing issue with the active pharmaceutical ingredient. During this time, we worked closely with all suppliers of naproxen tablets to expedite further deliveries.

Supplies of naproxen tablets are currently available in volumes sufficient to meet national requirements. We will continue to work closely with all manufacturers of naproxen tablets to monitor the overall supply situation to ensure supplies continue to remain available. We have provided updates about the naproxen supply situation to the National Health Service via primary and secondary care networks and will continue to do this.

We understand that naproxen, and other medicines, are vitally important to many people in this country. Our contingency plans include sensible mitigations for medicines that come to the United Kingdom from or via the European Union to ensure that the supply of medicines for patients is not disrupted.

The Department is unable to discuss the specific arrangements for naproxen, because to reassure companies engaging in our contingency plans, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme.

A comprehensive plan has been put in place in the form of a multi-layered approach to minimise any supply disruption:

  • securing, via the Department for Transport, additional roll on roll off freight capacity (away from the short straits) for goods to continue to come into the UK from 29 March;
  • buffer stocks and stockpiling (where this is practical) or asking industry to build up buffer stocks in the UK before 29 March;
  • buying extra warehouse space for the additional stock to be held in;
  • supporting companies in booking space on aircraft for products which require an immediate shipment due to short shelf-life or specific storage conditions;
  • making changes to, or clarifications of, certain regulatory requirements so that companies can continue to sell their products in the UK even if we have ‘no deal’; and
  • strengthening the processes and resources used to deal with shortages in the event that they do occur.

No one of these measures will work on its own. A combination of securing freight, buffer stocks, stockpiling and warehousing, regulatory flexibility, and clinical assessment and decision making, will be required help to ensure the continuation of medical supplies.

Throughout enacting our plans, the response from pharmaceutical companies has been hugely positive. Companies 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 event the UK leaves the EU without a deal.

 

Full Coverage

Brexit: Warehouse space arranged to stockpile NHS products

BBC News (Wales), James Williams, 07 March 2019

More warehouse capacity is being arranged by the Welsh Government to stockpile NHS products.

The space, in south east Wales, will be used to hold medical supplies such as syringes, bandages and rubber gloves.

Six weeks’ additional stock has been arranged in case a no-deal Brexit leads to a disruption in supplies.

The Welsh NHS has also identified “alternative providers” of these day-to-day items as part of its Brexit preparations.

Some are concerned if the UK leaves the EU without a deal then extra checks at ports could lead to a backlog of lorries carrying essential items from Europe to the UK.

MPs will once again vote on Theresa May’s Brexit deal by next Tuesday at the latest.

If it is rejected, the prime minister has promised to give MPs votes which could delay Brexit beyond the scheduled departure of 29 March.

Despite the possible delay, First Minister Mark Drakeford said the Welsh Government will continue with no-deal Brexit preparations “until we are completely sure that the only way we could leave the European Union is with a deal”.

As part of its no-deal Brexit preparations for the Welsh NHS, the Welsh Government has been working on back-up plans for medical products and devices, following a review of the relevant supply chains by the accountancy firm Deloitte.

About half the items bought within the Welsh NHS are from EU countries, according to the body that represents health boards in Wales.

Vanessa Young, director of the Welsh NHS Confederation, said: “We’ve gone out to suppliers and said to them to work with us to increase that supply and so through doing that we’ve identified a small number where there might be potential difficulties in getting those supplies and then putting in place plans to say, well, if we can’t get that exact product – what’s an alternative product we could source and secure?”

  • ‘No need’ to stockpile own drugs
  • What preparations are being made for a no-deal?
  • Drug firms fear ‘wasting’ money on Brexit

The Welsh NHS stores much of its medical supplies in three big warehouses in Bridgend, Cwmbran and Denbigh.

The Welsh Government and Welsh NHS Confederation confirmed to BBC Wales contracts are likely to be finalised in “the next week or so” for additional warehousing capacity in the south east.

‘No disruption’

A source at Abertawe Bro Morgannwg University Health Board said they were “highly confident that we will ensure continuity of supply and that there’ll be no disruption to the clinical services that are being provided”.

In response to a Freedom of Information request, Cardiff and the Vale University Health Board released notes from its Brexit No Deal Business Continuity Task and Finish Group, which highlighted the need for additional storage and raised particular concerns around the supply of medical goods.

The notes, dated 15 November, said: “A key risk which relates specifically to the UHB [University Health Board] relates to supplies of radio-pharmacy products, and products used in the provision of tertiary services – such as coils used in neurosurgery where there is a single supplier which is based in mainland Europe.

“It was confirmed that we hold the SE [south east] Wales contract for renal dialysis fluid products, and the supplier is based in Europe,” it added.

Ms Young said the NHS in Wales “has done a lot of preparations”, including desk-based rehearsals and role-play exercises to deal with the possibility of disruption.

She reiterated previous official warnings that there is “no need” for patients to stockpile their own supply of drugs.

Health Minister Vaughan Gething is hoping to raise any outstanding issues around Brexit preparations for the NHS at a meeting with the UK and Scottish health secretaries, provisionally booked in for next week.

Delays to cancer testing and treatment ‘inevitable’ after Brexit

PharmaTimes, Anna Smith, 07 March 2019

A senior medic has warned that delays to cancer testing and treatment will be “inevitable” as a result of a no-deal Brexit.

Clinicians have been urged to reduce their workload in the days after 29 March, when the UK is due to leave the European Union.

BBC Newsnight reported the news that The Royal College of Radiologists (RCR) has told doctors to prepare for possible delays for some drugs used to detect cancer, regardless of the outcome of Brexit.

With just 23 days to go before we leave the EU, MPs still need to get a meaningful vote on the Brexit deal, and if the no-deal is rejected, there is still potential to vote on extending Article 50, thus delaying the exit.

Dr Richard Graham, of the RCR, told the programme: “Of course now there will inevitably be delays to treatment as a result of the Brexit process because we need to start booking our lists for the post-Brexit date.

“We will need to book clinics less heavily so that we’ve got more wriggle room if we don’t have the radioisotopes in order to diagnose and treat the patients.”

The RCR doctors also penned a five-page guidance urging clinicians to keep their “workload lighter for the first week following a no-deal Brexit, in order to see more clearly what the impact is likely to be. In the weeks leading up to Brexit you should consider how to prioritise requests based on clinical need, should supplies be compromised.”

Epilepsy expert issues warning over vital medication

BBC News (Scotland), 07 March 2019

A top neurologist has warned patients are being “left in the dark” about access to medicines after Brexit.

Prof John Paul Leach says patients are already reporting shortages in some vital epilepsy drugs.

Specialists in palliative care also say they have concerns about the impact of Brexit.

The UK government has said uninterrupted supply of medicines will be a priority in the event of a no-deal Brexit.

Advice issued by Whitehall states that “if everyone does what they need to do” (including suppliers, hauliers and the NHS) then the UK government is confident medicine supplies will be uninterrupted.

‘Leaving patients in the dark’

But Prof Leach, a neurologist at Queen Elizabeth University Hospital, is among a number of medical experts demanding more clarity on arrangements.

He said: “There is not enough information and it is leaving patients somewhat in the dark.

“These are patients who depend on their treatment, and depend on the certainty of their treatment, and leaving them in the dark is not acceptable.

“In the last few months it has become apparent that there are some difficulties in obtaining different types of anti-epilepsy drugs.”

The epilepsy expert added: “We need more information about what is happening, what the risks are and what is being done to mitigate those risks.

“In approaching the UK government we have asked for reassurance, we have been told that things will be fine and that measures are in place – but we have no idea what these measures are.

“The worst thing that can happen is to have patients uncertain and worried about where their next dose of medication is going to come from.”

  • No-deal Brexit: Should patients worry?
  • Six key questions Brexit poses for the NHS
  • What preparations are being made for a no-deal?

The supply of medicines is reserved to Westminster but a string of health charities – Diabetes Scotland, Epilepsy Scotland, Marie Curie Scotland and the MS Society – have called for the Scottish government to reveal its own contingency plans about how the storage and distribution of medicines will work north of the Border in the event of a no-deal Brexit.

Kathryn Hamling, head of clinical services at Highland Hospice, which offers palliative care services throughout the Highlands, said the impact of Brexit was already being felt in the hospice sector.

She said: “We are aware that there may be some delay or some difficulty in getting some very necessary medication.

“This is a cohort of people who are often taking complex drug regimes and if there was a delay or an inability to access those drug regimes it would obviously affect the care we can give them

“To have patients or families with that extra concern at a very distressing time is something we would want to avoid. So I think we would be looking for assurances about that access.”

She added: “I think one of the main areas where we are going to see an impact, and maybe we already are, is in the workforce.

“The majority of people being cared for at the end of life are at home or in the care homes, and a significant proportion of people who work in those areas are non-UK EU nationals, and if that is going to reduce, then a service that is already stretched is going to be stretched even further.”

John Mitchell, a pharmacist at the Lochardil Pharmacy in Inverness, which supplies Highland Hospice, said he was experiencing supply issues but was not sure at this stage if it was attributable to Brexit.

He said: “Generally, we can put our hands on most things the day after they’ve been ordered.

“Unfortunately what’s happening now is that things are coming in and out of stock on a random basis and all we can really do is take advice from other people, talk to manufacturers to see if there are any long-lasting shortages, or when they might expect to have things back in stock.”

Health Secretary Jeane Freeman said: “It is unacceptable that the issue of medicine supply should arise.

“The concerns raised by Prof Leach outline the profound and lasting impact a ‘no deal’ Brexit would have on patient care as well as wider health services.

“We are working closely with health boards to ensure they are as prepared as possible for all Brexit scenarios, including ensuring supplies of medicines, devices and vaccines are protected.”

Preparing for a no-deal Brexit

European Pharmaceutical Review, Nikki Withers, 06 March 2019

The pharmaceutical industry has increasingly voiced its concerns about the possibility of a no-deal Brexit and its impact on supplies and access to medicines. Here, the European Medicines Agency (EMA) gives some last-minute advice to pharma companies ahead of March 2019.

Do you have any advice for pharma companies to ensure they are prepared?

“The pharmaceutical industry has primary responsibility for the continuity of supply of medicines and ensuring they are compliant with regulatory requirements. Thus, EMA and EU authorities have been reminding industry of the need to plan and take any necessary regulatory steps to ensure their medicines remain on the EU market post Brexit; thus minimising disruption to medicines supply and avoiding shortages. Since May 2017, we have been providing guidance to help pharmaceutical companies prepare for Brexit. According to EU legislation, the marketing authorisation holders of all EU medicines must be located within the EU/EEA. Marketing authorisation holders currently based in the UK should be transferred to the EU/EEA territory for their medicines to remain authorised in the EU. In addition, for medicines authorised via decentralised or mutual recognition procedures, the Reference Member State must be an EU/EEA Member State. Marketing authorisation holders carrying out certain operations in the UK need to implement several regulatory steps in order to guarantee continuous supply of their medicines in the EU/EEA territory. This includes changing the location of their qualified person for pharmacovigilance (QPPV), relocating their pharmacovigilance system master file (PSMF) or relocating some manufacturing sites.”

Will the EMA’s move to Amsterdam impact pharma companies in any way?

“All EMA’s core activities related to the evaluation and supervision of medicines will continue uninterrupted, and to the same quality and timelines during the Agency’s relocation to Amsterdam and throughout 2019. Except for some delays in processing of EMA certificates, there should be no impact on other EMA procedures (eg, scientific advice, orphan designation, paediatric investigation plans (PIPs), applications for marketing authorisation, and post-authorisation activities). Companies are advised to submit applications and requests as normal. Between 11 February and 15 March 2019, while EMA moves to its new premises, no pre-submission meetings for initial marketing authorisation applications will take place. Once we are settled in the Netherlands, companies will travel to Amsterdam rather than Canary Wharf for oral explanations and other face-to-face meetings with EMA.”

Are there still concerns around centrally authorised medicinal products?

“Concerning centrally authorised medicinal products (CAPs), we have sent a survey to those companies that hold their marketing authorisations and are located, or carrying out certain operations, in the UK. This survey was intended to identify those medicines that will require regulatory changes and industry’s plans for implementing these changes. The outcome of EMA’s survey to industry on centrally authorised medicinal products, which identified gaps in the industry’s preparedness, was published in July 2018. It showed that marketing authorisation holders for more than half (58 percent) of the 694 CAPs with an important step in their regulatory processes in the UK, were on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union. However, for 108 (88 human products and 20 veterinary products), or 16 percent, of these medicines with manufacturing sites located in the UK only, there were serious concerns that the necessary actions will not be carried out in time. For 10 percent of the products included in the survey, EMA received no feedback from companies. Since July, EMA has been contacting these individual companies and reminding them of their obligation for continuity of supply. As a result, the majority of marketing authorisation holders concerned have taken steps to either transfer their marketing authorisation to an EU/EEA country; change their QPPV; relocate their PSMF; adapt their logistics, supply chains and contracts; or relocate some manufacturing sites. For products where there are still outstanding issues, the Agency has been working directly with the marketing authorisation holders to address them. In addition, EMA has been analysing how best to minimise potential supply disruptions and any resulting impact on public and animal health. It is discussing relevant mitigation measures with its scientific committees, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.”

Manufacturers body: The FMD will cause generics prices to rise

C+D, Thomas Cox, 06 March 2019

The cost of implementing the EU’s medicines scanning law across the supply chain will cause medicines prices to increase, the BGMA has said.

The EU’s anti-counterfeit legislation, the Falsified Medicines Directive (FMD) – which requires all pharmacies to be able to scan barcodes on medicines packaging at the point of dispensing – came into force last month.

BGMA director Warwick Smith warned that financial pressures of the FMD are being felt across the supply chain, and this will be reflected in the price of medicines.

“The cost is already in the market, even if the packs are not,” he told C+D at the Sigma conference in Muscat, Oman, last month.

The FMD has already cost the pharmaceutical industry “hundreds of billions of pounds” in production costs of adding 2D barcodes, Mr Smith claimed.

On top of this cost, manufacturers paid £9 million to register with SecurMed – the UK group tasked with implementing the FMD, he claimed.

“I suspect [the FMD] is having an impact already, but it will be quite gradual and quite small,” Mr Smith added.

Brexit having “minor” effect on prices

Mr Smith acknowledged that Brexit is having a “small” effect on medicines prices, but “it will get bigger”.

Of the factors affecting generics prices, Brexit is “probably the least impactful”, he said.

Media And Political Bulletin – 07 March 2019

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