News

Media And Political Bulletin – 27 July 2018

Media and Political Bulletin

27 July 2018

Media Summary

RPS: DH plan to stockpile drugs a ‘significant concern’ for pharmacy

Chemist and Druggist, Thomas Cox, 26 July 2018

Chemist and Druggist reports that the government’s plans to stockpile medicines ahead of Brexit is a “significant concern” for community pharmacy.

The article includes quotations from HDA’s Executive Director, who attempting to reassure pharmacists, states that the Department of Health, had already “communicated its view” to stockpile medicines with the organisation and “ideally, it won’t affect community pharmacists”.

They also cite him as stating that while he “understands the concerns” about the stockpiling proposals, Mr Sawer argued “we need to look at whether medicines can be stockpiled to some degree…in the anticipation of the worst-case scenario next March”.

Wholesalers “have experience” of stockpiling, Mr Sawer explained, including in preparation for the London Olympics in 2012. “Manufacturers will put advance stock into the UK anyway and wholesale keeps up to two weeks’ worth,” he added.

“Pharmacists need to be reassured there is robust planning occurring in the supply chain along with the DH and NHS to ensure there is a buffer of stock in the UK that will aim for supplies to be maintained normally,” he added.

Stockpiling medicine edges closer to reality in the midst of Brexit

BMA, Press Release, 26 July 2018

The British Medicines Association has released a Brexit briefing on medicines and medical device regulation which warns that that failure to agree a withdrawal agreement by March 2019, would lead to considerable uncertainty around the regulation of drugs and medical devices.

The association warns that such uncertainty could ultimately have ‘significant ramifications’ on the UK’s ability to access new treatments in a timely fashion.

This briefing was a response to Matt Hancock’s statement earlier this week that confirmed that Vaccines and blood products could be stockpiled ahead of a possible ‘no-deal’ Brexit.

Royal Pharmaceutical Society – RPS statement on stockpiling medicines for Brexit

Press Release, 27 July 2018

The RPS has issued a press release responding to reports that the stockpiling of medicines could occur in the case of a no-deal Brexit.

In a statement, RPS President, Ash Soni said that “Patient health is paramount and we agree with the Government that patients in the UK and across the EU should continue to be able to access the best and most innovative medicines.”

“Without a negotiated deal, risks of the UK’s withdrawal from the EU include delays in patients accessing medicines, a concern widely recognised across the healthcare sector.”

Dispensing doctor excused from new ‘Information Regulations’ scheme

DDA, Charles Gladwin, 27 July 2018

The DDA reports that dispensing  doctors with pharmacy contracts will not have to register under the new scheme requiring pharmaceuticals supply chain organisations to provide quarterly purchase invoice information.

It states that DDA members who operate pharmacy businesses from their premises with a wholesaler dealers licence  received a letter on July 13 from the Department for Health and Social Care. This requested information about the quarterly sales and purchases of generic medicines, as required under the new regulations. The communication had been sent out to all manufactures, importers and wholesalers of generic and special medicinal products.

DDA states that board members have looked at whether the required data could be identified, but as most of their generics are price bundled, it is not possible to ‘unbundle’ them to identify individual drug prices. It states that the work involved in supplying quarterly figures could also detract from patient care.

As a result, the DDA has now been informed that while the regulations do not allow for exemptions for wholesalers, the DHSC has now stated that if there are no sales involved in the transfer of stock then there is no need to provide information or register with the scheme.

While the Department has said that “there is no need for dispensing doctors with pharmacy contracts to provide quarterly information,” this will be kept under review.

AstraZeneca chief urges faster Brexit progress as drug firm stockpiles medicines

The Telegraph, Ian Withers, 26 July 2018

The Telegraph reports that the Chief Executive of AstraZeneca, Pascal Soriot, has called for faster progress to avoid a ‘no-deal’ Brexit, and confirmed that the is increasing stockpiles of medicines in case of an abrupt exit by the UK from the European Union.

Soriot said that the UK and EU governments needed to speed up talks to ensure drugs were delivered on time to patients on both sides of the Channel, after the firm posted solid half-year results today.

“It’s not yet where we should be,” he said, commenting on Brexit. “We are doing all we can to make sure patients don’t run out of medicines. But all parties need to find a way to negotiate with the EU to clarify things.”

AstraZeneca has started to increase its medicine inventory in Britain from three months’ supply to four in case drug shipments hit delays after March next year, Mr Soriot said.

Parliamentary Coverage

 

Full Coverage

RPS: DH plan to stockpile drugs a ‘significant concern’ for pharmacy

Chemist and Druggist, Thomas Cox, 26 July 2018

The government’s plans to stockpile medicines ahead of Brexit is a “significant concern” for community pharmacy, the Royal Pharmaceutical Society (RPS) has warned.

Health secretary Matt Hancock told the parliamentary health and social care committee on Tuesday (July 24) that he had “asked the Department of Health and Social Care (DH) for options for stockpiling [medical supplies]” to prepare for “the unlikely scenario” of the UK and the European Union failing to secure a deal ahead of Brexit next March.

“We’re working with industry to prepare for a potential need for stockpiling,” Mr Hancock said.

“We need to make sure that we get the balance right between preparing for all eventualities and making sure that people are going to be able to access the drugs they need,” he added.

The DH’s stockpiling plans focus on medicines with a short shelf-life, and other drugs that will “need to be flown in”, but Mr Hancock said he hopes that in a “no-deal” scenario “there will still be smooth movement [of medicines] through ports”.

The DH told C+D it could not comment further on how the plans might affect community pharmacy.

RPS: “Huge logistical challenge”

RPS English pharmacy board chair Sandra Gidley told C+D that stockpiling would present “a huge logistical challenge, given the number of transactions across borders daily and of medicines dispensed to patients every day”.

Distribution warehouses do not have enough free space, and stockpiling risks medicines going out of date or being improperly stored, she added. “There are so many aspects to this that need thinking through,” she told C+D.

The current stock availability problems caused by a “myriad” of factors are “likely to get worse” in a “no-deal” Brexit, “because there will be greater price differentials across Europe”, Ms Gidley said.

She stressed the RPS “doesn’t want to start a panic”, but added “unless people realise there is a potential concern, this won’t receive the attention [it needs]”.

RPS president Ash Soni welcomed Mr Hancock’s commitment to ensuring patients continue to have access to medicines post-Brexit, but said “the details of any potential stockpiling arrangements remain to be seen”.

“As the government now looks to engage with industry around contingency plans, they should also engage with pharmacists across all settings,” he stressed.

HDA: “Robust planning in place”

Martin Sawer, chief executive of the Healthcare Distribution Association (HDA), said the DH had already “communicated its view” to stockpile medicines with the organisation and “ideally, it won’t affect community pharmacists”.

While he “understands the concerns” about the stockpiling proposals, Mr Sawer argued “we need to look at whether medicines can be stockpiled to some degree…in the anticipation of the worst-case scenario next March”.

However, “nothing changes” for pharmacists in the short-term, Mr Sawer stressed, as the DH plans “to build up the normal supply chain”, and not to manage it via a central system.

Wholesalers “have experience” of stockpiling, Mr Sawer explained, including in preparation for the London Olympics in 2012. “Manufacturers will put advance stock into the UK anyway and wholesale keeps up to two weeks’ worth,” he added.

“Pharmacists need to be reassured there is robust planning occurring in the supply chain along with the DH and NHS to ensure there is a buffer of stock in the UK that will aim for supplies to be maintained normally,” he added.

Brexit group of pharmacy leaders

The RPS is due to have an “imminent” meeting with the Medicines and Healthcare products Regulatory Agency on stockpiling.

It is also one of seven organisations to join the Pharmaceutical Services Negotiating Committee (PSNC)’s new community pharmacy Brexit forum, set up “to identify relevant issues and concerns that Brexit may present”.

“The forum will want to ensure that community pharmacies have appropriate access to all sources of medicines so they can continue to fulfil prescriptions of vital medicines for their patients,” PSNC said in a statement yesterday (July 25).

Stockpiling medicine edges closer to reality in the midst of Brexit

BMA, Press Release, 26 July 2018

Vaccines and blood products could be stockpiled ahead of a possible ‘no-deal’ Brexit, the health and social care secretary has confirmed.

The Government is working with the health sector and pharmaceutical industry on how best to prepare the health service in the event of the UK leaving the EU next March with no deal in place – and stockpiling is one of the options being reviewed.

Health secretary Matt Hancock said that, while he was confident a deal would be reached in time, efforts needed to be stepped up to ‘mitigate the worst of the circumstances’.

And, speaking before the Parliamentary health and social care committee, on Wednesday, Mr Hancock added that, since taking over as health secretary, he had requested that work on these preparations be accelerated.

He said: ‘We are working right across government to ensure the health sector and industry are prepared, and that people’s health will be safe-guarded in the event of a no-deal Brexit

‘This includes the chain of medical supplies [such as] vaccines, medical devices, clinical consumables, blood products, and I have asked the department to work up options for stockpiling by industry … we are working with industry to prepare for the potential need for stockpiling in the event of a no-deal Brexit.’

Pressed on preparations

The admission that stockpiling was being considered came after Mr Hancock was questioned by the committee as to what the implications of a hard or no-deal Brexit would be for the NHS and its patients.

The BMA’s Brexit briefing on medicines and medical device regulation warns that failure to agree a withdrawal agreement by March 2019, would lead to considerable uncertainty around the regulation of drugs and medical devices.

The association warns that such uncertainty could ultimately have ‘significant ramifications’ on the UK’s ability to access new treatments in a timely fashion.

Mr Hancock said that emphasis was being given to those treatments with short shelf lives and raised the possibility of such medicines being flown into the UK in the event of gridlock at sea ports.

He said: ‘We need to make sure that we get the balance right between being prepared for all eventualities and making sure that people are going to be able to access all the drugs that they need. Obviously, there is a cost implication of doing this.

‘I hope that even under a no-deal scenario there will still be smooth movement in through ports … but you can imagine that it’s terribly important for me as secretary of state that people will have access to the medicines that they will need.

‘It is vital that we get the preparations right, but I’m also confident that with the right amount of work that we can mitigate the worst of the circumstances.’

Reservations realized

Speaking on the BBC on 1 July, NHS chief executive Simon Stevens said steps to protect the continued supply of medicine were being made.

He said: ‘There is now significant planning going on around all the scenarios… which the health department, with other parts of the Government, are undertaking, around securing medicine supply and equipment under different scenarios.

‘That will obviously crystallise, when it’s clear later this autumn, what the UK’s position will be [but] there’s extensive work under way now between the DHSC and other parts of the Government, the life-sciences industry and pharmaceutical companies.’

The BMA changed its stance on Brexit at its annual representative meeting in June. In a statement it said: ‘While we acknowledge there has been some progress in the negotiations, the challenges and the risks to the NHS posed by Brexit remain considerable. As raised in our Brexit briefings, there is too much uncertainty around the implications of Brexit for patients, doctors and health services.

‘Given what we now know about the potential impact of Brexit on the NHS and the nation’s health, and the dangers a ‘no-deal’ Brexit presents for the NHS, the BMA’s ARM voted in June to change our policy to opposition to Brexit’.

Royal Pharmaceutical Society – RPS statement on stockpiling medicines for Brexit

Press Release, 27 July 2018

Commenting on reports that stockpiling of medicines could occur in the case of a no-deal Brexit, RPS President Ash Soni said:

“Patient health is paramount and we agree with the Government that patients in the UK and across the EU should continue to be able to access the best and most innovative medicines.

“Due to the complex and integrated nature of medicine supply chains, if patients in the UK are to continue to receive the medicines they need quickly, it’s vital there is effective movement of pharmaceuticals and medical devices across borders with the European Union (EU).

“Without a negotiated deal, risks of the UK’s withdrawal from the EU include delays in patients accessing medicines, a concern widely recognised across the healthcare sector.

“With some medicines manufacturers now talking about contingency plans to stockpile medicines in the absence of a negotiated deal, we are engaging with regulators and the NHS about their plans to minimise any potential disruption to the medicines supply chain.

“We welcome the Government’s intention for the UK to continue participating in agencies for highly regulated sectors, including for medicines, supported by arrangements covering all relevant compliance activity to reduce additional regulatory burden.

“It’s understandable that current uncertainties about Brexit are raising concerns about patient care. Ultimately, I’m confident that pharmacists will continue to ensure that patient safety remains their top priority, and that the RPS will be on hand to help the profession manage future changes.”

Dispensing doctor excused from new ‘Information Regulations’ scheme

DDA, Charles Gladwin, 27 July 2018

Dispensing doctors with pharmacy contracts will not have to register under the new scheme requiring pharmaceuticals supply chain organisations to provide quarterly purchase invoice information.

The DDA has expressed its gratitude to the Department of Health and Social Care for the speed and pragmatism with which it responded to the DDA’s concerns about the requirements of the Branded Health Service Medicines (Costs) Regulations 2018. These came into effect on April 1 under the Health Service Medical Supplies (Costs) Act 2017.

The regulations have been introduced so the Department can gain a better understanding of medicines costs to drive better value for money. It means wholesalers are required to provide information about their purchase and sales to NHS primary care service providers, such as community pharmacies and GPs.

DDA members who operate a pharmacy contract from their premises with a wholesaler dealers licence (WDL) received a letter on July 13 from the DHSC. This requested information about the quarterly sales and purchases of generic medicines, as required under the new regulations. The communication had been sent out to all manufactures, importers and wholesalers of generic and special medicinal products.

In raising the matter with the DHSC, Matthew Isom, the DDA chief executive, explained: “The affected practices have to hold a wholesaler dealers licence (WDL) because they are both a dispensary and a pharmacy contract. Even though the physical space is often the same, they are required to hold the WDL in order that their stock can be moved seamlessly between the two entities.”

Practices are “not selling to anybody; it is simply because of the two legal entities and the need to move the stock between the two,” he emphasised. “The ‘hybrid’ practices are those who are trying to act as a dispensing practice and a pharmacy for all their patients. They need contracts because of the regulations.

“They act as one dispensing outlet as far as patients are concerned. They need a WDL to move stock from one contract to the other. The stock normally does not leave shelf never mind the building during the wholesaling …”

While the regulations do not allow for exemptions for wholesalers, the DHSC has now informed the DDA that if there are no sales involved in the transfer of stock then there is no need to provide information or register with the scheme.

While the Department has said that “there is no need for dispensing doctors with pharmacy contracts to provide quarterly information,” this will be kept under review.

AstraZeneca chief urges faster Brexit progress as drug firm stockpiles medicines

The Telegraph, Ian Withers, 26 July 2018

The boss of drugmaking giant AstraZeneca has called for faster progress to avoid a ‘no deal’ Brexit and confirmed the firm is increasing stockpiles of medicines in case of an abrupt exit by the UK from the European Union.

Chief executive Pascal Soriot said the UK and EU governments needed to speed up talks to ensure drugs were delivered on time to patients on both sides of the Channel, after the firm posted solid half-year results today.

“It’s not yet where we should be,” he said, commenting on Brexit. “We are doing all we can to make sure patients don’t run out of medicines. But all parties need to find a way to negotiate with the EU to clarify things.”

AstraZeneca has started to increase its medicine inventory in Britain from three months’ supply to four in case drug shipments hit delays after March next year, Mr Soriot said.

Mr Soriot welcomed Theresa May’s recent White Paper – which proposed close alignment with EU medicines regulations and continued single market access for goods – but said politicians needed to reach agreement fast.

“We don’t even know how medicines will cross borders. Sometimes they cross several times during the manufacturing cycle,” Mr Soriot said. Duplicating some operations in Sweden was also “costing us a lot of money”, he said.

Mr Soriot’s comments come after health secretary Matthew Hancock told MPs earlier this week the Government was making plans to stockpile vital blood products and medicines in case of a no-deal scenario.

AstraZeneca had previously told BBC Newsnight the firm was increasing stockpiles in both the UK and Europe by a fifth.

Meanwhile a jump in sales for AstraZeneca’s portfolio of new cancer drugs failed to make up for another steep decline in sales for out-of-patent blockbuster statin medicine Crestor.

AstraZeneca’s revenues came in at $10.3bn (£7.8bn) for the first half of 2018, down 1pc on the previous year. Pre-tax profits also fell, down 27pc to $786m due to higher investment.

Mr Soriot said he still expected the firm to return to sales growth in the second half of the year, and for this to “accelerate” in the years to come as new drugs pick up market share.

The firm’s cancer drugs unit posted a 42pc increase in sales to $2.7bn, boosted by demand for cutting-edge treatments including Tagrisso, Lynparza and Imfinzi.

However this was offset by a further dive in sales for legacy drugs including Crestor, which was down 39pc to $727m as it faced competition from copycat drugs.

Mr Soriot also said AstraZeneca would not increase drug prices in the US in the second half of the year, amid intense pressure from President Donald Trump on pharmaceutical companies to bring down prices.

He claimed AstraZeneca’s prices were “declining” in the US due to rebates it was paying to clients and it had “had a plan all along not to increase prices in the second half”.

Media And Political Bulletin – 27 July 2018

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?