Media And Political Bulletin – 15 October 2018

Media and Political Bulletin

15 October 2018

Media Summary

Public Accounts Committee tells government to reveal how it will control generic drug costs by end of year

Pharmacy Business, Neil Trainis, 12 October 2018

Pharmacy Business reports that the Public Accounts Committee has called on the government to reveal by the end of the year how it intends to control the rising cost of generic drugs and ensure that patients in the UK do not suffer a shortage of medicines in the lead-up to and following Brexit.

The article states that five recommendations were put forward in a report by the PAC, as concerns over the increasing cost of generics, highlighted earlier this year by a National Audit Office report which claimed the price of some generic drugs greatly increased in 2017-18, persists.

The  PAC said the Department of Health and Social Care had failed to reveal the full range of actions it could take other than collecting information to keep generic prices under control and called for that to be disclosed by December.

Read the full report from the PAC here.

Medicines and Healthcare products Regulatory Agency – Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

MHRA, 12 October 2018

The MHRA has released guidance regarding the continuity of supply of Investigational Medicinal Products in the event of a ‘no-deal’ Brexit.

Within the guidance, the MHRA states that although the Government is ‘working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted.’

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Public Accounts Committee tells government to reveal how it will control generic drug costs by end of year

Pharmacy Business, Neil Trainis, 12 October 2018

The Public Accounts Committee (PAC) has called on the government to reveal by the end of the year how it intends to control the rising cost of generic drugs and ensure patients in the UK do not suffer a shortage of medicines in the lead-up to and following Brexit.

Five recommendations were put forward by the PAC as concerns over the increasing cost of generics, highlighted earlier this year by a National Audit Office report which claimed the price of some generic drugs greatly increased in 2017-18, persists.

Legislation introduced last year gave the government powers to compel manufacturers, importers and wholesalers to provide it with information about pricing and purchasing of generic medicines and instruct pharmaceutical companies to lower the price of a generic where it is deemed excessive.

However, the PAC said the Department of Health and Social Care (DHSC) had failed to reveal the full range of actions it could take other than collecting information to keep generic prices under control and called for that to be disclosed by December.

The PAC also called on the DHSC and NHS England (NHSE) to produce updated guidance for clinical commissioning groups (CCGs) setting out contingency plans to lessen the financial impact on them in the event of unforeseen price rises.

According to the NAO, generic prices increases “resulted in additional unforeseen costs” for CCGs whose net spend on concessionary-priced medicines was estimated to be £315 million in 2017-18, seven times more than that spent in 2016-17. NHSE said CCGs were faced with a £250 million deficit at the end of 2017-18, something the NAO “partly attributed to concessionary pricing increases.”

The DHSC’s failure last year to address the rising price of some medicines quickly enough was also the subject of the PAC’s report. The PAC said “there were clear signs” that some medicines went up in price from June 2017 but it was not until November that the DHSC took action “to manage costs.”

“The Department told us it became aware of the price rises in summer 2017 but did not have the information it needed to take action. For the financial impact of the price rises, the Department relied on NHS England to alert it, which in turn relied on clinical commissioning groups,” the PAC said.

The DHSC’s power to collect thorough information from companies on the medicines they sell was called into question despite regulations compelling them to provide quarterly data and allowing the Department the right to request more information within two days if there are supply or pricing issues.

“The new regulations allow companies to give ‘reasonable estimates’ of how much they buy and sell medicines for in some cases, rather than actual figures, limiting the accuracy of the information available to the Department,” the PAC said.

“Companies are also required to notify the Department if they intend to stop supplying a medicine, or they expect a supply shortage. But this only applies if the company itself judges that its actions will affect patients and does not give the Department any control over which medicines companies notify it about.”

The PAC said the DHSC was only able to collect quarterly information on “a minority” of specials following concerns the NHS was paying high prices for those medicines.

The DHSC was urged to ensure that by September next year, its first annual review of the regulations “includes an assessment of how well the provisions for companies providing estimates and notifying the Department of an impending shortage are working, as well as the application of new information collection powers to ‘specials’ medicines.”

The Committee also called on the DHSC and NHSE to “establish clear and timely information flows between each other and local bodies to identify and inform about generic medicine supply and/or pricing issues.” That, the PAC said, should allow clinicians to have more transparency of the price of generic medicines they prescribe.

Mark Burdon, an independent community pharmacy contractor and PSNC regional representative for the North East and Cumbria who gave evidence to the PAC inquiry in July, said: “PSNC was pleased to assist the PAC in this inquiry and it is good to see that MPs recognise the important role that community pharmacy teams play in ensuring that patients do get their medicines when they need them.

“As we know and is made clear in the report, generic medicines shortages are a very complex global issue and with Brexit on the horizon that is likely to remain the case.

“We would now like to see the Department of Health and Social Care working with us to develop a fairer and more responsive concession system that ensures that hard working pharmacies do not face unfair risks, and that the impact of supply problems is not passed on to them or their patients.”

In giving evidence to the inquiry, the National Pharmacy Association said community pharmacies had “spent a considerable amount of extra time and effort sourcing generic medicines in order to meet patient expectations.”

It added: “In addition to the increases in workload, the situation has put immense financial pressure on pharmacies that have been forced to purchase medicines at inflated prices without knowing whether they will be adequately reimbursed.”

The NPA also said it was “reasonable to expect that wholesalers are transparent about their pricing and margins, as these feed through the supply chain and directly impact independent pharmacies and their patients.”

The NAO report identified a range of supply-related factors that may have been behind the price rises and an unexplained “unexpected growth” in the margins of wholesalers.

A spokesman from the NPA said: “This puts further pressure on the government to act on a matter of great importance to pharmacists and patients alike.

“The committee appears to have taken on board the points we, PSNC and others have made. Their focus is on the ultimate cost to the NHS, rather than on the costs to community pharmacy directly, but we all have an interest in a system that is cost-effective and works well for patients.”

Medicines and Healthcare products Regulatory Agency – Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

MHRA, 12 October 2018

A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome. With talks ongoing, we remain committed to reaching agreement in the Autumn. However, it’s our duty as a responsible Government to prepare for all eventualities, including ‘no deal’ and that is exactly what we are doing.

Although the Government is working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted. The Government has set up the Medicines Supply Contingency Programme to ensure the continued supply of licensed medicines in the UK in the event of a ‘no deal’ Brexit, read this page for more information.

We would encourage organisations running clinical trials in the UK to consider their supply chains for IMPs ahead of the 29th March 2019. Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit that we reach March 2019 without agreeing a deal with the EU.

It may be necessary to start making any contingency arrangements ahead of the 29th March 2019 to provide assurance to trial participants and for the trials.

The life sciences sector may also wish to consider the relevant technical notices published on 23 August, under the heading ‘Regulating medicines and medical equipment’.

Media and Political Bulletin

22 February 2018

Media Summary

Government watchdog launches generics investigation

Dispensing Doctor, 22 February 2018

The Dispensing Doctors’ Association reports that the DDA will take part in a National Audit Office investigation into the costs of generic drugs to the NHS.

The study, which is expected to be published in the summer, aims to identify the extent of the increased spend on generic drugs, the causes of generic price increases and the Department of Health and Social Care’s response to the increased expenditure.

Brexit: just one month to agree transition deal, says UK pharma

Pharmaphorum, Andrew McConaghie, 21 February 2018

 

Pharmaphorum highlights that the UK pharma and biotech industries have warned that clarity on Brexit arrangements for medicines is needed urgently.

 

Pharma industry body the ABPI and its biotech counterpart the BIA say a deal needs to be struck on the ‘transition’ period which would begin after 29 March 2019 – and that the sector needs at least 12 months to prepare or else face a ‘cliff edge’ scenario.

 

They are warning that without clear terms for the transition, more money and time will have to go into planning for the worst case scenario. This is already involving companies shifting medicines supply chains to the EU, but in the long term it could pose a real threat to investment in UK life sciences.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Government watchdog launches generics investigation

Dispensing Doctor, 22 February 2018

 

The DDA will take part in a National Audit Office investigation into the costs of generic drugs to the NHS.

The study, which is expected to publish in the summer, aims to identify the extent of the increased spend on generic drugs, the causes of generic price increases and the Department of Health and Social Care’s response to the increased expenditure.

Recently, the prices of generics have increased creating unexpected pressure on the NHS, including on the concession/adjusted reimbursement price system.  This was queried recently in the House of Commons.

In its response to the NAO, the DDA will highlight reimbursement system anomalies that result in loss-making dispensing. Practices may submit individual contributions via email to the NAO.

 

Brexit: just one month to agree transition deal, says UK pharma

Pharmaphorum, Andrew McConaghie, 21 February 2018

 

The UK pharma and biotech industries have warned that clarity on Brexit arrangements for medicines is needed urgently – but no deal is in sight just 13 months ahead of its official departure date.

Pharma industry body the ABPI and its biotech counterpart the BIA say a deal needs to be struck on the ‘transition’ period which would begin after 29 March 2019 – and that the sectors needs at least 12 months to prepare or else face a ‘cliff edge’ scenario.

They are warning that without clear terms for the transition, more money and time will have to go into planning for the worst case scenario. This is already involving companies shifting medicines supply chains to the EU, but in the long term it could pose a real threat to investment in UK life sciences.

Agreement on the terms of the transition period should be relatively easy, with most politicians agreeing that the status quo can be maintained (or mirrored) for two years. However these talks are moving too slowly for the medicines supply chain, which often requires years even to make minor changes.

The ABPI and BIA today issued a joint submission to (yet another) parliamentary hearing on Brexit that a transition deal couldn’t wait any longer.

“This should be a single step transition that adequately reflects the time needed by pharmaceutical companies to transition to a new framework. Many companies are making critical business decisions now, including about their future investments,” they warned.

The organisations say this certainty and consistency was need to avoid a ‘cliff-edge’ for business as the UK leaves the EU.

Government in-fighting

Calls for progress come against a background of continuing confusion and in-fighting within Theresa May’s Conservative government and parliamentary party, where hardline Brexiteers are jostling with pro-European factions for control of the agenda.

Pro-Brexit MPs are insisting that the UK must leave the EU single market and the customs union, but this will make any kind of alignment with Europe on medicines, research budgets and immigration far more difficult to agree.

EU leaders, including chief negotiator Michel Barnier continue to reiterate that the UK won’t be able to ‘cherry pick’ access and alignment.

The Government’s policy is currently that it will leave the single market and customs union, even though this is seemingly incompatible with maintaining an open border between Northern Ireland and the Republic of Ireland, part of the first phase of Brexit talks already agreed in principle last year.

Mutual recognition

The UK trade bodies and European pharma organisation EFPIA have been warning for many months that medicines supplies in the UK and the continent will be disrupted and patients affected if no transition deal is agreed in advance.

They also want to avoid a ‘two step’ transition, whereby further negotiations would be needed during the transition period to agree the final permanent relationship between the UK and Europe regarding medicines.

Most life science companies are backing the idea of the UK agreeing a permanent mutual recognition deal with the EU for after the transition period. This proposal was put forward by UK government health secretary Jeremy Hunt and business secretary Greg Clark last summer, but EU-UK negotiators haven’t even begun to tackle the issue – meanwhile the Brexit day of 29 March 2019 is fast approaching.

The chair of the House of Commons health select committee Sarah Woollaston MP wrote to Jeremy Hunt last week.

She wrote: “With only 13 months until the UK exits the European Union on 29 March 2019, healthcare services and businesses, including those manufacturing and distributing medicines, remain in the dark. Many businesses told us they are having to prepare for a worst-case scenario despite the cost because time is running out for a transition period to be announced.”

Woollaston added that delay in announcing the transition terms beyond March 2018, would see businesses “forced to invest money in contingency plans at the expense of this funding going towards advancing patient care.”

She concluded: “This is an unnecessary cost and distraction, which should be avoided.”

The ABPI and others, including the head of Novartis UK tweeted their support of Woollaston’s points.

The ABPI and BIA will be among many groups present at a specially convened UK Parliament Brexit science and innovation Summit taking place tomorrow.

Media and Political Bulletin

7 December 2017

Media Summary

Patients hit by shortage of drugs as prices soar

The Times, Billy Kenber and Chris Smyth, 7 December 2017

 

The Times reports that generics shortages have cost the NHS £180 million in six months. The publication highlights that at least 100 drugs have been affected by supply issues, which has forced health officials to approve temporary prices of up to 4,000 per cent to boost stocks.

The NHS is spending more than £50 million a month overpaying for the medicines but pharmacies are still consistently running out of supplies for days at a time and having to turn patients away, according to the article.

Martin Sawer, Executive Director of the HDA, reiterated to The Times that price rises had nothing to do with large wholesalers manipulating the market but he called for more scrutiny of smaller wholesale licence-holders. “Our members do not sit on stock, they make generics available to customers as soon as they get them,” he said.

 

Drugmakers line up to invest in UK life sciences

PharmaTimes, Selina McKee, 6 December 2017

 

PharmaTimes highlights that GlaxoSmithKline and AstraZeneca have announced significant investment in the UK as part of the government’s sector deal for the life sciences industry.

GSK has said that it would stream £40 million of new investment into initiatives that harness advances in genetic research in the development of novel medicines. The investment will support the sequencing of data from all 500,000 volunteer participants in the UK Biobank, beyond the first 50,000 subset announced earlier this year.

AstraZeneca, which is investing £500 million in its new strategic R&D centre and global headquarters in Cambridge, is also among the 25 organisations from across the sector that are investing in the UK, ensuring that the country is at the forefront of developing new innovative treatments and medical technologies.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Patients hit by shortage of drugs as prices soar

The Times, Billy Kenber and Chris Smyth, 7 December 2017

 

Cancer patients and people with severe mental illness are going without essential medicines because of shortages that have cost the NHS £180 million in six months, The Times has learnt.

At least 100 drugs have been affected by supply problems, forcing health officials to approve temporary price rises of up to 4,000 per cent to boost stocks. The NHS is spending more than £50 million a month overpaying for the medicines but pharmacies are still running out for days at a time and turning patients away.

Ministers are now investigating amid fears that the market is being manipulated to drive up prices. Pharmacists have complained that there have been cases where a drug in severe shortage becomes available immediately when a higher price is granted.

Warwick Smith, director-general of the British Generic Manufacturers Association, said “something very unusual” was going on and suggested that wholesalers were artificially inflating prices.

Mr Smith said that concessionary prices agreed by the government were on average two and a half times larger than manufacturers’ charges. “It’s not in manufacturers’ interest to exaggerate their price increases,” he said. “It doesn’t make them any money, it just makes them less popular. Something is going on somewhere else in the supply chain.”

Prostate and breast cancer drugs taken by tens of thousands of people are among those affected as well as epilepsy treatments and several common anti-psychotic medicines used to treat schizophrenia and bipolar disorder.

Simon Wigglesworth, head of the charity Epilepsy Action, said that people were being forced to change drugs because of shortages. “The impact of this should not be underestimated . . . [People with epilepsy] may not be able to drive or work, and experience severe anxiety or depression as a result of switching medication,” he said.

Baroness Morgan of Drefelin, chief executive of Breast Cancer Now, said that shortages of the hormonal therapy anastrozole, taken for years after surgery to stop tumours returning, were incredibly worrying, adding: “Delays in receiving treatments can cause further uncertainty and anxiety at an already difficult time. Crucially, if adherence to hormone therapy drops further, breast cancer recurrence rates could increase, ultimately costing women’s lives.”

Under rules to combat supply problems, a pharmacy industry body can ask the Department of Health to grant a month of higher prices, known as price concessions, for drugs that are difficult to obtain. The cost to the health service of one drug, the anti-psychotic quetiapine, has risen from £1.62 to £65 and the total extra cost to the NHS of the concession price rises has increased from £2.5 million in April to £32.1 million in June and £53.4 million in September. Overall the shortages have cost an extra £177.9 million between April and September, the most recent month for which data is available.

The cost is likely to be rising further as pharmacists report “unprecedented” shortages, with difficulties obtaining 97 drugs last month, up from 27 in April.

Mark Burdon, a member of the Pharmaceutical Services Negotiating Committee, which makes these formal requests, said that high street chemists were “scratching around” for crucial supplies. “The most worrying ones are drugs for mental health. It’s terrifying for patients when they can’t get something they are stable on. Anti-cancer drugs too cause huge anxiety for patients,” he said. “We have to spend a lot of time reassuring people — ‘Yes, we’ll definitely have it, but probably not today or tomorrow. Can you scratch by until Friday?’ . . . It does happen that we have to say to patients, ‘We can’t get this for love nor money’.” He said that pharmacists were having to beg GPs and hospitals for supplies.

Many of the shortages have occurred in drugs made by several companies that have been available for years without any supply problems. At least two manufacturers have been forced by regulators to suspend some production this summer but the rise in shortages appears to have begun at least two months before these problems.

Martin Sawer, executive director of the Healthcare Distribution Association, representing large wholesalers, insisted that they were not manipulating the market but called for more scrutiny of smaller wholesale licence-holders. “Our members do not sit on stock, they make generics available to customers as soon as they get them,” he said.

The Department of Health said: “Our priority is to ensure medicines used by the NHS are certified as safe and effective, even if this costs the NHS more money . . . The generic drugs market is particularly volatile at present due to shortages of supply and other factors but we still have some of the cheapest prices in Europe.”

Case study

Dr Wayne Kampers, 53, a consultant psychiatrist in London, said his patients had suffered depression and suicidal thoughts as a result of medicine shortages (Billy Kenber writes).

“About 20 per cent have either not been able to get the medication that’s been prescribed or they’ve been given a different form of that medication and that has significantly affected their mental health,” he said.

Dr Kampers, who works at the Priory in southwest London as well as in Harley Street, said that one patient had been stable on an antipsychotic drug for many years but recently had to switch because it suddenly became unavailable. “They really struggled,” he said.

He described the problems suffered by another patient who was prescribed an antidepressant. “He went to at least 12 different pharmacies around where he lived and worked and not a single one was able to dispense it and nor could they tell him when it was going to become available. The impact of the shortages has been far reaching.”

 

Drugmakers line up to invest in UK life sciences

PharmaTimes, Selina McKee, 6 December 2017

 

GlaxoSmithKline and AstraZeneca have announced significant investment in the UK as part of the government’s sector deal for the life sciences industry.

GSK said it would stream £40 million of new money into initiatives that harness advances in genetic research in the development of novel medicines.

The investment will support the sequencing of data from all 500,000 volunteer participants in the UK Biobank, beyond the first 50,000 subset announced earlier this year.

The funding will also bolster GSK’s ‘Open Targets’ collaboration with the European Bioinformatics Institute, the Wellcome Trust Sanger Institute, Biogen and Takeda, set up in to make genetic and biological data openly available to help researchers identify and prioritise new targets for developing future medicines.

AstraZeneca, which is investing of £500 million in its new strategic R&D centre and global headquarters in Cambridge, is also among 25 organisations from across the sector and supported by government that are investing in the UK, ensuring that the country is at the forefront of developing new innovative treatments and medical technologies that improve patient lives.

Also included is a major investment by global healthcare firm MSD, which plans to establish a new world-leading life sciences discovery research facility and headquarters in the UK, supporting 950 jobs including 150 new high-skilled and high-value research roles.

“Our new site will combine MSD’s powerful and proven R&D engine with the cutting edge technologies and deep discovery capabilities afforded by the biomedical research community in the golden triangle of London-Oxford-Cambridge as well as access to the continental European life science ecosystem,” said Roger Perlmutter, president of MSD Research Laboratories.

The Life Sciences Sector Deal sets out an agreed strategic vision, built on co-investment, “that will modernise the industry, boost businesses large and small within it, and ensure the sector is perfectly positioned to respond to the challenges and opportunities of demographic change and pioneering research and development,” the government said.

The deal sets out a plan for the sector going forward, “with a vision and strategy that are aligned to the pillars of the Industrial Strategy and the themes of Sir John Bell’s Life Sciences Industrial Strategy.”

Its key themes are: building on the UK’s position as a world leader in biomedical discovery with major inward investments; to grow the UK’s international reputation for pioneering early diagnostics and genomics programme, with a government investment from the Industrial Strategy Challenge Fund of up to £210 million; ensuring that the UK leads the world with its clinical trials, through innovative new trials platforms and investments in the country’s digital evidence collection abilities; and to develop innovative medicines manufacturing infrastructure and enable SMEs to manufacture advanced therapies, supported by a government commitment of £162 million via the Industrial Challenge Fund.

The announcements “are a great start towards industry and government working together to deliver the long-term strategic roadmap set out in the Life Sciences Industrial Strategy,” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.

“These are smart investments for the future that acknowledge the government’s willingness to build upon the UK’s global strength in R&D, our leadership in new technologies such as genomic medicine and the potential that exists in making the best use of health data.”

Also commenting on the deal, Phil Thomson, president of Global Affairs at GSK, said: “The UK has a world class life sciences sector, but that will only continue to thrive through a strong partnership of Government, industry and academia. This Sector Deal contains a number of very practical commitments to strengthen the UK’s life science base and make it more attractive to international investment in areas such as clinical trials and high-tech research. Ultimately, this should provide benefits to the economy and create jobs.”

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.

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