Media And Political Bulletin – 12 May 2020

Media and Political Bulletin

12 May 2020

Government guidance published to help ensure workplaces are as safe as possible. The government, in consultation with industry, has published guidance to help employers, employees and the self-employed understand how to work safely during the coronavirus pandemic.

There are 8 guides, which cover a range of different types of work, notably:

  • Factories, plants and warehouses. Guidance for people who work in or run factories, plants and warehouses.
  • Vehicles. Guidance for people who work in or from vehicles, including couriers, mobile workers, lorry drivers, on-site transit and work vehicles, field forces and similar.
  • Offices and contact centres. Guidance for people who work in or run offices, contact centres and similar indoor environments.
  • Shops and branches. Guidance for people who work in or run shops, branches, stores or similar environments.

 

Media Summary

Ranitidine 50mg/2ml injection out of supply from May

Dispensing Doctors’ Association, Ailsa Colquhoun, 11 May 2020

Dispensing Doctors’ Association reports that Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. This is due to on-going regulatory investigations into the presence of the contaminant, N-nitrosodimethylamine (NDMA).

At present, in Europe all suppliers of Ranitidine’s active ingredient have had their Certificate of Suitability (CEP) suspended. Therefore, until regulatory investigations are complete, no further supplies of ranitidine products can be manufactured.

View the supply disruption alert for clinical advice on alternatives of ranitidine preparations for adults and children.

Parliamentary Coverage

 

There was no parliamentary coverage today.

 

Full Coverage

Ranitidine 50mg/2ml injection out of supply from May

Dispensing Doctors’ Association, Ailsa Colquhoun, 11 May 2020

Ranitidine 50mg/2ml injection is anticipated to be unavailable from the end of May 2020 until further notice. Ranitidine film-coated tablets, effervescent tablets and oral solution continue to remain unavailable with no date for resupply. This is due to on-going regulatory investigations into the presence of the contaminant, N-nitrosodimethylamine (NDMA). Clinical advice on alternatives of ranitidine preparations for adults and children has been shared in the previous supply disruption alert. View the alert.

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

8 February 2018

Media Summary

Swift deal on EU transition is vital, says Glaxo chief

The Times, Alexandra Frean, 8 February 2018

 

The Times reports that the Head of Glaxosmithkline has urged the government to sign a two-year Brexit transition deal within two months to minimise disruption to medicine supplies.

Emma Walmsley also called for zero tariffs and minimal customs procedures after Britain leaves the European Union so that drug makers could be sure of “getting the right medicines to the patients”.

“The most important thing is that we get a transition period of at least two years, starting from March 2019, but . . . secured by April 2018, and we need to make sure that the negotiations that are ongoing are very clearly focused on patient safety and the continued supply of medicines to patients,” Ms Walmsley said yesterday.

 

Parliamentary Coverage

House of Commons Tabled Written Question – NHS: Drugs, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect of leaving the EU on access to existing medicines in the NHS.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines, and be assured that their safety is protected through the strongest regulatory framework and sharing of data. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – NHS: Drugs, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what discussions he has had with the Secretary of State for Exiting the European Union on access to medicines (a) in the event of a no deal Brexit and (b) during a transitionary period.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines, and be assured that their safety is protected through the strongest regulatory framework and sharing of data. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – European Medicines Agency, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what assessment he has made of the benefits to the UK of remaining in the EU Medicines Agency after the UK has left the EU.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines, and be assured that their safety is protected through the strongest regulatory framework and sharing of data. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – Drugs: EU Law, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what discussions he has had with the Secretary of State for Exiting the European Union on the UK remaining in the EU Medicines Agency and complying with EU regulations for medicines after the UK leaves the EU.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines, and be assured that their safety is protected through the strongest regulatory framework and sharing of data. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

Full Coverage

Swift deal on EU transition is vital, says Glaxo chief

The Times, Alexandra Frean, 8 February 2018

 

The head of Glaxosmithkline has urged the government to sign a two-year Brexit transition deal within two months to minimise disruption to medicine supplies.

Emma Walmsley also called for zero tariffs and minimal customs procedures after Britain leaves the European Union so that drug makers could be sure of “getting the right medicines to the patients”.

“The most important thing is that we get a transition period of at least two years, starting from March 2019, but . . . secured by April 2018, and we need to make sure that the negotiations that are ongoing are very clearly focused on patient safety and the continued supply of medicines to patients,” Glaxo’s chief executive said yesterday.

Glaxo is Britain’s biggest drugs manufacturer, employing almost 100,000 people worldwide, and is an important contributor to the domestic economy and research and medicine.

Ms Walmsley, a former L’Oréal manager who joined as chief executive last April, has emphasised that the company’s pharmaceuticals business and research and development should be its top priority under her leadership.

She has attended the prime minister’s business advisory council and has been outspoken on Brexit, repeatedly talking of the importance of a transition period to help Britain to adjust after it officially leaves the EU in March 2019 but before the permanent arrangements for UK-EU relations kick in.

Although the impact of Brexit on Glaxo’s overall business will not be material, as Britain accounts for only 4 per cent of sales, drugs companies are particularly affected by Brexit because their business is highly regulated. Ms Walmsley called for mutual agreements between the UK and the EU to avoid duplication of regulatory procedures and full co-operation with the European Medicines Agency.

In its first annual results since Ms Walmsley took over, Glaxo reported an 8 per cent rise in revenue to more than £30 billion, for the first time and better than expected. Pre-tax profits rose by 82 per cent to £3.5 billion in the 12 months to December 31.

Glaxo warned that its earnings could slip this year in the face of increased competition in its core respiratory and HIV businesses, particularly if generic copies of its Advair inhaler, which accounts for 10 per cent of group sales, are launched in the American market by mid-year, as many analysts expect.

However, Ms Walmsley said she was optimistic that Glaxo would deliver on a promise of mid to high-single-digit earnings growth in the five years to 2020.

“Given the momentum we are seeing in our new products and recent launches, the performance improvements we are driving and the benefit of US tax reform, we are increasingly confident in our ability to drive growth over the next few years,” she said.

She added that the company would pay a dividend of 80p for the full year and expected the same figure for 2018.

Nicholas Hyett, an analyst at Hargreaves Lansdown, the broker, said that although Advair sales were holding up better than expected, the looming increase in competition remained a ticking time bomb under the group. “If a generic makes it to market early next year, it will blow a hole in the Glaxo income statement,” he said.

Glaxo’s shares, which have fallen by nearly 18 per cent in the past 12 months, rose 3.4 per cent to close at £12.85½.

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.”

Media and Political Bulletin

6 December 2017

HDA Executive Director, Martin Sawer on BBC Radio 4’s Today Programme

 

Yesterday morning Martin Sawer, HDA Executive Director, was interviewed on the Today Programme on the potential impact of Brexit on the regulation and supply of medicines. Martin discussed the need to mitigate any impact to the cross-border flow of medicines following the UK’s exit from the European Union which could place patient safety at risk. To listen to the full interview, please click here. The interview can be found 51 minutes into the programme.

 

Reminder: Registration for the GIRP UK conference 2018

This is a reminder to all members that the GIRP conference ‘Supply chain to value chain together adding value’ will take place at Oakley Court, Windsor from 21-22 March 2018. To register, please follow the link here.

 

MHRA Newsletter: November 2017

The MHRA Safety Features Newsletter is available to view on the HDA website. To view the newsletter, please click here.

 

Media Summary

Fanfare and optimism for UK’s Life Sciences Sector Deal

Pharmaphorum, Andrew McConaghie, 6 December 2017

 

Pharmaphorum reports that the Life Sciences sector has been chosen as the flagship for the UK’s post-Brexit industrial strategy. While Theresa May’s government looks fragile after the row that erupted with its parliamentary partners, the DUP, over its plans for Brexit and Ireland, it has won over the pharma, biotech and medtech sectors with a promise of special status for the industries.

Business Secretary Greg Clark and Health Secretary Jeremy Hunt will unveil the Sector Deal for the Life Sciences industries today, which the UK government has said will be ‘transformative’.

No fewer than 25 organisations from across the sector have pledged ‘significant investment’ in the UK, which the government hopes will put the country at the forefront of developing treatments and medical technologies.

Industry leaders are nonetheless warning that a Brexit that sees the UK out in the cold, not ‘aligned’ with European rules and regulations, will almost certainly see disinvestment from the UK.

 

Fears of ‘jolt’ to NHS supply chain

Evening Standard, Kate Procter, 5 December 2017

 

The Evening Standard reports on comments by Martin Sawer, HDA Executive Director, during his BBC Today programme interview, in which he highlighted that any separation from the EU on medicine regulation could ‘jolt’ the medicines supply chain.

The publication also reiterates the warning of medical suppliers that for in-demand products there might only be enough stock to last the country a matter of days in the event of a regulatory divergence from the EU.

 

 

Parliamentary Coverage

Health Select Committee: Brexit and regulation of medicines, medical devices and substances of human origin, 5 December 2017

During a session of the Health Select Committee’s inquiry on Brexit, MPs heard evidence from several witnesses on the potential impact of Brexit on the regulation and supply of medicines including Martin Sawer, Executive Director of the Healthcare Distribution Association, Richard Freudenberg, Secretary-General of the British Association of European Pharmaceutical Distributors and Ian Bateman, Director of Quality, NHS Blood and Transplant.

Martin appeared to discuss the need to mitigate any disruption to the cross-border flow of medicines following the UK’s exit from the European Union.

To view the full summary of the session, please click here.

Full Coverage

Fears of ‘jolt’ to NHS supply chain

Evening Standard, Kate Procter, 5 December 2017

 

Supplies of medicines used by the NHS could be at risk if Brexit means changes to cross-border trade, experts warned today. Martin Sawer, executive director of the Healthcare Distribution Association, told the BBC he was concerned any separation from the EU on medicine regulation could ‘jolt’ the supply chain.

He said: ‘We are concerned about the regulatory divergence and about tariffs on product. Over 90 per cent typically in a warehouse is imported in part or in full into the UK. In the longer term, there could be severe jolts to the system’.

Medical suppliers say that for in-demand products there might only be enough stick to last the country a matter of days.

 

 

Fanfare and optimism for UK’s Life Sciences Sector Deal

Pharmaphorum, Andrew McConaghie, 6 December 2017

 

The Life Sciences sector has been chosen as the flagship for the UK’s post-Brexit industrial strategy, with an impressive roll-call of deals assembled for its launch later today.

While Theresa May’s government looks fragile once again after a row erupted with its parliamentary partners, the DUP, over its plans for Brexit and Ireland, it has won over the pharma, biotech and medtech sectors with a promise of special status for the industries.

Business Secretary Greg Clark and Health Secretary Jeremy Hunt will unveil the Sector Deal for the Life Sciences industries today, which the UK government believes will be ‘transformative’.

It will lay out an agreed set of strategic goals that it says will ensure the UK builds on its exceptional reputation for science and research, genomics and clinical trials.

No fewer than 25 organisations from across the sector have pledged ‘significant investment’ in the UK, which the government hopes will put the country at the forefront of developing treatments and medical technologies.

Industry leaders are nonetheless warning that a Brexit that sees the UK out in the cold, not ‘aligned’ with European rules and regulations, will almost certainly see disinvestment from the UK. But for the meantime, the UK focus on listening closely to the sector’s demands seems to have paid off.

Here are the highlights of the new investments announced:

• MSD is to establish a state-of-the-art life sciences discovery research facility in London, focussed on early bioscience discovery and entrepreneurial innovation, which the company believes will expand its opportunity to engage with leading researchers in the UK and Europe

• Janssen (J&J’s pharma division) and the University of Oxford intend to collaborate on novel clinical trial methodologies in the UK; these would include platform trials, focused on mental health disorders such as depression

• The Medicines Company has initiated two projects – one with the University of Oxford to perform a large multi-national cardiovascular disease clinical trial and another with The Greater Manchester Health and Social Care Partnership to improve the understanding, management and economics of cardiovascular disease.

• GSK and AstraZeneca: significant investments from both companies in initiatives to harness advances in genetic research in the development of medicines

• Roche Diagnostics says the government supports the mainstream implementation of Digital Pathology services across the NHS. This could see innovative approaches to cancer testing trialled in the NHS, includes whole slide scanners, image management software and image analysis algorithms

This co-ordination of good news came together at a reception held at 10 Downing Street last night, with life science leaders rubbing shoulders with BEIS secretary Greg Clark, health secretary Jeremy Hunt and NHS leaders and academic research chiefs to toast the future success of the UK sector.

But industry leaders won’t be getting carried away when there are hugely significant questions about the UK’s post-Brexit future to be decided in 2018.

Mike Thompson, chief executive officer, ABPI said:  “Today’s 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.

“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.”

The Sector Deal won’t include a deal on probably the most crucial UK market question – the uptake of new medicines. This will instead be decided in late 2018, when the existing PPRS pricing deal must be renegotiated.

The Life Sciences Industrial Strategy, authored by leading Oxford scientist Sir John Bell, was essentially an ambitious industry wish-list, but the ABPI and its biotech counterpart the BIA will push to have as many of its demands met as possible.

“If we get this right – if the Life Sciences Industrial Strategy is implemented in full – the UK can open itself up to be at the forefront of cutting-edge clinical research,” said Mike Thompson.

“NHS hospitals will reap the benefits of global clinical trials and the financial rewards they bring; doctors can prescribe the latest treatments and patients will get the best standard of care. This ecosystem will deliver for everyone.

“Next year could be a transformative year for the NHS as we work together to deliver this innovation to underpin a more productive health service.”

The details of the Sector Deal will be revealed later this morning, with an expectation that an quasi-independent structure will be set up within the UK to oversee the Industrial Strategy.

The ABPI has called for an “open and collaborative relationship between government, and Sir John Bell and key representatives from the sector, with regular dialogue on progress on the implementation and delivery of the deal’s vision,”  This will be the true acid test for the Sector Deal, with the denouement of Brexit negotiations in 2018 being the last crucial piece of the jigsaw.

Media and Political Bulletin

16 October 2017

Media Summary

Drug Companies Fear Brexit Will Hit Medicine Trade

Bloomberg, John Lauerman, 16 October 2017

 

Bloomberg highlights that time is running short for a Brexit agreement that will allow the free movement of medicines through the U.K. and the rest of the European Union.

 

Alan Morrison, vice president of regulatory affairs international for Merck & Co., said in an interview in London last week that  a myriad of issues, including guidance on transferring product registration and drug testing in the region, are yet to be resolved. The problem is particularly acute for drug and biotech companies whose products sometimes take years to make, test and navigate through regulatory channels.

 

Concerns about a messy breakup are flaring after chief EU negotiator Michel Barnier said last week that discussions with the U.K. are “in a state of deadlock.”

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Drug Companies Fear Brexit Will Hit Medicine Trade

Bloomberg, John Lauerman, 16 October 2017

 

Time is running short for a Brexit agreement that will allow the free movement of medicines through the U.K. and the rest of the European Union.

 

A myriad of issues, including guidance on transferring product registration and drug testing in the region, are yet to be resolved, Alan Morrison, vice president of regulatory affairs international for Merck & Co., said in an interview in London. The problem is particularly acute for drug and biotech companies whose products sometimes take years to make, test and navigate through regulatory channels.

 

“Will we be able to do everything on time? Probably not,” Morrison said.

 

Concerns about a messy breakup are flaring after chief EU negotiator Michel Barnier said last week that discussions with the U.K. are “in a state of deadlock.” AstraZeneca Plc Chief Executive Officer Pascal Soriot warned last month that it was “impossible” for the government to forge new trade accords, establish a regulatory framework and develop new procedures for shipping products by the time the country exits the EU in 2019. Others echoed that sentiment, saying questions hang over a host of issues from duties and tariffs to the movement of products and people over borders.

 

“There could be some administrative delays to products being available in Europe,” Morrison said. Just changing registrations for medicines — which have to be filed in a EU member state to be recognized through the region — will be “a large logistical exercise in every company having to make the appropriate market transfer.”

 

Stale Lists

 

While Brexit leaders have suggested that the U.K. could revert to World Trade Organization rules, drugmakers counter that the WTO list of pharmaceuticals is far out of date. Products that aren’t on the list might be subject to tariffs for further restriction.

 

“The list hasn’t been updated since 2010,” David Boyd, Cambridge, England-based AstraZeneca’s director of European government affairs, said in an interview. Any drugs that the U.K.’s second-largest drugmaker has introduced over the past seven years wouldn’t be included, he said.

 

Pharma and biotech companies that depend on access to highly skilled employees are also concerned about Brexit’s impact. And those companies aren’t alone.

 

The top European drugs regulator, set to relocate from London following Brexit, could lose more than seven out of 10 employees, a survey of its staff showed. The exodus would trigger a “public health crisis,” the European Medicines Agency said last month.

 

Potential hires are increasingly concerned about their status following the U.K.’s move, Boyd said.

 

“There’s a lot of anxiety,” he said Friday in London.

Media and Political Bulletin

12 October 2017

Media Summary

Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The MHRA blog reports on the effect of the catastrophic weather conditions across the globe that have had a significant impact on the pharmaceutical supply chain in the last couple of months.

 

The blog highlights that the Inspectorate has already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, they are requesting that those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

The blog states that there is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

Politico reports on comments by the head of NHS England in a parliamentary health committee hearing on 11 October.  Simon Stevens highlighted that the U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Mr Stevens said that the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

 

The Pharmaceutical Journal publishes an opinion piece by Mark Burdon on potential solutions to generic shortages. Mr Burdon is an independent community pharmacy contractor and PSNC regional representative. The article highlights that the supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. Mr Burdon writes that the Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Potential supply issues

MHRA Inspectorate Blog, Ian Jackson, 11 October 2017

 

The last couple of months have seen some catastrophic weather conditions across the globe.  These can have a significant impact upon the pharmaceutical supply chain.

 

We have already received reports of some manufacturing sites being affected and possible shortages occurring as a result.  Therefore, we request those companies that have sites within their supply chain that could be at risk due to recent weather events (such as those in Puerto Rico, Southern USA, India and Bangladesh) take steps to identify any potential supply issues.

 

We are also liaising with our international regulatory partners in order to gain additional information on potential supply issues and support plans to ensure continued supply of products to patients.

 

You can play a big part by providing relevant information to help with this process.

 

Notifying MHRA

 

There is an obligation for licence holders to notify the MHRA of any interruption in supply, for GMP matters this can be done via the Interim Compliance report which should be submitted to gmpinspectorate@mhra.gov.uk

 

Assurances that there are no issues would also be welcomed via the same email address.

 

NHS unprepared for no Brexit deal, says NHS England boss

Politico, Helen Collis, 11 October 2017

 

The U.K. government has not instructed the National Health Service to prepare for a Brexit “no deal” scenario, under which the citizenship rights of a significant proportion of the workforce would be in jeopardy.

 

Speaking to the parliamentary health committee today, Simon Stevens, head of NHS England, said the system has a “superb contribution from staff who’ve trained and come from the rest of the European Union.” They account for over 9 percent of NHS doctors and about 5 percent of the 1.3 million NHS workforce.

 

Pressed by Labour committee member Ben Bradshaw if he’d been asked to prepare for a no-deal scenario “which is what the Prime Minister [Theresa May] was talking about yesterday,” Stevens responded: “We have not.”

 

Stevens said he remained confident the U.K. government would ensure the health service can continue to employ EU workers after Brexit. “I don’t detect any disagreement with the proposition that … we will continue to rely on our international staff,” he said.

 

Interviewed today on LBC radio station, May said the message to EU citizens was “we want you to be able to stay” but that there were no guarantees if negotiations collapsed without agreement.

 

After the meeting, Bradshaw told anti-hard Brexit movement Open Britain it was “shockingly irresponsible” for May to “repeatedly threaten a no-deal Brexit” without asking the head of the NHS to prepare for the consequences.

 

“Theresa May and the hard Brexiters in Cabinet are putting our NHS at risk,” he said.

 

Generic shortages: what can be done?

The Pharmaceutical Journal, Mark Burdon, 11 October 2017

The supply of generic medicines is vulnerable to the vicissitudes of market forces, with exchange rates fluctuating and manufacturers restricting distribution. The Department of Health needs to intervene to shield pharmacies from the impact of price spikes and ensure the resilience of the supply chain.

Way back in 2012, before funding cuts and Brexit and countless other of today’s challenges were on the horizon, one problem was already coming to light. In fact, the voices of community pharmacy had grown so loud warning about the problem that the All-Party Pharmacy Group (APPG) — a group of MPs across all parties, with an interest in pharmacy — decided to hold an inquiry into it. Their verdict? Medicines stock shortages are a problem; sort them out.

But fast-forward half a decade and if you’re working in a community pharmacy it won’t feel like much has changed. We are still spending hours every week trying to get hold of the medicines our patients need; and things seem to be getting worse, rather than better.

Medicines sources limited

There are many factors currently affecting the supply of medicines to pharmacies and causing these problems. The restricted distribution models implemented by many manufacturers — whereby they only allow a few selected pharmacy wholesalers to stock their medicines — certainly had an impact. They have limited the places from which we can source medicines and diluted competition in the market. This makes the market less resilient, so when things go wrong — a power outage at a major wholesaler, for instance — it can be chaos for pharmacies who have to borrow medicines from one another to meet patient needs.

For many years the UK could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines

A second factor is the global nature of the market for medicines. For many years this benefited the UK as we could import drugs cheaply, but exchange rates mean importing is often no longer a good way to source reasonably priced medicines. In fact, generics prices in the UK are now so low that it is not difficult to imagine why the UK market might not appeal to generics manufacturers at all — why would any business want to sell at lower prices when they could fetch higher ones elsewhere?

Manufacturing plant closures

Another recent and unprecedented problem has been the inspections by regulatory authorities which led to the closures of manufacturing plants owned by two major generics companies. Inevitably, a plant closure means fewer medicines can be produced, prompting potential worldwide shortages of some medicines.

But alongside issues like these which can create real physical shortages of some medicines, a whole host of other market factors come into play and can affect our ability to source medicines. Pricing is a major worry; when medicines are in short supply they tend to become more expensive, and sometimes we simply cannot obtain medicines for anywhere near the Drug Tariff (which sets out how much we will be reimbursed for medicines) prices.

Manipulation of the market can make it very difficult for pharmacy contractors to purchase medicines and can lead to price distortions

Generics pricing is complicated at the best of times, because prices are adjusted regularly to try to set the amount of margin that pharmacy contractors can make on the medicines (this margin forms part of our core funding). But when shortages come into play the market can be even more volatile. There can also be manipulation of the market, which can make it very difficult for pharmacy contractors to purchase medicines as they usually would.

Branded generics distort prices

One example of this is when local NHS commissioners ask GPs to prescribe medicines called ‘branded generics’. Branded generics are produced by manufacturers and priced at levels below the Drug Tariff levels, making them attractive locally because they bring down local drugs bills. But nationally, because generic medicines are priced at a level designed to assure delivery of our core funding, this does not lead to savings. And in fact the local distortions of pricing can mean that pharmacies are not able to earn core parts of their funding, which is a problem.

So what can we do about all of this? Well some things we are already doing. Every month a huge amount of work goes into assessing market prices for any medicines known to be in short supply, to ensure that ‘concessions’ are granted. These mean pharmacies can purchase and be reimbursed for the medicines at the higher market prices. But this system takes a lot of work, and pharmacies often have to go for long periods without knowing whether they will be granted a concession price.

The PSNC is seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain

The Pharmaceutical Services Negotiating Committee (PSNC) would like to see a simpler process, with the Department of Health making speedy adjustments to address the impact of high price rises like the ones we are now seeing. With so many medicines lines currently affected we are also seeking urgent intervention from the Department of Health to ensure the resilience of the medicines supply chain. Unfortunately, there is no simple answer in such a complex market — if there were, they would have done it.

So in the meantime, for community pharmacies the job remains pretty much the same as back when the MPs investigated in 2012. Keep pushing your wholesalers for the best possible deal; keep telling us about the problems; and keep explaining to patients that you are doing all you can, but that sometimes the supply problems are national, and simply out of your control.

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

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