HDA UK Media and Political Bulletin – 03 March 2021

Media Summary

There was no media coverage today.

 

Parliamentary Coverage

NHS planning for “substantial increased supply” in vaccines
Emily Lawson, NHS Chief Commercial Officer & Dr Nikita Kanani, Medical Director for Primary Care, 02 March

In a letter to NHS systems, NHSE&I has set out the next steps for the COVID-19 vaccination deployment programme.

The letter urged local systems to use recent guidance and other interventions to ensure all eligible frontline health and social care workers, the clinically extremely vulnerable and clinically vulnerable, as well as unpaid carers and those aged 60 and over are offered a vaccination.

According to the letter, second dose delivery is already underway and national supplies for second doses will be distributed in the usual way.

From 11 March, the NHS is reportedly expecting vaccine supply to increase substantially and be sustained at a higher level for several weeks. Therefore, from the week of 15 March, NHSE&I are asking systems to plan and support all vaccination centres and local vaccination services to deliver around twice the level of vaccine available in the week of 01 March.

Delivery models will shortly receive supply notifications for the week of 08 March, with minimal allocations of new vaccine expected, as well as advanced notification of anticipated supply for the week of 15 March, which is expected to be much higher.

You can read the letter in full here.

 

Full Coverage

There was no media coverage today.

Media and Political Bulletin

30 April 2018

Media Summary

Lords slam government commitment to life sciences strategy

PharmaTimes, Selina McKee, 30 April 2018

PharmaTimes reports that the House of Lords has slammed the government’s commitment to delivering the Life Sciences Industrial Strategy, deeming it “incoherent” and “wholly inadequate”.

An inquiry by the House of Lords Science and Technology Committee has uncovered “complicated arrangements” for the Strategy’s implementation, as well as “a lack of clear authority and accountability”, which, it says, raises questions about the government’s commitment to driving it forward.

In its report, Life Sciences Industrial Strategy: Who’s driving the bus?, the Committee recommends a “sweeping simplification” of the Strategy’s implementation arrangements, and calls for “immediate action” to ensure development and expansion of the sector.

Also reported in The Pharmaceutical Journal.

ABPI response to the House of Lords Science and Technology Committee report

ABPI, 26 April 2018

In response to the House of Lords report on the Government’s Life Sciences Industrial Strategy, the ABPI have published the following statement:

“The Life Sciences Industrial Strategy is the blueprint for the UK’s success in life sciences as we leave the EU. In the short time since the strategy was published, the Government has worked closely with industry – with the first sector deal published only a few months after the report’s publication. We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

 “We want the UK to become a world leader in health data, in clinical trials and in the development as well as adoption of new treatments for patients. Now we have the structures in place, through the implementation of the Life Sciences Industrial Strategy, to work closely with government, academia and health charities, we look to mirror this with the NHS as well. The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI responds to Kings Fund report into the cost of medicines for the NHS

ABPI, 26 April 2018

Last week, the Kings Fund published a new report into the cost of medicines looking at how much the health service spends in total on medicines; both generics and branded medicines.

Dr Richard Torbett, commercial policy director of the ABPI, responded, saying:

“This report provides some very good analysis and insight into UK medicines policy.

“The vast majority of new hospital medicines, including those for Hep C, HIV prevention and new cancer drugs are part of a scheme which caps the amount the NHS spends on medicines, so any suggestion that they are causing an uncontrollable rise is costs is not accurate.  We know with absolute certainty that the spend on these medicines has actually fallen in real terms in the past five years.

“As the report shows, any increase in spending is largely due to the NHS treating more patients with highly effective, older and cheaper medicines, like statins.”

Parliamentary Coverage

House of Commons, Customs and Borders debate, 26 April 2018

Conservative MP Dr Sarah Wollaston was one of several MPs to raise concerns about the impact of Brexit on pharmaceuticals in increased delays, costs, and shortages during a House of Commons debate on customs and borders.

Ms Wollaston said:

“For years, we have taken it for granted that when a prescription is issued, it will be available on the pharmacy shelf.

“I am afraid that we will not be able to take that for granted in the future, because the complex supply chain—from the research lab right through to the pharmacy shelf—will be disrupted by delays at the border, and that will affect costs.”

To read the full debate, please follow this link.

Tabled Written Questions, House of Commons, 26 April 2018

Tom Brake MP: To ask the Secretary of State for Health and Social Care, when he plans to publish the Government’s commissioned analysis by Ernst and Young of the effect of the UK leaving the EU on the medicines supply chain.

Answered by Steve Brine: Due to the large volume of commercial and sensitive information that has been shared by the pharmaceutical industry throughout this work, the Department will be unable to publish the final report. However, we will consider publication of an executive summary of the work.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what progress he has made on negotiations for a new pharmacy contract; and what the timetable is for the interim arrangements published in the Drug Tariff to remain in place.

Answered by Steve Brine: We have agreed interim arrangements for the Community Pharmacy Contractual Framework whilst Ministers consider further their substantive proposals for 2018/19 and beyond. These arrangements published in the Drug Tariff will remain in place until any revised arrangements are determined. Ministers expect negotiations with the Pharmaceutical Services Negotiating Committee to discuss a substantive settlement for community pharmacy will commence shortly.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that stocks of medicines that are in short supply are distributed equitably and proportionately amongst community pharmacies.

Answered by Steve Brine: The Department is unable to directly control how stock is distributed as this is under the control of the individual suppliers or wholesalers. However, in the event of supply issues the Department will work with suppliers and wholesalers to encourage and support them, so where possible, supplies are distributed equitably and proportionally.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the (a) competitiveness and (b) effectiveness of the wholesale pharmaceutical market to provide an affordable supply of medicines for patients.

Answered by Steve Brine: The Department has not made such an assessment.

Luciana Berger MP: To ask the Secretary of State for Health and Social Care, what plans his Department has to support the maintenance of links between regulators, research ethics committees, researchers and the pharmaceutical industry in the UK and the European Medicines Agency after the UK leaves the EU.

Answered by Caroline Dinenage: The Department has always made clear its intention to retain a close working partnership with the European Union, in the interest of ensuring patients continue to have timely access to safe medicines and medical innovations. This includes maintaining a strong working relationship with the European Medicines Agency on all aspects of the life sciences sector.

It is of mutual benefit for the EU to collaborate closely with such a well-developed life sciences market in the United Kingdom. Both sides will always be stronger by working in partnership.

Tim Farron MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 April 2018 to Question 136501, how the Government plans for the UK to participate in the European Medicines Agency during the transition period after the UK leaves the EU.

Answered by Jackie Doyle-Price: From 30 March 2019, the United Kingdom will no longer be a Member of the European Union. However, under the terms of the implementation period agreement regulatory standards and market access for all medicines will continue on current terms.

Both sides agree that for the implementation period to function effectively, the UK will need to remain in step with the EU. In this context, the Withdrawal Agreement will be underpinned by a duty of good faith, with a Joint Committee in place enabling either side to raise issues or concerns. These arrangements will help ensure that the implementation period works properly for both sides.

Common rules will remain in place and the UK may continue to participate in EU agencies and bodies where the presence of the United Kingdom is necessary and is in the interests of the EU, or where the discussion concerns acts addressed to the UK and its citizens. The exact nature of this participation will be a matter for further discussion.

Regarding the future relationship, the Prime Minister’s Mansion House speech outlined that we will also explore the terms on which the UK could remain part of the European Medicines Agency. While it would not be appropriate to pre-judge the outcome of the negotiations, we will discuss with the EU and Member States how best to continue cooperation in medicines regulation.

Luciana Berger MP: To ask the Secretary of State for Health and Social Care, if he will negotiate a deal with the EU to allow mutual recognition agreements on the manufacture and distribution of investigational medicinal products and pharmacovigilance services after the UK leaves the EU.

Answered by Jackie Doyle-Price: From 30 March 2019, the United Kingdom will no longer be a Member of the European Union. However, under the terms of the implementation period agreement regulatory standards and market access for all medicines will continue on current terms.

Regarding the future relationship, the Prime Minister’s Mansion House speech outlined that we will also explore the terms on which the UK could remain part of the European Medicines Agency. While it would not be appropriate to pre-judge the outcome of the negotiations, we will discuss with the EU and Member States how best to continue cooperation in medicines regulation more broadly, including manufacturing and distribution of investigational medicinal products and pharmacovigilance services.

Our overall 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 continued sharing of data.

Full Coverage

Lords slam government commitment to life sciences strategy

PharmaTimes, Selina McKee, 30 April 2018

The House of Lords has slammed the government’s commitment to delivering the Life Sciences Industrial Strategy, deeming it “incoherent” and “wholly inadequate”.

An inquiry by The House of Lords Science and Technology Committee has uncovered “complicated arrangements” for the Strategy’s implementation, as well as “a lack of clear authority and accountability”, which, it says, raises questions about the government’s commitment to driving it forward.

In its report, Life Sciences Industrial Strategy: Who’s driving the bus?, the Committee recommends a “sweeping simplification” of the Strategy’s implementation arrangements, and calls for “immediate action” to ensure development and expansion of the sector.

It also suggests the establishment of a single body that has complete oversight of implementation, called the Life Sciences Governing Body, which must have cross-party support.

“Prompt and vigorous action by the government can save the day. This strategy has already secured the commitment of the business, charity and academic communities. But the central role of the NHS in the life sciences means only the government can take the lead,” it argues.

According to the report, the government has failed to engage the NHS effectively, and so the NHS’ commitment to the strategy has so far been “incoherent, uncoordinated and ineffective”.

The NHS does not have the capacity to rise to the challenge of implementing the strategy, and its current structures “stifle innovation”.

The NHS must give greater priority to the uptake and spread of innovation and to rewarding clinicians and managers who make such adoption successful, the Committee stressed, and called on the government to explore financial incentives for those NHS trusts that do so.

“If implemented correctly the Life Sciences Industrial Strategy will make a major contribution to the future economic prosperity of the UK but what became clear throughout our inquiry is that it stands little chance of success without a detailed plan for implementation and clear lines of authority, responsibility and accountability,” said Chairman of the Committee, Lord Patel.

“The government has an opportunity right now to get ahead of international competition. It can, and must, take bold steps to secure the future growth and expansion of the life sciences sector. This is even more vital as the UK prepares for life outside the European Union.”

But the government said it “does not recognise the Committee’s assessment”.

In a statement emailed to PharmaTimes, a spokesperson noted that the Life Sciences Sector Deal has “committed £500 million of government investment into UK life sciences, backed by investment from 25 organisations across the sector, that will build on the sector’s strengths, secure thousands of jobs and create new innovative medicines and technologies, giving NHS patients access to the best possible treatments.

“The government will continue to work closely with industry to seize the future opportunities in this area and we will respond to the report in due course.”

Sir John Bell also said the government has made “enormous progress” in implementing its recommendations.

“With the help of industry and the charity sector, it has launched the world’s largest genomics programme, is creating digital pathology centres with industry and digital innovation hubs to work with industry. This is in addition to a new set of manufacturing facilities.”

Highlighting that the Strategy is “the blueprint for the UK’s success in life sciences as we leave the EU”, the Association of the British Pharmaceutical Industry ABPI said: “We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

“The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI response to the House of Lords Science and Technology Committee report

ABPI, 26 April 2018

This week, the House of Lords Science and Technology Committee published a report into the Life Sciences Industrial Strategy, asking: “Who’s Driving the Bus?”

26 Apr 2018 Posted in ABPI response By Press Office

In response, the ABPI said:

“The Life Sciences Industrial Strategy is the blueprint for the UK’s success in life sciences as we leave the EU. In the short time since the strategy was published, the Government has worked closely with industry – with the first sector deal published only a few months after the report’s publication. We need to see the full implementation of the strategy to deliver on its aims, and we welcome the Government’s collaborative approach and the leadership from Sir John Bell to see this happen.

“We want the UK to become a world leader in health data, in clinical trials and in the development as well as adoption of new treatments for patients. Now we have the structures in place, through the implementation of the Life Sciences Industrial Strategy, to work closely with government, academia and health charities, we look to mirror this with the NHS as well. The NHS is the heart of our sector and critical to its success: the strategy cannot succeed without its support.”

ABPI responds to Kings Fund report into the cost of medicines for the NHS

ABPI, 26 April 2018

This week, the Kings Fund published a new report into the cost of medicines looking at how much the health service spends in total on medicines; both generics and branded medicines.

26 Apr 2018 Posted in ABPI response By Press Office

Dr Richard Torbett, commercial policy director of the ABPI, said:

“This report provides some very good analysis and insight into UK medicines policy.

“The vast majority of new hospital medicines, including those for Hep C, HIV prevention and new cancer drugs are part of a scheme which caps the amount the NHS spends on medicines, so any suggestion that they are causing an uncontrollable rise is costs is not accurate.  We know with absolute certainty that the spend on these medicines has actually fallen in real terms in the past five years.

“As the report shows, any increase in spending is largely due to the NHS treating more patients with highly effective, older and cheaper medicines, like statins.”

Media and Political Bulletin

25 April 2018

Media Summary

Lords to debate on the long term sustainability and funding of NHS

Pharmacy Business, Kiran Paul, 24 April 2018

 

Pharmacy Business reports that the House of Lords will this week debate a report from the Committee on the Long-term Sustainability of the NHS. The report was critical of the successive governments, slamming their ‘short sightedness’ in planning the long-term future of the health service and adult social care.

The debate attains particular significance as it comes in the wake of a letter from the Health Secretary Jeremy Hunt to Tory MPs, seeking their help in resolving the funding crisis of the NHS.

A number of peers with a background in healthcare and health policy are due to speak in the debate scheduled to begin tomorrow.

 

 

Pharmacy minister says government willing to open negotiations on new pharmacy contract

The Pharmaceutical Journal, Julia Robinson, 23 April 2018

 

The Pharmaceutical Journal highlights that pharmacy minister Steve Brine has recently revealed that the Department of Health and Social Care (DHSC) will open negotiations on moving from a community pharmacy contract that rewards the dispensing of higher volumes of medicines to one that rewards care provided for patients.

A letter to the All-Party Pharmacy Group (APPG) confirming that negotiations would begin came in response to correspondence from Kevin Barron, chair of the APPG, sent earlier this year. Brine wrote that he was interested in the APPG’s work looking at community pharmacy and the management of long-term conditions.

Barron said he welcomed the pharmacy minister’s reply and said it represented “a strong indication” that the DH will come to the negotiating table with a real ambition to develop services that make the best use of the community pharmacy network for patients and the NHS.

 

Parliamentary Coverage

House of Commons, Tabled Written Questions – Department of Health, 24 April 2018

 

Frank Field MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that stocks of medicines that are in short supply are distributed equitably and proportionately amongst community pharmacies.

Frank Field MP: To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the (a) competitiveness and (b) effectiveness of the wholesale pharmaceutical market to provide an affordable supply of medicines for patients.

Luciana Berger MP: To ask the Secretary of State for Exiting the European Union, what plans his Department has to support the maintenance of links between regulators, research ethics committees, researchers and the pharmaceutical industry in the UK and the European Medicines Agency after the UK leaves the EU.

Tim Farron MP: To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that patients can promptly access drugs if the UK is no longer a member of the European Medicines Agency during any transition period after the UK leaves the EU.

Answered by Jackie Doyle-Price: During the implementation period, the United Kingdom will no longer be a Member State of the European Union, but market access will continue on current terms. We will continue to have access to drugs at the same time as countries within the EU, and the UK will continue to participate in and have access to European Medicines Agency (EMA).

In regard to the future relationship, the Prime Minister’s Mansion House speech outlined that we will also explore the terms on which the UK could remain part of the EMA. While it would not be appropriate to pre-judge the outcome of the negotiations we will discuss with the EU and Member States how best to continue cooperation in medicines regulation.

Tim Farron MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 April 2018 to Question 136501, how the Government plans for the UK to participate in the European Medicines Agency during the transition period after the UK leaves the EU.

 

Full Coverage

Lords to debate on the long term sustainability and funding of NHS

Pharmacy Business, Kiran Paul, 24 April 2018

 

The House of Lords will this week debate a report from the Committee on the Long-term Sustainability of the NHS. The report was critical of the successive governments, slamming their  ‘short sightedness’ in planning the long-term future of the health service and adult social care.

The debate attains particular significance as it comes in the wake of a letter from the Health Secretary Jeremy Hunt to Tory MPs, seeking their help in resolving the funding crisis of the NHS.

A number of peers with a background in healthcare and health policy are due to speak in the debate scheduled to begin on on April 26, Thursday.

Lord Naren Patel, the chairman of the Committee and a professor of obstetrics & consultant obstetrician, described the report as one of the most comprehensive analyses of the long-term sustainability of the NHS.

“We were interested in the future of the NHS 15-20 years into the future, not the five year planning schedule which has dominated healthcare policy in the UK for too long. We heard from over 100 witnesses in person and received more than half a million words of written evidence,” he said in a statement.

He expressed his disappointment in the late response to the report by the government, which came in February this year. The committee published its report in April 2017. The response was also “not as considered as we would have expected,” he added.

Lord Patel, at the same time, credited the government for adopting a key recommendation in the report, by making the Health Secretary responsible for both health and social care, helping in better integration.

He also welcomed “recent reports of a long-term funding plan for the NHS,” but maintained that “this will not solve anything unless a sustainable future for social care is also secured.”

Secretary Hunt, in a letter dated April 20 and addressed to Tory MPs stressed the need to move away from the “annual top-ups to the NHS budget towards a sustainable long-term plan.”

He added that this has to be done by building on the work of the Five Year Forward View, a major reform programme initiated by the government, but also by looking beyond it. The government, as announced by Prime Minister Theresa May, will come up with such a long term plan this year itself, he said in the letter.

Hunt urged colleagues to come forward with ideas on the long term funding and reform issues, informing them that he has begun meeting group of MPs as part of the preparations of this plan.

Health activists described the letter as sign of movement and asked the politicians to show ‘courage and leadership’ on the issue.

“We are starting to see signs of movement from government and politicians more widely on a challenge we have long argued is the most pressing domestic issue of our age. This is an opportunity for the government and politicians on all sides to show courage and leadership,” commented Niall Dickson, chief executive of the NHS Confederation, which represents organisations across the healthcare system.

“The NHS is facing a funding and workforce crisis which means the next decade must be very different from the last. Any long-term funding settlement must bring health and care together and move away from short-term cash injections that do not enable transformation,” he pointed out.

Pharmacy minister says government willing to open negotiations on new pharmacy contract

The Pharmaceutical Journal, Julia Robinson, 23 April 2018

Brine wrote to the All-Party Pharmacy Group confirming his interest in their work looking at community pharmacy and the management of long-term conditions.

Pharmacy minister Steve Brine has revealed that the Department of Health and Social Care (DHSC) will open negotiations on moving from a community pharmacy contract that rewards the dispensing of higher volumes of medicines to one that rewards care provided for patients.

A letter to the All-Party Pharmacy Group (APPG) confirming that negotiations would begin came in response to correspondence from Kevin Barron, chair of the APPG, sent earlier this year. Brine wrote that he was interested in the APPG’s work looking at community pharmacy and the management of long-term conditions.

Barron said he welcomed the pharmacy minister’s reply and said it represented “a strong indication” that the DH will come to the negotiating table with a real ambition to develop services that make the best use of the community pharmacy network for patients and the NHS.

“It’s been a long-standing aim of the [APPG] to move towards a contract that incentivises high quality care, rather than volumes of pills,” said Barron.

“It’s vital, now, that pharmacy and government put their heads together and commission the most effective services,” he added.

In his letter, Brine also acknowledged the Pharmaceutical Services Negotiating Committee’s (PSNC) proposals for the development of community pharmacy services, including the introduction of a care plan service, with pharmacists supporting patients with long-term conditions, as part of a new Community Pharmacy Contractual Framework.

The proposals were discussed at the PSNC’s January 2018 meeting, and put to the DHSC and NHS England.

“PSNC’s ambition is to move to a funding framework that fairly rewards community pharmacies for offering a wide range of patient care and services including the dispensing of medicines,” said PSNC chief executive Sue Sharpe.

“This is in line with the sector’s shared vision for its future, and would include allowing pharmacies to offer more patient care, particularly for people with long-term conditions,” she added.

“The minister has given no detail on what the substance of our negotiations with the DHSC and NHS England for 2018/2019 will be, but we hope that we will be able to have substantive discussions on the future of community pharmacy.”

HDA UK Members to Circulate NHS England’s Stay Well Campaign Materials

London, 16 February 2018 –  The Healthcare Distribution Association (HDA UK) has continued its long running partnership with NHS England, by agreeing to circulate materials for its Stay Well campaign that promotes the use of community pharmacies.

HDA members will distribute for free the campaign’s toolkit that will encourage patients to use community pharmacy as the first point of call for minor ailments such as sore throats, coughs, colds and stomach complaints. The toolkit will include up to date clinical information that can help pharmacists manage the conditions highlighted in the campaign.

The toolkits will be delivered as part of HDA members’ just in time distribution service, that enable patients to access the right medicines, in the right place, at the right time. The materials will begin arriving in pharmacies from 12th February and are another example of healthcare distributors forming the hidden backbone of the medicines supply chain across the UK.

-END-

About the Healthcare Distribution Association

The Healthcare Distribution Association (HDA UK)  represents  those  businesses  who  supply  medicines, medical   devices   and   healthcare   services   for   patients,   pharmacies,   hospitals,   doctors   and   the pharmaceutical industry. HDA UK members operate across the 4 nations of the United Kingdom enabling a safe, efficient and high-quality supply chain for the healthcare sector.  They are responsible for distributing over 92% of NHS medicines and provide wholesaling services including working capital, stock management and IT systems to their supply chain partners. Formerly known as the British Association of Pharmaceutical Wholesalers (BAPW), the Association rebranded in February 2016 to better reflect the evolving healthcare supply chain, as innovative practices and technologies make new services possible for manufacturers and to those who dispense medicines, reflecting the needs and choices of individual patients.

MEDIA SUMMARY 

Who are newest recruits to parliamentary pharmacy group?
Chemist and Druggist, Emily Bright and Annabelle Collins, 27 July 2017

The All-Party Pharmacy Group (APPG) has approved two Conservative MPs to sit as vice-chairs on the organization. Julian Sturdy, MP for York Outer, and Steve Double, MP for St Austell and Newquay will replace MPs who lost their seats in the election. Both Mr Double and Mr Sturdy voted for pharmacy cuts after a parliamentary debate in November 2016. Mr Sturdy has consistently voted to allow GPs to commission services on behalf of patients. Mr Double “voted against ‘immediate extra social care funding and better NHS and social care funding'”.

UK government hires ex-pharma chief to lead pricing talks with industry
Pharmaphorum, Andrew McConaghie , 27 July 2017

Pharmaphorum reported on the recent news at the NHS, with the appointment of Steve Oldfield as Chief Commercial Officer. It is a newly created position and Mr Oldfield will lead negotiations with the ABPI over the upcoming renewal of the PPRS. Given Mr Oldfield’s long career in the private sector, Pharmaphorum notes that the appointment is somewhat like the “poacher turned gamekeeper”, with someone with deep knowledge of pharmaceutical negotiating tactics now working for the other side. McConaghie also supposed that it is a sign of trust between the Department of Health and industry that the Department would so readily appoint someone from the latter’s ranks.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

UK government hires ex-pharma chief to lead pricing talks with industry
Pharmaphorum, Andrew McConaghie , 27 July 2017

The Department of Health has appointed a former UK head of Sanofi and Teva to be its chief commercial officer, with responsibility for negotiating a new pricing deal top of his priorities.

Steve Oldfield will take up this newly-created position in October, and will lead talks with the industry association the ABPI on the PPRS, the key pricing agreement between pharma and the NHS.

The new position is very much a break with tradition, as such senior roles have been filled by civil servants in the past.

But the Department of Health (DH) has lost a great deal of its in-house expertise over the last few years, seeing its headcount slashed thanks to Whitehall spending cuts. It has also just seen the Commercial Medicines Unit (CMU) transferred to NHS England, which is increasingly cutting its own pricing deals direct with pharma.

But the DH still retains responsibility for negotiating the PPRS for the whole of the UK, which covers around £8 billion a year in medicines spending.

The current PPRS agreement is due to expire in December 2018, and both sides are keen to start talking about what should replace it. NHS England and the ABPI are both keen to see more outcomes-based pricing deals, but the current PPRS and limitations on NHS data make this difficult to extend to all medicines.

The NHS is also under extreme budget pressure, and the DH and NHS England want to keep a tight grip on medicines expenditure, especially in the face of a boom in highly specialised, high cost new drugs coming to market.

All this means that the DH needs someone with a deep understanding of medicines pricing to get the best deal from pharma.

Oldfield will be joining the Government Commercial Function and his initial focus will be to create and develop a commercial strategy, which the DH says will ‘underpin upcoming negotiations with a variety of commercial suppliers, including key engagements with the pharmaceutical industry in particular on the PPRS scheme’.

Currently chief operating officer for PGT (the consumer health joint venture between Procter & Gamble and Teva) based in Geneva, Steve Oldfield has more than 25 years of experience in pharma.

In addition to his UK leadership roles at Sanofi and Teva, he has also held senior positions in Asia and Latin America. He has been involved in industry-government initiatives over the years, having served on the ABPI’s board and co-chaired committees looking at the introduction and adoption of new medicines.

Steve Oldfield commented: “I am delighted to be joining the Department of Health, especially at such an exciting time. Demands on the health system have never been greater, and I hope to be able to bring my previous commercial experience to bear on the activities of the department.”

He added, “In particular, I look forward to working collaboratively across the department, the NHS and the life sciences to find new ways of working for the benefit of patients and the health economy.”

The appointment looks to be very much in the mould of ‘poacher turned gamekeeper’, in that Oldfield will have first-hand insights into pharma’s business models, and will use this to drive the best possible deal for the government.

At the same time, his ‘pharma insider’ status can also be seen as a sign of trust between the DH and the industry, demonstrating a desired wish to support the life sciences sector.

This is particularly vital at the moment, as Brexit and the threat of an economic slowdown in the UK are threatening the future of the industry here, as well as the NHS’ ability to pay for new medicines.

The ABPI was quick to welcome the appointment, its chief executive Mike Thompson saying Oldfield would provide it with ‘valuable expertise’.

Mike Thompson added: “I’m confident that this appointment will also positively impact our ability to have open and transparent negotiations with Government and find win-win solutions in which everyone can have confidence.”

Feelings are running high in the industry about an ongoing squeeze on prices, however. The ABPI recently revealed it is seeking a judicial review of the new NICE and NHS England budget impact test, a new mechanism which could be used to delay and limit uptake of new medicines.

MEDIA SUMMARY 

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation big data genetic informatics system is predicted to be worth $500 million by 2021. The use of genomic data-sets to craft tailored prescriptions has become increasingly prevalent in Europe, leading to the more widespread use of end-to-end genetic mapping in prescribing and diagnosing illnesses. The current informatics systems are currently providing substantial benefits to life sciences and diagnostic firms, where competitive pricing has made genetic data much more easily available and harvestable. This comes after intensifying demand in the industry for genomic data. At the moment, further commercialization is prevented by country-level data protection laws, but most states are currently developing their own genetic data storage systems. In particular, Britain’s 100,000 genomes project is one of the leading programmes of its kind in Europe, and looks set to grow in the coming years.

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification on the MHRA Blog, and the full statement can be found in Full Coverage below.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE

Growth in next-generation sequencing informatics market fueled by big data
European Pharmaceutical Review, Steve Bremer , 25 July 2017

The European next-generation sequencing informatics market is predicted to be worth over $500m by 2021, supported by big data-driven clinical interpretation in novel areas, according to a new report.

Frost & Sullivan’s report predicts that strong demand from the biopharma Industry will encourage NGS informatics providers to deliver customised solutions. Reduced costs of sequencing costs have led to burgeoning genomic datasets, and these, coupled with data from multi-omics and electronic medical/health records (EMR/EHR), are fueling the adoption of big-data methodologies in data analysis, it says.

Growth Opportunities in the European Next-generation Sequencing Informatics Market‘ details unmet needs and highlights potential opportunities across the secondary analysis, tertiary analysis and storage solution segments.

“As the industry matures, users of NGS informatics services will seek seamless end-to-end genetic solutions in an easy-to-use format at competitive prices,” said Frost & Sullivan Analyst Neelotpal Goswami. “Intensifying demand from pharmaceuticals, biotech, and diagnostic firms will propel NGS informatics providers to develop customised solutions that address user needs – from sample analysis to actionable informatics.”

Trends supporting market development include:

  • Focus on personalised medicine across European nations such as France, Germany, and the UK, along with a number of pan-Europe initiatives
  • National-level genomics data collection and analysis initiatives, such as the UK’s 100,000 Genomes Project and the French Plan for Genomic Medicine 2025
  • Strong research and development and wider application of NGS informatics-based services in Benelux and the Nordics
  • Presence of cutting-edge NGS technology infrastructure in the region, like the Wellcome Trust Sanger Institute, a highly-educated population receptive to NGS technologies and significant government support.

“Europe is a fragmented market, where revenue potential varies significantly in individual countries,” said Mr Goswami. “Additionally, at a pan-European market level, countries have differing regulations and reimbursement practices that may hamper successful commercialisation of NGS informatics solutions. However, innovative approaches such as storing genomic data for analysis within specified geographic borders to match data storage regulations, and evolution in reimbursement policies that increase clarity and coverage for NGS-based tests, will support growth opportunities.”

Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate Blog – Do wholesale distributors require pharmacovigilance agreements?
MHRA, Peter Twomey, July 26 2017

MHRA Good Distribution Practice (GDP) inspectors have received a number of queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate has provided clarification below:

According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of medicinal products is “all activities consisting of procuring, holding, supplying or exporting medicinal products apart from supplying medicinal products to the public…”. If a wholesale distributor could potentially receive safety-related information on behalf of the MAH, or if they are providing a service relating to pharmacovigilance, then they are effectively part of the MAH’s pharmacovigilance system. In this situation, contracts or agreements between the MAH and wholesale distributor need to exist, in order for the MAH to ensure that activities performed and services provided by these third parties are in accordance with applicable legislation and guidelines, and in order to ensure that all parties understand and formally agree to the tasks that have been contracted. In this blog post, the terms contract and agreement are used synonymously.

The good pharmacovigilance practices (GVP), are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union.
GVP Module VI.2.2 states that “Each marketing authorisation holder shall have in place a system for the collection and recording of all reports of suspected adverse reactions which are brought to its attention”. As indicated earlier, wholesale distributors may be a potential source of safety information. Hence, the MAH will need to have a mechanism to collect reports of adverse reactions received by wholesaler distributors.

GVP Module VI.B.7 outlines the reason why agreements between the MAH and wholesale distributors may be required “Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the reporting obligations. These procedures should in particular specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities and should avoid duplicate reporting to the competent authorities”.
As reports of suspected adverse reactions may be brought to the attention of wholesale distributors, agreements between the MAH and the wholesale distributor support the fulfilment of the collection and recording of these reports by the MAH.

Indeed, section 6.3 of the European Commission Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) states “In the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and/or marketing authorisation holder should be informed without delay”. Complaints received by wholesale distributors may include reports of suspected adverse drug reactions and should be forwarded to the MAH, the implementation of an agreement between the parties may help facilitate this activity.

Factors influencing whether an agreement is required

The MAH needs to assess if the wholesale distributor they have engaged with are a potential source of safety information (such as reports of adverse reactions, medical enquiries or product quality complaints), and/or are providing pharmacovigilance services on behalf of the MAH, and whether an agreement is required to fulfil pharmacovigilance requirements. Some factors which are likely to result in an agreement being required include:

  • if the name and/or contact details of the wholesale distributor appears on product packaging, the patient information leaflet (PIL) or the MAH’s website,
  • if the MAH does not have a contactable presence in the market where the product is being distributed, which may increase the likelihood of the wholesale distributor becoming a point of contact by a member of the public or health care professionals (HCPs),
  • if the wholesale distributor is providing services which may increase their interaction with HCPs and the likelihood of receiving safety information, such as actively promoting products via a sales team,
  • if the wholesale distributor is performing pharmacovigilance services on behalf of the MAH, for example, undertaking follow-up of adverse events in their territory on behalf of the MAH, undertaking local literature searching activities or distributing risk minimisation materials.

The above list is not intended to be exhaustive and the MAH should consider all factors which may result in the wholesale distributor becoming part of the MAH’s pharmacovigilance system.
There may be situations when an agreement is not required, for example, if the wholesale distributor is not in a contractual relationship with the MAH and would not be regarded as a potential source of safet

safety information and thus would not form part of the MAH’s pharmacovigilance system.

Content of agreements

If an agreement between the MAH and the wholesale distributor is required, it should contain sufficient detail to ensure that pharmacovigilance requirements are met. It is the responsibility of the MAH to decide what provisions need to be included in these agreements, particularly considering the content required in agreements may vary depending on the parties involved. Some provisions which the MAH may wish to consider in agreements are outlined below, however, this list is not intended to be exhaustive and the MAH should use their judgement when deciding what information should be included in agreements:

  • the roles and responsibilities of each party
  • the types of safety information which should be collected and forwarded to the MAH by the wholesale distributor (e.g. suspected adverse reactions, lack of efficacy reports, product quality complaints etc.)
  • timeframes for the exchange of safety information between parties and case confirmation and/or reconciliation provisions
  • contact details of where the wholesale distributor should send safety information received to
  • how the transfer of outstanding safety information to the MAH will be handled should commercial arrangements be terminated
  • provision for the oversight of the wholesale distributor by the MAH (e.g. in process compliance measures and the right of the MAH to audit the wholesale distributor).

The MAH should consider how to ensure all parties are complying with the terms of the agreements, such as including wholesale distribution partners on the MAH’s risk-based audit programme, or implementing routine checks of pharmacovigilance relevant wholesale distributor activity, such as periodic reconciliation of reports of adverse events between the distributor and the MAH which may identify discrepancies in information exchanged.

Conclusion

In conclusion, when deciding if an agreement between the MAH and the wholesale distributor is required, the MAH needs to consider if the wholesale distributor is a potential source of safety information and/or performing pharmacovigilance tasks on behalf of the MAH, and implement agreements as appropriate. Provided the aforementioned factors have been considered, it is anticipated that there may be instances where an agreement between the MAH and the wholesale distributor is not required. The MAH should ensure that where an agreement is required, these agreements contain sufficient detail and provisions relative to the relationship between the MAH and the partner.

MEDIA SUMMARY 

NHS England launches ‘non-essential’ medicines consultation
Dispensing Doctors, Ailsa Colquhoun, 24 July 2017

The NHS Clinical Commissions and NHS England have initiated consultations to remove 18 drugs from routing GP prescription. These 18 medicines are either being considered clinically ineffective or where the NHS can provide a clinical alternative that has already been tested. The objective of the review is to guide Clinical Commissioning Groups in their decision making about drugs. The review’s outcomes will not remove clinical discretion. Any savings will be reinvested in improving patient care, according to NHS England.

Drug firms build Brexit stockpile
The Sunday Times, Sabah Meddings, 23 July 2017

British pharmaceutical companies have announced that they will be stockpiling medicines to avert any potential shortages caused by Brexit. British medication, upon leaving the European Medicines Agency, may have to be retested when it lands in the EU, causing shortages of medication in European markets. In response, British firms are considering stockpiling medicines in European storage facilities and warehouses so that, in the event of the ‘hardest of Brexits’, shortages are either prevented or mitigated.

Pay for medicines based on effectiveness, NHS told
The Financial Times, Sarah Neville, 23 July 2017

The NHS should pay for medicines based on their effectiveness, according to a report from the Social Market Foundation (SMF). They also said that drugs that met a specific criteria – such as ‘unmet need’ – should undergo a fast-tracked approval process. In terms of effectiveness, the Social Market Foundation proposed that the NHS negotiate with drug companies to establish effectiveness ‘yardsticks’, the meeting of which would qualify the company for payment. The report also acknowledged that small firms may need a different system, to ensure that they are not put off by uncertain or delayed payment. The SMF noted that a similar proposal was already in place in Italy and currently, there was a central tension between “increasingly constrained spending on the nation’s taxpayer-funded health service and the need to maintain, or accelerate, investment in the UK’s life sciences industry”.

PARLIAMENTARY COVERAGE

 

House of Commons Questions – July 21, 2017

 

Chi Onwurah MP

What assessment the Government has made of the potential effect on the NHS budget of the UK withdrawing from the European Medicines Agency.

Department of Health Response

Steve Brine MP:

As part of the exit negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU. While it would not be appropriate to pre-judge the outcome of the negotiations, the Government’s position was clarified in an open letter to The Financial Times, dated 5 July 2017. In that letter we made clear that 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.

FULL COVERAGE 

NHS England launches ‘non-essential’ medicines consultation
Dispensing Doctors, Ailsa Colquhoun, 24 July 2017

NHS Clinical Commissioners (NHSCC) and NHS England have launched the consultation to remove 18 medicines from routine prescribing by GPs in England.

The consultation is open from 21 July to 21 October 2017 and, in addition to the initial 18 medicines, the consultation also seeks views on a wider list of 3,200 products that are available over-the-counter, without prescription, that may be appropriate for future restriction.

View the consultation document.

According to NHS England, the NHS currently spends £141 million p.a. on medicines that are considered either:

  • clinically ineffective; unsafe; or not cost effective; or
  • where the NHS can offer a clinically-proven alternative for patients.

The objective of the review is to produce commissioning guidance to support clinical commissioning groups (CCGs) in their decision-making, to address unwarranted variation, and to provide clear national advice to make local prescribing practices more effective. The consultation is accompanied by an equality and health inequalities impact assessment, but this contains no specific arrangements for people living in rural areas in which dispensing GPs operate, and where access to a community pharmacy is difficult or non-existent.

NHS England says the proposed guidance would not remove the clinical discretion of the prescriber in deciding what is in accordance with their professional duties.

Any savings from implementing the proposals will be reinvested in improving patient care, NHS England says.

Media Summary

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

HDA UK Chief Executive Martin Sawer told delegates at the Sigma conference that Brexit will not disrupt plans to implement the EU’s Falsified Medicines Directive. The Directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019. “FMD and medications verification scanning will happen whether the sector is ready or not”, Sawer said. SecurMed UK will appoint an IT provider to deliver the UK’s Medicines Verification System over the coming weeks. With this, systems will need to be tested and pharmacies will need to consider altering the flow of the dispensing process to ensure that efficiency and data protection are safeguarded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has criticised the Government for its ‘complete ignorance about the tremendous value’ community pharmacy delivers. Condemning the funding cuts, Sharpe said that they will particularly hit low volume, urban pharmacies.  “You really need to be prepared for what’s coming down the line.”, she said, focusing on the need to develop relationships with commissioners and establish local links.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

The big pharmaceutical companies were driven into a £250 million bailout to help fill a £500 million gap in the NHS budget; now, with fear over NHS finances Sir Jeremy Heywood has threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money. Opposition MPs say that ministers must come clean on the gap in the NHS budget. Shadow health secretary Jonathan Ashworth said: “Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent”.

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are hoping to benefit from the relocation of the European Medicines Agency (EMA). This week, Portugal joined the competition, with the Portuguese minister of health, Adalberto Campos Fernandes, saying: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines”. In the UK, Hunt has promised that the UK will keep the closest possible regulatory equivalence with the EU. The array of countries courting the EMA voice their commitment to the EU, strong cities, and vibrant medical research industries as points of merit.

Parliamentary Coverage

House of Lords, Written Answers, Department of Health

16 February 2017

Lord Bradshaw: further to the Written Answer by Lord O’Shaughnessy on 19 January (HL4501), whether the Answer also applies to the Automated Repeat Prescription Service offered by some high street pharmacies; and what checks there are to ensure that this does not lead to over-ordering.

Lord O’shaughnessy:

My Written Answer of 19 January applies also to repeatable prescriptions provided through the Electronic Prescription Service.

Any service provided by a pharmacist including ordering prescriptions on behalf of patients, should be carried out in accordance with their professional code of conduct, ethics and performance and the standards for registered pharmacies – both regulated by the General Pharmaceutical Council. This would include obtaining all the information they require to assess a person’s needs in order to give safe and effective treatment and to obtain consent for professional services they provide.

Full Coverage

Murray review of community pharmacy services will ‘direct’ government policy, says health minister

The Pharmaceutical Journal, 15 February 2017

UK health minister David Mowat says that the Murray review into the provision of community pharmacy services will “direct” government policy.

The independent review, published on 14 December 2016 and led by Richard Murray, director of policy at the King’s Fund, looked at clinical services provided by community pharmacy and recommended greater use of repeat dispensing and independent prescribing. It also called for pharmacists to have full read and write access to the patient medical record.

Speaking to delegates at the Sigma conference in Rio de Janeiro on 13 February 2017 via a video recording, Mowat said that the report’s findings are now with England’s chief pharmaceutical officer Keith Ridge, who commissioned the review.

David Mowat told delegates at the Sigma conference in Rio de Janeiro that a “great deal” of the recommendations within the Murray review are worthwhile and will direct government policy.

“I do know that [Keith Ridge] welcomed the review, there was a great deal in there which is very worthwhile and will direct policy,” Mowat said, adding that community pharmacists should become a more “clinically focused” and “services-orientated” profession.

Mowat also pointed out that 50% of pharmacies in England were delivering a minor ailment service and he, along with NHS England, wanted the rest of the country to have the service in place by April 2018.

He told delegates that pharmacists wanted greater integration with the NHS and to contribute more: “I agree with both of those objectives, as we build a seven-day NHS. We frankly don’t have enough GPs, health professionals and it really is a massive opportunity for the pharmacy sector to step up and work with us as we try to get things integrated right across the primary care sector.”

Earlier at the conference, a message was read out to delegates from prime minister Theresa May, who said that government reforms would “ensure we have a modern and efficient community pharmacy sector, properly integrated in primary care and public health, offering better patient choice and easier access”.

Brexit won’t stop UK implementation of Falsified Medicines Directive

The Pharmaceutical Journal, 15 February 2017

The UK government has confirmed that Brexit will not put a stop to its plans to implement the EU’s Falsified Medicines Directive, Martin Sawer, executive director of the Healthcare Distribution Association, told delegates at the Sigma conference in Rio de Janeiro on 14 February 2017 via a live video link.

Martin Sawer told delegates at this year’s Sigma conference in Rio de Janeiro that the Falsified Medicines Directive “will happen whether the sector is ready or not”

The directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019.

As part of the directive, measures to verify the authenticity of medicines at certain points in the supply chain will be introduced — for example, 2D barcodes on individual medicines packs to be scanned and checked before dispensing.

“FMD and medications verification scanning will happen whether the sector is ready or not,” Sawer said, adding that implementation will probably have “significant costs and training requirements”.

Also, speaking via live video link, Gareth Jones, head of corporate affairs at the National Pharmacy Association, which represents independent pharmacies, said the pharmacy sector was unlikely to see a “big bang” on launch day but that it should expect to see an increase in the number of packs with barcodes from that date. Pharmacies will likely need to fund software and hardware updates to link with a new medicines database, he added.

SecurMed UK, a not-for-profit organisation set up to deliver the UK’s Medicines Verification System, will appoint an IT provider for the project in the next few weeks, said Sawer. After this, a verification system will be developed and will then need to be tested with UK system suppliers.

Jones said that decisions still have to be made on when pharmacies will need to scan each medicine pack, adding that the fact that medicines cannot be returned into a pharmacy’s stock after ten days “could create a lot of waste”.

“Pharmacies need to consider changing the flow of the dispensing process for efficiency, and data protection needs to be considered,” he concluded.

Next four months “very difficult” warns Sharpe

Pharmacy Magazine, 16 February 2017

PSNC chief executive Sue Sharpe has slammed the Government for making “stupid decisions” about community pharmacy borne of “complete ignorance about the tremendous value it delivers to the NHS and general public”.

The funding cuts were targeting urban pharmacies, she said. “If you’re a low volume pharmacy in an urban area, you need to think really carefully about what the future looks like for you.” Now is the time to focus on developing local services to meet local needs, develop good relationships with commissioners and maybe even merge or join forces with other pharmacies in the locality.

“You need to make sure that local commissioners, GPs and social care think you’re the people they want to deal with.”

Address delegates in a pre-recorded video, she warned that the funding situation for contractors over the next four months would be “very, very difficult” before becoming a little easier. “You really need to be prepared for what’s coming down the line.”

Contractors should aim to get 100 per cent of the new quality payments. “This is going to be a great differentiator between pharmacies in the future. Commissioners may well look at that”.

Drug companies propped up NHS with £250m after cabinet’s threat

The Times, Chris Smyth and Oliver Wright, 17 February 2017

Britain’s top civil servant forced the big pharmaceutical companies into a £250 million bailout to help to plug a £500 million hole in the NHS budget.

In the latest sign of panic over NHS finances, Sir Jeremy Heywood, the cabinet secretary, threatened to impose statutory price caps on drugs in an “aggressive” attempt to raise more money.

The pharmaceutical industry then agreed to cover part of a shortfall in an attempt to win government goodwill in talks over medicines regulation and avoid an “acrimonious” row.

Opposition MPs say that ministers must come clean on the gap in the NHS budget and explain why they were spending money that they had yet to receive. The bailout stems from an

agreement in 2014 which capped NHS spending on branded medicines at about £8 billion, with any costs above that level refunded by drugs companies.

The pharmaceutical industry had hoped that this would free doctors and hospitals from worrying about the cost of medicines and encourage them to change Britain’s traditional reluctance to use new drugs.

However, instead of funnelling rebates back to areas that spent the most, ministers opted to use the money to prop up the central NHS budget. As a result the Department of Health was caught short when rebates were less than predicted, having already allocated the expected refunds to NHS budgets for 2017-18.

At a meeting in November, Sir Jeremy told the industry that the scheme was failing and threatened statutory price cuts to medicines unless they stumped up more money.

The Association of the British Pharmaceutical Industry said that while it “fundamentally disagree[d]” with the government’s approach, it felt that it was best to agree some sort of deal.

“At best even if the government does not end the scheme early, there would be a significantly more acrimonious relationship going into the next negotiations. There would be significant immediate impact on industry ability to influence and shape the UK commercial environment now and in the future,” industry minutes say.

David Watson of the association told The Times that goodwill with ministers was crucial as the industry approached talks on the shape of the economy and how drugs would be approved once Britain left the EU.

“We are aware that we’ve got a new industrial strategy coming along and there is a lot up for grabs about regulation after Brexit that we want to be working on as partners with the government,” he said.

“Having allocated that money in advance, they found there was a gap in their budget for 2017-18 of £400-£500 million. We agreed to meet them halfway.”

Jonathan Ashworth, the shadow health secretary, said: “It’s embarrassing that ministers have had to go cap in hand to big pharmaceutical industry to plug gaps in the NHS finances. Yet again it exposes the reality that the NHS simply hasn’t been given the investment it needs. With Brexit and the consequent upcoming negotiations over the future of medicine regulation it’s crucial that all transactions between government and the pharmaceutical industry are totally transparent.”

Norman Lamb, the Liberal Democrat health spokesman, said: “What these arrangements expose is the government’s appalling financial planning for the NHS. They have scraped around to find ways of claiming that funding for the NHS has been increased, and now resort to these emergency deals which will inevitably raise eyebrows.”

Countries line up to host European Medicines Agency after it leaves UK

The Guardian, Patrick Wintour, 15 February 2017

As many as 20 EU countries are seeking to take the headquarters of the European Medicines Agency from the UK once Brexit is complete – and with it 900 highly skilled staff.

Portugal has joined the competition for the EMA this week, which is fiercely sought after because acting as host is likely to have a huge knock-on effect for any country’s medical and pharmaceutical industry. As well as the loss of 900 staff, there is already deep concern in the UK about the ripple effect of the move on the industry.

The EMA’s chief role is to act as the regulatory agency deciding if products are safe for the European single market. Two Portuguese ministers visited its HQ in Canary Wharf on Monday and acknowledged that competition to house the agency is going to be stiff across Europe.

Nationals from every EU industry save Malta and Luxembourg work at the agency. France has 112 employees in the headquarters, and there are 50 British staff. No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision.

Germany is the single largest manufacturer of medical products followed by Italy, and Rome has been arguing that apart from the European Food Safety Authority, it has been given no major EU agency so far. Other countries making bids are the Netherlands, Ireland, Sweden, Austria, Denmark and Spain.

The health secretary, Jeremy Hunt, has acknowledged this month that the EMA would quit Britain as part of Brexit, largely because Theresa May has asserted that the UK would no longer be subject to the decisions of the European court of justice.

The ECJ at present adjudicates appeals against EMA decisions or rulings that require interpretation of pharmaceutical legislation, such as the recent clash between Novartis and Apozyt over the use of the label Avastin.

Hunt has promised the UK would keep the closest possible regulatory equivalence with the EU. Critics claim that this means UK firms would largely have to accept the rules devised in the EU if they are to trade in the single market.

The Portuguese minister of health, Adalberto Campos Fernandes, said before the visit: “We have been actively engaged in the European medicine system from its inception and the Portuguese medicine agency, Infarmed, is highly regarded in the assessment procedures of medicines, being one of its major contributors in several roles.”

Lisbon, like almost every candidate city, is touting itself as being committed to the EU, with a cosmopolitan culture and a vibrant medical research industry.

Pfizer fined record £84.2m for overcharging NHS

BBC News, Tom Espiner, 7 December 2016

 

BBC News reports that Pfizer has been fined £84.2m by the Competition and Markets Authority (CMA) for overcharging the NHS for an anti-epilepsy drug. The UK competition watchdog also fined distributor Flynn Pharma £5.2m for the 2,600% price increase for the drug in 2012. The CMA explained that the drug was more expensive in the UK than in Europe. Pfizer said it rejects the findings and would be appealing against the decision.

 

The news was also reported by The GuardianMetroSky NewsReuters UKCity AM and MailOnline.

 

Parliamentary Coverage

House of Commons Questions, 6 December 2016, UN High-level Panel on Access to Medicines 

 

Dr Alasdair Mcdonnell: What steps the Government is taking on implementing the recommendations in the UN High-Level Panel on Access to Medicines report published in September 2016; and what the timescale is for that implementation.

 

Department for International Development

James Wharton: DFID supports the aims of the UN High Level Panel on Access to Medicines, but we note that this panel of experts could not reach consensus. The World Health Organisation has analysed the barriers that limit access to medicines, and developed a Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. It is, therefore, well-placed to consider, with partners, which of the Panel’s recommendations add value.

 

Full Coverage

Pfizer fined record £84.2m for overcharging NHS

BBC News, Tom Espiner, 7 December 2016

 

Drugs giant Pfizer has been fined a record £84.2m by the UK’s competition watchdog for overcharging the NHS for an anti-epilepsy drug.

 

The Competition and Markets Authority (CMA) also fined distributor Flynn Pharma £5.2m for the 2,600% price increase for the drug in 2012.

 

NHS spending on the capsules, used by 48,000 UK patients, rose from £2m a year in 2012 to about £50m in 2013.

 

Pfizer rejected the findings and said it would appeal against the decision.

 

UK prices for the drug were many times higher than in Europe, the CMA said.

‘Extraordinary price rise’

 

Philip Marsden of the CMA said: “The companies deliberately exploited the opportunity offered by de-branding to hike up the price for a drug which is relied upon by many thousands of patients.

“These extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds.”

Before 2012 Pfizer manufactured and distributed the drug, which went by the brand name Epanutin.

 

Pfizer then sold the UK rights to distribute the phenytoin sodium capsules to Flynn Pharma, which de-branded the drug.

 

That allowed the firms to charge more for the drug because it was no longer subject to a pricing scheme agreed between the NHS and the drugs industry, the CMA said.

 

Losses

 

However, Pfizer said the drug was a loss making product, and that the deal with Flynn “represented an opportunity to secure ongoing supply of an important medicine for patients with epilepsy.”

 

“Pfizer believes the CMA’s findings are wrong in fact and law and will be appealing all aspects of the decision,” it said.

 

The drugs giant said the increased price of the drug was still 25% to 40% below the cost of an equivalent medicine by another supplier to the NHS.

 

But the CMA said by its calculations “all such losses would have been recovered within two months of the price rises.”

 

Pfizer has between 30 days and four months to reduce the price to a level acceptable to the CMA, and has two months to appeal against the CMA decision to the Competition Tribunal.

GPs report drug shortages

25 August 2016, Pharma Times, Selina KcKee

GP Online has conducted a survey of 441 GPs which found that 4 out 5 doctors are unable to prescribe patients their first choice treatment due to drug shortages. 18 percent of these doctors said that their patients had experienced a negative effect from their treatment as a result. Andrew Green, Chairman of the GPC Clinical and Prescribing Subcommittee commented on the situation, noting that “The issue of secure drug supply is an on-going problem that no one has been able to adequately address,”. He suggested that doctors would welcome a centralised alert system warning them of low drug stocks. Dr Rick Greville, ABPI Director, Wales and Distribution & Supply added that The Department of Health, Wholesalers, Pharmacists and others are consistently working together to minimise any impact on patients.
Four NHS geographic committees to be set up to appraise drugs across England

23 August 2016,  The Pharmaceutical Journal

NHS England has plans to establish four Regional Medicine Optimisation Committees (RMOCs) in England for the evaluation of drugs that do not go through NICE’s technology appraisals programme. The committees are being set up in a bid to reduce the duplication of drug evaluation in the NHS in response to concerns that new medicines and new indications for existing medicines that do not go through the National Institute for Health and Care Excellence (NICE) technology appraisals programme end up being evaluated multiple times at a local level across the NHS.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

 

GPs report drug shortages

25 August 2016, Pharma Times, Selina KcKee

The issue of drug shortages is coming to the fore again as a survey by GP Online finds that four out of five doctors are not able to give patients their first choice of treatment.

Eighty-two percent of 441 GPs responding to the survey said drug shortages had forced them to prescribe a second-choice medicine in the past 12 months, and 18 percent of these said patients had experienced a negative effect – an adverse event or reduced efficacy – as a result.

“The issue of secure drug supply is an on-going problem that no one has been able to adequately address,” said Andrew Green, chairman of the GPC clinical and prescribing subcommittee. “Sometimes problems can be very localised, so you can have difficulties in one part of the country and not in others. That makes informing GPs really quite a difficult task to do”.

He went on to note that GPs usually only know of drug shortages when patients return because they were unable to get their prescription, and suggested doctors might welcome a central alert system to warn of low stocks.

Drug shortages in branded medicines, which occur when demand is outstripping supply, are caused by various reasons including manufacturing problems, medicine recalls, safety concerns or parallel exports.

“The reasons for instances of medicines shortages are often both complex and varied and we have consistently worked with our members, the Department of Health and others, including regulators, wholesalers, pharmacists and parallel distributors, in order to minimise any impact on patients,” said Dr Rick Greville, ABPI Director, Wales and Distribution & Supply.

“We are committed to closely monitoring the availability of branded medicines in the UK and will continue our engagement with all involved in the medicines’ journey to the patient,” he added.

 

Four NHS geographic committees to be set up to appraise drugs across England

23 August 2016,  The Pharmaceutical Journal

NHS England plans to establish four regional medicines optimisation committees in England to evaluate drugs that do not go through NICE’s technology appraisals programme.

Four regional medicines optimisation committees (RMOCs) will be set up across England to reduce the duplication of drug evaluation in the NHS, according to a consultation published by NHS England in August 2016.

RMOCs were first outlined by Keith Ridge, chief pharmaceutical officer at NHS England, in a letter to regional medical directors in February 2016. They are being set up in response to concerns that new medicines and new indications for existing medicines that do not go through the National Institute for Health and Care Excellence (NICE) technology appraisals programme end up being evaluated multiple times at a local level across the NHS.

With the formation of four committees covering all geographic areas, NHS England says it aims to cut down on duplications and save resources. The move should also free the time of staff at clinical commissioning group (CCG) and trust level to focus on implementation, it says

“Whilst it’s important to recognise that CCGs and trusts have clinical and financial duties to deliver, it must be possible to eliminate unnecessary duplication of effort, and instead focus local expertise on optimising outcomes from medicines use,” says Ridge.

“I believe the best way to eliminate duplication of medicines evaluation is to bring those activities to regional level through the establishment of four [RMOCs]. This will ensure any evaluation activity is coordinated, done once only, and shared across the four NHS regions.”

Following a workshop with stakeholders in April 2016, NHS England has published more detailed plans for consultation. The proposals set out the aims of the RMOCs, how they will operate, how membership will be composed, and how work plans will be determined.

The proposals state that the output of RMOCs will be advisory rather than mandatory. NHS England also says the roles of secondary care Drug and Therapeutic Committees (D&TCs), or equivalent, and Area Prescribing Committees (APCs) will need to be repurposed towards the local implementation of RMOC evaluations, and APCs will also feed back to RMOCs about local experience.

“NHS England recognises that the roles of secondary care [D&TCs] or equivalent, and of [APCs], is greater than the evaluation of new medicines and indications. These committees have the greatest knowledge of their local populations, healthcare systems and patient need,” the proposals state.

The Association of the British Pharmaceutical Industry (ABPI) supports the establishment of RMOCs.

“Our sector is ready and willing to play a key role to support the evaluation of those medicines that are not appraised by NICE in a timely, consistent, robust and transparent manner, and in better supporting the use of non-specialised medicines across the NHS governed by the principles of medicines optimisation,” says Paul Catchpole, ABPI’s value and access manager.

He says that RMOCs will improve productivity and reduce inefficiencies within the system. “This has the potential to ensure NHS patients get access to the right medicines at the right time, without being slowed down by unnecessary red tape.”

Mia Rosenblatt, assistant director of policy and campaigns at Breast Cancer Now, says the charity welcomes the proposals. However, she says that it will be a missed opportunity if they do not address the problems that stop patients gaining access to off-patent drugs that have been shown effectiveness in new indications.

“Despite significant clinical evidence for new uses of a number of these drugs, without a patent there is no financial incentive for pharmaceutical companies to seek licences for the new purposes, and so research innovations are just not reaching patients,” she says.

“We need clarity from these proposals on who should take responsibility for making off-patent treatments available. They offer effective and very cheap ways of treating a variety of conditions and we must ensure the NHS is able to make the most of them.”

Breast Cancer Now, which campaigns for better access to off-patent drugs, says it is preparing an official consultation response.

A NICE spokesperson said: “NICE supports initiatives that aim to eliminate duplication of activities across the system to support medicines optimisation. We are engaged with NHS England on the establishment of the committees, including selection of topics, how medicines are assessed and committee membership.”

The consultation is open until 19 September 2016.

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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