HDA UK Media and Political Bulletin – 24 February 2021

Media Summary

Number of UK COVID-19 vaccinations falls by a third as vaccine supply dips
The Guardian, Dan Sabbagh & Natalie Grover, 23 February

The Guardian reports that the number of COVID-19 vaccines administered in the UK has fallen by over a third in the last week as ministers warned of a short-term dip in supply, coupled with stockpiling to ensure people get second doses within the recommended 12-week limit.

The latest data showed 192,341 people received a first jab on Monday, the second-lowest daily total since 17 January – taking the number of people in Britain who have had an initial COVID-19 vaccination to 17.9 million. On Sunday the number of vaccinations was 141,719. Taken together, the total for the past two days is 35% lower than the equivalent figures last week.

Matt Hancock, the Health Secretary, said in a radio interview the country could expect “a quieter week this week” for vaccinations because of supply pressure but that the rollout would bounce back next month. “We’re going to have some really bumper weeks in March,” he added.

Nicola Sturgeon, Scotland’s First Minister, also said in her daily press briefing that there had been “a temporary dip,” but added there were other factors at play to suggest that UK vaccine stocks had been reduced. Other reasons for the slowdown, the First Minister said, included “the higher than expected uptake so far, and also the need to reserve stock so that second doses can be offered to people who received their first dose in December.”

 

Parliamentary Coverage

Dr June Raine appointed as CEO of MHRA
Department of Health and Social Care, 23 February

Dr June Raine has been appointed as the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Chief Executive, having been the interim CEO since 2019.

Dr Raine played a crucial part in setting up rolling reviews during the pandemic to ensure the UK was the first in the world to authorise the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines. Her work has helped improve patient safety and patient engagement and has helped establish the UK as a world-leading destination for life sciences.

Health Minister Lord Bethell said: “It is thanks to Dr Raine’s strong leadership during the pandemic that the UK was the first country in the world to authorise COVID-19 vaccines. The MHRA is widely regarded as one of the best regulators in the world with the highest standards of safety and I’m delighted to confirm Dr Raine’s appointment as CEO.”

You can read the full press release here.

 

House of Commons – Written Answer, 23 February

Sarah Owen (Labour, Luton North): To ask the Secretary of State for Health and Social Care, what preparations the Government is making with community pharmacies for the distribution of a COVID-19 vaccine.

Jo Churchill (Conservative, Bury St Edmunds): NHS England and NHS Improvement are working with all the national pharmacy organisations on plans to ensure that community pharmacies, including large chain pharmacies, are used to optimal effect in the COVID-19 vaccination programme, starting with the sites that can do this at scale. As of 22 February 2021, 196 community pharmacies have now started to offer the COVID-19 vaccination service, with more pharmacies joining the service over the coming weeks. We expect 200 community pharmacies sites to offer the COVID-19 vaccination service as of 8 March 2021. Some pharmacists and members of their team have also been working with general practitioners to deliver the vaccine in many areas of the country.

 

Northern Ireland Assembly, Written Question, 22 February

Paula Bradshaw (Alliance, South Belfast): To ask the Minister of Health, given that community pharmacy is not mentioned in any detail in the document referred to, for an update on the detail of the precise role to be played by community pharmacists during the vaccination roll-out.

 

Full Coverage

Number of UK COVID-19 vaccinations falls by a third as vaccine supply dips
The Guardian, Dan Sabbagh & Natalie Grover, 23 February

The number of COVID-19 vaccines administered in the UK has fallen by over a third in the last week as ministers warned of a short-term dip in supply coupled with stockpiling to ensure people get second doses within the recommended 12-week limit.

The latest data showed 192,341 people received a first jab on Monday, the second-lowest daily total since 17 January – taking the number of people in Britain who have had an initial COVID-19 vaccination to 17.9 million.

On Sunday the number of vaccinations was 141,719, the lowest figure since the UK daily count began on 10 January. Taken together, the total for the past two days is 35% lower than the equivalent figures last week.

Matt Hancock, the Health Secretary, said in a radio interview the country could expect “a quieter week this week” for vaccinations because of supply pressure but that the rollout would bounce back next month. “We’re going to have some really bumper weeks in March.”

Nicola Sturgeon, Scotland’s First Minister, also said in her daily press briefing that there had been “a temporary dip”, but added there were other factors at play to suggest that UK vaccine stocks had been reduced.

Other reasons for the slowdown, the first minister said, included “the higher than expected uptake so far, and also the need to reserve stock so that second doses can be offered to people who received their first dose in December”.

UK ministers have repeatedly said they expect supplies to be uneven, particularly while Pfizer reduces production at its European plant in Belgium during February to increase the amount it can make in March. AstraZeneca has promised to produce an average of 2m doses a week, but it acknowledges its production can be lumpy.

Modelling documents released by the Scientific Advisory Group for Emergencies (Sage) on Monday also appear to suggest that the UK could speed up its pace of inoculation towards the end of March.

A document from Sage’s modelling subcommittee produced earlier this month suggests that vaccinations could potentially be carried out at the rate of 4m a week from 22 March based on scenarios “commissioned by Cabinet Office” – although a second, more conservative forecast, suggests 4m a week could be hit by 25 April.

A little over a week ago, with average vaccination rates running at more than 400,000 a day, the UK hit a target to provide a vaccine to the 15 million people in the first four priority groups. Paul Hunter, a professor in medicine at the University of East Anglia, said: “Maybe they used up a lot more doses in the first part of February to make the self-imposed target and to look good.”

Dr Michael Head, a senior research fellow in global health at the University of Southampton, said it was too soon to tell if there were any serious problems. “We probably need another week of data to have a clearer picture around whether this is a concerning trend, or indeed part of natural fluctuations,” he said.

Sturgeon said Scotland would follow an announcement made by England over the weekend to bring forward a target to reach all people in the first nine priority groups by 15 April instead of 30 April.

That would mean everybody over 50 being offered a first shot shortly after Easter, as well as those with underlying health conditions plus health and care workers – a total of 32 million people across the UK. A rolling programme of second jabs in large numbers would also have begun by then.

Media and Political Bulletin

19 April 2018

Media Summary

Our view: Redistribution of UK’s portfolio of centrally authorised products

ABPI, 18 April 2018

 

The ABPI has responded to the European Medicines Agency (EMA) announcement that it has completed the reallocation of the medicines for which the UK’s national regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

In response, Mike Thompson, chief executive of the ABPI, said:

“Given that the MHRA assesses up to 20 per cent of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise.

“It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.

“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

 

 

Parliamentary Coverage

House of Commons – Tabled Written Questions: Health and Social Care, 18 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.

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.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications of the Medicines and Healthcare products Regulatory Agency being excluded from the European Medicines Agency during the implementation 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.

It will be in the interests of both sides for the UK to participate in some EU bodies and agencies, including the European Medicines Agency, during the implementation period – and the agreement we have reached allows for this.

The UK is fully committed to continuing the close working relationship with our European partners. As my Rt. hon. Friend the Prime Minister outlined in her Mansion House speech, we will want to make sure our regulators continue to work together and the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines and other industries after the implementation period.

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.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, whether the UK will remain a member of the European Medicines Agency during the implementation 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.

It will be in the interests of both sides for the UK to participate in some EU bodies and agencies, including the European Medicines Agency, during the implementation period – and the agreement we have reached allows for this.

The UK is fully committed to continuing the close working relationship with our European partners. As my Rt. hon. Friend the Prime Minister outlined in her Mansion House speech, we will want to make sure our regulators continue to work together and the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines and other industries after the implementation period.

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

Our view: Redistribution of UK’s portfolio of centrally authorised products

ABPI, 18 April 2018

 

Last week, the European Medicines Agency (EMA) announced it has completed the reallocation of the medicines for which the UK’s national regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

In response, Mike Thompson, chief executive of the ABPI, said:

“Given that the MHRA assesses up to 20 per cent of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise.

“It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.

“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

The pharmaceutical industry’s priorities for the second phase of Brexit negotiations are:

Regulation: For the mutual benefit of patients and industry in the UK and the EU, the UK should seek to negotiate alignment and continued collaboration with the EU for the regulation of medicines

Trade: Due to the existing integrated nature of pan-European supply chains and to ensure continuity in medicines supply, the UK should seek to negotiate free and frictionless ​trade with the EU for pharmaceuticals and medical supplies

Science and innovation: The UK should seek to negotiate continued access to long-term European funding and collaboration programmes for science, such as Horizon 2020 and its successor

Access to talent: The UK should seek to negotiate an agreement with the EU that guarantees the rights of EU citizens already in the UK and facilitates the ease of movement for highly-skilled talent

Media and Political Bulletin

17 April 2018

Media Summary

MHRA will lose EMA work before Brexit transition period

The Pharmaceutical Journal, Alison Moore, 16 April 2018

 

The Pharmaceutical Journal reports that the UK will lose its involvement in evaluating medicines for the European Medicines Agency (EMA) from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the European Union (EU) during a transition period lasting until the end of 2020.

The EMA has appointed new rapporteurs and co-rapporteurs for 370 centrally authorised products where the UK’s Medicines and Healthcare Regulatory Agency (MHRA) and the Veterinary Medicines Directorate had co-ordinated post-authorisation work.

Despite post-Brexit transition plans the EMA said the MHRA could no longer engage in “centralised regulatory procedures” after 29 March 2019 unless another date for Brexit is agreed.

You can find more information on the EMA website.

 

Parliamentary Coverage

House of Commons – Tabled Written Questions: Health and Social Care, 16 April 2018

 

Jeremy Lefroy MP: To ask the Secretary of State for Health and Social Care, what the timetable for negotiations on the new pharmaceutical price regulation scheme is; and if he will make a statement.

Anne Marie Morris MP: To ask the Secretary of State for Health and Social Care, with reference to the Health Service Medical Supplies (Costs) Act 2017, when he plans to bring forward legislative proposals to regulate the costs of specials dispensed in community pharmacies.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, whether the UK will remain a member of the European Medicines Agency during the implementation period after the UK leaves the EU.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications of the Medicines and Healthcare products Regulatory Agency being excluded from the European Medicines Agency during the implementation period after the UK leaves the EU.

 

Full Coverage

MHRA will lose EMA work before Brexit transition period

The Pharmaceutical Journal, Alison Moore, 16 April 2018

 

Despite plans to continue its close work with the EMA, the MHRA will lose involvement in evaluating medicines for the EU from March 2019.

The UK will lose its involvement in evaluating medicines for the European Medicines Agency (EMA) from the date it formally leaves the European Union in March 2019, despite plans for the UK to remain closely tied to the European Union (EU) during a transition period lasting until the end of 2020.

The EMA has appointed new rapporteurs and co-rapporteurs for 370 centrally authorised products where the UK’s Medicines and Healthcare Regulatory Agency (MHRA) and the Veterinary Medicines Directorate had co-ordinated post-authorisation work.

The new rapporteurs — who come from the other EU states plus Norway and Iceland — will take on full responsibility for the medicines on 30 March 2019, the day after the UK leaves the EU.

Despite post-Brexit transition plans the EMA said the MHRA could no longer engage in “centralised regulatory procedures” after 29 March 2019 unless another date for Brexit is agreed.

The MHRA said there has been no decision yet on the future relationship with the EMA. “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical innovations. We are committed to continuing a close working relationship with the European Medicines Agency,” it said in a statement. “This was reiterated further by the Prime Minister in her Mansion House speech of 2 March, where she confirmed the government would like to explore with the EU the terms on which the UK could remain part of EU agencies, such as the EMA.”

It said it is considering the impact of the EMA decision, but that most of its regulatory work is national rather than EU. It would not comment on whether it had requested that that work remain with it post-Brexit.

Niall Dickson, co-chair of the Brexit Health Alliance, which includes the Academy of Medical Royal Colleges, the NHS Confederation, and the Association of the British Pharmaceutical Industry among its members, said: “Our shared approach to regulation has given patients throughout Europe faster access to treatment. The UK has been a significant player in shaping the current system and now we are leaving the EU we accept that is bound to change.

“The EMA’s decision that the UK will no longer be leading work assessing new medicines, therefore, comes as no surprise. But we very much hope that the UK and EU will reach an agreement which will enable us to participate more fully. We believe that would be in the interests of both sides.

Work on licensing and monitoring medicines has been one of the first areas to be directly affected by Brexit. In November 2017, the 27 remaining EU member states took the decision to relocate the EMA headquarters from London to Amsterdam.

02 February 2018

FMD Safety Features – Newsletter 09

 

Implementation Advisory Board – 23rd January 2018

 

MHRA welcomed stakeholders from across public sector bodies and industry associations for the latest Implementation Advisory Board. The Board provides advice and guidance to support the UK’s implementation of the safety features aspects of FMD.

 

MHRA and DHSC updated the group on implementation work and news since the last meeting in September 2017 including:

  • Publication of guidance in different sectors.  FAQs for secondary care published in November and Community Pharmacy (see below);
  • A reaffirmed commitment to issue the public consultation as soon as possible.  The consultation will focus solely on flexibilities, sanctions and enforcement where the UK has legal scope to make changes.  It will not include other issues which must be implemented according the Regulation;
  • Working collaboratively with SecurMed UK to address challenges in its delivery of the UK national verification organisation; and
  • Our work at a European level harmonising implementation.

 

There was also a wide ranging discussion on implementation throughout the supply chain which covered some of the important work being done and the issues facing different sectors.  We do not underestimate the challenge of delivering implementation on time and to the right standard.  We also remain committed to continuing to work constructively to deliver the benefits of the safety features aspects of FMD.

 

 

Article 23 Flexibility

 

The Board also heard reports from three of the groups potentially impacted by the Article 23 Flexibility.  Under Article 23 the UK can require wholesalers to decommission for others supplying to the public as long as they are not operating in a healthcare institution or pharmacy.  Our positions on the flexibilities are subject to change during the public consultation.

 

Provisional discussions have included:

  • Health and Justice & Hospices: A mixed model with bulk stock decommissioned at wholesaler level under the Article 23 flexibility, and named patient medicines decommissioned by community or hospital pharmacies.
  • Homecare: As registered pharmacies they will be expected to meet the obligations of suppling medicines to the public rather than coming under the Article 23 flexibility.

 

If there are issues you would like to raise either to do with these groups or others covered under Article 23, please email our mailbox – FMD.safetyfeatures@mhra.gov.uk with the subject field ‘Article 23’.

 

 

New guidance in community pharmacy

New guidance for community pharmacy owners has been issued by the UK FMD Working Group for Community Pharmacy (for further details on the group please see their website). The guidance is intended to build understanding of the options open to pharmacy contractors as the 12-month milestone for implementation approaches.

 

The Way Forward for FMD in community pharmacy covers key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety.

 

The guidance has been published on FMD Source (www.fmdsource.co.uk) and will be updated by the Working Group as new information becomes available.

 

 

SecurMed UK Information

 

We understand that during Q1 2018 SecurMed UK will publish the UK Funding Model, setting out the fee structure and contracting model for Marketing Authorisation Holders. SecurMed UK request all manufacturers and parallel distributors pre-register with SecurMed UK. Please refer to the SecurMed UK website at www.securmed.org.uk for more details on pre-registration information required, the FMD implementation and how to register for the IT System Solution Provider toolkit.

 

For questions to SecurMed please email info@securmed.org.uk Questions relating to FMD process or compliance should be addressed to FMD.safetyfeatures@mhra.gov.uk

 

 

Mailbox

 

MHRA will continue to answer your questions about FMD through our dedicated mailbox, FMD.safetyfeatures@mhra.gov.uk Please send queries to this mailbox rather than other MHRA email addresses.

 

Best regards,

MHRA Safety Features team

 

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK

gov.uk/mhra

Media and Political Bulletin

31 January 2018

Media Summary

Small number of pharmacies diverting prescription medicines to the black market

Pharmacy Business, Neil Trainis, 30 January 2018

 

Pharmacy Business reports on an investigation carried out by the Medicines and Healthcare Regulatory Agency which has uncovered a criminal network involving “a small number” of registered pharmacies and wholesalers who have diverted prescription-only drugs on to the black market.

More than 40 arrests were made following extensive investigations which found that between £115 million and £200 million worth of medicines were channelled to the criminal market from the legitimate supply chain between 2013 and 2016.

Medicines such as Benzodiazepines and anxiolytics including Diazepam and Zopiclone and the painkiller Tramadol were found to have been sold on illegal websites. Indeed, the MHRA said there had been “a significant diversion of benzodiazepines and other hypnotics/anxiolytics” to the black market in 2016.

Alastair Jeffrey, head of enforcement at the MHRA, said: “Selling medicines outside of the regulated supply chain is a serious criminal offence and we are working relentlessly with regulatory and law enforcement colleagues to identify and prosecute all those involved in this activity”.

The results of this investigation by the MHRA were also reported by the National Pharmacy Association and Chemist and Druggist.

 

Parliamentary Coverage

Department of Health and Social Care – Written question: Drugs Licensing, 30 January 2018

 

Alex Sobel: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that licensing for new drugs in the UK is not slowed down by the UK leaving the EU and the European Medicines Agency.

Jackie Doyle-Price: In July last year the Government set out three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the United Kingdom market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.

As the Prime Minister has stated, the UK is fully committed to continuing the close working relationship with our European partners. In this context, the UK will be working with the European Union to agree how best to continue cooperation in the field of medicines regulation, for the benefit of public health and safety in both the UK and the EU Member States.

Department of Health and Social Care – Written question: EMA, 29 January 2018

Virendra Sharma: To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the UK’s withdrawal from the European Medicines Agency on the UK health sector.

 

Full Coverage

Small number of pharmacies diverting prescription medicines to the black market

Pharmacy Business, Neil Trainis, 30 January 2018

 

An investigation by the Medicines and Healthcare Regulatory Agency (MHRA) has uncovered a criminal network involving “a small number” of registered pharmacies and wholesalers who have diverted prescription-only drugs on to the black market.

More than 40 arrests have been made following extensive investigations which found that between £115 million and £200 million worth of medicines were channelled to the criminal market from the legitimate supply chain between 2013 and 2016.

The General Pharmaceutical Council (GPhC) said it had suspended five pharmacists and pledged to work closely with the MHRA.

Medicines such as Benzodiazepines and anxiolytics including Diazepam and Zopiclone and the painkiller Tramadol were found to have been sold on illegal websites. Indeed, the MHRA said there had been “a significant diversion of benzodiazepines and other hypnotics/anxiolytics” to the black market in 2016.

“Criminals are known to exploit vulnerable people by selling medicines through unregulated websites and stealing their credit card details,” said the medicines regulator whose investigation resulted in arrests for possession with intent to supply a controlled drug and offences under the Proceeds of Crime Act.

“Our investigations have revealed an extensive network of criminality involving businesses such as wholesale dealers and a small number of registered pharmacies throughout the UK diverting medicines,” the MHRA added.

There has been no indication that the diversion of medicines to the black market has driven a drugs shortage and the MHRA said “medicines supplied with a prescription, through registered pharmacies, are unaffected.”

However, the revelation that some registered pharmacies across the UK have been involved in the transfer of medicines to the criminal market will be a serious concern for a community pharmacy sector which has worked tirelessly to convince the government of the value it brings to local communities.

The MHRA has consistently warned people against buying medicines from illegal websites and the black market. A recent Home Office study revealed that 7.6% of adults had taken a prescription-only painkiller which had not been prescribed to them.

Duncan Rudkin, the chief executive of the GPhC, said: “We are working closely with the MHRA on the ongoing investigations into these very serious criminal offences. We have already taken action to suspend five pharmacists under interim orders and are actively reviewing at each stage of the investigations whether we need to take further action to protect the public.

“We would also strongly urge people not to take any prescription medicines unless they have a valid prescription as they could be putting their health at serious risk.”

Alastair Jeffrey, head of enforcement at the MHRA, said: “Selling medicines outside of the regulated supply chain is a serious criminal offence and we are working relentlessly with regulatory and law enforcement colleagues to identify and prosecute all those involved in this activity.

“The medicines being sold are potent and should only be taken under medical supervision. Criminals involved are exploiting people when they are at their most vulnerable; their only objective is to make money.

“We will continue to concentrate our efforts on identifying the criminals involved and ensure they are prosecuted through the courts.”

DeHavilland definitive political intelligence

Exiting the European Union Committee – Airbus, FSA, EDF, MHRA – Progress of the UK’s negotiations on EU withdrawal

Analysis

Overview

During a meeting of the Exiting the European Union Committee on the progress of the UK’s negotiations on EU withdrawal, the Committee heard from:

  • Katherine Bennett, Senior Vice President, Airbus UK
  • Rod Ainsworth, Director of Regulatory and Legal Strategy, Food Standards Agency (FSA)
  • Angela Hepworth, Director of Corporate Policy and Regulation, EDF UK
  • Dr Ian Hudson, Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA)

 

Summary

 

Medicines

Opening the session, Labour Committee Chair Hilary Benn noted that some had argued that creating a separate medical and healthcare products regulatory process in the UK posed the risk manufacturers would choose to submit their products for approval elsewhere in the EU.

Replying, Dr Hudson noted that the Government’s intention was to continue collaborating with the European Medicines Agency (EMA). If this proved impossible, contingency work was underway to ensure an appropriate regime to ensure the UK could maintain a “global role” and remain as attractive as possible.

 

Aerospace

Turning to Ms Bennett, Conservative MP Richard Graham noted that the UK was already an independent member of the International Civil Aviation Organization (ICAO), but that the aerospace industry supported remaining in EASA, the European Aviation Safety Industry. He asked how the UK’s relationship with EASA would look in future.

Replying, Ms Bennett said that ICAO was very important as global regulation was “the future”. She said she believed the UK ought to be able to continue its high-profile role in EASA. Airbus wanted it to remain a full member to avoid duplicating regulation and preserve voting rights, she said. She noted that this was a reflection of the interests of the whole sector, rather than those of Airbus itself. She noted that the US and Chinese aviation authorities had an important role in EASA, though they were not full members.

The Department for Transport (DfT) and the Civil Aviation Authority (CAA) had been involved in detailed discussions with the industry about Brexit, she said.

Mr Graham asked about the UK’s continued involvement in the EU’s Global Navigation Satellite System (GNSS) “Galileo” programme. Replying, Ms Bennett said that European Commission officials felt EU-funded work could not continue to take place using EU funds, and had made some individual representations to firms about this. She called on the Government to clarify its intentions.

Asked about what would happen if the UK fell back on WTO rules for trade, she replied that civil aerospace would be tariff free, but non-tariff barriers posed a greater concern. Airbus was considering how it could import and export wings as quickly as possible, given the crucial importance of exports for the company. “We can’t have anything that holds up our production line”, she said.

SNP MP Joanna Cherry asked whether Ms Bennett knew any of the details of the Government’s plans for the UK’s future relationship with EASA. Ms Bennett reiterated that Airbus wanted the UK to be as involved as possible in EASA. She warned about the danger of a loss of influence, noting that Norway and Switzerland were not full members, and lacked voting rights. There was a risk companies could move their certification staff to EU member states, she noted.

When it came to air safety agreements with the USA, she noted the UK could fall back on older accords if needed.

SNP MP Peter Grant asked Ms Bennett about the US Federal Aviation Administration (FAA)’s recent warning that the UK had just a month to clarify post-Brexit aviation safety plans to avoid potential disruption.

Ms Bennett said that as she understood the FAA’s position, it related to concerns that the UK could need to re-establish a system of repair stations if it left EASA, impacting US airlines.

On the significance of EASA for component manufacturers, she explained that it administered certifications. Much of the CAA’s expertise was put to use in EASA, she said, stressing that the regulator could face additional costs as a result of the Brexit transition. She asked whether the Government would provide funding to reflect this.

Asked what would happen if no EASA associate membership were granted, Ms Bennett emphasised that a separate process existed for Switzerland so it could avoid the jurisdiction of the European Court of Justice (ECJ). If all participation in EASA were precluded, this would cause “chaos”, and the CAA would face significant additional costs, she said.

Food Safety

Next, the Chair asked Mr Ainsworth what would be lost by altering the UK’s relationship with the European Food Safety Authority (EFSA).

Mr Ainsworth explained that the UK was involved in setting EFSA’s work programme through its advisory forum, and also noted that EFSA provided the risk assessment function to the FSA. Losing this would mean the FSA had to create the means to do its own risk assessments, he explained, noting that the body was undergoing contingency planning. He added that while EFSA judgements were published, not participating in it would mean not having access to the underlying data.

He noted that the FSA supplied significant scientific expertise to EFSA, and said he would be surprised if this did not continue. Asked if the UK would still have access to the Rapid Alert system, he said it had a limited public-facing dimension, and thus the UK would be made aware of incidents affecting it, but would not be privy to data around other risks elsewhere in the EU. The UK would lose one aspect of its “surveillance jigsaw” relating to risky products, he explained.

He said that the FSA was currently building bilateral relationships with individual bodies in other EU countries which provided information to EFSA. He said that the FSA had told DExEU that reciprocal access to the Rapid Alert system was mutually beneficial.

Conservative MP Peter Bone asked why collaboration should not continue. Mr Ainsworth said he could see no advantage to this. The only reason the UK would not have such access would be as a result of a wider failure to achieve an agreement, he said.

Nuclear

Next, the Chair asked Ms Hepworth if EDF had concerns about the future supply of nuclear fuel.

Replying, Ms Hepworth said this was a major concern arising from the decision to leave EURATOM, as the treaty provided for the movement of nuclear materials, components and information within the EU and with key third countries.

The existing nuclear fleet provided some 20% of UK electricity, and was reliant on EU imports. Thus, alternative arrangements would be needed when the UK left the EU.

Asked if future supply was a concern, she said the Government had given “very strong commitments” in this area, and would be seeking clarity in Brexit negotiations as soon as possible.

Asked who needed to agree to achieve this, Ms Hepworth said that the UK needed to negotiate an agreement with the EU to cover nuclear materials and components. EURATOM already had nuclear cooperation agreements with third countries, she noted. In the short term, transitional arrangements were needed to continue the status quo while a full cooperation agreement was put in place.

Asked about how EDF had approached the issue upon first learning of the Brexit decision, she said the company had made the case that it was best for the UK to remain within EURATOM.

Conservative MP Craig Mackinlay asked how Hungary was able to trade in nuclear materials with Russia. Ms Hepworth said that it was possible a third country could impose different requirements for this type of trade. She explained that fuel supply was determined by reactor type, and the UK’s existing nuclear reactors had established fuel supply routes. While change might be made, it would take years, she said.

Asked if EDF wanted an extended Brexit transition period for nuclear materials, Ms Hepworth said that it was “absolutely critical” to put a safeguards regime in place. She noted that the Office for Nuclear Regulation (ONR) had said a basic safeguards regime meeting international standards could be put in place by March 2019, though EURATOM standards could not be achieved by that point.

She called for a transition period to permit cooperation between the ONR and EURATOM until the new regime were put in place. Ultimately, approval of arrangements would be an issue for the negotiations, she added.

Labour MP Stephen Kinnock asked how long the Japanese and American bilateral agreements with EURATOM had taken to negotiate. Ms Hepworth was unsure, but believed it had taken longer than two years.

Transition Period

Mr Kinnock asked if the transition period would involve a continuation of the functions of EU agencies.

Responding, Mr Ainsworth said he felt the transition period would be of “considerable assistance” to the food industry. The FSA would not expect a significant change in its relationship with EFSA during this period, though its membership of the advisory forum was likely to end.

Ms Bennett mentioned that the European Chemicals Agency (ECHA) and its REACH programme were also of great importance for the aerospace industry, and continued membership would be important over the transition period.

Dr Hudson said that the negotiated outcome of Brexit would determine the significance of ongoing collaboration through the transition period. He did not want the existence of the transition period to delay a more definitive statement on the outcome.

Ms Hepworth said continued involvement with EURATOM through the transition period was important, but some other arrangements were also needed, so the UK could stand on its own feet “come what may” in 2019. Thus, EDF supported measures to create independent nuclear safeguards. Additionally, third party agreements would come out of commission, and thus bilateral agreements were needed with a number of other nations.

She raised concerns about the impact of delays in importing parts for current nuclear facilities or those under construction.

Brexit Impact

Conservative MP John Whittingdale asked whether Brexit uncertainty impacted EDF’s investment plans.

Ms Hepworth explained that trade relationships were essential to ensure access to components, and also expressed concern about access to construction workers. EDF was training and recruiting UK workers, but given the scale of projects like Hinkley Point C, it needed some foreign workers.

Mr Graham asked if Ms Hepworth could imagine a situation in which nuclear safeguarding issues were not resolved, given Franco-British collaboration in the industry. Ms Hepworth said that “assuming economic rationality prevails”, there should be strong incentives on all sides to find a solution.

She pointed to what she said was “full alignment” between the Government and the nuclear industry on what needed to be done, and highlighted progress on the implementation of domestic nuclear safeguarding arrangements.

Liberal Democrat MP Wera Hobhouse asked if the witnesses had assessed the cost of Brexit to their industries.

Replying, Mr Ainsworth said that the FSA had estimated that it would need more than an additional 50 people to deal with Brexit, plus related new staff at other agencies.

Dr Hudson said 90% of medicines on the market in the UK were nationally licensed, and much of the EMA’s work would thus be handled by the MHRA, as was currently mostly the case. Resource needs would depend on the nature of the final Brexit agreement, he said.

He added that new drugs on the UK market would henceforth need to come to the MHRA. He argued that the European Medicines Network had served all involved very well, and the UK had played a major role with significant influence. While collaboration was preferable, the UK had the capacity to meet its own needs, he concluded.

Ms Hepworth said that the ONR was recruiting new inspectors, and the UK would have to negotiate with the EU over whether it would buy EURATOM monitoring equipment currently in use in the UK. There would also be ongoing costs involved in running a nuclear safeguards regime via the ONR.

Media and Political Bulletin

15 December 2017

Media Summary

Drug price manipulations destabilise pharmacy

The Pharmaceutical Journal, 13 December 2017

 

The Pharmaceutical Journal reports on drug shortages and the way in which they are affecting pharmacies. In an editorial piece, the publication highlights that current drug shortages are forcing pharmacists to pay extortionately high prices for generic medicines, while the Department of Health is slow to reimburse contractors, creating financial instability for community pharmacists, and risking empty shelves.

The current difficulties in obtaining hundreds of drugs have resulted in thousands of community pharmacists ending 2017 with the very real prospect of severe financial hardship as they are forced to pay extortionate prices for some of the most common generic medicines, the publications reports.

 

Parliamentary Coverage

House of Commons – Tabled Written question – Department for Exiting the European Union, 14 December 2017

Marsha De Cordova MP: What assessment the Government has made of the effect on the UK economy of the (a) European Medicines Agency and (b) European Banking Authority relocating from London to other EU countries.

 

Existing the European Union Committee – MHRA – Progress of the UK’s negotiations on EU withdrawal, 14 December 2017

Dr. Ian Hudson, Chief Executive of the Medicines and Healthcare Products Regulatory Agency appeared before the committee on Existing the European Union to discuss the progress of the UK’s negotiations on EU withdrawal on 14 December. The full transcript of the session is available to view on the HDA website, to view please click here.

Full Coverage

Drug price manipulations destabilise pharmacy

The Pharmaceutical Journal, 13 December 2017

 

Drug shortages are forcing pharmacists to pay extortionate prices for generic medicines, while the Department of Health is dragging its feet on reimbursing contractors creating financial instability for community pharmacists, and risking empty shelves.

Emerging reports that some smaller pharmaceutical wholesalers and independent pharmacist wholesalers could be manipulating the markets to cause unprecedented drug price rises are deeply concerning.

Difficulties obtaining hundreds of drugs have resulted in thousands of community pharmacists ending 2017 with the very real prospect of severe financial hardship as they are forced to pay extortionate prices for some of the most common generic medicines.

The Pharmaceutical Services Negotiating Committee (PSNC) has reported numerous calls from pharmacists struggling to get hold of medicines. Drugs in short supply include the antipsychotic drug quetiapine, which by October had risen 4,221% above the drug-tariff price from £1.62 to £70.00 for a 60-pack of 100mg tablets; schizophrenia treatment chlorpromazine which had risen by 2,545%, from £1.55 to £39.45 for a 28-pack of 25mg tablets; and the epilepsy drug levetiracetam, which has seen a 1,389% rise from £2.76 to £41.10 per 60-pack of 500mg tablets. There are many more examples.

Various reasons have been put forward for the price rises, including Brexit and supply problems after manufacturing licences were temporarily withdrawn from Indian drugmaker Dr Reddy’s in India and Luton-based pharmaceutical company Bristol Laboratories, following an inspection by the European Medicines Agency (EMA) in August 2017 that found neither company had complied with ‘good manufacturing practices’.

However, several sources, including the Healthcare Distribution Association (HDA), the British Generic Manufacturers Association and large wholesaler Sigma, have told The Pharmaceutical Journal they believe that some of the smaller wholesalers and independent pharmacist wholesalers may have been ordering and stockpiling excessively large quantities of the more common generic medicines, causing shortages and then waiting for concessionary prices to be announced before releasing them into the market at signficantly inflated prices.

 If this is the case, there must be an urgent investigation by the Department of Health to ensure sufficient supply of essential medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for issuing licences to wholesalers, has stated that it would normally only investigate if drugs were being exported abroad leaving a shortage of medicines in the UK. It is the responsibility of the Department of Health (DH) to consider drug shortages generally, and the PSNC’s responsibility to look at prices, they said.

The situation worsened further in November when the PSNC asked the DH for concessionary prices on 97 medicines. But by 5 December, the date community pharmacists were required to submit their prescription bundles, DH had agreed concessionary prices on just 38 of those products.

It is the first time that price concessions have not been settled in the month they were applied for and comes as pharmacists also grapple with financial pressures caused by the funding cuts and changes to reimbursement for category M medicines, used to set the reimbursement prices of more than 300 medicines and the principal price adjustment mechanism to ensure the delivery of the retained margin guaranteed as part of the contractual framework.

At the time of going to press, the PSNC had responded to concessionary prices proposed by DH for a further 52 of the outstanding drugs, but no final decision had been reached.

As a result, thousands of pharmacists have been left having to pay high prices for December supplies at the end of this month while not knowing if they will be fully reimbursed for the drugs they purchased in November. One independent community pharmacy owner in west London told The Pharmaceutical Journal that she had never known such a bad situation in her 30 years of practice.

She said she was so anxious about the impact it was having on her business that she was repeatedly checking the PSNC website for updates, adding that she was currently operating at a loss and would not be able to continue on that basis for much longer.

The overall cost to the NHS is also unsustainable. Researchers from Oxford University’s Evidence-Based Medicine DataLab have reported that the excess cost of concessionary prices is now hitting £50m per month.

Analysis of October’s agreed concessionary prices estimates that an extra £56m was spent on concession-priced drugs in that month, putting the total increase in cost to the NHS from concessionary prices at £233m since April 2017.

If the situation continues in the same vein, and November’s debacle is suggesting it could, the extra £350m promised to the NHS by Chancellor Philip Hammond in the Autumn Budget to help with winter pressures will be wiped out by this alone.

There could be some hope on the horizon if proposed government regulations, which form part of the Health Service Medical Supplies (Costs) Act 2017, requiring manufacturers, importers and wholesalers to provide quarterly information about sales and purchases of generic medicines and special medicinal products, come into force.

The regulations, the subject of consultation between August and November 2017, would enable DH officials to weed out smaller wholesalers who regularly buy large supplies of generic medicines from the larger wholesalers and hold on to them until the price is right.

The DH has acknowledged that the current situation is untenable, saying it recognises that there needs to be a mechanism to ensure contractors are fairly paid when, for whatever reason, there are exceptional increases in the market that are not reflected in the drug tariff.

But until such time as DH holds companies to account, introduces a new payment system or new regulations uncover what is really going on in the market, pharmacists should continue to report shortages and be extra careful about which companies they source their medicines from.

Media and Political Bulletin

20 October 2017

Media Summary

International regulators inspecting in the UK

MHRA Inspectorate Blog, Mark Birse, 19 October 2017

 

This blog post highlights that the MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries. The MHRA reports that in the last few years they have had an increasing number of trade associations and individual companies approach them when the outcome of an inspection in the UK, conducted by an international inspectorate, has differed from the company’s own expectations.

 

From now on, the inspectorate requests that UK companies inform inspectionplanning@mhra.gov.uk if they are hosting an inspection from another medicines regulator.

 

 

Parliamentary Coverage

House of Commons, Medical Equipment, 18 October 2017

 

Tom Brake MP: To ask the Secretary of State for Health, what assessment his Department has made of the potential effect on the supply of medical devices to NHS patients in the event that there is no transitional period prior to the UK leaving the EU during which to implement changes in EU law made before or during such a transitional period.

Department of Health
Philip Dunne, Minister for Health: The Medicines and Healthcare products Regulatory Agency, the Office of Life Sciences, and the Department for Exiting the European Union are leading our work in this area.

Medical devices are important for transforming health outcomes, and our top priority for the Life Sciences sector in the negotiations is to protect the safety of patients and ensure the integrity of cross-European public health systems.

After the European Union referendum, the UK EU Life Sciences Steering Group was established to oversee a programme of work that is informing our departure from the EU. The group’s remit includes people and skills; research and grants; intellectual property; regulation and trade, manufacturing and supply – to organisations including the National Health Service.

Regarding potential transposition of any changes in EU law, the general approach taken in the European Union (Withdrawal) Bill is that EU law which applies directly in the UK legal system immediately before exit will be converted into domestic law after exit. The purpose of the Bill is to provide a functioning statute book on the day we leave the EU, and it is designed to ensure that the United Kingdom exits the EU with certainty, continuity and control. After we leave the EU, Parliament will be free to change the law where it decides it is right to do so.

In the negotiations the Government will discuss with the EU and Member States how best to continue to cooperate. We start from the position of having an aligned regulatory partnership and any changes should consider the impact on patient and public health. However, we appreciate that this is a negotiation, so we are prepared for all eventualities. Whatever the outcome we will protect the best interests of patients and the NHS.

 

House of Lords, Drugs: Manufacturing Industries, 18 October 2017

Lord Laird: To ask Her Majesty’s Government what assessment they have made of the role of manufacturers of medical products in restrictions of supply to pharmacists, and of the relationship of such restrictions to the pricing of those products.

Department of Health

Lord O’Shaughnessy, Parliamentary Under-Secretary for Health: No such assessment has been made. However, the majority of products supplied through restricted wholesale models are branded medicines, for which prices are controlled by the Pharmaceutical Price Regulation Scheme. The Department, Medicines and Healthcare products Regulatory Agency, and pharmaceutical supply chain stakeholders agreed best practice guidelines for dealing with supply and distribution of medicines. These set out that where restricted wholesale models are in place, manufacturers should put contingency arrangements in place so that pharmacies can obtain the product directly from the manufacturer if they cannot get it from their wholesaler.

 

Full Coverage

International regulators inspecting in the UK

MHRA Inspectorate Blog, Mark Birse, 19 October 2017

 

The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.

 

Notifications and observing

 

Whilst it is standard practice for the MHRA to notify national regulators when we perform overseas inspections in their country, the reverse of this is not as robust.  We do get notifications from many of our regulatory partners, but not from all.

 

Often our overseas inspections are observed by the national regulator of the country we are inspecting in and we also on occasion observe inspections that are being undertaken in the UK.  This helps to build confidence in the international regulatory network, in turn facilitating information sharing and more effective use of risk based inspection.

 

Is this an issue?

 

Over the last few years we have had an increasing number of trade associations and individual companies come to us where the outcome of an inspection in the UK, conducted by an international inspectorate, has differed from the company’s own expectations.

 

From discussions internationally the accuracy of registration dossiers and variations is a key component of many of these inspections.

Anecdotally we have heard of instances across the European network where the local regulators presence has been cited as helpful by both parties.

Risk based inspections

 

You’ll be well aware that we have a risk based inspection programme within the Inspectorate and outcomes from these inspections within the UK can also be used to support our inspection frequency

 

Informing MHRA

 

Going forward the MHRA Inspectorate requests that UK companies inform inspectionplanning@mhra.gov.uk if they are hosting an inspection from another medicines regulator.

MEDIA SUMMARY 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

The Pharmaceutical Services Negotiating Committee (PSNC) has told contractors in the NHS to “exert maximum pressure on wholesalers” to drive down the price of pregabalin. This comes after the drug was moved onto Category M on August 1st. Director of Pharmacy Funding for the PSNC, Mike Dent, said that pregabalin met all the criteria for M after the patent expired in July. This means that pharmacies will get reduced funding to buy the drug, but wholesaler prices have not caught up. Dent said “when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.”

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The Royal Pharmaceutical Society has welcomed a recent statement from the General Pharmaceutical Council that outlines more clearly policies concerning conflicts of interest. The RPS agreed that those in the healthcare industry should “refuse all but the most trivial gifts, favours or hospitality”. The statement also includes the following recommendations:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible

The General Pharmaceutical Council said that “as health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care…we are underlining the consistent expectations of health professionals in managing conflicts of interest”.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

The MHRA has released a summary press release covering recent Brexit developments, saying that it is “working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK”. It notes that while negotiations continue, the UK remains a “full member of the EU”. It also notes that is will seek to “maintain a close working partnership” with the EU. The MHRA plans to “continue to cooperate with all involved”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

Contractors struggling to source pregabalin at list price since restrictions placed by NHS England limiting the use of generic pregabalin were lifted have been told by the Pharmaceutical Services Negotiating Committee (PSNC) to “exert maximum pressure on wholesalers” to drive down its price.

In a letter to community pharmacies dated 21 June 2017, NHS England said previous dispensing guidance on pregabalin, which instructed pharmacists to return all prescriptions for generic pregablin for pain to the prescriber, was being withdrawn.

It informed pharmacists that from 17 July 2017 “when dispensing pregabalin for the treatment of any condition, you should dispense in accordance with your normal practice”.

Mike Dent, director of pharmacy funding at PSNC said pregabalin met all the criteria for inclusion in Category M (where the Department of Health calculates the reimbursement price of readily available generic drugs based on information submitted by manufacturers), so it was moved from 1 August 2017, following the patent expiry on 17 July 2017.

But some contractors claim they are now being forced by wholesalers to pay several times more than the drug tariff price for each pack of pregabalin.

Dent said: “The DH sets Category M prices at levels above the prices notified by manufacturers,” he explained. “But when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.

“During this period, it is essential that contractors exert maximum pressure on wholesalers. There have been a number of examples where manufacturers’ prices were below the Drug Tariff price but a product could not be obtained at the Drug Tariff price from a number of wholesalers.”

“We are aware that sometimes Category M medicines are difficult to obtain at the reimbursement set in the Drug Tariff and apply for price concessions as needed.”

The issue arose after a long-running patent dispute by Pfizer against generic drug manufacturers Actavis and Mylan over its product Lyrica. NHS England issued guidance on 2 March 2015 stating that any prescription for generic pregabalin for pain should be returned to the prescriber.

Pfizer developed Lyrica for the treatment of generalised anxiety disorder (GAD) and epilepsy but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could relieve pain, it took out a second medical use patent for Lyrica to cover this use, which expired in July 2017. When the first patent expired, Actavis and Mylan launched generic versions of the drug to treat GAD and epilepsy and the long-running court battle ensued.

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The comment from the RPS came as the General Pharmaceutical Council joined other healthcare regulators in signing a statement setting out how conflicts of interest should be avoided, declared and managed across all healthcare settings.

Among the expectations outlined, the joint statement says healthcare professionals should “refuse all but the most trivial gifts, favours or hospitality” if accepting them could be seen as an attempt to gain preferential treatment or could go against their professional code of practice.

The statement also includes the following expectations of healthcare professionals:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible.

Case studies

The regulators have also published case studies to illustrate these principles. GPhC worked with the General

Medical Council and the Pharmaceutical Society of Northern Ireland to produce a case study scenario involving a private practice GP whose employer has told her to encourage patients to take their prescriptions to a pharmacy it has bought recently. This could also apply to a range of healthcare professionals who may have a direct or indirect financial interest in another business, GPhC says.

GPhC chief executive Duncan Rudkin said: “As health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care, and the trust they place in the professionals who provide that care. By working closely with our fellow regulators, we are underlining the consistent expectations of health professionals in managing conflicts of interest, to help give patients and the public the assurance that their interests will always be put above any other interest a health professional may have.

“The joint statement supports the principles and guidance outlined in our standards for pharmacy professionals, and I hope the statement and case studies will provide helpful insight for our registrants when facing potential conflicts of interest.”

‘If in doubt, find out’

When contacted by P3, the Royal Pharmaceutical Society offered this advice for pharmacists: “There are well known concerns about actual and potential conflicts of interest across the NHS. If you are ever in doubt about whether you should declare a conflict or how to do it, find out. Transparency and openness will enhance the reputation of pharmacy and pharmacists and assure professional integrity and public confidence, while enabling collaborative working and constructive dialogue with suppliers of goods and services to the NHS.”

A professional guide on identifying and appropriately making declarations of interest is available to RPS members.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.

Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.

We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.

Statements are also available from the British Pharmacopoeia and the National Institute for Biological Standards and Controls (NIBSC)

On 4 July the UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.

These principles and the government’s position were developed further in a speech by the Parliamentary Under Secretary of State at the Department of Health, Lord O’Shaughnessy, at the BIA/MHRA conference in London on 14 July.

We are aware of the recent notices to Marketing Authorisation Holders issued by the EMA/EU-27 and CMDh advising of preparations MA holders may want to consider ahead of the UK’s exit from the EU.

Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. We therefore continue to play a full role in the network and to undertake our work as a Reference Member State (RMS) in the decentralised procedure, and as (co-) rapporteur in the centralised procedure. If, however you do want to consider preparation for any potential changes to marketing authorisation or RMS, please see the information provided by the EMA and the HMA.

Whatever the outcome of the negotiation we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.

MEDIA SUMMARY 

NMS could save NHS £500m in the long-term, academics predict
Chemist and Druggist, Annabell Collins, 9 August 2017

Chemist and Druggist, Pharmacy Business (Neil Trainis, 9 August 2017), and Dispensing Doctors (Charles Gladwin, 10 August 2017) further reported on the Manchester University study that showed that the New Medicines Service could save up to £517.6 million. The study showed that the short term savings would be £75.4 million, and overall 179,500 quality of life adjusted years (QALYs) would be gained by the new scheme. The regimen is supported by The Pharmaceutical Services Negotiating Committee (PSNC), who noted that “The New Medicine Service is provided by community pharmacists in pharmacies across the country.” The PSNC fully endorsed continued use of systems like the NMS to help patients, insisting that “it is vital to use community pharmacists to help support GPs”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

 

New Medicines Service saves costs and improves quality of life
Dispensing Doctors Association, Charles Gladwin, 10 August 2017

The New Medicines Service offered as part of the community pharmacy contract in England saved the NHS potentially over £500 million in its first five years.

An economic evaluation of the service, part of the community pharmacy contract in England, indicates that pharmacy interventions to support patients prescribed new medicines improves medicines concordance. This has concomitant quality of life benefits and associated overall cost reductions.

Between its launch in 2011 and the end of August 2016, there have been 3.59 million NMS consultations, with over 820,000 in 2015-16. “From the results of this economic evaluation, this suggests £75.4 million short-term savings to the NHS, £517.6 million long-term cost savings to the NHS and 179,500 QALYs gained,” said the researchers.

The NMS is targeted at specific conditions – asthma/COPD, type 2 diabetes, hypertension or antiplatelet/anticoagulant treatment. Researchers based at Manchester, Nottingham and London Universities “simulated the effect of observed adherence increases on patient outcomes and NHS cost by designing economic models for each drug–disease pair study.”

They concluded: “Our study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost.”

Sue Sharpe, PSNC Chief Executive, commented: “With the current pressures on the NHS it is vital to use community pharmacists to help support GPs and other parts of the health care system, using their expertise in medicines and the relationship they have with their patients.”

At the Royal Pharmaceutical Society, Sandra Gidley, Chair of RPS England, has called for the list of medicines covered by the service to now be extended to cover all long-term conditions including mental health issues.

Previous University of Nottingham research estimated that non-adherence costs NHS England over £930 million per year for five diseases: asthma, type 2 diabetes, high cholesterol/coronary heart disease, hypertension and schizophrenia.

“We’d also like to see more patients referred into the service by primary or secondary care providers to ensure the service is used as widely as possible. All patients prescribed new medication should be encouraged to take part in the New Medicine Service by their prescriber,” said Ms Gidley.

New Medicine Service saves NHS £517.6 million in long term, claims report
Pharmacy Business, Neil Trainis, 9 August 2017

The New Medicine Service (NMS) generates long-term savings of £517.6 million for the NHS and improves patients’ adherence to their medicines by 10% according to a study funded by the Department of Health Policy Research Programme.

The evaluation carried out by the universities of Manchester and Nottingham and University College London examined the impact of non-adherence for medicines treating conditions under the NMS such as hypertension, type 2 diabetes, chronic obstructive pulmonary disease and asthma.

Researchers concluded the NMS “increased patient medicine adherence compared with normal practice which translated into increased health gain at reduced overall cost.” They also found the NMS generates short-term NHS cost savings of £75.4 million.

Over 3.5 million consultations were claimed on the NMS between its introduction to the community pharmacy contractual framework in October 2011 and the end of August 2016. Over 820,000 were claimed in 2015-16.

“This economic evaluation suggests that NMS will deliver better patient outcomes than normal practice at overall reduced costs to the NHS in the long term. In the short term, extra costs incurred by remunerating community pharmacists were absorbed by small reductions in other NHS contact-related costs,” the study said.

Sue Sharpe, chief executive of the PSNC, said: “The New Medicine Service is provided by community pharmacists in pharmacies across the country. Pharmacists recognise that helping patients when they first receive a prescription for a new medicine can be pivotal to ensuring that they get the best possible outcomes.

“With the current pressures on the NHS it is vital to use community pharmacists to help support GPs and other parts of the health care system, using their expertise in medicines and the relationship they have with their patients.

“Many people, particularly as they get older, depend on medicines to keep them well, and we are committed to developing community pharmacy’s support for them.”

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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