HDA UK Media And Political Bulletin – 15 September 2017

STATEMENT: Joint Medical Technology Associations Letter on Brexit

MedTech Europe, the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA), 12 September 2017

 

In a joint letter to Michel Barnier, EU Chief Negotiator and David Davis MP and Secretary of State, the three trade associations representing the medical devices and in vitro diagnostics industry in Europe and the United Kingdom called for sector specific measures during the negotiations to exit the European Union. This letter reiterated the importance of consistent pan-European regulatory agreements to protect European citizen’s public health and ensure the industry continues to thrive.

 

The medtech chiefs plead for a transitional to buy time to implement secondary legislation for medical devices and in vitro diagnostic medical devices and maitain parity with the EU. Other asks include considering actors in the approval chain, including notified bodies and authorized representatives “Europe-based” even if they’re located in the U.K and making British products to part of a new post-market surveillance database.

 

Junior health minister, James O’Shaughnessy told an ABHI gathering Thursday that EU regulations would be transposed in UK law even if there is no deal at the end of the negotiation period. Nonetheless, O’Shaughnessy urged ABHI delegates to lobby their position and help avoid a no deal situation.

 

Parliamentary Coverage

NHS: Procurement, House of Commons Questions, 14 September 2017

 

Justin Madders, MP: What progress he has made on reviewing the operation of the internal market in the NHS.

 

Department of Health

Mr Philip Dunne, MP: The Department regularly considers the operation of the health and care system including the different mechanisms that enable commissioners to secure high-quality, sustainable services for patients. Where improvements can be made to secure greater value for patients and taxpayers, we will work with the National Health Service to ensure they are delivered.

 

Full Coverage

STATEMENT: Joint Medical Technology Associations Letter on Brexit

MedTech Europe, the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA), 12 September 2017

 

Mr. Michel BARNIER
EU Chief Negotiator
Task Force for the Preparation and Conduct of the
Negotiations with the United Kingdom under Article 50 TEU
European Commission
Rue de la Loi/Wetstraat 200
1049 Brussels
Belgium

 

Rt. Hon David DAVIS MP
Secretary of State
Department for Exiting the European Union
9 Downing Street
SW1A 2AG
London
United Kingdom

 

Dear Mr. Barnier and Secretary of State,

 

As the trade associations representing the medical devices and in vitrodiagnostics industry in Europe and the United Kingdom, MedTech Europe, the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA), we would like to highlight the importance of the medical technology industry for public health, and the need for sector specific measures during the ongoing “Brexit” negotiations between the European Union (EU) and the United Kingdom (UK). Such measures will not only ensure that patients continue to receive timely access to life-saving technologies but also ensure the future global competitiveness of an important sector for both the EU and UK economies.

In the UK, the medical technology industry employs around 90,000 people in 2,500 companies. The industry generates a turnover of £17 billion and has seen an 11 per cent employment growth in recent years. Additionally, companies are supported by a service and supply sector of 1000 companies, employing 28,500 people with a turnover of nearly £5 billion.

 

In Europe, the sector employs more than 575,000 people in some 25,000 companies. As in the UK, 95 per cent of these companies are small and medium sized enterprises (SMEs). The industry files a patent every 50 minutes and has an annual turnover of €110 billion, with an average annual growth of 4 per cent over the past six years.

 

Like many sectors, the medical technology industry thrives due to the European Single Market, where both EU and UK citizens benefit from access to innovative medical technologies. A key element of this has been consistent, pan European regulatory arrangements.

 

EU wide Medical Devices and In Vitro Diagnostic Medical Devices legislations, which provide marketing approval via the CE marking process, have played a key role in delivering high-quality care to patients for over 25 years, allowing them timely access to safe and effective medical technologies.

 

The current EU wide system is being updated in stages, and the new Medical Devices and In Vitro Diagnostic Medical Devices Regulations will be applicable to EU members in full in May 2020 and May 2022, respectively. The UK is subject to these updates until it leaves the EU in March 2019. Unchecked, from that date, the UK’s Medical Devices and In Vitro Diagnostic Medical Devices Regulations will become increasingly divergent from the CE marking system. We believe that any such divergence would be unhelpful, and that, whatever other arrangements may be in place, a transitional period to implement secondary legislation for medical devices and in vitro diagnostic medical devices, and maintain parity of regulation with the EU, is needed. Ensuring the complete adoption of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations up until the end of May 2020 and May 2022 will protect the supply of medical technologies to patients throughout the EU and beyond.

 

Collaboration between organisations based in the UK and those in the other Member States, has also played an important role in the development and administration of regulation throughout Europe. The UK’s Competent Authority, the Medicines and Healthcare Products Regulatory Agency (MHRA) enjoys a preeminent position internationally, and with a trend towards global harmonisation, any weakening of existing EU wide networks would leave both parties poorer.

 

Similarly, the sharing of post market surveillance data does much to protect patients and will be negatively impacted if current arrangements were to end.

 

Critical factors to ensure regulatory stability are:

 

  1. The UK to remain an active part of the European regulatory framework (CE marking regime) for medical devices and in vitro diagnostic medical devices under a full implementation of the new Medical Devices and In Vitro Diagnostic Medical Devices Regulations;
  2. The UK Notified Bodies (NBs) to remain European designated NBs;
  3. Legal entities, such as Authorised Representatives or legal manufacturers located in the UK to be considered as “European-based” under the new regulations;
  4. MHRA to participate formally in the European Commission’s new Medical Devices Coordination Group (MDCG);
  5. The UK to continue having full access to – and reliance on – the newly set European Database for Medical Devices (Eudamed): EU-wide pre and post-market data, registration of economic operators, details of clinical investigations, and so forth.

The points above should be included in a comprehensive agreement post-Brexit. Any regulatory divergence will increase both bureaucracy and cost. Creating two distinctive regulatory frameworks would disrupt innovation and growth in the industry, and hinder patient access to medical technologies.

 

To maintain and protect the health of both EU and UK citizens, it will also be important to ensure the movement of goods across borders remains as seamless as possible. Medical technologies are often moved around different jurisdictions during their life cycle. Components sourced from a number of different countries may be assembled in one, moved to another for packaging and sterilisation, and taken to a distribution hub in yet another, before being delivered to their end user. Similarly, finished products are also moved around for cleaning and maintenance.

 

To protect the supply of medical technologies to patients, it will be critical to limit regulatory and administrative barriers for products being moved between the EU and the UK.

 

Indeed, it is non-tariff barriers, such as those resulting from regulatory changes or extensive requirements at customs, that are likely to have a significantly higher impact on businesses and the markets they serve than macroeconomic factors such as currency depreciation. For our sector, the consequences are disruption to the supply of devices and diagnostics critical to the delivery of modern healthcare, the maintenance of patient safety and the preservation of public health throughout Europe.

 

For the reasons outlined above, we believe an appropriate transition period is essential for our sector to be able to implement the necessary measures to ensure the continuity of access to medical technologies in the UK and the EU post-March 2019.

 

We are keen to continue engaging with both the UK and EU authorities to ensure that the medical devices and in vitro diagnostics industry is well-represented and considered in ongoing negotiations. We hope to have the opportunity to meet with you in the near future to further discuss these issues in detail.

 

Yours sincerely,

 

Peter Ellingworth
Chief Executive, ABHI

 

Doris-Ann Williams MBE
Chief Executive, BIVDA

 

Bernasconi
Chief Executive Officer, MedTech Europe

c.c.:

Lord James O’Shaughnessy, Secretary of State, Department of Health, England,
Ms. Elżbieta Bieńkowska, Commissioner Internal Market, Industry, Entrepreneurship and SMEs, Belgium,
Mr. Vytenis AndriukaitisCommissioner Health and Food Safety, Belgium.

Media Summary

Pharmacy bodies launch General Election resources hub
PSNC, 5 May 2017

The national pharmacy bodies have agreed on a collaborative approach to political communications throughout the General Election campaign with the launch of www.pharmacymanifesto.com. The website will host a range of communications resources to help pharmacists engage in the political process such as downloadable General Election leaflets and guidance on arranging candidate visits. Additionally, #pharmacy17 is being used by the pharmacy bodies as a social media tag for general election related matters.

Regulations on medical devices and in-vitro diagnostic medical devices published
GIRP, 5 May 2017

The two European regulations on medical devices and In-vitro diagnostic medical devices have been published in the Official Journal. They will come into force on 20th May 2017. The regulations will apply three years after publication for medical devices and five years after publication for in-vitro diagnostic medical devices. The published texts are available at the following links: Medical Devices and In-Vitro Diagnostic Medical Devices.

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

Pharmacy bodies launch General Election resources hub
PSNC, 5 May 2017

The national pharmacy bodies have agreed a joined up approach to political communications throughout the General Election campaign.

Today they launched www.pharmacymanifesto.com, which hosts a range of communications resources to help pharmacists engage in the political process.

PSNC chief executive, Sue Sharpe, said:

“Last year all those taking part in the campaign for community pharmacy helped to build a huge amount of public and Parliamentary support for the sector. With a general election approaching we now have a chance to build on that success, ensuring that as many Parliamentary Candidates as possible know about community pharmacy teams and the value that they do and could provide.

There remain challenges ahead for community pharmacy and all those working in healthcare, but this election offers us an important opportunity to seek more constructive relationships with the new Government; the earlier we start building those relationships with potential MPs, the better.”

NPA Chair, Ian Strachan, said:

“The general election gives pharmacists a platform to get the message across to politicians that pharmacy is a vital part of the NHS frontline and requires their active and consistent support. We are maintaining a high level of political activity – using the energy and awareness generated during the campaign against pharmacy cuts in England to pursue a positive agenda for the development of the pharmacy sector.”

Margaret MacRury, Chair of the Company Chemists Association said:

“The community pharmacy sector has a lot to offer any incoming Government in terms of value to the NHS, value to local communities and the potential to improve the lives of patients and the public through the support and expertise available within the network. We have worked hard through the ongoing campaign to get the message across, and the general election provides another opportunity to engage positively with prospective candidates about the difference we can make and to build upon in the new Parliament.”

Chair of the RPS English Pharmacy Board, Sandra Gidley, said:

“With only a few short weeks before the general election, and with a range of issues jostling for attention, we are calling on all our members to speak to their future MPs about how patients can benefit from the pharmacist’s expertise in medicines. We will be encouraging candidates from all the parties to read our new general election toolkit, show their support for the pharmacy profession, and visit a local pharmacist to hear first-hand about how they make a real difference to constituents’ health.”

Resources available at www.pharmacymanifesto.com include downloadable General Election leaflets, guidance on arranging candidate visits and key messages to get across to the election candidates and parties.

#pharmacy17 is being used by the pharmacy bodies as a social media tag for general election related matters.

Media Summary

United Kingdom’s withdrawal from the European Union
The European Medicines Agency, 3 May 2017

The European Medicines Agency (EMA) and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines to remind them of their legal obligations in preparation for Brexit. Discussions have been initiated with the national competent authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States. This is currently based on a scenario foreseeing that the UK will no longer participate in the work of EMA and the European medicines regulatory network as of 30th March 2019. The EMA announcement can be found here.

Medical Devices and CE Marking and the Impact of Brexit
Institution of Mechanical Engineers, 3 May 2017

The Institution of Mechanical Engineers have urged British Brexit negotiators to settle parallel policies for device approvals. They also urged the industry and NHS to maintain their influence over EU devices regulations. The report highlights the challenge of extricating the UK from the EU without the Medical Technology industry suffering. Recommendations include negotiating a Med Tech compliancy arrangement with the EU to ensure continuity in the Conformité Européene (CE) marking process for UK manufacturers, and removing the current funding imbalance between early-stage start-ups and large established companies in order to support research and innovation in the UK.

New legislation passed to prevent excessive price hiking of generic drugs
The Pharmaceutical Journal, 3 May 2017

A new law which aims to bring stricter price control to unbranded generic drugs has received Royal Assent in the House of Commons. The Health Service Medical Supplies (Costs) Act gives the UK Government the power to instruct pharmaceutical companies to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics. Manufacturers could face financial penalties if they fail to comply with the new law.

Report illicit drug harms: Pilot reporting site set up in response to soaring illicit drug use
Dispensing Doctor, Alisa Colquhoun, 4 May 2017

Public Health England is piloting a Yellow Card-type scheme for reporting adverse effects associated with illicit drugs. The site enables healthcare professionals to report illicit drug reactions (RIDR) and aims to collect data on the acute and long-term harm to health associated with the use of the drugs and potential interaction with licensed medicines. The reporting site will be available until mid-March 2018. Suspected interactions between licensed medicines and illicit drugs should also be reported via the Yellow Card scheme

Parliamentary Coverage

There is no Parliamentary Coverage.

Full Coverage

United Kingdom’s withdrawal from the European Union
The European Medicines Agency, 3 May 2017

On 29 March 2017, the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU). The implications of Brexit for the European Medicines Agency’s (EMA) location and operations depend on the future relationship between the UK and the EU, which is unknown at present.

No Member State has previously decided to leave the EU, so there is no precedent for this situation.

The Agency is in close contact with the EU institutions and national competent authorities in the EU Member States. EMA will share information on the latest developments with its stakeholders.

EMA’s ongoing mission

The Agency, its 890 employees and all the European experts contributing to EMA’s work will continue to focus on EMA’s mission to protect human and animal health and ensure access to medicines that are safe, effective and of good quality.
EMA’s procedures are not affected by Brexit. The Agency will continue its operations, in accordance with the timelines set by its rules and regulations.

The European medicines regulatory network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardising the quality and effectiveness of its work.

Regulatory preparedness (new)

On 2 May 2017, EMA and the European Commission published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit:

Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use

In April 2017, EMA initiated discussions with the national competent authorities on how work related to the evaluation and monitoring of medicines will be shared between Member States in view of the UK’s withdrawal from the EU.

This is currently based on a scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory network as of 30 March 2019.

Decision on EMA’s location

The location of the Agency after Brexit will depend on the future relationship between the UK and the EU, which is unknown at present. Representatives of the Member States will determine the Agency’s location by common agreement.
EMA welcomes the interest expressed by some Member States in hosting the Agency in future.

EMA is confident that the Member States will make the most appropriate decision on the Agency’s location and arrangements, taking the complex political and legal environment into account.

New legislation passed to prevent excessive price hiking of generic drugs
The Pharmaceutical Journal, 3 May 2017

A new law which aims to bring tougher price control to unbranded generic drugs received Royal Assent in the House of Commons on 27 April 2017.

The Health Service Medical Supplies (Costs) Act gives the government the power to instruct pharmaceutical companies to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics.

Manufacturers could face financial penalties if they fail to comply with the new law.

The government has traditionally relied on the market to keep generic costs down but in cases where there is no competition, prices have been hiked, according to the Department of Health briefing paper on the new legislation.

The intention is for the department to work with industry representatives and the Competition and Markets Authority to determine when a price is “unreasonably high”. The new legislation will also give the government more powers to collect information about the sale of drugs.

The Health Service Medical Supplies (Costs) Act was among a raft of bills which were granted Royal Assent on 27 April, before the dissolution of Parliament on 3 May 2017 ahead of the 8 June 2017 UK general election.

Report illicit drug harms: Pilot reporting site set up in response to soaring illicit drug use
Dispensing Doctor, Alisa Colquhoun, 4 May 2017

Public Health England is piloting a Yellow Card-type scheme for reporting adverse effects associated with legal highs and other illicit drugs.

The site enables healthcare professionals to report illicit drug reactions (RIDR) and aims to collect more detail on the acute and long-term harm to health associated with the use of the drugs and potential interaction with licensed medicines.

NHS Digital reports that hospital admissions for poisoning by illicit drugs are up by more than 50 per cent in a decade. Illicit drug use is said to be particularly prevalent in rural areas.

The reporting site will be available until mid-March 2018.

Suspected interactions between licensed medicines and illicit drugs should also be reported via the Yellow Card scheme.
The website also details where healthcare professionals can find out more information about legal highs.

Media Summary

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

The Council has adopted new EU rules to improve the safety of medical devices. The rules encompass certain products which do not have a specifically medical purpose, such as coloured contact lenses. Accessibility and timeliness are key to these rules, as are follow-up guidelines to improve the availability of clinical data on devices. The European Parliament is expected to adopt the two regulations in April, when they will be published in the Official Journal.

Contractors, stop ‘covering your ears’ on hub-and-spoke

Chemist and Druggist, Annabelle Collins, 7 March 2017

At Numark’s conference in Cape Town, Steve Anderson said that contractors can either position themselves against hub-and-spoke, or they can see it as a way to benefit their business. Highlighting how different the current wholesale model is from previous years, Anderson said that wholesalers need to keep up with digital developments. He also stressed that in order to achieve profitable growth, a different type of collaboration is needed across the sector.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct and HR Healthcare Ltd. Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those it considers as presenting a significant risk to patients.

Parliamentary Coverage

House of Commons, Written Answers, Department of Health

Tuesday 7 March 2017

Kevin Hollinrake (MP):

What steps his Department is taking to regulate the online sale of (a) antibiotics and (b) other medicine.

Nicola Blackwood (MP):

In the United Kingdom, there are legal controls on the retail sale, supply and advertising of medicines which are set out in the Human Medicines Regulations 2012. These apply without distinction to medicines advertised, sold or supplied through the internet.

This means that Prescription Only (POM) and Pharmacy medicines (P) can only be sold or supplied at registered pharmacy premises by, or under the supervision of, a pharmacist. Furthermore, POMs can only be sold or supplied in accordance with a prescription from a doctor, dentist or relevant healthcare professional. POMs cannot be advertised to the general public.

The vast majority of antibiotics are only available as POM for supply only under the supervision of a suitably qualified healthcare professional.

Websites offering to supply POMs without a relevant prescription are in breach of UK legal requirements and the Medicines and Healthcare Products Regulatory Agency will investigate and take appropriate action including criminal investigation and prosecution.

Full Coverage

Safer medical devices: Council adopts new EU rules

European Council, 7 March 2017

On 7 March 2017, the Council adopted new EU rules improving the safety of medical devices for the benefit of patients while preserving a timely access to innovative healthcare solutions.

Medical devices and in vitro diagnostic medical devices help diagnose, prevent and treat or alleviate diseases. They cover a wide range of products, from sticking plasters to hip replacements and hearing aids, and from pregnancy tests to HIV tests.

The new rules keep pace with recent technical developments. Their scope has been extended to cover certain products which do not have a specifically medical purpose, such as coloured contact lenses. The experience of metal-on-metal artificial hips and faulty silicone breast implants also has been taken into account in the preparation of the new rules, in particular by requiring the systematic scrutiny of vital implants by medical experts.

“Medical devices play a crucial role in all our lives. We all regularly use sticking plasters or have dental fillings, and we know people who are still alive thanks to devices that have helped in the diagnosis and treatment of serious diseases. These new rules will do more to help save lives, by having more innovative and safer devices on the market” – Mr Christopher Fearne, Minister for Health of Malta and President of the Council.

The two new EU regulations:

  • provide a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthen the oversight of these bodies by national authorities; the new rules also ensure that notified bodies meet the same high safety standards throughout the EU; these measures will improve the safety of medical devices
  • improve the availability of clinical data on devices and clearly set out manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; this will allow manufacturers to react quickly in the event of concerns being raised and help them improve their devices continuously on the basis of actual data
  • improve the traceability of medical devices throughout the supply chain to the end-user or patient by using a unique identification number; this will allow fast and effective measures to be taken in the event of safety problems
  • set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; this will enable them to make better informed decisions

Next steps

The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.

Web GPs shut down in CQC swoop

Dispensing Doctor, 8 March 2017

Web GPs shut down in CQC swoop.

CQC slams providers where patients self-medicate.

Two online GP and pharmacy providers have shut down following CQC urgent inspections.

The providers are MD Direct (which had traded through the website assetchemist.co.uk and HR Healthcare Ltd (through the website treated.com).

CQC’s inspection of HR Healthcare Ltd was influenced by an investigation by Dr Faye Kirkland for BBC Radio 5 Live Investigates in October 2016, which looked at the online sale of antibiotics from this provider.

Immediately after the inspections, CQC suspended the registration of HR Healthcare Ltd. MD Direct responded to CQC’s concerns by voluntarily cancelling its registration. Both providers have stopped providing services to patients in England (assetchemist.co.uk now uses an alternative online GP provider for its prescription service).

Inspectors found that the two providers demonstrated significant clinical safety and organisational risk to patients, with widespread failings to provide safe care. Among the concerns which were identified:

No (or minimal) identity checks for patients.

No way of identifying whether or not patients lacked capacity to consent or understand their prescribed treatment or medical advice, or if there were any safeguarding concerns (and if they were identified, minimal structures in place to handle them).

No systems or processes to contact the patient’s regular GP, including when medication was prescribed that required monitoring or follow-up

Prescribing practice that did not take account of the patient’s clinical condition or consider differential diagnoses.

Inadequate medical history-taking to inform appropriate prescribing.

No assurances that clinicians had relevant skills or qualifications for the role they were performing.

Following an internal review of all 43 online services that are registered, CQC has brought forward a programme of inspections prioritising those services it considers as potentially presenting a significant risk to patients.

CQC chief inspector of GPs, professor Steve Field said: “We have found websites which in effect allow people to select their own medication, including medicines restricted as prescription only, with little or limited clinical oversight.”

Duncan Rudkin, chief executive of the General Pharmaceutical Council, said: “Where necessary, we are carrying out further inspections of the pharmacies linked to the online primary care services being inspected by the CQC, to assess whether they are meeting our standards and appropriately addressing the issues and risks linked with online prescribing and dispensing.”

Media Summary

Operational Productivity: Hospital Pharmacy and Medicines Optimisation, Stakeholder Update, February 2017

NHS Improvement, 28 February 2017

The Hospital Pharmacy and Medicines Optimisation project (HoPMOp) team is now receiving board-approved HPTP plans from non-acute specialist trusts, hoping that most of these will be submitted by the end of March and reviewed to identify common themes where further support may be beneficial. Other developments include the drafting of an NHS Improvement top ten medicines list, which is likely to be published on the Model Hospital portal during April 2017, and the expansion of the NHS Improvement Getting It Right First Time programme. Recommendations have also arisen from a 2016 audit of discharge summaries. The final report suggests that there are still significant gaps in sharing information and reconciling medicines when a patient is discharged from hospital.

Safety Features Newsletter

MHRA, 28 February 2017

As part of their stakeholder engagement work, the MHRA has set up a dedicated email to receive enquiries about the implementation of the safety features aspect of the Falsified Medicines Directive (FMD). They have also confirmed that the Delegated Regulation does not make any reference to linear barcodes, therefore it is necessary to consider whether customers still require the linear barcodes to manage supply of the medicine within the specific sector of the supply chain. Further to the FMD, a website containing information to help community pharmacists prepare for the introduction of the FMD safety features has been launched.

Proposed regulations on medical Devices and in vitro diagnostic Medical Devices Regulations – updates

GIRP, 28 February 2017

Following the 2016 proposed regulations on the medical device and in vitro diagnostic medical devices, the final version of the two proposed regulations, as approved by the Council of the EU after the first reading on 22 February 2017, have been released. These considered that a fundamental revision of the medical devices directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. The GIRP team will monitor developments.

Parliamentary Coverage

House of Commons, Written Answer, Tuesday 28 February 2017, European Medicines Agency

Stephen Timms, MP:

To ask the Secretary of State for Health, what his Department’s policy is on the UK’s relationship with the European Medicines Agency after the UK leaves the EU.

Answered by Department of Health

David Mowat, MP:

The Government is fully assessing how the United Kingdom’s decision to leave the European Union will impact on medicines regulation in the UK, including the potential relocation of the European Medicines Agency (EMA). Whatever the future relationship between the UK and EMA, the Government will work to ensure that patient access to medicines will not be adversely impacted.

House of Commons, Written Answer. Tuesday 28 February, Patients: Medical Equipment

Oliver Colvile, MP:

To ask the Secretary of State for Health, what advice is given to patients and families of deceased patients who no longer require prescribed medicines, aids and medical equipment.

Answered by Department of Health

David Mowat , MP:

Disposal of waste medicines is an essential service within the community pharmacy contractual framework, to be provided by all community pharmacies in England. NHS England is responsible for commissioning National Health Service pharmaceutical services.

Patients are normally advised to return unused medicines to their local community pharmacy for safe disposal. This is the case also for patients and families of deceased patients who no longer require prescribed medicines.

Appliances are normally collected by community nurses. Occasionally there is a local amnesty with appeals to patients to return equipment, for example crutches and wheelchairs to accident and emergency departments.

Full Coverage

Operational Productivity: Hospital Pharmacy and Medicines Optimisation, Stakeholder Update, February 2017

NHS Improvement, 28 February 2017

This Hospital Pharmacy and Medicines Optimisation project (HoPMOp) stakeholder update provides information and updates for external stakeholders from the team implementing the recommendations of the review of NHS productivity and efficiency by Lord Carter.

HPTP planning process

Board approved HPTP plans are now beginning to arrive back with the HoPMOp team from acute non-specialist trusts. We are hoping that the majority of these will be submitted by the end of March and these will then be reviewed by the team to identify common themes, linked to the Carter recommendations, where further collaboration and support may be beneficial.

HoPMOp programme and team

Andrew Davies, currently Chief Pharmacist at North Bristol NHS trust, will become the professional pharmacy lead for the existing HoPMOp work programme. Seventeen specialist hospital trusts have also been invited to join the Hospital Pharmacy and Medicines Optimisation programme. Initial contact has been made with the trusts concerned who will be invited to send representatives to an orientation event during March 2017.

Top 10 medicines update

The governance processes to support the development and publication of an NHS Improvement top ten medicines list have been drafted and are the subject of a consultation with stakeholders. It is anticipated that this process will be completed imminently with the first “live” list scheduled for publication through the Model Hospital portal during April 2017.

Getting it right first time

The NHS Improvement Getting It Right First Time (GIRFT) programme is being expanded. Having started as a pilot within orthopaedic surgery and then expanded to a further 10 medical specialities, the GIRFT methodology and process has now been extended to a total of more than 30 medical and clinical specialities. The programme is in the process of appointing clinical leads for each speciality.

Job planning and eRostering

We are looking to work with a number of trusts who are already making progress with or thinking about clinical pharmacy job planning, particularly approaches to eRostering.

Regional Medicines Optimisation Committees

The HoPMOp team is working closely with colleagues in NHS England and NHS Clinical Commissioners to support the establishment of regional medicines optimisation committees. There have been four national engagement workshops held during February and work is now underway to formally establish the committees and agree priorities for the work programme. This is likely to focus on key medicines optimisation topics in consultation with NHS stakeholders.

Advice on Advanced Therapy Medicinal Products (ATMPs)

The National Pharmaceutical Quality Assurance Committee and the National Pharmacy Clinical Trials Advisory Group have published a joint document on ATMPs for Chief Pharmacists. Since ATMPs are medicines they are subject to the same requirements as for other medicinal products and the Chief Pharmacist is responsible for their governance and management. A full version of the document will be posted on the Specialist Pharmacy Service website.

CPPE support for hospital pharmacy and medicines optimization

CPPE has recently published a summary of materials and products that support hospital pharmacy and medicines optimisation. The brochure covers wide range of topics such as therapeutics, the Carter Report, leadership and workforce development and also includes links to relevant CPPE learning programmes.

BOPA position statement and guidance on biosimilars

The British Oncology Pharmacy Association (BOPA) has issued a position statement on the implementation of biosimilar monoclonal antibodies alongside a comprehensive guide on the important role that pharmacy plays in implementation.

Cost savings calculator

UKMI has updated its cost-savings calculator for use as a tool when setting local drugs budgets. Based on Microsoft Excel, the worksheets provide summaries of already-released and pending NICE technology appraisals and interventions. The tool is intended to be used alongside Prescribing Outlook – National Developments.

Medicines reconciliation

In 2016, the medicines use and safety team from the Specialist Pharmacy Service undertook a collaborative audit of over 1,400 discharge summaries (over 10,000 medicines) to assess the quality of medicines information provided. The final report suggests that there are still significant gaps in sharing information and reconciling medicines when a patient is discharged from hospital.  For example, less than 12% of summaries included an indication for the medicine prescribed and only three-quarters correctly documented allergy status. The reports makes a number of recommendations for hospital pharmacists.

Sourcing ready-made chemotherapy

This guide published by the NHS Pharmaceutical Quality Assurance Committee and BOPA is available to registered users. It contains useful information on dose-banding as well as guidance on the sourcing of ready-to-administer doses.

Antifungal stewardship

Antifungals are essential in modern healthcare due to the increased incidence of invasive fungal infections linked to immunosuppression and the widespread use of invasive devices. Despite their costs, the quality of antifungal prescribing is poor leading to unnecessary usage, the wrong choice of antifungal and suboptimal duration of treatment. NHS Improvement is working with colleagues in Public Health England to consider an appropriate metric for future inclusion in the Model Hospital dashboard.

 

Safety Features Newsletter

MHRA, 28 February 2017

New Mailbox for FMD enquiries

As part of our stakeholder engagement work we have set up a dedicated email mailbox to receive enquiries about the implementation of the safety features aspect of the Falsified Medicines Directive.  The mailbox is monitored daily and you can expect to receive a response within 5 working days.   Please contact us at FMD.safetyfeatures@mhra.gsi.gov.uk

Linear barcodes – can they remain

We have been asked whether the current linear EAN barcodes which are present on most packs can remain or have to be removed under the new requirements.  The Delegated Regulation does not make any reference to linear barcodes.  You will need to consider whether your customers still require the linear barcodes to manage supply of the medicine within their sector of the supply chain.   When you submit your notification to advise us that you will be adding the 2D data matrix code to your pack we will not expect you to remove the linear barcode at that time.  It may be that in the future the linear code will become redundant and you will want to remove it.  That can be done at any suitable regulatory intervention.   The regulatory guidance on how to submit updates to marketing authorisations impacted by the FMD safety features can be found here.

Community pharmacy resources

A website containing information to help community pharmacists prepare for the introduction of the FMD safety features.  It has been launched by the UK FMD working group for community pharmacy which includes representatives of the all the main bodies in community pharmacy.   This link will take you to the website.

Difference between decommissioning and verification

Verification can take at any time during the movement of the medicine through the supply chain.  It is a check of the repository (IT database) that the product is authentic and originates from a legitimate manufacturer.  Decommissioning takes places at the end of the supply chain when the product is being supplied to the patient and closes the unique identifier in the repository – so that any other pack bearing the same unique identifier cannot successfully be verified/or decommissioned.

SecurMed UK is pleased to announce the appointment of Jerome Bertin as SecurMed UK General Manager from 01 January 2017. SecurMed UK is the UK Medicines Verification Organisation, a not-for-profit organisation which will deliver the UK Medicines Verification System.

Media Summary

Margins Bill costs tackled in the Lords 
Dispensing Doctor, Alisa Colquhoun, 12 January 2017

Former pharmacy minister Lord Hunt of Kings Heath has voiced concern at the cost burden for dispensers of the so-called ‘Big Brother margins’ Bill. In a heated debate at the House of Lords, Lord Hunt stated that the costs of implementing the Bill in the workplace – for dispensers, wholesalers and manufacturers – had not yet been quantified. Under-secretary of state for health Lord Prior of Brampton said that the Health Service Medical Supplies (Costs) Bill would “clarify and modernise provisions to control the cost of health service medicines and to ensure that necessary sales and purchase information can be appropriately collected and disclosed”.

Hunt denies community pharmacy funding cuts will deepen NHS crisis
The Pharmaceutical Journal, 11 January 2017

Health secretary Jeremy Hunt refuted speculation that the Government’s decision to cut the community pharmacy budget in England will worsen the NHS crisis. Hunt said that the pharmacy sector would have to endure its share of cuts in line with the drive for efficiency savings.
EU to adopt medical devices Regulations in May
Chemical Watch, Luke Buxton, 11 January 2017

The European Commission has announced plans to adopt Regulations on medical devices and in vitro diagnostic medical devices (IVDs) by the end of May. These moves have already been endorsed by the Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (Envi). Within a year of the Regulation’s entering into force, the Commission will put forward mandates to regulate the preparation of guidelines.

 

Parliamentary Coverage

Pharmacies and Integrated Healthcare: England 
House of Commons, Debates, 11 January 2017

Mrs Anne Main (St Albans) (Con)

[…] We need to come up with a seamless, flexible model that makes the best use of precious resources and benefits patients. It is therefore timely to explore in this debate the role that local pharmacies play in local health services and the potential role that they might play to ease the strain on more congested frontline services. I also want to make the Government aware of the continuing importance of pharmacies in communities and their potential to do so much more.

In an ever-changing world, we have a duty continuously to challenge the old models of health delivery systems. In October, the Government proposed to reallocate money towards NHS frontline services. We all accept that the NHS is labouring under huge financial pressures, so any areas in which precious resources are dissipated due to inefficiencies or duplications ought to be considered. It is important to integrate community pharmacies into the NHS urgent care system and GP services. We need to promote a pharmacy-first culture for minor ailments to take pressure off frontline services.

Community pharmacies currently see some 1.6 million people a day in the UK. It is worth noting that the recent standard patient experience report for the East of England Ambulance Service NHS Trust in 2016 showed that 0% of respondents in my county of Hertfordshire had contacted a walk-in service, an out-of-hours GP service or a pharmacy service before contacting the ambulance service. I think we can agree that a lot more can be done to take the pressure off emergency frontline services […].

A full transcript can be found here.

Full Coverage

EU to adopt medical devices Regulations in May

Chemical Watch, Luke Buxton, 11 January 2017

The European Commission has said it expects to adopt Regulations on medical devices and on in vitro diagnostic medical devices (IVDs), by the end of May.

The Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (Envi) endorsed the texts in June last year. They will replace existing Directives and their provisions will apply three years after publication for medical devices, and five years for IVDs.

The endorsed text for the medical devices Regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in devices

that:

  • are invasive and come into direct contact with the body; or
  • (re)administer, transport or store medicines, body liquids or other substances, including gases, to/from the body.

Devices would only be permitted to contain such substances at a level above this limit if a justification is provided.

Within a year of the Regulation’s entry into force, the Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a benefit-risk assessment of their presence, as they are CMRs or EDCs. And such assessments would have to be updated within five years.

The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.
The Regulations include labelling provisions. A label on the device and the packaging would have to say if the devices, their parts or materials contain a CMR or EDC above the concentration limit. And a list of such substances must be included.

The Commission released a timetable, at a steering committee meeting of the European database for medical devices (Eudamed), on 14 December.
The timetable is as follows:

  • 18-19 January: experts meet to approve final text in English after lawyer-linguists (LL) verification;
  • mid-February: completion of translation of other languages; text distributed;
  • 1 March: Coreper expected to endorse texts;
  • 6 or 7 March: Council expected to give endorsement;
  • 16 March: announcement in Council plenary; first reading position and transmission to Envi;
  • 20-21 March: announcement in Envi and vote;
  • 3-6 April: plenary vote and signature expected; and
  • May: entry into force.

The Regulations will be published in the Official Journal shortly after adoption and enter into force on the 20th day after this.

Hunt denies community pharmacy funding cuts will deepen NHS crisis
The Pharmaceutical Journal, 11 January 2017
Health secretary Jeremy Hunt has denied that the government’s decision to cut the community pharmacy budget in England will deepen the current NHS crisis.
During a debate on mental health and NHS performance in the House of Commons on 9 January 2017, Hunt told MPs that the pharmacy sector had to face its share of the cuts and contribute to efficiency savings.
He also argued that it “did not make sense” for the NHS to continue to subsidise pharmacies that were “[geographically] very close to other pharmacies”, stating that 40% of pharmacies were “clustered in groups of three or more”. “Our reforms are designed to ensure, however, that where there is only one local pharmacy that people can access, that pharmacy is protected,” he said.
Hunt was responding to a question by Michael Dugher, Labour MP for Barnsley East, who asked: “Given the evidence that one in five people who would usually see a pharmacist for medical advice say that they will make a GP appointment if their local pharmacist is closed… and with the risk that many of those people in desperation will turn up at the local hospital, [is] the government in danger of making an appalling crisis in the NHS even worse?”
Earlier in the debate, Philippa Whitford, Scottish National Party MP for Central Ayrshire, said 93.5% of patients at A&E departments in Scotland were seen within four hours during Christmas week compared with between 50% and 60% of patients in England.
“That difference is down to how it [the NHS] is organised,” she said. “It is the fragmentation and the lack of integration. There are things that can be done. We can use community pharmacies and GPs, and try to bring the NHS back together.”
Hunt admitted Scotland “has gone further than England in the use of community pharmacy, which is to be commended” but said that England has gone further than Scotland in its plans to “reform and increase investment” in general practice.

Margins Bill costs tackled in the Lords 
Dispensing Doctor, Alisa Colquhoun, 12 January 2017
Former pharmacy minister Lord Hunt of Kings Heath has raised the cost implications for dispensers of the so-called ‘Big Brother margins’ Bill in an hour-long debate in the House of Lords.
During its second reading, Lord Hunt told the Lords that the costs of implementing the Bill in the workplace, for dispensers,wholesalers and manufacturers had not yet been quantified.
Given that the Government has a policy in relation to reducing the regulatory burden on industry, he said: “It is very difficult to understand why the department has gone for such a broad-based power. I will certainly be interested in seeing … focus on the information that the Government can prove they actually need.”
Moving the debate to its second reading in the Lords, under-secretary of state for health Lord Prior of Brampton said that the Health Service Medical Supplies (Costs) Bill would “clarify and modernise provisions to control the cost of health service medicines and to ensure that necessary sales and purchase information can be appropriately collected and disclosed.”
This would allow Government to control the cost of excessively priced unbranded generic medicines and provide comprehensive and accurate data with which to reimburse dispensers, including GP dispensers. “Taken together, these measures will secure better value for money for the NHS from its spend on medicines,” he explained.
Former health secretary Lord Lansley told the Lords that the pharmacy sector has a history of “significantly exceeding” planned margin retention, because of a lack of good information.
“An important purpose of the Bill is to get the margin survey right and … to make the reimbursement price deliver the agreed gross margin as part of the global sum to pharmacies,” he said.

Introduction of Office Based Risk Assessments for pharmacy collection sites

17 November 2016, MHRA, Diane Leakey

 

Due to the rising volume of applications for Wholesale Dealer’s Authorisations (WDA), the Good Distribution Practice (GDP) inspectors have been developing a model for Office Based Risk Assessment (OBRA). OBRA will allow inspectors to remotely assess applications for WDA’s instead of conducting traditional site visits. The OBRA model was officially launched at the beginning of 2016 and has been used for the review of pharmacy collection sites. The new approach allows inspectors to prioritise their physical site visits on higher risk organisations and reduce inspection costs, protecting public health by effectively maintaining regulatory standards.

 

MHRA leading European action to reinforce market surveillance of medical devices to protect public health

17 November 2016, MHRA

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched the Joint Action on Market Surveillance of Medical Devices. The project aims to improve the market surveillance system for medical devices and improve the coordination and communication between the member states of the European Union. John Wilkinson, MHRA’s Director of Medical Devices, said that the MHRA is pleased to be leading the new initiative and are looking forward to collaborating with colleagues across the EU to reinforce market surveillance of medical devices.

 

Parliamentary Coverage

There is no Parliamentary coverage today.

Full Coverage

Introduction of Office Based Risk Assessments for pharmacy collection sites

17 November 2016, MHRA, Diane Leakey

 

Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.

 

Over recent years the volume of applicants for WDA’s has increased significantly which has necessitated the introduction of risk based systems to ensure GDP Inspectorate resources are used to maximum effect.

 

As part of this project, work began last year on developing a model for Office Based Risk Assessment (OBRA); this was intended to allow inspectors to remotely assess applications for and variations to WDA’s.  Having been worked up and validated the model was introduced and is now being used for pharmacy collection sites.

 

Launch of the scheme

 

The scheme was officially launched in at the start of 2016 and is now fully bedded in.  In the first six months over 200 sites were assessed, covering nine companies. Had these assessments been undertaken in the ‘conventional’ way they would have required nearly 200 GDP inspector days on site.  Additionally, by assessing applications in this way the regulatory costs to applicants have been significantly reduced.

 

Site selection process

 

Assessments are initially being carried out on retail pharmacy sites that undertake the ordering and collection of medicines which are sent onto a central hub within the same organisation for onward supply to another wholesaler. In this model stock is ordered from a small number of wholesalers in excess of the pharmacy need, holding these products for a short while on the pharmacy premises and then selling on. The intention is not to use this type of assessment process to replace an actual inspection but to more adequately assess and understand the risks associated with pharmacy wholesaling sites of this type. The following criteria are used to judge suitable sites for inclusion in the programme:

 

  • The site is undertaking limited activity: its purpose is the procurement of stock, with the stock being transferred to the company’s warehouse or head office and not directly to another customer outside the company’s ownership

 

  • The company is known to have a good level of compliance with no major deficiencies in the last inspection cycle

 

  • The company uses a common Quality Management System across the group and this has been assessed at inspection at the head office or central warehouse site which continues to be inspected on a normal risk based frequency.

 

  • A GDP certificate for the site is not required – the lack of a GDP certificate does not prevent the wholesaler from trading at this site as the site is supplying the hub only

 

Assessment

 

Assessment is based on three inputs, the company’s answers to questions about the size and value of its wholesaling business, the quality of the company’s procedures together with the control and conditions of the site’s holding areas. An overall risk score is derived from these scores and the next risk review assessment set, based on the risk rating achieved.

 

Outcomes and benefits to both stakeholders and the MHRA

 

This new approach helps Inspectors focus their physical site visits on higher risk activities and operations, increase coverage of the inspection universe and helps to increase trust with stakeholders whilst at the same time reducing their inspection costs. It therefore clearly demonstrates how the Inspectorate continues to find innovative ways to address challenges and thereby continue to protect public health by effectively maintaining regulatory standards.

 

MHRA leading European action to reinforce market surveillance of medical devices to protect public health

17 November 2016, MHRA

 

The Medicines and Healthcare products Regulatory Agency (MHRA) has officially launched the Joint Action on Market Surveillance of Medical Devices.

 

Medical devices cover a wide range of products – from sticking plasters to hip replacements, from contact lenses to personal oxygen tanks and implanted pacemakers. These devices and others like them, can be found in every household across Europe, once they have been CE marked.

 

To make sure devices like these are acceptably safe and perform as intended, Competent Authorities need to have a strong programme of market surveillance.

 

On 19 October 2016, at the 39th meeting of the Competent Authorities for Medical Devices in Bratislava, Slovakia, MHRA officially launched the Joint Action on Market Surveillance of Medical Devices.

 

The project aims to reinforce the market surveillance system for medical devices by improving the coordination of activities by all member states of the European Union, and ensuring adequate communications and cooperation. These are crucial for success and effectiveness of the market surveillance in the field of medical devices.

 

The Joint Action supports the Consumers, Health, Agriculture and Food Executive Agency’s (Chafea) programme of community action in the field of health to deliver against one of its objectives: to contribute to innovative, efficient and sustainable health systems.

 

Chafea is entrusted by the European Commission to implement the health programme and EU Members States involved in the programme – in January 2016.

 

John Wilkinson, MHRA’s Director of Medical Devices, said:

 

We are pleased to be leading this important activity and look forward to working with our colleagues across the EU in delivering improvements to reinforce market surveillance.

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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