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ABPI briefing on the Falsified Medicines Directive (FMD) OCT 2016

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This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx

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ABPI briefing on the Falsified Medicines Directive (FMD) OCT 2016

  1. 1. ABPI Briefing Falsified Medicines Directive October 2016 1
  2. 2. Today’s Agenda • 11.00am Welcome • 11.05am FMD – UK Update • 11.30am FMD – View from the MHRA • 12.30pm FMD – EU Update • 1.00pm Close 2
  3. 3. What are falsified medicines? • Growing threat to public health and safety in Europe • Involving nearly 2500 cases , EU Customs seized 27.4 million doses of falsified medicines at EU borders in 2011- an almost seven-fold increase from 2007 • MHRA seized £8.6m and discovered fraudsters are infiltrating the NHS drugs supply chain and diverting medicines to street drug dealers and illegal websites – May 2014 • Falsified medicines may: • Contain low quality ingredients or the wrong doses • Have their identity or source deliberately mislabelled • Have fake packaging or the wrong ingredients 3
  4. 4. Falsified Medicines Directive (FMD) 20011/62/EU 4 • Directive published 1 July 2011 • Entered into force 1 January 2013 • Contains measures to increase security of the medicinal supply chain in Europe 1. Strengthen Good Manufacturing and Good Distribution Practices including the sourcing of active ingredients 2. Improve supervision of actors in the distribution chain (e.g. wholesalers, parallel distributors and internet sales) 3. Ensure product integrity and authentication of medicines (safety features and product serialisation)
  5. 5. Delegated Regulation to the FMD 5 • Adopted on 2nd October 2015 • Published on 9th February 2016 • Enacting terms: Safety Features 1. Characteristics and technical specifications of the unique identifier 2. Modalities for the verification of the safety features 3. Establishment, management and accessibility of the repository systems 4. List of RX medicines exempted from carrying the safety features 5. Notification procedure for exceptions by Member States 6. Procedure for rapid assessment of notifications
  6. 6. Requirements for safety features Code (‘safety feature’) + Tamper evidence  Unique identifier  Data-Matrix Code  Randomised serial number Product #: 09876543210982 Batch: A1C2E3G4I5 Expiry: 140531 S/N: 12345AZRQF1234567890
  7. 7. ImplementationRequired in Member States 3 years after publication Objective: Protection of patients from falsified medicines in the legal distribution chain Content: Pan-European system to verify the authenticity of medicinal products 2011 2018 (2015+3) Complete Implementation 9 February 2016 Publication of Delegated Regulation July 2011 Publication of FMD 36 Mon. 20192016 Non-compliance puts supply and sales at risk 2013 Jan 2013 FMD except Safety Features implemented *Italy, Belgium, Greece have 6 years longer for implementation
  8. 8. Costs are incurred by all stakeholders • Each stakeholder pays for costs of own installations • Manufacturers pay for cost of verification system Manufacturers and Marketing Authorisation Holders Manufacturers and Marketing Authorisation Holders – contact EMVO to sign up for European Hub testing Dispensing & Verification Entities e.g. Pharmacies and Wholesalers Installation for pack codingVerification system (Hub & national systems) Installations for pack verification Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor European Hub
  9. 9. European Principle Stakeholders developed a European Stakeholder Model 9
  10. 10. Common Basic Concept: Point of Dispense Verification Required by Delegated Acts 10
  11. 11. Pan-European architecture: The “National Blueprint System“ approach National System Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor National System National System European Hub National System National System National System National Blueprint System National Blueprint System National Blueprint System National Blueprint System 11
  12. 12. The UK Stakeholders 2012-2015 • Meeting regularly since 2012, with ABPI, BAEPD, BAPW, NPA, PSNI, RPS, • Co-operation and consensus vital – Supporting European Stakeholder Model • Keeping stakeholders informed: – Associations’ own members – The Competent Authorities – Reaching out to other parts of the medicines supply chain – Joint seminars – EMVO documentation was important • BGMA joins UK ESM – 2015 • RPS/PSNI drop off
  13. 13. UK Principle Stakeholders System set up and governed by stakeholders under supervision of national competent authorities
  14. 14. Development of UK Partners • Adoption of Interim UK Memorandum of Understanding (MOU) and then more formal Framework MoU • ‘Observer group’ formed including: – DH/MHRA – RPS, DDA, – Guild Hospital Pharmacists • Full engagement with Competent Authorities – MHRA letters to all MAHs and WDA holders – Nov 2015 and June 2016 – Membership of DH/MHRA FMD Implementation Board & associated workstreams – MHRA Impact Assessment work - manufacturers site visits
  15. 15. Where Are We Now? • BREXIT • Formal Consultation with wider stakeholders - Summer – MoU and URS lite • Incorporation of UKMVO – SecurMed UK - Summer – Articles/Statutes – 5 Directors (1 Director per Constituency) – voting and Annual Constituency Fee agreed – Officials rotate every 6 months – secretariat in place – 6 Full members – MHRA/DH in attendance at Board meetings
  16. 16. Where Are We Now? • Selection of BSP – Autumn – ‘Request for Proposal’ issued to 3 BSP’s – Proposals and Pitches to every Constituency – August – Additional clarification – BSP’s advised of next steps – end of September • Open formal negotiations with 2 ‘preferred providers’ • Recruit General Manager - Autumn – Job Description – end of September • ABPI Briefing – MHRA and EMVO input – 19th October
  17. 17. Who will have to pay ? Pharmacists, wholesalers, … Installations for pack verification Marketing Authorisation Holders Installations for pack coding Marketing Authorisation Holders Repository system (Hub & national systems) Pharmacy Wholesaler Pharmaceutical Manufacturer Parallel Distributor European Hub MAHs selling products in a Member State pay for respective national system and a share of the European Hub 17
  18. 18. Mechanisms for system funding in different phases 2014 2015 2016 2017 2018 Design and Development Phase (funding: EFPIA/ABPI) Ramp Up Phase (funding: loans from member companies at National and EU) Full Operation Phase (funding: all MAHs via NMVO’s) 2019 2020
  19. 19. Phased-in: 3 phases • Start-up phase: – Financed by EFPIA/ABPI • Ramp-up phase: Total Europe wide Costs - €90Million – Period of connecting companies and national / regional repository systems with the EU-hub up to almost complete level of participants – Expected to start early-2016 and last until end-2018 (based on provisions of the FMD coming into effect February 2019) – Monies collected at both EU and National level – Loans not Levies! • Full operations phase: Total Europe wide Costs - €90Million/Annum – Period after the ramp-up phase is finished. – Post February 2019 – Monies collected via NMVO’s – Flat rate per Marketing Authorisation Holder 19
  20. 20. National Ramp-Up Costings National system cost estimateSep 2015 20 System cost x k€ IT service providers’ proposals NMVO cost x k€ Set-Up, Pilot and Admin/Governance Costs Total: x k€ Loan per Company: x k€ Loan Model
  21. 21. National Full Operation Costings National system cost estimateSep 2015 21 System cost x k€ Average of IT service providers’ offers Pre-negotiated offers vary between average +/- 50% NMVO cost x k€ As per system size Hub cost x k€ Share: x % (Approx double during first 3 years to pay off loans) Total: x k€ Annual fee per MAH: x k€ Flat fee model
  22. 22. Cost allocation: The Flat fee model • The flat fee is transparent, non-discriminatory and proportionate in relation to the services received. • Practicality • Easy way of calculating: equal division amongst MAHs and PD • Fairness • Takes into account market activity: companies with multiple MAHs pay more • Transparency • Simple accountancy / audit • Predictability • Calculations based on number of active participants in the market the year before the fee adjustment • Balanced • A larger company often hold multiple MAH’s so will pay multiple ‘flat fees’ • Upfront payment • In order to prevent free-riders, easy calculation gives opportunity to pay upfront
  23. 23. SecurMed UK Organisational Structure • General Manager – Leads and manages the project at SecurMed UK – SecurMed UK Finance and resource provision • System Manager – Technical understanding of national processes and systems, including PMR, hospital and wholesaler IT systems and others when Article 23 flexibilities agreed. • Stakeholder Manager – Organise communication including marketing activities – Coordinate rollout validation, registration and certification (on-boarding) of system users, including CRM (database) management • Quality Manager – Develop KPI’s, reports and audits – Investigation of Exceptional Events/Alerts – Lead for engagement with MHRA/GPhC and others re system user identification and pre on-boarding validation • Board Secretariat/Administration – Secretarial support for Board and Management Meetings
  24. 24. Progress across Europe • 6 NMVO’s Founded • 3 Selections announced (Finland, Norway and Sweden) • 2/3 Countries behind schedule • 9 Countries not yet engaged with BPS’s • Several countries without stakeholder alignment (pharmacy and wholesalers) • 37 companies started on-boarding to EU Hub • 8 fully connected to EU Hub
  25. 25. 26 Falsified Medicines Directive - ‘Safety Features’ ABPI presentation – 19 October 2016 Jan MacDonald
  26. 26. 27 Overview of progress • Implementation Advisory Board (IAB) and Working Groups: – IAB meets on a quarterly basis with representatives from across the UK supply chain. It’s role is to provide recommendations. – Working groups: Seven working groups have met (including Community Pharmacy & Wholesales). We are now seeking to join meetings to continue to capture the views of stakeholders. • European Commission: – Continuing our engagement with the Commission through attendance at expert group meetings. – Commission aim to create working groups on four areas: (1) supervision, (2) access to information/data in the repository, (3) data traceability and (4) best practice. UK plan to participate. • SecurMed: – Continuing to work with the SecurMed in our supervisory role.
  27. 27. 28 Impact Assessment As a part transposition we assess the impact of the directive on the UK. This “impact assessment” will consider both the costs and benefits of the Safety Features policy. The impact assessment will be published in two parts: • Consultation impact assessment: This will be published with evidence gaps showing our initial analysis on the impact of the proposal on the UK, and our decisions on any flexibilities we have under the act. At this point the public has the opportunity to write in and formally provide evidence and opinions on our assessment of the impact and the policy decisions we are proposing. • Final impact assessment: This will take account of the evidence provided during the consultation, and assess the impact of the final policy decision. We are currently in the process of visiting businesses impacted by Safety Features. Enter the presentation's title using the menu option View > Header and Footer
  28. 28. 29 Timelines – key dates: • Developing initial UK position on flexibilities + legal changes on enforcement: February-December 2016 • Developing initial impact assessment : February-December 2016 • Public consultation (12 weeks): Proposed early 2017 • Review of consultation – amendments: Proposed Q2 and Q3 2017
  29. 29. 30 Safety Features Introduced to enable manufacturers, wholesale distributors and those who supply to patients: • to verify the authenticity of the medicinal product, • to identify individual packs, • to verify, by means of a device, whether the outer packaging has been tampered with • Published February 2016 • UK has 3 years to implement Delegated Regulation – Safety Features
  30. 30. 31 • 2D bar code with a unique identifier • Tamper evident packaging • Affects all prescription medicines (unless exempted) POM • No P or GSL products impacted (unless an issue of falsification has been notified) P & GSL X Delegated Regulation – Safety Features
  31. 31. 32 Delegated Regulation – Safety Features
  32. 32. 33 Tamper Evidence • Medicines required to include the safety features need to include anti-tampering devices • CEN standard already approved “Tamper verification features for medicinal product packaging – EN 16679:2014” • Choice will be for the MAH/manufacturer to determine Delegated Regulation – Safety Features
  33. 33. 34 Delegated Regulation – Safety Features
  34. 34. 35 Chapter 2 – Unique Identifier • Technical specifications of the UI – Sequence of alpha-numeric or numeric characters given to individual pack – Code allowing identification of the name, common name, pharmaceutical form and strength as a minimum – Reimbursement information if required by MS – Batch number – Expiry date • 2D data matrix carrier • Human readable format in addition • No other codes may be displayed Delegated Regulation – Safety Features
  35. 35. 36 Delegated Regulation – Safety Features
  36. 36. 37 EU-wide implementation plan • Anti-Tampering Device • Does not impact the PI templates • If placed on immediate packaging may impact the dossier 1. New MAs – may need to include information ins section 3.2.P.2.4 and/or 3.2.P.7 of NTA Vol. 2B – Information required by day 180 2. Existing MAs – Will need to update dossier – Section B.II.e. of the Variation Guidelines applies • Compliance by February 2019
  37. 37. 38 EU-wide implementation plan • Unique Identifier: • Must be included in the product information annexes and associated artwork • QRD template – new sections 17 and 18 in Annex IIIA 1. New MAs must comply at the time of authorisation 2. Existing MAs – Utilise the next regulatory intervention impacting the packaging – If no suitable intervention notify NCA under article 61(3) of Council Directive 2001/83/EC Compliance by February 2019
  38. 38. 39 Chapter 3 – Verification • General provisions on the verification of the safety features – Check the UI against the numbers held in the repository – Ensure the tamper-evident feature is intact • At the point of supply UI will be “checked-out” of the repository • UI can be checked back into the repository in certain circumstances Enter the presentation's title using the menu option View > Header and Footer
  39. 39. 40 Chapter 4 – Manufacturers • Impact on manufacturers – Must verify the UI – Keep records – If repacking must verify and replace UI and safety features – Safety features are deemed equivalent if they comply with the delegated acts – Must take action if concerns are raised and inform the NCA – If also a wholesaler dealer the obligation following apply Delegated Regulation – Safety Features
  40. 40. 41 Chapter 5 – Wholesaler Dealers • Impact on Wholesalers – Risk based verification – Decommission the UI in specific circumstances – Take action if issues arise and inform the NCA – Can decommission the UI on behalf of others if flexibilities have been used by MS Enter the presentation's title using the menu option View > Header and Footer
  41. 41. 42 Chapter 8 – General obligations • Companies to upload certain information to the repositories • Products recalled, withdrawn or stolen – UI must be decommissioned – Repository updated • Free samples to have UI decommissioned before supply to HCPs • Remove redundant information Delegated Regulation – Safety Features
  42. 42. 43 Flexibilities within the Regulation • Member states may – Extend the products to which the unique identifier/safety feature applies – Require a national reimbursement or other national number to be within the data elements of the unique identifier • Member states may allow – Manufacturer to put additional information in the bar code Question for discussion: your view on use of these flexibilites Delegated Regulation – Safety Features
  43. 43. 44 Information to support the impact assessment – We are interested in looking at the areas of the business that will require a process change or new equipment, and we are interested in the views of manufacturers of any costs and benefits associated with these changes. Enter the presentation's title using the menu option View > Header and Footer
  44. 44. 45 Other concerns: Delegated Regulation – Safety Features
  45. 45. dd/mm/yyyy On-boarding and Data Management Paul Mills
  46. 46. Paul Mills, 19th Oct 2016, securMed Onboarding - Introduction  EMVO is tasked with the on-boarding activities for manufacturers and MAH’s.  EMVO refers to these clients as OBP’s.  On-Boarding Partners.  OBP’s have contracts with EMVO.  OBP’s are entirely responsible for the data upload process.  OBP’s cannot request a direct connection to the Hub for use by others. 47
  47. 47. Paul Mills, 19th Oct 2016, securMed Relationship between OBP and EMVO 48 Marketing Authorization Holders (MAH) EMVO EU Hub OBP Client Production 1 Production 2 Marketing Authorisation Holder A Marketing Authorisation Holder B Production 3 (CMO) Marketing Authorisation Holder C Collects data from
  48. 48. Paul Mills, 19th Oct 2016, securMed 49 1) Participation Request •Initial Contact •Portal registration •Non-Disclosure Agreement 2) Legitimacy Check •Level 1 checks •Person checks •(more detailed checks if necessary) 3) Contractual/ Commercial On- boarding •Registration fee payment •Connection Request •Participation Agreement 4) Technical On- boarding •System Connection •System Testing •System Operation Managed and administered by the EMVO’s Commercial and Partnership Management Team Managed by the EMVO’s Operations Team & Solidsoft Reply Managed by EMVO and supported by IMS* NDA CAR PA CRF Ticket
  49. 49. Paul Mills, 19th Oct 2016, securMed Purpose and Context The European Hub is the central element of the European Medicines Verification System infrastructure required by the EU-FMD. It is to the European Hub that the data that forms the critical element of the point-of-dispense verification concept is uploaded, namely:  For every Medicinal Product: Product master data  For each individual sales pack of medicines: Unique Identifier Any incorrect or fraudulent data uploaded will severely affect the medicines verification process and seriously undermine the trust in the system and Europe-wide process. It is therefore critical that:  the access to the European Hub for the upload of these critical data is tightly controlled and that  the Legitimacy of any party requesting access to the European Hub is established through a rigorously administered process. 50
  50. 50. Paul Mills, 19th Oct 2016, securMed Checks for legitimacy 1. Is the organisation requesting access an established and legitimate business? 2. Is the organisation requesting access a pharmaceutical “manufacturer” as defined for EMVO purposes that is entitled to access the European Hub? 3. Is the person making the access request entitled to make this request on behalf of the organisation? 4. Is the request a duplicate (i.e. an organisation already covered or registered for example duplicate request? Erroneous request by subsidiary of a registered parent/group organisation)? 5. Are there any other causes for concern about giving this organisation access? 51
  51. 51. Paul Mills, 19th Oct 2016, securMed Legitimacy Check Process steps Information received through Portal (CAR form) Level 1 checks by 3rd party Level 2 checks by 3rd party Proceed with next steps of onboarding process STOP Onboard ing process 52
  52. 52. Paul Mills, 19th Oct 2016, securMed Overall timeline Ad-hoc process •Current on-boarding of early adopters •Will need to be run through the new process Pilot phase •Operating the new process manually •Piloting to ensure that the process is fully workable and deal with any unknowns/unanticipated areas •EMVO Portal > email to IMS > Ticket captured manually Semi- automatic •Refined Process automated (where this makes sense) •EMVO Portal > EMOV Ticketing System > IMS Ticketing System BAU •Business – as – Usual process •Focus shifts from on-boarding many new organisations to change and issues management to Q3 2016 Q4 2016 Q2 2017 Q1 2019 53
  53. 53. Paul Mills, 19th Oct 2016, securMed Summary / Conclusions  EMVO is in the final stages of establishing a thorough and robust legitimacy check process  The process will be controlled by EMVO but will leverage what a specialised IMS can provide  Checks for a corporation requesting to become an OBP (On-boarding Partner) will take a risk-based approach  There will be an Audit Trail for each decision: Why it was taken, by whom, when, based on what information  Phased roll-out will commence in October 2016  NMVO’s are expected to undertake similar processes to verify the clients connecting with them e.g. Pharmacies and Wholesalers. 54
  54. 54. Paul Mills, 19th Oct 2016, securMed EMVS Master Data 55 Product Master Data Product code Coding scheme Name Common name Pharmaceutical form Strength Pack type Pack size (Dose Count) Product Code Status Product Code Version Product per Market Data Member state ISO ID National code Article 57 code/PCID (TBC) MAH ID MAH Name MAH Address Serialisation Flag List of Wholesalers with ID, name and address Batch Data Batch number Expiry date Manufacturer ID Manufacturer Name Manufacturer Address Batch Number Status Pack Data Serial Number Serial Number Status 1 N 1 1 N N
  55. 55. Paul Mills, 19th Oct 2016, securMed Master Data by Market  All the relationships reduce to this when the data is sent from the European Hub to each National System 56 Product Master Data Product code Coding scheme Name Common name Pharmaceutical form Strength Pack type Pack size (Dose Count) Member state ISO ID National code Article 57 code/PCID (TBC) MAH ID MAH Name MAH Address Serialisation Flag List of Wholesalers with ID, name and address Batch Data Batch number Expiry date Manufacturer ID Manufacturer Name Manufacturer Address Batch Number Status Pack Data Serial Number Serial Number Status
  56. 56. Paul Mills, 19th Oct 2016, securMed Master Data Guidance 57 Common Master Data (sample sheet only shown)
  57. 57. Paul Mills, 19th Oct 2016, securMed Questions? Thank you. 58

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