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Introduction to FMD Implementing the EU Falsified Medicines Directive in the UK Alastair Buxton Director of NHS Services PSNC 6th September 2018 Falsified medicines a real problem The Pharmaceutical Journal, 5 th June 2014 2 Why we need a

  1. Introduction to FMD Implementing the EU Falsified Medicines Directive in the UK Alastair Buxton Director of NHS Services PSNC 6th September 2018

  2. Falsified medicines – a real problem The Pharmaceutical Journal, 5 th June 2014 2

  3. Why we need a Directive • Falsified products still being found in legitimate medicines supply chain – major risk to patient safety • Failure to address falsification could put trust in our entire industry at risk • Up to half of medicines purchased online believed to be falsified – action taken to improve security of legitimate internet pharmacies • Stronger controls now over raw materials and products manufactured under contract outside EU

  4. FMD overview and timeline

  5. Falsified Medicines – what’s the solution? “Safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.” Directive 2011/62/EU, Para 11 • All packs of almost all prescription medicines will have to have two safety features: • Visual tamper-evident seals or packaging • Unique identifiers (serial numbers) in a 2D barcode • Authenticity is checked in two ways: • Visual inspection of the tamper-evident features • Scanning and checking unique identifiers against databases (“repositories”) at EU and national levels 5

  6. FMD and safety features Anti- Safety Unique tampering features Identifier device “Medicinal products subject to prescription shall bear safety features on their packaging” FMD Delegated Regulation 2016/161, Article 2 6

  7. FMD concept for verification Unique Unique Identifiers Identifiers Manufacturers Parallel traders (brands or generics) European Hub National National system system National system National Pharmacies Wholesalers system Wholesalers Pharmacies Pharmacies Wholesalers Pharmacies Wholesalers Data uploads Data exchange Verification Authentication 7

  8. Falsified Medicines Directive (FMD) timeline Directive First elements of EMVO and 2011/62/EU Directive come in to European Hub EU logo for online adopted force (APIs and established pharmacies starts excipients) 2011 2013 2015 Delegated Set up Regulation NMVOs/ Full requirements End of non-2D 2016/161 pick BSPs of Directive start packs (could be FMD published (scanning) earlier) pilots 2019 2016 2017 2018 2024 FMD Brexit? onboarding 8

  9. 9

  10. FMD Delegated Regulation – key questions answered

  11. FMD – key questions answered Who is involved? You are “ Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public .” Delegated Regulation 2016/161, Article 25(1) 11

  12. FMD – key questions answered What is included? Everything “ This Regulation applies to: medicinal products subject to prescription … unless included in the list set out in Annex 1; medicinal products not subject to prescription included in the list set out in Annex 2” Delegated Regulation 2016/161, Article 2(1) 12

  13. FMD – key questions answered When does it start? Very soon “ This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from Saturday 9 th February 2019 .” Delegated Regulation 2016/161, Article 50 13

  14. FMD – key questions answered Will I have to pay for it? In part “ The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features.” “ The repositories system shall not include the physical scanning equipment used for reading the unique identifier.” Draft Delegated Regulation, Articles 31(5) and 32(4) PSNC is assessing the costs (implementation and ongoing) to discuss with DHSC 14

  15. FMD – key questions answered Can we opt out? No? “ This Regulation shall be binding in its entirety and directly applicable in all Member States .” Delegated Regulation 2016/161, Article 50 15

  16. FMD Delegated Regulation – what do you have to do?

  17. FMD – requirements for manufacturers • Delegated Regulation requires manufacturers to: • Put safety features (tamper-evident and unique identifier) on almost all prescription medicines • Encode unique identifier in 2D barcode meeting certain standards • Print 2D barcodes and certain details on all relevant packs • Upload unique identifiers into repositories system (consisting of European hub and national repositories) • Set up and pay for the repositories system via non-profit legal entities • Report any suspected incidents of tampering or falsification • Decommission certain products • Notify repositories of any recalled, withdrawn or stolen products 17

  18. FMD – requirements for wholesalers • Delegated Regulation requires wholesalers to: • Verify authenticity of any returns and products not bought directly from manufacturers or their contracted distributors • Decommission identifiers of products being exported, withdrawn, destroyed or taken as samples • Decommission products being supplied to public by other routes (i.e. not via pharmacy, dispensing doctors or hospitals) • Not distribute or supply decommissioned products (other than those they are required to decommission for others) • Notify authorities of any suspected incidents of tampering or falsification [Note: also applies to pharmacies who hold wholesale licences] 18

  19. FMD – requirements for pharmacies • Delegated Regulation requires pharmacies to: • Verify the authenticity of products (checking tamper-evident and unique identifiers) and then decommission identifiers “at the time of supplying it to the public” • Only be able to revert decommissioned products (undispense) within 10 days of the original dispensing • Decommission products that cannot be returned to wholesalers or manufacturers or which are taken as samples • Not to supply decommissioned products (other than those they decommission themselves as part of dispensing) • If technical problems prevent authentication, to record unique identifiers and then verify and decommission when possible • Notify authorities of any suspected incidents of tampering or falsification 19

  20. The journey of a patient pack

  22. Potential benefits from FMD (beyond identification of falsified medicines)

  23. FMD – potential benefits Patient safety benefits • Accuracy and date checking made easier • Impact on indemnity costs? Pharmacy stock benefits • Accurate pack-level data for all products Patient information benefits • Able to generate patient-specific information 23

  24. FMD implementation – key players

  25. European Stakeholder Model and EMVO Research -led Generics Parallel Wholesalers Pharmacies manufacturers manufacturers distributors NMVO NMVO NMVO NMVO NMVO 25

  26. SecurMed UK – the UK’s NMVO Research -led Generics Parallel Wholesalers Pharmacies manufacturers manufacturers distributors ABPI HDA BGMA BAEPD NPA/CCA National Medicines Verification System Manufacturers Wholesalers Pharmacies Hospitals GP surgeries 26

  27. UK FMD Working Group for Community Pharmacy Pharmacy contractor associations Pharmacy negotiating bodies NPA AIM CCA PSNC CPNI CPS CPW • Representing contractors’ interests to DH/MHRA • Process mapping and options development • Establishing FMD Source as trusted FMD resource • Bringing suppliers and IT providers together 27

  28. FMD Implementation Advisory Board Health Ministers FMD Implementation Ministerial Advisory Board Wholesale Pharmacy Private Ambulances NHS Digital hospitals NHS Trusts Prisons Manufacturers Distributors Other Devolved GPs healthcare SecurMed UK Administrations • Established by DHSC/MHRA to advise Health Ministers • Brings together all those involved with implementing FMD • Many working groups established • Leading to Impact Assessment and formal consultation 28

  29. Implementing FMD – what happens next?

  30. FMD timeline for the UK Delegated Directive UK bodies EMVO and Regulation 2011/62/EU participating in ESM European Hub 2016/161 adopted discussions established published 2016 2011 2014 UK BSP FMD pilots decision start in UK Full requirements IT system SecurMed UK of Directive start upgrades DH/MHRA established (scanning) consultation 2016 2017 2018 2019 All parties FMD stock starts EU referendum Brexit? connected to appear to NMVS 30

  31. What about Brexit? • The UK’s decision to leave the European Union adds an extra layer of confusion and complexity • In theory, the Delegated Regulation will be incorporated in to UK legislation under EU (Withdrawal) Bill • UK progress on implementation has been heavily delayed • Lack of clarity about what happens afterwards and whether UK would “inside” FMD and connected to EMVS • Clear patient safety risks if UK is outside FMD • Expect a UK solution will be developed if we can’t access the European system 31

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