Falsified Medicines Directive (FMD) EMIG Quarterly Meeting Monday 06-Nov-17

Transcription

1 Falsified Medicines Directive (FMD) EMIG Quarterly Meeting Monday 06-Nov-17

2 Objectives What is FMD all about and when does it need to happen? Who are SecurMed UK and what is our role in FMD? What is the scope of FMD and who is obliged to comply? What do you need do to prepare for FMD?

3 Falsified Medicines - What is the problem? There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. These products usually contain substandard or falsified ingredients, or no ingredients, or ingredients (including active substances) in the wrong dosage thus posing an important threat to public health. Directive 2011/62/EU, Para 2 Involving nearly 2500 cases, EU Customs seized 27.4 million doses of falsified medicines at EU borders in 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 MHRA seized 6.2m medicine doses/ medical devices worth 15.8m as part of Operation Pangea June 2015 Herceptin, Spiriva Turbohaler and Kaletra WHO estimated in 2014 that 1% of sales in developed countries could be counterfeit. With approx. 2 billion items dispensed per year in the UK, this would equate to 20 million medicine packs if correct. But where is the evidence?

4 FMD is a Regulatory requirement Objective: To ensure people are kept safe by making sure patients can always get genuine medicines. Delivered by: A pan-european system to verify the authenticity of medicinal products July 2011 Jan 2013 Publication of FMD except FMD Safety Features implemented Oct 2015 Delegated Regulation approved by UK Ministers 9 February 2016 Publication of Delegated Regulation 36 Mon (2015+3) Complete Implementation Non-compliance puts supply and sales at risk FMD Go-Live - 09 February 2019

5 Safety features added to medicine packs Marketing Authorisation Holders (MAHs) are obliged to add Safety Features on all Prescription Only Medicines (POMs) Introduced to enable wholesale distributors (all WDA holders) and those who supply or dispense medicines to patients: to verify the authenticity of the medicinal product, to identify individual packs, to verify whether the outer packaging has been tampered with (Anti-Tamper Device check) Anti-tamper Device Unique identifier 2D Data-Matrix Code Randomised serial number Product #: Batch: A1C2E3G4I5 Expiry: S/N: 12345AZRQF1

6 Point of Dispense Verification Required by Delegated Regulation Commissioning Verification Decommissioning

7 Some labelled packs are already out there FMD requires Prescription Only Medicines (POMs) to be verified/decommissioned Key labelling feature s shown Product Code (GTIN) Batch Number Expiry Date Unique serial number 2D encoded matrix (for scanner) No anti-tamper proofing on these packs Picture taken at Minal Pharmacy, Twickenham, 15-Sep-17

8 SecurMed UK - NMVO Service A not for profit legal entity to establish and manage the verification system. A joint venture funded by pharmaceutical industry via industry associations Scope governed by Delegated Regulation of Falsified Medicines Directive UK Blueprint Service Provider is Arvato s GmbH Supervised by National Competent Authority (DH/MHRA)

9 Wholesaler Interface Manufacturer Interface Interface NMVO Scope of Responsibility Manufacturer European Medicines Verification (EMVS) Paralell Parallel Distributor Interface Wholesaler/ Distributor Interface Pharmacy UK MVS UK Medicines Verification (UK MVS) Interface Hospital Interface Other Build, test and deploy UK MVS Enable IT providers to create connections to UK MVS On-board wholesaler and dispensing users Develop UK NMVO Service MAH contracting and fee collection Reporting exceptions & compliance to NCAs. Maintain data integrity and security for all users Community Pharmacy Hospital Pharmacy Other Dispensing 9

10 UK FMD Implementation Overview SecurMed UK IT Solution Providers Community Pharmacy UK Medicines Verification (UK MVS) Wholesaler /Distributor to Connections End User to IT Provider Hospital Pharmacy GP Practice /Health Centre End User Registration/ Legitimacy Check SecurMed/Arvato provide IT Provider Solution Developers Kit and User Onboarding IT Solution Providers develop end user solutions encompassing IT system changes, interface to UK MVS, scanners, upgraded IT infrastructure and working practices changes End Users Community Pharmacy Users Wholesaler Users/ Article 23 Hospital Pharmacy Users GP Practice /Health Centre Users Registration Body e.g GPhC, CQC, GMC, PSNI End users verify/ decommission/ dispense medicines in supply chain through to dispense to patients 10

11 FMD Implementation Scope In FMD Implementation Scope England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man All persons authorized to dispense medicines to the public All pharmacies and healthcare institutions supplying medicines to the public All wholesalers holding Wholesaler Dealer Authorisations Article 3 healthcare institution means a hospital, in- or out-patient clinic or a health centre. Dept of Health have confirmed all GP practices and surgeries are considered healthcare institutions (July 2016). Article 23 persons authorized to supply or dispense medicines to the public who do not operate within a healthcare institution or a pharmacy (managed by wholesaler) Dentists, vets, opticians, paramedics, universities/ higher education, prisons, hospices, nursing/ care homes (subject to confirmation by DH/MHRA) Out of FMD implementation scope British Overseas Territories e.g. Gibraltar and Crown Dependencies e.g Bermuda, Falkland Islands, St Helena (subject to MHRA confirmation) All other healthcare organisations e.g Phone/Advice Lines

12 Size of UK User Community Channel Islands Isle of Man England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man 15,000 Community Pharmacies 260 Acute NHS Hospital Trusts 190 Private Hospitals 1,200 Dispensing Doctors 9,800 GP Practices & Surgeries 2,160 Wholesaler/ Dealer Authorisations 200,000+ End Users to be trained 17,000+ Article 23 locations 18,000 Other Locations (Care Homes, etc) Market Authorisation Holders (MHRA & EMA) Ministry of Defence 60+ IT Solution Providers

13 FMD and Brexit FMD legislation passed into UK law in 2013 (part of Human Medicines Act). Delegated Regulation approved by UK government in DH MHRA position April The UK remains a full member of the EU and all the rights and obligations of EU membership remain in force until Brexit. The government will continue to negotiate, implement and apply EU legislation, including the Safety Features policy under the Falsified Medicines Directive.. SecurMed UK has been instructed to continue as full member of Europe-wide FMD implementation. SecurMed has sought guidance from Dept of Health/MHRA since the General Election and the direction remains the same. Arvato s appointed in July 2017 as UK IT Blueprint Service Provider.

14 Pharmaceutical Packaging, Labelling and Artwork Origination October 2017 Implementation Approach July 2017 Feb 9, 2019 Phase 1 Initialisation Phase 2 Ramp-up stage A Verify EMVS-NMVS connection Phase 3 Ramp-up stage B Early Adopter dispensers & wholesaler testing Phase 4 Ramp-up stage C Ramp oup of dispensers, wholesalers and MAHs Phase 5 Operations Manufact r Data upload (products, packs) EU Hub (EMVS) Data upload (products, packs) National Blueprint (UK MVS) Parallel Distributor Requests and pack status changes Wholesaler Dispenser Wholesaler system Web app Dispenser Web app Verification, dispense

15 Costs are incurred by all stakeholders Verification system (Hub & national systems) Installation for pack coding Installations for pack verification Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy Wholesaler Manufacturers and Marketing Authorisation Holders Manufacturers and Marketing Authorisation Holders Dispensing & Verification Entities e.g. Pharmacies, Hospitals and Wholesalers Each stakeholder pays for costs of own installations. Manufacturers pay for cost of the verification system. SecurMed is funded only for UK system set-up, no-one else.

16 MAH Onboarding with UK MVO MAH Onboarding has two processes 1. EMVO OBP Contracting, Onboarding and Pack Upload MAH Holder Ready to Onboard OBP Portal Request EMVO Verification EMVO OBP Agreement OBP-EMVO Testing MAH Ready to Upload Packs Notify UK MVO Intention to Onboard UK MVO Verification UK MVO MAH Agreement UK MVO Fee Collection MAH ready to use UK MVS 2. SecurMed UK Contracting, Fee Collection and Readiness to use UK MVS

17 Who are the UK MAHs? Delegated Regulation Article 31(5) requires the costs of the repositories system to be borne by the manufacturers, identified as ALL Marketing Authorisation we need you to help us by Holders (MAH) in receipt of one or more; An UK Marketing Authorisation (MA) applied for and issued by the MHRA An UK MA applied for and granted via the EU s Decentralised Procedure (DCP) An MA applied for and granted by the EU s Centralised Procedure (CP) UK PLPI (parallel import licence) How many MAHs are there in the UK? MHRA MAH ?? EMA CP/DCP holders ~330 MHRA PLPI ~80 To minimise our overhead costs identifying to us: 1. Your company and details 2. Your Marketing Authorisation Holdings 3. The Responsible Person for your organisation for MAH contracting EMVO will help provide information too.

18 Manufacturer WDA Holders Organisation Type WDA Holder 3PL 55 Article Clinic 11 Community Pharmacy 598 Health Centre 79 Hospital 118 Manufacturer 286 Other 516 Parallel Distributor 9 Prison Pharmacy 1 Wholesaler 420 Grand Total 2160 Manufacturers who have WDA licenses may need to connect to the UK MVS. See for more info Source: EUdraGDMP WDA holders

19 Some labelled packs are already out there FMD requires Prescription Only Medicines (POMs) to be verified/decommissioned Key labelling feature s shown Product Code (GTIN) Batch Number Expiry Date Unique serial number 2D encoded matrix (for scanner) No anti-tamper proofing on these packs There will be many packs in the supply chain with data not loaded into EMVS. Picture taken at Minal Pharmacy, Twickenham, 15-Sep-17

20 Transition to Serialised Packs Non - Serialised Pack Availability - Decreasing Serialised Pack Availability - Increasing 4-5 YEARS 09 February 2019 MAHs need to capture and upload the serialised pack history into EMVS The more gaps there are in the pack data information, the more exception reports will be generated by the UK MVS, leading to: Increased effort to investigate exceptions, Increased resource required to support reporting and investigation, Increased costs for SecurMed UK.

21 When will packs arrive at Dispensers? Non - Serialised Pack Availability - Decreasing Serialised Pack Availability - Increasing 4-5 YEARS 09 February 2019 Important for manufacturers to start early and help minimise the pack arrival delay. Considerable time may elapse before serialised packs arrive at dispensing locations. End users may be trained too early, re-training may be needed or packs may not get decommissioned. May lead to increased reporting and investigation effort from SecurMed UK.

22 Where to get more information? ABPI: BGMA: BAEPD: EMVO: SecurMed UK: Arvato Developers Toolkit: EMIG: To register for monthly MHRA FMD Safety Features newsletter please with your name, organisation and your title.

23 Questions/ What information do you need from SecurMed UK Questions to