Bilskilt på legemiddelpakninger Koding (2 D-matrixing) og EU Direktivet om forfalskning av legemidler Eckart Holtz, LMI
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Bakgrunn - Falske legemidler Viagra, found in Korea, contained 317mg sildenafil citrate, three times the maximum legal dosage Viagra, found in Hungary, contained only amphetamine or speed, a potent stimulant www.lmi.no
Falske legemidler Kan ha: Manglende virkestoff For mye / lite virkestoff Feil virkestoff Giftige substanser / forurensninger Riktig innhold, men dårlig kvalitet www.lmi.no
Konsekvenser for pasienten Pasient kan bli alvorlig syk/ dø av falske legemidler Sykdom kan forverre seg som følge av at falsk medisin ikke inneholder aktivt virkestoff. Risiko for at pasient som importerer/internett handler ikke tørr oppsøke lege/apotek hvis ubehag/bivirkninger Pasient kobler ikke plager med medisin Helsepersonell lite kjent med falske legemidler www.lmi.no
Organisert kriminalitet - Falske legemidler Grove anslag av omfang i milliarder NOK Worldwide (2010) Falske sigaretter 120 Narkotika 300 Falske legemidler 210 www.lmi.no
Fra Legemiddelverkets webside 90 % av «nettapotekene» ulovlig virksomhet 62% av medisin kjøpt over internett er falske legemidler www.lmi.no
Hva kan vi gjøre i Norge? Internett Legal kjede Lovgivning Europeisk samarbeid: - Endre lovgivning - Lettere å gjøre beslag - Internasjonalt samarbeid - Samarbeid på tvers av profesjoner - Forfalskede legemidler bør staffes på nivå med narkotika Innføre europeiske sporbarhetssystemer som kan verifisere at legemidlet som selges på apotek er ekte www.lmi.no
EU Falsified Medicines Directive Published 1.7. 2011, enters into force 1.1.2013 EU Contains measures to increase security of the medicinal supply chain in Europe Strengthen GMP and GDP including the sourcing of active ingredients Improve supervision of actors in the distribution chain (e.g. wholesalers, parallel distributors...) Ensure product integrity and authentication of medicines (safety features and product serialisation) 7.2 www.lmi.no
EU Falsified Medicines Directive (FMD) published on 1 July 2011 Safety Features Manufacturing Authorisation Holders (MAH) must apply safety features to allow verification of authenticity and identification of individual packs and provide evidence of tampering Risk-based approach White List for prescription medicines, Black List for OTC Parallel distributors must replace safety features with equivalents and are liable for errors Repositories System Systems must be established to house information on the safety features Member States may use safety features for other purposes e.g. reimbursement Costs shall be borne by the Manufacturing Authorisation Holders (MAH) Internet EU trust mark logo must be used by approved EU online pharmacies National authorities and European Medicines Agency (EMA) to maintain lists of approved online pharmacies Monitoring of Internet by national authorities Active Ingredients Compliance of active ingredient manufacturer with GMP principles and guidelines, to be verified by audits both inside and outside the EU Mandatory control of API producers by competent authorities in non-eu countries
Four Ways to tackle Falsified Medicines Safety features Internet Criminal sanctions Regulatory issues Safety features: serial number and tamper evidence Risk-based approach white list for Prescription only Medicines black list for over-the-counter Repackers must replace features with equivalents EU online pharmacies must be registered and display EU logo National and EMA lists of registered online pharmacies Monitoring of internet by national authorities Public awareness campaigns Criminal penalties to be enforced for violations of the Directive Mandatory registration of non-eu Active Ingredient producers Specific guidelines for excipients including GMP compliance Brokering of medicines better regulated New rules on import for export 1 JAN 2017 1 JAN 2013 1 JAN 2013 1 JUL 2013
EFPIA proposes a 2D Data Matrix for Pack Verification Data matrix coding proposal derived from GS1 standards (EAN 128 syntax with Application Identifiers; Data matrix ECC200) Manufacturer Product Code (GTIN or NTIN) 14 digits Unique Serial Number (randomized) up to 20 alpha-numeric characters Expiry Date 6 digits (YYMMDD) Batch Number Example: up to 20 alpha-numeric characters + minimum requirements on quality of randomisation GTIN: (01)09876543210982 Batch: (10)A1C2E3G4I5 Expiry: (17)140531 S/N: (21)12345AZRQF1234567890 Specifications provided in EFPIA s European Pack Coding Guidelines On the Way to a European Medicines Verification System
EFPIA: Point-of-Dispense Model sets out Modalities for Pack Verification Pharma Manufacturer Wholesaler Wholesaler Pharmacist/ Hospital Patient Product Flow Unique Randomized Serialization 2D Data Matrix on 2 nd pack Verification Verification Dispensing Data Transfer Medicines Verification Repository The key stakeholders all support Point-of-Dispense verification On the Way to a European Medicines Verification System
Point-of-Dispense Model successfully operated in Swedish Pharmacies Key figures 25 pharmacies in the greater Stockholm area with a total of 180 dispensing points 25 products (SKUs) with total of 110.000 packs 14 manufacturers Operational phase from Sep 2009 Feb 2010 Key learnings System availability and performance allow pharmacists to work at normal pace System should be customised to existing workflows and integrated into existing pharmacy software More than one code on pack causes confusion for user and will jeopardise user acceptance Pharmacists & wholesalers are highly interested in accessing expiry date and batch number in machine-readable form On the Way to a European Medicines Verification System
ESM System Architecture Manufacturer European Hub Parallel Distributor National System n National Blueprint System (nbps) National System 1 Pharmacy Pharmacy Wholesaler Pharmacy Wholesaler Wholesaler Pharmacy: mandatory verification Manufacturer: data upload + voluntary verification Wholesaler: voluntary verification Parallel Importer: mandatory verification + data upload Periodic cross-region update On the Way to a European Medicines Verification System Page 15
Major Supply Chain Partners working together EAEPC, EFPIA, GIRP, and PGEU Have agreed upon a joint position paper Ten Core Principles to Protect Patients from Falsified Medicines Have elaborated a Memorandum of Understanding (MoU) towards foundation of a European stakeholder organisation Will launch a Request for Proposals for implementation of European Medicines Verification System (EMVS) Talks ongoing with AESGP, EGA, and HOPE AESGP EAEPC EGA GIRP HOPE PGEU Association of the European Self-Medication Industry European Association of Euro-Pharmaceutical Companies European Generic Medicines Association European Association of Pharmaceutical Full-line Wholesalers European Hospital and Healthcare Federation European Association Representing Community Pharmacists On the Way to a European Medicines Verification System Page 16
EFPIA Koding prosjektet i Norge Mars 2011 LMI ad-hoc gruppe 2 D Matrixing med deltakere fra fem selskaper Mai 2011 første norske stakeholder -møte hos LMI med Apotekforeningen og Farmalogg, NiGeL, Parallelimport/eksport, Sykehusapotekene, Grossistorganisasjonen, Legemiddelverket. Nordisk koordinering LIF (S), LIF (Dk), PIF, LMI, Frumtök Utredning av alternative løsninger i Norden (plan: sommer 2012) www.lmi.no
EFPIA Koding prosjektet i Norge Info møte med EFPIA eksperter i Norden januar/februar 2012. I Norge 9.februar: - LMI infomøte for medlemmer og - Stakeholder-møte med hos LMI med Apotekforeningen og Farmalogg, NiGeL, Parallelimport/eksport, Sykehusapotekene, Grossistorganisasjonen, Legemiddelverket. Videre oppfølging med alle involverte for å få en for alle akseptabel løsning, med forankring i den europeiske (ESM) stakeholder modellen. www.lmi.no