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Falsified medicinal products

Falsified medicinal products. Chaïma MRIZAK Regulatory seminar 15th of November 2017. Outline. Definition : Falsified medicines Scope of the problem EU laws on falsified medicines : Directive 2011/62/EU Role of the European Medicines A gency. Introduction.

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Falsified medicinal products

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  1. Falsifiedmedicinalproducts Chaïma MRIZAK Regulatory seminar 15th of November 2017

  2. Outline • Definition: Falsifiedmedicines • Scope of the problem • EU laws on falsifiedmedicines: Directive 2011/62/EU • Role of the EuropeanMedicinesAgency

  3. Introduction

  4. 1. What are falsifiedmedicines? • « Falsified medicines are fakemedicinesthatpassthemselves off as real, authorisedmedicines. » • Thoseproductsusually • containsub-standard or falsifiedingredientsor no ingredients or ingredients, including active substances, in the wrong dosage • bedeliberately and fraudulentlymislabelledwith respect to theiridentity or source; • have fake packaging

  5. 2. Scope of the problem • Recentyears: medicineswere the leadingcounterfeitproductsseized by European customs, ahead of counterfeitcigarettes • (Pharmaceutical Security Institute “2011 situation report”) • Alarmingincrease of falsifiedmedicinalproducts in the Union (identity, history or source) • Falsified medicines: do not passthrough the usualevaluation of quality, safety and efficacy .. • Particularthreat to humanhealth • Lack of trust of the patient in the legalsupplychain.

  6. 2. Scope of the problem • Untilrecently: in wealthycountries expensive 'lifestyle' medicines (hormones, steroids and antihistamines) • In developingcountries life-threateningtreatments ( malaria, tuberculosis and HIV / AIDS) • Phenomenon on the increase: expensivemedicines ++ (anticancermedicines), highdemand (antivirals)

  7. Falsified cancer medicine • Bevacizumab(unknownorigin) • The falsifiedproductclosely matches the appearance of the real medicine, but tests indicatethatitcontainsstarchand acetoneinstead of active ingredient. • The fakesweretrafficked on a complexsupplychain, throughTurkey, Switzerland, and Denmark to US, in part by a Canadian firm and its offshore affiliates => The extent of harm to patients isunknown. • Substandardheartmedicine • More than125 people diedin Pakistan of bonemarrow suppression after a public cardiologypharmacyprovidedgeneric isosorbide-5- mononitratetabletsadulteratedwith a toxicoverdose of pyrimethamine, an antimalarialdrug. • Resultof a manufacturingerror, although police allegethatcompany, officialslearnt of the error and sold the medicineanyway. • If the allegationprovestrue, the medicinewouldbereclassified as falsified. BMJ | 24 NOVEMBER 2012 | VOLUME 345

  8. 3. EU laws on falsifiedmedicines • Directive 2001/83/EC of the EuropeanParliament and of the Council lays down the rules for, inter alia, manufacturing, importing, placing on the market, and the wholesale distribution of medicinalproducts in the Union as well as rulesrelating to active substances. • Directive 2001/83/EC shouldbeamended in order to respond to thisincreasingthreat. •  EC: Directive 2011/62/EU of the europeanparliament and of the council of 8 june 2011

  9. Directive 2011/62/EU • The Directive came into force on 21 July 2011. • Member States had to startapplyingitsmeasures in January 2013. • This Directive aims to preventfalsifiedmedicinesentering the legalsupplychain and reaching patients. • It introducesharmonisedsafetyand strengthened control measuresacross Europe by applying new measures

  10. Counterfeitmedicines medicinesthat do not complywithintellectual-propertyrightsor thatinfringetrademarklaw Falsified medicines Licitmedicines • fakemedicinesthat are designed to mimic real medicines • containingunintentionaldefectsof qualityattributable to errors of manufacturingor distribution First Definition!

  11. Verifyauthenticity and identification of individual boxes of medicines • Verifywhether the outer packaging has been violated The Directive provides for affixingdevices for security and inviolability • On 9 February 2016, the European Commission published a delegatedregulation (Commission DelegatedRegulation (EU) 2016/161): safetyfeatures to beplaced on the packaging of mosthumanmedicines: a unique identifier (a 2-dimension barcode) and an anti-tamperingdevice. • The annexes of the regulation:listof medicines subject to the new requirement • Application: no laterthan 9 February 2019 1. AFFIXING OF SECURITY AND TRACEABILITY DEVICES

  12. New requirementsfor improving the distribution chain • New player: the broker whotakes part in transactions but withoutenteringintophysical contact with the medicines. • Directive: new responsibilities for wholesalers, definitionof brokeringactivities as well as new responsibilities for brokers • Agency: revision of good-distribution-practice guideline (2013/C 68/01) => specificprovisions for brokeringactivities • The EudraGMDPdatabasenowalsoincludes information on good distribution practice (GDP). 2. IMPROVED CONTROL OF THE DISTRIBUTION CHAIN

  13. Upgrading the requirements on verifications applicable to the manufacturers of medicinesguaranteeingtheirauthenticity and quality • FromJuly 2013, all active substances manufacturedoutside the EU and importedinto the EU have had to beaccompanied by a written confirmationfrom the regulatoryauthority of the exporting country. 3. NEW REQUIREMENTS CONCERNING RAW MATERIALS AND EXCIPIENTS

  14. Statementsisued /manufacturing site /active substance • ensurethat standards of good manufacurting practice (GMP) equivalent to those in force in the EU are upheld. • Regular controls,repeated and unexpected inspections duringwhichcertificates of good practices for active substances canbeissued NEW REQUIREMENTS CONCERNING RAW MATERIALS AND EXCIPIENTS

  15. atanygiven moment, over 400 criminalwebsiteswith a .eu suffix, are online, targeting and sellingfalsifiedmedicinesinto the EU • Falsifiedmedicinesmayreach the public in thisway • The Directive includes the minimal conditions to be met by online pharmacies to beauthorizedso as to engage in distance selling • Counterthe illegal sale of medicines to the public through the Internet 4. CONTROL AND HARMONISATION OF THE SALE OF MEDICINES ONLINE

  16. Since July 2014: Obligatory logo thatwillappear on the websites of legally operating online pharmacies and approved retailers in the EU. • Link to the national regulatoryauthoritywebsites, where all legally operating online pharmacies and approvedretailers in their respective countries willbelisted.  • Member States: conductcampaigns to raiseawareness of the logo and the dangers of falsifiedmedicines • .

  17. www.fightthefakes.org

  18. 4. Role of the EMA • Cooperation+ EC + MemberStates • Implement the Directive 2011/62/EU • EuropeanDirectorate for the Quality of Medicines and Healthcare (EDQM) • and the World HealthOrganization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT). • The Heads of Medicines Agencies • have identifiedfalsifiedmedicines as being a key issue facing the Europeanregulatory network for the five years to 2015. • enforcementof thislegislationis the competency of MemberStates • But: coordination between the national and international bodies involved in fightingfalsifiedmedicinesisnecessary

  19. Role of the EMA • A strategy for the Heads of MedicinesAgencies, 2011-15 • The Agency isalsocooperatingwith international anti-counterfeitingtradeagreements and othercriminal-law instruments: • the Council of Europe'sMedicrime convention • The Organisation for EconomicCo-operation and Development (OECD) project on counterfeiting and piracy

  20. Penalties for FalsifyingMedicine « Effective, proportionate and dissuasive penalties » *Additional penalties and fines maybeassociatedwithspecific infractions

  21. Conclusion • The Falsified Medicines Directive will not stop thiscrimes • Whatitwill do – through the identification of medicinesat the pack level, stricterregulation and stiffer penalties – => Traditionalsupplychain more secure => lessattractive to the criminal. • Identifyingfinancialimpact of falsifiedmedicinesacross the EU: extremelydifficult. • *Peter Pitts (et al) : by 2010 the global trade in falsifiedmedicineswouldreach $75bn. • And thisdoes not of course takeintoaccount the humancost! • EMA: workingcloselywithitspartners on the implementation of theselaw Makingprogressbut a long road to travel

  22. Thankyou for your attention

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