Falsified Medicines The UK Perspective Mark Jackson – Head of Intelligence MHRA

Outline Introduction - MHRA Enforcement Group Role and challenges Powers & legislation MHRA Falsified Medical Products Strategy Pangea/ The internet Conclusion 2

Enforcement Group Structure 50 members of staff Head of Enforcement Executive Support Intelligence Manager Operations Manager Prosecutions Manager Senior Expert Inspector Senior Policy Adviser/ Relationship Manager Case Referral Centre Internet Infrastructure Investigator Intelligence Team Disclosure Officer Disclosure/ Property Officer Complex Case Management UK Regulator for Medicines and Medical Devices Powers to investigate and prosecute breaches of relevant legislation The Enforcement Group comprises of Investigators, intelligence analysts, financial investigators, lawyers, and support staff Prosecutions brought through our in house Legal Team and prosecuted by the Crown Prosecution Service INTELLIGENCE FOUR ANALYSTS INTERNET INVESTIGATOR – WEB TAKE DOWN COVERT INTERNET INVESTIGATOR – TEST PURCHASE CASE REFERRAL CENTRE – ALL CASES IN THE FIRST INSTANCE INCLUDING WHISTLEBLOWING AND COUNTERFEIT HOTLINE OPERATIONS RECENT RESTRUCTURE –THREE INVESTIGATION TEAMS NOW ALSO HAVING RESPONSIBILITY FOR MEDICAL DEVICE INVESTIGATIONS AS WELL Investigation Team 1 Investigation Team 2 Investigation Team 3 (includes Property Manager) Financial Investigation Team

So what’s the mission of the MHRA Enforcement Group?

Some of the challenges we face

Concealment

Enforcement Group - Powers Human Medicines Regulations 2012 (and former Medicines Act 1968) – maximum sentence 2 years and/or unlimited fine as well as array of administrative sanctions Crown Prosecution Service (CPS) solicitors Powers available to MHRA Enforcement Officers: Investigation and prosecution Entry to commercial premises/ private dwellings Inspection (Search), Seizure MHRA has surveillance powers under RIPA 2000 MHRA pursues Proceeds of Crime under POCA 2002 MHRA will use most appropriate offence available in addition to Human Medicines Regulations and associated legislation; typically Fraud Act, Trade Marks Act and Proceeds of Crime Act

Enforcement Group - Responsibilities Illegal advertising Illegal wholesaling Illegal sale and supply Illegal importation Illegal manufacture Falsified medicines Clinical trial fraud Unlicensed medicines Internet supply Illegal herbal medicines Diversion Stolen medicines 9

Falsified Medical Products Situation - UK Now approaching 1 billion prescription items dispensed annually in England and Wales Counterfeit medicines in the legitimate supply chain are rare Obtaining medicines from unregulated , i.e. the internet, significantly increases the risk of receiving falsified and unlicensed medicines This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 10

MHRA Falsified Medical Products Strategy Download from: www.mhra.gov.uk Report a suspected counterfeit through hotline: email: counterfeit@mhra.gsi.gov.uk tel: 020 3080 6701

MHRA Falsified Medical Products Strategy Objective: The aim of the strategy is to: reduce the risks to patients and consumers increase the risk to those behind the illegal activity 12

Prevention Strategy key themes: Incident handling Investigation MHRA Falsified Medical Products Strategy Strategy key themes: Prevention Incident handling Investigation

MHRA Falsified Medical Products Strategy Prevention: Communication This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 14

15

Raising Awareness – Operation Pangea This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 16

MHRA Falsified Medical Products Strategy Prevention: Communication Collaboration This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 17

Falsified Medicines Stakeholders (FMS) Group Membership MHRA ABPI (research manufacturers) PSI (manufacturer security) BAPW (wholesalers) BAEPD (parallel traders) HMRC-UKBF (customs) GPhC (pharmacy inspectors) Police chemist liaison BGMA (generics manufacturers) Function Establish SPOC n/w Twice yearly meeting Assess recent seizures Identify trends Future threat products Produce watch list

MHRA Falsified Medical Products Strategy Prevention: Communication Collaboration MHRA Market testing scheme This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 19

Proactive Surveillance Continuous Sampling of High Risk Products Products identified from Intelligence, e.g. spam offers) “Highest risk” Proactive sampling programme Taken from Pharmacies

MHRA Falsified Medical Products Strategy Prevention: Communication Collaboration MHRA Market testing scheme International partnerships HMA WGEO, EU Commission, PFIPC, CoE, WHO SSFFC This chart sets out the 15 known incidents in the UK regulated supply chain. You can see the range of therapeutic categories touched by counterfeits 10 of these incidents led to recalls of the medicine from the market. 1 was found that was about to be used in a clinical trial 21

Recall of medicines MHRA Falsified Medical Products Strategy Incident Handling: Initial Actions Quarantine or seize Analytical sample testing (sophisticated methods) Check adverse events and defective medicine reports Recall of medicines Trigger Recall management Media engagement Review 22

Financial investigation The internet (Op PANGEA) MHRA Falsified Medical Products Strategy Investigation: Investigation and prosecution Financial investigation The internet (Op PANGEA) International law enforcement collaboration INTERPOL, Europol, Eurojust…. 23

MHRA Falsified Medical Products Strategy Date Medicine Indication MAH Unit Price Total Value Purchased From Falsified April 2013 Remicade Crohn’s Disease MSD £420 £84,000 Romania Packaging falsified Sept Symbicort Turbohaler Asthma Astra Zeneca £38 £9,348 Lithuania 2014 Herceptin Breast Cancer Roche £410 £4,100 Italy Tampered/refilled June 2014 Kaletra HIV Abbvie £280 £61,040 Latvia Nov £94,506 Bulgaria 24

Responding to a worldwide phenomenon? 25

Pangea II 2009 Pangea III 2010 Pangea IV 2011 Pangea V 2012 Pangea VI 2013 Pangea VII 2014 Participants 25 44 81 100 99 113 Websites Shutdown 153 297 13,495 18,629 13,763 11,863 Packages Inspected 11,164 278,524 65,000 143,709 534,562 618,191 Packages seized 2356 21,200 7482 9551 41,954 35,206 Arrests 12 87 92 169 213 434 Medicines Seized - 2,300,000 2,600,000 4,353,193 10,192,274 9,695,815 26

The continuing impact of the internet 27

Challenges Global Problem = Global cooperation and understanding. This is about protecting public health, not simply intellectual property. Not simply counterfeit drugs or medical devices – it’s the integrity of the global supply chain. 29

Conclusion No supply chain is impenetrable No room for complacency Collaborative effort from all key stakeholders is the only way to successfully tackle this issue Legal frameworks and/or a national strategy can be very helpful to combat this issue and act as a deterrent Protecting public health is the overarching aim 30

All Enforcement enquiries and potential referrals to: Thank you All Enforcement enquiries and potential referrals to: MHRA Case Referrals Centre casereferrals@mhra.gsi.gov.uk or tel +44 (0)20 3080 6330 Mark Jackson Head of Intelligence Medicines and Healthcare products Regulatory Agency +44 (0) 203 080 6332 mark.jackson@mhra.gsi.gov.uk