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

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

3. 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

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

5. Some of the challenges we face

6. Concealment

8. 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

9. 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

10. 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

11. MHRA Falsified Medical Products Strategy
Download from:
Report a suspected counterfeit
through hotline:
tel:

12. 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

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

14. 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. 15

16. 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

17. 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

18. 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

19. 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

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

21. 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

22. 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

23. 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

24. 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

25. Responding to a worldwide phenomenon?25

26. 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

27. The continuing impact of the internet27

29. 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

30. 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

31. All Enforcement enquiries and potential referrals to:
Thank you
All Enforcement enquiries and potential referrals to:
MHRA Case Referrals Centre or tel +44 (0)
Mark Jackson
Head of Intelligence
Medicines and Healthcare products Regulatory Agency
+44 (0)