The UK Medicines and Healthcare products Regulatory Agency (MHRA) has developed a strategy to combat falsified medical products with the objective of reducing risks to patients and consumers. The strategy aims to enhance legal frameworks at the European Union and Council of Europe levels related to falsified medicines and strengthen safety features and controls for actors in the medical supply chain. It also addresses issues like internet sales of medicines and controls on active pharmaceutical ingredients.

1. PRESENTATIONS
THE UK (MHRA) APPROACH TO
C O M B AT I N G F A L S I F I E D M E D I C I N E S
GERALD W HEDDELL, DIRECTOR
INSPECTION, ENFORCEMENT &
S TA N DA R D S D I V I S I O N
M E D I C I N E S & H E A LT H C A R E P R O D U C T S
R E G U L AT O R Y A G E N C Y
SEPTEMBER 28, 2012
N AT I O N A L P R E S S C L U B
WWW.SAFEMEDICINES.ORG

2. Partnership for Safe Medicines
Interchange 2012
“The UK (MHRA) approach to combating
Falsified Medicines”
Gerald W Heddell
Director
Inspection, Enforcement & Standards Division
Medicines & Healthcare products Regulatory
Agency
©

3. MHRA – Our Mission
The MHRA’s mission is to enhance and safeguard the health
of the public by ensuring that medicines and medical devices
work and are acceptably safe
Gerald Heddell
Slide 3
Partnership for Safe Medicines Interchange – September 2012

4. Outline
Falsified medical product situation – Global
Falsified medical product situation – UK
The Risks
Legal frameworks
MHRA Falsified Medical Products Strategy
Conclusion
Gerald Heddell
Slide 4
Partnership for Safe Medicines Interchange – September 2012

5. Falsified Medical Products Situation - Global
Europe
Eur-Asia
South
North West East
America Africa Asia
Middle
East
Gerald Heddell
Slide 5
Partnership for Safe Medicines Interchange – September 2012

6. Falsified Medical Products Situation - Global
2012 (all reported in the Press):
• Nigeria (Jan): Smuggler arrested by Customs Service - 10m naira-worth (£40,293) of counterfeit medicines (Feed Fine
cyproheptadine, antihistamine, vitamin tablets) concealed in textile materials.
• Switzerland-Denmark-UK-USA (Jan): Avastin and Altuzan cancer medicines – hundreds of counterfeit packs originating in Turkey
moved through Europe to the USA where they reached patients.
• Russia (March):a Moscow police officers seized a large quantity of counterfeit Arbidol antiviral medicine (containing starch)
distributed through a pharmacy chain. The flu remedy was produced in the Moscow region where 700 boxes were purchased by
police in a covert operation.
• USA (March): A former South Korean law enforcement officer was arrested at a US airport for trafficking in counterfeit goods,
following the discovery of nearly 40,000 counterfeit Viagra, Cialis and Levitra pills in his luggage.
• Armenia (April): Counterfeit medicines discovered within the licensed supply chain, listed as Actovegin Forte and Concor. It is
thought that the medicines were within pharmacies for up to two weeks before the discovery.
• China (April): Fake and expired medicines valued at more thank 100,000 yuan (£9,985) were seized by authorities from 18 rural
pharmacies in Changsha. Separately a drug producer in east China was stripped of its licence and fined on charges of making
counterfeit medicines - several oral liquids and syrups without authorization under a forged consigned manufacturing document.
• Vietnam (April): Ho Chi Min City Department of Health seized quantities of fake or low quality oriental medicines circulating on the
market - products were said to be contaminated with bacteria, illegally mixed with fresh medicine or had become mouldy.
• Niger (April): A husband and wife were arrested following being found in possession of 25kg bags of Gelosyle, and large quantities
of Paracetamol, Piriton and Flagyl tablets - suspected that they were using the raw pharmaceutical ingredients to manufacture
counterfeit medicines.
• Jordan (May): A Jordanian doctor has been referred to court for selling smuggled and counterfeit medicine - mainly sexual
enhancers and psychotropic drugs in his own apartment.
Gerald Heddell
Slide 6
Partnership for Safe Medicines Interchange – September 2012

7. Falsified Medical Products Situation - UK
• Vast majority of counterfeits discovered in the UK are supplied over
the internet
• 10 instances of counterfeit medicines in the legitimate supply chain
that reached pharmacies and led to recall since 2004
• 850 million+ prescriptions written annually
• Counterfeit medicines in the legitimate supply chain are rare
• Obtaining medicines from unregulated sources significantly exposes
the risk of receiving counterfeit medicines
Gerald Heddell
Slide 7
Partnership for Safe Medicines Interchange – September 2012

8. Falsified Medical Products Situation - UK
6
5
4
Wholesale level
3 Clinical Trial
2 Pharmacy level
1
0
04
05
06
07
08
09
10
11
3
00
20
20
20
20
20
20
20
20
-2
94
19
Wholesale - Anti- cholesterol, Anti- inflammatory, Anti-platelet,
Alopecia, Erectile Dysfunction, Rheumatoid Arthritis, HIV.
Pharmacy - Anti-cholesterol, Anti-platelet, Anti-psychotic, Erectile dysfunction,
Prostate cancer, Appetite suppressants, Chronic asthma.
Clinical Trial - Anti - platelet
Gerald Heddell
Slide 8
Partnership for Safe Medicines Interchange – September 2012

9. The Risks
To public health:
The products are sub standard in terms of their method of
production and/or pharmaceutical ingredients/impurities
and/or contamination
Consumers and patients deserve to have a high degree of
confidence when obtaining their medical products especially
with a prescription from a pharmacy
Counterfeit medical products undermine that level of trust,
and lead to recalls, further damaging consumer confidence
A number of fatalities and serious adverse reactions have
been seen around the world
To industry/trade:
public health as above
reputational damage
financial impact
Gerald Heddell
Slide 9
Partnership for Safe Medicines Interchange – September 2012

10. Legal Frameworks
EU Falsified Medicines Directive
Safety Actors in the
features supply chain
Directive
2011/62/EU
on falsified
medicinal
products
Internet Active
sales substances
Gerald Heddell
Slide 10
Partnership for Safe Medicines Interchange – September 2012

11. Falsified Medicines
Gerald Heddell
Slide 11
Partnership for Safe Medicines Interchange – September 2012

12. Legal Frameworks
CoE Medicrime Convention
Gerald Heddell
Slide 12
Partnership for Safe Medicines Interchange – September 2012

13. MHRA Falsified Medical Products Strategy
Download from:
www.mhra.gov.uk
Gerald Heddell
Slide 13
Partnership for Safe Medicines Interchange – September 2012

14. 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
Gerald Heddell
Slide 14
Partnership for Safe Medicines Interchange – September 2012

15. MHRA Falsified Medical Products Strategy
Strategy key themes:
• Prevention
• Incident handling
• Investigation
Gerald Heddell
Slide 15
Partnership for Safe Medicines Interchange – September 2012

16. MHRA Falsified Medical Products Strategy
Use of Social Media:
Engagement
Accessibility
Targeted
Mass audience
Gerald Heddell
Slide 16
Partnership for Safe Medicines Interchange – September 2012

17. MHRA Falsified Medical Products Strategy
Impact (last 5 years):
No of counterfeit incidents significantly reduced
No of individuals convicted – 24
No of years sentenced:
– 30 yrs 2 months imprisonment
– 5 yrs 9.5 months suspended
– 930 hours Community Service
– £1,300 fines
Total costs awarded – £66,000
Total amount of proceeds of crime ordered to
be confiscated from criminals - £15.3m
Gerald Heddell
Slide 17
Partnership for Safe Medicines Interchange – September 2012

18. 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
Gerald Heddell
Slide 18
Partnership for Safe Medicines Interchange – September 2012

19. © Crown Copyright 2012
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Gerald Heddell
Slide 19
Partnership for Safe Medicines Interchange – September 2012

20. Safeguarding public health
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
Gerald Heddell
Director
Inspection, Enforcement and Standards Division
Medicines and Healthcare products Regulatory Agency
+44 (0) 203 080 6500
gerald.heddell@mhra.gsi.gov.uk
Gerald Heddell
Slide 20
Partnership for Safe Medicines Interchange – September 2012