Safeguarding public health

MHRA Anti-counterfeiting
Strategy & Supply Chain
Guidance

7th Annual Pharma Packaging & Labelling Conference,

17-18 September 2008, Barcelona, Spain

Danny Lee-Frost
Head of Operations
Enforcement & Intelligence Group
Medicines and Healthcare products Regulatory Agency
© Crown copyright 2005
Overview
¾ Counterfeit medicines - the facts and trends

¾ MHRA Anti-counterfeiting Strategy

ƒ Communication
- Ease of Reporting
- Supply Chain Guidance
ƒ Collaboration
ƒ Regulation

¾ Conclusion

¾ Case overview – Largest UK counterfeit medicines

penetration 2007

¾ Questions/Discussion
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Counterfeit Medicines – The Facts & Trends

• The WHO estimate that up to 1% of medicine

is counterfeit in the developed world

• There have been nine recalls of counterfeit

batches of medicines in the UK since 2004
(4 of these in 2007)

• The UK is not typically a manufacturer of

counterfeit medicines, but is a transit point
and end user

• Counterfeit medicines available in the UK

include ‘lifestyle’ and ‘lifesaving’ medicines

- Erectile dysfunction and weight

loss to cancer and heart medicines

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Counterfeit Medicines – The Facts & Trends (2)

• Counterfeit medicines in developed

countries are more commonly available
through the unregulated supply chain,
usually the Internet
• Less frequently, but more worryingly, they
are sometimes available through the
regulated supply chain via wholesalers,
distributors and pharmacies to patients
• Visual examination alone often fails to
identify the counterfeits
• There have been no known fatalities in the
UK, but thousands around the World
• Counterfeit medicines are dangerous
and undermine public confidence in
medicines and healthcare systems

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MHRA Anti-counterfeiting Strategy

• MHRA Anti-counterfeiting Strategy

- Communication

- Collaboration

- Regulation

• Review

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Communication

Public Healthcare Professionals

• Media Coverage • Specialist press

• Advice • Guidance for Pharmacists

• Ease of reporting • Increase vigilance

• Guidance for patients • Encourage reporting

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Communication - Supply Chain Guidance

¾Aim – to maintain vigilance including appropriate

safeguards to keep the UK supply chain clean from
counterfeit medicine penetration in order to protect public
health

¾MHRA is conducting thorough examination of UK supply

chain arrangements

¾One small piece of information from you, may:

ƒ prevent a counterfeit medicine reaching patients

ƒ result in the closing down of a counterfeit distribution arm

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Communication - Supply Chain Guidance (2)

¾Counterfeit medicines are not good for anyone, except the

criminals
ƒ Risks:
- to the public – physical harm
- to the distributor and manufacturer:
- reputational damage
- financial impact
- to the Regulator – safeguarding public health,
undermining credibility of the healthcare system

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Communication - Supply Chain Guidance (3)

What we want from you:

ƒ intelligence gaps – help fill them

ƒ report all suspicious approaches

ƒ conduct thorough due diligence

ƒ make use of MHRA hotline/online

reporting:
- [email protected]
- 0207 084 2701

to protect public health!

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Communication - Supply Chain Guidance (4)

Good Examples:

ƒ BAPW Gold Standard for GDP

ƒ “full-line” wholesaler discovering

two counterfeits from vigilant
procedures so intercepted before
reached pharmacies/patients

ƒ Anonymous tip-off from “short line”

wholesaler led to discovery and
seizure of 15,000 packs of counterfeit
Casodex for prostrate cancer – very
few packs got to patients
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Communication - Supply Chain Guidance (5)

Bad Examples:

ƒ suspicious approaches turned

away but not reported

ƒ wilful blindness, not enough due

diligence

ƒ buying parallel traded product in

large numbers from 3rd EU country

ƒ ‘wrong’ medicines delivered, unlicensed

for UK sale so keep hold of them?

ƒ inappropriate use of brokers

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Supply Chain Guidance (6)

Guidance for Pharmacists:

ƒ Joint MHRA-RPSGB guidance published and can be accessed
from www.mhra.gov.uk or www.rpsgb.org

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Communication - Supply Chain Guidance (6)

Guidance for Pharmacists:

ƒ Joint MHRA-RPSGB guidance published and can be accessed
from www.mhra.gov.uk or www.rpsgb.org.uk

ƒ Focuses on:

- Briefing on counterfeit medicines

- Reporting suspicions to MHRA
- Establishing supply history
- Conducting due diligence
- Listening to patients
- Checking for altered expiry dates
- Observing for unusual packaging
changes
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Collaboration - International

• Heads of Medicine Agencies (EU)

Working Group of Enforcement Officers

• European Commission

• Council of Europe

• World Health Organisation (IMPACT)

• Interpol

• Permanent Forum on International

Pharmaceutical crime

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Collaboration – UK Law Enforcement /
Regulatory Bodies

• Serious and Organised Crime Agency

• Police

• Her Majesty’s Revenue and Customs

• UK Border Agency

• Royal Pharmaceutical Society of Great

Britain

• Trading Standards

• Intellectual Property Office

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Collaboration – Industry and Trade

• Anti counterfeit Stakeholders Group

• Manufacturers

• Wholesalers

• Parallel Importers

• Generic Medicines Sector

• Postal Services

• Security Technology Providers

• Devices Sector

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Regulation – Threat Assessment

• Deep analysis of each UK incident

• Scope risk to public health

• Scope economic impact

• Identify drivers

• Identify trends

• Identify weaknesses

• Predict future trends

• Make recommendations to Government

(call for UK Supply Chain Review)

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Regulation – Targeted Market Surveillance

Regulated Supply Chain

• Projects focused upon ‘at risk’

medicines

• Sampling throughout the supply

chain, wholesalers and pharmacies

• Laboratory analysis

Un-Regulated Supply Chain

• On-line pharmacies with UK presence

• Test purchase of ‘at risk’ medicines

• Laboratory Analysis

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Regulation – Investigation and Prosecution

Regulated Supply Chain Internet

• Incident Handling Procedure • Automated search tools
• Protection of Public Health • Locate websites selling ‘at risk’
• Seizure of product medicines
• Potential recall of medicine • Covert test purchase
• Criminal prosecution • Laboratory analysis
• Trace audit trail • Criminal investigation
• Arrest of offenders • Trace suppliers
• Suspension of licences • Internet Day’s of Action (IDA)
• Trace and restrain offender’s • Seizure of product
assets for later confiscation • Criminal Prosecution, asset seizure
• Proactive publicity • Proactive publicity

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Conclusion

• Counterfeit medicines are here and are a clear and present danger

• The MHRA Anti-counterfeiting Strategy outlines the MHRA activity in this

area 2007-2010

• The strategy will be subject of audit and reporting

• Tackling counterfeit medicines and devices will remain a high priority for the
MHRA

• UK Supply Chain Review has commenced

• The over-riding aim of the strategy is to reduce the risks to patients

and increase the risks to counterfeiters

• To achieve this, committed participation is required from all

stakeholders

To best safeguard public health

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 UK Largest Counterfeit Penetration
•May 2007, most serious breach of UK supply chain

• 4 x class1 recalls (cancer, heart, anti-

psychotic)
• 40,000 packs seized by MHRA

• All packs in French livery

• Product aimed at Parallel re-packagers in the UK

• Over £7m of counterfeit medicines brokered through

front companies in Far East and Europe
• Packs ‘finished’ at licensed wholesaler in UK prior to
selling to ‘full line’ wholesaler and subsequent
re-packager

• Counterfeit manufactured in China and shipped to

Europe via Singapore and Belgium
• 6 persons arrested in the UK (two pharmacists) and
2 x wholesaler dealer licences suspended
• Chinese national arrested in Houston, Texas, tried in
July 2008, found guilty and awaiting sentencing

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 Global Supply Route

UK Luxembourg/Belgium

China

Singapore
Counterfeit Medicine
Money Mauritius

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Questions/Discussion?

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Safeguarding public health

Thank you
All Enforcement enquiries and potential referrals to:
MHRA Case Referrals Centre
[email protected] or tel +44 (0)20 7084 2330

Danny Lee-Frost
Head of Operations,
Enforcement and Intelligence Group,
Medicines and Healthcare products Regulatory Agency.
+44 (0) 207 084 2618
[email protected]

© Crown copyright 2005