A presentation given at a recent conference in the USA. It looks at the global issues involved in pharmaceutical anti-counterfeiting, pointing out the problems involved in scaling up what is proposed in USA and Europe into a global drug tracking system.
2. Agenda
What are the global issues?
What anti-counterfeiting technologies could work
everywhere?
How do we best serve developing countries?
What do the patients want?
mark.davison@bluespherehealth.com 2
3. No Man is an Island…
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4. How We See the World:
People or Territory?
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7. Response: Logistics-Based Security
Control the product
flow, control the crime…
Serialization, pedigree,
RFID etc.
Tech-centric approaches
Infrastructure
requirements
Pay-offs in patient safety,
logistics efficiency
Reduces opportunity for
large-scale crime
Provides a modular,
scalable, global
framework
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10. Logistics is Only One Aspect
Tech-centric approaches are difficult in developing
countries
Doesn’t deal with locally-produced fakes
Wider approach is needed
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15. Who Pays the Costs of
Anti-Counterfeiting?
“The costs associated with implementing E-pedigree will
be too high for some California pharmacists to absorb.
This means even more small business pharmacies will
be put in jeopardy. This will harm patient access to
prescription drugs and consultation care.”
National Community Pharmacists Association, Dec 2007
http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
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16. Who Pays the Costs of
Anti-Counterfeiting?
“The costs associated with implementing E-pedigree will
be too high for some California pharmacists to absorb.
This means even more small business pharmacies will
be put in jeopardy. This will harm patient access to
prescription drugs and consultation care.”
National Community Pharmacists Association, Dec 2007
http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
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17. Who Pays the Costs of
Anti-Counterfeiting?
“The costs associated with implementing E-pedigree will
be too high for some California pharmacists to absorb.
This means even more small business pharmacies will
be put in jeopardy. This will harm patient access to
prescription drugs and consultation care.”
National Community Pharmacists Association, Dec 2007
http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
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#8
GDP
Worldwide.
If California
cant afford it,
who can?
18. “Ubiquitous Anti-Counterfeiting
Technology” Must Be:
Secure
Easy to use with minimal / no training
Physically robust
Low entry costs (or subsidized)
Flexible and scalable
Upgradable and Replaceable
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20. Role of the State
Centralized solutions may be the best option
Europe, USA, China, Brazil etc.
Not all states will cope with serialization
Heavy subsidy and technical help needed
Scalable approaches to aid phased uptake
Supportive, non-punitive environment
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22. How About the Pharmacist?
The last professional to touch the pack
Trained and trainable (in anti-counterfeiting systems)
Ubiquitous in every community?
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25. Pharmacy-Based Drug Security
Relatively simple, logical approach
May not work everywhere
Not all pharmacists are equivalent
Sometimes they are the problem not the solution
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26. How About the Consumer?
Ubiquitous
Least trained element of the supply chain
Most to lose if product security fails:
We invest, but they ingest
Very effective if given the right systems
Communication is vital:
Education, education, education
Should only be the “sentinel of last resort” against fake
drugs
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31. Consequences
Low literacy levels and high language diversity need to
be dealt with and planned for
Don’t assume that the message transmitted is the
message received
Adapt materials and channels to local requirements
Culture, language, taboos etc
Use verbal communication when necessary:
Radio, local networks, village meetings
Reinforce the message repeatedly and frequently
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32. Clue: They don’t care about anti-counterfeiting technologies…
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33. Patients Want Safe Medicines
Supply chain security is vital
Customer is a useful last link for security
Many people are too poor to have choices
Choice of fake or real may actually be drug or no drug
Distinctions are often blurred
Traditional medicine versus western drugs
Expensive versus cheap
Genuine versus fake
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34. Why Don’t Drug Companies Just Concentrate on
Keeping Developed Markets Safe?
Serialize (code) everything but only check a subset
Developed countries, Major urban centres
Protect (paying) patients’ health, share price, revenues
Eliminate the costs and complexity of a global system!
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“Devil’s Advocate” question!
36. Or Share of Tuberculosis…
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37. “Fake tuberculosis and malaria drugs alone are estimated
to kill 700,000 people a year. That’s equivalent to four
fully laden jumbo jets crashing every day.”
Julian Harris, International Policy Network, 2009
www.policynetwork.net/health/publication/keeping-it-
real-protecting-worlds-poor-fake-drugs
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38. The World is Small, Disease Travels and Everyone is Connected
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39. Send me an email if you want to know more about
global anti-counterfeiting issues.
Photo on title slide by John Steven Fernandez www.flickr.com/photos/stevenfernandez/2069638117/
Maps are from Worldmapper.org and Buckminster Fuller Institute
Any man's death diminishes me,
For I am involved in mankind.
And therefore never send to know
For whom the bell tolls;
It tolls for thee.
(John Donne)
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