global perspectives on pharmaceutical anti-counterfeiting
DESCRIPTION
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.TRANSCRIPT
A Global View of Anti-Counterfeiting
Mark Davison
© John Steven Hernandez
AgendaWhat are the global issues?What anti-counterfeiting technologies could
work everywhere?How do we best serve developing countries?What do the patients want?
World Map by Land Area
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
“Headline” Counterfeit Flows
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Response: Logistics-Based SecurityControl 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
Deadliest Counterfeit Flows
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
“Internal”Counterfeits
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Logistics is Only One AspectTech-centric approaches are difficult in
developing countriesDoesn’t deal with locally-produced fakesWider approach is needed
Global Share of Land…
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
… Share of Population
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
…and Share of Poverty
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
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 2007http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
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 2007http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
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 2007http://www.pharmacy.ca.gov/meetings/minutes/2007/07_dec_enf1.pdf
#8GDPWorldwide.If California cant afford it, who can?
“Ubiquitous Anti-Counterfeiting Technology” Must Be:SecureEasy to use with minimal / no trainingPhysically robustLow entry costs (or subsidized)Flexible and scalableUpgradable and Replaceable
Role of the StateCentralized solutions may be the best option
Europe, USA, China, Brazil etc.Not all states will cope with serialization
Heavy subsidy and technical help neededScalable approaches to aid phased uptakeSupportive, non-punitive environment
But…Share of Public Health Spending
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
How About the Pharmacist?The last professional to touch the packTrained and trainable (in anti-counterfeiting
systems)Ubiquitous in every community?
Unequal Share of Pharmacists
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Publicly-funded Healthcare and Private Pharmacists
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Mostly private-sector pharmacists
Pharmacists
Public funding
Pharmacy-Based Drug Security
Relatively simple, logical approachMay not work everywhereNot all pharmacists are equivalentSometimes they are the problem not the
solution
How About the Consumer?UbiquitousLeast trained element of the supply chainMost to lose if product security fails:
We invest, but they ingestVery effective if given the right systemsCommunication is vital:
Education, education, educationShould only be the “sentinel of last resort”
against fake drugs
Cultural FactorsHow to get the message across to consumers?
Share of Literacy
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Share of Personal Computers
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Share of Languages
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
ConsequencesLow 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 requirementsCulture, language, taboos etc
Use verbal communication when necessary: Radio, local networks, village meetings
Reinforce the message repeatedly and frequently
What Do Patients Want?Clue: They don’t care about anti-counterfeiting technologies…
Patients Want Safe Medicines
Supply chain security is vitalCustomer is a useful last link for securityMany people are too poor to have choicesChoice of fake or real may actually be drug or
no drugDistinctions are often blurred
Traditional medicine versus western drugsExpensive versus cheapGenuine versus fake
Why Don’t Drug Companies Just Concentrate on Keeping Developed Markets Safe?
Serialize (code) everything but only check a subsetDeveloped countries, Major urban centres
Protect (paying) patients’ health, share price, revenues
Eliminate the costs and complexity of a global system!
“Devil’s Advocate” question!
Here’s why: Share of Malaria
© SASI Group (University of Sheffield) and Mark Newman (University of Michigan)
Answer!
“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
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 knowFor whom the bell tolls;It tolls for thee.
(John Donne)