Global Perspectives on Pharmaceutical Anti-Counterfeiting

transcript

A Global View of Anti-Counterfeiting

Mark Davison

mark.davison@bluespherehealth.com 2

AgendaWhat are the global issues?What anti-counterfeiting technologies could

work everywhere?How do we best serve developing countries?What do the patients want?

What are the Global Issues?No Man is an Island…

How We See the World: People or Territory?

World Map by Land Area

“Headline” Counterfeit Flows

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

“Internal”Counterfeits

Logistics is Only One AspectTech-centric approaches are difficult in

developing countriesDoesn’t deal with locally-produced fakesWider approach is needed

What Technologies Could Work Everywhere?

Global Share of Land…

… Share of Population

…and Share of Poverty

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

How Best to Serve Developing Countries?

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

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

Publicly-funded Healthcare and Private Pharmacists

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

Share of Personal Computers

Share of Languages

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

Answer!

Or Share of Tuberculosis…

“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

The World is Small, Disease Travels and Everyone is Connected

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)

Global Perspectives on Pharmaceutical Anti-Counterfeiting

Business