Global counterfeit drugs sold online pose a major public health risk. Unregulated internet pharmacies sell counterfeit medicines to unsuspecting consumers around the world, threatening patient safety. Current enforcement efforts are inadequate, as illicit online drug sales can still be easily found. A coordinated, multi-sector approach is needed involving public-private partnerships between law enforcement, regulatory agencies, internet and payment companies, and others. Through active surveillance of online drug sales, information sharing, and prevention efforts, partnerships can help curb this growing global health threat.

1. Global Counterfeits and Public Health
Leveraging Public Private Partnerships in Surveillance,
Enforcement and Prevention of Illicit Online Drug Sales
Timothy K. Mackey, MAS
GRF One Health Summit
February 2012

2. Global Counterfeits
In Search of Better Global Health Governance
Current Challenges
• Global distribution of counterfeit
medicines in both resource-poor and
developed country settings
• Argument over terminology of
“counterfeits” based on IPR and
public health considerations
• Lack of coordinated surveillance/data
• Exacerbated by frenetic pace of
globalization and technology advance
(Internet/Online Pharmacies)

3. Scope of Problem: Online Dangers
Growing Use of the Internet
Growing Use of the Internet
• Drug Safety: Sell tainted, unapproved,
• 2 billion people currently access fake, misbranded, or poor quality drugs to
internet today unsuspecting users (counterfeit)
• Approximately 51% of users access • Patient Safety: Online sales advertised
internet for health information “do not require a prescription,” marketing
of drugs may be misleading,
• Online searches for health establishments are unregulated
information may lead to risky online
drug purchases • Security Issues: Online pharmacies are
connected with financial fraud and funding
• Online pharmaceutical sales of other criminal activities
estimated at $11 billion

4. Scope of Problem: Online Dangers
Drug Safety
Global Scope and Reach
• Anything and Everyone: Online
drugs available for anything and
accessible to anyone.
• Dangerous: High prevalence of
counterfeit medicines sourced from
various countries using
questionable manufacturing
practices
• Counterfeit Drugs almost
impossible to differentiate:
Packaging and labeling of drugs
very authentic though drugs may
be dangerous

5. Plethora of Actors
The Need to Engage Multiple Actors/Stakeholders
• Multifaceted problem involving both
public and private sectors. Need for
coordination and cooperation from
multiple stakeholders
• Global drug trade implicates many
different countries and impacts global
patient populations
• Private sector role key in surveillance
and identification of illicit drugs/online
pharmacies
• Global enforcement efforts against
online pharmacies have only been
successful through multi-sector efforts

6. Network of Private Sector Actors
Role of Service Providers
Illegal Manufacturers
Search Engines: Index
Often overseas in countries such as online pharmacies through
1 India, China, Pakistan. Require paid and non-paid systems.
local enforcement efforts Receive ad fees.
Facilitators
Logistic Providers: Freight
carriers/forwarders involved
Source counterfeit or diverted in shipment and detection of
2 products for online drug sellers
illicit online drug sales
Service Providers Payment Processor: Allow
for payment and financing of
Mostly legal providers which enable illicit online pharmacies. Also
3 e-commerce of online drug sales benefit from service fees.
and secure financial benefit

7. Global Counterfeits
Fragmented Global Health Governance
Challenges and Regional
Progress
• Ryan Haight Act: U.S. legislation
against online pharmacies but only for
controlled substances and limited to
U.S.
• Kenya: Kenya Anti-Counterfeit Act
criticized as protected IPRs and
precluding access to medicines
• ACTA: Currently in discussion but may
emerge as a plurilateral instrument for
IPR enforcement of counterfeits
• MEDICRIME: A dozen countries signed
on to Council of Europe’s “MEDICRIME”
convention that seeks to criminalize
trade in counterfeit medicines.

8. Challenges of Online Regulation
Virtual Criminals in a Virtual Marketplace
Private Sector Enabled Public Enforcement Challenges No Partnership
1 • Websites are easily 2 • Regional law 3 • Fragmented local laws
opened and closed with enforcement not and regulations
many affiliate sites sufficient in bringing addressing counterfeits
making it difficult to down online pharmacy that serve only as a
pinpoint source networks patchwork
• Forms of online and • Impossibility in • No global regulatory
eMarketing can impact screening and regime to surveil and
thousands of confiscating millions of engage public and
consumers instantly illegal imports private sectors leading
driving demand to fragmented
• Difficult to attribute regulation
• Anonymity of the web patient death or injury
allows criminals to to online drug • Failure of state-based
endanger patient safety consumption or law makers to
without getting caught purchase specifically address
and leads to lack of challenges of online
transparency • Territorial/jurisdictional pharmacies
challenges

9. Additional Research
High prevalence of FDA Shortage and WHO Essential
Medicines List Vaccines available from online pharmacies
Prevalence of Online Vaccines
• All FDA Biologic Drugs
Shortage list vaccines
were available online
• None of the identified
FDA shortage vaccine
sellers were VIPPS
accredited, 75% were
“international” and 10/12
were “not recommended”
• Wide range of WHO EML
vaccines available online
Vaccine shortages and suspect online pharmacy sellers.
Liang BA, Mackey TK.
Vaccine. 2012 Jan 5;30(2):105-8. Epub 2011 Nov 15.
PMID: 22094281

10. Online Vaccines
“Over-the-counter”

11. Case Study
Operation Pangea III: Global Cooperation
Operation Pangea III
• Global Response: Participation of more
than 40 countries in int’l week of action
against online sale of counterfeit drugs
• Multi-sector: Involved law enforcement,
customs, national drug regulators, ISPs, and
payment providers and delivery services
• Results: Shut down 290 websites, 1 million
counterfeit pills confiscated, 76 individuals
under investigation. Seized illicit drugs
valued at $2.6 mil
• Criticized: IMPACT has been criticized by
member states and its future is under
question

12. Solutions: Need for Public-Private Partnerships
Multiple Actors, Multiple Problems, Need for Public-Private Cooperation
PPPs are a required solution
in a new GHG framework
• Private Sector: Role of surveillance
and reporting of illegal activity.
Private Sector Public Sector Adherence to laws and regulations.
(surveillance, (Law making, Public-Private
prevention, research, Partnerships • Public Sector: Role of enforcement
education and education (comprehensive) and prevention through law
reporting) enforcement) enforcement and legislation/regulation
• PPPs: Comprehensive solution
involving cooperation and sharing of
information to engage in active
surveillance, enforcement, and
prevention.

13. PPPs Combating Online Pharmacies
Active Coordination and Cooperation
Surveillance: Enforcement: Prevention:
>Active and real-time >Sharing of information >Utilize centralized
surveillance by ISPs, search from service providers and database for
engines, domain registrars, public to manufacturers, communicating information
etc. to central database regulators, and law to stakeholders for
>Development of web tools enforcement for verification proactive prevention
including algorithms, search >Collaborative evaluation of >Partnership in providing
bots/crawlers, online information and takedown education to patients about
screening of technical infrastructure purchasing online
Public – Private Partnership Models

14. Counterfeit Drugs and the One Health Paradigm
Integration, governance and multidisciplinary efforts
• Multidisciplinary: Requires cooperation
and coordination from many fields in public
and private sector through improved
governance
• Human Health: Public health
professionals to assess, surveil and
research counterfeit medicines.
• Environmental Science: Assess climate
change and impact on vector control that
can lead to increase use of counterfeited
medicines (i.e. antimalarials)
• Economic Security: Populations of low
SES purchase counterfeit medicines due to
lack of access. Health system
strengthening a must.

15. Final Summary
Action is needed to protect the global public
Internet Pharmacies Present Global Health Risks
1 Unregulated internet pharmacies sell counterfeit drug products and represent a
significant threat to global public health with tragic consequences for consumers.
Current Enforcement is Inadequate
Current enforcement is inadequate. Search now and you will still be able to find
2
illicit drugs online. PPPs are necessary to combat this global problem.
Progressive Reform is Necessary
3
Additional research is necessary on the scope of this problem. Dynamic and
active surveillance, enforcement and prevention through PPPs is necessary.

16. THANK YOU!
Questions?