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Leveraging Public-Private Partnerships in Surveillance, Enforcement and Prevention of Illicit Online Counterfeit Drug Sales
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.
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Leveraging Public-Private Partnerships in Surveillance, Enforcement and Prevention of Illicit Online Counterfeit Drug Sales
- 1. Global Counterfeits andPublic 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 Searchof 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 TheNeed 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 PrivateSector 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 OnlineRegulation 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 prevalenceof 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
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- 11. Case Study Operation PangeaIII: 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 forPublic-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 OnlinePharmacies 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 andthe 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 isneeded 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.
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