Leveraging Public-Private Partnerships in Surveillance, Enforcement and Prevention of Illicit Online Counterfeit Drug Sales
Global Counterfeits and Public HealthLeveraging Public Private Partnerships in Surveillance,Enforcement and Prevention of Illicit Online Drug Sales Timothy K. Mackey, MAS GRF One Health Summit February 2012
Global CounterfeitsIn 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)
Scope of Problem: Online DangersGrowing 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
Scope of Problem: Online Dangers Drug SafetyGlobal 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
Plethora of ActorsThe 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
Network of Private Sector ActorsRole 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
Global Counterfeits Fragmented Global Health GovernanceChallenges and RegionalProgress• 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.
Challenges of Online Regulation Virtual Criminals in a Virtual MarketplacePrivate 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
Additional ResearchHigh prevalence of FDA Shortage and WHO EssentialMedicines List Vaccines available from online pharmaciesPrevalence 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
Case StudyOperation Pangea III: Global CooperationOperation 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
Solutions: Need for Public-Private PartnershipsMultiple 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.
PPPs Combating Online Pharmacies Active Coordination and Cooperation Surveillance: Enforcement: Prevention:>Active and real-time >Sharing of information >Utilize centralizedsurveillance by ISPs, search from service providers and database forengines, domain registrars, public to manufacturers, communicating informationetc. to central database regulators, and law to stakeholders for>Development of web tools enforcement for verification proactive preventionincluding algorithms, search >Collaborative evaluation of >Partnership in providingbots/crawlers, online information and takedown education to patients aboutscreening of technical infrastructure purchasing online Public – Private Partnership Models
Counterfeit Drugs and the One Health ParadigmIntegration, 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.
Final SummaryAction 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.