Table 1.
Organizations addressing falsified and substandard (FS) medicines, 2018
| Organization | Examples of projects/role | Website | |
|---|---|---|---|
| Multi-lateral/International and Legislative Agencies | |||
| 1 | WHO | Provides technical guidance, implements capacity building, and conducts product pre-qualification; manages WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Coordinates with other UN agencies | http://www.who.int/medicines/regulation/ssffc/en/ |
| 2 | UN Office on Drugs and Crime | Focuses on criminal justice tied to the trade of falsified medicines; works with other UN agencies | http://www.unodc.org/unodc/en/fraudulentmedicines/introduction.html |
| 3 | World Bank | Leads the regional medicines regulatory harmonization initiatives in Africa and Southeast Asia | https://themedicinemaker.com/issues/0917/harmonization-regulation-goes-global/ |
| 4 | Council of Europe/Medicrime Convention | First international treaty that criminalizes activities associated with supply/trafficking of counterfeit medicines | https://www.coe.int/en/web/medicrime |
| 5 | World Customs Organization | Partners with INTERPOL and field customs organizations on raids and provides technical assistance on strengthening capacity of customs professionals | http://www.wcoomd.org/en/media/newsroom/2016/june/wco-participates-in-operation-pangea-ix-against-fake-and-illicit-medicines.aspx |
| 6 | INTERPOL | Serves as an international legislative organization, conducting raids on FS medical products (Operation Pangea) | https://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea |
| Donor and Aid Agencies | |||
| 7 | U.S. Agency for International Development | Purchases and delivers life-saving drugs and commodities; strengthens regulatory systems, and/or chains working closely with LMIC governments and implementing partners. Special focus on HIV and malaria medicines through the President's Malaria Initiative and President’s Emergency Plan for AID’s Relief | https://www.ghsupplychain.org/our-work/project-approach |
| 8 | The Global Fund | Invests in LMICs to support HIV, tuberculosis, and Malaria programs. Funds several implementing partners and governments securing supply chains and the quality assurance of medicines. Established an interagency working group to deal with medicines quality assurance | https://www.theglobalfund.org/en/oig/updates/2017-04-28-message-from-the-executive-director-supply-chain-processes/ |
| 9 | Wellcome Trust | Focus on antimicrobial resistance; detection and tracking technologies for poor-quality medicines | https://www.gphf.org/images/downloads/library/20091wellcometrustreport.pdf |
| 10 | The Bill & Melinda Gates Foundation | Health product value chains across the foundation’s portfolio; indirectly addressing FS medicines | https://www.gatesfoundation.org/What-We-Do/Global-Development/Integrated-Delivery |
| 11 | U.K.’s Department for International Development (DFID) | Market approaches to quality assurance of medicines. DFID’s investments in vaccine regulatory systems strengthening | https://www.gov.uk/government/news/new-initiative-to-improve-access-to-quality-essential-medicines-in-kenya |
| Implementing Agencies | |||
| 12 | U.S. Pharmacopeia | Reference standards; conducts regulatory strengthening. Technical assistance in quality assurance via its Global Health Impact Programs and the Promoting the Quality of Medicines Program | https://www.usp-pqm.org/ |
| 13 | Chemonics | Implementer optimizing supply chains to deliver essential commodities in LMICs | https://www.chemonics.com/technical-areas/supply-chain-solutions/ |
| 14 | Population Services International | ACT-watch gathers malaria case management commodity market data on diagnostics, medicines, and fever case management availability, readiness, market share, and price in the private and public health sectors | http://www.psi.org/project/actwatch-malaria-treatment/#about |
| 15 | Family Health International 360 | Focus on quality of clinical laboratories in under-resourced countries, enhancing the quality of research studies and public health programs | https://www.fhi360.org/services/quality-assurance |
| Private Sector Consortiums | |||
| 16 | Pharmaceutical Security Institute | Non-profit composed of more than 34 security departments of major pharmaceutical companies; develops systems to identify the extent of FS medicines | http://www.psi-inc.org/index.cfm |
| 17 | International Federation of Pharmaceutical Manufacturers | Trade association for research-based biopharmaceutical companies. Convener and thought leader to facilitate collaboration and dialog across industry and associated stakeholders | https://www.ifpma.org/topics/falsified-medicines/ |
| Academic Organizations | |||
| 18 | London School of Tropical Medicine and Hygiene | Field surveillance of medicine quality to policy analysis. Offers a course on Quality of Medical Products and Public Health | https://www.lshtm.ac.uk/study/courses/short-courses/quality-medical-products |
| 19 | Wellcome-Mahosot-Oxford University Tropical Medicine Research Collaboration | Vientiane, Laos; conducts research, including forensic analysis on medicines | https://www.ndm.ox.ac.uk/principal-investigators/researcher/paul-newton |
| 20 | Georgia Tech | Mass spectroscopy analysis on medicines | https://www.chemistry.gatech.edu/faculty/fernandez/ |
| 21 | UNC Gillings School of Global Public Health | Works with stakeholders to study the pandemic of poor-quality medicines and its economic burden. Collaborates with the School of Pharmacy | https://sph.unc.edu/global-health/badmedskill/ |
| 22 | Johns Hopkins Center for Communication Programs | Created the Promoting the Quality of Malaria Medicines project with an implementation toolkit. | https://sbccimplementationkits.org/quality-malaria-medicines/contactus/ |
| 23 | Notre-Dame | Developed the first paper-based test of medicine quality; continues to develop and test technologies | http://www.bbc.com/news/health-32938075 |
| 24 | Centers for Disease Control and Prevention | Quality control and new technologies using advanced referral and field-based approaches | http://www.cdc |
| 25 | University of California San Diego, Global Health Policy Institute | Research risk of online pharmacies and using blockchain for supply chain security | http://www.ghpolicy.org/about/about.html |
| Think Tanks/Research Organizations/Consortiums/Advocacy Orgs | |||
| 26 | Fogarty international Center, National Institutes of Health | Research and convenes stakeholders on the global extent of poor-quality medicines and agenda setting. | https://www.fic.nih.gov/News/Pages/2015-global-pandemic-of-fake-medicines-poses-urgent-risk.aspx |
| 27 | QUAMED | Implements projects on improving access to quality medicines | https://quamed.org/en/home.aspx |
| 28 | The Infectious Diseases Data Observatory/World Wide antimalarial Resistance Network | The Medicine Quality Scientific Group is sharing expertise and collating information to increase understanding of the prevalence and distribution of poor-quality medicines around the world | http://www.wwarn.org/working-together/scientific-groups/medicine-quality-scientific-group |
| 29 | Rx-360 | Volunteer consortium led by manufacturers and suppliers from the pharmaceutical and biotech industries working together to strengthen supply chains, mainly via audits | http://rx-360.org/about/ |
| 30 | The Institute of Research against Counterfeit Medicines | Training and research on FS medicines. Mostly in France, and participates in training and awareness campaigns implemented by other organizations | http://www.iracm.com/en/about-iracm/ |
| 31 | New Partnership for Africa’s Development | Led development of the Africa Medicine Quality Forum to tackle falsified medicines | http://www.nepad.org/content/strategic-partners-align-nepad-fight-fake-drugs-africa |
| 32 | Fight the fakes | Raises awareness about the dangers of falsified medicines | http://fightthefakes.org/ |
| Pharmacy Organizations including Online | |||
| 33 | National Association of Boards of Pharmacy | Tracks and protects against illicit online pharmacies | http://nabp.pharmacy |
| 34 | Alliance for Safe Online Pharmacies | Thought leader and advocacy organization for protecting consumers globally and combating illegal online drug sellers | https://buysaferx.pharmacy/about-asop-global/ |
| 35 | Center for Safe Internet Pharmacies | Group of Internet service providers and technology companies to decrease consumer access to illegitimate pharmaceuticals from illegal online pharmacies and other sources | https://safemedsonline.org/ |
| 36 | LegitScript | Supports search engines, payment providers, and e-commerce platforms for business with legally operating pharmacies in 20 countries and 15 languages | https://www.legitscript.com/ |
ACT = artemisinin combination therapy; LMIC = low- and middle-income countries.