The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Implications
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



The iatrogenic pandemic of untreated illness related to falsified and substandard medicines is intolerable, but has a logical explanation: in many countries, inadequate laws make it barely illegal to manufacture or distribute poor-quality medicines. The law hardly punishes those who intentionally or recklessly deal in falsified or substandard medicine, when clearly it should criminalize these perpetrators in proportion to the grievous—even fatal—injury they inflict on public health. To solve this omission, this article presents a new , which countries may freely use as a template for strengthening their national laws. The includes criminal prohibitions against manufacturing, trafficking, or selling poor-quality medicines; principles for appropriately punishing offenders; special provisions for Internet-based medicine crimes; tools for encouraging whistle-blowers to cooperate with law enforcement; incentives for developing governments to strengthen their drug regulatory capacity; and important exceptions to prevent the law being abused, such as to prevent the prosecution of legitimate medical researchers or to prevent good-quality generic medicines being seized while in transit. The Model Law is discussed and explained and is offered free of charge under a Creative Commons license to any governments wanting to implement it.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Article metrics loading...

The graphs shown below represent data from March 2017
Loading full text...

Full text loading...



  1. Public health code, Chapter 1 bis, falsified medicines, Article L5421-14.
  2. General Civil Penal Code of 22 May 1902, no. 10, section 360.
  3. Medicines Act, Article 101.
  4. Baker BK, 2012. Settlement of India/EU WTO Dispute re Seizures of In-Transit Medicines: Why the Proposed EU Border Regulation Isn't Good Enough. PIJIP Research Paper no. 2012-02. Washington, DC: American University Washington College of Law.
    [Google Scholar]
  5. Council of Europe, 2011. Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health. Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/211.htm. Accessed February 19, 2015.
    [Google Scholar]
  6. WHO International Medical Products Anti-Counterfeiting Taskforce, 2007. Principles and Elements for National Legislation against Counterfeit Medical Products, 12 December 2007. Available at: http://www.who.int/impact/events/FinalPrinciplesforLegislation.pdf. Accessed April 10, 2015.
    [Google Scholar]
  7. Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, Kickbusch I, Kohler JW, Midha K, Newton PN, Nishtar S, Orhii P, McKee M, 2012. How to achieve international action on falsified and substandard medicines. BMJ 345 e7381.[Crossref]
    [Google Scholar]
  8. 21 United States Code §331.
  9. Medicines Act 1968, sections 7, 8 and 45.
  10. Penal code, Article 121–3.
  11. Drug Administration Law of the People's Republic of China, Chapter IX.
  12. Drugs and Cosmetics Act 1940, s. 18.
  13. LegitScript and KnujOn, 2010. Rogues and Registrars: Are Some Domain Name Registrars Safe Havens for Internet Drug Rings? Available at: http://www.legitscript.com/download/Rogues-and-Registrars-Report.pdf. Accessed February 19, 2015.
    [Google Scholar]
  14. FDA Office of Criminal Investigations, 2015. January 23, 2015: Turkish Man Sentenced for Smuggling Adulterated and Misbranded Cancer Drugs. Available at: http://www.fda.gov/ICECI/CriminalInvestigations/ucm433570.htm. Accessed February 19, 2015.
    [Google Scholar]
  15. Weaver C, Whalen J, 2012. How fake cancer drugs entered U.S. Wall Street Journal, July 20, 2012. Available at: http://www.wsj.com/articles/SB10001424052702303879604577410430607090226. Accessed February 19, 2015.
    [Google Scholar]
  16. International Convention for the Suppression of Counterfeiting Currency, 1929.
  17. Nayyar GM, Breman JG, Newton PN, Herrington J, 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12 488496.[Crossref]
    [Google Scholar]
  18. U.S. Department of Justice, 2013. Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA. Press release, May 13, 2013. Available at: http://www.justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false. Accessed February 19, 2015.
    [Google Scholar]
  19. National Agency for Food and Drug Administration and Control Ports Inspection Directorate. Guidelines for Clearance of Imported Drugs (Human and Veterinary) and Related Products in Nigeria. Document NAFDAC/PID/001/00. Available at: http://www.nlipw.com/wp-content/uploads/2013/08/GUIDELINES-FOR-CLEARANCE-OF-IMPORTED-DRUGS-HUMAN-AND.pdf. Accessed April 10, 2015.
    [Google Scholar]
  20. WHO, 2003. Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality. Available at: http://apps.who.int/medicinedocs/pdf/s4921e/s4921e.pdf. Accessed April 10, 2015.
    [Google Scholar]
  21. Attaran A, Bate R, 2010. A counterfeit drug treaty: great idea, wrong implementation. Lancet 376 14461448.[Crossref]
    [Google Scholar]
  22. Bonino S, 2014. UN draft law against medicine crime is fatally flawed. The Conversation, August 14, 2014. Available at: http://theconversation.com/un-draft-law-against-medicine-crime-is-fatally-flawed-30281. Accessed April 10, 2015.
    [Google Scholar]
  23. New W, 2014. UN Office of Drugs and Crime enters debate over fake medicines and IP. Intellectual Property Watch, December 9, 2014. Available at: http://www.ip-watch.org/2014/12/09/un-office-of-drugs-and-crime-enters-debate-over-fake-medicines-and-ip/. Accessed February 19, 2015.
    [Google Scholar]
  24. Attaran A, Bate R, Bonino S, Newton P, 2015. Europe and the United Nations: clinical trials, not criminal trials. Harvard Public Health Review. Special Commentary, February 2015. Available at: http://harvardpublichealthreview.org/europe-and-the-united-nations-clinical-trials-not-criminal-trials/. Accessed February 19, 2015.
    [Google Scholar]
  25. Das S, 2014. India-led BRICS opposes UN arm's move on model drug law. The Economic Times, December 15, 2014. Available at: http://articles.economictimes.indiatimes.com/2014-12-15/news/57072196_1_expert-group-model-law-brics-countries. Accessed February 19, 2015.
    [Google Scholar]
  26. World Health Professions Alliance, 2010. WHPA Joint Statement on Counterfeiting of Medical Products. Available at: http://www.whpa.org/WHPA_Joint_Statement_on_Counterfeiting.pdf. Accessed April 10, 2015.
    [Google Scholar]
  • Received : 24 Feb 2015
  • Accepted : 12 Apr 2015
  • Published online : 03 Jun 2015
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error