Intended for healthcare professionals


How to achieve international action on falsified and substandard medicines

BMJ 2012; 345 doi: (Published 13 November 2012) Cite this as: BMJ 2012;345:e7381
  1. Amir Attaran, Canada research chair in law, population health, and global development policy1,
  2. Donna Barry, policy and advocacy director2,
  3. Shamnad Basheer, professor in intellectual property law3,
  4. Roger Bate, resident scholar4,
  5. David Benton, chief executive officer5,
  6. James Chauvin, president6,
  7. Laurie Garrett, senior fellow for global health7,
  8. Ilona Kickbusch, director, global health programme8,
  9. Jillian Clare Kohler, director global health9,
  10. Kamal Midha, immediate past president10,
  11. Paul N Newton, reader in tropical medicine11,
  12. Sania Nishtar, president12,
  13. Paul Orhii, director-general13,
  14. Martin McKee, professor of European public health14
  1. 1University of Ottawa, 1 Stewart St, Ottawa, ON, K1N 6N5, Canada
  2. 2Partners in Health, Boston, USA
  3. 3National University of Juridical Sciences, Kolkata, India
  4. 4American Enterprise Institute, Washington, USA
  5. 5International Council of Nurses, Geneva, Switzerland
  6. 6World Federation of Public Health Associations, Geneva, Switzerland
  7. 7Council on Foreign Relations, New York, USA
  8. 8Graduate Institute, Geneva, Switzerland
  9. 9University of Toronto, Toronto, Canada
  10. 10International Pharmaceutical Federation, The Hague, Netherlands
  11. 11University of Oxford, Oxford, UK
  12. 12Heartfile, Islamabad, Pakistan
  13. 13National Agency for Food and Drug Administration and Control, Abuja, Nigeria
  14. 14London School of Hygiene and Tropical Medicine, London, UK
  1. Correspondence to: A Attaran aattaran{at}
  • Accepted 26 October 2012

Substandard and falsified medicines kill patients, yet progress on the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones has been held back by controversy over intellectual property rights and confusion over terms. Amir Attaran and colleagues propose a global treaty to overcome the problems

Every day patients in need of effective treatment receive substandard or fake drugs and other medical products.1 2 At best patients taking these compromised products get no relief from their symptoms; at worst they may die. In poor countries, half of medicines for some deadly diseases are fake and have little or no active ingredient.3 In rich countries, medicine safety is better, but substandard and falsified drugs still cause thousands of adverse reactions and some deaths.4 5 6 As the outsourcing and international trading of medicines becomes standard, patients everywhere are vulnerable.4 5

In 2010, after years of debate, WHO’s member states established a working group to decide how best to tackle this scandal, but progress remains halting.7 The working group (now called the member state mechanism) still cannot agree how to define the various poor quality medicines, much less settle on any concrete actions.

There are several reasons for this inadequate progress, yet all are possible to overcome. In this article we—a diverse group of authors from the health professions, health charities, legal and medical academia, and former or current government officials in health—outline the current challenges and propose possible solutions.

Common interest

The most fundamental reason for current and past inaction is a failure to recognise shared goals. Although drug companies, non-governmental organisations, and governments all want reliable access to safe and effective medicines and deplore unsafe fake medicines, it is difficult to achieve agreement on action because discussions too often trespass into conflict prone areas …

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