How to achieve international action on falsified and substandard medicines

Article Highlights

  • Grouping all illegitimate medicines together gives the false impression that they require the same solution.

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  • Falsification occurs not just in expensive proprietary medicines but also the cheapest generic ones.

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  • An effective global health treaty would define illegitimate medicines and public health crimes and create a cooperative forum.

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How to achieve international action on falsified and substandard medicines

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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. 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. In rich countries, medicine safety is better, but substandard and falsified drugs still cause thousands of adverse reactions and some deaths. As the outsourcing and international trading of medicines becomes standard, patients everywhere are vulnerable.

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. 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.

Download the PDF to read the full paper.

Authors:

Amir Attaran Canada research chair in law, population health, and global development policy 1, Donna Barry policy and advocacy director 2, Shamnad Basheer professor in intellectual property law3, Roger Bate resident scholar4, David Benton chief executive officer5, James Chauvin president6, Laurie Garrett senior fellow for global health 7, Ilona Kickbusch director, global health programme8, Jillian Clare Kohler director global health9, Kamal Midha immediate past president10, Paul N Newton reader in tropical medicine11, Sania Nishtar president12, Paul Orhii director- eneral13, Martin McKee professor of European public health 14

1University of Ottawa, 1 Stewart St, Ottawa, ON, K1N 6N5, Canada ; 2Partners in Health, Boston, USA; 3National University of Juridical Sciences, Kolkata, India; 4American Enterprise Institute, Washington, USA; 5International Council of Nurses, Geneva, Switzerland; 6World Federation of Public Health Associations, Geneva, Switzerland; 7Council on Foreign Relations, New York, USA; 8Graduate Institute, Geneva, Switzerland; 9University of Toronto, Toronto, Canada; 10International Pharmaceutical Federation, The Hague, Netherlands; 11University of Oxford, Oxford, UK ; 12Heartfile, Islamabad, Pakistan; 13National Agency for Food and Drug Administration and Control, Abuja, Nigeria; 14London School of Hygiene and Tropical Medicine, London, UK

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