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

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Jerry Norris raises the important issue of the oversight of drug quality and the role of the World Health Organisation’s pre-qualification program (WHO PQ). He is correct that WHO PQ had significant problems early on, but teething problems were resolved more than 5 years ago, and his observations today seem dated and irrational.

For example, Mr. Norris complains that when in 2004 WHO discovered low quality medicines being sold as prequalified, it withdrew its prequalification. That actually seems reasonable to us—or would Mr. Norris rather the alternative that WHO sweep the problem under the rug and not withdraw its prequalification?

Mr. Norris implies that because WHO is ineffectual, so would be a global treaty to improve medicine quality. That is a wild leap of illogic, and simply wrong. First, a global treaty would cover far more products than just the small number of WHO-prequalified medicines. Second, a treaty would not depend on WHO for its enforcement mechanisms (indeed, WHO is not a law enforcement agency). Third, in the limited role it plays today, WHO has achieved much to improve medicine quality. As we have shown elsewhere ( WHO-prequalified malaria medicines, while not always perfect, are significantly less likely to be substandard than their competitors.

We agree with Mr. Norris when he concedes that WHO processes can help bring about “a substantial mitigation of substandard drugs.” The pressing need now is for an international law mandate—basically, a treaty—to prioritize that task, not just for WHO, but for all its member states.

Competing interests: None declared

Roger N Bate, Health Economist

Amir Attaran, Ottawa University

American Enterprise Institute, 1150 17th St NW, Washington DC 20036

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Dear Editor

All the Good that is being Done can be Undone

The authors have made an important contribution to the increasingly critical subject of falsified and substandard medicines. Perhaps this is best expressed through a recent World Bank Workshop in October which confined itself to the subject of counterfeit drugs, saying that “30% of medicines circulating in Africa are counterfeits”. (1) Still, a participant from U. S. Pharmacopeia took the opportunity to comment on that percentage by saying: “we see more substandards than counterfeits”. (2)

Unfortunately, there are UN institutional forces that place their specialized agencies in compromising positions. As a Membership Organization, WHO is required to support the drug requirements of its Member States. From May – September 2004, WHO had to de-list 36 ARVs that it had previously approved for use by poor patients. It then issued a public press release to explain the rationale behind the de-listings, commenting: it was “due to a lack of proof of bioequivalence because not all Members require in vivo bioequivalence”. (3) All the ARVs in question were from India; it did not require this standard for exported drug products.

While WHO issues a GMP Certificate to Members, this is a manufacturing requirement. A product standard is granted by recognized regulatory authorities which attest to a drug’s quality, safety and efficacy. In all issues of WHO’s Prequalification Programme, it contains this Disclaimer: “inclusion in the list does not constitute an endorsement, or warranty of the fitness, of any product for a particular purpose, including in regard of its safety and/or efficacy in the treatment of HIV/AIDS”. (4)

The path to a substantial mitigation of substandard drugs lies through WHO. By blending its considerable moral forces with the enforcement mechanisms of stringent regulatory authorities, access to quality medicines for the poor would be assured, lowering greatly the use of substandard medicines in the developing world.

Without this kind of collaborative partnership, a “new global treaty” as the authors recommend would be ineffectual. All the good that is being done by the use of products that have been approved for use by stringent regulatory authorities can be undone by this troublesome acceleration in the use substandard drugs, some of which bear the imprimatur of WHO as a Membership Organization.


Jeremiah Norris
Center for Science in Public Policy
Hudson Institute
1015 15th Street, N. W.
Washington, D. C. 20005
(202) 974-2430

End Notes:
1.A Workshop on Counterfeit Medicines promoted by the Global Forum on Law, Justice and Development and hosted by the World Bank, October 2-3, 2012, Washington, D. C.
2.Op cit.
3.Announcement (Removal of Antiretroviral Products from the WHO List of Prequalified Medicines, Information and Guidance for Regulatory Bodies, National AIDS Programms, Doctors and Patients) in response to the many questions it has been receiving on this subject, WHO, Geneva, September 21, 2004.
4.Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality, Procurement Quality and Sourcing Project, WHO, Geneva, all Editions since October 2003.

Competing interests: None declared

Jeremiah Norris, Senior Fellow

Center for Science in Public Policy Hudson Institute , 1015 15 th Street NW Washington DC 20005

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Congratulations to the Authors for highlighting a critical issue in the delivery of Healthcare globally, particularly for vulnerable communities. It provides a really excellent overview of the current state of play in respect of "Counterfeit/Falsified Medicines".

It was noteworthy ,however, that no mention was made of a current important EU Directive: the 'so-called' Falsified Medcines Directive. This is intended to ensure that all packs of at-risk Medicines are verified through a central EU Data Repository, along with measures to control Online sales of Medicines, to secure points all along the Supply Chain and to secure the quality and safety of starting materials.

For those readers who may have an interest following up on the text and progress of the 'Falsified Medicines' Directive; please follow the next two links:



Again allow me thank the Authors for providing a high quality (accurately-referenced) summary of how the battle against 'Falsified Medicines' is progressing at a global level. Their proposal of a Global Treaty to bring the disparate strands together is worthy of closer scrutiny.

Competing interests: None declared

Tom Taaffe, Pharmacist

Community Pharmacy, Co Leitrim, Ireland, Ballinamore, Co Leitrim, Ireland

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Global regulation in place to prevent and prosecute companies that produce and flood the market with fake drugs is the need of the hour. Life saving drugs that do not exert the required action put patients in grave danger. Every nation has drug control and regulatory bodies. Yet there are companies who produce fake drugs and label them with standard company names and sell them. It is unethical and unthinkable that companies could resort to such practice tampering with life saving drugs.

In a world where people do unthinkable things for the sake of money, however, the production of fake drugs is not so strange. A global policy and legal system could act on such illegal issues. Global education and awareness of the presence of fake drugs in the market could help solve the problem to some extent. We have countries who sell prescription drugs over the counter, so how can we check the flow of fake drugs into the market?

A few non-governmental organizations (NGOs) could be formed with expertise who could randomly check drugs sold over the counter to detect fake drugs. These organizations could make a list of centres selling such drugs and make it public. They could also share the information with government regulatory agencies and through their lawyers send legal notices to bring the centres to a court of law.

Yet as long as we have a very big gap between professed values and operational values markets for fake drugs or banned narcotics will flourish. The organizations who sell them are sometimes more powerful with their money and fire power. It is true that global action needs to be taken to benefit the patient. Corporate pharmaceutical industries must come forward to fight the menace with their resources. We have pending global issues like climate change. We are adding one more issue to the bag of warnings, hoping for real action to be taken.

Competing interests: None declared

dhastagir s sheriff, Professor

Faculty of Medicine, Benghazi University, Benghazi, Libya

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