Time for global action on fake and substandard drugs

Re: Time for global action on fake and substandard drugs

23 November 2012

Efforts to deal with the problem through a treaty beg the question whether a treaty is the solution to the problem. If we understand the problem better, perhaps we may conclude the problem is evolving.

The pharmaceutical supply chain is very, and overly, complex: active ingredients are sourced in country A, drugs are manufactured in country B, they are shipped through intermediate country C, for use in destination country D. The regulator in D needs to be able to exert oversight in A, B, and C at least as most countries import their drugs, but invariably lack extra-jurisdictional authority.

Who owns this problem and what solution knits together the various regulatory overseers, the commercial intermediaries, wholesalers and distributors who operate from a variety of countries? That there has been disharmony by those trying to come up with a solution is no surprise nor that it has foundered on definitions, given the way the problem has been framed by those charged with finding solutions.

Three issues contribute to characterising this as a complex (wicked) problem, requiring new thinking.

The first is that countries most at risk of counterfeits are also the countries that also score badly on international corruption rankings.

The second is that cash markets for drugs, and high medicine co-payments put pressure on patients to seek alternative and cheaper sources of supply in any country for that matter. One could argue that national policies on medicines availability and reimbursement may actually be contributing factor.

Which brings us to the third factor: the emergence of alternative sources of supply. An emerging disruptive culprit is the internet and internet pharmacies which have created what can be characterised as a parallel pharmaceutical supply chain. This has attracted organised crime. For them, counterfeits are a business, there are customers, there is a supply chain for fulfilment, and ways to get paid, so there is a market.

Competing interests: Author has advised on ways to stem trade in counterfeit medicines, and has published on determinants that contribute to the rise of counterfeiting as a problem.

Michael Tremblay, policy advisor

Tremblay Consulting, Canterbury, Kent CT1 2TU

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