PSI should make its counterfeit medicines data public, says Lancet

The Pharmaceutical Security Institute should be more transparent about the information in its databases on counterfeit medicines, argues The Lancet in an editorial in its latest (May 15) edition.

"Evidence of a dangerous iatrogenic epidemic is … being hidden by industry and this situation must change," according to the journal, which says PSI holds vital information about the global extent of counterfeiting, the categories of drugs being falsified and the locations where fake drugs are being marketed.

The call ties in with a move towards openness in pharma, which is a big trend at the moment, with new regulations and guidelines making the sector ever more transparent in areas such as political lobbying, payments to healthcare practitioners and the conduct and results of clinical trials.

It is arguable, however, whether such an approach is advisable in counterfeiting, where criminality lies at the core of the issue. Organisations with a critical need to view PSI's data such as enforcement agencies can already gain access, so investigations into the crimes are not generally compromised.

There could also potentially be negative consequences, for example by alarming the public unnecessarily and by alerting the counterfeiters - who seem to be increasingly fast-moving - to scrutiny that will enable them to move onto other activities and evade detection. It is common for regulatory agencies to keep their 'watch lists' of counterfeited medicines under wraps for exactly these reasons.

Fair play to The Lancet though for raising the issue, which has a bearing on the ongoing debate about how much consumers should be involved in the fight against counterfeiting, for example by authenticating their own products using smartphones or reporting suspected fakes to the brand owner, something which has worked well for manufacturers in other sectors such as luxury goods.

PSI response

PSI sent the following comment in response to The Lancet's editorial:

Thomas T. Kubic, President and CEO of the Pharmaceutical Security Institute, stated that the need for close working relationship between the industry, drug regulators and law enforcement is critical to successfully confronting well organized global illegal counterfeiting groups.

To facilitate these efforts, the PSI was established, said Kubic  He noted that information concerning “the global extent of counterfeiting, the categories of drugs being falsified and the locations where fake drugs have been detected" is collected on an annual basis. The most recent information can be found on the Institutes’ website.

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