Don't let counterfeits distract from substandard drugs, says think tank

The dangers of substandard medicines are being ignored and policymakers must do more to ensure that patient safety is maintained, according to the Stockholm Network, a European think tank.

The call comes in the wake of the publication of a new report entitled Keeping Medicines Safe, which suggests that substandard medicines - i.e. those which are legally authorised for manufacturing and often approved for market but do not meet required quality and safety standards - are being overlooked by policymakers whose attention is currently trained on counterfeit drugs.

"There must be a better understanding at the regulatory, policy and public level of the differences between substandard and counterfeited drugs," notes the report, which is authored by Drs. David Torstensson and Meir Pugatch.

"Counterfeiting is the deliberate production of illegal, unsanctioned and mostly harmful medicines," they write.

"Substandard drugs, by contrast, can be produced, sold and distributed by completely legitimate and authorised entities who are often unaware of their product being (or becoming) substandard," they add.

The report focuses on four emerging and fast-growing pharmaceutical markets - China, India, Brazil, Argentina and Turkey - which have been affected by substandard and counterfeit drugs. It examines the response to the problem by the national authorities and gauges their success, and puts forward general and country-specific recommendations for policy.

China is making strides forward, note the authors, but has one of the highest rates of substandard and counterfeit medicines in the world and needs to implement its existing regulatory framework more effectively, particularly with regard to enforcement.

India, on the other hand, suffers from disparate and inefficient regulations, for example a split in responsibility between national and provincial authorities, which is hampering progress.

Brazil - which is in the process of drawing up its own plans for serialisation of medicines to thwart counterfeiting - needs to strengthen its enforcement mechanisms and accelerate the implementation of new legislation which is currently due to come into force in 2015.

Brazil's pharmaceutical market contains a lot of so-called 'similars' - loosely drugs with a given active pharmaceutical ingredient (API) which have not undergone specific bioequivalency testing like generics - a phenomenon which also applies to neighbouring Argentina.

For Argentina the primary issue is one of visibility of the substandard and counterfeiting problem, as it does not yet operate a robust pharmacovigilance system.

Finally, Turkey should also improve regulations governing pharmacists and pharmacovigilance. The country is also attempting to introduce a serialisation programme to prevent counterfeiting and reimbursement fraud issues but is facing resistance to its implementation from pharmacists.

The key issue identified in the report is got governments around the world to acknowledge the extent to which the production of substandard drugs and counterfeiting is a real threat to public health and safety.

"This is the first step towards action," conclude the authors.