Spotlight on: Substandard & Counterfeit Medicines

Substandard or counterfeit medicines

Legitimate, quality generic medicines have nothing to do with counterfeit or substandard drugs.  Confusing generic medicines with counterfeit, substandard or spurious medicines is dangerous.

What’s in a name? Quite a lot when it comes to medicines...

  • generic medicine is a legitimately-produced medicine that is an exact copy of the originator product and performs in exactly the same way.  Generic medicines used in donor-funded treatment programmes and by MSF must meet quality standards to prove they are just as effective as the originator product. Health programmes around the world rely on these affordable copycat medicines.

  • substandard medicine is a drug that does not meet quality standards – it may contain too much or too little of the active ingredient, may be contaminated, may be poorly packaged or fail to meet quality standards in other ways. These medicines may be legitimately-produced mistakes or may have been knowingly produced to a substandard level. Both originator and generic medicines can be found to be substandard, and the issue of substandard medicines is a neglected one that needs far more attention.

  • fake medicine is deliberately and fraudulently mislabelled, giving false information on where it was made or by whom, so that people will think it is a legitimate medicine. Fake medicines are dangerous as they are unlikely to contain the active pharmaceutical ingredient needed to make the medicine effective, and may even contain harmful substances. These medicines present a serious threat for public health that needs to be appropriately addressed.

  • The term ‘counterfeit medicine’ is overly-broad and creates confusion because it conflates intellectual property issues with public health problems. Different organisations and countries use different definitions of the word, making it hard to know exactly which problem is being referred to when this term is used. Some definitions focus on broad intellectual property terms and so confuse legitimate generic medicines with dangerous fakes.  For this reason, MSF believes the term counterfeit should not be used in relation to medicine and instead more accurate and precise terms such as ‘fake’ or ‘substandard’ should be used.

Generics caught in the crossfire

Authorities are trying to crack down on fake medicines – and they should. These dangerous, illegal products need to be taken out of the market. But some authorities are – intentionally or otherwise – confusing legitimate generic medicines with counterfeit and substandard medicines.  This could seriously hamper the flow of safe, legitimate and life-saving generic medicines that are so essential to MSF’s work and the work of other treatment providers.

The European Commission has been closely involved in several activities that promote this dangerous confusion and pose a threat to access to affordable medicines. EU customs authorities have seized a number of shipments of legitimate generic drugs in transit through the EU to patients in developing countries on the grounds that they might be ‘counterfeit.’ This meant that health staff in developing countries were left scrambling to find medicines so that their patients wouldn’t have their treatment interrupted.

Putting and end to the confusion and protecting generics

MSF has been advocating for a clear understanding of the difference between generics, substandard drugs and fakes to ensure that legitimate generic medicines are not caught in the crossfire. We also lobby governments to remove harmful customs regulations in trade agreements and other legislation.