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Counterfeit, substandard and generic drugs: distinct definitions for distinctly different problems

People often seem to confuse counterfeit, substandard and generic medicines – using the terms interchangeably. But they are very separate issues and clearly defining their differences is critical to any discussion. Ellen ‘t Hoen, former Policy Advocacy Director of MSF’s Campaign for Access to Essential Medicines, explains here how the repercussions of confusing counterfeit, substandard and generic drugs can be very negative indeed…

So what is a counterfeit medicine?
Precise definitions are at the heart of this issue: counterfeit medicines are products that are presented in such a way as to look like a legitimate product although they are not that product. In legal terms this is called trademark infringement. They are the result of deliberate criminal activity that has nothing to do with legitimate pharmaceutical producers – be it generic or brand producers. The pills and their packaging may look exactly like, for example, a GlaxoSmithKline product, or like a generic Ranbaxy product, but they aren’t, and they may or may not have any active pharmaceutical ingredient. They can therefore be harmful and should not be given to patients. Whenever we come across counterfeit products in our work, we immediately report it and share the information with our partners. We believe everyone should do the same because transparency is important in preventing the availability and use of counterfeit medicines.

And what is the definition of a substandard medicine?
This is a very separate issue. Substandard is when a legitimate drug producer has a product that does not meet the standards set by the relevant drug regulatory authority. So this is an issue of quality control that can affect both brand name drugs, as well as generic drugs. An example of a substandard issue was when Roche had to recall European batches its HIV/AIDS drug nelfinavir in 2007. It had been discovered that during the European manufacturing process of the pills, high levels of a known carcinogen in animals had entered the production. So Roche’s licence for marketing nelfinavir in Europe was temporarily suspended for a few months whilst the problem was resolved and then the licence was reinstated. It was essentially a problem of quality control for a legal drug.
 
And a generic?
A generic drug is a legitimately produced medicine that is the same as the original brand name product – it contains the same active ingredients but is not made by the company that first developed, marketed and often patented the drug. A generic product is in general not patent-protected but it will have the same effect as the patented brand name product. Because generics are in general a lot cheaper than patented products, they have played a huge role in making sure people actually have access to essential medicines in the developing world.  MSF relies overwhelmingly on quality Indian generics for its antiretrovirals to treat HIV/AIDS, for example.


If substandard, counterfeit and generics are such distinct issues why are they often referred to together?
Today there is a real attempt by certain actors to confuse the debate. You will often see articles in the media that discuss counterfeit, substandard and generic medicines as if they are all one problem and the same solution can be used for all of them. Often these articles deliberately try to confuse the issue of counterfeit drugs with generic drugs. Of course this confusion can have a negative impact – because if the public believes that generic medicines are the same as counterfeit medicines, they will lose confidence in generic medicine, which may be problematic given the huge positive impact generic medicines have had for access to medicines in the world. Another negative consequence of confusing counterfeit and generic drugs, is that this often leads to calls for stronger intellectual property enforcemement, which then creates access to medicines problems.

Are policy makers aware of the dangers of confusing the issues?
We have seen that even at the level of policy makers, these confused messages can have a very negative effect. Today there is draft legislation before the Kenyan parliament designed to combat counterfeiting of medicines. But the definition of counterfeit medicine used in the legislation is so confused that if the bill actually passes, access to legitimate health products may be hampered. [see MSF briefing note]  

What is the role of the World Health Organization here?
WHO has a role to play in supporting national regulators to take measures against both counterfeit and substandard medicines. On counterfeiting, WHO can help identify what effective measures can be used to combat it as well as clarifying that counterfeit products are very different from a legitimate generic product. For example, WHO, in our view, should speak out and give some guidance to Kenyan policy makers in the current debate about the Kenyan counterfeit act to make sure that the bill does not become a barrier to access to affordable quality medicines and other health care products. But perhaps most importantly WHO should shift its attention to substandard medicines. From our perspective of working in the field, this is a much bigger problem than counterfeit medicines. In recent years WHO has perhaps overemphasised the counterfeit problem, at the detriment of giving support to upgrade pharmaceutical production capacity in developing countries. WHO also has a part to play in assisting national regulatory agencies to ensure the quality of medicines is maintained. The WHO Prequalification Project already plays an important role. We believe, however, that not enough attention has been given to measures to improve the quality of pharmaceutical products and this is something we think should change.

Last updated April 2009