Published on
Updated
Reading 2 min.
The European Union has asked its members to withdraw several hundred generic drugs from the market, saying their effectiveness had been poorly assessed. National health agencies have until Monday to decide, while taking care not to deprive patients of treatment.
What is going on ?
The European Commission asked EU states in late May to suspend the authorisation of around 400 generic drugs, giving them a one-month deadline. It will expire on Monday.
Generics are drugs whose basic molecule, the active substance, has fallen into the public domain. Their manufacture is therefore no longer reserved for the owner of their patent.
Their authorization is subject to much less strict rules than a new treatment. The manufacturer of generic drugs, such as the Israeli Teva or the French Biogaran, does not have to prove again their clinical efficacy or their absence of danger.
It just has to demonstrate in vitro that the generic drug releases the same amount of active substance as its model. This is called “bioequivalence” and this is the issue that is problematic here.
Where does the problem come from?
Generic manufacturers often do not do these tests themselves. They use subcontractors, known as “contract research organizations”, CROs.
However, the European health authority, the European Medicines Agency (EMA), discovered that one of these groups, the Indian Synapse Labs, was not carrying out these tests with the required rigour.
“For the majority of treatments tested by Synapse Labs, (…) data are lacking or insufficient to prove bioequivalence“, the EMA summarized in March.
Which treatments are concerned?
The 400 drugs targeted cover a wide range: anticancer drugs, particularly against leukemia and breast cancer, antidiabetics, therapy against HIV infection, antiepileptics, treatment of schizophrenia, etc.
As many generic manufacturers use Synapse’s services, the concern is not limited to one generic manufacturer but concerns all major players in the industry.
EU countries are affected unequally, depending on the treatments approved there. France, for example, is quite affected with 72 problematic drugs.
What risk for patients?
There is no immediate danger and health authorities, like patient associations, are taking care not to create panic.
“There is no manufacturing defect“, insisted Yann Mazens, one of the heads of France Assos Santé, the main French federation of patient associations, to AFP.
But “we are faced with products that potentially do not have the same effectiveness because the studies have not met the standards” he said.
And if this lower effectiveness is not proven as it stands, it remains a possibility and the patients concerned therefore run the risk of being less well treated, sometimes for serious and deadly pathologies.
What’s going to happen ?
National authorities are certainly not going to withdraw all these drugs from the market on Monday.
First, because some manufacturers of these generics have already re-tested and proven the bioequivalence of treatments on the list.
Then, and above all, the European Commission has left a wide margin of manoeuvre to the States not to immediately withdraw irreplaceable treatments for patients.
“These critical drugs are those that would have large market shares or would not have a therapeutic alternative.“, stressed the French drug agency, ANSM, questioned by AFP.
In this case, Brussels gives states up to two years to finally withdraw a treatment, in the event that supporting data has still not been provided by the manufacturer.
The ANSM, which will make a decision on Monday but will not make any public announcement immediately, is refusing for the time being to give any order of magnitude on the number of immediate withdrawals.
Similarly, in Germany, another country concerned by many treatment references, the Federal Institute for Medicines and Medical Devices refrained from commenting to AFP.