Hundreds of generic drugs may be withdrawn from European markets.. What are the motives and consequences?

Written By Mark

The European Union asked its member countries to withdraw hundreds of generic drugs from the market, considering that the evaluation of their effectiveness was not correct. National health agencies have until Monday to decide their position, while ensuring that patients are not deprived of treatment.

what’s going on?

At the end of May, the European Commission asked European Union countries to suspend the licensing of about 400 types of generic medicines, and gave them one month to comply with this request, with a deadline ending on Monday.

Generic medicines are medicines whose basic molecule, or what is known as the active ingredient, is in the public domain. Therefore, its manufacture is no longer assigned to the patent owner.

The licensing of these generic medicines (or generic medicines) follows rules that are much less stringent than those approved for the launch of new treatments. Generic drug manufacturers, such as the Israeli Teva or the French Biogaran, do not have to prove again their clinical effectiveness or the absence of an associated risk.

These companies only need to prove in the laboratory that the generic drug releases the same amount of active ingredient as its original form. This is known as “bioequivalence,” and it is a problematic topic at the moment.

What is the source of the problem?

Generic drug manufacturers often do not conduct these tests themselves, but rather use third parties, called “contract research organizations.”

But the European Health Authority, that is, the European Medicines Agency, discovered that one of these groups, the Indian Synaps laboratories, was not conducting these tests with the required accuracy.

The European Medicines Agency noted last March that “the majority of treatments tested by Synapse Labs (…) show missing or insufficient data to prove bioequivalence.”

What treatments are involved?

The 400 targeted drugs cover a wide range, as they include anti-cancer drugs, especially against leukemia and breast cancer, drugs to treat diabetes, treatments against human immunodeficiency virus (HIV) infection, anti-epileptics, treatments for schizophrenia, and many others.

Since a large number of generic drug producers use the services of Synapse laboratories, the concern is not limited to one manufacturer, but to all major players in the sector.

European Union countries are affected unequally, depending on the treatments approved there. In France, for example, there are 72 generic drugs under investigation in this context.

What is the risk to patients?

There is no immediate danger, and health authorities and patient associations are also keen not to cause panic.

“There is no manufacturing defect,” Yann Mazens, one of the directors of France Assos Santi (the main French federation of patient associations), told Agence France-Presse.

“But we are faced with products that may not be as effective because the studies did not meet the standards,” he added.

While this lower effectiveness has not been proven in the current situation, the possibility remains, and thus the patients concerned are exposed to the risk of receiving lower-quality medicines, sometimes for serious and fatal diseases.

What will happen?

Certainly, national authorities in EU countries will not withdraw all of these drugs from the market on Monday.

First, because some manufacturers of these generic drugs have already retested and proven bioequivalence to the listed treatments.

Then, the European Commission – above all – left wide room for maneuver for countries so as not to immediately withdraw treatments that are irreplaceable for patients.

In response to questions from Agence France-Presse, the French Medicines Agency confirmed that “these medicines with precise status are those that have large market shares, or for which there is no therapeutic alternative.”

In this case, the European Commission gives countries up to two years to withdraw the treatment permanently, in the event that conclusive data is not provided by the manufacturer.

The French Medicines Agency, which will make its decision on Monday but will not announce it immediately, at the present time, refuses to give any order of magnitude regarding the number of expected immediate withdrawals.

Likewise, in Germany, another country concerned with a large number of therapeutic references, the Federal Institute for Medicines and Medical Devices declined to comment to Agence France-Presse.