“In time, the consequences will really be felt,” continues board member Jan Dietert Brugma. “Patients then run out of medication.”
InnoGenerics annually produced around 600 million medicines for the Dutch market, including medicines against epilepsy, cardiovascular disease, diabetes, antidepressants, antipsychotics, antibiotics, painkillers and blood thinners. These are so-called ‘generic’ medicines, a kind of copy of a branded medicine.
In December, InnoGenerics was already declared bankrupt. The government then came to the rescue, keeping the company afloat until the new year. Only the restart that was hoped for failed to materialize: all interested parties dropped out. “It does not have a simple solution,” says Minister Ernst Kuipers of Health, Welfare and Sport to RTL Nieuws.
Major concerns
“The shortages of epilepsy medicines are already distressing at the moment,” says a spokesperson for EpilepsyNL. “It creates constant stress, anxiety and uncertainty for patients and carers.”
The Heart Foundation sees similar concerns among cardiovascular patients. “For example, they wonder whether the alternatives are just as good as the medication they received from their cardiologist and whether there are other possible side effects,” says a spokesperson for the foundation.
Shereeta Rosheuvel is one of those people who are deeply concerned. Her 17-year-old son Joshua suffers from severe epilepsy and is dependent on the drugs Carbamanzepine and Clobazam. The latter was unavailable for a while, so they had to try a different drug. “Well, that was a big drama. It gave him hallucinations and the epileptic attacks increased again,” she tells RTL Nieuws.
She now has a supply of Clobazam in her house again. “But if shortages also arise with Carbamenzepine, then I really don’t know anymore.”
‘Joint Action’
Minister Kuipers cannot dispel the concerns either: “I think that the concerns in that respect are absolutely justified and also call for action.”
He emphasizes that the shortage of medicines is not only an issue in the Netherlands, but also in other European countries and elsewhere in the world. “It requires joint action.”
The problem therefore extends further than just the producer. According to Kuipers, these are the parties that market the drug, the wholesaler, the insurer, the prescriber and ‘of course also the government’.
Depends on China and India
Meanwhile, dependence on China and India for generics is increasing. And that, according to the board member of the NVZA, is worrying: “The supply route from Asia is vulnerable and the Netherlands is not an attractive market because of the very low prices.”
The shortages can cause serious problems for patients. “If you do not receive an epilepsy drug, the chance that you will have seizures increases significantly. With all the consequences that entails,” says the board member.
There are two other factories in the Netherlands that produce the same medicines as InnoGenerics, but according to Bart van den Bemt, endowed professor of personalized pharmaceutical care at Radboudumc, they cannot simply solve the shortages. “That requires capacity from factories that also have to make other generic medicines and it is real that that capacity will become a problem.”
Importing comparable medicines from other countries in Europe is not an immediate solution either. According to the NVZA, another medicine, for example a comparable substance, soon entails many risks. “The balance between effectiveness and side effects is incredibly narrow.”
‘Situation is worrying’
Lucas Jan Wiarda, one of the entrepreneurs behind InnoGenerics, tells RTL News that he cannot give specific names of medicines because this could lead to a run on those medicines.
He calls the situation worrying. “There is no real alternative for certain medicines. Especially not for patients with unique treatments, such as epilepsy.” In the best case, a different dosage can be considered. In the worst case, it won’t work. “Especially for a few thousand elderly people, this can have nasty consequences.”
Which medicines are concerned?
InnoGenerics worked on medicines for epilepsy, cardiovascular disease, diabetes, antidepressants, antipsychotics, antibiotics, painkillers and blood thinners. The epilepsy medicines are carbamazepine and valproic acid.
The Medicines Evaluation Board (CGB) is closely monitoring the situation and is taking measures to prevent shortages as much as possible. The CGB expects that in most cases there will be sufficient stock for the time being or that replacement medicines will be available.
