It came as a shock to addicts: at the beginning of this year, one of the most important heroin substitutes, methadone, was running out. This is because the Swiss therapeutic products institute Swissmedic has revoked the operating license of the only manufacturer, the Amino company, due to safety deficiencies – after years of legal dispute.
There was a mandatory supply of the drug. But ironically, it was also blocked because the shares were owned by the sanctioned company. The impending catastrophe was just averted, mainly thanks to the pharmaceutical company Streuli. They stepped in and produced high-dose methadone capsules on a large scale within weeks.
Streuli had no regular approval for the preparation. However, in the event of shortages, pharmaceutical companies may manufacture certain preparations in limited quantities on behalf of pharmacies. As the whole market collapsed due to the monopoly situation for methadone tablets, Swissmedic had to exceptionally lift the quantity limit of 3,000 packs. For the first time.
The Amino company has been allowed to produce the tablets for addiction therapy again since May. Has the situation calmed down? Not at all, says Thilo Beck, chief psychiatrist and board member of the Swiss Society for Addiction Medicine. In addition to the availability of the drug, the specialized association has been struggling for some time with another problem: financing.
In fact, methadone tablets are not approved for long-term drug replacement programs, but only for (short-term) withdrawal symptoms. “So the health insurers could say at any time: we no longer pay for the tablets for this application,” says Beck. When the price of methadone rose for a short time due to the emergency solution with Streuli, the situation was particularly tense, according to the addiction doctor.
Beck says that the specialized association Amino, based in Gibenstorf AG, had asked several times before the bottleneck to apply for the necessary approval for long-term addiction therapy from Swissmedic. ‘Too complex and too expensive’ was the answer. Because for the new application (which has existed for decades), Amino would have to submit an entirely new dossier, including efficacy studies.
After the emergency in the spring, the specialist association decided to take matters into its own hands and find alternative methadone manufacturers, says Beck. A task that took a lot of time and energy. “We are frustrated that we have to deal with these kinds of questions at all,” he says. The good news: A German company has now applied for approval for methadone tablets for long-term therapy. Swissmedic’s decision is still pending.
The supply situation with Podomexef, a liquid antibiotic for children, did not end well: the Japanese manufacturer Daiichi Sankyo stopped selling the preparation in Switzerland almost a year ago. Since then, the drug of choice for renal pelvic infections with fever has been missing – a daily diagnosis in children’s practices, says Christoph Aebi, a pediatrician and infectiologist at the Inselspital in Bern.
A broad-spectrum antibiotic is now used instead. However, the bacteria that cause the infection are more often resistant to it. The result: more children have to be treated with an IV in hospital. The antibiotic is still available on the market, but selling the preparation no longer makes sense, says Aebi. According to the chief doctor, this is due to approval barriers between Switzerland and the EU and the pricing policy of the Federal Office of Health (BAG).
The FOPH pays far too little attention to the relatively complex production of children’s preparations such as syrups or suppositories for the small children’s drug market in Switzerland, says Aebi. When a manufacturer announces that it will withdraw an important product from the market, pediatric associations try to change their minds. “Usually these conversations are unsuccessful.” In some cases companies could have been persuaded to keep a drug only through personal contacts.
Monika Schäublin is a program manager for the security of supply of medicines at the National Economic Facility (BWL). For preparations with active ingredients that are on the list of ‘essential medicines’, manufacturers have been required to report supply bottlenecks to the FONES since 2015. In addition, the agency regularly checks the supply risk of all active substances on the list.
You look at how often the active ingredient is used in therapy, how many manufacturers there are and whether replacement products are approved in Switzerland, as Schäublin says. Such a risk assessment was also drawn up for the discontinued antibiotics. But while the BWL seeks alternative manufacturers or approves mandatory stockpiles of drugs in temporary supply bottlenecks, the agency’s hands are tied when the market pulls back.
“There is no legal basis on which we could force a pharmaceutical company to resell a product,” says Schäublin. Nevertheless, FONES seeks dialogue with manufacturers when supply-relevant medicines are withdrawn from the market. However, because most of the preparations came from large companies abroad, the decision was usually made long before you heard about it from the company selling it in Switzerland, says Schäublin.
The BWL still classifies the supply situation for the drugs as “problematic”. Schäublin is part of an interdisciplinary working group that is to make proposals to the Federal Council by mid-2024, including cost estimates, on how to stabilize the situation. In addition to the BAG and business administration, representatives from the pharmaceutical industry and medicine are also involved.
The working group bases its work on a report by the FOPH from 2022, which already outlined various measures. The “improvement of incentives for manufacturers of essential medicines” is mentioned in the report as an important area of action. Exactly how the market situation should be improved, especially for Swiss manufacturers of basic medicines, remains unclear.
This is despite the fact that urgent action is needed: for example, the company Streuli is under great pressure in the production of sterile painkiller ampoules due to the huge increase in energy costs, management member André Vecellio recently told CH Media.
The BAG reports that it takes security of supply into account when setting prices. However, a price increase is out of the question if there are alternative therapies. According to hospital pharmacist Enea Martinelli, the system is reaching its limits precisely because of this setting. He has been fighting bottlenecks in the supply for years and has set up the private online platform Drugshortage, on which medicine shortages are mapped.
Only as long as there are still companies in Switzerland with the necessary production capacity for different forms of medicines, can we react quickly enough to fill gaps in crucial medicines. “The larger the market share of a drug, the more difficult this is,” says Martinelli. This should be clear to everyone at the latest after the methadone incident. (aargauerzeitung.ch)
source: watson
I’m Maxine Reitz, a journalist and news writer at 24 Instant News. I specialize in health-related topics and have written hundreds of articles on the subject. My work has been featured in leading publications such as The New York Times, The Guardian, and Healthline. As an experienced professional in the industry, I have consistently demonstrated an ability to develop compelling stories that engage readers.
