Switzerland is experiencing medicine shortages due to source chain issues linked to COVID lockdowns in China and war in Europe. The state of affairs led the doctors to procure the medicine from abroad.
The Federal Office for National Economic Source is well aware of the complications associated with the monopolization of medicines. Haudenschild has been noting a contrast in the giving out of medicines for years. It’s a globalized marketplace, particularly for economical products. Large scale such as generics and many vaccines are almost 100 percent imported. The active element is mostly produced in new countries. And that’s for the whole marketplace.
The causes for source bottlenecks are manifold and often do not even have their origin in Switzerland.
Main causes:
1. Complications in the manufacturing or procuring of the active substance or an excipient.
2. Manufacturing complications.
3. Safety complications at the place of manufacture (in Switzerland or abroad)
4. Detain with the officials (regarding inspections of the manufacturing site or the drug).
Other causes:
1. An unexpected increase in demand in Switzerland or other countries (e.g. due to the failure of another drug and the subsequent chain reaction or due to “tenders” i.e. public tenders leading to postponements – partially or indirectly affecting Switzerland).
2. Various interruptions in the source chain (e.g. due to strikes)
3. other factors beyond the control of the distributors or creator (e.g. natural disasters).
“Short-sighted cheapskate principle“
A dangerous dynamic is developing in the medicines marketplace. More and more new high-priced medicines are flooding the marketplace: “Two percent of medicines are responsible for almost 50 percent of the costs charged to compulsory health insurance,” says a pharma Suisse statement. “Comprehensive framework conditions required”.
Medical companies are discontinuing the production of low-cost or patent-expiring original medication for causes of profitability.
The Swiss Chemists Association and parliamentarians such as Bea Heim and others directly involved are now pulling together to maintain the security of sources for the population. Instead of the short-sighted lowest price principle, which drives many creators out of the Swiss marketplace and exacerbates source complications, pharma Suisse calls for a comprehensive national healthcare strategy with framework conditions that ensure a sustainable and good source of medicines. Even if fever syrups or antibiotics for children, louse or cough medicine, blood pressure lowering medication, or gastric acid blockers: Anyone who is dependent on a certain drug is presently looking into the tube. Chemists in Germany have been complaining about an unchecked shortage of medicines for weeks.
Now the state of affairs has worsened. Particularly when it comes to medicines for young children. The need for medicines there is presently particularly high. The cause for this is the respiratory syncytial virus, or RSV for short.
They’ve reached a sad state of affairs. The biggest trouble is children’s medication, particularly fever-reducing syrup, as well as blood pressure medications, psychiatric medications, and Parkinson’s medications. Painkillers are also rouble. The causes are numerous but largely stem from the ongoing lockdowns in China and the war in Ukraine that have created source bottlenecks. In some cases, it’s the active element that’s missing while in others it is the vial or packaging. Switzerland is also a small country so not a big first concern for drug makers.
The shortages have forced doctors to procure the medicine from abroad in some cases, said Philippe Luchsinger, who heads the Swiss physicians’ association. Luchsinger called on people not to hoard medicines but rather “only buy medicines when you need them”.
Global Switzerland may be the land of medical companies, but it is facing a shortage of medication, with some hospitals preparing to make key medicines themselves. The number of unavailable medications has doubled in five years
The drug shortage is affecting specialist addiction centers, in particular: for sample, Antabus, a key drug treatment for chronic alcoholism, is no longer available in Switzerland. Mepha is the only company in Switzerland that makes Antabus, even though the patent for the active element expired many years ago, and it’s rationing supplies. Delivery complications aren’t the only issue here, either: medications are also ‘disappearing’. Seven medications have gone off the marketplace in the last four months.
These are usually older medications; they might be proven but it’s no longer profitable for companies to make them as the price is often only slightly higher than the cost of production. Seriously ill patients who need opioid pain relief are particularly affected by the shortages.
Three modified-release opioid products are accepted in Switzerland and none of them have been available for months.
The source of medicines in Switzerland can no longer be assured in all cases. The standards taken so far have not yet had the desired effect. The federal government is now looking into supplemental steps to counter shortages of medicines.
Bottlenecks in the source of medicines (medicinal products and vaccines) are on the increase all over the world, and in Switzerland too. Evidence of this can be found in the lists of source disruptions maintained by the reporting office of the Federal Office for National Economic Source (FONES) and private initiatives such as medicationhortage.ch. The media and national politics have taken up the theme on numerous causes and are calling for solutions.
Various groups of medicines are affected, but cancer medication and vaccines are in particular. These bottlenecks and gaps in the source of medicinal products are primarily due to the laws of economics:
- The economic pressure created by globalization is resulting in the centralization of production at a small number of locations.
- There are heavy fluctuations in demand, particularly for vaccines.
- Lean inventory management is leading to low goods at the end of the source chain.
- The impact of failures and quality complications in the manufacturing chain is global rather than limited to a specific locality.
To improve this state of affairs, further standards have to be taken in addition to those already initiated by federal and cantonal officials. There needs to be coordinated collaboration between the federal and cantonal officials, service providers, and the industry, and a cross-border proceed has to be acquired. There also needs to be clarity on what (supplemental) tools and operations will have the greatest possible impact in terms of improving the source state of affairs in the long term.
In 2021, the manufacturer of diamorphine reported a possible impending shortage in Switzerland and Germany. This led us to investigate this controlled medicine’s manufacture, marketplace, and regulatory constraints. Based on our survey of legal texts and Gray literature in the form of reports and documents, we propose guidance to prevent and address diamorphine shortages in Switzerland. Diamorphine, also known as medical “heroin,” is used medically to treat persons with severe opioid use disorder in a handful of countries.
The controlled medicine is invented from morphine, which, in turn, is extracted from opium poppies. Switzerland accounts for almost half of the global medical utilization of diamorphine. It manufactures more than half of the global total and keeps the wide goods. Moreover, Switzerland is dependent on a sole distributor of diamorphine (monopoly). Such a shortage would instantly threaten a valuable public health program for around 1,660 Swiss patients. We believe it is urgent to curtail the monopoly and ensure a stable source for the future.
Diamorphine, also known under its old brand name Heroin, is one of the most controversial substances globally. In Switzerland, diamorphine is classified as a forbidden controlled substance (scheduled), but it can be used as a medicine under particular conditions.
Indeed, the Swiss Agency for Therapeutic Products accepted diamorphine (under the brand name Diaphin) for treating persons with severe opioid use disorder in 2001. It was introduced in 1994 in Switzerland as a pragmatic solution to an AIDS crisis and open medication scenes. Under heavy criticism at first, it is now enshrined in Swiss law and recognized internationally as a successful and cost-fruitful public health program. In 2019, 1663 persons in Switzerland received TDP, which has been compensated since 2002 by health insurers.
In Switzerland, DiaMo Narcotics GmbH holds the marketplace’s authorization for the only three diamorphine products available: Diaphin i.v. (intravenous), Diaphin IR (immediate-release) capsules, and Diaphin SR (slow-release) capsules. DiaMo Narcotics GmbH sources the active element, diamorphine, from two active element creators. Two other agreement creators then formulate the active element: One agreement manufacturer formulates Diaphin i.v., whereas Diaphin IR and SR capsules are formulated by another. Due to the small order volume, finding another agreement manufacturer is not a realistic option, as noted by a report which analyzed the diamorphine source state of affairs in January 2021.
The risk of a diamorphine shortage was already identified in 2016 by the Swiss Federal Council. In November 2020 the risk of a source shortage of Diaphin i.v. became acute, due to the bankruptcy of the agreement manufacturer, which formulated Diaphin i.v.: Legacy Medicals. There were no goods of Diaphin i.v. because of past difficulties with the agreement manufacturer.
The impending shortage was not made public, and communication was restricted to the involved Swiss officials and TDP centers. According to a report on the Swiss TDP, the communication regarding the source was not transparent enough. In contrast to Swiss officials, the German Medicines Agency announced an impending source disruption of Diaphin i.v. for the German marketplace in March 2021. Based on publicly available information it is not possible to know if the bankruptcy of Legacy Medicals also caused the German Diaphin i.v. source disruption.
Shortages of diamorphine pose significant trouble for people in TDP and their treating physicians. Risks associated with treatment discontinuation are poorer mental and physical health, increased illegal activities, and utilization of illicit substances (. Hence, a rapid solution is needed to source the affected population in case of a shortage.
It describes Switzerland’s dependence on a diamorphine monopoly. We analyzed legal texts and gray literature in the form of reports and documents from Swiss and other officials.
In closure, Switzerland has so far been lucky in that it has not suffered a shortage of diamorphine; nevertheless, the unstable source was evidenced recently by reports in Switzerland and Germany. Standards that prevent a shortage in the future and precise planning for a shortage state of affairs must be implemented. TDP is a valuable and successful public health program, and an insufficient source of diamorphine would affect persons in treatment but also society as a whole.
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Khushal Jain