Drug shortages in Switzerland

For many product groups, such as antibiotics, insulin or hormone preparations, there is practically complete foreign dependence, one learns online without further ado on the subject of "remedies" from the Federal Department of Economic Affairs, Education and Research.

It goes on to say: "There has been a concentration of both suppliers and production sites. The fact that stock levels have been reduced at all levels for cost reasons is therefore an open secret.

"The supply chains of remedies have thus become correspondingly more vulnerable ", writes the Federal Office for National Economic Supply BWL.

According to the BWL, however, information on the stock of therapeutic products is still voluntary and only concerns essential substances. Because deliveries are more irregular and there is a lack of specific information on interruptions to deliveries and other bottlenecks, the pharmacists' association pharmaSuisse is insisting on an up-to-date therapeutic products database.

Moreover, the manufacturers of medicinal products or marketing authorisation holders are to be obliged to ensure transparency in the supply chain.

The basic problem: in order to increase profits, pharmaceutical companies often have their active ingredients produced exclusively in countries such as India or China. There, they are sometimes dependent on a single manufacturer, even if the drugs have different names and are distributed through various channels. In order to save money, drug manufacturers hardly stockpile any more, but produce only as needed. "The supply of medicines has become more volatile".

When production of a scarce medicine starts up again, the countries where the companies obtain the best prices are supplied first. For obvious reasons, Switzerland and the regional pharmacies are quite dependent on having a sufficiently broad contingent of compulsory medicines and remedies at their disposal.

Demand for state intervention

Ibuprofen, antibiotics or anaesthetics - of course there are serious differences in medicines. In many areas, however, there is a lack of effective stocks of medicines. Often, even the pharmacists don't know why that particular remedy has been taken off the market. For the past five years, Enea Martinelli himself has been keeping a list of all the missing medicines on the Swiss market at www.drugshortage.ch.

According to the chief pharmacist of the Meiringen, Frutigen and Interlaken hospitals, the supply bottlenecks have steadily increased during this time: "When I started, I thought 150 was an insane number. Because some of the shortages are lasting longer and longer, the entire hospital staff is being called upon.

"The effort to organise everything so that the patient doesn't notice any of this has become enormous," Martinelli admits in a 2019 feature on Swiss television SRF.

This means that drugs have to be replaced more often. However, the active ingredients in the pills are not always the same. Chronically ill patients are therefore switched to other therapies. This not only involves extra work, but also costs, a lot of frustration and annoyance. Patients have to visit their family doctor more often because of prescriptions. In many cases, substitute medications are more expensive.

According to Martinelli, there are no simple solutions: "We have increased our stocks in recent years. But it is very difficult to predict which products will be affected." It is also not possible to have a year's supply of every medicine in stock: "We are at risk ourselves. It's perishable goods. They expire at some point."

Grey area drug trade

One example is the antihypertensive drug with the active ingredient valsartan. At the beginning of July 2018, batches of antihypertensives with the active ingredient valsartan, which was contaminated with N-nitrosodimethylamine (NDMA) in elevated concentrations, were recalled worldwide as a precautionary measure. The Chinese manufacturer was no longer able to deliver, its product was contaminated with the carcinogenic NDMA. On 24 August 2018, the laboratory results for the Swiss market were available at Swissmedic:

Valsartan preparations approved and currently available on the Swiss market complied with the legal requirements. Nevertheless, the antihypertensive drug was no longer supplied.

The Federal Office for National Economic Supply (FONES) is well aware of the problems associated with the monopolisation of medicines. Ueli Haudenschild is head of the Therapeutic Products Division. Haudenschild has been noting an imbalance in the distribution of medicines for years: "It's a globalised market, especially for cheap products. Bulk products such as generics and many vaccines are almost 100 percent imported," says the Head of the Nutrition & Therapeutics Division, "the active ingredient is mostly produced in low-wage countries. And that's for the whole market."

The reasons for supply bottlenecks are manifold and often do not even have their origin in Switzerland.

Main reasons:

• problems in the manufacture or procurement of the active substance or of an excipient
• Manufacturing problems
• Safety problems at the place of manufacture (in Switzerland or abroad)
• Delays with the authorities (regarding inspections of the manufacturing site or the drug).

Other causes:

• an unexpected increase in demand in Switzerland or in 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).
• Various interruptions in the supply chain (e.g. due to strikes)
• other factors beyond the control of the suppliers or manufacturers (e.g. natural disasters).

"Short-sighted cheapskate principle"

A dangerous dynamic is developing on the medicines market. More and more new high-priced medicines are flooding the market: "Two per cent of medicines are responsible for almost 50 per cent of the costs charged to compulsory health insurance," says a pharmaSuisse statement. "Comprehensive framework conditions required".

Pharmaceutical companies are discontinuing the production of low-cost or patent-expiring original drugs for reasons of profitability.

The Swiss Pharmacists Association and parliamentarians such as Bea Heim ("Parliamentary Initiative 19.465: Volksapotheke zur Sicherung der Versorgung der Bevölkerung mit Medikamenten und Impfstoffen") and others directly involved are now pulling together to maintain the security of supply for the population.

Instead of the short-sighted lowest price principle, which drives many manufacturers out of the Swiss market and exacerbates supply problems, pharmaSuisse calls for a comprehensive national healthcare strategy with framework conditions that ensure a sustainable and good supply of medicines. (Source: pharmaSuisse "On the distribution of original medicines ").

No sovereignty of interpretation yet

Unfortunately, it has not yet been possible to find a common approach throughout Switzerland. Many responsible parties are not yet sufficiently aware that supply shortages can lead to medication errors and put people at risk. "Enea Martinelli, Chief Pharmacist, emphasises that there is a lack of information both among patients at home and in the hospital or nursing home environment.

Problem for admission managers and quota distributors. They want to avoid information about supply interruptions becoming public. The competition could use the information to their own advantage. However, drug shortages also affect the future quality assurance of the healthcare industry.

no longer able to produce their own antibiotics and vaccines. In the event of a pandemic, existing medicines could quickly run out. Due to its insignificant market size, Switzerland may soon be one of the world regions suffering from continuous supply shortages.