The supply of medicines in Switzerland is not assured in all cases. Despite the action already taken, the supply is tight. The federal government is now taking additional measures to improve the supply situation.
Disruptions to supplies of medicines are increasing worldwide, and Switzerland is no exception. The situation remains tight and is clearly reflected in the number of reports to the Essential Human Medicines Reporting Office for National Economic Supply (NES).
This particularly involves generics and medicines with expired patent protection, especially strong painkillers such as opioids, vaccines, insulin and antibiotics. Many patients are therefore affected.
The causes of disruption in the supply of medicines
The causes of such disruption and the consequences thereof are complex. They are largely of global origin, and have evolved over the decades. In addition to the global causes, there are also some Switzerland-specific characteristics which may promote such supply disruption. These causes and consequences can be summarised as follows:
1 Economic pressures, subsidisation policies and looser regulatory provisions in low-wage countries have led to a globalisation of the pharmaceuticals sector.
2 Vital parts of the value chain, including the production of key active pharmaceutical ingredients (APIs), have been relocated to Asia (e.g. China and India).
3 The concentration on a handful of suppliers and the resulting interdependencies have substantially increased. Around a third of the APIs used in the US generic medicines market are now supplied by a single provider, and a further third are supplied by just two or three providers.
4 Modern production and supply chain approaches such as just-in-time manufacture and delivery result in fewer reserves being maintained throughout the value chain. Just-in-time supply and production is a synchronous-with-demand production approach in which the materials needed are delivered in the precise quantities and at the precise time required for the product’s manufacture. But because of limited production reserves, sharp increases in demand cannot be managed.
5 The cluster risks to which global supply chains are exposed are increasing, and this in turn has weakened their resilience to external factors such as geopolitical conflicts, export restrictions, natural disasters, pandemics and sudden peaks in demand.
6 To bring a medicine to market in Switzerland, a manufacturer must have its products approved in accordance with Swiss regulations.
7 For the globally-focused pharmaceutical industry, the Swiss market is relatively small by international standards and thus not particularly attractive in economic terms.
8 For the reasons outlined above, the markets cannot respond adequately.
What the Swiss Confederation has done so far in response
In Switzerland, it is not only the federal government that is responsible for security of supply; it is primarily the responsibility of the economy (Art. 102 Federal Constitution and Art. 3 para. 1 NESA). The cantons are generally responsible for the healthcare system in their territory (subsidiary general competence of the cantons; Art. 3 and Art. 42 para. 1 Federal Constitution). The federal government has a subsidiary responsibility to provide healthcare only in the event of severe shortages (Art. 102 Federal Constitution in conjunction with NESA) or a pandemic, if vital goods and services or the most important remedies to combat communicable diseases are lacking (Art. 118 para. 1 let. b Federal Constitution and Art. 44 EpidA).
Such a constitutional requirement does not exist in the current situation. The federal government’s scope for action is therefore limited, but it is nevertheless taking on a coordinating role and looking for solutions.
2006 The Federal Council takes the first actions to improve supply chain security.
2009 The first phase in the revision of the legislation on therapeutic products lays the legal foundations to enable hospitals to better ensure that their patients can be provided with the medicines they require.
2012 The Federal Council is mandated through a parliamentary postulate (Heim Postulate 12.3426) to analyse the supply situation in Switzerland.
2015 The NES puts its Essential Human Medicines Reporting Office into operation.
2016 The Security in the Supply of Medicinal Products Report from the Federal Council in response to the Heim Postulate of 2012 proposes structural and procedural actions for both the Confederation and the cantons which should effectively improve the secure and orderly supply of medicinal products for the longer term.
2019 With the second phase in the revision of the legislation on therapeutic products, the changes proposed under the Heim Postulate enter into effect. Under these, the Federal Council again takes actions to expand the scope available to the parties responsible for ensuring the provision of medicinal products for patients. These include expanded possibilities of own production and the temporary placing on the market of medicinal products that are not authorised in Switzerland.
2019 To steadily expand the actions already taken by the Confederation and the cantons, the FOPH is commissioned together with the Therapeutic Products Division of the NES, Swissmedic and the Armed Forces Pharmacy to conduct a renewed analysis of supply chain security in Switzerland and propose additional actions.
2022 The ‘Disruptions of Supplies of Medicinal Products for Human Use in Switzerland: situational analysis and improvements to be considered’ report is formally acknowledged by the Federal Council on 16 February 2022.
2022 With the publication of the Disruptions of Supplies Report, the Federal Department of Home Affairs FDHA (FOPH) and the Federal Department of Economic Affairs, Education and Research EAER (NES) are commissioned to work with the Federal Department of Defence, Civil Protection and Sport DDPS (and the Armed Forces Pharmacy in particular) along with further relevant stakeholders from the healthcare sector to study the actions listed in the report in greater depth and devise concrete proposals on how they may be implemented.
2023 The first proposals for implementation are submitted to the Federal Council. At the request of the NES Therapeutic Products Division, the Federal Council resolves to extend the reporting obligation and look into expanding the reporting platform.
2024 The NES submits various expansion options to the Federal Council. In January, the Federal Council instructs the EAER to develop a high-performance, future-oriented monitoring platform for therapeutic products.
2024 In August, the Federal Council takes note of the 2024 Final Report «Implementation proposals for the measures of the FOPH report on shortages in the supply of medicinal products, final report of the interdisciplinary working group». This contains the results of the appraisal together with an additional package of implementation proposals for improving the supply situation for medicines in Switzerland. The Federal Council issues orders to the FDHA, EAER and DDPS to implement structural measures designed to make the system more resilient to supply disruptions.
In addition, the Federal Council gives the FDHA a mandate to set up a further expert group on security of supply. The idea is to take account of the dynamic developments in connection with the supply of medicinal products.
2025 The expert group is constituted and begins work. The results and any further implementation proposals are to be submitted to the Federal Council at the end of 2025.
At the same time, initial implementation work to strengthen security of supply will begin. Swissmedic examines further simplifications to the simplified authorisation procedure. The results are to be submitted to the Federal Council at the end of 2025 and the next steps determined.
As part of the ongoing revision of TPA 3b, amendments are to be requested in the areas of in-house manufacturing by the federal government and the placing on the market of medicinal products that are not authorised in Switzerland for a limited period or in limited quantities. The consultation process is to be opened in the 4th quarter of 2025.
To bridge acute shortages of medicinal products, Switzerland’s Cantonal Pharmacists (KAV), the FOPH and Swissmedic have jointly agreed to temporarily extend the meaning of the term “emergency” in Article 49 of the Medicinal Products Licensing Ordinance (MPLO). This means that healthcare professionals can import and store in the short term urgently required medicinal products that are not authorised or not available in Switzerland even if they are not intended solely for one particular patient. The new regulation is a transitional solution that will apply until the legislative provisions amended as part of the ongoing revision of TPA 3b take effect. This will improve the situation in paediatrics in particular, because medicines suitable for children are particularly susceptible to shortages, both as a result of economic factors and because of a lack of alternatives. The measure makes it possible to respond quickly and in a legally compliant fashion to acute need so that sick children do not have to wait for the medicines they need.
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Last modification 27.05.2025
Contact
Federal Office of Public Health FOPH
Health Protection Directorate
Competence center for supply security
Schwarzenburgstrasse 157
3003
Bern
Switzerland