Federal Council steps up measures to combat shortages of medicines

The Federal Council has discussed a corresponding package of measures and issued various implementation mandates. Among other things, it wants to extend compulsory stocks, waive price reductions for certain medicines that are important for supply and allow imports more easily if necessary. The Federal Council also wants to create incentives to promote the manufacture/production of important medicines. It has also discussed possible solutions to improve the supply of important medical goods in the event of a pandemic.

An adequate supply of medicinal products is important for Switzerland. That is why the federal government works with other stakeholders to ensure this. The National Economic Supply has been operating a reporting office since 2015. In addition, numerous essential medicines are subject to compulsory stockpiling. Compulsory stocks are used to bridge shortages. However, with the relocation of important production steps to Asia and the concentration on just a few suppliers, supply chains have become vulnerable worldwide - and bottlenecks are increasing. In spring 2023, the federal government therefore took short-term measures to improve the situation, such as the partial distribution of medicines and simpler reimbursement for imports.

The Federal Council now wants to further strengthen healthcare provision with another package of measures. This is based on a report drawn up by the Federal Office of Public Health (FOPH) and the Federal Office for National Economic Supply (FONES) with the involvement of other federal agencies. It has now issued various orders based on this report.

For example, the Federal Council is aiming to implement the following measures:

-    Warehousing: Obligation to stock additional essential medicines in order to ensure a wider range of supplies.

-    Market accessLegal adjustments so that medicines not approved in Switzerland can be introduced temporarily for larger patient groups in the event of shortages. In addition, the approval procedure should be simplified with further optimizations and Switzerland's participation in European approval processes should be examined in greater depth.

-    IncentivesThe aim is to create incentives for manufacturers of essential medicines to continue producing these medicines in the future. Under certain conditions, it should be possible to waive a review of the cost-effectiveness of these medicines or a price reduction as part of the three-year review by the FOPH. This is intended to prevent manufacturers from withdrawing the medicines from the market for reasons of profitability. It is also being examined whether reimbursement or approval can be linked even more closely to the criterion that the supply of this medicine is guaranteed.

-    In-house procurement and productionIn order to avoid shortages of individual medicines, the federal government should be able to conclude capacity contracts with manufacturers. This would ensure the production of a certain quantity of a medicine. In the event of a severe shortage, the Confederation's own production (army pharmacy) will also be examined. In addition, the Confederation should be able to be exempted from the WTO tendering obligation for the procurement of medicinal products, active ingredients and medical devices.

-    International levelAs supply bottlenecks are a global problem, Switzerland is also working internationally to make supply and value chains more secure and resilient.

The Federal Council has also given the Federal Department of Home Affairs (FDHA) the mandate to set up an expert group on security of supply. The group of experts is to develop additional measures for the Federal Council by the end of 2025. The aim is to further improve the security of supply of medicinal products.

Supply of medical goods in the event of a pandemic
In addition, the Federal Council discussed possible solutions and clarified responsibilities in order to improve procurement and the supply of important medical goods in the event of a pandemic. In order to cope well with a pandemic, vaccines, medicines, laboratory tests and other important medical supplies must be available to the population quickly and in sufficient quantities.

Delays occurred during the Covid-19 pandemic because responsibilities, funding and procedures were not clearly defined. After the pandemic, the FOPH, together with other federal agencies and the cantons, was therefore commissioned by the Federal Council to investigate how Switzerland could better prepare for the next pandemic.

Based on this report, the Federal Council has discussed various solutions. These include, for example, keeping a list of the medical supplies that Switzerland needs in a pandemic and clearly regulating the procurement of these supplies and their delivery to hospitals, doctors and pharmacists. Where appropriate, the existing competencies of the Federal Administration should be used. For example, the FONES already operates a market monitoring platform that the federal government can expand in the event of a pandemic.

The Federal Council has now decided to transfer overall responsibility for the specification and implementation of preparations for the supply of essential medical supplies in a pandemic to the FOPH. It has instructed the federal offices involved to intensify the corresponding work. In doing so, it is clarifying responsibilities for the supply of essential medical supplies in a pandemic.

Source: Federal Office of Public Health