Improved access to medicines – particularly paediatric medicinal products – during shortages

To bridge acute shortages of medicinal products, Switzerland's Cantonal Pharmacists (KAV), the Federal Office of Public Health (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 currently undergoing amendment take effect. In particular, it will improve supplies of urgently needed paediatric medicinal products.

To bridge acute supply shortages, Switzerland's Cantonal Pharmacists have decided, in agreement with the FOPH and Swissmedic, to apply a new interpretation to Article 49 MPLO and the term "emergency" contained in the Article. An emergency is understood to be any situation in which the treatment of acute conditions with a medicinal product that is authorised in Switzerland but not available must be started as soon as possible. Emergency medicinal products are medicinal products that must be administered immediately in such situations. In such cases, healthcare professionals who are entitled to do so can import medicinal products from another country and store them in limited quantities even if the products in question are not directly intended for a particular patient.

Imported, temporarily unavailable medicinal products that are in the List of Pharmaceutical Specialities mandated by the Health Insurance Act can be reimbursed by mandatory health insurance. Other imported vital medicinal products can only be reimbursed in exceptional, individual cases following approval of the costs by the health insurance provider and the provider's independent medical officer. The procedure to be followed when medicinal products on the List of Pharmaceutical Specialities are unavailable and for reimbursing imported vital medicines will be set out in a Federal Office of Public Health circular on reimbursement during supply shortages.

For paediatric medicinal products in particular

This extension of the scope of the term "emergency" 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.

The expanded interpretation of the term "emergency" in Art. 49 MPLO is supported by the Swiss Society of Paediatrics (pädiatrie schweiz) and Kinderärzte Schweiz (Swiss Paediatricians, KIS). These organisations were part of a working group set up by the Federal Department of Home Affairs to develop rapidly implementable measures to relax the conditions for importing unauthorised or unavailable medicinal products in shortage situations. The solution is a transitional arrangement that will apply until the ongoing amendment of the Ordinance enters into force.

The provisional interpretation of Art. 49 MPLO is part of a Federal Council mandate to refine medicinal product supply structures and legal requirements so that they become more resilient to future crises. The focus here is on patient wellbeing. The aim is to ensure that nobody has to wait for the treatment they need because of supply issues.