A new, early submission procedure is set to enable enhanced and tighter parallel processing of Swissmedic and the Federal Office of Public Health (FOPH) applications and the simultaneous reimbursement of vital medicinal products at the time of their market authorization.
On September 22, 2023, the Federal Council approved important changes to the Health Insurance Ordinance (KVV), the Nursing Care Benefits Ordinance (KLV) and the Medicinal Products Ordinance (VAM), which are due to enter into force in January 2024.
The main aim of these revisions is to optimize the process of drug approval and reimbursement in order to provide patients with faster access to essential medicines and treatments for rare diseases.
“Early dialogue” with the FOPH is being introduced for the first time, enabling pharmaceutical companies to clarify in advance if a drug can be considered as vital treatments or complex applications. This speeds up inclusion in the specialty list and reduce negotiation timelines.
In addition, the process will be extended by “early access”, which will allow approval by Swissmedic and inclusion in the list of specialties to take place simultaneously.
These steps mark a significant advance in the efficiency of the healthcare system in Switzerland.
Do you have questions about the new early access pathway? Contact us for answers.