The European Parliament recently decided to postpone the transition timeline to implement the EU Medical Device Regulation, which was set to expire on 26 May 2020, until 26 May 2021. Although there has been no official statement from the European Union, the competent Swiss authorities consider it as granted that the status quo regarding medical devices continues to apply to Switzerland. This article discusses the presumed impact of the postponement on the Swiss medtech industry.
The Federal Department of Home Affairs recently decided that two new autologous cell therapies (CAR-T therapies) for the treatment of blood and lymph gland cancer will in future be covered by compulsory healthcare insurance. Further, preventive investigations of colorectal cancer will be exempted from the franchise in the Cantons of Fribourg and Basel-Stadt. In addition to these changes, a number of other adaptations have been made to the Healthcare Benefits Ordinance and its annexes.
The Lausanne University Centre for General Medicine and Public Health, in close cooperation with the Swiss Biobanking Platform, recently commenced the pilot phase of the so-called 'Swiss health study', which aims to determine which chemicals accumulate in the human body. The pilot phase is supported by the Federal Office of Public Health.
The popular nursing care initiative 'For Strong Nursing Care' is calling for more nursing staff and quality safeguarding in nursing care. The Swiss parliamentary Commission for Social Security and Health recently presented an indirect counterproposal to this popular initiative. The counterproposal adopts a number of the initiative's important demands and aims to counter the nursing staff shortage and increase nursing staff skills with an educational campaign.
The Federal Administrative Court recently annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The FOPH had permitted a temporary (ie, two-year) price increase of 20%; however, the Federal Administrative Court upheld the manufacturer's argument that such time limits may be imposed only for comprehensible and appropriate reasons, which the FOPH could not convincingly provide.