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.
The Federal Supreme Court recently dismissed an appeal against a Zurich Social Insurance Court decision concerning the replacement of an appellant's breast implant under compulsory health insurance. According to the Federal Supreme Court, a gynaecologist's reasoning that the appellant's pain was most likely caused by the implant was incomprehensible and therefore the Zurich Social Insurance Court's decision was not arbitrary.
The Federal Council recently submitted to Parliament a dispatch approving the Council of Europe Convention against Trafficking in Human Organs. The Federal Council supports the convention, which aims to harmonise criminal provisions internationally. In particular, the convention provides for the prosecution of all human organ trafficking, regardless of where it takes place.
The Federal Council recently adopted new measures to combat rising costs in the public healthcare sector. With this first set of measures, the Federal Council intends to provide all stakeholders with the instruments needed to reduce costs and expects to save several hundred million Swiss francs annually.
The Federal Council recently approved a draft of the Social Security and Health Commission of the Council of States in order to improve the legal basis for the transfer of data of insured persons. The Federal Council intends to collect personal data from insured persons while guaranteeing the protection of personal data and upholding the principle of proportionality.
The Federal Supreme Court recently clarified that although certain provisions of the Health Insurance Act and the Health Insurance Ordinance are based on patent protection (or expiration), the Health Insurance Ordinance sets out no pricing rules for generics if the original's exclusivity is only partially lost. Further, protected indications of a multi-indication pharmaceutical, of which some indications have lost exclusivity, cannot be exchanged by a generic.
The Federal Council recently submitted a draft amendment to the Narcotics Act for consultation that aims to facilitate patients' access to cannabis-based treatments. The revised act would allow patients to obtain direct medical prescriptions for cannabis-based treatments with a tetrahydrocannabinol content of more than 1% without having to obtain an exceptional licence from the Federal Office of Public Health.
The Federal Department of Home Affairs recently decided that measures to preserve the fertility of people suffering from cancer will now be covered by compulsory health insurance. Under the new measures, if cancer patients run the risk that a planned treatment will lead to impaired ovarian or testicular function, sperm, egg cells or ovarian tissue can be frozen (so-called 'cryopreservation') and reused after therapy. Cerebrospinal fluid analyses for diagnosing dementia will also be covered.
The Federal Council intends to improve access to psychotherapy, especially for children and adolescents, as well as adults in crisis situations. In order to facilitate such access and ensure adequate care, the Federal Council has proposed a change to the existing system which will allow, among other things, psychotherapists to provide their services independently within the compulsory healthcare insurance framework.
The popular initiative 'Supporting organ donation – saving lives' calls for the introduction of a narrow contradiction solution in order to substantially increase the number of organ donations. At present, the consent solution applies in Switzerland and organ donation is possible only if the deceased agreed during their lifetime to donate their organs. The new contradiction solution would allow organs to be removed from a deceased person if they did not oppose this during their lifetime.
In a recent decision on the ownership of inventions created with the involvement of universities, the new Federal Patent Court held that the university was not the (joint) owner of the patent, despite the fact that the professor participating in the invention had used the university's facilities for his contributions to the invention. The court held that there was no cantonal law conferring the rights of the professor to the university.
The Swiss Federal Council recently adopted a revision of health claims legislation in order to harmonise it with EU law. The revision is intended to prevent the creation of new barriers to trade and to provide consumers with the same information that is available in the European Union. The ban on health claims for slimming products has also been revoked.
In a series of recent cases the Opposition Board found a likelihood of confusion between trademarks for pharmaceutical products with phonetic similarities. In its decisions it took into account the fact that consumers usually purchase pharmaceutical products with a higher degree of attention.