Historically cantonal authorities have been the principal organizers of healthcare in Switzerland. In recent years organization, procurement, management and regulation –including reimbursement- have become more centralized and unitary. An efficient and sustainable reimbursement and regulatory mechanism are key components to a stable and healthy healthcare system. This article provides a description of the pertinent authorities involved in the regulation of medical devices, and the process of including or excluding a particular product in the national reimbursement plan.
Authorities and agencies for Swiss medtech
The authority in Switzerland to oversee the regulation and introduction of medical devices and products in Switzerland is Swissmedic. Swissmedic is a federal body that derives its policies and authority from the Federal Act on Medicinal Products and Medical Devices.
It registers, licenses, and monitors medical devices that wish to circulate and be traded in Switzerland. Its organization is divided into four branches: authorization, market surveillance, licensing, and legal affairs.
FASMED is the umbrella organization for Switzerland’s medical technology’s trading and industrial organizations. It promotes highly qualitative, economically and socially responsible healthcare, and serves as a competence center for the member firms in regards to business and service activities. It also provides extensive market data and trends from the medtech market in Switzerland.
FASMED’s activities aim to improve the legal framework within Switzerland for the medical technology sector and it engages with relevant legislation at a national and international level. In commissions and via delegates it deals with economic-political and sector-relevant topics.
The Confederation’s Commission for Technology and Innovation (CTI, or KTI in German) is the Swiss state’s funding agency for innovation, and considers itself amongst the most successful organizations worldwide of its type, in terms of national funding. CTI stimulates the transfer of knowledge and technology between tertiary education institutes and industry, partakes financially in start-up firms and entrepreneurship, R&D, and project grants.
Operations performed by Swissmedic
Swissmedic provides a comprehensive overview of the approval and supervision process of medical devices in Switzerland. It can be broken down into the following seven steps:
- Approving clinical trials
- Designation and surveillance by the Conformity Assessment Bodies (CAB)
- Mandatory notification to place product on the market; some exemptions possible
- Export certificates (Free Sales Certificates, FSC)
- Market surveillance
Swiss CAB assessments in comparison to other nations are relatively quick and have a reputation for being performed very efficiently. CABs ensure that the importing country conforms to the product regulations within Switzerland. Since Swiss product regulations are generally conform to EU standards, the CAB assessment guarantees a certain level of quality and safety from the imported product. CAB is continuously present in the pre- and post-marketing of medical devices in Switzerland.
Swiss CAB are key competence centers and also perform advisory tasks in regards to innovation projects.
Medical devices in Switzerland must adhere to the stipulations of the Swiss Law on Therapeutic Products of 2000 (most recently updated 2014) for marketing approval, entailing EEC and CE-certification.
Reimbursement of medical devices in Switzerland
MiGel, stands for Mittel und Gegenständeliste, meaning Means and Items list; it provides the reimbursement criteria and lists general medical product categories that the health insurance companies are obliged to reimburse. MiGel is created by the Federal Office of Public Health in conjunction with other Federal advisory bodies.
The general conditions for the entitlement to reimbursement for a medical device are:
- The product must be admissible in the Swiss market
- The product must fulfill the required therapeutic purpose –or the purpose of supervising the treatment- of an illness and its consequences
- The approved delivery point of the product must hand the product directly to the insured
Whether the medical product is a service, performance or in the form of a medical device, it must be effective, purposeful and economic to qualify for Swiss insurance company reimbursement.
Products and performances not specifically listed in MiGel are nonetheless entitled to reimbursement if they are rational and financially justifiable.
The FOPH will periodically review reimbursed medical devices and other medical products and evaluate whether an appraisal process is required to assess the coverage being granted.
When an evaluation is deemed necessary, it is the responsibility of the applicant to provide Health Technology Assessments, which the FOPH will evaluate from clinical to legal parameters. Their report will be forwarded to the Federal Commission of Medical Benefits and Principles (FCMBP, or ELGK in German) who will use it to shape its recommendations to the Federal Department of Home Affairs (FDHA) for the final decision.
Its primary objective is to evaluate the effectiveness and cost-justification of particular medical devices.
The FDHA decides whether a medical device is:
- Conditionally reimbursed
- Not reimbursed
Conditional reimbursement includes products used for particular indication groups, specific medical centers, second line therapy, and or on-going diagnosis with yearly reports. Products in this reimbursement category will be valid until renounced.
For further quantitative information on the Swiss healthcare system and the macroeconomic climate, please look into our Business intelligence platform or order the TforG Deep Dive report for Switzerland containing volumes of 620 surgical procedures in 13 specialisms.