Swiss healthcare regulation is spread over various statutes, ordinances and guidelines, including self-regulatory instruments such as best practice codes and references to international provisions. This makes navigating the life sciences landscape depend in large part on legal and regulatory expertise, as well as extensive practical industry experience.

The following key acts provide the principles of the national regulation of pharmaceuticals and medical devices, whereby the legal terminology in Switzerland refers to “therapeutic products” as the generic term encompassing both “medicinal products” (pharmaceuticals) and “medical devices”.

• Medicinal products – Therapeutic Products Act (TPA), Ordinance on Medicinal Products (OMP), Medicinal Products Licensing Ordinance (MPLO), Ordinance on the Requirements of Marketing Authorisation of Medicinal Products (OMAMP), Ordinance on Advertising of Medicinal Products (OMPA), and the Ordinance on Integrity and Transparency (OIT).
• Medical devices – TPA, Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO). Switzerland recently revised its medical devices law to align it with Regulation (EU) 2017/745 on medical devices (EU-MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU-IVDR).

Duties and responsibilities for Swiss healthcare are divided among the federal, cantonal and municipal authorities, whereas this practice guide focuses on the federal level. As part of the Federal Department of Home Affairs (FDHA), the Federal Office of Public Health (FOPH) is responsible for public health in Switzerland. The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss authority responsible for the authorisation and supervision of therapeutic products. As a federal public law institution, Swissmedic is autonomous with respect to its organisation and management.

Administrative decisions of regulatory bodies are usually issued in the form of a ruling and can be challenged in administrative procedures or administrative court proceedings. The appropriate legal action depends on whether a federal or a cantonal regulatory body has issued the decision. If issued by a federal authority, decisions can be appealed to the Federal Administrative Court. Decisions of the Federal Administrative Court are subject to further appeal to the Federal Supreme Court.

These challenge procedures in general also apply to other regulated products. In certain areas, such as public procurement or social security, special provisions may apply. Besides, criminal procedure rules may apply to administrative and criminal sanctions issued by regulatory bodies.

Medicinal products are divided into four dispensing categories:

• category A – medicinal products that may be dispensed on a one-time basis on a physician’s prescription (Article 41 OMP);
• category B – medicinal products that require a prescription and can be obtained several times, whereby medicinal products on list B+ can also be dispensed without a prescription (Article 42 OMP);
• category D – medicinal products that may be dispensed without a prescription, but after specialist advice (Article 43 OMP); and
• category E – medicinal products that may be dispensed without a prescription and without specialist advice (Article 44 OMP).

The assignment to a particular category determines who is authorised to dispense, prescribe and use the medicinal product (Articles 24 et seq TPA). Non-prescription medicinal products, known as “over-the-counter” medicinal products, are intended for self-medication. The classification into the different categories is made by Swissmedic (Article 23a TPA).

The TPA further contains special provisions for blood and blood products (Articles 34 et seq TPA) as well as for veterinary medicinal products (Articles 42 et seq TPA).

Medical devices are divided into different categories (classes I, IIa, IIb, III) for which different conformity assessment procedures apply. The classification follows the respective regulation in the EU-MDR (Article 16 paragraph 1 MedDO) and is based on the intended purpose and the associated risk. Certain medical devices may be classified as intended for use by healthcare professionals (HCPs) only.

Clinical trials are mainly governed by the TPA, the Human Research Act (HRA), the Human Research Ordinance (HRO), the Clinical Trials Ordinance (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). In principle, clinical trials with therapeutic products require prior authorisation from Swissmedic (Article 54 paragraph 1 TPA) and the competent ethics committee (Articles 24 et seq ClinO and Articles 9 et seq ClinO-MD). Regarding medicinal products, Swissmedic examines whether the Good Manufacturing Practice and safety requirements are met (Article 54 paragraph 4 lit a TPA); regarding medical devices, the assessment includes the conformity of the products with the safety requirements (Article 54 paragraph 4 lit b, Article 45 paragraphs 1 and 3 TPA).

Clinical trials must be conducted in line with the rules of good clinical practice as set out, with regard to medicinal products, in the ICH Guideline on Good Clinical Practice of 9 November 2016 and the WMA Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (Article 5 paragraph 1 ClinO; Article 3 ClinO-MD). With regard to medical devices, the applicable rules on good clinical practice were incorporated into Swiss legislation by way of reference to Article 72 and Annex XV Chapters I and III of Regulation (EU) 2017/745 on medical devices (MDR) as well as in EN ISO 14155.

In order to secure authorisation for the conduct of a clinical trial, the investigator must submit an application to the ethics committee in the canton in whose territory the study is conducted (Articles 24 et seq ClinO; Articles 10 et seq ClinO-MD):

• acknowledgment of receipt/possible deficiencies’ notification within seven (medicinal products) or ten (medical devices) days respectively; and
• decision within 30 (medicinal products) or 40 (medical devices) days respectively and information of Swissmedic in case an authorisation by Swissmedic is necessary; in case of multi-centre clinical trials with medicinal products, the deadline is extended to 45 days.

The submission of the application to Swissmedic is made by the sponsor:

• acknowledgment of receipt/possible deficiencies’ notification within seven (medicinal products) or ten (medical devices) days respectively;
• as a general rule, decision within 30 (medicinal products) or 45 (medical devices) days respectively; and
• in certain circumstances, Swissmedic must obtain the opinions from the Swiss Expert Committee for Biosafety (SECB), the Federal Office for the Environment (FOEN) or the FOPH before granting the authorisation.

Sponsors of authorised clinical trials with medicinal products are subject to registration obligations (Articles 64-67 ClinO). Before conducting a clinical trial with medicinal products, the sponsor must enter the clinical trial either in a primary register recognised by the World Health Organisation (WHO) or in the register of the National Library of Medicine of the United States of America as well as in the supplementary Swiss federal database using a Swiss national language. The publicly accessible portal SNCTP (Swiss National Clinical Trials Portal) displays studies that are being conducted in Switzerland as soon as they have been approved by the cantonal ethics committee and released for publication by the researchers. The data originates from (i) the cross-cantonal application submission platform BASEC and (ii) the international study database ICTRP (WHO database comprising 17 worldwide primary registers). The operation of the portal – as well as the supplementary federal database – is guaranteed by the co-ordination office Kofam (Article 67 paragraph 3 ClinO). The following data may be accessed publicly: a brief description of the clinical trial, the site(s) where the clinical trial is conducted, the criteria for the participation in the clinical trial, the disease category and the health condition investigated, as well as an indication of whether the clinical trial includes rare diseases.

Sponsors of clinical trials with medical devices are subject to analogous registration obligations (Article 41 ClinO-MD). Public access to the results of the clinical trials is ensured by publication in one of the above-mentioned registers (Article 42 ClinO-MD).

Generally, the results of clinical trials are not publicly available. However, physicians that are member of the Swiss Medical Association (FMH) are subject to a publication obligation contained in the ethical guidelines of the Declaration of Helsinki (2013) regarding the results of human research.

Personal data held for research purposes must be protected by appropriate operational and organisational measures (cf. Article 5 paragraph 1 HRO). The applicable ICH Guideline explicitly refers to the increasingly widespread use of electronic data handling and remote electronic trial data systems and outlines the additional requirements that must be met by the sponsor when using such tools (see Section 5.5.3 of the Guideline for Good Clinical Practice EG(R2) of 9 November 2016). In addition, the use of online and electronic tools is subject to the limitations imposed by Swiss data protection law (in particular the Federal Act on Data Protection (FADP) and the respective Ordinance (DPO) both of which have been completely revised as of 1 September 2023).

Health data is considered personal data requiring special protection. The HRA regulates in detail the further use and disclosure of health data that falls within its scope of application. In principle, the disclosure of health data is permissible both within an organisation and to third parties depending on the type of health data, the intended further use and the assignability to a specific person. The data protection provisions do not apply to anonymised and pseudonymised data, insofar as the data subjects are no longer identifiable.

According to the HRA and its implementing provisions (Article 43 HRA; Article 5 HRO), anyone who stores biological material or health-related personal data for research purposes must take appropriate technical and organisational measures to prevent the unauthorised use thereof, and must fulfil certain operational and professional requirements.

Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki.

The decisive criterion for the classification of a product as a therapeutic product – ie, as a medicinal product or as a medical device, is the intended purpose of the product, which – considering all objective (nature of a product) and subjective (designation and promotion of a product) circumstances of the individual case – must be the medical effect or application on the human organism.

As regards the distinction between medicinal products and medical devices, the decisive factor is not the material composition of the product, but whether its intended main effect in or on the human body is caused by pharmacological, immunological or metabolic means (medicinal products), or rather through mechanical, physical or physico-chemical effects (medical devices; Article 4 paragraph 1 lit a and b TPA; BVGE C-2093/2006, E. 3.5).

No specific requirements need to be met for the authorisation of biological medicinal products (Article 2 paragraph 1 lit d Ordinance on the Simplified Marketing Authorisation Procedures (OSMA)). It is, however, necessary that an equilateral black triangle standing on its apex is included in the package leaflet and information, which is accompanied by the statement that this medicinal product is subject to additional monitoring (Article 14a lit b OMAMP).

The authorisation of medicinal products is initially valid for a period of five years and is subject to subsequent renewal upon application (Article 16 paragraph 2, Article 16b paragraph 1 TPA). If a medicinal product is not placed on the market within three years of the granting of the authorisation, or if it is no longer actually on the market during a period of three consecutive years after it has been placed on the market, Swissmedic may revoke the authorisation (Article 16a paragraph 1 lit a TPA). Medicinal products must fulfil their authorisation requirements for each production unit during the entire distribution period, whereby such requirements may only be modified, extended or restricted by a formal amendment procedure. Swissmedic may at any time review the authorisation, adapt it to changed circumstances or revoke it (Article 16c TPA).

Regarding medical devices, the necessary certificates of conformity (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices) are valid for a maximum of five years and are extended following a re-assessment (Article 26 MedDO). If a designated body finds that a manufacturer no longer fulfils the requirements of the MedDO, it must set a deadline for correction and otherwise suspend, revoke or restrict the certificate (Article 27 MedDO).

An authorisation to place medicinal products on the Swiss market is granted based on a respective application (Article 11 TPA) and after a detailed examination by Swissmedic. Applicants must hold a manufacturing, import or wholesale licence issued by Swissmedic (see 4. Manufacturing of Pharmaceuticals and Medical Devices), have a registered address, office or branch office in Switzerland and must prove that the medicinal product is of high quality, safe and effective (Article 10 TPA).

Different authorisation procedures apply depending on the characteristics and the application of the medicinal product.

• Ordinary procedures for first authorisations of new active pharmaceutical ingredients (APIs) and major deviations (Article 9 paragraph 1, Articles 11 et seq TPA).
• Compassionate use authorisations (in a simplified procedure, Articles 14 et seq TPA) for a limited period – ie, for life-threating or debilitating diseases if they are compatible with the protection of health, their use is expected to have a major therapeutic benefit, and no authorised, alternative or equivalent medicinal product is available in Switzerland (Article 9a TPA; Articles 18 et seq OSMA).
• Fast-track procedures for first authorisations of new APIs and major deviations on request, available for promising therapies for the prevention or therapy of a severe, debilitating or life-threatening disease with a high therapeutic benefit and where the standard treatment is either unavailable or unsatisfactory (Article 7 OMP).
• Simplified procedures for certain categories of medicinal products where this is compatible with the quality, safety and efficacy requirements and where there is no conflict with Swiss interests or international agreements, in particular for generics (but not for biosimilars), orphan drugs and certain categories of medicinal products authorised and/or used in foreign countries (Articles 14 et seq TPA; Articles 12 et seq OSMA).
• The authorisation procedure on the basis of a notification, in particular for certain complementary medicines without indications and other medicinal products with a low-risk potential (Article 15 TPA).

Changes to an authorisation that have no or only minimal consequences for the quality, safety or efficacy of a medicinal product must be communicated to Swissmedic within 12 months of their implementation (Article 21 OMP). Substantial variations require an additional marketing authorisation procedure. Marketing authorisations are in principle transferable upon approval of a respective application by Swissmedic.

Medical devices do not require an authorisation by a public authority prior to being placed on the Swiss market. Instead, they must bear a respective conformity (MD or CE) marking testifying the conformity of the device with the general safety and performance requirements.

The conformity assessment procedure is based on Articles 52 and 54 and Annexes IX-XI of the EU-MDR (Articles 21 et seq MedDO; Articles 17 et seq IvDO). Depending on the risk qualification of the medical device (see 1.3 Different Categories of Pharmaceuticals and Medical Devices), the conformity is either to be declared by the manufacturer or by a private body certified to conduct conformity assessments.

In principle, ready-to-use medicinal products may only be placed on the market after they have been authorised (Article 9 paragraph 1 TPA). However, there are a number of exceptions to this general rule.

• Medicinal products for which a review of the ordinary approval requirements (of high quality, safe and effective) is not necessary or useful – eg, formula magistralis, officinalis and hospitalis products or products intended for clinical trials (Article 9 paragraphs 2 et seq TPA).
• Orphan use – the use of medicinal products for the treatment of diseases that are so rare that there is hardly any incentive for a regular marketing authorisation to be approved in Switzerland for a limited period in a simplified approval procedure (Article 9a, Article 14 paragraph 1 lit f TPA).
• Temporary authorisation for use outside of clinical trials – Swissmedic may temporarily authorise the use of yet unauthorised medicinal products intended for clinical trials outside the scope of a clinical trial (Article 9b paragraph 1 TPA; Articles 52 et seq MPLO).
• Temporary authorisation to bridge temporary unavailability – medicinal products may be temporarily or quantitatively authorised by Swissmedic to bridge the unavailability of an identical medicinal product in Switzerland, provided that they are authorised in another country with an equivalent medicinal product control and no essentially identical medicinal product is authorised and available in Switzerland (Article 9b paragraph 2 TPA).
• Off-label use – off-label use – eg the use of a (properly) authorised medicinal product for other indications, is generally permissible within the scope of Articles 3 and 26 TPA.
• Unlicensed use – an unlicensed medicinal product may be imported under the restrictive requirements of Article 20 paragraph 2 TPA and Articles 48 et seq MPLO.

Manufacturers of medical devices must generally carry out a conformity assessment before placing the device on the market (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices). However, in the interest of public health or patient safety or health, Swissmedic may, upon application, grant an authorisation even though the relevant conformity assessment procedure has not been carried out (Article 22 paragraph 1 MedDO; Article 18 paragraph 1 IvDO).

Holders of marketing authorisations for medicinal products, as well as medical device manufacturers, must have a post-market surveillance system (ie, pharmacovigilance and materiovigilance plans) in place (Article 11 paragraph 2 lit a no 5 TPA; Article 56 MedDO; Article 49 IvDO).

Holders of marketing authorisations for medicinal products with a new API or a biosimilar must periodically and automatically file safety update reports (PSURs) with Swissmedic on the safety and risk-benefit ratio for four years after authorisation (Article 60 OMP). With its marketing authorisation, Swissmedic may impose additional conditions or obligations on the applicant, including further product evaluations (eg, in Phase IV clinical trials). Depending on the classification of a medical device, its manufacturer has similar trend report, periodic summary report and PSUR obligations to the designated body involved in the conformity assessment (Articles 59 et seq MedDO; Articles 52 et seq IvDO).

As for incident notification requirements, manufacturers of medicinal products, distributors of ready-to-use medicinal products and HCPs must notify Swissmedic of adverse events, adverse drug reactions and quality defects within 15 days in case of serious adverse reactions and within 60 days of non-serious reactions. Similarly, anyone placing medical devices on the Swiss market must report to Swissmedic all serious incidents as well as all field safety corrective actions that are undertaken in Switzerland (Article 66 MedDO; Article 59 IvDO).

Authorities must in principle treat all data collected within the framework of the TPA and its implementing regulations as confidential, including all data communicated to the authorities in the context of a marketing authorisation application (Article 62 TPA). Granted marketing authorisations for medicinal products are published in the monthly Swissmedic Journal, together with essential information about the medicinal product. Swissmedic publishes an assessment report (SwissPAR) for all medicinal products with a new API, as well as for transplant products, for which a decision to approve or reject authorisation has been issued. The SwissPAR includes the evaluation results of the application for new authorisation or additional indication of a medicinal product, but not the applicant’s commercial or manufacturing secrets or personal data.

Regarding medical devices, the conformity assessment procedures by Swiss or European assessment bodies are not accessible to third parties. The successful completion of a conformity assessment is made public together with the issuance of the declaration of conformity for the respective product (Article 90 lit f MedDO).

Switzerland has signed and ratified the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (Medicrime-Convention). Accordingly, several provisions were introduced into the TPA, including mandatory licensing for persons trading medicinal products in foreign countries from Switzerland or acting from Switzerland as brokers or agents for medicinal products (Article 18 paragraphs 1 and 2 TPA), the designation of Swissmedic as the national contact point under the Medicrime Convention (Article 69 paragraph 4 TPA), and criminal provisions (Articles 90 et seq TPA).

Customs authorities are involved in monitoring the importation, the transit and the exportation of therapeutic products. In particular, they monitor whether the medicinal products are authorised or compliant and whether the quantity lies within the maximum limit. In the case of suspicious shipments of goods, the customs office notifies Swissmedic and holds back the products in question. Decisions in application of healthcare regulations are, however, made exclusively by Swissmedic.

Following the ratification of the Medicrime-Convention (see 3.8 Rules Against Illegal Medicines and/or Medical Devices), the Federal Office for Customs and Border Security (FOCBS) was granted the competence, alongside Swissmedic, to order secret surveillance measures (Article 90a TPA).

The manufacture of medicinal products in Switzerland is subject to a mandatory licence (Article 5 paragraph 1 lit a TPA). The same applies to anyone withdrawing blood from humans for the purpose of transfusion or the manufacture of therapeutic products or for supply to a third party (Article 34 TPA). The licence is issued if Swissmedic has successfully verified during an inspection that the necessary technical and operational conditions have been fulfilled and an appropriate system of quality assurance exists (Article 6 TPA; Articles 3 et seq MPLO). The licence is issued for an unlimited period of time, whereby Swissmedic performs periodic inspections and may revoke licences if the requirements are no longer fulfilled.

Manufacturers of medical devices are not subject to licensing requirements in Switzerland. However, if a manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised representative in Switzerland that is responsible for the related formal and safety-related aspects and is registered with Swissmedic (Articles 51 and 55 MedDO; Articles 44 and 48 IvDO; Article 11 EU-MDR/ EU-IVDR).

Any person engaged in the wholesale trade of medicinal products must possess a licence (Article 28 paragraph 1 TPA). The licence is issued following an inspection by Swissmedic (Article 28 paragraph 2 TPA; Articles 11 et seq MPLO).

No licences are required for the wholesale (Article 4 paragraph 1 lit i MedDO; Article 4 paragraph 1 lit h IvDO) of medical devices. Foreign manufacturers, however, need to appoint an authorised representative domiciled in Switzerland (see 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices).

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

Importation and exportation of medicinal products and medical devices are mainly governed by the TPA, MPLO, MedDO and the Swiss customs legislation. At the point of entry, the responsibility for the application and enforcement of the respective regulations lies with the FOCBS. The competent governmental authority for any subsequent market surveillance is Swissmedic. FOCBS and Swissmedic co-operate closely in their joint areas of competence (cf. Article 65 MPLO).

Any person that professionally imports medicinal products intended for distribution or dispensing must possess a licence issued by Swissmedic (Article 18 paragraph 1 lit a TPA) following an inspection confirming that the necessary technical and operational conditions have been fulfilled and that an appropriate system of quality assurance exists (Article 19 paragraph 1 TPA; Articles 11 et seq MPLO).

Importers of medical devices (Article 4 paragraph 1 lit h MedDO; Article 4 paragraph 1 lit. g IvDO) are not subject to licensing requirements in Switzerland. However, if a manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised representative in Switzerland that is responsible for the related formal and safety-related aspects and if the importer is registered with Swissmedic and is assigned a CHRN (Article 55 MedDO; Article 48 IvDO; see 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices).

In principle, only medicinal products that have been granted a marketing authorisation by Swissmedic can be imported into Switzerland (Article 9 TPA), and importation is subject to a specific licence (Article 18 paragraph 1 lit a TPA). Subject to certain exceptions, in particular in connection with an official batch release from a foreign control authority belonging to the Official Control Authority Batch Release Network (OCABR), anyone wishing to import immunological medicinal products or blood and blood products generally requires a special licence for each individual shipment (Article 44 MPLO). Under certain circumstances, ready-to-use medicinal products without a marketing authorisation in Switzerland may be imported in small amounts by persons for private use or by HCPs (cf. Articles 48 and 49 MPLO).

While no licence for the import of medical devices is required (see 6.2 Importer of Record of Pharmaceuticals and Medical Devices), medical devices must, prior to their placing on the Swiss market, undergo a conformity assessment to ensure that general safety and performance requirements are met (Articles 6, 21 et seq MedDO; Articles 6, 21 et seq IvDO). Certifications of conformity (CE markings) issued by bodies from EU/EEA countries are unilaterally recognised in Switzerland (Article 25 paragraph 4 MedDO; Article 21 paragraph 4 IvDO).

Non-tariff restrictions are set forth in the Swiss customs tariff. The entries in the relevant Harmonised Tariff Schedule (HTS) line will determine which market surveillance authority is competent to examine and approve import. The product-related laws and implementing ordinances set out the restrictions in detail.

Switzerland is a member of the European Free Trade Association (EFTA) and is, amongst others, signatory to the Free Trade Agreement with the EU of 1972 as well as to a network of currently 33 free trade agreements with 34 partners. The EU has unilaterally ceased the application of the Mutual Recognition Agreement as regards medical devices. As a result, exportation of medical devices from Switzerland into the EU has become more burdensome. Negotiations are currently taking place between the USA and Switzerland on a free trade agreement concerning the pharmaceutical sector, which is intended to facilitate market access for Swiss pharmaceutical companies.

Under Swiss law, prices of therapeutic products are controlled to the extent that they are reimbursed by the compulsory health insurance. With regard to therapeutic products not reimbursed by compulsory health insurance, manufacturers, wholesalers and retailers are, in principle, not restricted in their pricing.

Pharmaceuticals are reimbursed subject to a listing on the Specialties List (SL) where ready-to-use medicinal products are included. Medicinal products that are manufactured in a pharmacy are reimbursed if their APIs are included in the List of Medicines with Tariff (LMT). The requirements for price fixing are mainly contained in the Health Insurance Act (HIA), the Health Insurance Ordinance (HIO) and the Ordinance on the Benefits under the Mandatory Health Insurance (OBHI). The SL determines the ex-factory price as well as the public price, which is the maximum amount (including VAT) that must be reimbursed by health insurers.

The FOPH decides on the inclusion of a medicinal product on the SL after consultation with the Federal Drugs Commission (EAK), except in case of certain medicinal products, such as generics and new galenic forms or package sizes of already listed medicinal products (Article 31 paragraph 2 OBHI). An accelerated procedure applies in case of an accelerated market authorisation (Article 31a OBHI). The procedure is initiated by the market authorisation holder (Article 31 paragraph 1 OBHI). Medicinal products can only be included in the SL if the criteria of efficacy, appropriateness and cost-effectiveness are met (Article 32 paragraph 1 HIA). The prices are reviewed every three years (Article 65d HIO), and additional reviews take place upon patent expiry and in case of the authorisation of further indications.

The List of Items and Tools (LIT) determines which devices are covered by the compulsory health insurance. Unlike the SL, the LIT does not fix the ex-factory and public price, but only sets the maximum reimbursement amount. In principle, higher prices may be charged and the difference is borne by the patient. There are specific provisions governing the application for inclusion on the LIT. The FDHA decides upon consultation of the Federal Commission for Analyses, Instruments and Tools (FCAIT) on the addition, change, or delisting (cf. Articles 21 et seq OBHI). The criteria of efficacy, appropriateness and cost-effectiveness also apply to medical devices.

When setting and reviewing the prices of the medicinal products included in the SL, the FOPH relies on the following comparisons: (i) a therapeutic comparison in which the effectiveness of the medicinal products is assessed in relation to other medicinal products used for the same indication (Article 65b paragraph 4bis HIO); and (ii) a price comparison with the same medicinal product abroad (cf. Article 34a and 34b OBHI). The two comparisons are given the same weight. The latter comparison is carried out according to the guidance of the EAK taking into account foreign countries whose pharmaceutical sector is economically comparable with Switzerland.

Under the compulsory health insurance, insurers must reimburse costs for prescribed medicinal products listed in the SL and the LMT at the maximum amount set out therein. The reimbursement may be restricted to specific indications, quantities or durations. Reimbursement is, in general, only granted for listed medicinal products under the condition that they are used in connection with indications approved by Swissmedic and within approved quantities. Exceptions from this general rule apply on a case-by-case basis subject to the conditions set out in Article 71a HIO. In addition, there is also room for reimbursement in individual cases of medicinal products not yet authorised, not yet included in the SL or used outside their marketing authorisation (Articles 71b-d HIO).

Medical devices applied by the patient are reimbursed under the condition that they belong to a specific group of medical devices in the LIT, are prescribed by a physician or chiropractor and are dispensed by an authorised provider. The reimbursement of listed medical devices may be restricted to specific medical indications, quantities or durations. Case law has not yet addressed the question of whether the provisions of Article 71a-d HIO are also applicable to medical devices by analogy.

Among the conditions for the inclusion of medicinal products on the SL are their efficacy, appropriateness and cost-effectiveness, and the existence of these conditions must be periodically reviewed (Article 32 HIA). Medicinal products that no longer meet these criteria are removed from the SL by the FOPH. The same applies to medical devices (to be) included on the LIT.

It is usually undisputed that an authorised medicinal product is effective and appropriate. In practice, the main focus is therefore on the criterion of cost-effectiveness, including the respective comparisons with other medicinal products and markets (see 7.2 Price Levels of Pharmaceuticals or Medical Devices).

While the main purpose of the prescribing and dispensing regulations is to safeguard patient welfare and safety in the dispensing and use of medicinal products by requiring that only HCPs with sufficient education, training and continuing education are involved (Articles 24-26 TPA), HCPs are required by their professional duties and corresponding provisions in their self-regulations to also observe the aspect of economic efficiency. Furthermore, the legal provisions on the advertising of medicinal products explicitly provide for the inadmissibility of advertising, including to HCPs, which may encourage the excessive use of medicinal products (cf. Article 32 paragraph 1 lit b TPA). Lastly, the integrity provisions (cf. Article 55 TPA; OIT) prohibit the excessive prescribing of medicines.

In general, physicians may prescribe any authorised medicinal product for a given indication without regard to its price, and they are not obliged to propose a more affordable (generic) alternative. That said, if the SL contains different medicinal products containing the same API, the cost share that must be borne by the patient may vary. Physicians must inform their patients accordingly. Equally, for medicinal products that are not included in the SL or that are used off-label or off-limitation, HCPs must inform the patients that the costs might not be reimbursed under the compulsory health insurance. According to Article 52a HIA, pharmacists are allowed, but not obliged, to substitute a prescribed original medicinal product listed on the SL with a generic unless there is an explicit request by the prescribing physician or chiropractor to dispense the original.

Medical apps are not subject to specific regulation in Switzerland, but are considered medical devices provided that the app is intended to be used for a medical purpose as set out in the TPA (see 3.1 Product Classification: Pharmaceuticals or Medical Devices; Federal Administrative Court decision C-669/2016 of 17 September 2018). Therefore, such apps must comply with the legal requirements for medical devices, including regarding conformity assessments.

While telemedicine is established in Switzerland, only few cantons have issued specific regulation (eg, § 8 Health Care Act of the Canton of Basel-Landschaft). Thus, telemedicine is governed by general healthcare law and the medical code of ethics. As soon as the treating physician can no longer assume that a patient can be treated carefully by means of telemedicine, the treatment must be adjusted and the patient must be either physically examined or referred to another physician. The provisions of data protection and medical secrecy (Article 321 Swiss Criminal Code (SCC)) are also applicable to treatments using telemedicine methods.

Electronic advertising of medicinal products, such as via online portals and social networks, without any access restriction, qualifies as advertising to the general public (Article 15(c) OMPA), which is prohibited for prescription medicines (Article 32 paragraph 2 lit a TPA). Access to professional advertising via electronic means must be restricted by appropriate technical and password protection to professionals authorised to dispense or apply medicinal products (Article 5a OMPA). The same applies to media releases and press kits which directly or indirectly reference the prescription of specific medicinal products (Swissmedic Guidance “Advertising of medicinal products on the internet”).

There are no specific regulations governing online promotion and advertising of medical devices. The promotion to the general public of products intended solely for the use by HCPs is prohibited (Article 51 TPA; Article 69 paragraph 3 MedDO; Article 62 paragraph 3 IvDO).

Rules on electronic prescription are part of the regulation on the electronic patient record. The FMH and the Pharmacists Association “Pharmasuisse” announced in a 2022 statement that they intend to create an electronic prescription, and initial pilot tests have already been launched. The most recent draft revision of the TPA, for which consultation was opened in December 2023, intends to create a legal basis for electronic prescriptions and their digital transmission.

The online sale of medicinal products is, in principle, prohibited (Article 27 TPA). By exception, a licence may be granted by the competent cantonal authorities to persons already in possession of a cantonal retail authorisation to run a public pharmacy if (Article 27 paragraphs 2 and 4 TPA; Article 55 paragraph 2 OMP):

• there is a physician’s prescription for the medicinal product (irrespective of whether it qualifies as a prescription-only product);
• no safety requirements oppose it; and
• appropriate consultation and sufficient medical supervision of the effect of the medicinal product are guaranteed.

The online sale of medical devices is, in principle, permitted (Article 7 MedDO; Article 7 IvDO).

In 2017, the Federal Act on the Electronic Patient Record (EPR) and the related ordinances came into force and regulate the conditions for the introduction and implementation of the electronic patient dossier (EPD). The EPD is a filing system for treatment, with relevant information containing copies of medical records, whereby the decision whether to open an EDP is left to the patients (opt-in). The data is stored in encrypted form and can only be viewed by the patients and authorised HCPs. The EPR is currently being revised.

Health-related data is regarded as sensitive data pursuant to the FADP and the DPO, provided that the data directly or indirectly references an identified or identifiable person’s physical or mental health. This means that, in principle, anonymised data is not regarded as sensitive data.

More stringent requirements apply to sensitive data, including requiring data controllers to:

• inform the person concerned about the collection of their data;
• ensure that the disclosure of sensitive data to third parties is based on a legal justification; and
• comply with specific registration and notification obligations with the Federal Data Protection and Information Commissioner (FDPIC).

Moreover, the general provisions of the FADP must be complied with. The transfer and storage of health data on a cloud platform is, in principle, permitted under the FADP. However, this is only possible if, among others, no legal or contractual confidentiality obligation prohibits such transfer. Physicians are bound by professional secrecy regarding the medical history or the contents of the patient file (Article 321 SCC). They remain responsible for keeping confidentiality even when transferring the data and therefore must ensure that the patient data is protected against unauthorised processing. The FMH recommends that physicians do not store health data of their patients in clouds located abroad.

The Federal Act on Patents and Inventions (PatA) and the Ordinance on Patents and Inventions (PatO) apply to patents in Switzerland. Further, Switzerland is a member of the major international patent treaties, such as the European Patent Convention (EPC) and the Patent Co-operation Treaty (PCT).

Most patents in Switzerland are granted within a harmonised procedure under the EPC. Generally, patents are granted for new inventions with an industrial application.

Certain inventions, such as gene sequences, are excluded from patent protection. Accordingly, the patentability of medicinal products developed from human gene sequences is subject to a scrutinous examination. Methods for medical treatment and diagnostics are also excluded from patent protection. While it is in essence undisputed that the exclusion from patentability only refers to the methods, and not to products used in such methods, it can be difficult to draw a clear distinction between device-related methods and functional device features.

Pharmaceutical substances or compositions that – even though they are part of the state of the art as such – do not yet form the state of the art in relation to a specific use in a surgical, therapeutic or diagnostic method are deemed to be new and, hence, patentable, provided they are intended for use in the manufacture of a means to a surgical, therapeutic or diagnostic end (Article 7c PatA). Any subsequent new surgical, therapeutic or diagnostic use for which the substance or composition is not considered state of the art can also be claimed as new (Article 7d PatA). Consequently, the use of a substance or composition for the manufacturing of a means for a medical procedure is patentable. Such claims are referred to as Swiss-type claims.

New dosage regimes and the indication for a new or selected patient population as such cannot be patented. However, if a dosage regime or indication is new and based on an inventive step, such new dosage regime or new indication can be patented. In most cases, however, a new dosage regime will be considered obvious and, hence, not patentable.

To date, it is unclear what activities constitute infringement of second and subsequent patents of medicinal products. More specifically, it has yet to be decided whether and to what extent the exclusive rights conferred by a traditional substance claim, by a claim for second and subsequent medical use under Articles 7c and 7d PatA and by a purpose-oriented substance claim under Article 54(5) of the EPC differ from each other.

In principle, patent protection is granted for a term of 20 years from the filing date of the application and cannot be extended. Unlike other jurisdictions, Switzerland does not have a patent linkage system. However, for medicinal products, the Swiss Intellectual Property Institute (IPI) can grant a supplementary protection certificate (SPC) for a patent-protected API or combination of APIs (or manufacturing process or use of such API or API combination) contained in a medicinal product authorised in Switzerland. An SPC takes effect on expiry of the maximum patent term for a period equal to the period which elapses between the date of filing and the date of the first authorisation of the medicinal product in Switzerland minus five years, but for a maximum term of five years. Subject to statutory conditions, the SPC’s term of protection may be extended once for a period of six months. The application for an SPC must be filed with the IPI (i) within six months of the first marketing authorisation of a medicinal product containing the API or API combination in Switzerland; or (ii) within six months of the grant of the patent if the patent was granted later than the first marketing authorisation. On certain conditions, patent holders can also apply for a paediatric SPC or extension of a non-paediatric SPC with a term of six months.

Medicinal products and medical device patents confer the exclusive right to commercially use the invention in Switzerland. This exclusive right can be infringed through direct or indirect misconduct. A direct infringement occurs when an unauthorised party uses a patent commercially by, inter alia, manufacturing, storing, offering, advertising to Swiss customers, placing on the market, importing, exporting and carrying in transit a patent-protected product, or by possessing the patent-protected product for any of these purposes. An indirect infringement occurs if a party contributes to a direct patent infringement – ie, if a party instigates, participates in, favours, facilitates or contributes in other ways to a direct patent infringement (aiding or abetting). Such contribution must have an adequate causal link to the direct patent infringement.

Apart from actual patent infringements, the mere threat of infringement is actionable as well. In such cases, the claimant must deliver proof of a sufficient interest in legal protection. Such an interest exists if the unlawful act is imminent – ie, if the alleged infringement of rights is to be seriously expected.

In practice, key defences to patent infringement relate to the invalidity of a patent as well as the lack of an infringement.

Further, defendants may invoke statutory exemptions, such as the so-called “experimental use exemption”, according to which the effect of a patent does not extend to acts undertaken for research or experimental purposes under Swiss law (Article 9 paragraph 1 lit b PatA). Additional exemptions and respective defences are, inter alia, provided for:

• acts necessary for obtaining a marketing authorisation for a medicinal product in Switzerland or in countries with equivalent medicinal product control – ie, EU/EEA countries, USA, Singapore, New Zealand, Canada, Japan, and Great Britain (Article 9 paragraph 1 lit c PatA);
• acts undertaken as part of a medical activity by legally authorised persons concerning an individual person and involving a medicinal product (compassionate or off-label use) (Article 9 paragraph 1 lit g PatA); and
• the direct individual preparation of medicinal products in pharmacies in accordance with a physician’s prescription (Article 9 paragraph 1 lit h PatA).

Patent infringement proceedings may be initiated by the patent owner and by a patent licensee who holds an exclusive licence and whose right to initiate an infringement action is not explicitly excluded in the licence agreement. Exclusive and non-exclusive licensees are eligible to join a pending infringement proceeding in order to claim their own losses or damages.

Through a patent infringement proceeding, a claimant may seek a variety of remedies, such as injunctive relief, the remedying of an unlawful situation, damages or a declaratory judgment. Further statutory remedies are the provision of information and accounting, the destruction of infringing goods, the recall of patent infringing goods or the publication of the decision.

Typical patent infringement actions are carried out in the form of inter partes preliminary injunction proceedings for interim relief, followed by ordinary proceedings on the merits.

A defendant may raise the defence of invalidity in preliminary injunction proceedings. If such a defence is raised, the Federal Patent Court examines both the question of validity and the question of infringement in almost as much detail as in ordinary proceedings on the merits. In ordinary proceedings on the merits, the invalidity may be invoked either as a defence or by way of a counteraction. Unlike courts in other jurisdictions, the Federal Patent Court is competent to rule on both the validity and the infringement of a patent. Accordingly, plaintiffs need not bring validity and infringement actions before different courts.

There is no requirement of a declaratory action for a generic product to enter the Swiss market. While a prior marketing authorisation is required for a medicinal product to enter the market, the authorisation procedure as such is not considered to constitute a patent infringement.

At the same time, the simplified authorisation procedure used for generic entry in Switzerland (Articles 14 et seq TPA; Articles 12 et seq OSMA) is based on references to the marketing authorisation documents of the medicinal product with the known APIs. These documents can benefit from regulatory data protection for a certain period. Accordingly, the marketing authorisation for generic entrants can, in principle, only be granted upon expiry of the regulatory data protection.

For medical devices, Swiss law does not provide for a marketing authorisation procedure. It is for the competitor to decide on its market entry, and for the holder of a patent in the original medical device to take legal action.

In Switzerland, various intellectual property laws and procedures are in place to combat the counterfeiting of medicinal products and medical devices, including the following: the PatA, the Trade Mark Protection Act (TmPA), the Federal Design Act, the Federal Act on Copyright and Related Rights, and the Federal Unfair Competition Act (UCA).

In case of infringements, these statutes grant civil law remedies such as injunctions, damages and account of profits.

In addition to civil law remedies, under criminal law, counterfeiting medicinal products and medical devices constitutes a criminal offence. The Swiss intellectual property laws provide for criminal penalties against counterfeiters, including custodial sentences of up to five years and monetary penalties.

Under customs laws, the FOCBS is responsible for enforcing intellectual property rights at the Swiss border – eg, by withholding goods and notifying the proprietor of the intellectual property right if there is a suspicion that the import, export or transit of such goods infringes rights in Switzerland.

In principle, trade marks for medicinal products and medical devices are subject to generally applicable trade mark and unfair competition laws.

Notably, the IPI can refuse the registration of a trade mark if the registered sign is (i) in the public domain, (ii) misleading, (iii) contrary to public policy, morality or applicable law, (iv) technically necessary or representing the nature of the goods themselves (Article 2 TmPA). Inter alia, trade mark protection can be withdrawn for lack of use or infringement of a prior trade mark.

In addition to generally applicable standards, the name of a medicinal product (unlike the name of a medical device) is subject to prior authorisation by Swissmedic as part of the marketing authorisation proceedings. Swissmedic can reject or request amendments to a contemplated name if there is a risk of confusion between medicinal products or if the name is considered (i) misleading about the product’s composition, quality, efficacy, risks, or safety, or (ii) promoting improper consumption.

In principle, the design of medicinal products and medical devices, as well as their packaging, are eligible for trade mark, design and/or copyright protection, as well as protection under the UCA. The scope of protection will generally depend on the (intellectual property) right that is being claimed and on the level of distinctiveness of the specific design or trade dress.

Upon registration, trade mark protection is granted in Switzerland to protect the use of a registered sign for a specified class of products and/or services. The trade mark can, in principle, consist in packaging or trade dress elements. In order to be protected, the trade mark must be distinctive.

Upon registration, design protection is granted in Switzerland to protect the appearance of a product and/or its packaging. A design is protected to the extent that it is new and has an individual character.

Copyright protection is granted as of the moment of the creation of a design. No registration is required. To benefit from protection, the design must, however, qualify as an original work of authorship.

Where an imitation of a medicinal product or medical device trade dress violates fairness principles (eg, if the user is intentionally misled about a product’s origin or if the imitator intentionally exploits the reputation of a competing product), protection can be sought under the UCA.

The documents that are submitted to obtain marketing authorisation for new active substances are generally protected for a period of ten years from the granting of the marketing authorisation in Switzerland (Article 11a TPA). New indications, modes of administration, dosages or dosage forms can benefit from regulatory data protection of three years. Further document protection can be granted for important orphan medicinal products (15 years), medicinal products specifically and exclusively for paediatric use (ten years), and medicinal products that are expected to have a significant clinical benefit compared to existing therapies (ten years) (Article 11b TPA).

During the respective data protection period, the simplified procedure allowing for a reference to marketing authorisation documents of a known API is unavailable and a marketing authorisation for another product cannot be granted based the protected data, including trial data for the protected authorised product, unless the marketing authorisation holder consents. Unlike jurisdictions providing for market exclusivity, the Swiss system only protects the data and does not prevent other manufacturers from entering the market based on independently generated data.

Numerous (temporary) regulations were issued in connection with the COVID-19 pandemic, also affecting the marketing and distribution of therapeutic products. As of today, the key regulation in this respect is the Ordinance 3 on Measures to Combat the Coronavirus (COVID-19 Ordinance 3), which is intended to ensure that Switzerland can maintain adequate medical care for the population and sufficient essential medical supplies. To this end, the COVID-19 Ordinance 3 establishes notification requirements for stocks of essential medical supplies, procurement and distribution requirements and simplifying exemptions for the placing on the market and importation of medicinal products and medical devices for the prevention and control of COVID-19. The COVID-19 Ordinance 3 will cease to apply as of 1 August 2024.

Swissmedic and Swissethics issued joint recommendations for the handling of clinical trials with medicinal products during the COVID-19 pandemic (“Joint Guidance”). The Joint Guidance provided, among other things, that applications for clinical trials related to COVID-19 were prioritised and that applications for clinical trials could be submitted electronically and in bundles of multiple applications. Furthermore, for the period of the pandemic, specific amendments regarding the distribution of investigational medicinal drug products and the monitoring of clinical trials were provided.

During the pandemic, different exemptions from the general authorisation requirement for medicinal products were issued.

• Certain medicinal products used for the treatment of COVID-19 patients, can already be placed on the market during the approval process (Article 21 paragraph 1 of the COVID-19 Ordinance 3).
• The same applies to medicinal products that prevent the COVID-19 infection of immunosuppressed persons under certain conditions (Article 21 paragraph 1bis COVID-19 Ordinance 3).
• Variations to the authorisation for certain authorised medicinal products can be implemented immediately upon application (Article 21 paragraph 2 COVID-19 Ordinance 3).
• Swissmedic was enabled to approve the import of essentially identical medicinal products as a short-term solution for any temporary non-availability of medicinal products (Article 22 paragraph 3 COVID-19 Ordinance 3).

Likewise, certain exemptions were introduced for medical devices.

• Subject to approval by Swissmedic, medical devices that have not (yet) undergone the required conformity assessment procedure in Switzerland or in a recognised third country (eg, the EU) may nevertheless be placed on the Swiss market under certain requirements (Article 23 paragraph 1 COVID-19 Ordinance 3).
• Face masks that have not undergone a conformity assessment procedure can be placed on the market, provided that they are not used in the medical field and are labelled accordingly (Article 23 paragraph 4 COVID-19 Ordinance 3).

No simplifications regarding manufacturing licences were introduced in connection with the pandemic. However, for a short period of time, Swissmedic inspections were suspended or modified, and Swissmedic confirmed that all GMP certificates issued in 2017/2018 would remain fully valid until the end of 2021 or the next routine inspection. In January 2023, Swissmedic provided an update according to which all planned routine inspections in Switzerland were carried out and that it was no longer necessary to generally extend GMP certificates. Extended EU GMP certificates are, however, accepted by Swissmedic.

Different regulations were introduced during the pandemic to facilitate the import of medicinal products.

• Following the submission of an authorisation application according to Article 21bis COVID-19 Ordinance 3, the applicant can import the medicinal product before the decision on the authorisation or entrust a company carrying a wholesale or import licence with the import (Article 22 paragraphs 1 and 2bis COVID-19 Ordinance 3).
• Pharmacists who have pharmaceutical responsibility in a hospital pharmacy are authorised to import certain medicinal products (Article 22 paragraph 1bis COVID-19 Ordinance 3).
• For the temporary non-availability of a medicinal product, Swissmedic may allow the temporary import of an identical medicinal product, provided no other essentially identical medicinal product is authorised and available in Switzerland (Article 22 paragraph 3 COVID-19 Ordinance 3).
• Article 22 paragraph 4 Covid-19 Ordinance 3 permits the import and storage of COVID-19 vaccines before their authorisation, under certain conditions.

Under the pandemic, a wider range of remote services delivered by HCPs was reimbursed by the compulsory health insurance in order to comply with the requirements of social distancing.

Applicants may bring action before Swiss courts for a compulsory non-exclusive licence for the manufacture of patent-protected medicinal products and for their export to a country that has insufficient or no production capacity of its own in the pharmaceutical sector and which requires these products to combat public health problems, in particular those related to epidemics (Article 40d paragraph 1 PatA). However, no such licence has been granted to date in the medicinal products area, including for COVID-19-related treatments or vaccines.

No liability exemptions were introduced for COVID-19 treatments and vaccines in Switzerland, and the general product liability rules continue to apply.

In addition to these general rules, the Epidemics Act (EpA) provides a special ground for liability claims for vaccines. Accordingly, anyone who is harmed by an officially ordered or officially recommended vaccination is entitled to damages, and also to moral compensation of maximum CHF70,000, if the severity of the impairment justifies it (Articles 64 et seq EpA). However, the Swiss State only grants compensation if the damage cannot be covered otherwise with reasonable efforts – eg, by the vaccine manufacturer. While this compensation scheme existed already prior to the COVID-19 pandemic, it has attracted greater attention since.

There was no requisition or conversion of manufacturing sites due to COVID-19.

The Swiss Armed Forces Pharmacy has been granted extended rights in connection with the procurement of essential medical goods if requirements cannot be covered through the normal procurement channels (Article 14 COVID-19 Ordinance 3).