Commercialisation of healthcare in Switzerland: overview

A Q&A guide to the commercialisation of healthcare in Switzerland.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Switzerland. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

The main legislation relating to the commercialisation of medical products in Switzerland is the Swiss Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act) (TPA), which specifies the health protection principles set out in the Swiss Constitution. Detailed rules and regulations are set out in various ordinances, including the:

  • Ordinance on Medicines.

  • Medicinal Products Authorisation Ordinance.

  • Ordinance on Advertising for Medicinal Products.

  • Ordinance on Medical Devices.

  • Ordinance of the Swiss Agency for Therapeutic Products on the simplified authorisation of homeopathic and anthroposophic medicines.

Pricing is regulated in different acts, in particular the:

  • Federal Health Insurance Act.

  • Ordinance on Health Insurance.

  • Ordinance on Services in the Compulsory Health Insurance.

  • Price Surveillance Act.

The commercialisation of medical products is also governed by the provisions of the Swiss Unfair Competition Act and the Swiss Cartel Act.

Internationally, Switzerland aims to facilitate the free circulation of medical devices. Therefore, numerous treaties have been concluded to harmonise standards and adapt Swiss regulations to the EU medical device directives. In particular, bilateral treaties exist between Switzerland and the EU member states, European Free Trade Association (EFTA) member states and Turkey relating to the mutual recognition of conformity assessments for medical devices.

Regulatory authorities

In Switzerland, the cantons and the Swiss Agency for Therapeutic Products (Swissmedic) are responsible for enforcing the TPA. They are responsible for authorising therapeutic products and for licensing and monitoring the manufacturing, distribution, dispensing and presentation of such products (including blood and blood products).

The Federal Office of Public Health (FOPH) is responsible for the "list of pharmaceutical specialties" (LS) (Spezialitätenliste (SL)), which lists the medicinal products that are covered by the compulsory health insurance and the maximum amount of reimbursement for each product. The FOPH is also responsible for the "list of devices and appliances" (Mittel und Gegenständeliste (MiGeL)), which lists the medical devices that are covered by the compulsory health insurance, and their prices.

Prices are further monitored by the Federal Price Regulator (FPR). The Competition Commission (ComCo) oversees general competition issues in accordance with the Swiss Cartel Act.

For more information on Swissmedic, the FOPH, the FPR and ComCo see box: The regulatory authorities.

Private parties

In Switzerland, private parties grouped in associations have developed various self-regulatory standards and guidelines. The Federation of Swiss Medical Devices Trade and Industry Association (FASMED) has developed a Code of Business Conduct, which provides guidelines on interactions with healthcare professionals. The Swiss Academy of Medical Sciences (SAMS) has also issued guidelines for the collaboration between the medical profession and industry. The Swiss Business Association for Chemical, Pharmaceutical and Biotech Industries (Scienceindustries Switzerland) has adopted the:

  • Pharma Code, which is a code of conduct of the pharmaceutical industry relating to the professional promotion of medicinal products.

  • Pharma Co-operation Code, which provides guidelines on co-operation with healthcare professionals and patients' organisations.

 
2. What types of medical products are regulated?

In Switzerland, there is a distinction between medicinal products and medical devices, which are both regulated.

Medicinal products are products of chemical or biological origin which are intended to have, or are presented as having, a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps (including blood and blood products). Veterinary medicines are regulated in the same way as human medicinal products, unless the Federal Council has excluded such medicines from the scope of the Therapeutic Products Act (TPA).

Medical devices are products (including instruments, apparatus, in vitro diagnostics, software and other goods or substances) that are intended to have, or are presented as having, a medical use and whose principal effect is not obtained with a medicinal product.

Complementary medicines are a special category of medicinal products, which comprises:

  • Asian, homeopathic and anthroposophic medicinal products.

  • Herbal medicinal products containing one or more herbal substances or preparations as active substances, and which cannot be classified within specifically oriented therapies.

Vitamins, minerals or other supplements that are not marketed as therapeutic products do not fall within the traditional scope of healthcare regulations. They are classified as foodstuffs, which are nutritional products that are intended to develop and maintain the human body and which are not marketed as therapeutic products. Generally, such products are regulated under the Swiss Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act) (FSA) and the related ordinances.

See Questions 19 to 24 for more information on complementary medicines, vitamins, minerals and other supplements.

Utility articles such as soaps, which can serve general health in the broader sense, are not regulated by the general medical regulations. They also fall within the scope of the FSA, as they are utility and consumable products that are not marketed as therapeutic products and which fall within the categories of either:

  • Personal hygiene articles and cosmetics, which, when used as normally intended, come into contact with the mucus membrane of the mouth.

  • Other articles, which, when used as normally intended, come into contact with the body.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

The manufacture of medicinal products (and adding medicinal products to animal feed) requires a mandatory licence from Swissmedic. Exceptionally, mandatory cantonal licence or reporting requirements apply instead of a licence from Swissmedic. This is generally the case for the manufacture of small quantities of medicinal products that are produced in accordance with magistral, officinal or own formula and are destined to the producer's own clients.

The manufacture of medicinal products must comply with the recognised rules of good manufacturing practice (GMP) as defined in the Medicinal Products Authorisation Ordinance, which takes international standards into account. In particular, the Ordinance directly refers to several EU directives. A licence must be issued if the following technical and operational conditions are fulfilled and if an appropriate system of quality assurance is in place. To this end, the manufacturer of medicinal products must prove that:

  • A functional system is in place to ensure the pharmaceutical quality of a medicinal product, and that the company's management and relevant personnel participate actively in such areas.

  • Each area has sufficient qualified technical specialists to reach the targets of quality assurance.

  • There is a qualified specialised person responsible for the facility.

  • The facility is organised functionally.

  • The facility is designed, equipped and maintained constantly in order to ensure:

    • secure manufacturing of medicinal products; and

    • that the premises and equipment that can influence the quality of medicinal products are adequate.

  • A documentation system is in place, which encompasses the instructions, procedure descriptions and protocols for the relevant production stages.

  • Production, examination and cleaning procedures are validated.

  • Quality control is independent from production.

  • Due diligence obligations as set out in the Rules of GMP are complied with.

  • The duties of the responsible persons are set out in the specifications sheet (Pflichtenheft) and the corresponding hierarchy is specified in the organigram.

Advertising

Different rules apply to advertising intended for the public and advertising directed at healthcare professionals.

Advertising directed exclusively at persons who prescribe or dispense drugs is in principle permitted for all types of medical products. Advertisement of non-prescription medicinal products to the general public is also permitted. However, advertising is not allowed if it:

  • Is misleading or contrary to public order or morality.

  • May incite an excessive, abusive or inappropriate use of medicinal products.

  • Is for medicinal products that cannot be placed on the market in Switzerland.

An advertisement directed to the general public is unlawful if the medicinal product:

  • Can only be supplied on a prescription.

  • Contains narcotic or psychotropic substances as referred to in the Swiss Narcotics Act.

  • Cannot be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment.

  • Is frequently the object of abuse or leads to addiction.

Generally, the prior approval of advertisements is not required. However, prior approval of Swissmedic is required in the following cases:

  • Advertisements for categories C (for example, Canesten or spasmo-canulase) and D (for example, aspirin) medicinal products on radio, television and in cinemas.

  • Advertisements for analgesics, soporifics and sedatives, laxatives and anorectics intended for the public in newspapers, magazines and books, brochures, posters, circulars or by audiovisual means including the Internet.

The Ordinance on Advertising for Medicinal Products contains further specific rules relating to advertisements to specialists and the general public. For example, this ordinance prescribes specific wordings that must be mentioned at the end of television and radio commercials.

Comparative advertising directed at specialists is allowed provided that it is scientifically correct and proven and complies with the current status of scientific knowledge. The general provisions of the Unfair Competition Act also apply, so that comparative advertising can be prohibited if the comparison is deceptive, degrading, incorrect or unnecessary.

In addition, the various self-regulatory codes contain further guidelines with regard to advertising (see Question 1, Private parties). In particular, the Swiss pharmaceutical industry enacted the Pharma Code, a self-regulatory code of conduct which contains additional rules and guidelines on the professional promotion of medical products.

Sale

The general principle is that medicinal products and excipients placed on the market must meet the requirements of the Pharmacopoeia, if such requirements exist. The Pharmacopoeia (Pharmacopoeia Europaea and Pharmacopoeia Helvetica) is a collection of regulations on the quality of medicinal products, excipients and certain medical devices.

Ready-to-use medicinal products and veterinary medicinal products intended for the manufacture of medicinal foodstuffs (pre-mixed medicinal products) can only be placed on the market if they are authorised by Swissmedic, subject to international agreements on the recognition of marketing authorisations. No marketing authorisation is required for medicinal products that are produced in small quantities according to magistral, officinal or own formula for a small group of persons. In addition, medicinal products intended for clinical trials and medicinal products that cannot be standardised do not need a marketing authorisation.

In relation to compassionate use, Swissmedic can authorise, for a limited period, the distribution or dispensing of unauthorised medicinal products to treat life-threatening diseases if the following conditions are satisfied:

  • The authorisation is compatible with the protection of health.

  • A significant therapeutic benefit is to be expected from the administration of these medicines.

  • No comparable medicine exists.

To obtain a marketing authorisation for a medicinal product or procedure, the applicant must:

  • Prove that the medicinal product or procedure is of high quality, and is safe and effective.

  • Be the holder of an authorisation to manufacture, import or conduct wholesale trade issued by the competent authority.

  • Have a registered address, registered office or branch office in Switzerland.

The criterion of effectiveness must be proven by providing the necessary data in the application. The application for a marketing authorisation must contain all the data and documents necessary for its assessment, in particular the:

  • Brand name of the medicinal product.

  • Name of the manufacturer and distribution company.

  • Manufacturing process, composition, quality and stability of the medicinal product.

  • Attestation of residues and the withdrawal period for medicinal products intended for animals kept for the production of foodstuffs.

  • Therapeutic effects and adverse effects.

  • Labelling, medical information, dispensing method and method of administration.

  • Results of physical, chemical, galenic and biological or microbiological tests, as well as of pharmacological and toxicological tests.

  • Results of clinical trials.

For clinical trials of therapeutic products on humans, the Human Research Act and the Ordinance on Clinical Trials apply in addition to the provisions of the Therapeutic Products Act (TPA). Clinical trials require prior authorisation from Swissmedic. An exemption from mandatory authorisation can be granted if the trial involves an authorised medicinal product administered in accordance with the approved conditions of use.

In the case of a second notification (that is, an application for a marketing authorisation for a medicinal product that is essentially the same as an already authorised medicinal product and is intended for the same use), the application can under certain circumstances be based on the results of the pharmacological, toxicological and clinical tests of the authorised medicinal product.

Simplified authorisation procedures may apply to certain categories of medicinal products if this is compatible with the quality, safety and efficacy requirements. The TPA explicitly refers to the following cases:

  • Medicinal products made with known active pharmaceutical ingredients.

  • Medicinal products of complementary medicine.

  • Medicinal products prepared for stocks by a public pharmacy, drugstore or another establishment holding a manufacturing licence, according to its own formula (specialities of the house) conforming to the Pharmacopoeia or another pharmacopoeia, or a formula recognised by Swissmedic, and which are dispensed to its own customers.

  • Medicinal products prepared by a hospital pharmacy or in the hospital's own radiopharmaceutical unit for the needs of the hospital.

  • Medicinal products prepared by the army and used in the context of the co-ordinated army medical corps.

  • Important medicinal products for rare diseases.

  • Veterinary medicinal products that are intended exclusively for animals not kept for the production of foodstuffs.

Additionally, a mandatory licence is required for:

  • Import and export by professionals of ready-to-use medicinal products intended for distribution or dispensing.

  • Trades in medicinal products in foreign countries conducted from Switzerland, without such products entering Switzerland.

The revised TPA will facilitate the market entry of complementary medicinal products by simplifying the authorisation procedure (see Question 25). For traditionally used non-prescription medicines consisting of natural and synthetic substances, the safety and efficacy requirements will be reduced.

Only medicinal products that have been authorised, or are not subject to authorisation, can be imported. Export is prohibited if the products are prohibited in the target country, or if circumstances suggest that they could be used for illegal purposes.

The distribution of medicinal products is regulated according to the category of medicinal product involved. Basically, there is a distinction between prescription and non-prescription medicinal products. Swissmedic decides to which category a medicinal product is allocated on the basis of a risk-benefit ratio.

Prescription-only medicinal products can only be dispensed by:

  • Pharmacists.

  • Medical professionals.

  • Duly trained professionals under their supervision.

Non-prescription medicinal products can be dispensed by:

  • Persons entitled to dispense prescription medicinal products (see above).

  • Drugstore assistants.

  • Duly trained persons under their supervision.

  • Other duly trained persons within the limits of their right to dispense medicinal products.

Wholesale traders of medicinal products must possess a licence issued by Swissmedic. Any person dispensing medicinal products in a pharmacy, drugstore or another retail trade establishment must have a cantonal licence.

Special provisions apply to blood and blood products, which require an operating licence for the persons transfusing, manufacturing or supplying such products. Veterinary medicinal products are subject to additional specific prescription and dispensing provisions.

 
4. Are there different requirements for patented and generic drugs?

According to the Therapeutic Products Act (TPA), a market authorisation is personal and relates to a specific product. Therefore, a generic drug requires a separate and independent market authorisation from the original market authorisation for a patented drug. However, generic drugs benefit from a simplified authorisation procedure if the medicinal product is made with known active pharmaceutical ingredients. In addition, the application follows the general procedure for second notifications. An application for a medicinal product that is essentially the same as an already authorised medicinal product (original preparation), and is intended for the same use, can be based on the results of the pharmacological, toxicological and clinical tests of the already authorised medicinal product if either:

  • The applicant for the original preparation provides a written permission.

  • The protection period for the original preparation has expired. This protection lasts ten years and must be distinguished from the protection derived from a patent or supplementary protection certificate (SPC).

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

Generally, the Swiss Parliament, which consists of the National and State Council, is responsible for issuing the regulations relating to medicinal products. Swissmedic, the Swiss Federal Council and to a certain extent the cantons are responsible for specifying the regulations, and for their implementation.

For more information on the Swiss Federal Council and Swissmedic see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

There is no automatic recognition of foreign authorisations in Switzerland. Apart from the tariff union with the Principality of Liechtenstein, there are no international agreements on mutual recognition of authorisations in relation to medicinal products. However, the bilateral agreement between the EU and Switzerland on the Mutual Recognition of Conformity Assessments regulates mutual recognition of clinical trial results.

In the absence of mutual recognition agreements for market authorisation, the ordinary application procedure for marketing authorisation applies. However, if a medicinal product or procedure is already authorised in a country having equivalent medicinal product controls, the results of tests carried out for this purpose can be taken into account. In practice, Swissmedic is not bound by such foreign results and can decide autonomously of the outcome of an application for marketing authorisation.

In the case of parallel imports, a simplified authorisation procedure can be applied if the medicinal product satisfies the same requirements as the medicinal product already authorised in Switzerland, in particular with regards to labelling and medical information. In addition, the person responsible for placing the authorised medicinal product on the market must be able to guarantee that all the authorised medicinal products continue to fulfil the same safety and quality requirements as those of the parallel imports applicant.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

In principle, medicinal products that have been authorised or are not subject to authorisation can be imported. The import of small quantities of non-authorised ready-to-use medicinal products for private use is generally allowed except for:

  • Medicinal products with genetically modified organisms.

  • Medicinal products for use on livestock.

  • Immunological medicinal products for veterinary use.

Medical professionals can also benefit from an exception to import non-authorised ready-to-use medicinal products, typically for individual cases. The import of veterinary medicinal products is subject to additional provisions under the Ordinance on Veterinary Medicinal Products.

The export of medicinal products is not allowed if the products are prohibited in the target country or if circumstances suggest that they could be used for illegal purposes.

Professional import and export of drugs require a mandatory licence for ready-to-use medicinal products intended for distribution or dispensing. Professional trading of medicinal products in foreign countries from Switzerland, without the product entering Switzerland, also requires a mandatory licence.

In principle, distance selling is prohibited. Exceptionally, cantons can grant licences if the following conditions are met:

  • There is a doctor's prescription for the medicinal products issued.

  • It is not contrary to safety requirements.

  • An appropriate consultation is guaranteed.

  • Sufficient medicinal supervision of the product's effect is guaranteed.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

It is permitted to advertise non-prescription medicinal products to the general public. However, advertising is deemed unlawful if:

  • It is misleading or contrary to public order and morality.

  • It incites an excessive, abusive or inappropriate use of medicinal products.

  • It is for medicinal products that cannot be placed on the market in Switzerland.

An advertisement directed to the general public is expressly prohibited if the medicinal product:

  • Can only be supplied under a prescription.

  • Contains narcotic or psychotropic substances as referred to in the Swiss Narcotics Act.

  • Cannot be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment.

  • Is frequently the object of abuse or leads to addiction or dependence.

The Ordinance on Advertising for Medicinal Products specifies the conditions and requirements for advertisements to the general public. It further provides a non-exhaustive list of unlawful elements and measures relating to such advertisements.

For information on advertisement to specialists, see Question 3, Advertising.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

The market introduction and distribution of medical devices in Switzerland does not require any prior official authorisation or licence. The Swiss system for distribution of medical devices is widely adapted to and harmonised with EU regulations. It follows the EU concept of the new and global approach and is based on the principle of self-responsibility of the manufacturer/distributor, as well as the procedure of conformity assessment.

As a general rule, the Therapeutic Products Act (TPA) provides that any person handling therapeutic products must take all measures necessary according to the state of the art to ensure that human or animal health is not endangered. This rule is not only addressed to healthcare professionals, but also to manufacturers, importers, distributors and authorities, as well as patients and consumers. In addition, the TPA provides that medical devices must, in their intended use, not in any way endanger the health of users, consumers, patients or third parties.

Any person placing a medical device for the first time on the market (in Switzerland or in a state with which Switzerland has entered into an international agreement regarding the mutual recognition of conformity assessments and procedures for medical devices) must be able to prove that the device satisfies the fundamental requirements. These requirements mainly relate to technical and medical requirements, and to product information and marking of the device under Directive 93/42/EEC concerning medical devices (Medical Devices Directive). Swiss law does not impose any other fundamental requirements than those under the Medical Devices Directive.

The specific fundamental requirements depend on the classification of the medical device. The first distributor must therefore also classify the medical device (that is, classes I, IIa, IIb, and III as defined in the Medical Devices Directive).

The first distributor in Switzerland (or a contracting state) that has a place of business in Switzerland must inform Swissmedic of the first distribution of class I devices, custom-made devices and systems/treatment units. Medical devices in classes IIa, IIb and III need not be notified to Swissmedic, as they must in any case be subject to a conformity assessment through a notified body.

Switzerland and the EU have entered into an Agreement on the Mutual Recognition of Conformity Assessments regarding, among others, medical devices. This means that when a medical device has obtained a detailed EU CE certificate (including the identification number of the notified body), the certificate (and the conformity procedure relevant to this certificate) is recognised in Switzerland.

The manufacturer of the medical device is responsible for the assessment regarding the safety and performance of the device. Depending on the classification of the device, the conformity assessment is either:

  • The sole responsibility of the manufacturer, in which case the manufacturer must mark the product with the Swiss MD mark or the European CE mark.

  • Carried out by an external body (notified body), in which case the CE or MD mark is followed by the identification number of the notified body.

The assessment procedure is carried out in accordance with the annexes of the Medical Devices Directive. Once the assessment procedure is concluded, the manufacturer must complete a declaration of conformity.

Under the Ordinance on Medical Devices, the product information for a medical device must be available in all three Swiss national languages (that is, German, French and Italian). Exemptions from this rule may be granted. The rules of the Medical Devices Directive regarding product information also apply in Switzerland.

Compliant medical devices applied in accordance with the intended used specified in the conformity assessment do not require an authorisation for clinical trials.

Advertising

The advertising of medical devices is not subject to any authorisation or licensing requirements. However, advertising must conform to the product information and must not be misleading with regards to the device's efficacy and performance. The Ordinance on Medical Devices contains further obligations regarding advertising.

See also Question 13.

Sale

The distributor of a medical device (other than the manufacturer) must guarantee the conformity of the product and, on request of the relevant authority, prove such conformity. Therefore, any distributor should thoroughly examine:

  • The declaration of conformity of the manufacturer and the completeness of the product information in all necessary languages.

  • The existence and validity of the certificates executed by the responsible conformity assessment bodies (both EU certificates and MD certificates).

Regarding product monitoring, the Ordinance on Medical Devices differentiates between first time distributors and subsequent distributors. The person distributing the medical device in Switzerland or a contracting state for the first time must take appropriate measures to:

  • Identify any potential dangers in connection with the device.

  • Avoid potential dangers.

  • Trace the device.

The distributor must operate a product monitoring system. The distributor must notify Swissmedic and take appropriate measures if it receives notice of any serious incidents in Switzerland.

The person who further supplies or distributes a product that is already on the market must contribute to compliance with the safety requirements. Such person must collect any notices and complaints and forward them to the existing product monitoring system.

See also above, Manufacturing.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

Generally, the Swiss Parliament, which consists of the National and State Council, is responsible for issuing any regulations relating to medical devices. Swissmedic and the Swiss Federal Council are responsible for specifying the regulations in ordinances. Swissmedic is in charge of enforcing regulations.

For more information on Swissmedic see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Switzerland and the EU have entered into an Agreement on the Mutual Recognition of Conformity Assessments regarding, among others, medical devices. This means that when a medical device has obtained a detailed EU CE certificate (including the identification number of the notified body), the certificate (and the corresponding conformity procedure) is recognised in Switzerland.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

Switzerland has a very liberal import and export system with regard to medical devices, and medical devices can generally be traded freely. However, the general requirements described in Question 9 must be observed. In particular, the applicable conformity assessment procedure must have been successfully completed, and the importer must be in a position to produce product conformity and related certificates. Detailed EU CE certificates are recognised in Switzerland (see Question 11).

An importer that first places a device on the market in Switzerland or in a state with which Switzerland has entered into an agreement regarding the mutual recognition of conformity assessments and procedures for medical device must observe the requirements above.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

Generally, the advertising of medical devices must conform to the product information and must not be misleading with regards to efficacy and performance. Advertising to the general public is excluded for medical devices that are only available on prescription or which are placed on the market for exclusive use by professionals.

The Swiss regulatory practice for the advertising of medical devices is relatively liberal. The Ordinance on Medical Devices contains only one legal provision regarding the advertising of medical devices.

However, general laws such as the Swiss Law on Unfair Competition (which contains various prohibitions regarding unfair commercial practices, misleading or comparative advertising, and so on) must be complied with at any time.

The Confederation of Swiss Associations for Trade and Industry of Medical Device Technology (FASMED) (similar to EUCOMED) has issued a (non-binding) Code of Business Conduct, which summarises the rules of advertising for medical devices and the respective conduct of persons involved. The FASMED Code was specifically developed to compensate for the small amount of legal rules and case law regarding the advertising of medical devices.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Manufacturing

Biological products (or biologics) are medicines made from living organisms. In Switzerland, these products fall within the category of biotechnological products, which are products manufactured in a technical process out of living organism. If such process involves genetic engineering, the genetically manufactured medicinal products must fulfil additional authorisation requirements under the Release Ordinance (RO) (for example, other public authorities must also consent to the commercialisation of these products). Generally, the regulation of gene technology is rather strict in Switzerland. Accordingly, simplified marketing authorisations are excluded for this category and any modification of the genetically modified organism requires a new application.

Biosimilars form a special category of biological products. Similarity to the reference product must be proven according to complete comparability studies, as laid out in the Swissmedic Guideline on Similar Biological Medicinal Products. Swissmedic accepts a reduced documentation for the application in justified cases only, mainly concerning pre-clinical and clinical study results. The administrative Ordinance for the Authorisation of Similar Biological Medical Products issued by Swissmedic defines the general requirements and principles that apply to such justified cases.

Advertising

See Question 3, Advertising.

Sale

See Question 3, Sale.

The marketing of biotechnical medicinal products containing genetically manufactured organisms require the consent of the Federal Office of Public Health (FOPH) and Federal Office for the Environment (FOEN).

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

See Questions 5 and 14, Sale.

For more information on Swissmedic, the FOPH and the FOEN see box: The regulatory authorities.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

See Question 6.

In relation to biosimilars, it is possible to refer to a comparator product of the EU, the USA or Japan by means of comprehensive comparability studies. To benefit from a reduced documentation in the application process, the equivalence of the comparator product with the reference product must be proven.

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

See Question 7.

The importation of any medicinal product with genetically modified organisms always requires a licence. Under the Medicinal Products Authorisation Ordinance, imports of non-authorised ready-to-use medicinal products for private use are not allowed for medicinal products with genetically modified organisms (even in small quantities).

For biological products or devices that contain genetically modified organisms, the Gene Technology Act (GTA) and its ordinances also apply.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?
 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

In Switzerland, there are different categories of natural health products, which either fall within the scope of the Therapeutic Products Act (TPA) or the Foodstuffs Act (FSA), and the relevant ordinances.

Complementary medicines and herbal products form a special category of medicinal products and therefore fall within the general scope of the TPA. The Swissmedic Ordinance on the Simplified Authorisation of Complementary and Herbal Medicinal Products contains the specific requirements relating to the manufacturing and simplified marketing authorisation procedures for such products. Complementary medicines include Asian, homeopathic (including homeopathic/spagyric) and anthroposophic medicinal products. Herbal medicinal products are products that contain one or more herbal substances or preparations as active substances, and cannot be classified within specifically oriented therapies.

Vitamins, minerals or supplements either fall within the scope of the TPA or foodstuffs legislation. Lower dosages normally fall under foodstuffs legislation if they are not marketed as therapeutic products. High doses of vitamins, minerals or supplements, which are accordingly marketed as therapeutic products, fall within the scope of the TPA. Therefore, the marketing of a healing effect determines which regulations apply. Vitamins in food supplements that are used in the production of foodstuffs to obtain particular properties or effects are regulated in the Ordinance on Special Foodstuffs. In addition, the Ordinance on Food Additives determines the permitted additives, and the Ordinance on adding Essential or Physiologically Helpful Additives to Foodstuffs contains details of the permissible quantities of vitamins, minerals and other supplements that can be added to foodstuffs.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

Complementary medicines are principally subject to the same procedures as medicinal products. However, they benefit from a simplified authorisation procedure. Complementary and herbal drugs can be authorised through a simplified authorisation procedure or on the basis of an application procedure under the Ordinance of the Swiss Agency for Therapeutic Products on the simplified authorisation of homeopathic and anthroposophic medicines. Generally, the documentation on pharmacological and toxicological trials can be purely bibliographical, provided that the published literature can provide sufficient proof. However, the applicant must in principle provide proof of tolerance, which can be replaced under certain conditions by:

  • Proof of therapeutic or pharmaceutical equivalence between the product and a medicinal product that has already been authorised.

  • Treatment records.

  • Bibliographical documentation.

The manufacturing of homeopathic and anthroposophic medicinal products must be sufficiently documented and must comply with both:

  • Recognised rules of Good Manufacturing Practices (GMP).

  • Specific, recognised requirements applying to manufacturing processes for homeopathic and anthroposophic medicinal products.

Regarding simplified authorisations of Asian medicinal products, the composition of fixed combinations of medicinal products must take into account the relationship of the substances or the preparations with one another according to the theories of Asian medicine. For this purpose, bibliographical documentation can be submitted provided that the published literature contains sufficient proof, and that the knowledge can be transposed to the medicinal product for which authorisation is sought.

For homeopathic and anthroposophic medicinal products without indication, which are intended for placing on the market without mention of an area of application, the simplified authorisation procedure takes the form of a simple notification procedure.

Anyone who produces, processes, treats, stores, transports, markets, imports or exports vitamins, minerals or supplements must comply with the relevant foodstuffs legislation. Compliance with foodstuffs regulations, which are generally adapted to EU law requirements, is mainly governed by self-regulation obligations. Generally, the principles of self-regulation require that the general hygiene, good manufacturing procedures, the Hazard Analysis Critical Control Point (HACCP) and traceability requirements are met. Each product that can be marketed is listed in the Ordinance on Foodstuffs and Utility Articles (OFUA). The only regulatory duty is a notification to the competent cantonal enforcement authority. An authorisation is required for new foodstuffs that are not listed. For foodstuffs of animal origin, a licence is generally required, if none of the numerous exceptions applies.

See Question 25 regarding the future simplifications of the approval of complementary medicinal products without indication.

Advertising

For complementary medicines see Question 3, Advertising.

The advertising of vitamins, minerals or supplements is generally allowed. However, indications of any healing effect (as opposed to health-related references) are prohibited and are reserved for medicinal products. The Ordinance of the Federal Department of Home Affairs (FDHA) on the Labelling and Advertising of Foodstuffs contains a list of permitted indications and labelling requirements for each product. In certain circumstances, the Federal Food Safety and Veterinary Office (FSVO) can allow further indications provided that scientific studies can show that all health requirements of the Ordinance are fulfilled and that consumers are not misled. Health claims, which are claims with nutritional and health indications, can only be authorised if their effect can be scientifically proven. The Ordinance lists the permitted health claim indications to date.

Sale

For complementary medicines see Question 3, Sale.

For vitamins, minerals or supplements see above, Manufacturing.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

For complementary medicines see Question 5.

The Swiss Parliament enacted the laws relating to minerals, vitamins and supplements, on which basis the Federal Council is competent to pass ordinances. The Federal Department of Home Affairs (FDHA) is responsible for ordinances on specific products.

For more information on the Federal Council and the FDHA see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

For complementary medicines see Question 6.

Minerals, vitamins or supplements that do not comply with Swiss regulations can benefit from the Cassis de Dijon principle. According to this principle, a product can be sold in Switzerland if it is produced according to the regulations of a member state of the EU or European Economic Area (EEA), and is lawfully marketed in such state. However, an additional authorisation of the Federal Food Safety and Veterinary Office (FFVO) is required if the technical regulations do not fully correspond to Swiss regulations. The Swiss Parliament is currently discussing the repeal of this principle.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

For complementary medicines see Question 7.

It is in principle possible to buy and sell vitamins, minerals and supplements to and from other jurisdictions, provided that they comply with foodstuff and customs regulations. An authorisation is required for marketing food products in Switzerland which are not listed in the Ordinance on Foodstuffs and Utility Articles (OFUA) (see Question 20). The authorisation will only be granted to a person with a place of business or branch office in Switzerland.

Vitamins, minerals and supplements can also be sold electronically provided that all requirements set out in Questions 19 to 22 are fulfilled.

The export of any products that endanger health is prohibited.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

For complementary medicines see Question 8.

For minerals, vitamins or supplements, advertising is generally allowed provided that no reference to any healing effect is made. In contrast, reference to health can be made if it is objectively justified and not misleading. Such health claims, which are claims with nutrition and health indications, are listed in the Ordinance on the Labelling and Advertising of Foodstuffs.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

The revision process of the Therapeutic Products Act (TPA) was completed in spring 2016. The aim of the revision is to improve public access to medicines, improve the conditions for biomedical research and industry and optimise the transparency requirements. In particular:

  • Market entry for complementary and herbal medicines should be improved by facilitating the approval procedure. The approach consists in establishing a distinction between medicinal products with indication and complementary medicinal products without indication. The simplified authorisation procedure for complementary medicinal products without indication will take the form of a quality check to guarantee that only safe therapeutic products are placed on the market and that consumers' health is not at risk.

  • The availability of medicinal products for paediatric use has been enhanced by providing incentives to the industry in the form of special supplementary protection certificates (SPC) or prolongations of existing SPCs. Additionally, existing observations on the use of medicinal products for paediatric use will be compiled in a national database and made widely available.

  • The sale of medicinal products has been facilitated by giving more powers to drugstores and pharmacies. Druggists will be authorised to dispense all kinds of non-prescription medicinal products. Pharmacists will be authorised to dispense certain medicinal products without medical prescription. Additionally, a new exception to patent protection will allow physicians and pharmacists to prescribe or dispense the medicines they consider most appropriate without running the risk of infringing patents.

The regulations governing the disclosure of financial relationships between healthcare professionals and suppliers of products and services have also been improved. Under the revised TPA, the prohibition of undue material benefits will only apply to prescription drugs. The Federal Council will, however, be authorised to extend the scope of the provision to other categories of therapeutic products. Additionally, the list of exceptions has been amended. The following will no longer be considered as undue material benefits:

  • Material benefits of modest value.

  • Contributions to research and advanced training.

  • Compensation for services of equal value.

  • Discounts and refunds on therapeutic products that do not affect the choice of treatment.

The current statutory rule stating that discounts must have a direct effect on the prices has been abrogated. Many further related aspects were delegated to the ordinance level.

The revised TPA also contains amendments to the requirement that discounts must be passed on to consumers. In the future, insurers and healthcare providers will be able to agree not to pass on the benefit of discounts entirely, provided that the majority of discounts is still passed on to consumers. The other part of the discounts will need to be used to improve the quality of the treatment. Under the new transparency requirement, all discounts and refunds granted on the purchase of therapeutic products must be disclosed in the documents, invoices and accounting records of both the buyer and the seller. The competent authorities can require that this documentation, as well as the agreement on the amount of the discounts, be communicated to them.

The necessary ordinances implementing the provisions of the revised TPA are currently being drafted under the label "Therapeutic Products Ordinance Package IV". A public consultation regarding this package is planned to be initiated in spring 2017. The effective date of the revised TPA and its ordinances will be determined only after completion of this public consultation. Currently, entry into force on 1 January 2019 appears likely.

 

The regulatory authorities

Competition Commission (ComCo)

W www.weko.admin.ch/index.html?lang=en&

Principal responsibilities. The ComCo is the independent federal authority responsible for protecting competition and for applying the Cartel Act in general.

Federal Council

W www.admin.ch/gov/en/start.html

Principal responsibilities. The Federal Council is the highest executive body of Switzerland and is usually responsible for enacting ordinances.

Federal Department of Home Affairs (FDHA)

W www.edi.admin.ch/index.html?lang=en

Principal responsibilities. The FDHA is responsible at the federal level for all issues relating to health, health insurance and accident insurance. Its competences also encompass all issues relating to social security.

Federal Office for the Environment (FOEN)

W www.bafu.admin.ch/?lang=en

Principal responsibilities. The FOEN is a special environmental unit of the federal government.

Federal Office of Public Health (FOPH)

W www.edi.admin.ch/index.html?lang=en

Principal responsibilities. The FOPH, as part of the FDHA, is responsible for all issues relating to health at the federal level. Along with the cantons, it is responsible for public health in Switzerland and for developing a national health policy. It is responsible, among others, for social health and accident, insurance, relations for chemicals and medicines, legislation in the areas of biosafety, research on humans and transplantation medicine, health promotion, national health programmes, radiation protection, and the regulation of university medical and health professionals. It also represents Switzerland's interests in the fields of health before international organisations and with respect to other countries.

Federal Food Safety and Veterinary Office (FSVO)

W www.bag.admin.ch/index.html?lang=en

Principal responsibilities. The FSVO and its partner organisations are responsible for food safety, nutrition, animal health and welfare and species conventions in international trade. Its competences encompass (human) foodstuffs, consumer items and cosmetics.

Federal Price Regulator (FPR)

W www.preisueberwacher.admin.ch

Principal responsibilities. The FPR is responsible for ensuring adequate prices and a transparent price policy in the non-competition area.

Swiss Agency for Therapeutic Products (Swissmedic)

W www.swissmedic.ch/index.html?lang=en

Principal responsibilities. Swissmedic is the entity responsible for enforcing legislation on therapeutic products. Swissmedic's core competences encompass:

  • The authorisation of medicinal products.

  • Licences for manufacturing and wholesale.

  • Inspections.

  • Market monitoring of medicinal products and medical devices.

  • Establishing standards.

  • Clinical trials and laboratory testing regarding the quality of medicines.

  • The provision of information on medical products.

  • National and international co-operation.



Online resources

Swiss official legislation

W www.admin.ch/gov/en/start/federal-law/classified-compilation.html

Description. This website, which is maintained by the Federal Council, contains the classified compilation of the Swiss official legislation to date, in all official languages.

Swissmedic

W www.swissmedic.ch

Description. Swissmedic regularly publishes and updates all necessary information on authorised medicines, procedures and effective ingredients on this website.

List of pharmaceutical specialties

W www.spezialitaetenliste.ch/ShowPreparations.aspx?searchType=SUBSTANCE

Description. This website provides the list of pharmaceutical specialties, which is regularly updated by the Federal Office of Public Health (FOPH) (available in German, French and Italian).

List of devices and appliances

W www.bag.admin.ch/themen/krankenversicherung/00263/00264/04184/index.html?lang=de

Description. This website provides the list of devices and appliances, which is regularly updated by the FOPH (available in German, French and Italian).



Contributor profiles

Thierry Calame, Partner, Co-Head of Intellectual Property

Lenz & Staehelin

T +41 58 450 80 00
F +41 58 450 80 01
E thierry.calame@lenzstaehelin.com
W www.lenzstaehelin.com

Professional qualifications. Switzerland, Attorney at Law

Areas of practice. Intellectual property; licensing; unfair competition and technology transfer, with a strong emphasis on technology-related disputes; enforcement and regulatory advice in the life sciences and healthcare sectors.

Non-professional qualifications. Doctor of Law (Dr. iur); Degree in natural sciences (Dipl. nat. sc.), Swiss Federal Institute of Technology (ETH)

Lara Dorigo, Intellectual Property Counsel

Lenz & Staehelin

T +41 58 450 80 00
F +41 58 450 80 01
E lara.dorigo@lenzstaehelin.com
W www.lenzstaehelin.com

Professional qualifications. Switzerland, Attorney at Law

Areas of practice. Intellectual property; licensing; unfair competition and technology transfer, with a strong emphasis on technology-related disputes; enforcement and regulatory advice in the life sciences and healthcare sectors.

Non-professional qualifications. Master (Lic.iur.), University of St. Gallen; LLM in Trade Regulation, New York University (NYU)


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