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Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

In 2016 the Federal Parliament adopted a wide‑ranging revision of the Therapeutic Products Act (see Federal Gazette 2016, 1953 and following) which covered three main areas:

  • incentives for research and gaining market access – an amendment of the existing provisions regarding the simplified licence procedure for the marketing of medicines and improvement of the protection for orphan drugs and children’s medicines;
  • prescriptions and the dispensation of medicines – more liberal rules on dispensing medicines and exclusion of medical activities from patent protection in order to enable off-label use of generics; and
  • compensation – clarification of the regulation regarding material benefits granted to prescribers, increased penalties for granting or accepting illegal benefits and a duty to disclose all benefits to the authorities.

The pricing regime regarding medicines is also being revised. After several successful appeals challenging the pricing regime, the relevant ordinances must be amended in order to align the regime with case law, putting more emphasis on the internal reference price. These changes will become effective on March 1 2017.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The approval, distribution and marketing of medicines and medical devices are almost exclusively regulated at the federal level by the Therapeutic Products Act. Pricing and reimbursement through mandatory social healthcare insurance is governed by a separate federal act, the Health Insurance Act. Research on humans is regulated in a separate federal statute, the Human Research Act. The three acts are implemented by a number of ordinances that contain more detailed provisions setting out the general rules of the acts.

Are any legislative changes proposed or expected in the near future?

The Federal Parliament enacted the revised Therapeutic Products Act in Spring 2016. At present, the implementing ordinances are being drafted by the government. The ordinances are expected to enter into force in 2019.

The revised pricing regime will become effective on March 1 2017.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

While the Therapeutic Products Act is enforced mainly by the Federal Agency for Therapeutic Products (Swissmedic), the cantonal health departments also have some supervisory powers. The competent authority for the enforcement of the Health Insurance Act is the Federal Office of Public Health (FOPH). Cantonal ethics committees and the FOPH supervise compliance of research with the Human Research Act.

Swissmedic and the competent cantonal authorities (generally the Department of Health) are responsible for the supervision of manufacturing, distribution and marketing activities. They supervise the Swiss market in general, as well as the individuals manufacturing, distributing and marketing medicines. A specific investigation is opened if Swissmedic or the cantonal authorities discover a violation or if they are notified of a violation.

Swissmedic and the cantonal authorities may carry out any necessary investigation into a specific incident, and the parties involved must cooperate fully in the investigation. In particular, Swissmedic or the cantonal authorities may take samples, demand information and essential documents and request any necessary help for this purpose. Swissmedic or, in the case of a serious and immediate threat to health, the cantonal authorities, may take all necessary administrative measures in order to remedy a breach of the applicable rules (see Article 66 of the Therapeutic Products Act).

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Competition law Swiss competition law has no specific rules for the life sciences sector. Further, until now the Swiss competition law authorities and the courts have published no decisions on arrangements or practices specific to this industry (eg, ‘pay for delay’ or agreements between originators and generic manufacturers).

Data protection The Federal Data Protection Act applies to federal authorities as well as private individuals and companies processing data. Cantonal data protection acts apply with regard to cantonal authorities processing data. Health-related personal data is generally subject to a higher standard of protection.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No. However, some medicinal products are not subject to a marketing authorisation (see Article 9(2) of the Therapeutic Products Act).

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

According to Article 5(1) of the Therapeutic Products Act, the manufacture of medicines (but not medical devices) is subject to prior authorisation by the Federal Agency for Therapeutic Products (Swissmedic). In order to obtain a licence, the applicant must file an application with Swissmedic. Upon filing, Swissmedic examines whether the authorisation requirements are being met. This may include an inspection at the applicant's premises. If the applicant can prove that it meets the required technical and operational conditions and that an appropriate system of quality assurance is in place, it is entitled to a licence.

The entire authorisation procedure (the ordinary licence procedure) takes between 12 and 18 months.

What is the fee for obtaining authorisation?

The grant of a manufacturing licence costs Sfr500 (see Article 4(1) and Section A.IV.1.a of Appendix 1 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products). For a first application, when an inspection is definitely conducted, costs of at least Sfr2,000 incur. Other additional expenses may be charged separately (see Article 8 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products).

What is the validity period for authorisation?

Manufacturing licences may be granted for a maximum period of five years, but may be renewed on request (see Article 28(2) of the Ordinance on Authorisations in the Area of Medicines). Such request must be submitted at least six months before expiry (see Article 29(1) of the Ordinance on Authorisations in the Medicinal Sector).

How robust are the standard good manufacturing practices followed in your jurisdiction?

All medicines must be produced in accordance with the recognised rules of good manufacturing practices, which are set out in the Ordinance on Authorisations in the Medicinal Sector. According to Appendix 1 of this ordinance, the following international rules on good manufacturing practices are relevant:

  • EU Directives 2003/94/EEC and 1991/412/EEC;
  • EudraLex Volume 4; and
  • the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products of October 8 1970 (under the Pharmaceutical Inspection Cooperation Scheme PIC/S).

The competent authorities check whether these standards are met.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Swissmedic may take administrative measures to re-establish compliance with the law. This may include the closure of premises (see Article 66 of the Therapeutic Products Act). In addition, persons that wilfully manufacture medicinal products without a licence or in violation of other provisions of the Therapeutic Products Act may be punished by imprisonment or a fine of up to Sfr200,000. Violations on a commercial scale may even be punished by imprisonment of up to five years and a fine of up to Sfr500,000. Negligent contraventions may be punished by imprisonment or a fine of up to Sfr100,000 (see Article 86 of the Medicinal Products Act).

Distribution

How are the distribution and storage of medicinal products regulated?

The wholesale of medicines (but not of medical devices) requires a licence (see Article 28 of the Therapeutic Products Act). A licence will be issued by Swissmedic if the necessary professional and operational conditions are met and if an appropriate system of quality assurance is in place. If the applicant already holds a manufacturing or import licence for medicines, it will also be eligible for a wholesale licence. The licence may not be transferred to another person or another site. It is valid for five years but can be extended thereafter if the conditions for issuing a licence are still met (see Articles 28 and 29 of the Ordinance on Authorisations in the Medicinal Sector). The wholesale of medicines is permissible only with respect to medicines that have a marketing authorisation for Switzerland. In addition to the requirements for issuance of the licence, a company that is engaged in the wholesale trade of medicines must also respect the recognised principles of good distribution practice. A licence holder may sell medicines to persons that are allowed to trade, process, distribute or professionally apply medicines (see Article 2(e) of the Ordinance on Authorisations in the Medicinal Sector).

Any person dispensing medicines in a pharmacy, drugstore or other retail trade establishment must have a cantonal licence for retail trade (see Article 30 of the Therapeutic Products Act). The cantons set out the conditions and procedures for granting such licence.

Typically, wholesalers store medicinal products on a large scale and distribute to retailers that also store medicinal products to a certain extent. There is no specific regulation regarding storage of medicinal products on the federal level. However, the principles of good distribution practice must be observed when distributing medicinal products (see Article 29 of the Therapeutic Products Act and Article 9(2) of the Ordinance on Authorisations in the Medicinal Sector), which includes storage (see Article 2(k) of the Ordinance on Authorisations in the Medicinal Sector). The applicable European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use (see Annex 2 of the Ordinance on Authorisations in the Medicinal Sector) provide for regulation regarding storage (see its Section 5.5). Apart from that, requirements regarding retailer licences are governed by cantonal law (see Article 30(2) of the Therapeutic Products Act).

Import and export

How are the import and export of medicinal products regulated?

According to Article 18 and following of the Therapeutic Products Act, a licence granted by Swissmedic is required by any person who, in a professional capacity, imports or exports ready-to-use medicines intended for distribution or dispensation, or who trades medicines in foreign countries from Switzerland, without such medicines entering Switzerland. Such licence will be issued if the necessary professional and operational conditions are met and if an appropriate system of quality assurance is in place. The licence may also be issued to applicants which already possess a manufacturing licence for medicines or, with regard to export and trade abroad, to applicants already possessing a licence for the import or wholesale trade of medicines.

Are parallel imports permitted in your jurisdiction?

The parallel imports of medicinal products into Switzerland are not prohibited as such. However, based on its patent rights, a patent owner may prohibit parallel imports of any patent-protected medicines and medical devices:

  • for which the prices are regulated (ie, essentially those that are subject to reimbursement by the health insurance system) (see Article 9a(5) of the Patent Act); or
  • which have been put onto the market for the first time with the patent owner's approval outside the European Economic Area (see Articles 9a(1)-(4) of the Patent Act).

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

Categorisation Article 23 of the Therapeutic Products Act draws a distinction between two categories of medicine: prescription medicines and non-prescription medicines. These two categories are further divided into five subcategories (Categories A to E), depending on the degree of perceived risk represented by the product (see Article 20 of the Ordinance on Medicines):

  • Category A medicines are subject to a more stringent prescription requirement, so a prescription allows only for a one-off supply of the prescribed medicine.
  • Category B medicines are subject to a prescription that allows for a repeated supply of the prescribed medicine.
  • Category C medicines do not need a prescription, but may be supplied only after the advice of a medical person has been obtained.
  • Category D medicines do not require a prescription, but may be supplied only after expert advice has been obtained.
  • Category E medicines can be supplied without restriction (see Articles 23-27 of the Ordinance on Medicines).

Prescription medicines may be promoted to professionals, but not to consumers (see Article 14 of the Ordinance on Advertising of Medicines). Each medicine is classified in the authorisation process by Swissmedic (see Article 22 of the Ordinance on Medicines).

Dispensing prescription medicines Pursuant to Article 24(1) of the Therapeutic Products Act, pharmacists can distribute prescription-only drugs on prescription of a physician but also in justified exceptional cases (eg, in an emergency) without prescription. The distribution of prescription drugs to patients requires an authorisation that is issued by the cantonal authorities.

Physicians can also distribute prescription drugs to consumers if the cantonal regulations allow for so-called ‘self-distribution’. Therefore, whether a physician is allowed to distribute prescription drugs depends on cantonal law. Some cantons do not allow physicians to distribute prescription drugs at all, while others stipulate some restrictions. In the cantons where physicians are not allowed to distribute prescription drugs, only pharmacists can distribute prescription drugs (on prescription by a physician).

All duly trained professionals can also distribute prescription drugs provided that they are supervised by either a pharmacist or a physician. Therefore, nurses in hospitals can also distribute prescription drugs provided that a physician or a hospital pharmacist supervises the nurse.

Dispensing non-prescription medicines (over-the-counter medicines) Pursuant to Article 25(1) of the Therapeutic Products Act, everyone entitled to distribute prescription drugs to patients may also distribute over-the-counter (OTC) medicines. Therefore, pharmacists as well as physicians can distribute OTC medicines to consumers, if permitted under cantonal law.

Druggists that hold a federal diploma can distribute Category D and Category E OTC medicines, but not Category C OTC medicines. All duly trained professionals can distribute non-prescription medicines, provided that they are supervised by a pharmacist, a physician or a druggist. Those with a federally recognised education in complementary medicine can also distribute certain OTC medicines.

Standards The recognised rules of pharmaceutical and medical sciences must be respected when prescribing and dispensing medicines. A medicine may be prescribed only if the state of health of the consumer or patient is known (see Article 26 of the Therapeutic Products Act).

Are there any restrictions on the online sale and purchase of medicinal products?

Except for Category E medicines, the mail-order trade of medicinal products is generally prohibited. However, the cantons may issue licences for mail‑order trade if:

  • certain conditions are met, in particular if there is a prescription for the medicinal product; and
  • appropriate consultation and sufficient medical supervision of the effect of the medicinal product are guaranteed (see Article 27 of the Therapeutic Products Act).

In principle, these rules also apply regarding cross-border online trading with medicinal products. The import and export of drugs in a professional capacity requires a licence from Swissmedic (see Article 18(1)(a)-(b) of the Therapeutic Products Act). However, there is no legal basis for Swiss authorities directly to stop the purchase of medicines from foreign suppliers since they are not subject to Swiss jurisdiction. In contrast, a private person is allowed to import medicines up to a quantity of a month's supply (see Article 20(2)(a) of the Therapeutic Products Act and Article 36(1) of the Ordinance on Authorisations in the Medicinal Sector). 

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

According to Article 9(4) of the Therapeutic Products Act, Swissmedic may authorise, for a limited period, the distribution or dispensing of medicines not authorised for marketing to treat life-threatening diseases if:

  • such an authorisation is compatible with the protection of health;
  • a significant therapeutic benefit is expected from the administration of these medicines; and
  • no other comparable medicine exists.

In addition, based on Article 20(2)(b) of the Therapeutic Products Act and Article 36(2) and 36(3) of the Ordinance on Authorisations in the Medicinal Sector, medical persons may import medicinal products which have not been granted a marketing authorisation in Switzerland for individual patients under certain conditions.

By definition, a medicine that is not authorised for marketing cannot be included in the list of medicines to be reimbursed by the mandatory health insurance (see Section III, infra). However, based on Article 71b of the Ordinance on Health Insurance, such costs may be reimbursed on a case-by-case basis if they are adequate with regard to the therapeutic benefit.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Clinical trials are governed by the Human Research Act, Articles 53 to 54 of the Therapeutic Products Act and the Ordinance on Clinical Trials. The general conditions for conducting clinical trials are:

  • the explicit and free prior written consent of the trial subjects (informed consent) (see Articles 16-18 of the Human Research Act and Articles 7-9 of the Ordinance on Clinical Trials);
  • the guarantee of full and complete compensation for injuries suffered in the course of the trial (see Articles 19-20 of the Human Research Act and Articles 10-14 of the Ordinance on Clinical Trials);
  • the endorsement of the trial by the competent ethics committee (see Article 45 of the Human Research Act and Articles 24-29 of the Ordinance on Clinical Trials);
  • approval of the trial by the Federal Agency for Therapeutic Products (Swissmedic) (see Article 54 of the Therapeutic Products Act and Articles 30-34 of the Ordinance on Clinical Trials); and
  • registration of the trial by the sponsor in a public register (see Article 56 of the Human Research Act and Articles 64-67 of the Ordinance on Clinical Trials).

Clinical trials on minors, wards of the court, persons incapable of consent and pregnant women, and in emergency situations, are subject to additional conditions. The termination of the trial, as well as any change to the design of the trial, additional security measures and undesired incidents must be notified to the competent ethics committee and Swissmedic.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

All clinical trials of therapeutic products must be carried out in accordance with the recognised principles of good clinical trial practice. According to the Ordinance on Clinical Trials, trials with medicines must comply with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines on good clinical practice, and trials with medical devices must comply with the requirements of the applicable EU directives (Directives 93/42/EEC and 90/385/EEC), as well as International Organisation for Standardisation Standard EN ISO 14155: 2011 (see Articles 5(1) and Annex I of the Ordinance on Clinical Trials). 

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The person responsible for the conduct of the clinical trial (the ‘investigator’) must notify the ethics committee of the completion of the clinical trial in Switzerland within 90 days of completion (see Article 38(1) of the Ordinance on Clinical Trials). The investigator must submit a final report to the ethics committee within one year of completion (or discontinuation) of the clinical trial, unless a longer period is specified in the protocol (see Article 38(3) of the Ordinance on Clinical Trials). For clinical trials of certain categories, the sponsor must also report to Swissmedic (see Article 38(5) of the Ordinance on Clinical Trials).

Authorised clinical trials must be registered in a primary registry recognised by the World Health Organisation (WHO) or in the registry of the US National Library of Medicine. In addition, the sponsor must enter certain data in the supplementary federal database using a Swiss national language (see Article 64 of the Ordinance on Clinical Trials). Such information is publicly accessible (see Article 67(1) of the Ordinance on Clinical Trials).

What are the informed consent obligations with respect to clinical trial subjects?

Persons may be involved in a research project only after they have given their informed consent. Consent must be given in writing (see Article 16(1) of the Human Research Act). The persons concerned must receive comprehensible oral and written information on:

  • the nature, purpose and duration of, and procedure for, the research project;
  • the foreseeable risks and burdens;
  • the expected benefits of the research project, for themselves or for other people;
  • the measures taken to protect the personal data collected; and
  • their rights (see Article 16(2) of the Human Research Act).

Before a decision on consent is made by the persons concerned, they must be allowed an appropriate period of reflection (see Article 16(3) of the Human Research Act).

The details are set out in Articles 7 to 9 of the Ordinance on Clinical Trials.

Insurance

What are the insurance requirements for clinical trials?

For Category A clinical trials, where any measures for the collection of health-related personal data or the sampling of biological material entail more than only minimal risks and burdens, the policy value must be at least:

  • Sfr250,000 a person;
  • Sfr20,000 for damage to property; and
  • Sfr3 million for the entire clinical trial (see Annex 2(1) of the Ordinance on Clinical Trials).

For other clinical trials, the policy value must be at least:

  • Sfr1 million a person;
  • Sfr50,000 for damage to property; and
  • Sfr10 million for the entire clinical trial (see Annex 2(2) of the Ordinance on Clinical Trials).

The liability coverage must include damage occurring up to 10 years after completion of the clinical trial (see Article 13(3) of the Ordinance on Clinical Trials).

Data protection

What data protection issues should be considered when conducting clinical trials?

As a rule, if a private person conducts a clinical trial, the Federal Data Protection Act applies (in particular, Article 4 of the Federal Data Protection Act). If trials are conducted by cantonal hospitals, data protection is subject to regulation of the respective canton.

Moreover, the Human Research Act contains data protection rules that apply irrespective of the person conducting the trial. Pursuant to Article 58 of the Human Research Act, ethics committees and the other enforcement bodies are entitled to process personal data. Sensitive personal data may be processed as far as necessary. Regarding the disclosure and cross-border transmission of personal data, Articles 59 and 60 of the Human Research Act provide for detailed regulation.

If the intention exists to make further use of research regarding the health-related personal data collected, the consent of the persons concerned must be obtained at the time of such sampling or collection, or they must be informed of their right to dissent (see Article 17 of the Human Research Act).

The health-related personal data collected during a clinical trial in an emergency situation may be evaluated only once consent has been obtained. In exceptional cases, the health-related personal data may be evaluated before consent has been obtained if this is necessary for the sake of the participants' safety and health. If consent to participate in a clinical trial in an emergency situation is withheld after the event, the health-related personal data must be destroyed. If the validity of the clinical trial or its results would be compromised in essential respects by the destruction of the health-related personal data, the use of the data in the clinical trial is permissible despite the withdrawal of consent. The health-related personal data must be anonymised without delay. The concerned person’s right to dissent is reserved. If it is foreseeable that data may be evaluated before consent has been obtained, or used in spite of the refusal of consent, this must be stated in the protocol (see Article 17 of the Ordinance on Clinical Trials).

There are also detailed rules regarding the further use and storage of health-related personal data (see Articles 32 and following and Articles 41 and following of the Human Research Act, and Article 18 of the Ordinance on Clinical Trials).

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

The distribution of a medicine in Switzerland – irrespective of whether the medicine requires a prescription or may be sold over the counter – requires a marketing authorisation from the Federal Agency for Therapeutic Products (Swissmedic) (see Article 9 of the Therapeutic Products Act).

As well as the ordinary licence procedure, the statute provides for a simplified licence procedure that applies if this is compatible with the quality, safety and efficacy requirements provided for by Swiss law (see Article 14 of the Therapeutic Products Act). In particular, this is the case with regard to:

  • medicines made with known active pharmaceutical ingredients;
  • complementary medicines;
  • medicines prepared by a public pharmacy, a drugstore or another establishment holding a manufacturing licence according to its own formula, conforming to a pharmacopoeia or a formula recognised by Swissmedic, and which are dispensed to the manufacturer’s own customers;
  • medicines prepared by a hospital pharmacy or in the hospital’s own radiopharmaceutical unit for the needs of the hospital;
  • medicines prepared by the army and used in the context of the coordinated army medical corps;
  • important medicines for rare diseases; and
  • veterinary medicines that are intended exclusively for animals not kept for the production of foodstuffs.

Following the submission of the required documents, the application is examined by Swissmedic, which decides whether the marketing authorisation is to be issued based on the quality of the manufacturing, the medicine’s efficacy and its safety (see Article 16 of the Therapeutic Products Act). The marketing authorisation may be withdrawn if the medicine has not been marketed within the last three years (see Article 16a(1)(a) of the Therapeutic Products Act).

The entire authorisation procedure (in case of an ordinary licence procedure) takes between 10 and 12 months, or between four and five months if the applicant chooses the expedited procedure.

What criteria are considered in granting marketing authorisation?

A marketing authorisation will be issued if the applicant can prove that:

  • the medicine is high quality, safe and effective;
  • the applicant is licensed for manufacture, import or wholesale trade; and
  • its registered address, registered office or branch office is in Switzerland (see Article 10 of the Therapeutic Products Act).

What is the fee for obtaining marketing authorisation?

The fees for a marketing authorisation depend on the licensing procedure (see Article 4(1) and Appendices 1 and 2 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products):

  • the fees for licensing a medicine with a new active substance are between Sfr70,000 and Sfr140,000;
  • the fees for licensing a medicine with an existing registered active substance are between Sfr15,000 and Sfr42,000;
  • the fees for renewing an existing authorisation are Sfr500; and
  • there is no fee for market authorisations of products granted orphan drug status (see Article 14(1)(f) of the Therapeutic Products Act and Appendix 2 of the Ordinance on the Fees of the Swiss Agency for Therapeutic Products). 

What is the validity period for marketing authorisation?

The marketing authorisation is valid for five years but can be renewed provided that the conditions for issuing the marketing authorisation are met (see Article 16 of the Therapeutic Products Act).

What are the consequences of failure to obtain marketing authorisation?

If a marketing authorisation has not been obtained or granted, the respective medicinal product may not be placed on the Swiss market (see Article 9(1) of the Therapeutic Products Act). However, small quantities of non-authorised medicines may be imported by patients or medical persons subject to certain conditions (see Article 20(2) of the Therapeutic Products Act and Article 36 of the Ordinance on Authorisations in the Medicinal Sector).

The punishment for wilfully endangering human health (if there is no danger to human health, the penalties are less severe; see Articles 87(1)(f), (2) and (3) of the Therapeutic Products Act) by placing on the market medicinal products without authorisation is a custodial sentence not exceeding three years or a monetary penalty, or a fine of up to Sfr200,000. If the person concerned acts in his or her professional capacity, the punishment is a custodial sentence not exceeding five years or a monetary penalty, and a fine of up to Sfr500,000. In case of negligence, the punishment is a monetary penalty or a fine of up to Sfr100,000 (see Articles 86(1)(b), (2) and (3) of the Therapeutic Products Act). 

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

According to Article 59 of the Therapeutic Products Act, any person manufacturing or distributing ready‑to‑use medicines or medical devices must put in place a system of notification. It must notify the Federal Agency for Therapeutic Products (Swissmedic) of any adverse event or reaction that is or may be attributable to the therapeutic product itself, its use or incorrect labelling or instructions, or which may endanger or harm the health of the consumer, the patient or a third party. Further, any person manufacturing or distributing therapeutic products must notify Swissmedic of any quality defects or further findings and assessments that could influence the basis of evaluation for granting the respective authorisation.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

Information that relates to adverse events or reactions must be reported in an anonymised form (see Article 35(2) of the Ordinance on Medicines). 

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Consumer prices and ex-factory prices of medicines to be reimbursed by the mandatory health insurance are determined by the Federal Office of Public Health on application of the respective distributor taking into account external and internal reference pricing. The prices of medicinal products not subject to reimbursement are not regulated.

The prices (along with the effectiveness and suitability) of medicinal products to be reimbursed by the mandatory health insurance are subject to review every three years (see Article 65d of the Ordinance on Health Insurance Ordinance on Health Insurance and Article 34d and following of the Ordinance on the Indemnifications of Mandatory Health Insurance). Further, a review is conducted in case of changes of the indications and limitations of a medicine (see Article 65f of the Ordinance on Health Insurance and Article 37a and following of the Ordinance on the Indemnifications of Mandatory Health Insurance) and on patent expiry (see Article 65e on the Ordinance on Health Insurance and Article 37 of the Ordinance on the Indemnifications of Mandatory Health Insurance).

The price of a generic medicinal product is set depending on the price of the original medicinal product as well as the latter's market volume (see Article 65c of the Ordinance on Health Insurance).

The regime regarding pricing of medicines has been revised several times over the last decade. After several successful appeals that challenged the pricing regime, the respective ordinances have been revised in order to put more emphasis on the internal reference price again. The changes will become effective on March 1 2017.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

In Switzerland, health insurance is mandatory (see Article 3(1) of the Health Insurance Act) but the insurer may be chosen freely (see Article 4 of the Health Insurance Act). As a general rule, the same insurance premium must be charged to each insured person (see Article 61(1) of the Health Insurance Act). However, different insurers may charge different insurance premiums.

The statute defines who is allowed to provide goods and services (see Article 35 and following of the Health Insurance Act) and what goods and services are covered by the mandatory health insurance (see Article 24 and following of the Health Insurance Act). In principle, the service provider is to be reimbursed directly by the insured person while the latter is entitled to a refund by the insurance company (the tiers garant system) (See Article 42(1) of the Health Insurance Act). However, service providers and insurers may arrange for direct reimbursement by the concerned insurer (the tiers payant system) (see Article 42 (2) of the Health Insurance Act). Apart from the premium, the insured persons must pay a contribution to the actual costs incurred (see Article 64 of the Health Insurance Act).

To be eligible for reimbursement, medicines and medical devices must be included in specific lists: the list of specialties for ready‑to‑use medicines or the list of means and objects for medical devices. In both cases, in order to be listed the applicant must demonstrate that the respective product is effective, economical and suitable (see Article 32 of the Health Insurance Act).

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

Advertising and promoting medicines is primarily regulated by Articles 31 to 33 of the Therapeutic Products Act, and in more detail in the Ordinance on Advertising of Medicines. The advertisement of medical devices is governed by Article 21 of the Ordinance on Medical Products.

Advertising directed exclusively at persons prescribing or dispensing medicines is permitted for all types of medicine. Advertising directed to the general public is permitted only for non-prescription medicines (see Article 31(1) and Article 32(2)(a) of the Therapeutic Products Act). For medical devices that may be dispensed only on prescription or which must be applied by a healthcare professional, advertising directed to the general public is prohibited (see Article 21 of the Ordinance on Medical Products). However, mere factual information on human health and diseases that does not, directly or indirectly, make reference to a certain medicine is not considered advertising (see Article 1(2)(c) of the Ordinance on Advertising of Medicines).The same applies for package information leaflets and information on medical products to healthcare professionals (see Article 1(2)(a) of the Ordinance on Advertising of Medicines).

Any advertising for medicines that is misleading or contrary to public policy and morality, that may incite to an excessive, abusive or inappropriate use of medicines or that relates to medicines (or indications thereof) that are not admitted to the Swiss market is prohibited (see Article 32(1) of the Therapeutic Products Act and Article 5(1) of the Ordinance on Advertising of Medicines). Promotion of off-label use (ie, the use of a medicine for indications or treatments other than listed on its approved label) is not permitted (see Article 5(1) of the Ordinance on Advertising of Medicines e contrario).

Advertising of medicines directed to the general public (which is permissible only for non-prescription medicines) must contain explicit and easily legible advice to read the package information leaflets (see Article 16(5)(c) of the Ordinance on Advertising of Medicines). Advertising on radio, television and in cinemas must end with specific warnings (eg, “This is a medicine. Please take advice from a health professional and read the patient information"; see Article 17 of the Ordinance on Advertising of Medicines). Advertising for certain sensitive drugs (eg, anorectics or sedatives) is subject to an advance clearance requirement if there is a potential for abuse or addiction (see Article 23 of the Ordinance on Advertising of Medicines and Swissmedic Journal 08/2016, Page 644 and following).

Comparative advertising (including advertisements comparing prices) is permissible if directed exclusively to healthcare professionals, but not if directed to the general public (see Articles 7 and 22(c) of the Ordinance on Advertising of Medicines). Medicine samples may be furnished to healthcare professionals only on written request and in small quantities. Samples must be clearly and permanently labelled as ‘free samples’ and must not be larger than the smallest commercially available package. The sale of samples by healthcare professionals is prohibited (see Article 10 of the Ordinance on Advertising of Medicines). Samples provided to consumers may not contain more than one recommended daily dose and may be distributed only through the channels authorised to distribute such products (see Article 19 of the Ordinance on Advertising of Medicines).

In addition to the aforementioned medicine-specific regulations, the general legal framework regarding advertising and promotion must be observed. In particular, the limits set by the Unfair Competition Act, which generally prohibits unfair marketing activities (eg, false statements and passing-off), must be followed.

Do any special rules apply to online advertising of medicinal products?

Advertising for drugs of certain sensitive categories (eg, anorectics or sedatives) is subject to advance clearance requirement if there is a potential for abuse or addiction (see Article 23 of the Ordinance on Advertising of Medicines and Swissmedic Journal 08/2016, Page 644 and following).

Labelling

What are the packaging and labelling requirements for medicinal products?

Packaging and labelling are regulated in Articles 12-17 of the Ordinance on Requirements for Approval of Medicinal Products. There are detailed requirements laid down in the annexes to the Ordinance on Requirements for Approval of Medicinal Products – in particular, information provided to patients must be written in three official languages (German, French and Italian) (see Annex 5.1(1)(2)).

How is the promotion of off-label use regulated?

Promotion of off-label use is not permitted (see Article 5(1) of the Ordinance on Advertising of Medicines e contrario).

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

It is prohibited to grant, offer or promise material benefits to persons who prescribe or dispense medicines or to the organisations that employ such persons (particularly hospitals). Further, it is prohibited for the mentioned persons to solicit or accept such benefits or payments (see Article 33(1)‑(2) of the Therapeutic Products Act), but material benefits of modest value that relate to medical or pharmaceutical practice, as well as discounts that are customary or economically justified are permitted (see Article 33(3) of the Therapeutic Products Act). However, health professionals who receive such discounts for medicines that are eligible for reimbursement are obliged to pass them on (see Article 56(3)(b) of the Health Insurance Act). The relationship between the pharmaceutical industry and prescribers is addressed in more detail in several codes of conduct that are enacted by organisations of the respective industry or profession (and which are binding only for members of the respective organisations).

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Swiss law does not provide for a specific liability system in relation to persons injured by medicines or medical devices. Instead, the general liability regime, including both contractual and non-contractual liability (including the manufacturer’s liability) applies. In respect to injuries suffered in connection with medical treatment at public hospitals, cantonal state liability rules apply.

Self-employed medical professionals (eg, physicians, dentists and pharmacists) must take out adequate liability insurance (see Article 40(h) of the Swiss Act on Medicinal Professions).

Regarding research on humans, the Human Research Act stipulates a specific liability including an obligation to provide adequate insurance of the sponsors of clinical trials (see Article 19 and 20 of the Human Research Act).

Which parties can be held liable for a defective medicinal product?

There is no specific regulation regarding the liability for defective medicinal products. In general, the applicable law depends on whether the responsible party is a private person or a public official. In the first case, general Swiss tort law applies, in particular the relevant provisions of the Code of Obligations and the Product Liability Act. In the latter case, cantonal public liability laws apply, although these often refer to general tort law.

Pursuant to Article 41 of the Code of Obligations, the responsible party can be held liable if the injured party can demonstrate, among other things, a fault of the responsible party (eg, the manufacturer, a physician or hospital employees). In contrast, the liability pursuant to the Product Liability Act is strict, but limited to the manufacturer. The manufacturer (see Article 2 of the Product Liability Act for the definition) of a product (see Article 3 of the Product Liability Act for the definition) is liable if a defective (see Article 4 of the Product Liability Act for the definition) product leads to a person being killed or injured (see Article 1(1)(a) of the Product Liability Act). However, there are certain exceptions (see Article 5 of the Product Liability Act).

Remedies

What remedies are available to successful claimants?

The injured party is entitled to compensation payments and, as the case may be, compensation for personal suffering.

Exclusion and limitation

On what grounds can liability be excluded?

In general, within the boundaries of contract law, liability pursuant to Article 41 of the Code of Obligations can be excluded in advance by contractual stipulation. Liability pursuant to the Product Liability Act cannot be excluded in advance (see Article 8 of the Product Liability Act).

What preventive steps can be taken to limit liability?

All processes and products should be designed in accordance with relevant laws, regulations and standards. Pharmacovigilance obligations must be adhered to closely.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The Federal Agency for Therapeutic Products (Swissmedic) and the competent cantonal authorities (generally the Department of Health) are responsible for the supervision of manufacturing, distribution and marketing activities. They supervise the Swiss market in general, as well as the individuals manufacturing, distributing and marketing medicines. A specific investigation is opened if either Swissmedic or the cantonal authorities discover any violation during their supervision or if a violation is notified to them.

Swissmedic and the cantonal authorities may carry out any necessary investigation into a specific incident, and the parties involved have the obligation to cooperate fully in this investigation. In particular, Swissmedic or the cantonal authorities may take samples, demand information and essential documents and request any necessary help for this purpose. Swissmedic or, in the case of a serious and immediate threat to health, the cantonal authorities, may take all necessary administrative measures in order to remedy a breach of the applicable rules (see Article 66 of the Therapeutic Products Act).

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Apart from general provisions of the Criminal Code and the Cartel Act, specific criminal provisions in the Therapeutic Products Act and the Health Insurance Act apply in particular regarding bribery (see Article 86 and following of the Therapeutic Products Act and Article 92 of the Health Insurance Act). Professional codes provide for the possibility of additional measures in case their provisions have been violated (see Number 637 of the Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code) and Number 537 of the Code of Conduct of the Pharmaceutical Industry in Switzerland on cooperation with healthcare professional circles and patient organisations (Pharma Cooperation Code)).