Medicinal product regulation and product liability in Switzerland: overview

A Q&A guide to medicinal product regulation and product liability law in Switzerland.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Switzerland: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

Medicinal products are regulated by the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products) (Heilmittelgesetz) of 2000 (LTP). Several ordinances have been issued based on the LTP. Genetic testing is subject to the Act on Human Genetic Testing of 2004. Clinical trials with medicinal products are regulated by the LTP, the Federal Act on Research involving Human Beings (Human Research Act) (HRA) of 2011 and related ordinances.

Swiss legislation on medicinal products follows EU regulation in many areas.

Placing medicinal products on the market requires a marketing authorisation (with some exceptions). There is no automatic recognition of marketing authorisations granted in the EU. However, marketing authorisations in countries with a comparable marketing authorisation system such as the EU or the US are taken into account.

The LTP and related ordinances set out the conditions for licences required to manufacture, import, sell, trade or export medicinal products (establishment licences). The LTP also contains rules about the prescription, dispensing and advertising of medicinal products.

The Federal Health Insurance Act (Krankenversicherungsgesetz) 1994 (as amended) and related ordinances regulate reimbursement of medicinal products by social health insurance. They also regulate the pricing of medicinal products reimbursed by social health insurance.

Regulatory authorities

Marketing authorisations are granted by the Swiss Agency for Therapeutic Products (Schweizerisches Heilmittelinstitut) (Swissmedic) (www.swissmedic.ch). Its main areas of responsibility are:

  • Marketing authorisations.

  • Establishment licences.

  • Control of advertising and monetary advantages.

  • Supervision of clinical trials.

  • Market surveillance for medicinal products and medical devices.

Licences to manufacture, import, trade, or export medicinal products are granted by Swissmedic, or in certain exceptional circumstances by the cantons. Authorisations to operate a hospital, a pharmacy or a drug store and to dispense medicinal products are granted by the cantons.

Reimbursement status for medicinal products is granted by the Swiss Federal Office of Public Health (Bundesamt für Gesundheit) (FOPH) (www.bag.admin.ch). The FOPH decides on the maximum price for reimbursed medicinal products.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Biologicals are treated as a subcategory of pharmaceuticals. For pharmaceutical products containing genetically modified organisms additional authorisation requirements apply. Swissmedic assesses the product not only in accordance with the regulations of the LTP but also of the Ordinance on the Handling of Organisms in the Environment (Freisetzungsverordnung). Product information and labelling have to indicate that the product contains genetically modified organisms. Swissmedic requires specific wording to be placed in the product information with regard to the traceability of the product.

There is no simplified procedure for the marketing authorisation with regard to products with known active substances (see Question 11) containing genetically modified organisms.

Combination products also are subject to certain specific authorisation requirements. In particular, the application for marketing authorisation must contain data concerning specifically the combination product; it is not sufficient to submit data on the individual components only. For a guideline on the documents to be submitted with the application, Swissmedic refers to the WHO Guidelines for registration of fixed-dose combination medicinal products (WHO Technical report series, No. 929, 2005: Annex 5) and to the ICH guideline M3. Combination products containing only known active substances can be granted marketing authorisation in accordance with the simplified procedure for the marketing authorisation for products with known active substances (see Question 11).

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

Medical devices, including diagnostics, are regulated by the LTP. In the field of medical devices Switzerland has essentially transposed EU regulations, mainly into the Ordinance on Medical Devices (Medizinprodukteverordnung), which has been issued based on the LTP. There is no specific regulation of health IT issues and mobile medical applications but software and mobile medical applications may also fall within the definition of medical devices. Swissmedic is the authority responsible for monitoring and enforcing compliance with medical devices regulations. Medical devices do not require a marketing authorisation. However, a medical device may only be placed on the market by a manufacturer or importer when the applicable conformity assessment procedure has been successfully completed (this does not apply to classical or active implantable medical devices with components of human tissue which has been rendered non-viable). The CE mark allows the free movement of medical devices within the European Economic Area (EEA) and Switzerland. With regard to the placing on the market of certain products a duty to notify Swissmedic applies. For sales in Switzerland, the product information must be written in German, French and Italian (with some restrictive exceptions).

Clinical trials with medical devices are regulated by the LTP, the Human Research Act and related ordinances.

Reimbursement of medical devices by social health insurance is also regulated by the Federal Health Insurance Act and related ordinances. Reimbursement status is granted by the FOPH.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

Structure

The healthcare system reflects the federalist structure of Switzerland. Only certain areas are controlled by the confederation, the others by the 26 cantons. For example, most non-private hospitals are regulated and owned by the cantons.

The confederation's competences have grown in recent years. Important areas of the healthcare system are legislated, and are now controlled by the confederation, including:

  • Social health insurance (Soziale Krankenversicherung).

  • Academic professions in the healthcare sector.

  • Pharmaceutical products and medical devices.

  • Narcotics.

  • Research involving humans.

  • Reproductive medicine.

  • Transplantation.

Legislation on social health insurance provides that individuals must be insured with a sick fund of his choice. Sick funds form the basis of, and are part of, social health insurance. Cover provided by social health insurance, also called basic insurance (Grundversicherung), can be supplemented by optional additional private insurance (private Zusatzversicherung). The insurance system generally allows a free choice of healthcare provider(s).

Funding

The healthcare system is mainly financed by:

  • Social health insurance.

  • Private insurance.

  • The Swiss confederation.

  • The cantons.

  • The communities.

  • Direct payments by patients.

Insured individuals contribute to social health insurance through premiums to their sick fund and patient co-payments. The premiums can vary significantly between the different regions, sick funds and type of insurance that can be chosen within certain limits. The social health insurance premiums of low-income individuals are, in addition, subsidised by the cantons and the federal government.

 
5. How are the prices of medicinal products regulated?

Non-reimbursable products

For non-reimbursable products, there is no price regulation. Swissmedic does not evaluate prices when granting marketing authorisation. However, if there is price abuse or there are illegal agreements on prices, the Competition Commission or the price surveillance authority can intervene.

Reimbursable products

For reimbursable products, the Federal Health Insurance legislation sets out regulations for determining the maximum price that healthcare providers (that is, pharmacies, drug stores, hospitals and self-dispensing doctors) can charge for reimbursable products. For a pharmaceutical product to be reimbursed within the framework of the social health insurance system, it must generally be within the lists drawn up for this purpose, particularly the Speciality List (SL) issued by the FOPH (see www.bag.admin.ch/kv/gesetze/sl/d/index.htm).

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

Depending on the applicable insurance system, the costs of ambulatory treatment are directly paid for by the sick fund of the patient or reimbursed to him after he has paid the cost. The costs of stationary treatment are directly paid for by the sick funds. The sick funds are not part of the state administration, but they perform governmental tasks and are supervised by the state administration. Under the basic health insurance regime, medicinal products dispensed in ambulatory treatment are reimbursed if they are prescribed by a physician (or under certain circumstances, by a chiropractor) and listed in one of the lists drawn up for this purpose, particularly the SL. Optional additional private insurances also cover most authorised medicinal products that are not listed in the SL. The costs of medicinal products dispensed in stationary treatment are covered through the day rate paid by the sick fund.

Applications for a listing in the SL must be made to the FOPH. The granting of marketing authorisation does not mean that a pharmaceutical product is automatically reimbursed. The holder of the marketing authorisation can choose whether to apply for reimbursable status. However, the FOPH can place a pharmaceutical product of great importance on the SL without prior application from the marketing authorisation holder. About 57% of pharmaceutical products registered in Switzerland (sold packages) are listed on the SL. Prescription and non-prescription drugs can be listed on the SL.

A medicinal product is only admitted to the SL if the applicant can show its efficacy, usefulness and economy. The FOPH bases its decision on a recommendation of the Federal Commission for Medicinal Products. The following are the criteria for fixing the SL price:

  • The average ex-factory price (without VAT) of the product in other countries. Since 1 June 2015, the prices in Germany, Denmark, the UK, The Netherlands, France, Austria, Belgium, Sweden and Finland are used for the comparison. The FOPH can also use other countries for the comparison.

  • The prices of drugs that have the same indication or a similar mode of action.

If the pharmaceutical product constitutes a therapeutic advancement, an innovation premium can be granted. Following court decisions, the exact criteria for determining the SL prices are currently revised by FOPH. In determining the SL price, the FOPH adds a distribution margin to the ex-factory price determined according to the above criteria. In an application to list a drug in the SL, the applicant must indicate the requested price. If the FOPH considers the price to be too high, it can give an alternative price, which the applicant can accept or reject. If the applicant finally rejects the price proposed by the FOPH, a formal decision is issued by the FOPH. The decision can be appealed.

According to the current rules, fulfilment of the admission conditions is reviewed every three years for all pharmaceutical products listed in the SL. If the review shows that the price is too high, the price is decreased. There is also a review of the admission conditions:

  • Immediately after expiration of patent protection.

  • If an application for a price increase is filed.

  • In principle, if a new indication is authorised by Swissmedic for an original medicinal product or if a request for changing or deleting a limitation is filed.

Currently, the following rules apply for generic products listed in the SL:

  • The ex-factory price of the generic product must be at least 60% lower than the price of the original, if the Swiss market volume of the original (including its co-marketing products) exceeded CHF25 million per year on average during the three years before patent expiry.

  • The ex-factory price of the generic product must be at least 50% lower, if the market volume of the original (including its co-marketing products) was between CHF16 million and CHF25 million on average during the three years before patent expiry.

  • The ex-factory price of the generic product must be at least 40% lower, if the market volume of the original (including its co-marketing products) was between CHF8 million and CHF16 million on average during the three years before patent expiry.

  • The ex-factory price of the generic product must be at least 20% lower, if the market volume of the original (including its co-marketing products) was between CHF4 million and CHF8 million on average during the three years before patent expiry.

  • The ex-factory price of the generic product must be at least 10% lower, if the market volume of the original (including its co-marketing products) did not exceed CHF4 million on average during the three years before patent expiry.

The ex-factory price of parallel imports must generally be at least 15% lower than the ordinary ex-factory price, unless the product is already on the generic price level.

Any price increase of a reimbursed product must be approved by the FOPH. An application for a price increase can be submitted at the earliest two years after the listing of the product in the SL or after the last increase.

FOPH decisions relating to listing in the SL can be appealed first to the Federal Administrative Court and then to the Federal Supreme Court.

The SL sets out the maximum price that the healthcare providers can charge for certain medicinal products. The SL price takes into account a distribution margin which is different for prescription and non-prescription products. In relation to prescription medicines, pharmacists can charge for certain services in addition to the distribution margin (including control of the prescription, information and instructions, and the keeping of a patient file). The reimbursement of these services is based on a contract between the Swiss pharmacists' association and the insurances that must be approved by the Swiss government.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials are mainly regulated by:

  • The LTP.

  • The HRA.

  • The ordinances related to the HRA.

  • The Ordinance on Medical Devices.

  • The DPA.

  • The Guidelines on Good Clinical Practice of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use 1996 (ICH-GCP).

  • The WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, Brazil 2013.

  • Annexes VIII and X of Directive 93/42/EC concerning medical devices (Medical Devices Directive), if clinical trials involve medical devices.

Subject to exceptions, both Swissmedic and the competent ethics committee (see www.swissethics.ch) must approve the trial.

Authorisations

In principle, clinical trials with therapeutic products need authorisation by Swissmedic and the competent ethics committee. Clinical trials with pharmaceuticals authorised in Switzerland and administered within the scope of the authorised use as well as compliant medical devices used within the scope of the purpose designated by the conformity assessment do not need authorisation by Swissmedic.

The ethics committee assesses the trial from an ethical point of view, examines compliance with legal requirements and verifies its scientific quality, taking into account local conditions. The committee ensures the safety of the trial subjects. The Association of Swiss Ethics' Committees (Swissethics) issues templates and recommendations for the various documents such as study protocols and informed consent forms. Although the templates are declared to be "mandatory" by Swissethics, the ethics committees accept variations if they are materially in line with their templates. The ethics committees are appointed and supervised by the cantons. There are certain rules in federal law relating to their composition. Applications have to be submitted through a web portal (BASEC). The competent ethics committee confirms receipt of the application within seven days and advises of any formal flaws in the file. The committee issues its decision within 30 days after receipt of the application. In case the committee requests additional documents this time limit is suspended until the complete information has been received. In case of multicentre trials the leading ethics committee issues its decision within 45 days. Authorisation is granted if the trial complies with ethical, legal and scientific requirements.

Swissmedic examines whether the product used in the trial complies with the requirements of Good Manufacturing Practice and with safety requirements. The trial file has to be submitted to Swissmedic by the sponsor. Swissmedic requires one hard copy and one electronic copy of the file containing the documents listed in the annex of the Ordinance on Clinical Trials in Human Research. Swissmedic does not process incomplete files. Receipt of the application is confirmed within seven days and the applicant is informed of any formal flaws in the file. Swissmedic issues its decision within 30 days after receipt of the complete application. This time limit can be extended for another 30 days if the pharmaceutical is for the first time applied to human beings or if it is manufactured in a new process. Swissmedic can inspect compliance with legal rules any time.

The trial file can be submitted to the competent ethics committee and to Swissmedic simultaneously, if both approvals are required. The trial cannot start before both Swissmedic and the competent ethics committee have approved it. Essential changes in the trial plan have to be approved by Swissmedic and the ethics committee prior to their implementation. The same deadlines apply as for the initial trial authorisation.

Consent

Trial subjects must give their free informed consent to participation in the trial. Clause 4.8 of ICH-GCP applies. The HRA and the templates of Swissethics provide the necessary content for the consent forms. The complete information given to the trial subjects and the way the informed consent is obtained is reviewed by the competent ethics committee.

Trial pre-conditions

Pre-conditions for the performance of a clinical trial are that:

  • The trial project and documentation must be set up according to the applicable rules.

  • The sponsor must have its registered office in Switzerland or name a representative located in Switzerland.

  • The competent ethics committee has approved the trial.

  • Swissmedic has approved the trial, if necessary.

  • Trial subjects must be guaranteed full compensation for injuries suffered in the trial. This requires insurance cover or comparable securities up to a certain amount for any damage caused by the trial, occurring both during the trial and within ten years after it ends. The amount of insurance cover is generally at least CHF10 million for the whole trial and CHF1 million for each case of personal injury and CHF50,000 for each case of material damage. In certain cases involving lower risks for trial subjects the amount of insurance cover can be less or even no security is necessary.

Procedural requirements

Procedural requirements are set out in the Ordinance on Clinical Trials in Human Research and the ICH-GCP.

For example, the trial sponsor must notify Swissmedic of an interruption of the trial within 15 days, and of the trial's completion within 90 days. A final report must generally be filed with Swissmedic within one year of the trial's interruption or completion. With regard to trials for which Swissmedic's approval was not necessary, such notification has to be made to the competent ethics committee. In case safety or health of the trial subjects is endangered, the ethics committee can set additional requirements or suspend or withdraw the authorisation for the trial.

Public registration

The Human Research Act provides for mandatory public registration of authorised clinical trials. The trial has to be registered by the sponsor either with a primary registry accredited by the WHO or with the registry of the US National Library of Medicine, as well as in the public database of Switzerland (SNCTP Portal) (www.kofam.ch/en/swiss-clinical-trials-portal). Registration has to be made prior to conducting the trial. An exception are phase I trials which must be registered within one year after completion of the trial. The data must be registered in the version authorised by the competent ethics committee. Data registered in the international registry must be in accordance with the WHO Trial Registration Data Set (Version 1.2.1). Data registered with the national database must contain additional data as stipulated in Annex 5 of the Ordinance on Clinical Trials in Human Research. Trial results do not have to be published.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

The manufacturer must in principle obtain a manufacturing licence from Swissmedic. Hospital pharmacies and other establishments holding a retailing licence may have to apply to the canton.

Conditions

The following criteria must be satisfied to obtain a manufacturing licence from Swissmedic (Article 3 et seq., Ordinance on Establishment Licences of 17 October 2001):

  • The facilities of the applicant must operate a system to ensure the pharmaceutical quality of medicinal products and the management and staff in the individual departments concerned must be actively involved in this system.

  • Each department must have a sufficient number of qualified and competent staff members to enable it to achieve its quality targets.

  • A qualified person must be appointed for the facilities.

  • The facilities must be organised in an appropriate way.

  • The facilities must be designed, structured, maintained and modernised regularly to guarantee the safe manufacture of medicinal products, and the premises and equipment that can influence the quality of the medicinal products must be approved.

  • A document system must be available to provide the working instructions, procedure descriptions and protocols of the relevant manufacturing processes.

  • Manufacturing, testing and cleaning procedures must be validated.

  • Quality control must be independent of manufacture.

  • Care must be exercised in the manufacturing process (in particular, manufacture must be according to EU Good Manufacturing Practices (GMP), particularly as set out in Directive 2003/94/EC on good manufacturing practice for medicinal products).

  • The work of all persons occupying key positions in the company must be set out in job descriptions and their positions in the hierarchy shown in organisation charts.

Compliance with these conditions is inspected by Swissmedic. An inspection can also be performed any time during a licence term.

Restrictions on foreign applicants

The applicant must be located in Switzerland. There are no restrictions on foreign ownership.

Key stages and timing

The key stages in the process are:

  • Application.

  • Inspection.

  • Grant of the licence.

  • Regular inspections (in principle, every two years).

Fee

The fees for examining an application for a manufacturing licence are CHF500, plus fees for the inspection (including preparing and writing a report) calculated at CHF200 per inspector per hour. Inspections can take up to several days, depending on the size of the facilities, and the complexity of the products and manufacturing techniques. The fee for the issuance of the licence certificate is CHF100.

Period of authorisation and renewals

Licences are granted for renewable terms of five years.

Monitoring compliance and imposing penalties

Swissmedic and the cantons have powers to monitor compliance with manufacturing authorisations in their respective areas, which are defined in the LTP and related ordinances. They must verify by periodic inspection that conditions for authorisation are met. Swissmedic and the cantons can also, without incurring costs, take samples, request essential information and documents, and ask for any necessary assistance.

Swissmedic and the competent cantonal authorities can generally take any administrative measure necessary to enforce the LTP, subject to the principles of proportionality and of public interest. The LTP lists certain measures that Swissmedic or the competent authorities of the cantons can take. For breaches of the manufacturing licence, Swissmedic can:

  • Raise objections and set an appropriate time period for re-establishment of the lawful situation.

  • Suspend or revoke the licence (this decision will be published by Swissmedic).

  • Close down the establishment.

  • Seize, hold in official storage or destroy medicinal products which endanger health or which do not conform to the LTP.

  • Prohibit the distribution, supply, import, export and trade of medicinal products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage.

Apart from administrative measures, Swissmedic and the competent cantonal courts can also impose criminal sanctions.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

Marketing authorisation is required for placing a pharmaceutical product on the market, whether prescription-only or over-the-counter (OTC), except in certain limited circumstances. The application must be made to Swissmedic using standard forms, and for New Active Substances, the Common Technical Document (CTD) of the International Conference on Harmonisation. Swissmedic accepts registration documents in the form approved by the EU. It also supports submitting data electronically. The following documents must be included:

  • Analytical, chemical, pharmaceutical, pharmacological, toxicological and clinical documents that certify the quality, efficacy and safety of the product.

  • Drafts of the product information to be provided to professionals and patients.

  • Packaging design.

  • Samples of the medicinal product, active and auxiliary agents, intermediate and by-products, if requested by Swissmedic.

The required documents are listed in detail in the Ordinance on the Requirements for the Marketing Authorisation of Medicinal Products and its Annexes of 9 November 2001 (Ordinance on Marketing Authorisations) and guidelines issued by Swissmedic.

Authorisation conditions

The conditions for a marketing authorisation are the product's safety, efficacy and high quality. While high quality manufacturing must always be guaranteed, the application is mainly assessed on the drug's efficacy and relative safety (the ratio between benefit and risk). If a drug or process has already been approved in another country that possesses a similar system of drug control, those examination results are considered. Swissmedic does not examine whether there is patent protection.

A marketing authorisation can only be granted to a person or company having its domicile, registered office or branch office in Switzerland. The applicant must also have a manufacturing, import or wholesale licence.

Key stages and timing

The normal authorisation procedure takes at least about one year. Swissmedic's targeted internal time periods are:

  • Formal control: 30 days.

  • Examination and establishment of the list of questions: 120 days.

  • Advance notice of the decision: 90 days.

  • Decision: 90 days.

If Swissmedic has queries or requests further information or documents, these internal time periods are stopped and the authorisation process can take longer. Swissmedic personnel dealing with the application can be contacted. Hearings on important points can under certain conditions be held with Swissmedic. If Swissmedic rejects an application, its decision can be appealed to the Federal Administrative Court, and finally to the Federal Supreme Court.

Fee

The fees for an examination of an application for a marketing authorisation vary considerably, depending on the type of application, including:

  • CHF70,000 for a new active substance.

  • CHF28,000 for a product containing an existing registered active substance with innovation (simplified procedure).

  • CHF15,000 for a product containing an existing registered active substance without innovation (simplified procedure).

  • CHF500 for renewing an existing authorisation.

In addition, Swissmedic charges a sales fee of between CHF0.014 and CHF5 (depending on the ex-factory price of the product) for each pharmaceutical product unit sold. The fee contributes to Swissmedic market surveillance activities.

Period of authorisation and renewals

Marketing authorisation is granted for renewable terms of five years. The marketing authorisation holder must submit a renewal application with supporting information at least six months before the expiry date.

Monitoring compliance and imposing penalties

Swissmedic must verify that medicinal products conform to their marketing authorisation. It can, without incurring costs, take samples, request essential information and documents, and ask for any assistance. Swissmedic can also monitor compliance with marketing authorisations.

Swissmedic can take administrative measures to ensure compliance with a marketing authorisation similar to those for breach of a manufacturing authorisation (see Question 8). If the requirements are no longer met, Swissmedic can cancel the marketing authorisation.

If the marketing authorisation is breached, penalties can apply.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

Post-marketing commitments and pharmacovigilance obligations

Marketing authorisation holders for medicinal products with a new active substance must submit periodic safety update reports (PSURs) (in principle, annually) to Swissmedic, within five years from authorisation, and in certain other situations. Additional guidance is given by Swissmedic publications and the ICH efficacy guidelines.

The manufacturer or the marketing authorisation holder must maintain a pharmacovigilance system. They must also notify Swissmedic of any of the following risks relating to pharmaceutical products, which have been observed in Switzerland:

  • Serious adverse events.

  • So far unknown adverse events.

  • Accumulation of known or so far unknown adverse events, including serious abuse and serious intoxications.

  • Quality defects.

  • Unusual restrictions of distribution.

In relation to risks observed abroad, the following must be notified to Swissmedic:

  • So far unknown adverse events if product safety measures or further investigations for such measures are necessary.

  • Accumulation of known or so far unknown adverse events, including serious abuse and serious intoxications.

  • Quality defects if batches are affected that were put on the Swiss market.

Additional guidance on pharmacovigilance is given by publications of Swissmedic and notably ICH efficacy guidelines.

Other conditions

Marketing authorisation is revoked if a medicinal product is not actually placed on the market within three years of marketing authorisation or if the product is, after placing it on the market, not actually marketed for three consecutive years (with some exceptions).

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

Simplified procedure

The LTP and related ordinances offer simplified procedures for the marketing authorisation of certain medicinal products, including:

  • Generics.

  • Drugs with active substances that have already been registered.

  • Orphan drugs.

  • Drugs which are manufactured in a hospital pharmacy or a hospital internal radiopharmaceutical establishment for the needs of the hospital.

  • Complementary and herbal medicinal products.

  • Drugs containing certain allergens.

  • Radiopharmaceuticals and antidotes.

The procedure is mainly regulated by the:

  • Ordinance on the Simplified Marketing Authorisation of Medicinal Products and the Marketing Authorisation of Medicinal Products by Notification of 22 June 2006.

  • Ordinance on Simplified Marketing Authorisation of Complementary and Herbal Medicinal Products of 22 June 2006.

  • Ordinance on Simplified Marketing Authorisation of Medicinal Products containing Allergens of 11 December 2009.

The ordinances in particular specify the conditions the products and the application respectively must meet and which documents need to be submitted. With regard to medicinal products containing active substances that have already been authorised, it is under certain circumstances possible for applicants to rely on data of a product already authorised by Swissmedic and/or on literature. The documents which have to be submitted with the application are specified in the Ordinance on the Simplified Marketing Authorisation of Medicinal Products and Authorisation by Way of Notification.

Fast track procedure

The fast track procedure is more expensive (increase of 50% of the fee). It is available on the applicant's request and enables registration to be completed within about four months if both:

  • There is no treatment or no satisfactory treatment against a perilous or heavily disabling disease.

  • The medical preparation is of a high therapeutic benefit.

However, if Swissmedic has queries or requests further information or documents, these time periods do not apply. The fast track procedure must be requested at least three months before the marketing authorisation application is filed.

In addition, an accelerated procedure is available for medicinal products containing a new active substance and for extensions of the indication of such products: against an increase of 100% of the fees deadlines are reduced by 20%.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

For pharmaceutical products, there is no procedure for the automatic recognition of foreign marketing authorisations in Switzerland. Results of tests performed for obtaining marketing authorisation in a country with equivalent medicinal product control must be taken into account in Swiss authorisation proceedings. However, an independent application for marketing authorisation must be made to Swissmedic. Swissmedic has published detailed guidelines in this respect. For medicinal products containing an existing registered substance, Swissmedic generally limits itself to assessing the evaluation reports of the foreign authorities. However, Swissmedic does not assess European Medicines Agency (EMA) or US Food and Drug Administration (FDA) evaluation reports, provided these reports are not contradictory and Swissmedic has no essential concerns about them.

The Swiss-EU Bilateral Agreement on the Mutual Recognition of Conformity Assessments of 21 June 1999 provides for the mutual recognition of GMP inspections and batch certificates, clinical trial results and medical device conformity assessments. Switzerland is also a party to the Pharmaceutical Inspection Convention (PIC), the Pharmaceutical Evaluation Report (PER) Scheme and other international treaties and memoranda of understanding.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Under the LTP, a person or company wishing to make parallel imports can apply to Swissmedic for marketing authorisation using the simplified procedure (see Question 9, Simplified procedure). The following conditions must be met:

  • The product must originate from a country with an authorisation system equivalent to that of Switzerland.

  • The product must satisfy the same requirements as products already approved in Switzerland, in particular in relation to labelling and product information.

  • The parallel importer must be able to meet the same safety and quality requirements for the products as the original applicant.

Swissmedic does not consider whether the medicinal products are still patented. The patent owners must monitor the publication of marketing authorisations and defend their patent rights through a civil action.

Switzerland in principle has adopted the regional exhaustion of patent rights system (that is, patent rights are exhausted relating to the parallel imports if products have been put on the market by the patent owner, or with his consent, in Switzerland or the EEA).

If a product has been put on the market by the patent owner, or with his consent, outside Switzerland and the EEA, a patent of subordinate importance to the product's functional properties cannot be used to hinder parallel imports. For example, a patent for a sprayhead could be of subordinate importance if it was possible to reach an equally good spraying effect with a non-patented sprayhead.

As an exception to the principle of regional exhaustion, the patent owner's consent for placing the product on the Swiss market is required if the product price is government fixed in Switzerland and/or in the country where the product has been put into circulation, as is the case for many pharmaceutical products.

Switzerland recognises the principle of international exhaustion in relation to trade marks.

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

The LTP prohibits the offer and acceptance of financial or other advantages to individual medical practitioners or healthcare establishments, except for:

  • Gifts of a modest value, relevant to the professional activity of the recipient (for example, prescription pads or any other article for daily professional use). According to practice, gifts are considered to be of a modest value if their total value is not more than CHF300 per year per healthcare professional. Industry codes, which are based on the EFPIA-Codes, are more restrictive and prohibit any gifts to healthcare professionals, with the following reservations:

    • objects, information and training materials of moderate value, which are also beneficial to patients;

    • writing implements and pads of modest value, which cannot bear any references to the company or to particular medicinal products.

  • Discounts with a direct effect on the product price, which are standard in the relevant field or justified on business administration grounds, including the following:

    • volume discounts;

    • introducing a product to a market (during a certain period);

    • defending a product against generics.

      The exact meaning of such discount has not yet been determined in case law.

In early 2006, Swissmedic issued a publication containing detailed rules on physicians' participation in medical congresses sponsored by the industry.

According to the Health Insurance Act, if a medical professional receives a discount on medicinal products which are reimbursable, he must pass the reduction on to the patient or insurer that pays for the product. The LTP contains penalties for breaches of the ban on granting prohibited discounts and the Federal Health Insurance Act contains penalties for not passing on discounts received.

Penal provisions on bribery of the Swiss Criminal Law and the Federal Act against Unfair Competition may also apply. There is little case law in this area.

The above provisions are in principle intended to apply to practices performed or having an effect in Switzerland.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

Medicinal products can only be sold by a person or institution in possession of a licence to dispense such products. Prescription-only products can only be sold if the patient has a corresponding prescription. The products are categorised. Some categories of products can only be sold by pharmacists (and, depending on the cantonal law, doctors and possibly other professionals). Other categories can also be sold by chemists.

The LTP generally bans mail order distribution. This applies to all forms of orders at distance (order in writing, by e-mail or over the internet). However, the cantons can grant exceptions through authorisations to operate a mail order pharmacy. To obtain an authorisation for mail order distribution, the following conditions must be met in particular:

  • The applicant must own a cantonal retailing licence.

  • The applicant must give guarantees of:

    • proper advice to patients;

    • adequate medical monitoring of the effects of the drug; and

    • adequate safety measures addressing the specific risks of mail order distribution.

  • The patient must supply a doctor's prescription with any order, whether it is a prescription or non-prescription drug.

The advertising rules apply to advertising of drugs through the internet and e-mail (see Question 16).

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The advertising of medicinal products is regulated by the:

  • LTP.

  • Ordinance on Advertising for Medicinal Products.

  • Article 65 and 68 of the Ordinance on Health Insurance.

  • Federal Act against Unfair Competition.

  • Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code), which:

    • is operated by scienceindustries (the Swiss professional association of the chemical, pharma and biotech industries);

    • applies to advertising to professionals (including doctors, dentists and chemists).

Swissmedic supervises advertising and enforces the advertising rules for advertising to professionals and to the public using governmental powers. In practice, the Secretariat of the Pharma Code supervises and enforces the advertising provisions of the Pharma Code in relation to advertising to professionals. If a company does not comply with or refuses to follow the ruling of the Pharma Code Secretariat, the Pharma Code Secretariat will, if it considers the violation of the Pharma Code a possible health risk, transmit the matter to Swissmedic for evaluation and further procedures.

Restrictions

Advertising to professionals is allowed for all medicinal products registered in Switzerland. Advertising to the general public is only allowed for non-prescription drugs which are not listed on the SL.

Advertising to professionals and to the general public must not:

  • Be misleading.

  • Be inaccurate or unethical.

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

  • Refer to off-label use or products not authorised for marketing in Switzerland.

The relevant regulations contain detailed rules about advertising elements that are not allowed, particularly in relation to public adverts.

Adverts on radio, television and in the cinema concerning some categories of OTC products must be submitted to Swissmedic in advance for approval. The same applies to public adverts in a printed form for analgesics, sedatives, sleeping tablets, laxatives and anorectics if a potential risk of abuse or addiction is mentioned in the product information of the medicinal product in question.

Internet advertising

Swissmedic issued a communication in 2006 about internet advertising. In its communication, Swissmedic requires access to advertising for prescription-only medicinal products to be limited to healthcare professionals through password protection. In a decision of 24 April 2009, the Federal Administrative Court confirmed that this requirement is lawful. This has not been appealed to the Federal Supreme Court. This requirement should also be observed for advertising of reimbursable products.

Swissmedic requires the advertising for OTC products on the internet to conform to the general advertising rules. Swissmedic also explains which links and types of domain names it considers admissible. In 2009, Swissmedic published a further communication concerning information about the marketing authorisation holder in advertising to the general public. In this communication, it outlines the:

  • Kind of information that must be supplied about the marketing authorisation holder (for example, fax and phone numbers, e-mail addresses, logos, slogans and websites).

  • Conditions to be followed so that advertising does not constitute an unlawful invitation to the public to contact the marketing authorisation holder.

Swissmedic considers advertising in social media unlawful if the user can like, comment and/or forward the advert.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

Under Article 3 let. c of the Swiss Data Protection Act (DPA), data on health is considered sensitive personal data. Further, a collection of data that permits an assessment of essential characteristics of the personality of a natural person is considered a personality profile under Article 3 let. d DPA.

Both sensitive personal data and personality profiles are subject to specific protective measures under the DPA. For example:

  • Consent must be given expressly in the case of processing of sensitive personal data or personality profiles (Article 4, DPA).

  • There is a duty for private persons (individuals and private entities) to declare data collections with the Swiss Data Protection Officer (DPO) and a duty to provide information on the collection of sensitive personal data and personality profiles (Article 14, DPA).

Federal bodies can only process sensitive personal data and personality profiles if a formal enactment expressly provides for it or if, by way of exception any of the following applies (Article 17, DPA):

  • Such processing is essential for a task clearly defined in a formal act.

  • The Federal Council authorises processing in an individual case because the rights of the data subject are not endangered.

  • The data subject has given his consent in an individual case or made his data generally accessible and has not expressly prohibited its processing.

Hospitals are mostly subject to cantonal data protection laws, some of which are stricter or contain more precise rules than federal data protection law.

The above principles must be complied with also in the context of clinical trials, pharmacovigilance, adverse event reporting and processing of sensitive patient data.

Various laws relevant for pharmaceuticals contain additional specific regulations touching on data processing, like the LTP, the Ordinance on Pharmaceuticals, the Human Research Act or the Health Insurance Act.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

The packaging and labelling requirements are set out in detail in the Ordinance on Marketing Authorisations. There are also some relevant provisions in various other ordinances such as the:

  • Ordinance on Simplified Marketing Authorisation of Medicinal Products and the Marketing Authorisation of Medicinal Products by Notification.

  • Ordinance on Simplified Marketing Authorisation for Complementary and Herbal Medicinal Products.

Swissmedic has published guidelines and explanatory notes on the SPC and patient information.

Information requirements

Packaging intended for the patient must generally contain the following information:

  • Designation of the product, if necessary, stating the dose and dosage form.

  • Contents of the individual pack.

  • Name, type and quantity of the active substances.

  • Name and domicile of the marketing authorisation holder as recorded in the Commercial Registry.

  • Batch number.

  • Necessary medical instructions for using the product.

  • The calendar expiry date (not coded), storage instructions, and if needed, the time within which the product must be used after it is opened.

  • The marketing authorisation number.

  • The child warning notice and invitation to read the packaging leaflet/patient information.

Swissmedic can grant exceptions for bullet points three, four, six, seven, eight and nine above if, for technical reasons, it is not possible to mention all the details on the container. However, in this case it is compulsory to sell the container in external packaging (such as a folded box), which contains all the information listed above. If the container is sold in such external packaging, there is no need to mention the marketing authorisation number on the (internal) container.

If there is a risk of confusion that could lead to severe consequences, Swissmedic can order appropriate measures like the use of "tall man letters".

Special rules apply to packaging that contains a quantity of products for the treatment of several patients and to packaging used for free product samples.

The marketing authorisation holder must provide product information for members of the medical profession. The product information is published in the online directory managed by Swissmedic (at www.swissmedicinfo.ch).

Patients must also be provided with patient information, usually in the form of leaflets inside packaging. Information provided to medical professionals and patients must be approved by Swissmedic.

Other conditions

The product information must be written in the official Swiss languages of German, French and Italian.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

Swissmedic is competent for the surveillance of the safety of medicinal products. For this purpose it collects pharmacovigilance notifications, analyses them and takes appropriate measures. Swissmedic and the Cantons are entitled to require necessary information, documents and support. If required and appropriate, Swissmedic can order administrative measures. Measures include adaptations of the product information of a medicinal product, warning letters or product recalls. Most often, the measures are agreed between the company concerned and Swissmedic.

These measures prevent health risks and thereby reduce the potential for product liability. In spite of such measures, the manufacturer of a defective product may still be liable based on the Federal Act on Product Liability of 1993 (Product Liability Act) or general tort and contract law in case a defective product has caused damage (see Question 21).

 
20. Are there any mandatory requirements relating to medicinal product safety?

For the pharmacovigilance and quality defect notification requirements, see Question 10.

The law requires that all information on adverse events and quality defects that needs to be notified to Swissmedic has to be collected by the marketing authorisation holder or the manufacturer and must be evaluated without delay, and that the necessary measures for risk reduction must be taken. An important means are letters to healthcare professionals (Direct Healthcare Professional Communications, DHPC) describing safety signals. DHPC are also published on the website of Swissmedic. The marketing authorisation holder or the manufacturer has to appoint a responsible person for pharmacovigilance.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

There are no special rules relating to product liability for pharmaceutical products. Under the Product Liability Act, which is based on Directive 85/374/EEC on liability for defective products, a producer is liable if a defective product leads to the death or injury of a person, or damage to, or destruction of, property for private use. In addition, standard rules of contract, tort and criminal law (concerning death and physical injury) can apply if a product is defective.

Substantive test

A product is deemed to be defective if, at the time it is marketed, it does not offer the safety that can justifiably be expected of it, taking into account all circumstances. Special consideration must be given to the:

  • Ratio between benefit and risk.

  • Method and manner used to present the product (product information).

  • Use of the product that can be reasonably expected.

  • Point in time the product was placed on the market.

The subsequent launch of an improved product on the market does not in itself make an older product defective.

In 2015 the Federal Supreme Court decided a rather prominent case regarding the contraceptive Yasmin. The plaintiff claimed that she had suffered a pulmonary embolism because of Yasmin and that the drug was a defective product, as the patient leaflet did not contain sufficient information on the risks of the active substance. The Federal Supreme Court based its decision on the general legal rules on product liability. The court ruled that in case of prescription drugs for the question whether the product offers the safety that can justifiably be expected, only the expectations of the healthcare professional are relevant as the patient lacks the necessary expertise. The fact that drugs may have undesirable side-effects does not render them defective, if the product information for healthcare professionals contains corresponding information. According to the Federal Supreme Court, the (limited) information in the patient leaflet was not relevant. The court ruled that the marketing authorisation holder was not liable in this case.

 
22. Who is potentially liable for defective medicinal products?

Under the Product Liability Act, the producer is liable for a defective medicinal product. The following are deemed to be producers:

  • The manufacturer (in whole or in part) of the defective product.

  • Any person who applies its name or trade mark to the product.

  • Any person who imports the product for commercial distribution.

  • The person who supplied the product, if the producer in the sense of the above three bullet points cannot be identified.

 
23. What defences are available to product liability claims?

The producer is not liable for a defective product under the Product Liability Act if it proves any of the following:

  • It did not market the product.

  • The product was not defective when it was put into circulation.

  • It did not manufacture the product for a business purpose or within the framework of its professional activity.

  • The defect is attributable to compliance with binding, official regulations. Apart from that, there is generally no regulatory compliance defence.

  • The error was not identifiable on the basis of scientific and technological knowledge at the time the product was put into circulation (development risk).

  • It produced base material or part of the product only and the defect was caused by the construction of the product, in which the base material or part was incorporated, or by the instruction given by the producer of that product.

 
24. How can a product liability claim be brought?

A product liability claim is a civil law claim that needs to be brought in front of the competent civil court.

Limitation periods

The limitation period for claims under the Product Liability Act is three years from the date on which the injured party learns of the damage, liability and identity of the liable party. A claim is barred after ten years from the date on which the product was put into circulation.

Class actions

Class actions are not possible in Switzerland. Several claimants can ask that their respective claims be joined and the proceedings conducted together, but the claims remain separate from each other and are judged separately.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

The remedies under the Product Liability Act are compensation for personal damages and for damages to goods for private use. Based on tort law, financial compensation for severe pain and suffering is possible. Punitive damages are not awarded in Switzerland.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

A revision of the LTP covering several areas of the law has been decided by parliament. It aims to facilitate the marketing authorisation process in particular for complementary and herbal medicinal products and products for children, to improve safety and transparency of product information and clarify certain disputed provisions. The Act is estimated to come into force in 2019.

In October 2011 Switzerland signed the convention drafted by the Council of Europe on counterfeiting of medical products (MEDICRIME). The federal administration is preparing the legal amendments necessary for the ratification.

The protection of the Switzerland indication of source and the Swiss national cross will be strengthened. The revision of the Trade Mark Act contains more precise regulations relating to the geographical source of a product or service. It defines the criteria for natural products, processed natural products, industrial goods and services to be labelled as Swiss. The revision of the Federal Act on the Protection of Coats of Arms and Other Public Insignia allows, for the first time, the Swiss cross to be used on Swiss products. The Swiss cross is currently only permitted for Swiss services. The Swiss Coat of Arms will remain principally reserved for the state. The implementing regulations for the revisions are currently being prepared. The revisions are planned to come into force in 2017.

 

Online resources

Swiss Federation

W www.admin.ch/gov/de/start/bundesrecht/systematische-sammlung.html

Description. Official site of the Swiss Federation providing comprehensive Swiss legislation, up-to-date, translation of certain pieces of legislation for guidance only.

Swissmedic

W www.swissmedic.ch

Description. Official site of the Swiss Agency for Therapeutic Products, Swissmedic, providing information, forms, guidelines and comments by Swissmedic, up-to-date, translations of certain documents for guidance only.

Swiss Federal Office of Public Health

W www.bag.admin.ch

Description. Official site of the FOPH providing information on social health insurance, pricing and reimbursement, up-to-date, translation of certain documents for guidance only.

Swissethics

W www.swissethics.ch Description. Official site of Swissethics, the Swiss Ethics Committees' Association, providing templates and recommendations for clinical trials, with up-to-date, English documents available.



Contributor profiles

Frank Scherrer

Wenger & Vieli AG

T +41 58 958 58 58
F +41 58 958 59 59
E f.scherrer@wengervieli.ch
W www.wengervieli.ch

Professional qualifications. Licence en droit, University of Neuchâtel, Switzerland, 1991; LL.M. in European Legal Studies, University of Exeter, UK, 1993; Dr.iur., University of Zurich, Switzerland, 1996; admitted to the Bar in Switzerland, 1999

Areas of practice. Pharmaceutical and health law; contract law; unfair competition and cartel law; advertising law; product liability law.

Recent transactions

  • Advising and representing pharmaceutical companies on a regular basis regarding marketing authorisation and reimbursement, contracts, advertising, sponsoring and gifts, clinical trials and data protection.
  • Representing pharmaceutical companies in appeal proceedings regarding price decreases and revisions of marketing authorisations.
  • Advising and representing pharmaceutical companies in disputes concerning contracts, product liability and unfair competition.
  • Advising pharmaceutical companies concerning outsourcing.

Languages. German, English, French

Caroline Müller Tremonte

Wenger & Vieli AG

T +41 58 958 58 58
F +41 58 958 59 59
E c.mueller@wengervieli.ch
W www.wengervieli.ch

Professional qualifications. Lic.iur., University of Zurich, Switzerland, 2004; admitted to the Bar in Switzerland, 2008; LL.M. International Business Law, National University of Singapore, 2012

Areas of practice. Pharmaceutical and health law; life sciences; data protection law; product liability law; unfair competition and cartel law; employment law.

Recent transactions

  • Advising pharmaceutical companies on a regular basis regarding contracts, advertising, sponsoring and gifts, and data protection.
  • Performing the legal review for the advertising and PR material of a multinational pharmaceutical company concerning Switzerland.
  • Advising and representing pharmaceutical companies in legal proceedings concerning product liability and regarding marketing authorisations.
  • Advising and representing pharmaceutical companies in appeal proceedings regarding price decreases and revisions of marketing authorisations.

Languages. German, English

Claudia Keller

Wenger & Vieli AG

T +41 58 958 58 58
F +41 58 958 59 59
E c.keller@wengervieli.ch
W www.wengervieli.ch

Professional qualifications. Lic.iur., University of Basel, Switzerland, 2001; LL.M. at University of Hastings, College of the Law, San Francisco, 2004, admitted to the Bar in Switzerland, 2006; CAS Brand Management (HSLU) 2007; Social Media Management (Somexcloud), 2011.

Areas of practice. Intellectual property law; advertising law; media law; life sciences; data protection law; product safety and liability law; unfair competition.

Recent transactions

  • Advising companies on a regular basis regarding intellectual property law, in particular trademark and copyright law including licensing contracts, advertising.
  • Advising companies on advertising regulation and data protection.
  • Advising and representing companies in legal proceedings concerning product safety and product safety compliance.

Languages. German, English

Caspar Humm, Associate

Wenger & Vieli AG

T +41 58 958 58 58
F +41 58 958 59 59
E c.humm@wengervieli.ch
W www.wengervieli.ch

Professional qualifications. Lic.iur., University of Zurich, Switzerland, 2009; admitted to the Bar in Switzerland, 2014.

Areas of practice. Pharmaceutical and health law; life sciences; product liability law; corporate and commercial law; information technology and data protection law; intellectual property law; unfair competition law; litigation.

Recent transactions

  • Advising pharmaceutical companies and manufacturers of medical devises regarding contracts, co-operation with other stakeholders in the health sector, clinical trials and data protection on a regular basis.
  • Advising and representing pharmaceutical and other companies in legal proceedings concerning product liability.
  • Advising and representing pharmaceutical companies in appeal proceedings regarding price decreases and revisions of marketing authorisations.

Languages. German, English


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