Distribution and marketing of drugs in Switzerland: overview

A Q&A guide to distribution and marketing of drugs law in Switzerland.

The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.

To compare answers across multiple jurisdictions, vist the Distribution and Marketing of Drugs Country Q&A Tool.

This Q&A is part of the global guide to Distribution and Marketing of Drugs.

Contents

Distribution

Pre-conditions for distribution

1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

Distribution of drugs in Switzerland is almost exclusively regulated at the federal level, primarily by Articles 23 to 30 of the Therapeutic Products Act (HMG).

The distribution of a drug in Switzerland (irrespective of whether the drug requires a prescription or can be sold over the counter) requires a marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) (Article 9, HMG).

This marketing authorisation is issued if the applicant can prove (Article 10, HMG):

  • That the drug or the process is of high quality, safe and effective.

  • That it has a licence for manufacture, import or wholesale trade.

  • That its registered address or office is in Switzerland or that it has set up a subsidiary in Switzerland.

The marketing authorisation is valid for five years but can be renewed as long as the conditions for issuing the marketing authorisation are met (Article 16, HMG).

Exceptions

Besides the ordinary licence procedure, the law provides for a simplified licence procedure (Article 14, HMG). In particular, for generic and orphan drugs, the simplified application procedure applies if this is compatible with the quality, safety and efficacy requirements provided for by the law (Article 14, HMG).

 
2. Do any types of named patient and/or compassionate use programmes operate? If so, what are the requirements for pre-launch access?

The Swiss Agency for Therapeutic Products (Swissmedic) can authorise, for a limited period, the distribution or dispensing of unauthorised drugs to treat life-threatening diseases if (Article 9, Therapeutic Products Act (HMG)):

  • This authorisation is compatible with the protection of health.

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

  • No comparable other drug exists.

Licensing

3. What is the procedural structure regarding licensing a drug for distribution?

Structure

The distribution of a drug requires an application with the Swiss Agency for Therapeutic Products (Swissmedic) for a marketing authorisation for the drug to be distributed in Switzerland. The application for a marketing authorisation must contain all of the data and documents necessary for its assessment. In particular, the following information has to be provided (Article 11, Therapeutic Products Act (HMG)):

  • The name of the drug.

  • The name of the manufacturer and the distribution company.

  • The process of manufacture, the composition, the quality and stability of the drug.

  • The therapeutic effects and undesirable effects.

  • The labelling, the medical information (patient information as well as information for professionals), the method of supply and the method of administration.

  • The results of physical, chemical, galenic and biological or microbiological tests, the results of the pharmacological and toxicological tests.

  • The results of the clinical trials.

Under certain conditions, test and trial results are not required for an application regarding generic drugs (Article 12, HMG).

Following the submission of the required documents, the application is examined by Swissmedic that decides whether the marketing authorisation is to be issued or not based on the quality of the manufacturing, the drug's efficacy and its safety (Article 16, HMG). The entire authorisation procedure (ordinary licence procedure) takes between ten and 12 months or between four and five months if the expedited procedure is chosen by the applicant.

Regulatory authority

Swissmedic is responsible for issuing the marketing authorisation.

 
4. Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction?

Swiss law provides for a simplified licence procedure for certain kinds of drugs, including (Article 14, Therapeutic Products Act (HMG)):

  • Generic drugs.

  • Orphan drugs.

  • Authorisation of an additional distributor to market drugs already licensed for marketing in Switzerland, but imported from another country (parallel imports).

The simplified licence procedure is applicable for parallel imports, if the following conditions are fulfilled:

  • The drug must be imported from a country with a marketing authorisation system equivalent to the one in Switzerland.

  • The drug must satisfy the same requirements as the drug already approved in Switzerland, in particular for the labelling and product information.

  • The parallel importer can guarantee the same safety and quality requirements as the original applicant.

Possible patent claims are not considered in the licence procedure. However, patent owners can use civil actions for defending their patent rights.

If a drug is not yet licensed for marketing in Switzerland, but has been licensed in another country with a similar marketing authorisation system, the Swiss Agency for Therapeutic Products (Swissmedic) takes the results of the respective tests into account (Article 13, HMG).

 
5. Is virtual drug distribution possible from your jurisdiction?

It is possible to distribute drugs virtually from Switzerland. However, trading these drugs in foreign countries from Switzerland, without the drugs entering Switzerland, requires a licence from the Swiss Agency for Therapeutic Products (Swissmedic) (Article 18, Therapeutic Products Act (HMG)). This licence is issued if:

  • The necessary professional and operational conditions are fulfilled.

  • An appropriate system of quality assurance exists.

 
6. What is the procedure to appeal (legal remedy) a licensing decision?

If the Swiss Agency for Therapeutic Products (Swissmedic) rejects an application, the applicant can appeal to the Federal Administrative Tribunal, whose decisions can finally be appealed at the Federal Supreme Court.

 
7. What are the costs of obtaining licensing?

The fees for a licence depend on the licensing procedure:

  • The fees for licensing a drug with a new active substance are CHF70,000 or CHF110,000 if the expedited procedure is used.

  • The fees for licensing a drug with an existing registered active substance are between CHF15,000 and CHF28,000 (depending on whether there is an inventive step) if using the simplified licence procedure and between CHF27,500 and CHF47,000 if the expedited procedure is used.

  • For renewing an existing authorisation the fees are CHF500.

Distribution to consumers

8. What are the different categories of drugs for distribution?

The law differentiates between two categories of drugs:

  • Prescription drugs.

  • Non-prescription drugs.

These two categories of drugs have been further divided into five sub-categories (categories A to E) depending on the degree of perceived risk represented by the product. Each drug is classified in the authorisation process by the Swiss Agency for Therapeutic Products (Swissmedic):

  • Category A drugs are subject to a more stringent prescription requirement that means that a medical prescription only allows for a one-time supply of the prescribed drug.

  • Category B drugs are subject to a prescription that allows for a repeated supply of the prescribed drug.

  • Category C drugs do not need a prescription but can only be supplied after the advice of a medical person has been obtained.

  • For category D drugs no prescription is necessary. However, category D drugs can only be supplied after expert advice has been obtained.

  • Category E drugs can be supplied without any restrictions.

 
9. Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers?

Prescription drugs

Pharmacists can distribute prescription-only drugs on prescription of a physician but also in justified exceptional cases (for example, in case of an emergency) without prescription. The distribution of prescription drugs to patients requires an authorisation that is issued by the cantonal authorities and not by the Swiss Agency for Therapeutic Products (Swissmedic).

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, 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 either by 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.

Over-the-counter drugs

Everyone that is entitled to distribute prescription drugs to patients can also distribute over-the-counter (OTC) drugs. Therefore, pharmacists as well as physicians can distribute OTC drugs to consumers, if cantonal law permits.

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

 
10. What drugs can an attending physician distribute and under what circumstances?

Generally, a physician can prescribe any drug provided that he observes the recognised rules of pharmaceutical and medical science and does not endanger the health of the patient. A drug can only be prescribed if the state of the health of the patient is known.

However, distribution of drugs by the physician to patients directly depends on whether the canton of the physician's domicile allows self-distribution of drugs by physicians (see Question 9).

 
11. Who is authorised to prescribe prescription drugs to consumers?

Prescription drugs can only be prescribed by physicians.

 
12. Is direct mailing/distance selling of drugs permitted in your jurisdiction?

Conditions

In principle, direct mailing or distance selling of drugs is not permitted, except for drugs of category E. However, for all other drugs (categories A to D) the cantons can issue an authorisation for direct mailing or distance selling if all of the following requirements are met (Article 27, Therapeutic Products Act (HMG)):

  • The drug has been prescribed by a physician.

  • No safety requirements prohibit direct mailing.

  • Appropriate consultation with a physician is guaranteed.

  • Sufficient medical supervision of the effect of the drug is guaranteed.

The issuing of the authorisation for direct mailing or distance selling of drugs requires a cantonal retail trade licence for the operation of a pharmacy as well as the implementation of a quality assurance system. These requirements also apply to the distribution of drugs over the internet.

Cross-border sales

Sales can be made beyond the borders of Switzerland. However, the export of drugs requires a licence from the Swiss Agency for Therapeutic Products (Swissmedic) (Article 18, Therapeutic Products Act (HMG)). This licence is issued if:

  • The necessary professional and operational conditions are fulfilled.

  • An appropriate system of quality assurance exists.

However, the export of drugs and their foreign trade from Switzerland is prohibited if either:

  • The drugs are prohibited in the destination country.

  • Or if circumstances suggest that the drugs could be intended for an illegal purpose.

Anyone exporting drugs (pre-packaged or not) must provide the recipient with the appropriate basic medical and pharmaceutical information.

 
13. What regulatory authority is responsible for supervising distribution activities?

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

Swissmedic and the cantonal authorities can perform any necessary investigation into a specific incident and the parties involved must fully co-operate in this investigation. In particular, Swissmedic or the cantonal authorities can:

  • Take samples.

  • Demand information and essential documents.

  • Request any necessary help for this purpose.

Swissmedic, or in case of a serious and immediate threat to health the cantonal authorities, takes all necessary administrative measures to remedy a breach.

 
14. What is the procedure to appeal (legal remedy) a distribution decision?

Orders of the Swiss Agency for Therapeutic Products (Swissmedic) can be appealed to the Federal Administrative Tribunal and finally to the Federal Supreme Court. Criminal prosecution falls either within the competence of Swissmedic or in the competence of the cantonal authorities. In both cases, court appeals are possible.

 
15. What are the legal consequences of non-compliance with consumer distribution laws?

If the violation is committed intentionally, the criminal liability is imprisonment of up to three years or a fine of up to CHF200,000. If the responsible person acted in his professional capacity, the punishment is imprisonment for up to five years and a fine of up to CHF500,000. For negligence, the law provides for imprisonment of up to six months or a monetary fine of up to CHF100,000.

Wholesale distribution

16. What is the legal regime regarding wholesale distribution of drugs?

The wholesale of drugs requires a licence (Article 28, Therapeutic Products Act (HMG)). This licence is issued by the Swiss Agency for Therapeutic Products (Swissmedic) if:

  • The necessary professional and operational conditions are fulfilled.

  • An appropriate system of quality assurance exists.

If the applicant is already in possession of a manufacturing or import licence for drugs, it is also eligible for a wholesale licence. The licence cannot be transferred to anyone else or to any other site. It is valid for a period of five years but can be extended. An extension of the licence is granted if the conditions for issuing a licence are still fulfilled. The wholesale of drugs is only permissible for drugs that have a marketing authorisation for Switzerland. As well as the requirements for the issuance of the licence, a company that is engaged in the wholesale trade of drugs must also respect the recognised principles of Good Distribution Practice.

The wholesale of drugs is permitted by anyone in possession of a licence. A licence holder can wholesale drugs to persons that are allowed to trade with, process, distribute or apply drugs.

 
17. What regulatory authority is responsible for supervising wholesale distribution activities?

Regulatory authority

The Swiss Agency for Therapeutic Products (Swissmedic) is responsible for the issuance of the licence for the wholesale distribution of drugs. Depending on the nature of the drug, either Swissmedic or the respective cantonal authorities are responsible for the supervision of wholesale distribution activities.

Supervision

Either Swissmedic or the respective cantonal authority can perform inspections and verify whether the requirements for the issuance of the licence are fulfilled. If the authorities discover any violations, they can take all administrative measures that are necessary in order to re-establish compliance with the law. In particular, the authorities can:

  • Raise objections and fix an appropriate time period for the re-establishment of compliance with the law.

  • Suspend or withdraw establishment licences and marketing authorisations.

  • Close establishments.

  • Seize, hold in official storage or destroy therapeutic products that endanger health or that do not comply with the legal requirements.

Rights of appeal

Orders of Swissmedic can be appealed to the Federal Administrative Tribunal and finally to the Federal Supreme Court. Orders of cantonal authorities can be appealed to the competent cantonal courts and finally to the Federal Supreme Court.

 
18. What are the legal consequences of non-compliance with wholesale distribution laws?

If the violation has been committed intentionally, the criminal liability is imprisonment of up to three years or a monetary fine of up to CHF200,000. If the person responsible acted in his professional capacity, the punishment is imprisonment for up to five years and a monetary fine of up to CHF500,000. For negligence, the law provides for imprisonment of up to six months or a monetary fine of up to CHF100,000.

 

Marketing

Promotion

19. What is the general legal regime for the marketing of drugs?

Legal regime

Marketing of drugs is exclusively regulated at the federal level, primarily by Articles 31 to 33 of the Therapeutic Products Act (HMG), and by the Ordinance on Advertising for Medicinal Products (AWV), which implements and specifies in more detail the statutory requirements of the HMG. These legal texts contain a comprehensive regime regarding marketing of ready-to-use drugs to consumers and to professionals as well as its enforcement by the Swiss Agency for Therapeutic Products (Swissmedic). The regime is applicable to all drugs that are being marketed in Switzerland.

Limits to marketing activities

Generally, prescription drugs can only be marketed to professionals but non-prescription drugs can also be marketed to consumers (Article 31, HMG).

For drugs that are being listed on the Swiss List of Specialities (SL) and that are therefore reimbursed by the mandatory health insurance, additional rules contained in the Health Insurance Act (KVG) and the Ordinance on Health Insurance (KVV) apply. In particular, all marketing to consumers is prohibited for drugs that are reimbursed within this framework. Non-compliance with this prohibition can lead to delisting of the respective drug.

Apart from the above-mentioned drug-specific regimes, the general legal framework regarding advertising is also applicable to marketing of drugs. In particular, the Act Against Unfair Competition (UWG) prohibits any kind of unfair marketing activities such as:

  • False statements.

  • Unnecessary debasement of competitors.

  • Causation of confusion.

  • Aggressive marketing techniques.

The UWG also prohibits bribery of employees, directors or other staff of competitors, suppliers and customers.

 
20. Are there other codes of conduct for the marketing of drugs (for example, by professional or industrial organisations)?

The Code of Conduct of the Pharmaceutical Industry in Switzerland (dated 4 December 2003, last revision of 6 September 2013) (the Pharma Code) has been drafted by five associations of the Swiss pharmaceutical industry and has been signed by around 120 Swiss pharmaceutical companies. The Pharma Code is based on the respective codes of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). It is applicable to marketing activities and financial contributions regarding professionals but not to marketing activities regarding consumers. The Pharma Code also includes rules on the co-operation between pharmaceutical companies and healthcare professionals (and their organisations) on clinical trials and invitations to promotional events.

Based on the EFPIA Disclosure Code of June 2013, the Code of Conduct of the Pharmaceutical Industry in Switzerland on co-operation with Healthcare Professional Circles and Patient Organisations (dated 6 September 2013) (the Pharma Co-operation Code) was drafted by the same associations that drafted the Pharma Code. The Pharma Co-operation Code includes rules on the co-operation between pharmaceutical companies and healthcare professionals, healthcare organisations and patient organisations. It requires disclosure (in accordance with Swiss data protection law) of pecuniary benefits granted by pharmaceutical companies to professionals and such organisations as of 1 January 2016. The Pharma Co-operation Code also specifies the implementation of the relevant obligations by the pharmaceutical companies and how compliance will be monitored. Violations of the Pharma Code or the Pharma Co-operation Code are investigated by a Code Secretariat (affiliated with one of the associations) that can order the member companies to cease non-compliant activities. Non-observance of this order means that the Secretariat brings the case to the Swiss Agency for Therapeutic Products' (Swissmedic) attention if the public health is at risk.

Besides the general rules on (un)fair competition in the Act Against Unfair Competition (UWG), there are the Principles for the Fair Competition in Commercial Communication (dated April 2008), which the Swiss Commission on Fair Competition has defined. According to Principle 2.4, healthcare professionals cannot be used in advertisements that refer to products that relate to health but that are not subject to governmental approval if such use is intended to make the product look like a drug.

In addition, based on Principle 5.7, marketing of products relating to personal care, hygiene and wellbeing cannot give the impression that such products actually have medical effects. The Commission on Fair Competition decides on complaints about violations of the principles, but it has no power to give binding orders.

Marketing to consumers

21. What is the legal regime for marketing to consumers?

Only non-prescription drugs can be marketed directly to consumers (DTC), that is categories C, D, and E (Article 31, Therapeutic Products Act (HMG) and Article 14, Ordinance on Advertising for Medicinal Products (AWV)). Additionally, advertising of non-prescription drugs to consumers is prohibited if such drugs either:

  • Contain narcotic or psychotropic substances.

  • Or if they cannot, because of their composition and intended use, be used without the intervention of a physician for the relevant diagnosis, prescription or treatment.

  • Or if the drugs are frequently the object of abuse or if they lead to addiction or dependence (Article 32, HMG).

It is also prohibited to advertise drugs that are reimbursed by mandatory health insurance (Article 65, Ordinance on Health Insurance (KVV)).

 
22. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them?

Generally, all marketing activities must comply with the basic requirements of Article 32 of the Therapeutic Products Act (HMG). This means that advertising cannot be misleading or contrary to public order and morality and it cannot incite excessive, abusive or inappropriate use of drugs.

The following is a non-exhaustive list of permitted advertising methods that can be done directly to consumers (DTC) (Article 15, Ordinance on Advertising for Medicinal Products (AWV)):

  • Advertisements in newspapers, magazines, books.

  • Advertising on objects.

  • Advertising by audiovisual means including the internet.

  • Advertising statements made during home visits and presentations.

  • Advertising statements in physicians’ practices and pharmacies.

  • Provision of samples.

The ordinance also defines advertising that is prohibited (Articles 21 and 22, AWV). In particular, the following are prohibited marketing practices:

  • Advertising for indications or possible uses that require a diagnosis or treatment by a physician.

  • Acceptance of orders for drugs during home visits, exhibitions, presentations, or promotional excursions.

  • Individually addressed direct mailing.

  • Provision of drugs for sales promotion purposes.

  • Provision of vouchers for drugs.

  • The organisation of competitions.

  • Marketing that only or mainly targets children and adolescents.

However, some of these restrictions do not apply to drugs of category E.

 
23. Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers (for example, "buy-one-get-one-free")?

Drug samples given to the public must be clearly and permanently labelled as "free samples". These samples cannot contain more than one recommended daily dose and cannot be sold (Article 19, Ordinance on Advertising for Medicinal Products (AWV)). Samples of drugs of categories C and D can only be supplied to the public by the persons authorised to distribute these products to consumers. Regular packs of drugs cannot be given away as samples.

 
24. Are there particular rules of practice on the use of the internet/social media regarding drugs and their advertising?

While advertising for drugs of categories C and D on radio, television, and in cinemas must be submitted to the Swiss Agency for Therapeutic Products (Swissmedic) for approval before appearing (Article 23, Ordinance on Advertising for Medicinal Products (AWV)), no such preliminary control procedure is required for marketing activities on the internet. The mandatory warnings that must be included at the end of television and cinema commercials, (for example, "This is a medicinal product. Please take advice from a health professional and read the patient information."), do not apply to advertisements on the internet.

 
25. What regulatory authority is responsible for supervising marketing activities to consumers?

Regulatory authority

The Swiss Agency for Therapeutic Products (Swissmedic) is responsible for implementing and supervising compliance with the legal requirements in relation to marketing of drugs to consumers.

Supervision

Advertising for drugs of categories C and D on radio, television and in cinemas must be submitted to Swissmedic for approval prior to appearing (Article 23, Ordinance on Advertising for Medicinal Products (AWV)). The same applies to advertisements in print and audiovisual media for analgesics, soporifics and sedatives, laxatives and anorectics. In all other cases, there are no preliminary control procedures, but rather ex-post control procedures based on information that Swissmedic has gathered itself or that it has received from third parties (Article 24, AWV). The holder of the marketing authorisation must designate a person that is responsible for the advertising of the drugs that are placed on the market (Article 25, AWV).

Rights of appeal

Decisions of Swissmedic can be appealed before the Federal Administrative Tribunal whose judgments can then be appealed (if certain conditions are met) before the Federal Supreme Court.

 
26. What are the legal consequences of non-compliance with consumer marketing laws?

Persons that have wilfully violated the provisions regarding advertising of drugs can be punished by detention or a fine of up to CHF50,000 (Article 87, Therapeutic Products Act (HMG)). Contraventions in a professional capacity can be punished by imprisonment of up to six months and a fine of up to CHF100,000. Negligent contraventions can be punished by a fine of up to CHF10,000.

The Swiss Agency for Therapeutic Products (Swissmedic) can also take all administrative measures necessary to re-establish compliance with the law (Article 66, HMG). In particular, Swissmedic can seize, hold in official storage, destroy or prohibit the use of non-compliant advertising media and publish the prohibition at the expense of the responsible parties.

Swissmedic can oblige authorisation holders that have violated the provisions regarding advertising of drugs either repeatedly or to a serious extent to then submit all planned advertising for prior approval.

Marketing to professionals

27. What kinds of marketing activities are permitted in relation to professionals?

Generally, all marketing activities must comply with the basic requirements that advertising cannot be misleading or contrary to public order and morality and it cannot incite excessive, abusive or inappropriate use of drugs (Article 32, Therapeutic Products Act (HMG)).

The following is a non-exhaustive list of advertising methods (Article 4, Ordinance on Advertising for Medicinal Products (AWV)):

  • Advertisements in newspapers, magazines and books.

  • Advertising on objects.

  • Advertising by audiovisual means including the internet.

  • Advertising within the framework of scientific conferences or promotional events.

  • The organisation of promotional events and financial support for such events.

  • Hospitality provided within the framework of scientific conferences and promotional events.

  • Advertising by mail.

  • Visits by medical sales representatives.

  • Provision of samples.

 
28. Are there any restrictions on marketing to professionals?

Marketing activities

According to section 141 in connection with section 47 of the Code of Conduct of the Pharmaceutical Industry in Switzerland (dated 4 December 2003, last revision of 6 September 2013) (the Pharma Code), non-interventional studies cannot constitute an inducement to recommend, prescribe, purchase, supply, sell or administer a particular drug. The company's medical representatives can only collaborate in non-interventional studies under the supervision of the scientific service of the company and for administrative purposes. Their collaboration cannot be associated with a promotion for drugs.

Frequency

The authorisation holder must ensure that medical sales representatives are adequately trained and have sufficient knowledge to provide all the necessary information (Article 12, Ordinance on Advertising for Medicinal Products (AWV)). The representatives have to use scientific literature and the latest product information approved by the Swiss Agency for Therapeutic Products (Swissmedic) as the basis for any statements. There are no restrictions regarding areas such as the time, frequency and place of the visits. However, the professional cannot be paid for receiving sales representatives.

Provision of hospitality

It is prohibited to grant, offer or promise material benefits to persons that prescribe or dispense drugs or to the organisations that employ them (and for such persons to accept or solicit such material benefits) (Article 33, Therapeutic Products Act (HMG)). However, material benefits of modest value and that are related to medical or pharmaceutical practice are allowed.

Hospitality provided within the framework of scientific conferences or promotional events must remain reasonable and remain secondary in relation to the main purpose of the event. Additionally, third parties (such as spouses) cannot be included in hospitality (Article 11, AWV).

The Pharma Code, the Code of Conduct of the Pharmaceutical Industry in Switzerland on co-operation with Healthcare Professional Circles and Patient Organisations (dated 6 September 2013) (the Pharma Co-operation Code) and a guideline published by Swissmedic in 2006 contain detailed additional requirements regarding hospitality.

 
29. What information is it legally required to include in advertising to professionals?

All advertising must contain at least the following information (Article 6, Ordinance on Advertising for Medicinal Products (AWV)):

  • The product name (brand).

  • The active substances with their abbreviation.

  • The name and address of the authorisation holder.

  • At least one indication or possibility for use, plus the dosage and route of administration.

  • A summary of restrictions regarding use, adverse reactions and interactions.

  • The dispensing category.

  • A reference to the fact that more detailed information can be found in the patient information or the published product information, citing the exact source.

All the information in the advertising intended for professionals must comply with the latest product information approved by the Swiss Agency for Therapeutic Products (Swissmedic). In particular, only those indications and possibilities for use that have been approved by Swissmedic can be advertised.

The texts within the advertising must comply with and reflect the current status of scientific knowledge. They can only refer to clinical trials that have been carried out in compliance with the requirements of Good Clinical Trial Practice (GCTP) and whose results have been published or accepted for publication. These publications must be cited faithfully, in full and state the exact source. Advertising intended for professionals must also state that the professionals can request a full copy of the trial report from the company concerned (Article 5, AWV).

 
30. Are there rules on comparisons with other products that are particularly applicable to drugs?

Comparisons with other drugs are only permitted if they are scientifically correct and based on trials that fulfil the requirements of Good Clinical Trial Practice (GCTP) (Article 7, Ordinance on Advertising for Medicinal Products (AWV)).

 
31. What other items, funding or services are permitted to be provided to professionals?

Discounts

It is prohibited to grant, offer or promise material benefits to persons that prescribe or dispense drugs or to the organisations that employ them (and for such persons to accept or solicit such material benefits) (Article 33, Therapeutic Products Act (HMG)). However, commercially and economically justified discounts that directly reduce the price for the consumer or his health insurance are allowed.

Also, the healthcare professional must pass on to the debtor of the compensation all discounts he has received from suppliers of drugs (Article 56, Health Insurance Act (KVG)).

Free samples

Samples can only be supplied in small quantities and on written request by the professional. Samples cannot be larger than the smallest packaging available on the market. The sale of samples is prohibited (Article 10, Ordinance on Advertising for Medicinal Products (AWV)).

Sponsorship of professionals

According to section 141 in connection with section 222 of the Code of Conduct of the Pharmaceutical Industry in Switzerland on co-operation with Healthcare Professional Circles and Patient Organisations (dated 6 September 2013) (the Pharma Co-operation Code), pharmaceutical companies can support institutions, organisations or associations of healthcare professionals either financially or in some other way, in so far as the support:

  • Is restricted to research and other services in the healthcare sector.

  • Is confirmed in writing and the relevant documents are available in the company.

  • Does not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer certain drugs.

However, the financial or other sponsoring of individual healthcare professionals is not allowed.

In addition, section 4 of the Code of Conduct of the Pharmaceutical Industry in Switzerland (dated 4 December 2003, last revision of 6 September 2013) (the Pharma Code) contains detailed requirements regarding the sponsorship of clinical trials. The pharmaceutical companies are required to assure the transparency of the clinical trials sponsored by them.

Companies that sponsor clinical trials must ensure that the most objective trial results will be obtained and that the collaboration between sponsors and investigators is as transparent as possible. This is achieved by avoiding conflicts of interest and financial dependencies.

Other items, funding or services

According to the Pharma Code and the Pharma Co-operation Code, pharmaceutical companies can enter into agreements with institutions, organisations or associations of healthcare professionals, according to which the latter provide certain services to these companies, provided that these services are limited to research and other work in the healthcare sector and do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer certain drugs.

The pharmaceutical companies can also appoint healthcare professionals as consultants, in groups or individually, to undertake services such as providing reports and leading meetings, medical or scientific studies, clinical trials, training, consulting committees and market research. The companies can reimburse them appropriately for the associated expenditure according to the usual standards. The fact that consultants are used for services cannot constitute an inducement to recommend, prescribe, purchase, supply, sell or administer certain drugs. Also, consultancy arrangements allowing healthcare professionals to receive financial remuneration without having a duty to provide a service are explicitly prohibited.

 
32. What regulatory authority is responsible for supervising marketing activities regarding professionals?

See Question 25.

Violations of the Code of Conduct of the Pharmaceutical Industry in Switzerland (dated 4 December 2003, last revision of 6 September 2013) (the Pharma Code) and the Code of Conduct of the Pharmaceutical Industry in Switzerland on co-operation with Healthcare Professional Circles and Patient Organisations (dated 6 September 2013) (the Pharma Co-operation Code) are being investigated by the Secretariat that can order the member companies to re-establish compliance with the Codes. Where there is non-observance of the order, the Secretariat brings the case to the Swiss Agency for Therapeutic Products's (Swissmedic) attention if the public health is at risk.

 
33. What are the legal consequences in case of non-compliance with professional marketing laws?
 

Engagement with patient organisations

34. What kinds of activities are permitted in relation to engagement with patient organisations? What are the restrictions that are imposed on relationship with patient organisations?

Relationships between the pharmaceutical industry and patient organisations are regulated by section 3 of the Code of Conduct of the Pharmaceutical Industry in Switzerland on co-operation with Healthcare Professional Circles and Patient Organisations (dated 6 September 2013) (the Pharma Co-operation Code). According to the applicable rules, the pharmaceutical companies cannot ask patient organisations or accept offers from them to promote certain drugs. Companies cannot ask patient organisations to be their sole company support overall or for individual projects, whether financially or otherwise.

Contracts between companies and patient organisations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research. It is also permitted to engage patient organisations as experts and advisors for services such as participation at advisory board meetings and speaker services. In any event, the compensation for the services must be reasonable and cannot exceed the fair market value of the services provided. All forms of hospitality offered to patient organisations and their representatives must be reasonable, and strictly limited to the purpose of the respective event.

Each pharmaceutical company must publish on a website the patient organisations that it supports financially or otherwise to any significant extent. The disclosure must include a short description of the type of support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The description must indicate the monetary value of financial support and of invoiced costs. The published information has to be updated at least once per year.

Each company must also publish the patient organisations to which it provides significant contracted services. This list must include a description of the nature of the services and be sufficiently complete to enable the average reader to form an understanding of the nature of the arrangement without the necessity to divulge confidential information. Companies must also make public the total amount paid per patient organisation over the reporting period.

 

Reform

35. Are there any plans to reform the law on the distribution and promotion of drugs in your jurisdiction?

The Therapeutic Products Act (HMG) is currently being revised. The main objectives of the revision regarding drugs are the:

  • Simplification of market access for some kinds of drugs.

  • Improved safety of drugs.

  • An increase in the transparency of information.

  • Clarification of controversial regulations.

  • The removal of legislative loopholes.

The changes suggested by the government affect the regulation of material benefits granted by pharmaceutical companies and the distribution of drugs by pharmacies and druggists.

Regarding the material benefits granted by pharmaceutical companies to professionals, the revised draft of the HMG aims to increase the transparency of these benefits and extends the circle of professionals covered by the regime on the one hand. On the other hand, it only covers prescription drugs (categories A and B) in contrast to today's provision that prohibits granting benefits for all drugs. Regarding the categories of drugs for distribution, the draft suggests allowing distribution of some prescription drugs by pharmacies without a physician's prescription. Also, druggists should be allowed to distribute all non-prescription drugs.

The proposed draft of the revised HMG is still under discussion in the Federal Parliament. The revised HMG is planned to enter into force by the end of 2017 at the earliest.

 

Contributor profiles

PD Dr Markus Schott, Partner

Bär & Karrer

T +41 58 261 54 77
F +41 58 263 54 77
E markus.schott@baerkarrer.ch
W www.baerkarrer.ch

Professional qualifications. Switzerland, attorney-at-law

Areas of practice. Life sciences; food law; insurance law; administrative proceedings; governmental supervision; administrative sanctions; public procurement; regulatory law; public law.

Languages. German, English, French


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