Q&A: the promotion and sale of pharmaceuticals and medical devices in Switzerland

Advertising and promotion

Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

Advertising aimed at healthcare professionals is generally allowed for all medicinal products authorised in Switzerland. Advertising must not be misleading, inaccurate, against public policy or unethical, or incite excessive, abusive or inappropriate use of medicinal products. Advertising aimed at healthcare professionals must be in line with the latest product information approved by the Swiss Agency for Therapeutic Products (Swissmedic), the Swiss regulatory agency. Advertising must be accurate, balanced and provable. The claims must be based on and reflect the current state of scientific knowledge. They may only refer to clinical studies conducted in accordance with good clinical practice that are published or accepted for publication, or to meta-analyses or observational studies that are published in a scientifically recognised scientific journal. Publications must be quoted literally, completely and with the exact reference. Advertisements must not indicate that a medicinal product does not have adverse effects or is without risk or harmless; appear to be an editorial; or indicate that a human medicinal product does not lead to dependency. Advertising for prescription-only medicinal products on the internet must be limited to healthcare professionals by means of password protection.

Information about illnesses and treatment options in general is permissible. Advertising for the company as such is also permissible, as is ad hoc publicity of quoted companies. For deciding whether information is illegal product advertising or admissible information, all circumstances of the particular case need to be taken into account. The sole mention of a brand name does not necessarily make information advertising.

Advertising of medical devices and collaboration with patient organisations with regard to medical devices are currently not as rigorously regulated as advertising for medicinal products. The Ordinance on Medical Devices contains one provision on advertising that sets out the following rules (article 69):

• advertising must be limited to statements that correspond to the product information;
• misleading claims, in particular on the intended use, safety and efficacy of a medical device, are prohibited; and
• advertising to the general public is prohibited for medical devices that are exclusively intended for use by healthcare professionals.

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

Mainly, the following regulations discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medical product or medical device:

• the Law on Therapeutic Products, especially article 55, and the Ordinance on Integrity and Transparency in the Field of Therapeutic Products;
• the Ordinance on Advertising for Medicinal Products, especially article 11 on scientific congresses and promotional events;
• the anti-bribery provisions of the Swiss Criminal Code, article 322-ter to 322-decies, and of the Act against Unfair Competition, article 4a;
• the rules governing the employment and function of healthcare professionals;
• the Federal Act on Academic Medicinal Professions;
• the Pharma Code and the Pharma Cooperation Code issued by scienceindustries, and
• the Swiss MedTech Code issued by Swiss MedTech.

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

The Pharma Cooperation Code issued by scienceindustries and the Swiss MedTech Code and the Transparency Guidelines issued by Swiss MedTech require that transfers of value to healthcare professionals and organisations are published on a company website; if possible, on a named basis and, if the healthcare professional or organisation does not consent, in aggregate form. Full details of transfers of value to healthcare professionals and organisations that are in connection with prescription-only medicinal products must further be disclosed to the Federal Office of Public Health upon request.

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

Swissmedic is the authority competent for monitoring and enforcing compliance with the rules for advertising therapeutic products (medicinal products and medical devices) to professionals and to the public. Advertising of medicinal products to professionals is also and mainly supervised by the Secretariat of the Pharma Code based on the advertising provisions of the (self-regulatory) Pharma Code. If a company does not comply with or refuses to follow the ruling of the Pharma Code Secretariat, the Pharma Code Secretariat may, if it considers the violation of the Pharma Code a possible health risk, transmit the matter to Swissmedic.

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

The intentional breach of advertising rules for medicinal products may be sanctioned by Swissmedic with fines of up to 50,000 Swiss francs, and breaches by negligence with fines of up to 20,000 Swiss francs. In the case of commission of a breach on a professional basis, the fine may be higher. There is no equivalent provision for breaches of advertising rules for medical devices.

Swissmedic may also prohibit certain advertising in administrative proceedings and order that a future breach would incur fines.

The breach of the provisions on granting of financial benefits may be punished with a term of imprisonment of up to three years or a fine.

Sale and supply

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

For certain types of medicinal products and medical devices, special rules governing the dispensing or sale exist. One important category is narcotic medicinal products. In addition to the rules on medicinal products, the rules on narcotic products apply. These rules require a special licence and strict controls of each step in the supply and dispensing process. They provide special rules regarding separate secured storage, transportation, destruction, retention of documents for at least 10 years, special authorisation for off-label use of certain substances, etc.

Special rules also exist for blood and blood products. These rules provide special licensing obligations and recording and archiving obligations (30 years).

In respect of medical devices, it must be taken into consideration that, for example, the dispensing of certain medical devices requires a prescription or that in vitro diagnostics for the detection of communicable diseases in humans cannot be dispensed to the public (with the exception of HIV tests).

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

While online sale and supply of medicinal products in principle is prohibited, the cantons can grant authorisations to operate mail-order pharmacies. According to the Law on Therapeutic Products (LTP) and article 55 of the Ordinance on Pharmaceutical Products, in particular, the following conditions must be met for such an authorisation:

• the pharmacy must own a cantonal retailing licence;
• the pharmacy must operate a quality assurance system, assuring among other requirements:
  • the identification of the patient;
  • a check of adverse interactions with other medicinal products; and
  • proper advice to patients; and
• the patient must supply a doctor’s prescription with the order, whether it is a prescription or non-prescription drug.

Online dispensing, sale and supply of medical devices is governed by article 48 of the LTP and article 17 of the Medical Devices Ordinance. Medical devices that can be dispensed to the public and that are intended by the manufacturer for self-service can be offered and sold via the internet. Professional advice must also be assured (except for Class I devices).

What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

Medicinal products that are reimbursed by the basic health insurance are subject to government price control. The prices of non-reimbursed products are free and are not government-controlled. A finished medicinal product must, in principle, be listed on the speciality list (SL) established by the Federal Office of Public Health (FOPH) to be reimbursed in the outpatient sector of basic health insurance. When deciding on the admission of a medicinal product to the SL, the FOPH determines its list price. This price is the maximum price that can be invoiced by healthcare providers and that will be reimbursed by health insurance companies. About 80 per cent of the sales of pharmaceutical products in Switzerland relate to products listed on the SL.

The relevant criteria for fixing the SL price of an original product are the prices of drugs having the same indication or a similar mode of action and the average price of the product in other countries. Currently, the prices in nine reference countries – Austria, Belgium, Denmark, Finland, France, Germany, the Netherlands, Sweden and the United Kingdom – are used for this comparison. For determining the SL price, the FOPH adds a distribution margin to the ex-factory price determined according to the two criteria described above.

The fulfilment of the conditions for admission to the SL is, in principle, reviewed every three years. A review of the conditions for admission to the SL also takes place immediately after the expiry of the patent protection, as well as in the following situations: extension of an indication by the Swiss Agency for Therapeutic Products, request for changing a limitation of reimbursement and request for a price increase. The SL prices of generics and biosimilars are determined depending on the prices of their reference products.

Price increases may be applied for based on the above-mentioned pricing criteria. They are, however, generally rare and can be excluded for specific years based on certain criteria.

In 2015, the FOPH launched a health technology assessment (HTA) programme that evaluates medical services and therapies already reimbursed by mandatory health insurance. The HTA is intended to assess the effectiveness, appropriateness and cost-effectiveness of certain individual medical services and therapies. After completion of an HTA procedure, the FOPH or Federal Department of Home Affairs decides on the continuation or a possible restriction or cancellation of the reimbursement.

If a medicinal product is not listed on the SL or is listed on the SL but used off-label or outside a limitation of reimbursement, it must be taken over by the health insurance companies under basic health insurance if there is no effective and authorised treatment alternative and a high therapeutic benefit can be expected from its use. In this situation, the health insurance companies determine the reimbursed amount and negotiate a cost participation with the pharmaceutical company concerned.

In the inpatient sector, basic health insurance pays hospitals certain lump sums depending on the diagnosis of the patient (the DRG system). The lump sum also covers the costs of medicinal products and medical devices. For certain expensive medicinal products, additional remunerations are foreseen in the DRG system. An additional remuneration of a certain defined amount is only available if the product has been listed in the SL.

The reimbursement of medical devices applied by medical practitioners is regulated by tariff agreements. For medical devices that are directly used by patients, or prescribed by a doctor and used by nursing institutions or nursing staff, the medical aid and device list, MiGeL, lists the maximum prices that are reimbursed by the health insurance companies. The MiGeL does not impose a price control (ie, the distributors of medical devices are free to determine their own price).