Last Updated February 20, 2019

Law and Practice

Contributed By Walder Wyss Ltd

Authors



Walder Wyss Ltd has 200 legal experts and office locations in Zurich, Geneva, Basel, Berne, Lausanne and Lugano. Walder Wyss Ltd has a team dedicated to life science and pharmaceutical regulatory law, including healthcare insurance law. The key areas of practice in relation to the pharmaceutical advertising sector are pharmaceutical regulatory law, healthcare insurance law and the law regarding research on humans and clinical trials, stem cells and blood components, genetic testing, transplantation, special nutrition, medical devices and reproductive medicine. The firm has established www.lifesciencelaw.ch, a website dedicated to all legal issues surrounding life sciences where case law is discussed and where interested people can find publications from the team.

Material benefits of modest value that are related to medical or pharmaceutical practice are permitted (Article 33 paragraph 3 lit. a HMG). Such material benefits must not exceed CHF300 per healthcare professional or healthcare organisation and per year.

Only a small number of sample packages may be distributed per medicine, per year and per healthcare professional. They may be distributed only on the initiative of the healthcare professional and upon their written request. Sample packages must be clearly and permanently marked as a “free sample.” They must contain the necessary information and texts on the container and packaging material as well as an approved package leaflet. In the case of medicines that may be marketed without a package leaflet, the sample package must contain the required information on the container and the packaging material. The sample package must be accompanied by the drug information last approved by Swissmedic or contain a reference to its publication in the list in accordance with Article 67 para. 3 or Article 95b HMG. Sample packages must always correspond to the smallest approved package size and may not be sold. The supply of sample packages containing psychotropic substances or narcotics is subject to the provisions of the Narcotics Control Ordinance. The marketing authorisation holder must ensure that records are kept of the distribution of sample packages (Article 10 AWV).

According to Swissmedic, the following quantities qualify as “small quantity”: A maximum of five packages per healthcare professional, per year and per medicine in the first two years after market introduction and a maximum of two packages per healthcare professional, per year and per medicine from the third year on.

Representation expenses in connection with scientific congresses or promotional events must remain within reasonable limits and be of subordinate importance in relation to the main purpose of the event. They may not benefit persons who are not healthcare professionals authorised to prescribe, dispense or use medicines for professional means at their own responsibility (Article 11 AWV).

The Pharma Code states that events that are organised or receive financial support (sponsored) from pharmaceutical companies with subsidiaries in Switzerland and that are aimed purely at participants from Switzerland should, in principle, take place in Switzerland. Refreshments or meals (including beverages) may be offered only to the participants of the event and must be modest and reasonable according to the customary local standards (in Switzerland: maximum of CHF150 per healthcare professional per meal). The events should take place at appropriate venues conducive to the main purpose of the event and not be extravagant. Pharmaceutical companies must generally require that participants make an appropriate financial contribution, which may be reduced for healthcare professionals who are still in post-graduate medical training and may be waived for events that are held in Switzerland and that last for less than one day (rules 143.5, 313, 322 et seqq. and 331 et seqq. Pharma Code; Guideline II. 6 of the SAMW).

Pharmaceutical companies must not offer or pay for any entertainment or other leisure or hospitality activities (rule 322 Pharma Code; Guideline II. 6 of the SAMW).

It is prohibited to grant, offer or promise material benefits to persons who prescribe or dispense medicines or to the organisations that employ them and for such persons or organisations to solicit or accept such material benefits. However, material benefits of modest value that are related to medical or pharmaceutical practice as well as commercially and economically justified discounts that directly reflect on the price are permitted (Article 33 HMG). Such material benefits of modest value must not exceed CHF300 per healthcare professional or healthcare organisation and per year.

However, pharmaceutical companies may provide financial or other support to healthcare organisations for research or other services in the healthcare sector, provided that such support is limited to research or other services in healthcare, that it is set down in writing and that the relevant documents are available at the pharmaceutical company. Pharmaceutical companies must, however, fully disclose all pecuniary benefits that they grant (rules 222 and 23 et seqq. Pharma Cooperation Code).

Commercially and economically justified discounts that directly reflect on the price of the medicine are permitted (Article 33 paragraoh 3 lit. b HMG).

Economically justified rebates are rebates where the buyer provides an economic counter-value. Examples include purchase orders placed by the buyer via the internet, which save the supplier administrative and logistical costs, the handling of transport by the buyer or the purchase of large quantities, which relieves the supplier of storage costs. In contrast to an economically justified rebate, a commercially justified rebate is granted independently of a consideration from the customer. A rebate is commercially justified if it is granted over a certain period in a specific business relationship, so that both parties assume that it also applies in the future. In such a case, the discount no longer has any influence on the purchase decision. Discounts that are commercially justified can also be benefits that are granted upon the introduction of a new product or to acquire new customers or that serve to maintain the existing clientele with regard to new competing products.

Swiss courts have held that a rebate of 33% for one month to introduce a new medicine was exceptionally high, whereas a rebate of 1–25% was economically and commercially justifiable (Decision of the Federal Criminal Court BV.2005.28 of 28 November 2005 consid. 2.2; Decision of the Federal Administrative Court C-669/2008 of 17 December 2010 consid. 5.5.4).

Healthcare professionals must, in any case, pass on direct or indirect financial advantages granted to them by pharmaceutical companies to patients or healthcare insurances with regard to medicines covered by compulsory healthcare insurance (Article 56 paragraph 3 lit. b KVG).

Pharmaceutical companies may entrust healthcare professionals with consultancy tasks or services, such as papers and the conduct of meetings; medical or scientific studies; clinical trials; training and participation in consultancy bodies; and provide reasonable compensation for expenditure incurred by them in this connection according to the usual standards.

Such consultancy tasks or services are permitted only if they are agreed upon in writing beforehand, if there is a justified need for them, if the healthcare professional is qualified for them, if not more healthcare professionals are entrusted with them than are needed, if the pharmaceutical companies document them and if the agreements provide that the healthcare professionals will disclose their relationship if they write or speak in public about matters that are the subject of the agreement or otherwise related to the commissioning pharmaceutical company. Sham contracts are prohibited. In addition, pharmaceutical companies must fully disclose all pecuniary benefits and call the attention of the healthcare professional to that obligation in the contracts with them. They must stipulate in the agreement that the recipients of the pecuniary benefits agree to disclosure (rules 21 and 23 et seqq. Pharma Cooperation Code; Guidelines III. 1-7 of the SAMW).

There are no prior authorisations or notifications (eg regulatory authority approval) required in relation to any of the activities described in this section. However, whether the consent of an employer is required also depends on the contract between the healthcare professional and the employer.

Walder Wyss Ltd

Walder Wyss Ltd.
Seefeldstrasse 123
P.O. Box
8034 Zurich
Switzerland

+41 58 658 58 58

+41 58 658 59 59

reception@walderwyss.com www.walderwyss.com/en/home
Author Business Card

Authors



Walder Wyss Ltd has 200 legal experts and office locations in Zurich, Geneva, Basel, Berne, Lausanne and Lugano. Walder Wyss Ltd has a team dedicated to life science and pharmaceutical regulatory law, including healthcare insurance law. The key areas of practice in relation to the pharmaceutical advertising sector are pharmaceutical regulatory law, healthcare insurance law and the law regarding research on humans and clinical trials, stem cells and blood components, genetic testing, transplantation, special nutrition, medical devices and reproductive medicine. The firm has established www.lifesciencelaw.ch, a website dedicated to all legal issues surrounding life sciences where case law is discussed and where interested people can find publications from the team.

{{searchBoxHeader}}

Select Topic(s)

loading ...
{{topic.title}}

Please select at least one chapter and one topic to use the compare functionality.