Contributed By Walder Wyss Ltd
Swissmedic is the regulatory authority responsible for enforcing the rules on advertising as stated in the HMG and the AWV (Article 66 paragraph 1, Article 82 and Article 90 paragraph 1 HMG). As a general rule, the Federal Administrative Court adjudicates appeals against decisions by Swissmedic and the Federal Court adjudicates appeals against decisions by the Federal Administrative Court.
The Code Secretariat is the self-regulatory body that is responsible for the implementation of the Pharma Code and the Pharma Cooperation Code (rule 6 Pharma Code; rule 5 Pharma Cooperation Code).
Companies can initiate proceedings against competitors for advertising infringements before Swissmedic, which has the authority to take administrative measures and to initiate criminal prosecution (Article 66 and Article 90 paragraph 1 HMG). Companies may, however, also initiate proceedings against competitors for advertising infringements before the Code Secretariat, which is responsible for the implementation of the Pharma Code and the Pharma Cooperation Code.
If advertising of competitors constitutes unfair competition according to the UWG, companies can initiate proceedings before civil courts.
Any person who wilfully contravenes the regulations on the advertising of medicines is liable to a term of detention or to a fine not exceeding CHF50,000. If the person concerned acts in a professional capacity, the penalty is a term of imprisonment not exceeding six months and a fine not exceeding CHF100,000. If the person concerned acts through negligence, the penalty is a fine not exceeding CHF10,000. Attempts and aiding and abetting are also offences. The right to prosecute contraventions and execute the penalties for contraventions are subject to a time limit of five years. In particularly minor cases, prosecution and sentencing may be waived (Article 87 paragraph 1 lit. b and paragraph 2-6 HMG).
In addition, Swissmedic may take all administrative measures necessary to enforce the HMG. In particular, it may raise objections and set an appropriate time period for restoring the state of law, suspend or revoke licences and marketing authorisations and close down establishments. Furthermore, Swissmedic may also seize, hold in official storage or destroy medicines that endanger health or that do not conform to the regulations of the HMG as well as prohibit the distribution, dispensing, import, export and foreign trade from Switzerland of medicines, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage. Finally, it may seize, hold in official storage, destroy or prohibit the use of illegal advertising media and publish the prohibition at the expense of the responsible parties as well as temporarily or permanently prohibit the advertising of a specific medicine in the event of serious or repeated infringements of the provisions of the HMG, and publish the prohibition at the expense of the responsible parties (Article 66 para 1 and 2 HMG).
In addition, Swissmedic may require a marketing authorisation-holder who seriously or repeatedly infringes the provisions governing the advertising of medicines to submit to Swissmedic, for a reasonable period of time, all drafts of the planned advertising in the form specified by Swissmedic for review and approval prior to its appearance (Article 23 AWV).
Furthermore, the bribery offences in criminal law (Article 322ter et seqq. StGB) apply as well (see 8.1 General Anti-bribery Rules above).
Both the Pharma Code and the Pharma Cooperation Code state that pharmaceutical companies that undertake to comply with these Codes acknowledge their rules of enforcement if proceedings are taken for breach of a Code. As long as relevant proceedings are pending, they will in principle not refer the matter at the same time to a State authority or to a court on grounds of breach of the Swiss legal order. However, the safeguarding of rights, which may be endangered or defeated by compliance with these principles of conduct, is reserved.
In a rather recent decision concerning price agreements and competition law, the Federal Administrative Court had the opportunity to contemplate the effect that the general prohibition of public advertising of prescription medicines has on the transparency of the market with regard to especially comparative prices amongst medicines of the same kind. The process of searching for price information exercised by consumers prior to purchasing requires market and price transparency. The Court stated that the prohibition of public advertising enshrined in Article 32 paragraph 2 lit. a HMG considerably restricts the effective intra-brand price competition in the interest of health protection without completely excluding it. The conclusion of the Court in this respect was that the sales market of a prescription drug cannot be compared with that of a regular consumption good. This decision has been appealed before the Swiss Federal Court (Decision of the Federal Administrative Court B-843/2015 of 19 December 2017 consid. 6).
In another decision the Federal Administrative Court examined the difference between permitted information of a general nature and inadmissible information of an advertising nature. It held that information cannot be qualified in an abstract way, but that its qualification depends on the overall circumstances of the individual case. The magazine advertisements and exhibition stands in the case at hand obviously aimed at promoting the medicine and thus constituted advertising, according to the Court. It further examined the informative quality of those advertisements that are permitted only when directed exclusively at professionals. Incomplete, shortened, factually inaccurate and unspecific slogans violate the provisions of Article 5 paragraphs 1 and 3 AWV. Any information not included in the authorised drug information may not be used in advertising (Decision of the Federal Administrative Court C-5490/2015 of 28 March 2017 consid. 6, 7.1.2, 188.8.131.52, 7.3.6 and 184.108.40.206).
Swissmedic has recently published a statement with regard to approved complementary medicines without indication. Swissmedic has found that advertising to the public of authorised complementary medicines without indication very often does not comply with the relevant advertising regulations. In September 2018, Swissmedic has informed those pharmaceutical companies that market complementary medicines without indication that Swissmedic would in the future specifically check compliance with the relevant advertising provisions even for medicines authorised without indication and, if necessary, initiate according measures. Swissmedic has granted the pharmaceutical companies a period of six months to comply with the advertising provisions. After expiry of this period, Swissmedic will check compliance with the legal requirements on a random basis and, in the event of advertising infringements, will initiate administrative measures to restore the state of law. In the case of intentional violations, criminal proceedings may be initiated pursuant to Article 87 paragraph 1 lit. b HMG.