On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?

Pharmaceutical Advertising

Austria Small Flag Austria

Based on the UWG, any competitor or certain institutions (e.g. consumer protection association) may assert claims for injunctive relief, publication of judgements and damages before the general civil courts. This can lead to significant costs.

Belgium Small Flag Belgium

Under general rules governing fair market practices, competitors can act against pharmaceutical companies allegedly violating advertising rules. Under such rules, remedies include cease and desist procedures, injunctive relief and claims for damages.

Lithuania Small Flag Lithuania

See the response to the question 22.

Mexico Small Flag Mexico

For Health Advertisement Rules infringements, the corresponding body to initiate a proceeding is COFEPRIS.

For commercial related infringement and/or comparative advertisement infringements the corresponding body to initiate a proceeding is PROFECO.

For intellectual property infringement the corresponding body to initiate a proceeding is Mexican Institute of Intellectual Property and the Federal Administrative Courts.

Ireland Small Flag Ireland

A company can report advertisements of competitors which it suspects is in contravention of the advertising rules to the appropriate bodies mentioned at 22.

A company can issue proceedings in the Irish Courts if the advertisement of its competitor is in contravention of legislation and they feel their rights have been breached, such as the 2007 Regulations via section 32 of the Irish Medicines Board Act 1995. A company can apply to the Circuit Court or High Court under the Misleading Marketing Regulations to prohibit a trader in engaging in misleading or comparative marketing.

Portugal Small Flag Portugal

Companies may report advertising infringements to:

(a) the competent authority (Infarmed), which will assess the reported facts and shall decide on initiating or not an administrative procedure against the infringer;

(b) Apifarma, which Ethics Council shall assess the reported facts and may decide on imposing the penalties foreseen in Apifarma´s By-Laws.

In each of the cases the complainant company shall not be part of any of the procedures initiated by Infarmed or by Apifarma.

Germany Small Flag Germany

In Germany, there are multiple ways in which companies can proceed against unlawful advertising by competitors.

First and foremost, companies can initiate legal proceedings before the civil courts. Besides a main action, parties have the option of filing a motion for preliminary injunction ("einstweiliges Verfügungsverfahren"). The unique aspect of such PI-proceedings in Germany is that they are usually decided by the court within days after filing and usually "extra parte", i.e. in most cases without any involvement of the adverse party. For such preliminary injunction proceedings however, the urgency period within which any such motions will need to be filed has to be observed. This deadline is in general one month after having obtained knowledge of the infringement and the infringer. In such PI-proceedings, claims for cease and desist as well as information can be claimed.

Regular main action proceedings are also available, which do not require adherence to this urgency deadline but take roughly one year for a first instance decision to be reached, with appeal proceedings taking roughly one more year. In such proceedings, parties can also bring forward claims for damages, recall and destruction of marketing materials containing the advertorial claims in question.

In addition, any violations of the HWG are sanctionable offences or even punishable under criminal law. Competitors can thus also potentially file criminal complaints, leading to the prosecutor initiating investigations.

Lastly, if the competitor in question is a member of a self-regulatory organisation such as FSA, these organisations can initiate proceedings as laid out in their codices.

Philippines Small Flag Philippines

Violations of the laws, rules and regulations, issuances and guidelines issued by the competent authority on advertising (e.g., the DOH) will serve as basis for the institution of a complaint. For instance, the advertising of prescription pharmaceutical products in mass media is prohibited by FDA and DOH regulations. This may be the basis of a complaint or proceeding against the pharmaceutical company before the FDA. The decision of the FDA on the complaint or proceeding may be appealed to the DOH and subsequently to the appellate courts (i.e., the Court of Appeals and the Supreme Court).

In addition, depending on the circumstances of the advertisement, a party sustaining injury or damages as a result of the advertisement may commence a civil action for damages before the regular courts.

Sweden Small Flag Sweden

A company can initiate infringement proceedings against competitors before the Patent- and Market Court, if the competitor's marketing is in violation of any part of the Marketing Practices Act, such as the general clause prohibiting unfair advertisement.

A company can also report a violation of the Medicinal Products Act or of LVFS 2009:6 to MPA, which in turn can issue a prohibitive injunction against the competitor's advertisement. MPA decisions are appealed to the Administrative court in Uppsala, the Administrative Court of Appeal in Stockholm and the Supreme Administrative Court.

Further, companies bound to comply with the self-regulatory system established by LER (please see question 2 above) may turn to the disciplinary bodies IGN and NBL. Companies not bound to comply with LER can in individual cases agree to subject themselves to the procedures before IGN and NBL and their disciplinary regime. This is regularly seen. IGN and NBL monitor pharmaceutical companies' adherence to statutory law, LER and good marketing practices. A company can report a competitor's infringement of good marketing practices to IGN or NBL. For most types of cases, IGN is the first instance and NBL the instance of review to which the aggrieved party can appeal an undesired outcome in IGN. If the complaint concerns a pre-approved website (which is approved by IGN) (please see question 9 above) it can be reported to NBL directly.

Finally, an infringement of the Marketing Practices Act can be reported to the Swedish Consumer Agency which can issue a prohibitive injunction against the infringer.

Switzerland Small Flag Switzerland

First, the companies may file a complaint to Swissmedic (advertising) or to the Federal Office of Public Health (integrity and transparency) for any infringement of the rules set out in TPA, OAM and OITTP.

Second, the companies may file a claim to the civil courts in case of unfair competition according to the UCA.

Third, companies may also initiate a proceeding against a competitor before the Code Secretariat in case of breach of the Pharma Code or of the Pharma Cooperation Code.

Thailand Small Flag Thailand

The company may not initiate proceedings against competitors for advertising infringements unless the advertising causes damage to the company, e.g. the advertising that contains unfair or misleading comparisons, or comparisons implying therapeutic advantage to the company's product.

For the violations of the advertisement that require administrative remedies, companies can initiate proceedings against competitors by notifying the FDA on anonymous basis. When a complaint is made, some follow-up questions might be asked, and evidence will be requested from the complainant. The FDA will then take over, and begin by gathering preliminary information about the product and the responsible person. The advertisement will then be analyzed to determine whether an infraction occurred. Furthermore, the FDA conducts post-marketing control to monitor product compliance after approval has been granted.

United Kingdom Small Flag United Kingdom

Companies can initiate proceedings against competitors before the MHRA or any self-regulatory body. Offences are provided under Article 303(1) of the Regulations and include any contravention of any prohibition relating to advertising as well as any failure to comply with any requirement or obligation in Chapter 2 of part 14 of the Regulations.

There are no actions before English courts that can be initiated by companies against their competitors (as the breach of statutory duty would typically not cause loss to the companies and thus a private law cause of action would not be available).

Venezuela Small Flag Venezuela

Administrative actions would have to be lodged and prosecuted before the Ministry of Health (Board for Review of Pharmaceutical Products). The criminal actions must be lodged by the Office of the Attorney General after an investigation conducted by prosecutor after a notitia criminis.

United States Small Flag United States

Neither the FD&C Act nor the FTC Act provide a private right of action by competitors. However, competitors may initiate proceedings in federal or state court and before the NAD.

As discussed above, under the Lanham Act, a party may file a lawsuit in federal court for false or misleading advertising. Remedies under the Lanham Act are broad and may include actual damages, lost profits, injunctive relief, corrective advertising and recovery of attorneys’ fees.

A company may also challenge a competitor’s national advertising before the NAD. As discussed above, the process is voluntary, though most advertisers do elect to participate. In NAD actions, the advertiser bears the burden of showing substantiation for its claims, and remedies are generally limited to the NAD’s recommendation to modify or discontinue the challenged advertising.

Australia Small Flag Australia

Companies can lodge complaints with the TGA in relation to breaches of pharmaceutical advertising regulations, including the TG Advertising Code. Member companies can lodge complaints Medicines Australia and CHPA for non-compliance with the advertising provisions of the Medicines Australia and ASMI Codes. General advertising complaints can be lodged with the Advertising Standards Board. Complaints relating to breaches of the ACL can either be lodged with the ACCC or action can be taken directly by the company in the Federal Court of Australia or a Supreme Court of any State or Territory of Australia.

Updated: December 3, 2019