What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
Anyone who conducts advertising that does not comply with the provisions of the AMG commits an administrative offence, which is punishable by a fine of up to EUR 25,000, in the event of a repeat offence up to EUR 50,000. This does not apply if an ordinary court has jurisdiction.
Based on the UWG, anyone who knowingly uses aggressive or misleading business practices in the course of business for the purposes of competition in a public announcement or in a medium (according to the Austrian Media Act) may be punished by the court with a fine of up to 180 daily rates.
The Pharmig Code of Conduct provides for a separate procedure in the event of a violation. Such a procedure is open to competitors as well as third parties. Penalties for the violation of the Pharmig Code of Conduct can range up to EUR 100,000 for the first violation and up to EUR 200,000 for the second violation.
Violating the rules governing advertisement of pharmaceutical products may give rise to sanctions, such as fines (from EUR 1200 to EUR 90 000) and imprisonment (from 1 month to 1 year) for individuals and with fines ranging from EUR 3 000 to EUR 180 000 for legal entities.
The sanctions are as follows:
(i) For violations relating to the advertising of medicines – from EUR 560 to EUR 3000 (depending on the nature of the infringement);
(ii) For violations relating to comparative advertising of medicines – up to 3% of the annual financial turnover for the year in which the violation was committed;
(iii) For violations of the Code of Pharmaceutical Ethics – making a public statement on the website of the Supervisory Committee for the Code of Pharmaceutical Ethics that a penalized pharmaceutical company is unethical.
In very specific cases COFEPRIS and PROFECO may coordinated actions against a violation of the corresponding laws and regulations.
Both authorities, may order the suspension of an advertising in breach of legal framework in order to modify such ads, if not modified or the modification is considered not to comply with legal provisions, COFEPRIS and PROFECO may suspend the advertising activities, seize the advertise product and/or impose a fines according to articles 110, 111 and 112 from the HLR which may vary from $9,000 to $73,000 USD depending on the severity of the violation.
Penalties for breaching the 2007 Regulations start at a fine of up to €2,500 and/or up to a year’s imprisonment on summary conviction. On conviction on indictment, a first offence breach will attract a fine of up to €120,000 and/or up to 10 years imprisonment and subsequent offences attract a maximum fine of up to €300,000 and/or imprisonment of up to 10 years.
Penalties for breaching the CPA start at a fine of up to €4,000 and/or up to six months imprisonment on summary conviction. For subsequent summary convictions there is a fine of up to €5,000 and/or up to a year’s imprisonment. On indictment there is a fine of up to €60,000 and/or up to 18 months imprisonment for a first offence. For subsequent convictions on indictment, a fine of up to €100,000 and/or up to two years imprisonment may be ordered. For contraventions that continue, there are daily fines of up to €500 per day, following a summary conviction and fines up to €10,000 per day following convictions on indictment.
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.
The CCPC can serve compliance notices, issue penalties and seek injunctions.
The IPHA may impose the following (non-exhaustive list) for a breach of the Pharmaceutical Industry Code including advertising rules and inducing prescribing:
- Order that the breach be ceased;
- Reprimand the company;
- Order the correction of inaccurate information;
- IPHA can publish its decision;
- Refer the matter to the Minister of Health for difficult and/or persistent breaches; and
- Suspension or expulsion of membership to IPHA.
In relation to advertising rules, the complaints committee in the ASAI can publish their decision in a case report, including the name of the non-compliant company, to the public through the media. If a company does not comply with its decision, that company may be disciplined by the ASAI board and may be subject to penalties, including fines and/or suspension of membership.A non-compliant advertisement must be withdrawn or amended and the media will refuse to publish such advertisements.
Decree Law 176/2006 of August 30 establishes the penalties that may be imposed by Infarmed and by the Courts, in case of violation of the legal provisions contained in this legal diploma, namely the ones referring to advertising inducement to prescribe.
Such infringements may be punishable with a fine between 2000 € and 15% of the business volume of the infringer or 180.000 €, whichever is lower.
The following additional sanctions may also be imposed:
(a) Loss in favour of the State of illicit objects, equipment and devices;
(b) Interdiction, for a maximum period of two years, of the infringer business activity;
(c) Deprivation of the right to participate in public tenders for a maximum period of two years;
(d) Suspension of authorizations, licenses and of other titles attributing rights for a maximum period of two years.
In case of infringement of advertising legal provisions, the following sanctions may also apply:
(a) The decision on imposing of fines may also determine the publication in the social media of the essential elements of the condemnation;
(b) The suspension of the advertising of the relevant medicine for a maximum period of two years;
(c) A procedure to exclude the relevant medicine from its reimbursement by the State, may also be initiated;
(d) The infringer´s medical sales representative may be prevented from visiting NHS hospitals and services, in case of violation of the legal regime of such visits.
Depending on the violation in question, different sanction measures are possible: In the event of a violation of criminal law, a financial penalty or even a prison sentence can be imposed by the court. This especially applies in context with a violation of sec. 299a – 299c StGB.
The violation of provisions in HWG and AMG – if not subject to criminal law – may lead to a fine.
If sec. 128 SGB V is violated, this may result in a contractual penalty, imposed by the relevant statutory health insurance company: The background to this regulation are the contracts required for settlement with the health insurance fund.
In addition, competitors may be required to pay compensation for damages by a court ruling.
Health care professionals can also be punished according to the relevant professional law.
- Failure to comply with the FDA Act, FDA IRR, and regulations issued by the FDA may result in the following:
i. FDA issuing a cease and desist order against the responsible establishment to stop the further release, printing, broadcast or dissemination of the advertising or promotional material, and/or penalties and/or fines shall be issued by the FDA;
ii. Seizure and confiscation of products that are subject of violative promotional or advertising materials;
iii. Withdrawal by the FDA of accreditation of the establishment’s medical director;
iv. Suspension / revocation of the licenses and registrations of the establishment;
v. for the advertisement of any health product that is adulterated, unregistered or misbranded:
- Imprisonment ranging from one year but not more than 10 years;
- Fine of not less than PHP 50,000 or PHP 500,000 (approximately US$ 1,000 to US$ 10,000), depending on the violator;
- additional fine of one percent of the economic value/cost of the violative product or violation, or PHP 1,000, whichever is higher, for each day of continuing violation;
- Fine and/or imprisonment, at the discretion of the court
If the offense is committed by a juridical person (i.e., a partnership or a corporation), the penalty of imprisonment will be imposed on the chairman of the board of directors, the president, general manager, or the partners and/or the persons directly responsible in the erring entity. If the offense is committed by a foreign national, such violator shall, in addition to the penalties prescribed, be deported after service of sentence.
- Any violation of the provision of the ASC Code of Ethics is usually the subject of the complaint that is presented to the ASC for hearing. Decisions may provide for the issuance for a cease and desist order on errant ad materials. Compliance is assured through specific sanctions on violations. An extreme case may cause all media, print and broadcast, to refuse to print / broadcast advertising material found to have violated specific provisions of the Code.
- Members that violate the PHAP Code of Practice will be meted with the following:
- First offense shall be meted a fine of PHP 200,000.00
- Succeeding offenses of the same nature (e.g., interfering with HCP independence) or within the same section of the Code within a twelve month period shall be meted a fine of PHP 750,000.00 per offense.
- Clean slate if no violations of the same offense are committed within a 12-month period. Reckoning date for all violations is the date when a decision was issued by the PHAP Ethics Committee.
- Violations of Philippine procurement, anti-bribery and corruption laws, which would apply to gifts in favor or inducements of public HCPs, may result in imprisonment of up to 15 years (depending on the particular offense) and a fine of up to three times the value of the gift given.
A violation of the Medicinal Products Act will often result in a prohibitive injunction subject to fines. A violation of the Marketing Practices Act will often result in an injunction subject to fines, although several other measures are available to the courts, depending on the nature of the violation. E.g., misleading advertisement and special offers may result in market disruption fees up to SEK 10 million and damages suffered by third parties. However, this is generally not applicable when it comes to breaches of the general clause on unfair marketing.
The self-regulatory bodies NBL and IGN can order payment of disciplinary fines up to SEK 500 000 for violation of good business practices. IGN or NBL may in cases of gross violations, in addition to the fine, instruct the company to issue a corrective public statement.
Criminal sanctions can be taken against individuals guilty of giving or taking bribes or other similar criminal offences. Additionally, for such criminal offences a company may be imposed with a criminal corporate fine (maximum SEK 10 million).
Swiss authorities may order either administrative measures (in particular, to order to cease the infringement, to prohibit advertising for a certain period or definitively, to seize or destroy advertising materials, to prohibit distribution, and to submit any further advertising projects to prior approval) (Art. 66 par. 1 and 2 TPA and Art. 23 OAM) or criminal penalties. The criminal penalties depend on the type of violations as well as on the seriousness of the case. The new TPA provides penalties reaching up to custodial sentence not exceeding three years or a monetary penalty for unlawful benefits (up to ten year plus a monetary penalty in case of acting for commercial gain and achieving a high turnover or a significant gain) (new Art. 86 TPA) and up to a fine not exceeding CHF 50,000 for infringement to advertising and transparency rules (new Art. 87 TPA).
For bribery of public officials, the perpetrator may be sentenced to a custodial sentence not exceeding five years or to a monetary penalty. For bribery of private persons, the penalty is limited to a custodial sentence not exceeding three years or to a monetary penalty.
The Code Secretariat may order the company to discontinue the breach. If the company does not, the Code Secretariat may only forward the case to the competent Swiss authorities.
The Drug Act specifies fines for business operators who violate medicine advertising rules. For example, pharmaceutical companies which advertise without approval from the FDA shall be liable to a fine of up to Baht 100,000 (approximately USD 3,000). The Anti-Corruption Act and the Penal Code also provide criminal penalties that an individual who commits bribery offense to the official shall be liable to an imprisonment not exceeding 5 years or fine not exceeding Baht 100,000, or both.
If a person who has committed the bribery offense is related to a juristic person (e.g. an employee or agent), and the offense is committed for the benefit of the juristic person without appropriate internal control of that juristic person to prevent the commission of the offense, that juristic person shall be subject to a fine at least equal to, but no more than twice that value of the damage occurred or assets received from the commission of the offense.
The MHRA's prefers to resolve complaints quickly and informally, with companies agreeing to take voluntary action to amend their advertising, and as such prosecutions for advertising offences are rare. However, regulators do have the power to impose the penalties and sanctions set out below.
The sanctions for violating advertising and inducement rules can be criminal and/or civil. They are the same except where provided otherwise.
For any breach under Article 303(2) of the Regulations, the penalty is a fine not exceeding the statutory maximum and/or imprisonment for up to two years.
For breaches under Article 303(4) which include breaches of Article 298(1) (in relation to the supply of free sample of a medicine to persons qualified to prescribe or supply medicines), Article 299(2) or (3) (relating to information which must be provided by the medical sales representative to the persons qualified to prescribe or supply medicines), and Article 300(4) (in relation to the solicitation or acceptance of gifts, pecuniary advantages, benefits or hospitality by a person qualified to prescribe or supply medicinal products), the penalty is a fine not exceeding level 5 on the standard scale.
The failure to comply with any requirement imposed by a notice given by the MHRA under Article 301 is also a criminal offence pursuant to Article 308 and the penalty is the same as for breaches under Article 303(2). However, for a breach of Article 307(2) (in relation to corrective statements concerning the incompatible advertisement), the penalty is the same as for breaches under Article 303(4).
Civil sanctions include requiring publication of a corrective statement where the Ministers have prohibited publication of advertising for breaching the rules (Article 307).
The MHRA can also require a licence holder to refrain from publishing the advertisement under investigation until a final decision is reached on the investigated violation.
The Ministry of Health can enforce the following penalties against infringers:
- Verbal reprimand;
- Written reprimand;
- A publication in a mass media of a clarifying/rectification notice;
- Either definitive or temporary suspension (no longer than 1 year) of all products’ advertising or promotion;
- Payment of fines.
Potential penalties for violations of advertising rules can include injunction proceedings, which may result in a consent agreement restraining company conduct, civil penalties, seizure proceedings and even criminal prosecution. The FDA will typically first notify companies of violations through Untitled Letters, also known as Notice of Violation letters, and through Warning Letters. These letters require companies to discontinue certain practices, including certain advertising claims. FDA Untitled and Warning Letters are public. In addition, the FTC often issues Warning Letters.
For violations on inducements to prescribe, offenders can be subject to criminal and civil penalties, including significant monetary fines and even imprisonment. For instance, the Federal Health Care Program Anti-Kickback Statute (the “AKS”) provides for both criminal and civil penalties for violations, and a violation of the statute is a felony punishable by up to five years imprisonment, a fine up to $250,000, or both for an individual, and a fine up to $500,000 for companies. 18 U.S.C. § 3571. The civil monetary penalties for violation of the AKS are $50,000 for each illegal act, plus three times the amount of illegal remuneration. In addition, the statute authorizes the Office of the Inspector General (“OIG”) to exclude those who violate the law from the federal health care program for violations of the AKS, by either mandatory or permissive exclusion. For violations of the Federal False Claims Act, there are substantial per-claim monetary penalties that could apply, as well as potential criminal penalties, including imprisonment and fines. Additionally, for violations of the Foreign Corrupt Practices Act, there are substantial criminal and civil penalties for both anti-bribery violations and accounting provision violations, as well as potential imprisonment for individuals.
The TGA can take a wide range of enforcement actions in relation to pharmaceutical advertising violations. This can include educational or warning letters, substantiation notices requiring evidence be provided in relation to claims. Failure to provide information under a substantiation notice can result in publication of a warning notice to the public or prosecution with fines of up to $105,000. The Secretary of the Department of Health may direct a company to take steps to correct non-compliant advertising or the TGA may accept enforceable undertakings from the company that corrective measures will be taken. Alternatively the TGA may issue an infringement notice and a fine of up to $12,600. Failure to comply with directions, warning letters, undertakings or substantiation notices may result in suspension or cancellation of ARTG registration and civil or criminal action in the Federal Court, with penalties of up to $10,000,000 or 5 years imprisonment.
Sanctions for breaches of the Medicines Australia Code include orders that the company cease or modify its conduct, undertake corrective action and monetary fines. Fines may be up to $250,000 per breach and may be applied cumulatively. Similarly CHPA may impose a range of penalties for breaches of the ASMI Code, including requiring written undertakings to discontinue advertising, retractions or corrective statements and fines of up to $50,000.
Breaches of the ACL attract penalties of up to the higher of $10,000,000, three times the value of the benefit received, or 10% of annual company turnover. The ACCC also has the power to issue infringement notices with a fine of $12,500 per breach.
Breaches of the Health Practitioner Regulation National Law relating to inducements are punishable by fines of $60,000 per offence for a corporation.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 28.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 28.3.
 - Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 10.2.
 - Health Practitioner Regulation National Law (NSW), s136.