Enforcement

A person who violates the prohibition on false or exaggerated advertising in Article 66(1) is liable to imprisonment of up to two years or a fine of up to 2 million yen or both (Article 85 item 4), and the Minister must order payment of a surcharge of 4.5 percent of the total consideration for the products traded during the surcharge period of up to three years, except that no order may be made where the calculated amount is under 2.25 million yen. Separately from punishment and the surcharge, Article 72-5(1) empowers the Minister or the prefectural governor to order a person who has violated Article 66(1) or Article 68 to cease the act, to take the measures necessary to prevent its repetition, to give public notice in connection with those measures, and to take any other measures sufficient to prevent the occurrence of a danger to public health; such an order may be issued even where the violation has already ceased, and may be directed not only at the violator but also at a corporation surviving or created by merger, a corporation succeeding to the business by company split, and a transferee of the business. Article 72-5(2) allows the Minister or governor to request a specified telecommunications service provider to take measures to prevent the transmission of an unlawful advertisement sent by specified telecommunications. A person who disobeys an Article 72-5(1) order is liable under Article 85 item 6 to imprisonment of up to two years or a fine of up to 2 million yen or both.

The opening words of 21 U.S.C. 352 provide that a drug or device 'shall be deemed to be misbranded' in the listed cases. Section 352(n) provides that a prescription drug is misbranded unless the manufacturer, packer or distributor includes in all advertisements and other descriptive printed matter it issues with respect to that drug a true statement of (1) the established name, printed prominently and in type at least half as large as any trade or brand name, (2) the quantitative formula, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as the Secretary requires by regulation. Section 331 prohibits (a) the introduction or delivery for introduction into interstate commerce of a misbranded drug, (b) misbranding in interstate commerce, and (c) the receipt in interstate commerce of a misbranded drug and its delivery for pay or otherwise. The chain 'advertising violation to misbranding to prohibited act' therefore holds on the face of the statute. Under 21 U.S.C. 333(a)(1) a violation of section 331 carries up to one year of imprisonment or a fine of up to $1,000 or both, and under 333(a)(2) a violation after a conviction under that section has become final, or one committed with intent to defraud or mislead, carries up to three years or a fine of up to $10,000 or both. However, 18 U.S.C. 3571(e) preserves a lower statutory fine only where the law setting forth the offence 'by specific reference' exempts the offence, and the text of 333(a) contains no such reference. Consequently, under 18 U.S.C. 3559(a) the 333(a)(1) offence is a Class A misdemeanour and the 333(a)(2) offence a Class E felony, and under 18 U.S.C. 3571(b)(3) and (b)(5) and 3571(c)(3) and (c)(5) an individual may be fined up to $250,000 for the felony and up to $100,000 for the Class A misdemeanour not resulting in death, and an organisation up to $500,000 and $200,000 respectively. Section 3571(d) additionally permits a fine of up to twice the gross gain or twice the gross loss.

The general $500/$5,000 scheme in section 31 applies only 'subject to sections 31.1, 31.2 and 31.4', so for medicines those special provisions govern. Under the section 2 definitions, a 'therapeutic product' means a drug or device or any combination of them, and 'drug' includes any substance manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of disease. Section 31.2(1) provides that, subject to section 31.4, every person who contravenes any provision of the Act or the regulations as it relates to a therapeutic product is guilty of an offence and liable on conviction by indictment to a fine not exceeding $5,000,000 or imprisonment not exceeding two years or both, and on summary conviction to a fine not exceeding $250,000 or six months' imprisonment or both for a first offence and $500,000 or 18 months for a subsequent offence. Section 31.4(1) provides that a person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision as it relates to a therapeutic product, is liable on indictment to a fine in the discretion of the court or to imprisonment not exceeding five years or both, and on summary conviction to $500,000 or 18 months for a first offence and $1,000,000 or two years for a subsequent offence. Section 31.3 makes due diligence a defence except for a section 31.4 offence, and section 31.5 requires a court sentencing under section 31.2 or 31.4 to take into account the harm or risk of harm caused and the vulnerability of consumers of the therapeutic product.

Member States must confer upon the courts or administrative authorities powers to order the cessation of misleading advertising, or to order the prohibition of its publication where publication is imminent, even without proof of actual loss or damage or of intention or negligence on the part of the advertiser, and must determine the penalties for infringement of the national provisions adopted in execution of Title VIII (Directive 2001/83/EC, Articles 97(2)-(4) and 99). Equivalent powers appear in Article 5 of Directive 2006/114/EC: paragraph 1 requires adequate and effective means to combat misleading advertising and to enforce compliance with the provisions on comparative advertising, including legal provisions under which persons or organisations with a legitimate interest may take legal action or bring the advertising before a competent administrative authority; paragraph 3 requires powers to order cessation or prohibition even without proof of loss, intention or negligence, under an accelerated procedure with interim or definitive effect; paragraph 4 permits powers to require publication of the decision in whole or in part and of a corrective statement; and paragraph 6 requires reasons always to be given where the powers are exercised exclusively by an administrative authority, together with provision for judicial review. The level of penalties is set by each Member State, not by EU law. One national implementation has now been read: under the German Heilmittelwerbegesetz, section 14 punishes a breach of the prohibition on misleading advertising in section 3 with imprisonment of up to one year or a fine; section 15(1) makes breaches of sections 3a, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 regulatory offences; section 15(2) makes a negligent breach of section 3 a regulatory offence; and section 15(3) sets the administrative fine at up to 50,000 euro for a section 15(1) offence and up to 20,000 euro for a section 15(2) offence. Section 16 permits confiscation of the advertising material concerned.

A person guilty of an offence under the advertising provisions is liable on summary conviction to a fine not exceeding the statutory maximum, or on conviction on indictment to a fine, to imprisonment for a term not exceeding two years, or to both.

Publishing a medical, drug or medical device advertisement in breach of article 16 attracts an order to stop publication and eliminate the effects, a fine of one to three times the advertising cost (or 100,000 to 200,000 yuan where the cost cannot be calculated), and in serious cases three to five times the cost (or 200,000 to 1,000,000 yuan), possible revocation of the business licence, revocation of the advertising approval document and refusal to accept further advertising review applications for one year.

Advertising therapeutic goods in a way that does not comply with the Advertising Code carries a criminal penalty of up to five years' imprisonment or 4,000 penalty units where harm or injury results or is likely, up to 12 months or 1,000 penalty units otherwise, a strict liability offence of 100 penalty units, and a maximum civil penalty of 5,000 penalty units for an individual and 50,000 for a body corporate.

A person who violates article 68 of the Pharmaceutical Affairs Act (prohibition of exaggerated advertising) is punishable under article 95(1) item 10 by imprisonment for up to one year or a fine of up to 10 million won, and article 95(2) allows imprisonment and the fine to be imposed together. Under the dual-liability provision in article 97, where a representative or employee of a corporation commits an article 95 offence in connection with the business, the corporation or individual is also fined under that article, unless it did not neglect due care and supervision. As to administrative sanctions, article 76(1) provides that where a manufacturer of drugs, a holder of an item authorisation, a registrant of an active ingredient, an importer, a holder of clinical trial plan approval, a pharmacy founder, a drug seller or a drug sales-promotion operator falls under any of the listed grounds - which include item 3, 'where this Act or an order under this Act has been violated' - the Minister of Food and Drug Safety, or the mayor or head of the county or district, may revoke the authorisation, approval or registration, revoke acceptance of a notification, order closure of the consigned manufacturing and marketing site or the manufacturing site, order closure of the business office, prohibit the manufacture or import of the item, or order suspension of all or part of the business for up to one year. Article 68-2 further provides that a drug manufacturer, holder of an item authorisation or importer who intends to advertise a drug it has manufactured or imported must undergo review by the Minister of Food and Drug Safety as prescribed by Prime Ministerial Decree, and that the Minister may entrust that review to a corporation established under article 67.

Swissmedic may seize, officially impound or destroy unlawful advertising material, prohibit its use and publish that prohibition at the expense of those responsible, and in the event of a serious or repeated infringement of the advertising provisions may prohibit advertising for a particular therapeutic product temporarily or permanently and publish that prohibition likewise at their expense; intentional infringement of the provisions on medicinal product advertising is punishable by a fine of up to CHF 50,000, by a monetary penalty where the offender acts commercially, and by a fine of up to CHF 20,000 where the offender acts negligently.