1 GENERAL - MEDICINAL PRODUCTS
1.1 What laws and codes of practice govern the advertising of medicinal products in Ireland?
The advertising of medicinal products is governed by a combination of legislation and codes of practice. The principal regulations are the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. No. 541 of 2007) (the "Regulations"), which implement Titles VIII and VIIIa of Directive 2001/83/EC (as amended) (the "Directive"). In addition, general laws concerning advertising and commercial practices are set out in the Consumer Protection Act 2007 (the "CPA") and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 (the "Misleading Advertising Regulations"). The Ethics in Public Office Acts, 1995 and 2001 (as amended) (the "Ethics Acts"), apply to promotional practices involving healthcare professionals who also hold certain designated public positions or directorships. The Prevention of Corruption Acts 1889 to 2010 and the Criminal Justice (Theft and Fraud Offences) Act 2001, as amended, also apply in circumstances where promotional practices are found to be corrupt. The Health Products Regulatory Authority (the "HPRA") is the body responsible for monitoring the advertising of medicinal products and enforcing the Regulations. The National Consumer Agency is the regulatory body with oversight of general consumer law, while the Broadcasting Authority of Ireland is the regulator for radio and television broadcasts in Ireland.
The law is supplemented by a number of codes of practice. The Irish Pharmaceutical Healthcare Association ("IPHA"), the industry body representing the international research-based pharmaceutical industry in Ireland, has published two relevant codes of practice: the IPHA Code of Practice for the Pharmaceutical Industry (Edition 8.1, 2015) (the "Pharmaceutical Code"); and the IPHA Code of Standards of Advertising Practice for the Consumer Healthcare Industry (Revision 5.1, 2010) (the "Consumer Code") (together the "Codes"). The Association of Pharmaceutical Manufacturers of Ireland ("APMI"), the industry body representing manufacturers of generic medicinal products, has published the APMI Code of Practice on Advertising of Medicinal Products (Edition 1, 2010), a similar code based on the Regulations and the Directive. The Advertising Standards Authority for Ireland ("ASAI"), the independent self-regulatory body for the advertising industry, has issued a "Code of Standards for Advertising, Promotional and Direct Marketing in Ireland" (6th Edition), which applies to advertising generally, while the Broadcasting Authority of Ireland has produced a "General Commercial Communications Code", which applies to advertising broadcasts on radio or television channels licensed in Ireland.
1.2 How is "advertising" defined?
"Advertising" is defined in the Regulations as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. This specifically includes: advertising to the general public and those who are qualified to prescribe or supply medicinal products; supply of samples; inducements to prescribe or supply by the gift, offer or promise of any benefit or bonus, in money or in kind; sponsorship of promotional meetings and scientific conferences attended by persons qualified to prescribe or supply; and, in particular, the payment of travelling and accommodation expenses associated with such conferences.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
The Regulations require that a scientific service be established within the company to compile and collate all information relating to products. Medical sales representatives must be adequately trained and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about the product they are promoting. Companies must keep available samples of all advertising emanating from their undertaking together with information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination, and such information must be supplied to the HPRA upon request. The Codes require that the scientific service must include a doctor or, where appropriate, a pharmacist or other suitably qualified person who must approve all promotional material prior to release. Such person must certify that the advertisement complies with the Pharmaceutical Code and all applicable laws, is consistent with the relevant SmPC, and is a fair and truthful presentation of the facts concerning the medicinal product being promoted. The Pharmaceutical Code requires that each company appoint at least one senior employee who is responsible for supervising compliance with the Pharmaceutical Code.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities? If so, what aspects should those SOPs cover?
There are no legal or code requirements for SOPs governing advertising activities.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
There is no necessity to have advertising pre-approved. However, the HPRA reserves the right to pre-review advertisements.
1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/ or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
The HPRA can order the withdrawal of a misleading advertisement and the issuing of a corrective statement in respect of a published advertisement. The Irish Courts can order the withdrawal of an advertisement and that a corrective statement be issued, where a party is convicted of a specified offence under the Irish Medicines Board Act 1995, as amended (the "IMB Act"), and the court is satisfied that the advertisement was misleading. IPHA may require the withdrawal of an advertisement if it is of the opinion that it is not in the interests of consumer safety. Decisions of the IPHA Code Council may be appealed to the IPHA Appeals Board, and the decision of the IPHA Appeals Board is final and binding. Decisions of the HPRA may be appealed to the Irish Courts.
1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts?
Penalties for breach of the Regulations range from a fine of up to 2,000 and/or imprisonment of up to 12 months on summary conviction, to a fine of up to 120,000 and/or a term of imprisonment of up to 10 years on indictment. On subsequent convictions, the maximum fine increases to 300,000. If an offence is committed by a body corporate, personal liability may apply to the officers. Prosecutions may be brought by the HPRA, the Minister for Health (the "Minister"), the Pharmaceutical Society of Ireland and the Health Service Executive. A competitor may inform any of the above bodies of non-compliant advertising.
Penalties for breach of the Pharmaceutical Code are dealt with by the "Code Council" of IPHA and range from: an order to cease the breach; a reprimand; an order for the recovery of offending material; publication of a corrective statement; publication of the decision; referral of the matter to the Minister; and suspension or expulsion from IPHA. A competitor may inform IPHA of non-compliant advertising.
Penalties for breach of the Misleading Advertising Regulations and the CPA consist of a fine of up to 3,000 and/or imprisonment not exceeding six months on summary conviction, a fine of up to 5,000 and/or imprisonment not exceeding 12 months for subsequent summary convictions, a fine of up to 60,000 and/or up to 18 months' imprisonment on a first conviction on indictment, a fine of up to 100,000 and/or up to 24 months' imprisonment for subsequent convictions on indictment, and a daily fine of up to 500 for each day that the contravention continues following summary conviction, with this daily fine rising to a maximum of 10,000 for each day that the contravention continues following conviction on indictment. The Misleading Advertising Regulations and the CPA allow a competitor to apply to court for an order preventing a company from engaging in misleading marketing or prohibited comparative advertising.
1.8 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
The Codes fit into the framework established by Regulation 26 of the Regulations, which recognises the role of voluntary control of advertising of medicinal products. Breaches of the Pharmaceutical Code are generally dealt with by the Code Council (questions 1.6 and 1.7 above); however IPHA may refer difficult or persistent breaches of the Codes to the Minister. IPHA may also advise the ASAI of its findings against an advertiser and recommend action.
In addition, advertising is monitored and...