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 to 2001, as amended (the "Ethics Acts"), apply to promotional practices involving healthcare professionals who also hold certain designated positions or directorships. The Prevention of Corruption Acts 1889 to 2010 and the Criminal Justice (Theft and Fraud Offences) Act 2001, as amended (the "Anti-Corruption Laws"), also apply in circumstances where promotional practices are found to be corrupt. The Irish Medicines Board (the "IMB") 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 Marketing Practice for the Pharmaceutical Industry – Edition 7.4 2010 (the "Pharmaceutical Code"); and the Code of Standards of Advertising Practice for the Consumer Healthcare Industry – Revision 5.1, 2010 (the "Consumer Code") (together the "Codes"). The Advertising Standards Authority for Ireland, 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) (the "Advertising Code"), which applies to advertising generally, while the Broadcasting Authority of Ireland has produced a "General Commercial Communications Code" (the "BAI 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; supply of samples; inducements to prescribe or supply by 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 medicinal products; and in particular the payment of travelling and accommodation expenses.
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 to compile and collate all information relating to products. Medical sales representatives must be adequately trained with appropriate scientific knowledge and knowledge of products. The Codes require prior approval of each advertisement by the scientific service. The Pharmaceutical Code requires that each company appoint at least one senior employee who is responsible for supervising compliance with the Pharmaceutical Code. Sample copies of all advertising and details of its use must be retained and provided to the IMB on request.
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.
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 IMB can order the withdrawal of a misleading advertisement and the issuing of a corrective statement in respect of a published advertisement. The courts can order the withdrawal of an advertisement and a corrective statement to 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 for the withdrawal of an advertisement if it is of the opinion that it is not in the interests of consumer safety.
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 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. 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, to referral of the matter to the Minister for Health and Children (the "Minister"); and suspension or expulsion from IPHA. Penalties for breach of the Misleading Advertising Regulations and the CPA range from a fine of up to €3,000 or imprisonment not exceeding 6 months on summary conviction to a fine of €5,000 and imprisonment not exceeding 12 months for subsequent convictions together with a daily fine of €500, a fine of up to €60,000 and/or up to 18 months' imprisonment, or €100,000 and/or up to 24 months' imprisonment for subsequent convictions. Prosecutions may be brought by the IMB, the Minister, the Pharmaceutical Society of Ireland and the Health Service Executive. A more stringent approach to enforcement is taken each year. 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. IPHA may refer difficult or persistent breaches of the Codes to the Minister. IPHA may also advise the Advertising Standards Authority for Ireland (the "ASAI") of its findings against an advertiser and recommend action.
1.9. In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
Breach of intellectual property is also dealt with by legislation, including the Trade Marks Act 1996 (as amended), and by the common law, through the law of passing off. Recourse can also be found in the law of defamation through the Defamation Act, 2009 and in competition law through the Competition Act, 2002 (as amended) where appropriate.
PROVIDING INFORMATION PRIOR TO AUTHORISATION OF MEDICINAL PRODUCT
2.1. To what extent is it possible to make information available to health professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product's variants not authorised)?
The Regulations prohibit promotion of medicinal products that are not the subject of a marketing authorisation or a certificate of traditional use registration. There is an exception for certain herbal and homeopathic medicinal products until 30 April 2011, after which a certificate of traditional use registration or a marketing authorisation will be required. The Codes also prohibit promotion of products prior to authorisation. Separately, the CPA deems as a "prohibited commercial practice" a representation that a product has an authorisation which it does not have. However...
The International Comparative Legal Guide To: Pharmaceutical Advertising 2011 - Ireland
|Author:||Mr Declan Hayes and Colin Kavanagh|
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