1 General - Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
The advertising of medicinal products is governed by a combination of legislation and self-regulatory 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 Competition and Consumer Protection Commission 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"). These Codes apply only to those pharmaceutical companies that have voluntarily agreed to be members of IPHA. The Irish Generics Medicines Association ("IGMA"), the industry body representing manufacturers of generic medicinal products, has published the Code of Practice on Advertising of Medicinal Products (Edition 1, 2010), a similar code based on the Regulations and the Directive. The Advertising...