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.
Read the full publication: The International Comparative Legal Guide to: Pharmaceutical Advertising 2015