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 8.3, 2018) (the "Pharmaceutical Code"); and the IPHA Code of Standards of Advertising Practice for the Consumer Healthcare Industry (Revision 5.2, 2017) (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 Standards Authority for Ireland ("ASAI"), the independent self-regulatory body for the advertising industry, has issued a "Code of Standards for Advertising and Marketing Communications in Ireland" (7th Edition) ("ASAI Code"), 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 doorto- 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 Pharmaceutical Code requires 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 summary of product characteristics ("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 or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?
There are no legal or code requirements for SOPs governing advertising activities. Under section 21.1 of the Pharmaceutical Code, every company must establish a Scientific Service in charge of information about its medicinal products and the approval and supervision of no interventional studies. This Scientific Service must include a medical doctor or, where appropriate, a pharmacist or other suitably qualified person who will be responsible for: (i) approving any promotional material before release. Such person must certify that he or she has examined the final version of all promotional material and that, in his or her belief, it is in accordance with the requirements of the Code and any applicable advertising laws and regulations, is consistent with the relevant SmPC and is a fair and truthful presentation of the facts about the medicinal product being promoted; and (ii)...