1.1 Laws and Self-Regulatory Codes
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 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 8.2, 2017) (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 IPHA Codes). These IPHA 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, 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 Application and Legal Value of Regulatory Codes
The self-regulatory IPHA Codes listed above apply only to those pharmaceutical companies that have voluntarily agreed to be members of IPHA. They do not apply to healthcare professionals. The IPHA Codes fit into the framework established by Regulation 26 of the Regulations, which recognises the role of voluntary control of advertising of medicinal products. In general, the pharmaceutical industry usually looks to the IPHA Codes as best practice for advertising of medicinal products in Ireland.
The ASAI Code and General Commercial Communications Code apply to the advertising and broadcasting industries respectively. Industries that are involved in releasing marketing communications and sales promotions that promote the sale of medicinal products are bound by these codes. Again, neither of these codes apply to healthcare professionals.
Scope of Advertising and General Principles
2.1 Definition of Advertising
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.
2.2 Difference Between Information and Advertising
There is no definition of information as opposed to promotion in the applicable Irish legislation and codes of practice. The legitimate exchange of medical and scientific information to healthcare professionals is not prohibited, provided such information or activity does not constitute any form of promotion that would be prohibited under the Regulations.
Disease awareness campaigns are permitted to the extent that they do not in any way promote a brand of medicinal product, either directly by naming a product, or indirectly, for example:
If there are non-prescription, as well as prescription-only, medicinal products available to treat a particular condition, advising patients to visit their doctor for treatment could be regarded as promoting the use of a prescription-only medicinal product. To avoid any such inference, the Pharmaceutical Code advises that consideration should be given to advising patients to talk to their doctor or pharmacist. In the case of a disease awareness campaign sponsored by a company which promotes the only available medicinal product for that disease/condition, particular care is required to ensure that the campaign could not be regarded as promoting that product. The Pharmaceutical Code notes that statements such as: "Your doctor can prescribe a medicinal product to help you," should be avoided. 2.3 Restrictions on Press Releases
While not explicitly classified as advertising in the Regulations, press releases are expressly included in the definition of promotion in the Pharmaceutical Code. The Pharmaceutical Code prohibits the advertising or promotion of prescription-only medicinal products to the general public. However, information about a scientific discovery of a medicinal product may be supplied where it is desirable or necessary to do so in the public interest, or where the object is to keep the public informed of scientific or medical progress.
Press releases with this information must be presented in a balanced way to avoid the risk of raising unfounded hopes in the public mind from the results of treatment. Statements must not be made to or designed for the purpose of encouraging members of the public to ask their doctor to prescribe a medicinal product. Therefore, press releases must include only factual and non-promotional information.
2.4 Comparative Advertising
Comparative advertising is governed by the Misleading Advertising Regulations and the CPA. Comparative advertising is permitted but there are restrictions on such advertising and instances where comparative advertising is not permitted. For instance, misleading comparative advertising is prohibited. In addition, comparative advertising must not discredit or denigrate the goods or services provided by a competitor. For instance, under the Pharmaceutical Code, the use of competitor brand names cannot be used in comparator advertisements without the prior consent of the relevant brand owner. In addition, the products, services and promotions of other companies cannot be disparaged in advertising either directly or implicitly.
Advertising for Unauthorised Medicines or Unauthorised Indications
3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications
The Regulations prohibit the promotion of medicinal products that are not the subject of a marketing authorisation or a certificate of traditional use registration (the latter registration relates to herbal medicinal products). The IPHA Codes also prohibit promotion of products prior to authorisation, subject to certain exceptions such as materials at international congresses and symposia held within Ireland. Separately, the CPA deems as a "prohibited commercial practice" a representation that a product has an authorisation which it does not have. Advertisements as part of a vaccination campaign, however, are approved (provided the Minister has permitted it). However, the legitimate exchange of medical and scientific information to healthcare professionals is not prohibited, provided such information or activity does not constitute any form of promotion that would be prohibited under the Regulations.
Scientific, complete, objective, factual and non-promotional information concerning the off-label use of the products may be provided to healthcare professionals by representatives of the medical departments in response to an unsolicited request by the healthcare professional for such information.
In addition, correspondence to healthcare professionals in response to an unsolicited specific question about a particular medicinal product - which may include material of a non-promotional nature, and non-promotional, generic information about companies, including financial data, descriptions of research and development programmes - and discussions of regulatory developments affecting the company and its products, are not prohibited.
3.2 Provision of Information During a Scientific Conference
Indications for unauthorised medicinal products and unauthorised indications in Ireland may be referenced in promotional material appearing on exhibition stands or distributed at international congresses or symposia held in Ireland, provided such medicinal products and indications are in fact approved in at least one other country in the EEA. This exception applies only to meetings that are truly international and scientific. A clearly visible and legible statement must also be included, indicating that the material relates to a product or indication that is unapproved in Ireland. In addition, where prescribing information is provided, an explanatory statement must also be included indicating that licensing conditions differ internationally.
If products are not approved in the EEA or where the...
Chambers Global Practice Guides: Pharmaceutical Advertising 2018
|Author:||Mr Colin Kavanagh|
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