Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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1000. To ask the Minister for Health for an overview of the primary and secondary legislation regulating medical advertising and labelling, in particular the legislation regulating what health and medical claims sellers can make about their products. [23187/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The following response was provided by the HPRA.

The Health Products Regulatory Authority regulates a number of different types of health products including medicinal products (commonly referred to as medicines) and medical devices. Medical claims may be made in respect of both medicinal products and medical devices, which are subject to both EU and national legislation. The following summarises the main legislative provisions for medicinal products and medical devices related to medical advertising and labelling which are relevant to the HPRA’s regulatory remit. It should be noted that other public bodies (such as the Advertising Standards Authority of Ireland, Coimisiún na Meán) may also have a role relating to advertising of such products based on other legislation.

Medicinal products (medicines)

The key pieces of EU legislation related to medicinal products are Regulation (EC) No. 726/2004 as amended, which deals with centrally authorised medicinal products, and Directive 2001/83/EC of the Community Code relating to medicinal products for human use, as amended, which focuses on nationally authorised medicinal products. The relevant provisions from the Directive have been transposed into Irish law by the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540/2007).

In respect of medicines, all authorised medicines in Europe have an associated Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). The approved SmPC is a legal document that details the prescribing information (approved therapeutic use, dosage, clinical particulars, safety information etc). This SmPC is approved on the basis of supportive evidence related to the quality, safety and efficacy of the medicinal product that is assessed as part of the marketing authorisation application. Detail presented within the PIL, and other labelling is supported by that in the SmPC.

The legal basis for the advertising of human medicinal products in the European Union is set out in Title VIII of Directive 2001/83/EC of the Community Code relating to medicinal products for human use, as amended. The relevant provisions from the Directive have been transposed into Irish law by the Medicinal Products (Control of Advertising) Regulations of 2007, S.I. no. 541 of 2007:

• Part 2 of S.I. no. 541 of 2007 outlines the requirements for advertising human medicinal products in general, including the requirements around the accuracy of advertisements. In this regard, regulation 7 requires that:
  1. All parts of the advertisement comply with the particulars set out in the summary of product characteristics for the product.
  2. The advertisement encourages the rational use of the medicinal product by presenting it objectively and without exaggerating its properties.
  3. The advertisement is not misleading.
• Part 3 of S.I. no. 541 of 2007 outlines the specific requirements for advertising human medicinal products to the general public in Ireland. In this regard, regulation 11 outlines the information/material that is prohibited in advertisements for medicinal products that are directed at the general public.
• Part 4 outlines the specific requirements for advertising human medicines to persons qualified to prescribe or supply medicinal products. In this regard, regulation 16 requires certain advertisements directed at such persons to include information about the adverse reactions, precautions, and relevant contraindications associated with the medicinal product as per the Summary of Product Characteristics, and that this information is printed in a clear and legible manner and placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.

‘In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

(a) ascribing functions and properties to the device which the device does not have;

(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.’