Medicinal products
The advertising of human medicinal products is regulated in Ireland under the Medicinal Products (Control of Advertising) Regulations 2007[1] (Irish Advertising Regulations). The Regulations transpose Title VIII of Directive 2001/83/EC into Irish law.
Prescription-only medicines, controlled drugs and certain sizes of non-prescription medicinal products may not be advertised to the general public. The reimbursement status of a product can also have an impact on the extent to which it should be marketed to members of the public.
Part 3 of the Irish Advertising Regulations outlines the requirements for permitted advertising to the public. Specifically, it dictates that advertisements to the public must be:
- Accurate
- Present the medicine in an objective way, and
- Encourage rational use of the medicine
The IPHA Code of Practice for the Pharmaceutical Industry (IPHA Code) also contains rules regarding marketing and advertising of medicinal products including an annexed ‘Guideline on Digital Communication in the Pharmaceutical Sector’. The associated IPHA Self-Care Advertising Code contains additional requirements regarding advertisements, which apply to:
- Consumer healthcare products
- Over-the-counter products, and
- Traditional herbal medicinal products
At an EU level, Article 94 of Directive 2001/83/EC contains several restrictions on the provision of samples, promotional aids, gifts, hospitality and other incentives to healthcare organisations and medical practitioners. These EU-wide restrictions are also reflected in the Irish Advertising Regulations, which prohibit the supply, offer, or promise of a gift, pecuniary advantage or benefit to healthcare professionals unless it is inexpensive and relevant to the practice of medicine or pharmacy.
The IPHA Code also provides guidance on acceptable interactions between pharmaceutical companies and healthcare professionals. The Code sets down specific provisions governing:
- Consultancy agreements
- Donations and grants, and
- The provision of hospitality between healthcare organisations and professionals
Healthcare professionals are also bound by the ethical requirements set by their professional bodies and must adhere to these requirements when engaging with the medical device and pharmaceutical industries.
For further information, the HPRA has published a ‘Guide to Advertising Compliance (March 2025)’. The guidance provides information on:
- Acceptable content of advertisements in various formats and addressed to specific groups
- The advertising for traditional herbal medicinal products and homeopathic medicines, and
- The classification of promotional vs non-promotional materials
Medical devices and in vitro diagnostic medical devices (IVDs)
The advertising of medical devices is primarily regulated under relevant provisions of the EU Medical Devices Regulation[2] (MDR) and the In Vitro Diagnostic Regulation (IVDR)[3], specifically Article 7 in both frameworks. The provisions state that devices may not be presented or advertised in a way that may mislead the user or patient regarding that device’s intended purpose. This principle is further supported in Ireland under:
- The relevant provisions of the Irish statutory instruments implementing the MDR and IVDR, and
- The relevant sections of the Code of Standards for Advertising and Marketing Communications in Ireland (ASAI Code).
Compliance and enforcement
Non-compliance with advertising regulations can result in various penalties. The HPRA can order companies to withdraw misleading advertisements and to issue corrective statements. It is worth noting that companies can appeal these decisions via the courts. Although prosecutions are rare, proven breaches of the Irish Advertising Regulations can result on conviction in:
- A fine of up to €2,500 and/or a term of imprisonment up to 12 months on summary conviction, or
- A fine of up to €120,000 and/or a term of imprisonment up to 10 years on indictment
For subsequent convictions, the penalty increases to a fine of up to €300,000 and/or a term of imprisonment of up to 10 years.
If the IPHA determines that an advertisement runs counter to consumer safety, it can request that the company withdraw the advertisement. The IPHA can issue various other sanctions for breaches of the IPHA Code, including reprimands, suspension/expulsion of the company from the IPHA or referral to the Minister for Health.
ASAI complaints that are upheld will ordinarily result in the advertisement in question being removed from circulation by publishers.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
[1] S.I. 541/2007
[2] Regulation (EU) 2017/745
[3] Regulation (EU) 2017/746
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