On 25 January 2021, the Irish Pharmaceutical Healthcare Association (IPHA) released the latest edition of its Self-Care Advertising Code (Code), formerly the Code of Standards of Advertising Practice for the Consumer Healthcare Industry. The Code will take effect on 1 March 2021 and will expand the remit of the current code to traditional herbal medicinal products and certain medical devices.
Scope of the code:
| Type of products advertised | Code Applies |
| Non-prescription medicines | Yes |
| Non-prescription medical devices for self-care use | Yes (new) |
| Traditional Herbal Medicinal Products (THMPs) | Yes (new) |
| Prescription-only medicines advertising | No |
| Prescription-only medical devices advertising | No |
| Food Supplements | No |
| Homeopathic Medicines | No |
Key Changes
1. Introduction of THMP advertising requirements
The decision to expand the remit of the Code to include THMP advertising results in a number of rules being implemented in the herbal medicine field.
The term “traditional herbal medicine” or “traditional herbal medicinal product” in the Code covers a medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations (as defined in the Medicinal Products (Control of Advertising) Regulations 2007).
THMPs must be advertised in accordance with these new rules:
- Medicinal claims may not be made with regard to herbal medicines prior to traditional-use registration or granting of a marketing authorisation (MA);
- Promotion must be consistent with a product’s registration or MA;
- Advertising must make it clear that the product is a THMP;
- Advertising must not imply superiority over medicines subject to MA;
- Advertising shall not infer safety due to the product being natural or herbal;
- Where the indication states “traditionally used for..”, or similar wording, this must be stated in the advertising material; and
- Claims such as “clinically proven” or “effective in..” are not acceptable, as registration for traditional use is based on exclusively long-standing use.
2. Introduction of non-prescription medical device advertising requirements
Similarly, new rules have been introduced for non-prescription medical devices. The term “consumer medical device” in the Code means a medical device as defined in Regulation (EU) 2017/745, and which is available for consumers to purchase without a prescription, and for self-care use (CMD).
CMDs must be advertised in accordance with these new rules:
- Claims must not exceed the scope of CE certification or technical documentation of the CMD;
- Advertising must not mislead as to the status of the CMD, e.g. by implying it is a medicine;
- Advertising may only refer to a product as “herbal” if this is in line with the classification of the medical device and does not mislead or confuse as to the CMD’s status; and
- Advertising must not mislead regarding a CMD’s intended purpose, safety and performance by:
- Ascribing functions and properties a CMD does not have;
- Creating false impression regarding treatment, diagnosis, functions or properties;
- Failing to inform of a likely risk with its use when in line with intended purpose; or
- Suggesting off-label uses other than those stated to form part of the intended purpose.
Other key changes
- Clause on reputational damage (2.1): “activities of member companies must never bring the industry into disrepute or undermine confidence in advertising, or prejudice public confidence in consumer healthcare products.”
- Definition of “advertising” in line with underlying legislation.
- Inclusion of checklists for advertisements for consumer healthcare products, medicines and THMPs.
- Section on online activities, including guidance around websites directed towards young adults, website monitoring, website ownership and data protection requirements.
- Inclusion of checklists for advertisements for consumer healthcare products, medicines and THMPs.
- Press releases concerning medicines aimed at health care professionals must be non-promotional, and promotional press releases aimed at the general public must make it clear that they are advertisements.
Effect of the Code
While not a legally binding document, abiding by the Code is considered best practice. It applies to the activities of IPHA member companies, non-member signatories, affiliates and partners of member companies acting within Ireland or directing activities towards Irish consumers.
Separately, all advertising must comply with laws in relation to the advertising of medicines, in particular the Medicinal Products (Control of Advertising) Regulations 2007 (S.I. 541 of 2007), Regulation (EU) 2017/745 on Medical Devices, and any other applicable legislation.
Given the imminent implementation of the Code, we recommend those companies involved with the advertising of products under the Code’s remit, in particular their marketing personnel and sales teams, and their advertising and public relation agents, familiarise themselves with the Code.
Connect with Laura Scott, Charleen O’Keeffe or your usual William Fry Healthcare contact to discuss any questions about this article, or concerns you have in relation to the Code or your business.
Contributed by Florence Meagher & Louise Murray
