Overview of the HPRA's consultation process on the revised Guide to Advertising Compliance

In section 5.2.1 of the Guide, we gave guidance on updating advertisements after marketing authorisation variations are approved that lead to SmPC updates.

The Guide outlined how advertisements with information not in line with the SmPC should not be used after the variation's implementation date. In general, companies should start using new advertisements with the updated SmPC information in a timely manner. They should use risk-based principles to decide a cut-off date for stopping the use of the old advertisements. This should be no later than the variation's implementation date. This is particularly important for safety-related variations.

We received comments on this guidance. These suggested that the updated advertisements should not have to be used before the implementation date. We did not agree with this. We believe that it would not be responsible to not encourage companies to use risk-based principles to update advertisements when such variations are approved.

In section 8.1 of the Guide, we gave guidance on the term 'persons qualified to prescribe or supply' used in S.I. No. 541 of 2007. We received a comment asking how other classes of health professionals, like allied healthcare professionals such as physicians associates, would be classified.

Part 1 of S.I. No. 541 of 2007 defines a 'health professional' as a person of any of the following classes:

(i) registered medical practitioners

(ii) registered dentists

(iii) registered pharmacists

(iv) registered nurses

The term 'persons qualified to prescribe or supply', which is used in these Regulations, means those in the above defined classes of health professional who are legally entitled to prescribe or supply a human medicine in Ireland.

Since these Regulations do not refer to other classes of health professionals, anyone that is not one of the above defined classes of health professional should be considered a member of the public in the context of these Regulations.

In section 13 of the Guide, we gave guidance on how to classify materials used at meetings as promotional or non-promotional. In light of comments received, we updated the Guide to clarify when a presentation delivered during a promotional meeting can be considered non-promotional. We also clarified when this would not be appropriate.

In section 5.2.2 of the Guide, we discussed regulation 7(b) of S.I. No. 541 of 2007 and the rational use of medicines. The Guide referred to the need to present medicines objectively in advertisements by presenting a balanced view of the benefits and risks of the medicine. In light of comments received, we clarified these requirements. We differentiated between larger promotional materials, like detail aids, and shorter advertisements, like one-page journal advertisements.

In part 4 of the Guide, we gave guidance on the exemptions in regulation 5 of S.I. No. 541 of 2007 and here, the Guide referred to non-promotional patient information booklets. Some stakeholders asked for clarification on this guidance.

The Guide outlined that non-promotional patient information booklets should not be approved as promotional materials in a company's internal quality system. In light of the comments received, we updated the Guide to clarify why. If these booklets are approved as promotional materials, they become part of a company's promotional content. This means they are legally regarded as advertisements and should comply with S.I. No. 541 of 2007. This would not be appropriate for patient information booklets about prescription-only medicines. As per regulation 9 of S.I. No. 541 of 2007, such medicines cannot legally be advertised to the general public.

During the consultation, we received comments on Part 4 of the Guide which related to the exemptions in S.I. No. 541 of 2007. Stakeholders asked for more guidance on what documents could be included in these exemptions. We clarified the requirements.

Exemptions 5(b) and (c) indicate that sending a copy of the SmPC or PL does not constitute advertising. We clarified that it is acceptable to provide non-promotional information about a medicine to those qualified to prescribe or supply. This information should be factual, up-to-date, comply with the medicine's marketing authorisation, and be sent by those working in a non-promotional role, e.g. Scientific Services, Medical Affairs, etc. However, any promotional items or literature sent to those qualified to prescribe or supply would legally be regarded as advertisements to those persons and should, therefore, comply with the requirements for advertisements as per S.I. No. 541 of 2007.

In light of comments received, we updated the Guide to mention our ongoing collaboration with other regulatory bodies. This relates to advertising compliance issues that may also come within the regulatory framework of those other bodies. For example, Coimisiún na Meán, the PSI, etc.