The Irish Pharmaceutical Healthcare Association ("IPHA"), have recently published a number of changes to both the IPHA Code of Practice for the Pharmaceutical Industry and the Self-Care Advertising Code (the "Codes"). The updates will become effective on 1 March 2021. IPHA members are required to be compliant from 1 March 2021. Given that Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007 recognises the self-regulatory Codes, non-members of IPHA should also comply with the Codes.
Updates to IPHA Code of Practice for the Pharmaceutical Industry – Edition 8.5 effective 1 March 2021
- The European Federation of Pharmaceutical Industries and Associations ("EFPIA") Ethical Principles are now included in the Code.
- Medical Education will now be defined as relating to human health and diseases and specific non-promotional training related to medicines and may include material and activities.
- Press releases are now defined as non-promotional communications both in content and purpose. A number of changes have been made in relation to the content and approval of press releases.
- There will be a requirement of substantiation of product claims by speakers.
- The manner in which IPHA publishes findings on Code compliance has been updated.
- There are now additional requirements in relation to disclosures of Transfers of Value ("ToV").
- New requirements in relation to Patient Organisation ("PO") funding have been included.
- Detailed guidance is provided in the Code in respect of the organisation and conduct of Advisory Boards.
Updates to the IPHA Self-Care Advertising Code (formerly known as the Code of Standards of Advertising Practice for the Consumer Healthcare Industry) – Version 6.0 effective 1 March 2021
- This Code has been expanded to include Consumer Healthcare Products and non-Rx medical devices.
- A new clause on reputation has been added.
- Interpretative guidance is now included throughout the Code.
- A Checklist for advertisements has been included.
- All press releases aimed at HCPs must be non-promotional. Promotional press releases aimed at the general public must make it clear that they are advertisements.
- It has been confirmed that food supplements and homeopathic medical products do not come within the remit of the Code.
Originally Published by Arthur Cox, February 2021
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.