Updates to the Irish Pharmaceutical Healthcare Association (“IPHA”) Codes
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.
For more information on the IPHA Codes and compliance please contact Colin Kavanagh or Bridget McGrath in the Life Sciences Regulatory and Compliance Group for further information.