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Updated regulations in the Irish Pharma sector

The IPHA has updated its self-governance and advertising codes; key updates for those in the pharma sector.

The Irish Pharmaceutical Healthcare Association (IPHA) is a self-governing association, which represents the international originator biopharmaceutical industry in Ireland.  As part of this, the IPHA administers a number of Codes of Practice, including the Code of Practice for the Pharmaceutical Industry and the Code of Advertising Standards for the Consumer Healthcare Industry. The objective of these Codes is to ensure the highest possible standards in the promotion and advertising of medicines. As of 1 March 2021, the IPHA has published updates to the Code of Practice for the Pharmaceutical Industry, and renamed and updated the Self-care Advertising Code. 

While the IPHA codes are only binding on members, the codes impact the pharmaceutical industry as a whole and are considered best practice regardless. Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007 refers to self-regulatory codes in this area, and therefore it is recommended that even non-members should comply with these codes. This article sets out the key changes for both codes:

Code of Practice for the Pharmaceutical Industry (Code of Practice)

  • The ethical principles contained in the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) Ethical Principles have been formally included.
  • Updated definition of Healthcare Organisations, which means any healthcare, medical or scientific association or organisation such as a hospital, clinic, foundation, university or other teaching institution or learned society.
  • Medical Education is defined and subject to further provisions, with the aim of ensuring that education cannot be used as a cover for providing promotions of medicinal products. 
  • A new definition for Promotional Aid, which is covered by the Code of Practice. 
  • A specific obligation on Medical Sales Representatives not to mislead as to their identity or of the company represented. Companies should be mindful of this when considering policies and contracts with sales representatives.
  • Press releases are now treated as non-promotional communications, and there are further restrictions on their content and use of brand names.  Companies should ensure that internal policies are updated to reflect this change. 
  • More detailed disclosure of Transfers of Value, and clearer guidance on the data protection implications of such disclosures, in addition to the Best Practice for Transfer of Value Disclosure.  The IPHA has also provided guidance on the use of legitimate interest to process data under GDPR for transfers of value, and published a mandatory guide which must be followed - Minimum mandatory requirements for Privacy Policies (legitimate interest).  Companies may need to review and update applicable data privacy policies and procedures. 
  • More stringent requirements and increased disclosure where funding is provided to Patient Organisations, and a mandatory template for disclosure of funding.

Self-Care Advertising Code (Advertising Code)

  • Formerly know as the Code of Standards of Advertising Practice for the Consumer Healthcare Industry, this has been renamed to the Self-Care Advertising Code.
  • Interpretive guidance is provided for the first time to facilitate the understanding and application of the objectives of the Advertising Code.
  • Medical devices that require a prescription, for diagnostic purposes, or for cosmetic conditions, (i.e. those not considered a Consumer Medical Device) are expressly excluded from the Advertising Code.  Food supplements and homeopathic medicines are also excluded. 
  • A consumer healthcare advertising checklist is included for use by companies when advertising.
  • All press releases aimed at Healthcare Professionals must be non-promotional, and those aimed at the general public must make it clear that they are advertisements.
  • Companies should have a policy in place which provides for the moderation of dynamic content when posted on a platform over which a company has control; the policy should be provide for the removal of any content which is inappropriate or in breach of the Advertising Code.

Breaches

In respect of breaches of the Code, the IPHA Council generally investigates, but also has the ability to refer serious breaches to the Minister for Health. The IPHA Code Council may also refer breaches of the Advertising Standards Authority of Ireland ("ASAI") Code to the ASAI. 

It is important that companies take steps now to ensure their policies, procedures and practices are compliant.

Tags

healthcare, regulation