knowledge 1 March 2021 |

New Updates to the Irish Pharmaceutical Healthcare Association Codes

IPHA has updated its Code of Practice for the Pharmaceutical Industry (the “IPHA Code of Practice”) as well having issued a newly-renamed IPHA Self-Care Advertising Code.  The code amendments, which are available here, make a number of amendments which will be of interest to IPHA member companies and others in the industry, the most notable of which are: 

IPHA Code of Practice

Grants and financial support: One of the key elements of the IPHA Code of Practice is to regulate the giving of grants and forms of support by pharmaceutical companies.  To that end, the code updates include new requirements including that pharmaceutical companies must obtain written confirmation of the authorised account for transfer of value payments from the CEO, Finance Director or other comparable role of the healthcare organisation (“HCO”).  This requirement seems intended to raise the issue of the transfer of value to the highest level of authorisation in the HCO.

Consultancy agreements: In a similar vein, there is also a new express requirement that consultancy/service contracts between HCOs/healthcare professionals (“HCPs”) on the one hand and member companies on the other are only permitted where the services are ‘…provided for the purpose of supporting healthcare, research or education’ and do not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines.

Medical education: There is a new section on the provision of ‘medical education’, being education aimed at increasing scientific knowledge and competence of HCPs.   The code updates seem clearly aimed at ensuring that promotion of medicinal products is not undertaken under the guise of medical education and that all medical education materials or activities must be fair, balanced and objective and designed to allow the expression of diverse theories and recognised opinions.

Press releases: The amended code now more specifically regulates the use of press releases by member companies and includes different requirements between press releases to the general (lay) media and to the medical media.  There is particular focus on a more restricted use of brand names, e.g. in press releases to the general media (i) brand names must not be used unless the press release is a response to the publication of erroneous information or previous reference to the brand in the publication and (ii) notifications of corporate activities (e.g. M&A transactions) are only acceptable if they do not include reference to medicines.  In press releases to medical media, information relating specifically to the results of clinical trials should be scientific in tone and must not refer to the brand name.  As the code notes, companies will need to ensure its internal press release approval process complies with these revised principles.

Patient organisations: There are also significant changes to the requirements of the IPHA Code of Practice when member companies wish to provide financial support, significant indirect support and/or significant nonfinancial support to patient organisations.  Among other changes, when giving such support, the IPHA Code of Practice now expressly requires a written agreement which must state the amount of funding and also the purpose.  It must also include a description of significant indirect support and significant nonfinancial support and gives examples of those supports.

Transfers of Value and data protection: The IPHA Code of Practice updates also include revised requirements on transfers of value and also on the data protection aspects of the associated disclosures of those transfers.  As the code notes, disclosures of transfers of value for HCOs or HCPs, whether by the IPHA or by the company, may entail the processing of the personal data of HCPs, except where the data provided is in aggregated form only.  The code now notes that a legal basis for processing personal data under data protection law is required such as legitimate interests, consent or any other appropriate legal basis under the GDPR.  However, in a new development, the IPHA Code of Practice now requires that companies that wish to use legitimate interests as a legal basis under the GDPR for its transfers of value reporting must follow the requirements set out in the “Minimum mandatory requirements for Privacy Policies (legitimate interest)” document, a copy of which can be downloaded from the IPHA website (here).  Companies may need to revisit and revise their data protection notices to HCPs accordingly.

IPHA Self-Care Advertising Code 

Renaming: As a threshold matter, this newly renamed and augmented code was previously called the Code of Standards of Advertising Practice for the Consumer Healthcare Industry.  The overall objective of this code is to ensure the highest possible standards in the promotion and advertising of consumer healthcare products where the objective is to influence the supply, sale or purchase by a consumer.

Interpretive guidance: In addition to a more developed overall code (and associated length), one of the more significant aspects of the new code revision is the presence of new ‘interpretive guidance’ throughout the IPHA SelfCare Advertising Code.  This ought to be of significant benefit to member companies and others in seeking to ensure the objectives of the code are more readily understood and applied in practice.

Consumer healthcare advertising checklist:  Companies and their advisers will also find it useful that the IPHA SelfCare Advertising Code includes, in an annex, a new recommended checklist for advertisements for consumer healthcare products. 

Inclusion of traditional herbal medicines and consumer medical devices: Notably, the code revision here now expressly includes traditional herbal medicines which had previously been excluded from the scope of the previous code.  As to the substance of the code’s position on these, it now states, for example, that claims such as “clinically proven” or “effective in…” are not acceptable as registration for traditionaluse is based exclusively on long-standing use.  Similarly, medical devices which are available to consumers to purchase without prescription for selfcare use are also now included within the scope of the IPHA Self-Care Advertising Code, as ‘consumer medical devices’.

Online activities: There is a new section on online activities and associated online advertisements, and the revised code specifically states that the requirements for advertising of products apply equally to advertisements that appear online.  In addition, there is a new requirement on companies to ensure that they have appropriate monitoring in place where dynamic content can be added to a platform for which the company has ownership or control. This includes having and making available a moderation policy for acceptable content and the removal of inappropriate content that may be in breach of the letter or spirit of the IPHA SelfCare Advertising Code.  However, the code clarifies that genuine user generated posts (e.g. reviews that have not been influenced by a company) are not within scope of the code unless adopted and used by a company.