Pharmaceutical companies targeting Irish customers should note that updated rules have recently been published by the Health Products Regulatory Authority (“HPRA”) and the Irish Pharmaceutical Healthcare Association (“IPHA”). The changes centre around restrictions on advertising and inducement to prescribe, and come at a time of transition for the Irish pharmaceutical industry where negotiations on a new pricing agreement between IPHA and the Irish Public Health Service (HSE) will begin in May 2021 following an extension of the previous agreement until July 2021 being agreed in the context of the COVID crisis.
The HPRA is applying enhanced oversight procedures for Advisory Boards as of January 2021, which in particular (i) require companies to give the HPRA notice of any Advisory Board meetings and (ii) provide that HPRA representatives may ‘sit in’ on randomly selected Advisory Board meetings to oversee corporate compliance with pharmaceutical advertising law and related HPRA guidance rules against inducement to prescribe. HPRA objectives to both enhance the formality of Advisory Board documentation and restrict engagement with medics to what is absolutely necessary are apparent, for example from the requirements for written agreements with Advisory Board members and written agendas which demonstrate a real and specific need to engage with particular medics, in particular. Further details are available on the HPRA website here.
IPHA has updated its Code of Practice for the Pharmaceutical Industry (“IPHA Code of Practice”) and issued a new version of the Code of Standards of Advertising Practice for the Consumer Healthcare Industry, now re-named as the IPHA Self-Care Advertising Code. The changes to the IPHA Code of Practice appear to reflect similar objectives to that of the HPRA, with key changes including:
- Ensuring the highest level of management is aware of transfers of value to a healthcare organisation (“HCO”), by requiring companies to obtain written sign-off from the CEO, Finance Director or similar of the HCO when agreeing a transfer of value.
- Ensuring engagement with HCOs / medics is appropriate and balanced, by expressly requiring that any consultancy agreement or medical education engagement with HCOs / medics must be ‘…for the purpose of supporting healthcare, research or education’, must involve sharing of balanced information, must allow diverse views to be expressed, and must not give rise to inducement to prescribe.
- Restricting the potential for company press releases (eg, on M&A) to be construed as drug advertising, in particular by restricting the use of brand names and references to medicines.
- Requiring further transparency and formality in arrangements with patient organisations, in particular by requiring companies to put in place a written agreement which must state in particular the purpose of the arrangement and the value of the financial support provided by the company (including any significant indirect support and significant nonfinancial support). Ensuring that all IPHA members understand and apply advertising rules in exactly the same way by providing a new interpretive guide and compliance checklist in the IPHA Self-Care Advertising Code.
- Extending the scope of the IPHA Self-Care Advertising Code, by making online advertising as well as advertising of traditional herbal medicines and consumer medical devices subject to it for the first time.
Further details are available on the IPHA website here.