Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC).
We look at the issues relating to advertising a medicinal product in Ireland.
Editor’s note: This article was updated in 2020 to reflect the update to the IPHA code of practice in 2019 that became effective in August 2019.
What Is Transposition?
In simple terms, transposition is a means by which EU member states give force to a directive by passing appropriate implementation measures. This statutory instrument covers areas including advertising to the general public and advertising to health care professionals. In addition to S.I. 541/2007, the member companies of the Irish Pharmaceutical Healthcare Association (IPHA) must adhere to the IPHA advertising code, which sets out additional requirements. For example, all members are required to establish a scientific service in charge of information about its medicinal products and approving promotional material before release. Since January 2016, IPHA member companies have been required to disclose payments to healthcare professionals (often referred to as HCPs) in relation to fees for services and consultancy, and contribution to costs related to events (so-called ‘Transfer of Values’).
Read the Updated IPHA Code of Practice (2019)
You can read the IPHA Code of Practice, updated in 2019, here.
In Ireland, IPHA sanctions include public reprimands, implementation of steps to avoid future breaches, publication of corrective notices, referral to the Minister of Health, or suspension from IPHA.
In the UK, a number of advertising codes are in place, the most notable of which is the ABPI code of practice which is overseen by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA publishes case reports at the conclusion of cases where the code has found to be breached. These should be of interest to member companies for educational purposes, as it highlights common areas where companies fall down.
Six of the most common areas include:
• High standards not being met
• Discredit to, and reduction of confidence in, the industry
• Promotional material and activities must not be disguised
• Certification of promotional materials
• Meetings, Hospitality and Sponsorship
• Information, Claims and Comparisons
It should be noted that certification of materials under the ABPI code must be performed by a registered medical practitioner or a pharmacist (or a dentist for dental use products), something that is not an absolute requirement of the IPHA code, or S.I. 541/2007.
As the HPRA continue to perform random compliance reviews of advertisements in various media, it is important that promotional activities are performed within the applicable legislation and guidelines.
We Can Help
At Acorn Regulatory our experts have strong experience in providing consultancy and advice on medical advertising. Why not talk to us today to see how we can meet your needs. Simply complete the form below or call us on 00353 52 61 76 706.
Further Reading from Acorn Regulatory
Updated for 2020: Development of the Orphan Drug Sector
Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2020), there are almost 770 orphan drugs commercially available and more than 5600 orphan designated drugs in the biopharmaceutical pipeline.
As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability. We look at some facts about orphan designation that companies considering entering the sector should be aware of.
Read more about orphan drugs here.
Medicinal Product Labelling: What You Need To Know
Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended).
Read more about medicinal product labelling here.
Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.
We typically encounter three scenarios:
- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely
In this article, we will look at the benefits and the limitations presented by the three options presented above.