We work with a multitude of clients to ensure advertising compliance on a daily basis. 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). The team at Acorn Regulatory ensures that client companies are compliant with all relevant legislation.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 47 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. From January 2016, IPHA member companies will also be required to disclose payments to HCPs in relation to fees for services and consultancy, and contribution to costs related to events (so called ‘Transfer of Values’).
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 publish 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.
Some of the most common areas include:
• High standards not being met (Clause 9.1)
• Discredit to, and reduction of confidence in, the industry (Clause 2)
• Promotional material and activities must not be disguised (Clause 12.1)
• Certification of promotional materials (Clause 14)
• Meetings, Hospitality and Sponsorship (Clause 22)
• Information, Claims and Comparisons (Clause 7)
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. Earlier this year we noted an IPHA public reprimand published in the medical trade press. Here a large pharmaceutical company was found to have advertised a prescription only product in a national newspaper, a major breach of both S.I. 541/2007 and the IPHA code.
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.