From 1 July 2017, a new version of the Irish Pharmaceutical Healthcare Association Code of Practice (the “IPHA Code”) will become effective. The IPHA Code is a self-regulatory initiative applicable to IPHA members only which aims to ensure high standards with regard to promotional activities and interactions between the industry members and healthcare professionals and organisations.
While the majority of changes introduced in the new version 8.2 of the IPHA Code are administrative or minor in nature, there are a number of substantive revisions (detailed below) that may impact the industry in Ireland. IPHA member companies should take this opportunity to review their compliance process and procedures and ensure alignment with these changes.
1. NO MORE CORPORATE HOSPITALITY FOR CHARITABLE EVENTS
Perhaps the most significant change to the IPHA Code is that corporate hospitality will no longer be permitted to be extended to Healthcare Professionals (“HCPs”) at events organised by not for profit organisations or bona fide registered charities. Previously, the IPHA Code permitted the extension of such corporate hospitality provided certain criteria were met, including the presence of a clear and transparent objective to raise funds for charitable or benevolent purposes.
2. MORE OVERSIGHT OF THIRD PARTIES WORKING FOR INDUSTRY
Previously, the IPHA Code required their members to ensure third parties working for, or on their behalf, had a “good working knowledge” of the IPHA Code but did not demand full complicity. The new IPHA Code goes further to require third parties to be “fully conversant and compliant with the Code”.
Working with third parties, such as advertising agencies and market research companies, may be challenging for pharmaceutical companies as they can be held accountable for actions taken for or on behalf of the company under certain self-regulatory codes of practice. While this new language has the potential to impose a heavier monitoring obligation on member companies, in practice, it may not drastically change the landscape if member companies already conduct sufficient due diligence when contracting with third parties and require them to meet the obligations in the IPHA Code. However, those companies that are not already doing this should take heed of this change and adopt its internal procedures accordingly.
3. ITEMS TO BE PRESCRIBED TO PATIENTS
Persons, other than medical sales representatives, such as nurses or managers are now permitted to provide patient support items to a HCP. Under the previous version of the IPHA Code, only medical representatives could provide patient support items during the course of a promotional call.
This revision, arguably, offers pharmaceutical companies’ greater flexibility in the distribution of patient support items to HCPs.
4. 20 WORKING DAY PERIOD TO CORRECT BREACHES
Another of the significant changes is the introduction of a correctional period for breaches of the IPHA Code committed by members. In the event that the Code Council or Appeal Board has issued recommendations or sanctions on a member company who is found to be in breach of the IPHA Code, the offending company must comply with those recommendations or sanctions within 20 working days of the decision of the Code Council or Appeals Board. Furthermore, the company must, within that same time period, provide details in writing of the actions it will take to address the recommendations or sanctions. There is an opportunity for member companies to seek an exemption from this correctional period following advance written notice to the Code Council or the Appeals Board.
Depending on the nature of the recommendation or sanction, this timeframe may be challenging for companies. For example, the breach may necessitate re-training of employees or third parties working for the company. As such, the compliance and legal teams of IPHA member companies must be in a position to act expediently in the event of any breaches.
5. OTHER CHANGES
In bringing the IPHA Code in line with other EU Member States and the standard practice in the EU, other minor changes were introduced as follows:
» all materials relating to medical products and their uses, whether promotional in nature or not, which are sponsored by a company must clearly indicate that they have been sponsored by that company;
» sponsorship of HCPs attending international events is limited to economy class for flights of five or less hours in duration and business class for flights of five or more hours only;
» the requirement that companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities, as well as the requirement that venues that are renowned for their entertainment or leisure facilities or are extravagant must not be used, applies equally to the sponsorship of meetings as well as to their organisation; and
» making mandatory the publication of transfers of value on www.transferofvalue.ie.