The APME Code regulates:
- the promotion of prescription-only and non-prescription medicinal products to healthcare professionals;
- cooperation between manufacturers of medicinal products and healthcare professionals, healthcare organisations and patient organisations;
- disclosure of the payments made by manufacturers of medicinal products to healthcare professionals, healthcare organisations and patient organisations;
- the procedure for proceedings concerning breaches of the APME Code.
The APME Code applies to APME member companies, their subsidiaries, and any companies affiliated with APME member companies or their subsidiaries if such affiliates have agreed to be bound by the APME Code (Member Companies).
Member Companies shall be responsible for the obligations imposed under any relevant Applicable Code (defined below) even if they authorise third parties (defined below) to design, implement or perform activities covered by the Applicable Code on their behalf.
In addition, Member Companies shall take reasonable steps to ensure that any other parties that they authorise to design, implement or perform activities covered by the Applicable Code but that do not act on behalf of the Member Company (e.g. joint ventures, licensees) comply with Applicable Codes.
The APME Code covers all methods of promotion such as oral and written promotional activities and communication, journal and direct mail advertising, the activities of Medical Sales Representatives (defined in Section 20.01), the use of the digital communications methods and channels (e.g. websites and social media), the use of audio-visual systems (films, video recordings, data storage services and the like). The APME Code also regulates the distribution of informational and educational materials as well as items meant for medical utility, the provision of hospitality related to events and distribution of samples of medicinal products, and stipulates the prohibition on giving gifts.
The APME Code also regulates cooperation between Member Companies, healthcare professionals and healthcare organisations including, but not limited to, those in the context of research or contractual arrangements (including certain aspects of clinical trials, non-interventional studies and consultancy and advisory board meetings). The APME Code also regulates cooperation with patient organisations. The APME Code is not intended to restrain or regulate the activities directed towards the general public that relate solely to non-prescription medicinal products.