3. Scope and topics of codes of conduct


1. Scope and topics of codes of conduct

1.2. Overview of scope

In Essence, the EFPIA Code covers (abbreviated details in brackets):

Promotion of Prescription Only Medicines (POMs) to HCPs,
(all methods of Promotion including, oral and written, journal and direct mail advertising, the activities of Medical Sales Representatives, digital communications and channels, such as websites and social media, audio-visual systems such as films, video recordings, data storage services and the like. It also covers the provision of Informational or Educational Materials, Items of Medical Utility, hospitality in relation to Events and Medical Samples)

Interactions between Member Companies and HCPs, HCOs,
(including those in the context of research or contractual arrangements (incl. non-interventional studies as well as consultancies and advisory boards).

Interactions between Member Companies and POs,

Disclosure of ToVs from Member Companies to HCPs, HCOs and POs; and

Procedural requirements of the EFPIA Code.

Member Companies are responsible for the obligations imposed under any relevant Applicable Code (includes national codes based on the EFPIA code) even if they commission a Third Party to design, implement or engage in activities covered by the Applicable Code on their behalf.

The EFPIA Code is not intended to restrain or regulate activities directed towards the general public which relate solely to non-prescription Medicinal Products.

The EFPIA Code does not cover:

  • the items contained in the provisions of Article 86 (2) of Directive 2001/83 (listed), except ‘information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products’ (See also Lesson 2 Advertising and promotion of medicines to the public and to HCPs)
  • activities which relate solely to non-prescription Medicinal Products; or
  • non-promotional, general information about Member Companies, including financial data, descriptions of research and development programmes, and regulatory developments

Finally, a set of practical rules is annexed to the code to help national organisations implement these principles in specific national codes including how to process complaints, and to determine sanctions:

The following documents, binding to EFPIA members, are attached to the EFPIA Code:

Annex A  Standardised Disclosure template;
Annex B  EFPIA guidance;
Annex C  Guidance obligations for Member Associations under the EFPIA Code; and
Annex D  EFPIA Standard Operating Procedure related to processing of complaints and questions submitted to EFPIA;
Annex E  EFPIA Ethics rules and procedure (an on-line platform to pre-assess events).

Additional documents to illustrate the provisions of the EFPIA Code and provide explanations for a consistent implementation:

Annex 1  EFPIA recommendation Disclosure “Gateway” on Member Associations Websites
Annex 2  Examples of the ethical principles
Annex 3  Principles for the use of digital channels