EFPIA HCP Code Explained
The European Federation of Pharmaceutical Industries and Associations (EFPIA) serves as the representative body of the pharmaceutical industry in Europe where the relationship between industry and healthcare professionals (HCPs) is very well regulated. All interactions with HCPs are governed by EU Directive 2001/83/EC on the Community Code. Interactions include anything relating to medicinal products for human use, the EFPIA HCP Code, as well as applicable EFPIA Member Associations’ national codes and any other local policies, procedures and laws.
The EFPIA HCP Code benefits patients by fostering a collaborative relationship between industry and healthcare professionals. Simply stated, the code requires that any and all promotional activity and communications related to prescription-only medicinal products be conducted in a truthful manner, avoiding deceptive practices and potential conflicts of interest with healthcare professionals, and that they be in compliance with applicable laws and regulations.
The goal of the EFPIA HCP Code is to maintain an environment where the general public can be confident that choices regarding their medicines are being made on the basis of the merits of each product and the healthcare needs of patients.
The EFPIA HCP Code sets out the minimum standards and requires that its members, at a minimum, adopt any national code provisions no less demanding than the provisions contained in the EFPIA HCP Code. The code applies to any member of the medical, dental, pharmaceutical or nursing professions or “any other person who in the course of his or her professional activities may prescribe, purchase, supply, or administer a medicinal product.”
In the EFPIA HCP Code, “promotional activity” refers to any marketing activity undertaken, organized, and/or sponsored by an EFPIA member firm (or with its authority), which promotes the prescription, supply, sale, administration, recommendation or consumption of its medicinal products. Oral and written promotional activities and communications include, but are not limited to:
- journal and direct mail advertising;
- the use of internet and other electronic communications;
- the use of audio-visual systems such as films, video recordings, and data storage services;
- educational materials;
- items of medical utility, and;
- hospitality in relations to events and medical samples.
Equally as important as what the code covers is what it does not cover, including:
- the labelling of medicinal products and accompanying package inserts, which are subject to the provisions of Title V of the Directive;
- correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
- factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general precautions, trade catalogues and price lists, provided they include no product claims;
- non-promotional information relating to human health or diseases;
- activities which relate solely to non-prescription medicinal products; or
- non-promotional, general information about companies (such as information directed to investors or to current/prospective employees), including financial data, descriptions of research and development programs, and discussion of regulatory developments affecting a company and its products.
For more information, the EFPIA HCP Code (2014) can be downloaded here.