Compliance with all applicable codes, laws and regulations to which a pharmaceutical company is subject is particularly relevant when activities/materials involve more than one country or when a company based in one country is involved in activities in another country.
Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.
Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code as well as the national code of the country in which the activities are carried out and materials are used. For example, a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Conversely, a company located in France carrying out an activity in the UK must comply with the ABPI Code regardless of whether or not UK health professionals or other relevant decision makers are involved. Details of the various codes can be found at www.efpia.eu or www.ifpma.org.
The term ‘company’ means any legal entity that organises or sponsors promotion which takes place within Europe, whether such entity be a parent company (eg the headquarters, principal office, or controlling company of a commercial enterprise), subsidiary company or any other form of enterprise or organisation.
In the event of a conflict of requirements, the more restrictive requirements would apply. There is a potential exception with regard to the limits for subsistence set in European countries where the national association is a member of EFPIA and thus covered by the EFPIA Code as referred to in the supplementary information to Clause 10.7.
All international events, that is to say events that take place outside the responsible pharmaceutical company’s home country, must be notified in advance to any relevant local subsidiary or local advice taken.
Companies must take reasonable steps to ensure that any other parties that they commission to design, implement or engage in activities covered by the Code but which do not act on behalf of the company, and are therefore not covered by Clause 1.17, for example, joint ventures or licensees, comply with the Code.