European Union
Topic | Details |
Relevant statutory law(s) |
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (hereinafter: "Directive") |
Industry code(s) of conduct | |
Other | Not applicable |
European Union
Topic | Details |
Competent authority/authorities enforcing the above statutory law(s) |
Relevant authorities in Member States |
Competent authority/authorities enforcing the above code(s) of conduct |
The European Federation of Pharmaceutical Industries and Associations International Federation of Pharmaceutical Manufacturers & Associations |
Competent authorities enforcing any other provisions indicated above | Not applicable |
European Union
Topic | Detail |
Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc) |
DirectiveNo specific rules EFPIAAll Events must be held in "appropriate" locations and venues that are conducive to the main purpose of the event, avoiding those that are "renowned" for their entertainment facilities or are "extravagant". No member company may organise or sponsor an event that takes place outside its home country unless:
IFPMANo company may organize or sponsor an event for HCPs (including sponsoring individuals to attend such an event) that takes place outside the HCP's country of practice unless it is appropriate and justified to do so from the logistical or security point of view. International scientific congresses and symposia that derive participants from many countries are therefore justified and permitted. |
European Union
Topic | Details |
Restrictions or requirements regarding event venues (e.g., resorts, castles, SPAs, proximity to transport connections or centers with relevant medical expertise, etc) |
DirectiveNo specific rules. EFPIAAll events must be held in "appropriate" locations and venues that are conducive to the main purpose of the event, avoiding those that are "renowned" for their entertainment facilities or are "extravagant". IFPMAAll events must be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Companies must avoid using renowned or extravagant venues. |
European Union
Topic | Details |
Restrictions or requirements regarding accommodation provided to HCPs (e.g. five star hotels, maximum number of nights, minimum duration of events, etc.) |
DirectiveNo specific rules. EFPIAAs a general rule, the hospitality provided must not exceed what those individuals would normally be prepared to pay for themselves. IFPMANo specific rules. |
European Union
Topic | Detail |
Restrictions on air travel (e.g. economy class only; minimum flight duration for business class) |
DirectiveNo specific rules. EFPIANo specific rules. IFPMANo specific rules. |
Restriction on train transportation (class; duration; etc.) | No specific rules. |
Other restrictions regarding travel |
No specific rules. |
European Union
Topic | Details |
Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more) |
DirectiveNo specific rules. EFPIANo specific rules. IFPMARefreshments and/or meals incidental to the main purpose of the event can only be provided:
|
Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable |
DirectiveNo specific rules. EFPIAMember Companies must not provide or offer any meal (food and beverages) to HCPs, HCOs’ members or POs’ Representatives, unless, in each case, the value of such meal does not exceed the monetary threshold set by the relevant Member Association in its National Code. IFPMANo specific rules. |
Restrictions on where meals can be provided? (e.g. no Michelin-starred restaurant) | No specific rules. |
Other restriction (e.g. no alcohol may be offered) | No specific rules. |
European Union
Topic | Details |
Rules applicable to family members travelling together with HCPs to the event location. |
DirectiveNo specific rules. EFPIAHospitality may only be extended to persons who qualify as participants in their own right. In exceptional cases of established health needs (e.g. disability or injury), the travel, meals, accommodation and genuine registration fee costs of an accompanying person can be reimbursed within the same parameters. IFPMACompanies must not pay any costs associated with individuals accompanying invited HCPs, except in cases of medical necessity. |
European Union
Topic | Details |
Specific rules applicable to promotional events organized by/on behalf of MAH in comparison to independent scientific events described in previous points (incl. event location, venue, accommodation, transport, meals, family members, online conferences |
No specific rules. |
European Union
Topic | Details |
Specific rules on engaging or interacting with HCPs in regard of medical devices |
Industry code(s) of conduct: MedTech Europe Code of Ethical Business Practice EU legislation No specific legal rules at the EU level. MedTech Europe Code
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European Union
Marco de Morpurgo
Partner, Global Co-Chair, Life Sciences sector (International)
DLA Piper Rome
T: +39 066 888 0520marco.demorpurgo@dlapiper.com