Regulatory framework

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

EFPIA Code of Practice

IFPMA Code of Practice

Other Not applicable

Last modified 23 Mar 2021

European Union

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

EFPIA Code of Practice

IFPMA Code of Practice

Other Not applicable

Last modified 23 Mar 2021

European Union

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

Last modified 23 Mar 2021

European Union

European Union

Topic Detail
Restrictions on event locations (e.g., events abroad, touristic locations, mountain or beach locations during winter/summer season, etc)

Directive

No specific rules

EFPIA

All 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:

  • most of the invitees are from outside its home country and, given the countries of origin of most of the invitees, it makes greater logistical sense to hold the Event in another country; or
  • given the location of the relevant resource or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the event in another country. 

IFPMA

No 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.

Last modified 23 Mar 2021

European Union

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)  

Directive

No specific rules.

EFPIA

All 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".

IFPMA

All 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.

Last modified 23 Mar 2021

European Union

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.)

Directive

No specific rules.

EFPIA

As a general rule, the hospitality provided must not exceed what those individuals would normally be prepared to pay for themselves.

IFPMA

No specific rules.

Last modified 23 Mar 2021

European Union

European Union

Topic Detail
Restrictions on air travel (e.g. economy class only; minimum flight duration for business class)

Directive

No specific rules.

EFPIA

No specific rules.

IFPMA

No specific rules.

Restriction on train transportation (class; duration; etc.) No specific rules.
Other restrictions regarding travel

No specific rules.

Last modified 23 Mar 2021

European Union

European Union

Topic Details
Limitation on providing meals (e.g. only refreshment for events lasting for half a day or more)

Directive

No specific rules.

EFPIA

No specific rules.

IFPMA

Refreshments and/or meals incidental to the main purpose of the event can only be provided:

  • exclusively to participants of the event; and
  • if they are moderate and reasonable as judged by local standards.
Maximum value for meals (e.g., EUR 60) – please specify by meal (breakfast, lunch, dinner) where applicable

Directive

No specific rules.

EFPIA

Member 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.

IFPMA

No 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.

Last modified 23 Mar 2021

European Union

European Union

Topic Details
Rules applicable to family members travelling together with HCPs to the event location.

Directive

No specific rules.

EFPIA

Hospitality 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.

IFPMA

Companies must not pay any costs associated with individuals accompanying invited HCPs, except in cases of medical necessity.

Last modified 23 Mar 2021

European Union

European Union

Topic Details
Rules originally designed for traditional events (described in previous points) but applicable also to online conferences No specific rules.
Additional rules applicable specifically to online conferences (incl. communication / advertising rules in relation to events attended by multinational audience) No specific rules.

Last modified 23 Mar 2021

European Union

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.

Last modified 23 Mar 2021

European Union

European Union

Marco de Morpurgo

Marco de Morpurgo

Partner, Global Co-Chair, Life Sciences sector (International)

DLA Piper Rome

T: +39 066 888 0520[email protected]