Meals

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.

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

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)	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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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	Regulatory framework: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EU) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 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 the event location and venue should not become the main attraction of the event. The perceived image of the location and venue must not be luxury, or tourist/holiday-oriented, or that of an entertainment venue, the selected time of year for an event must not be associated with a touristic season for the selected geographic location, only actual and reasonable travel costs may be reimbursed, and they may not cover a period of stay beyond the official duration of an event. If the flight time, including combined flights, is more than 5 hours, only then business class travel may be refunded. First class is never appropriate. no hospitality for family members / third persons, no food deliveries during events, including the virtual ones.

Topic

Details

Specific rules on engaging or interacting with HCPs in regard of medical devices

Regulatory framework: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EU) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC,

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

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

the event location and venue should not become the main attraction of the event. The perceived image of the location and venue must not be luxury, or tourist/holiday-oriented, or that of an entertainment venue,
the selected time of year for an event must not be associated with a touristic season for the selected geographic location,
only actual and reasonable travel costs may be reimbursed, and they may not cover a period of stay beyond the official duration of an event.
If the flight time, including combined flights, is more than 5 hours, only then business class travel may be refunded. First class is never appropriate.
no hospitality for family members / third persons,
no food deliveries during events, including the virtual ones.

European Union

Marco de Morpurgo

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

DLA Piper Rome

T: +39 066 888 0520 [email protected]

Andrzej Balicki, Ph.D.

Partner

DLA Piper Warsaw

T: +48 225 407 401 [email protected]