Pharmaceutical companies frequently cooperate with patient associations by involving their representatives as speakers in events and meetings.

Relationships between pharmaceutical companies and patient associations are strictly regulated and no promotional purpose is allowed.

Farmindustria Code of Conduct provides guidelines and criteria companies should comply with when collaborating with patient associations.

With the latest version of the Code, released on 5^th April 2022, Farmindustria has introduced the “Expert Patient”.

Patients are considered “Expert Patients” if, beyond having a direct experience and knowledge of the disease, have specific skills related to research, regulatory and advocacy activities – certifications and certificates might be made available.

The collaboration should comply with several criteria and Farmindustria provides a guideline for hospitality, fees for service, transparency rules etc.

Regulatory Pharma Net is available to provide your company with any updates and to support on all regulatory needs on this topic.

Do not hesitate to contact us at info@regulatorypharmanet.com

If a medicinal product is not yet authorized in Italy, it is not possible to do promotional activities except for those of an institutional nature.

The three main scenarios described below can be outlined:

1. Before the EC decision on the EU Marketing Authorisation

Since the topics of the event do not concern any authorised medicinal product, related to the concerned company:

• no request of sponsorship can be done
• the company can sponsor disease awareness events only through institutional activities
• no promotional activities can be performed
• Italian HCPs cannot be invited as participants.

2. Following the EC decision and before the national Marketing Authorisation by AIFA

Since the topics of the events concern a medicinal product centrally approved, related to the concerned company:

• request of sponsorship is mandatory and only disease awareness events can be performed
• no promotional activities can be performed (i.e. no booth/ no promotional materials)
• Italian HCPs can be invited as participants.

3. Following the national Marketing Authorisation by AIFA

Since the topics of the events concern the medicinal product registered in Italy, related to the concerned company:

• request of sponsorship is mandatory
• promotional activities can be performed, provided that promotional materials have been deposited at AIFA and 10 days elapsed after the AIFA deposit without any comments raised by the Italian Authorities. Commercial materials are allowed.
• Italian HCPs can be invited as participants

Regulatory Pharma Net (RPN) can provide any regulatory assistance on meetings/events planning and sponsorship.

Feel free to contact us at info@regulatorypharmanet.com