What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
Sponsorship (e.g. sponsorship of sales promotion days as well as sponsorship of scientific congresses) and forms of direct marketing are subject to the general restrictions of the AMG.
As mentioned above, the hospitality offered to healthcare professionals within the framework of a scientific event must be limited to the organisation, payment or reimbursement of the healthcare professional’s travel, meals, overnight stay and registration for the event. It may in no case contain the organisation or funding of any cultural, sports or other leisure activities or any other form of entertainment.
None. It is an established practice that a pharmaceutical company is a sponsor of a sports event (running marathon), cultural event (exhibition, etc.).
The events geared towards to healthcare professionals must be celebrated in suitable place; entertainment, sports or recreational activities may not prevail over scientific activities; these activities shall occupy at least the 80% of the scheduled time. Affiliates to GPP must not offer support or finance social, recreative, sports activities or any other nature than academic.
According to the Pharmaceutical Industry Code, support and assistance can only be provided by companies with regards to the duration of the educational aspect of the meeting. Companies must not organise or sponsor meetings to coincide with sporting, entertainment or other leisure events or activities.
The Pharmaceutical Industry Code recognises companies may provide what may be considered as “corporate hospitality” (e.g. opening a new office). Corporate hospitality involving sporting, entertainment or social events or activities must not be extended to healthcare professionals.
As referred in the previous paragraph 14, the events cannot have any social program or activity that may prejudice or prevent the full attendance of the healthcare professionals to the professional or scientific sessions of the event.
However, Apifarma´s Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Healthcare Professionals and Institutions, Organisations or Associations Comprising Healthcare Professionals, establishes in what refers to the hospitality costs, that such costs are to be restricted to the main purpose of the event, and cannot include entertainment events (for example: leisure, entertainment of sport events/activities).
The above-mentioned Code of Ethics also establishes that cannot be selected locations and/or touristic resorts that are best known for its leisure, entertainment or sports facilities.
As explained in Question 14, expenses for non-scientific activities may not be covered. In addition, any leisure activities – even if paid for by the attendees on their own – may only accompany the main scientific event and must be of minor importance.
The PPPMD Guidelines provide that purpose of the event must be to provide scientific or educational information. Hence, organizing non-scientific events may not be allowed.
To ensure appropriate focus on education and informational exchange and to avoid the appearance of impropriety, PPPMD companies shall not provide any form of entertainment that would incur expenses for recreational items, such as tickets to the theatre or sporting events, sporting equipment, or leisure, or vacation trips, to any HCP.
Entertainment or recreational benefits shall not be offered, regardless of (1) the value of the items; (2) whether the company engages the health care professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose.
No stand-alone entertainment or other leisure or social activities shall be provided or paid for by companies during scientific meetings.
LER states that recreational activities in relation to scientific conferences arranged or sponsored by pharmaceutical companies are not allowed. Simple social activities, such as background music or local performances, playing at the venue in connection with the conference, shall not be considered as offered by pharmaceutical companies provided that it has neither been organized, requested nor paid for by the pharmaceutical company.
As explained, each participant in a continuing training event and each participant in a postgraduate training event shall pay, at least, respectively one third and one fifth of the optional activities fees, which are clearly of a secondary importance (user-friendly programs) (new Art. 6 par. 2 OITTP). If the activity is not considered as of secondary importance – considering its cost, duration or content (especially when it is particularly extensive or overlaps the professional part) – its costs shall be entirely borne by the participant. Moreover, none of user-friendly programs (secondary or not) for the person accompanying the participant shall be borne by the pharmaceutical company (new Art. 6 par. 4 OITTP).
On the self-regulatory level, the Pharma Code clearly prohibits pharmaceutical companies to offer or pay for any entertainment or other leisure or hospitality activities (Art. 322 in fine).
There is no specific restrictions on the organization of non-scientific conferences by pharmaceutical companies but doing so might be mistaken as giving anything of interest to the officials (in case of public hospitals HCPs) should there be any relevant procurements involving those relevant HCPs.
As noted above, the Regulations allow for the offering of hospitality within a scientific event provided that:
a. “the hospitality is strictly limited to the main scientific objective of the event; and
b. the person to whom it is provided or offered is a health care professional.”
Therefore, if the “cultural, sports or other non-scientific events” is included within a scientific conference, the hospitality could be regarded as prohibited under Article 300(3), which precludes hospitality that is not “strictly limited to the main scientific objective of the event”.
The general requirement is thus that the hospitality is tied and strictly limited to the purpose of the event (either promotional or scientific). Events that are for the general entertainment of the attendees and that go beyond these purposes are most likely to be regarded as inacceptable forms of hospitality.
Paragraph 6.16 of the Blue Guide clarifies that “hospitality should be strictly limited to the main objective of the meeting and should not be offered to persons who are not healthcare professionals (e.g. partners)”. Similarly, hospitality as “meetings or events held to promote medicines, provided it is strictly limited to the main purpose of the meeting or event. Hospitality should be reasonable in level”.
According to Article 7(2), the rules regarding advertisements relating to medicinal products in the Regulations apply to the sponsorship of promotional meetings or scientific congresses attended by persons qualified to prescribe/supply medicinal products, including the payment of their travelling or accommodation expenses in that regard, and therefore all the restrictions in Part 14 of the Regulations apply to such sponsorship arrangements.
No restrictions whatsoever other than the regular limitations for advertising and promotions of either OTC or prescription products.
The PhRMA Code on Interactions with Health Care Professionals (https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/Code-of-Interaction_FINAL21.pdf) states that the interactions between pharmaceutical companies and health care professionals “are intended to facilitate the exchange of medical or scientific information that will benefit patient care.” As such, in order to “ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theatre or sporting events, sporting equipment, or leisure or vacation trips, to any health care professional who is not a salaried employee of the company.”
Pharmaceutical companies' involvement in conferences must have the primary objective of enhancing medical education. Organising non-scientific events in relation to conferences is not likely to be consistent with this obligation. Additionally, organising any non-scientific event which could be considered entertainment is prohibited.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 9.1.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, ss 9.4.6, 9.5.8.