Frequently Asked Questions

a. Claims
 
Who decides whether an advertisement concerns advertising for a prescription-only medicinal product? If an advertising claim relates to a prescription-only product, its promotional nature will easily be accepted and will therefore constitute advertising. The IGZ monitors compliance with these rules. The Code Commission or the Commission for Appeal of the CGR can also give a decision on this matter after a complaint has been filed or an opinion has been requested.
 
Do the advertising rules also apply to participants from other countries?
The provisions of the Code of Conduct and the Dutch Medicines Act are aimed at the Dutch healthcare sector and so to persons working in the Netherlands. For participants from abroad the rules of their countries will apply. Because the European Medicines Directive also includes rules on advertising, the rules in other European countries will be more or less the same.
 
Is advertising for prescription-only products permitted during an event, if only a very limited group of non-healthcare professionals participate?
Non-healthcare professionals may not be exposed to advertising claims for prescription-only products. If an event is also targeted at this group, measures must be taken. An exception applies for persons who are inseparably connected with the operational implementation of the event, such as employees of pharmaceutical companies, the conference organisation, the conference location and the catering. In the case of large-scale international conferences, it will sometimes be permitted that a small part of the healthcare providers who are not ‘healthcare professionals’ can be passively exposed to advertising for prescription-only products at the event. This means they do not have to be kept away from the stand area (also see under chapter 2, paragraph c).

b. Venue 

Is a 5-star hotel a suitable venue?
The number of stars will provide an indication of the facilities offered by a particular venue. A 5-star hotel will generally not be considered to be a suitable venue, but in the end the classification or any other ranking is not the deciding criterion.
 
Is an estate a suitable venue?
If the estate is known as an exclusive venue, it will generally not be a suitable venue.

c. Costs 

What is the maximum amount of hospitality costs a pharmaceutical company may sponsor for non-healthcare professionals?
The sponsoring of hospitality costs for non-healthcare professionals is not permitted, if that sponsoring is evidently aimed at sales promotion. As long as the hospitality remains limited to a modest meeting arrangement with a simple sandwich, it will be assumed that there is no sales promotion object. If the hospitality goes beyond this, the person involved must pay for it him- or herself.
 
Does it make any difference whether an event is financed by pharmaceutical companies only partly or fully?
The most important difference is that in the case of multiple revenue sources, the amount sponsored by pharmaceutical companies can be lower than the costs of hospitality and speakers. In that case the assessment of whether the limits for hospitality and speakers’ fees are complied with will have to be based on the level of that sponsoring. If there are no revenues in the form of contributions from the participants, this means that no recreational/social activities can take place.
 
What are the consequences if the final settlement for an event differs from the budget?
The decision whether the advertising rules have been complied with will be made on the basis of the actual expenditure. As opposed to the budget, the final settlement will give a picture of the actual costs. In the case of the mandatory prior assessments (for instance via GAIA or by the Code Commission) the budget will be taken as the starting-point and the data provided by the applicant will be deemed to be accurate. In retrospect the parties themselves continue to be responsible for the compliance with the rules (also see Chapter 3, paragraph c, under iv).
 
What is the maximum amount of sponsored hospitality a healthcare professional may receive per year?
For scientific events the sponsored hospitality an individual healthcare professional may receive is a maximum of €1500 per year per therapeutic class. This annual maximum applies to the total of sponsoring received by a healthcare professional within the scope of a particular therapeutic class from all the pharmaceutical companies collectively. It is up to the healthcare professional to ensure that this annual maximum is not exceeded. This means that healthcare professionals must be able to have insight into the sponsored hospitality and the therapeutic class to which it relates. Sponsored hospitality does not in all cases count towards the annual maximum. If the healthcare professional has paid for at least one half of the hospitality costs, the hospitality for that event will not count towards the annual maximum. The pharmaceutical companies have a responsibility to check whether they are not paying a healthcare professional more than the annual maximum (directly) as an individual company.
 
Do the maximum hourly rates for services also apply to speakers from abroad?
No, the Dutch advertising rules have been introduced for the Dutch healthcare industry, so the maximum hourly rates apply to healthcare professionals working in the Netherlands, even if they give lectures abroad.
There may be rules on advertising in the speaker’s country that actually impose restrictions on the fee that speaker may receive.
 
Does a payment for a meal with a value under €75 count towards the maximum hospitality costs a healthcare professional may receive in the case of scientific events (the maximum of €500 or payment of 50% of the costs by the healthcare professional him-/herself)?
Yes, the limit for meal costs in the Netherlands applies in addition to the maximum amount for the total hospitality costs that may be sponsored for that meeting. The maximum of €75 applies for every individual meal enjoyed (in the Netherlands). In addition, the payment of the meal costs must always be restricted to what is ‘strictly necessary’ for participating in the event.

Are there also rules for payments to conference organisations?
Yes, that is the case if a conference organisation is a grouping of healthcare professionals or a body in which they participate and is receiving sponsoring from the industry. In this case services are being provided for which no more than market-conforming rates may be paid. If the conference organisation is not a grouping of healthcare professionals or a body in which they participate, then the rules for advertising do not impose any payment limits.

d. Other questions
 
Can different terms be used to distinguish between ‘non-healthcare professionals’ and ‘healthcare professionals’?
The law defines a ‘healthcare professional’ as a person who is authorised to prescribe and/or supply medicinal products. ‘Non-healthcare professional’ is not a legal term. The parties are free to make a distinction between healthcare professionals and other participants in the event using their own terms.
 
Which parts of the programme are accessible to stand holders?
Congress organisations must make agreements with the pharmaceutical companies about the access to the various parts of the programme for their representatives. The representatives must be recognisable as such (with badges).
 
What responsibility do professional conference organisations have for the compliance with the advertising rules?
The Code of Conduct is only binding for the members of the umbrella organisations associated with the CGR. Conference organisations are therefore not directly bound to the Code of Conduct, but must comply with the Dutch Medicines Act. In view of this, the conference organisation must ensure that proper organisational measures are taken so that the advertising rules are complied with. The organisation should for instance provide badges to the participants, guarantee that (signed) service provision agreements are concluded with the speaker, inform the healthcare professionals about the sponsored hospitality, compile a scientific programme, select a suitable venue, prepare a sound budget, etc.
 
Are physicians who are being trained to become a specialist ‘healthcare professionals’?
Yes, they are medical practitioners with independent authority to prescribe prescription-only medicines. Medical students, including interns, are not healthcare professionals (yet).
 
Are pharmaceutical companies allowed to organise side-events?
Yes, side-events are generally sales-promoting manifestations, which must be seen as independent events for which specific rules apply, provided the side-event is completely separate from the main event. If pharmaceutical companies sponsor specific parts of an event (or main event), these are not side-events and the sponsoring must be seen as sponsoring from which the whole event benefits. Therefore this type of sponsoring must be made visible in one total budget for that event and no separate budgets may be used for this purpose.
 
What are the rules for online programmes?
If e-learning is offered which is partly financed by pharmaceutical companies, then it must be assessed on the basis of the rules for gifts. The value of e-learning for instance may not exceed €50. ‘Value’ means the value a healthcare professional would have to pay for such e-learning.
However, if a physical meeting with a live-stream is sponsored, the rules for the sponsoring of hospitality apply and the costs of the live-stream itself are seen as general organisational costs.
 
May a follow-up/assessment talk be held with the sales department of the pharmaceutical company following the event?
Yes, but if the conference organisation is a grouping of healthcare professionals or a body in which they participate (such as a scientific association), restraint must be exercised. This type of contact must serve to assess the event that was held and may not have a sales promotion object.
 
Do the Dutch advertising rules also apply if foreign branches of pharmaceutical companies act as sponsor or organiser?
Yes. Based on the EFPIA HCP Code all the pharmaceutical companies associated with EFPIA are obliged to comply with the applicable self-regulation of the country in which the event is held.
 
How should amended legislation be dealt with in practice if a positive opinion has already given on the set-up of the event previously?
The event must be held in agreement with the advertising rules as they apply at the time of the event. If the Code of Conduct is amended, the CGR and the legislator will normally provide for a transitional period. This transitional period will allow the parties to make adjustments, if necessary, in the set-up of their event.