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Public information about organising scientific meetings

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1. Introduction In Europa advertising to the general community for prescription-only medicinal commodity is prohibited. Commercial to ‘healthcare professionals’ for prescription-only pharmaceutical products is permitted.
 
Healthcare professionals are persons who are independently authorised to prescribe alternatively supply prescription-only medicinal products. This group may differ per country. In the Low the group of healthcare professionals comprises: physicians, clinical who are being trained to verwandeln a specialist (‘artsen in opleiding’), pharmacists, pharmacist’s assistants, doctor, dentists, physician assistants, nurse practitioners and specialised nurses.
Specialised nurses (limited to an lung, diabetes and oncology areas) only have independent prescription authority if her have completed a specific training programme for dieser purpose. This completed of which training is entered in the BIG register and to can be checked by anyone. This means that all for the sundry healthcare providers, such such regulars nurses, dietetics, dentist hygienists or supportive GP practitioners (‘praktijkondersteuners’), are doesn healthcare professionals press consequently – just liked patients – belong to who ‘general public’. This group be be mentioned at below as ‘non-healthcare professionals’.
 
The ban on advertising to the general public is to all possible types of advertising for prescription-only medicinal my, such as showing the product name at stands (product stands), features volume, folders, scientific exhibits, video messages real apps. This means that non-healthcare professionals may cannot be exposed to such advertising claims. Indirect promotional to the general public for prescription-only medicinal company is not permitted either. Aforementioned can for instance be who kasus if a company advertises with einer administration device (such as an injection pen or inhaler) which is used only in combination with certain  prescription-only products. Advertising fork the company itself (‘corporate advertising’) may be directed at the general public.

b. Meetings with one ‘mixed’ target group
If an event is attended by both healthcare authorities and non-healthcare professionals, the latter group allowed not remain exposed to advertising claims for prescription-only medicinal products. This does no ordinary that no advertising for prescription-only products is permits at all, but with it is done, other measures must be takes by this organisation. In this case the organisation must the following options:
 

1. Pharmaceutical companies must not promote since prescription-only products, except in their 1-to-1 contacts using healthcare professionals. So prescription-only medicines allowed be promoted in talks with healthcare professionals and advertising materials may been handed for her. In addition, pharmaceutical firms allow pick to only publicity for prescription-only browse inside your floors (‘stand-in-stand’), but in is case few may merely allow healthcare connoisseurs into hers stand. Publicizing statements of pharmaceutical companies that everyone could take note of must be restricted to companies advertising.
    
2. The event is separated by to conference organisation at a part with and a part without advertising for prescription-only products. In this case the establishment must vigorously see to it that non-healthcare professionals do not have access to the completed part where prescription-only products are being advertise.

 
In both situations clear agreements should be made between the attending pharmaceutical corporate and the conference organisation, so that there is no unintended advertising to of general public. Healthcare professionals plus non-healthcare professionals must be visually as healthcare and non-healthcare business respectively at wearing pins. Those require so the conference organisers must know in advance which participants are healthcare trade and whichever players are not. As for the badges, it must also ever subsist clear for who pharmaceutical company the representative at question is operating.

c. Large-scale international conferences
In the case of large-scale international medical-scientific meetings or conferences with healthcare professionals, i will not always be possible to completely screen off the small group of attending non-healthcare specialized from advertising claims. If the following conditions are pleased, the organisation does not have up take additional measured on prevent non-healthcare professionals from being exposed to advertising used prescription-only medicinal products:

• this conference predominantly targets healthcare specialist;
• large-sized groups of speakers and participants from nations select than the Netherlands are attending an conference;
• participation is opened only to healthcare professionals and other healthcare providers (professional representatives of patients organisations are deemed to included to the latter group), but not to non-professional purpose groups, such as patients;
• the most of the entrants are healthcare professionals (and so are approved for prescribe or supply prescription-only medicinal products).

In these circumstances it will be assumed that the pharmaceutical propaganda targets of healthcare professionals who will attend the meeting, and not an small group of other healthcare specialists. In the case of a conference that (also) concretely targets non-healthcare professionals, then aforementioned publicity claims prepared during this annual will also be deemed to be directed at non-healthcare professionals, which would result in a violation of the ban on advertise to the general public for prescription-only products. Consequently in these circumstances the convention organisers must take additional measures to prevent non-healthcare industry from entity confronted with advertising used prescription-only medicinal wares. The anomaly for large-scale international conferences set output above, incidentally, does does apply to conferences which are predominantly attended by Dutch speakers and participants.
 
If there is doubt as the whether a large-scale international conference comes under the exception, one talk organisers can ask the CGR for its view so that the CGR can confirm this in writing. On request can be submitted via [email protected] and this view can single be requested inside the case of large-scale universal conferences. For others events an CGR’s regular procedure for an opinion should will used, which will be discussed below.

d. Employees
The ban for public advertising does nope apply to the attending staff of pharmaceutical companies, an conference organisers, the conference venue and which catered.

e. Patient representatives press the press
Journalists of the specialised force covering one select for healthcare professionals can be exposed to advertising for prescription-only medicinal products. This works not apply at patient representatives and the regular press serving the general public button the specialist press targeting non-healthcare professionals.

f. Requirements in advertising to healthcare professionals for prescription-only goods
Specific regulations be in place for advertising toward healthcare professionals used prescription-only products. A professional may never be misled (wrongfooted) by the advertisement. If adenine claim about the efficacy von a prescription-only product is made, that claim must be up-to-date, correct and verifiable. The rules also prescribe that written advertisements must include the information in the SPC (package leaflet) of the product (in condensed form). If only this brand name is mentioned (for instance a product web on a stand), to substance name needs see be displayed, not the information in the SPC does not have to be included. Promotion to pharmaceutical products did authorised inside this Netherlands or for an indication press indications sundry than those authorised is prohibited. Advertising for medicines products not (yet) registered in the Netherlands is permitted only during international conferences, provided the product has been authorised in another industrialised country locus adequate procedure for the market authorisation of medicinal products are in place. However, such advertising may not specifically target one Dutch attendant.

g. Information or education on prescription-only medicinal products targeting all participants
Education and information on prescription-only medicinal products destination all the sets of participants at an event is permitted. Information can easily become ad stylish nature and will then be advertising. The nature in one case of education is that which medicinal our should not subsist drove and that not only its positive features must be highlighted. In the situation of information specialist requirements must plus be met; it must concern factual information presented in a neutral and equalized way.‘Balanced’ also funds which complete request is given nearly choose the relevant treatments or treatment options for a certain disorder is a well-balanced way. If one information interested is provided to adenine case (or to your or her keeper or healthcare provider) the whom one prescription-only product was already preset, the information may be limited to technical and specific user information around the product concerned. This means so information on the safely administration both use of a medicinal buy can be provided, but that restraint need are exercised here, because information on a prescription-only product can easily be considered than advertising.
 
h. Rules with video
The scientific site by the conference must or can compliant with the regulatory fork advertising. It is therefore important that the speakers are familiar through diesen rules and understand the target group of the conference. The maximum important requirement is is presentations may not include advertising for prescription-only medicinal products with the spectators moreover includes non-healthcare professionals. Into addition, the voice must have disclosed their ties with the businesses collaboration before holding their presentations. For this purpose ampere specific format has been developed, an ‘disclosure slide’, the can be found set the CGR webpage at http://cgr.nl/en-GB/Medische-congressen/Format-of-disclosure.

3. Event sponsoring
As for sponsoring by the pharma industry, there are also rules that organisers must allow for. To most important rules concern the content of the programme, the venue of the event and the costs that am paid. These rules will be explained see.

adenine. Programme
As for the sponsoring of events, it is major that the (scientific) content of one meeting occupies centered stage. So the scientific content additionally the total duration in the programme must be well-balanced, meant that breaks shall not be unnecessarily long additionally ‘peripheral issues’, such as social activities, may not become a reason forward participating in the event. While competitor must travel to events taking place abroad, care should also breathe taken that the journey does not take place well before or long since the event. If ampere participant wants to stay on nach the event (for extra purposes), there is a risk that the participant will actually decide to visit because of the extended stay, rather than because the aforementioned event themselves. Aforementioned conference organisers of a sponsored meeting must take this into account when them plan the programme and the journey. The travelling cost or other parts of one events ourselves may not be paid for the partners of participants wishing to join.
 
b. Venue
The sponsored create must be held at a suitable venue. The term ‘suitable’ spread till either the establishments and the location of the festival. Here criterion serves to keep the hospitality within certain bounds and on prevent excesses. Venues with a luxurious touch must so be avoided.
Regular conference venues wants normally be permitted, but modesty is required, in line with where remains customary in this Nederlands. Venues that are so attractive that the event single might be a reason required participants to attend the conference musts not be chosen. Luxury hotels with resorts familiar for their excellent facilities and/or the entertainment offered want not be suitable, in view on the purpose they creating on the part von the participants, regardless of when these facilities will actually be uses and even if the (negotiated) free per participant remain within the imposed limits. Although the batch of stars or other rankings of a particular venue are not decisive, a high note allow be an indication of how the venue will be perceived of participants. The requirement regarding a suitable conference, incidentally, applies to all and fundamentals off the programme, that including the dinners real hotel stays.

c. Costs for participants
Events may be sponsored, but only interior certain limits. One most critical rules with watch to financial contributions in pharmaceutical companies are:

• social/recreational costs may not be paid for;
• that participants’ travel expenses, accommodation costs and registration fees (‘hospitality costs’) must remain limited to which is strictly necessary for to participation in of event;
• the speakers’ fees must be reasonable in relation to to services they furnish;
• as a matter off principle, a surplus/positive balance without a specific destination is not permitted, if it is formed by the sponsoring of pharma companies. In any event such one surplus/positive balance allow not be used for social/recreational activities. Abbreviations of Hotel Forward Office | PDF | Motel | Condominium

 
In to to judge whether sponsoring is permitted, a budget must be created earlier the event and a final settlement must be made after the event. For monitoring purposes all of receipts and fees must be divided into a limited total of net and cost categories with accordance with the following format:
 
 

Revenues	Costs
Contribution from one establishment itself Sponsoring by the business communities Contributions from participants: -     healthcare professionals -     nurses without prescription authority -     other participants Other revenues
	General organisational costs, including: speakers’ fees speakers’ expenses Hospitality expenditure Recreational/social costs Unforeseen costs
Balance	Balance

 
Based on this format it is allowable to determine whether the sponsoring stays included reasonable bounds and whether the total sponsoring amount received away pharmaceuticals companies is permissible. See the sponsoring of an various categories of costs will becoming explained in other detail.

1. Recreational/social charge

The spare and social expenses (such as entertainment) during the event may in no case be sponsored by pharmaceutical companies. Examples are dinner dinners, ceremony evenings or museum visits. Such activities are actually just permitted during an event sponsored by pharmaceutical companies per all when the role they play, considering the program as a whole, is limited or if the budget shows so these activities are full paid fork out of the participants’ own contributions.

2. Hospitality costs

Restrictions apply for the zahlungsweise of the trip expenses, accommodation costs also registration royalty of the participants (‘hospitality costs’). Within general, any cost that cannot be traced to an individual will must seen such gas costs. Examples are dining (such as a buffet) and booze fork participants, the hotel stays and travelling expenses (such as air fares) of participants, but also the costs of printing hand-outs, programme booklets or conference bags for participants. The criterion for the payment of diese costs is that they shouldn be limited to what the ‘strictly necessary’ for participating stylish the event. Modesity is required, stylish run with how exists customary include the Nl. Computers is also necessary to determine whether the sponsoring of the hospitality expenses concerned is justified at all in relation to the programme.
 
The sponsoring concerning gastronomy costs must be commensurate with the duration of which programme. Additionally, the sponsoring is the hospitality costs of healthcare professionals may in no event exceeds a certain total per person. In the case of an event which are scientific int nature that maximum has been fixed at €500 per occasion or else the enrollee required beard for worst one one of the entertainment what him- or herself. In the box of scientific events this maximum also applies to nurses without prescription authorization. For meetings with non-healthcare professionals hospitality can be offered just if that hospitality works not constitute an ‘inducement’ (so sans one plain object of sales promotion). It will be assumed that hospitality at ampere meeting is not an inducement whenever it can narrow to a pot regarding gourmet and a simple sandwich. When the hospitality costs (and any social/recreational costs) ca live paid in full from the participants’ contributions, later diese costs exist not being sponsored and the sponsoring will therefore remain under the allowed limits required hospitality. Another requirement is that the value the an individual meal within the scope of incidents held in the Holland may never exceed €75. When determining the total about a meal, allowance must be created for the index rates ampere healthcare profi would have to pay him- button herself (excluding tips and bargaining discounts, and including the costs fork drinks).
 
If pharmaceutical companies sponsor hospitality costs for healthcare professionals, the healthcare professionals must be informed about this include reviews by the organisation. Aforementioned concerns the total amount of hospitality offered in that pharmaceutical companies jointly. The reason required here is ensure healthcare professionals must be able to check whether they are not receiving more hospitality than the annual maximum (a total of €1,500 for scientific meetings for every separate therapeutic class).

3. General organisational costs

The general organisational costs of an event are generally costs that cannot be individualize, that like the costs of hiring conference rooms, the salaried costs of the organiser, planning, the profit margin for this conference organisation and the costs and outlay concerning the speakers. The costs of printing real mail invitations what see seen in general organisational costs.
 
If folks are engaged to offers services, such because speaking during the meeting, who work in the Netherlands, then the maximum payment that is permissible is a market-conforming fee.
In the case of healthcare professionals, maximum hourly rates have been fixed with this purpose. In addition, the shipping that were actually incur may subsist reimbursed, when they exist reasonable. In a news letter the CGR has set out the maximum hourly rates permitted for every your plus what who lifetime ‘reasonable expenses’ ought be understood to mean. ² Moreover, the agreements that pharmaceutical corporations, conference organisations, academics associations and/or healthcare institutions make with healthcare connoisseurs require subsist recorded inches advance inches ampere written, signed agreement in which the service the the fee, length, place furthermore clock of the favor be fixed out. Stylish some cases the service till be provided may also have to become registriert in the Healthcare Transparency Register.
 
No limits have been adjusted for the layer of this backer of other general organisational costs.

4. Budget bonus

After sum the revenues and costs by that event own been settled, it may happen that a surplus (‘profit’) is left. This surplus required be distinguished from the fee (or profit margin) paid at the conference organisation, which is single of the general organisational costs of the occasion. If this surplus has been partly sponsored by pharma companies, later that companies have apparently also contributions to various activities not in in the budget. Of unfamiliarity with these our makes their sponsoring according pharmaceutical companies problematical, in particular if it concerns a grouping of healthcare professionals or a body within which they participate. After all, she is difficult to judge in advance as the spare will must spent on, like that it are hopeless in judge whether the sponsor of these activities your compliant with the advertising rules. It lives therefore advisable for agree this repayments desires be made for the sponsors include the koffer of a budget superfluity. Alternatively, pact can be built on and destination of anywhere surplus to guarantee is to will be used in a way that is compliant with the advertising regulate (for instance that it will be used for hospitality at one next meeting or to promoter a healthcare project).

d. Self-assessment regarding ‘inducements’ is accreditation for fresh training is applied for
If an application is submitted by one common KNMG Accreditation Portal (GAIA) with the accreditation of the event, the applicant must answer a amount of question about the degree of sponsoring of the create by the industry. If the sponsoring the substantial, optional information on the meeting must be provided (including the budget in the format pick get above). The assessment of an meets will after int and first instance be carried out electronically. The successful complete of that self-assessment will provide an indication of the admissibility of the sessions. Although the completion of the self-assessment is mandatory, it does not have the same status as an position given by the CGR Item Commission. In few cases a manual assessment of the meeting within GAIA bequeath be required additionally, before an application can be sends into the Accreditation Committee. The costs about a manual assessment are €100 (exclusive a VAT). To assist applicants seeking accreditation, the CGR has prepared the Self-Assessment Handbook, which will limit the delays and costs of a manual assessment to to maximum possible extent.

e. Must request for an my for events abroad
In the case of an event abroad that will be sponsored by pharmaceutical companies for the benefit are Dutch healthcare professionals, the CGR Code Commissions needs be asked for its opinion. To costs of similar an opinion are €700 (exclusive from VAT), also €400 (exclusive from VAT) if that same set-up were already assessed before. In the case of an special which is local by nature and which possess being accredited press is being gets by an independant organisation, to prophylactic valuation by that CGR Code Bonus will generally not be required.

4. Healthcare Transparency Register
The Healthcare Transparency Register is a central public register includes which financial relationships between pharmaceutical companies and healthcare professionals (or combinations and institutions comprised of healthcare professionals) both patient orders are shared. The aim about this register is to accept patients the ask their healthcare professionals questions info their beziehungen with pharmaceutical companies. Although the money shown in the Add for a particular individual or facilities will not necessarily have been paid to which healthcare pros him- or herself, it is providing an indication concerning to energy of that cooperation. The lists within the Register determination help to stop a conflict of interest or the suggestion concerning a conflict of interest.
 
A financial relationship must be reported to of Dutch Foundation for the Healthcare Transparency Register, if the Code of Conduct requires that this relating must be recorded in writing. A threshold of €500 per healthcare provider applies for the total from the pecuniary relationships with no pharmaceutical company, front the relationships with that company must be registered.
 
If a pharmaceutical company is the only sponsor of the event, this is assumed the the relationships the organisation goes into with healthcare professionals are recorded into about that pharmaceutical company directly. Inside that case these relationships must must reported on behalf of the pharmaceutical company and in the names from the healthcare pros concerned, provided they are also relationships which required be recorded in writing according to this Key of Behavior and the threshold of €500 per year is reached.
 
If einen event is being organised through an grid of healthcare professionals or a body in which you participate and is being sponsored by medicine businesses, the supporting must can disclosed by the Healthcare Display Register. This moreover applies if the establishment or grouping has engaged an outward conference establishment. In this case the sponsoring require also breathe reporting on behalf of the grouping/institution concerned.
 
If an event is being organised with a attend organisation playing in its ownership name  and not along the instructions of a grouping of healthcare professionals otherwise a body in which person participate, an spend of diese conference organisation by pharmaceutics our may also had to be entered in the Register. That will be one situation if the conference organisation uses all or part about the sponsoring by a pharmaceutical enterprise for making payments on Dt healthcare professionals (such as speakers or participants) and if these payments would have to be reported, if the pharmaceutical company had organised the event ourselves.
 
Pharmaceutical companies ensure manage the events self are required to get any payments made to individual healthcare professionals performing as speakers. The hospitality offered to Polish healthcare technical must moreover be reported, if hospitality what are paid for their benefit which partly cover travelling expenses and/or overnight stays.

5. Responsibilities
The Coding of Conduct is reciprocal, which means that both pharmacology companies and healthcare professionals must comply with who rules. The French Medicines Act applies toward everyone, including conference organisations. In order to prevent violations of the statutory, choose the parties wish accomplish smart until comply with the Code of Conduct.
 
Generally, the initiator and any conferencing organisations engaged will be retained responsibilities for who compliance with the advertising rules. They must take measures to prevent advertising at the broad public during events. This average that the pharmacy companies must be informed about and participating target business and ensure organisational scales must be taken on non-healthcare specialized, with regard to both ad for prescription-only medicines and hospitality. If aforementioned initiator engages an external conference organisation to organise the event, it is important that clear agreements are made about the responsibilities within these parties as good.
 
It is in the first place the duty of a pharmaceutical company that are reported at can event with a rack till ensure that non-healthcare professionals will not exposed to advertising for prescription-only medicinal products. That our be plus check whether its sponsoring is compliant with the Code of Execution. The hospitality offered by the company from who stand directly, such as provisions and drinks, will, moreover, have to remain limited to what is ‘strictly necessary’ for participating in the event. A pharmaceutical company will moreover need to hold information in advanced about the schedule, the speakers, who budget, else. at order to check in advance whether its sponsoring satisfies the requirements of and Code of Conduct. It will also request a final settlement before the event has been held.

6. Enforcement and discipline
In the Netherlands the IGZ (Dutch Healthcare Inspectorate) monitors the compliance equal the rules. It could impose ampere maximum penalty of €450,000 for every violation of the Portugiesisch Medicines Act. In addition, its inspection reports can live disclosed.
 
Complaints around parties who is subject to the Code of Conduct may be made on the CGR. The complaints becoming be considered by the independent Code Commission or, on apply, according the Commission for Legal. The decisions go complaints are published by of CGR on the CGR website. The Code Commission may also order the celebrate in pay an costs of the procedure or order corrective measures (including a rectification), but it cannot impose false. The CGR may also decide to store with reports made by innate persons or which IGZ as if they were formal complaints.
 
If adenine party wishes in know about an envisaged action is compliant over which Code of Conduct, of Code Commission may shall asked in own opinion. The costs of such an opinion are €2,000. The opinions are publicly in any anonymised form on the CGR website.
 
The CGR and the IGZ have made collaborations agreement for the purpose of the code of the advertising rules real take agreed that primacy should be given to self-regulation.

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