Revised Dutch policy rules on inducement prohibition regarding medicinal products enter into force
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On 1 April 2018, revised policy rules concerning the inducements prohibition with regard to medicines ("Beleidsregels Gunstbetoon Gnw 2018") entered into force. These policy rules provide guidance on what qualifies as an "inducement" and the scope of the prohibition.
The new policy rules revise the previous version dating back to 1 May 2014 in light of recent case law of the Dutch Administrative Supreme Court ("Raad van State") commending a clarification of the policy rules (as it could not be deduced from them that an hourly rate of EUR 140 for a medical specialist would be unreasonable) as well as the recently adopted policy rules on the inducement prohibition regarding medical devices (see our previous blog post: Dutch guidance on inducements by medical devices companies published), which provide guidance on certain aspects that were not covered by the policy rules on medicinal products. The revised rules also seek the alignment with the Code of Conduct for Medicines Advertising (Code of Conduct) and the policies of the Health and Youth Care Inspectorate (HYI).
The Code of Conduct will need to be updated in accordance with the revised rules, and further harmonisation of the new policy rules with the policy rules on medical devices can be expected as well.
The inducement prohibition and relevant exceptions
In principle, offering inducements to practitioners (i.e. anyone who has the authority to prescribe or delivery prescription medicines) is prohibited. However, the Dutch Medicines Act (DMA) includes certain exceptions to this principle provided certain criteria set out in the DMA and the policy rules are met, namely:
- The offer or acceptance of money, services or goods for which the practitioner provides consideration in return.
- The provision and enjoyment of hospitality.
- The offer or acceptance of money, services or goods of limited value that are relevant for the practitioner's practice.
- The offer and acceptance of discounts and bonuses with regard to the purchase of medicines.
Updated guidance on the scope of the exceptions
The revised policy rules include the following revised or additional limitations with regard to these exceptions, in accordance with the Code of Conduct.
Services – The assessment regarding the reasonableness of the hourly rate for services has been aligned with the Code of Conduct. The remuneration provided to the practitioner must be in reasonable proportion to the services provided by the practitioner. Whether this is the case will be determined on the basis of the time spent and the hourly or daily rate of the practitioner (reference is made to the rates set in the Code of Conduct). Account must be taken of the nature and scope of the services provided and the position and qualifications of the practitioner concerned. Moreover, the conditions with which the written service provision agreement must comply have been further elaborated in accordance with the Code of Conduct. The service agreement must be established in advance in writing and must in any case include the content, nature, duration and scope of the service; the result or goal to be achieved; and the fee for the service and reimbursement of any expenses. For transparency purposes, certain information in the service agreement must be published in the Transparency Register.
Hospitality – The hospitality rules now also apply if the compensation is not provided directly, but via an intermediary. With respect to the criterion that hospitality must be strictly limited to the main purpose of the meeting, a few considerations have been added regarding the balance of time spent between the content programme and the other components. Furthermore, in accordance with the policy rules on the inducement prohibition regarding medical devices, the policy rules include requirements with regard to the suitability of the programme. These additions are in accordance with the Guidelines regarding the assessment of scientific meetings ("Uitgangspunten bij beoordeling van wetenschappelijke bijeenkomsten") published in February 2017.
Further, the policy rules slightly revise the guidance on specific financial limitations:
- Hospitality reimbursement for meetings: with respect to meetings (i.e. an organised gathering of practitioners whose sole purpose is to promote their scientific knowledge and expertise in the fields of medicine, pharmacy, dentistry, art of medicine or nursing) there are two alternative criteria. Either hospitality reimbursement does not exceed EUR 500 per event and EUR 1,500 per year or the practitioner contributes at least 50% of the travel, accommodation and enrolment costs related to the visit to the scientific meeting. The ‘per therapeutic class’ component has been removed. In addition, these maximum amounts only apply per authorisation holder and no longer per practitioner (i.e. EUR1,500 is no longer the maximum that a practitioner may receive per year).
- Hospitality reimbursement for other events: with respect to other events (i.e. an organised gathering of practitioners whose purpose is to promote the prescription of medicines) the maximum amount of hospitality reimbursement has been raised to a maximum of EUR 75 per event and EUR 375 (instead of EUR 225) per year. The ‘per therapeutic class’ component has been removed.
- Gifts: the policy rules now include an absolute maximum amount for gifts, which is EUR 50 each time and EUR 150 per year, per practitioner and per authorisation holder. The ‘per therapeutic class’ component has been removed.
- Discounts and bonuses: no revisions have been made in this regard compared to the previous policy rules. This constitutes a deviation from the policy rules on the inducement prohibition regarding medical devices.
Other financial relations
The updated policy rules also include important additions regarding inducements for non-practitioners and sponsoring which are in accordance with the Code of Conduct.
Inducements for non-practitioners are strictly prohibited. Nonetheless, money, services or goods may be offered to non-practitioners if this does not have the obvious purpose of promoting the prescription or use of a medicine. To determine whether this 'apparent purpose' is indeed absent, an assessment must be made regarding the extent to which the beneficiary has influenced or can influence the prescription, delivery and use of medicinal products, as well as the purpose and size of the inducement.
The policy rules now include a separate section regarding sponsoring (i.e. financial contributions of a different nature for the benefit of care activities or projects that are provided in principle to legal persons by entrepreneurs, in which both practitioners and non-practitioners can be involved). Sponsoring is allowed with respect to innovative or quality-improving activities that aim at the improvement of care to patients or the promotion of medical science and the following criteria have been met:
- The sponsorship does not oblige in any way the prescription, handing over or use of medicines from the sponsor.
- The sponsorship is useful and necessary to contribute to the intended health interest.
- The nature, purpose and extent of the sponsorship must be recorded in advance in writing.
- The sponsorship may not require a performance obligation from the recipient, with the exception of the name.
- The sponsorship may not lead to an impairment of the independence, reliability and credibility of the sponsored or other parties involved and of the sector.
- Scientific research that is sponsored must meet the criteria of scientific quality, objectivity and integrity.
The HYI will apply the policy rules when monitoring compliance with the DMA.