Netherlands compliance update

MedTechOn 13 January I presented the yearly complaince update for the Netherlands to the Medtech Europe Compliance Network in Brussels. Since the presentation is no secret know-how, I thought I’d share it on the blog, with an overview of the developments discussed in it.

Can’t ask what can’t be offered

2014 was the year in which most of the healthcare professionals (HCPs) in the Netherlands had to come to grips with the fact that their professional assocations had adhered to the GMH Code, thus solving the much lamented problem that HCPs were asking for benefits that the industry was not allowed to offer. Since 1 January 2014 HCPs cannot ask anymore what industry cannot offer. This closes an important gap that tends to undermine industry’s support of selfregulation.

The new version of the GMH code is here, and a track changes version of the code showing the changes for 2015 compared to 2014 is here.

2014 and 2015 are the years in which the Sunshine transparency requirements in the medical devices sector evolve and are implemented. If you read Dutch, you can read about it in detail in the Minister of Health’s update and the GMH’s plan for implementation, and if you don’t in slightly less detail in my below presentation:
[slideshare id=43851708&w=476&h=400&sc=no]

Duty to report

A pilot project started as of 1 January that requires reporting of financial contributions by industry to costs of participation of HCPs in meetings. Any arrangements made have to be laid down in writing and must be reported to the HCP’s employer or board of healthcare institution.

Requirement of prior approval

As of 1 January all interactions that require payment of more than 500 Euro to an HCP for services rendered have to be set out and approved in writing by the HCP’s employer or board of the HCP’s healthcare institution.

External transparency

As of 1 january 2015 the GMH code started a pilot project of Sunshine transparency limited to certain implantables and certain HCPs, which requires that:

  1. manufacturers of ICDs, stents, pacemakers and hip-/knee replacements;
  2. have to track and report consultancy and sponsoring (of other activities than meetings, like education) interactions;
  3. with a total value per HCP of more than 500 Euro per year;
  4. with HCPs admitted in the Netherlands for the specialities of orthopedics and cardiology; and
  5. publish the interactions in the healthcare transparency register (Transparantieregister Zorg) as of 1 January 2016, before 31 January 2016.

Also, there is a prohibition to incorporate clauses in agreements that prevent publication of the relevant details in the transparency register. The GMH code offers model clauses to be incorporated in agreements that address the publication of personal data of the HCPs concerned.

Maximum HCP consultancy fees and costs

Then there is another requirement that you do not see back in the Minister of Health’s report about developments in transparency nor in the GMH plan of implementation: maximum fees and costs for consultancy by HCPs. This caused industry significant concern because this requirement for 2015 was added at the very last moment before adoption of the changes to enter into force on 1 January 2015 without much notice or possiblity to respond. The concerns mainly relate to the fact that the mandatory maximum rates are supposed be normal market value, which, is the common objection, they mostly are not. However, these were the rates that the code body for the pharmaceutical industry had already agreed with the Healthcare Inspectorate for the pharmaceutical field, so these were assumed transposable according to the explanatory notes to the new rates.

The maximum hourly rates are as follows:

  • professor – 200 Euro
  • medical specialist – 140 Euro
  • general practitioner – 100 Euro
  • pharmacist – 100 Euro
  • dentist – 85 Euro
  • nurse – 70 Euro

In case your marketing department thinks it’s clever and says that if the P goes down the Q can go up to achieve the same result, that may not work because the explanatory notes to the GMH code say that also the Q of hours paid should be reasonable given the “nature, qualifications and expertise of the HCP”. However, this qualification sounds more to me like a factor that would impact on the hourly rate than on the quantity of hours (at least in my own business of lawyering: the more experienced and specialised, the higher the hourly rate).

The maximum travel costs that can be reimbursed are

  • Car – 0,37 Euro per kilometer
  • Plane – no 1st class, only business class on intercontinental flights
  • Train – 1st class
  • Taxi – all, but ‘in addition to public transport’ (so no taxiing the whole distance between A and B if public transport is available?)

These costs come from the rules for Dutch civil servants. As tax payer to the Dutch state it is highly reassuring that apparently all Dutch civil servants can always fly business class on intercontinental flights. It’s allowed to compensate additionally for loss of income due to travel (unclear whether the maximum hourly rates apply, because the loss of income is often higher) but it’s not allowed to facilitate double dipping (pay for travel time and for preparation time if the travel time can be used for preparation).

So

Things are happening in compliance requirements in the Netherlands. Medical devices companies with implants concerned that have sponsoring and/or consultancy arrangements with Dutch HCPs in the fields of orthopedics and cardiology have to keep track of payments in 2015, and report during the first month of 2016. The Netherlands has thus joined a growing group of countries requiring sunshine transparency of HCP payments, albeit with a limited pilot.

Want more information? Just let me know.


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