Compliance Update: The Netherlands

01.03.18 | By Michael Arbini

On November 14th, 2017, the Foundation for the Code for Pharmaceutical Advertising for the Netherlands (“CGR”) announced changes to its Code of Conduct (“Code”) that took effect immediately, and have a direct impact on existing transparency reporting rules.

There were five core changes:

Reporting of Indirect ToVs (Transfer of Values)

In the case of congresses arranged through an organizer/third party, the pharmaceutical company will be obliged to disclose ToVs toward HCPs (Healthcare Professionals) that participated in the event only if the two conditions below are met at the same time:

  • The Pharma Company acts as the sole external sponsor
  • And the Pharma Company has sponsored more than 50% of the total cost of the activity

Additionally, in the specific case that the organizer is a patient group, a partnership of HCPs or an institution of professionals, the remaining amount of the sponsorship cost (after that individual costs per HCP have been deducted and attributed to each HCP) must be reported against such organizations.

Reporting of Indirect ToVs – Third parties

Financial relationships with third parties (e.g. commercial providers) where the ToV cannot be attributed to an HCP or another covered recipient (e.g. Patient Organization) fall out of the scope of reporting under the Code.

This means that if the ToV cannot be disclosed against an HCP or an HCO (Healthcare Organization), this does not need to be reported at all.

Reporting of Hospitality Cost and General Expenses per HCP

When calculating the individual spend for hospitality and general expenses of each HCP, pharmaceutical companies are allowed to disclose the budgeted amount per HCP (e.g. €1000 for food and beverage divided by 10 HCPs = €100 per HCP) provided that it can reasonably be assumed that the actual reimbursement is not more than 15% higher.

Reduction and Simplification of Reportable Service Agreement Types

Currently in the Netherlands, companies can report according to eight different expense categories, five of which are classified as distinct service agreement types.  Following these changes, the service agreement types are reduced to two categories: (i) Fee for services and (ii) related expenses.

Revised Reporting Deadline

The deadline for the report (CSV) submission moves from March 1st to June 1st of each year.

All these changes are reflected in the 2018 edition of the CGR Code, and are immediately effective, meaning that they will apply to 2017 financial relations to be disclosed in 2018 (submission deadline: June 1st, 2018).

Polaris updated its STAR (Spend, Tracking, Analytics and Reporting) Solution reports to address these new requirements. The Polaris consulting team also helps our clients to define, collect and manage the requisite data feeds in a timely manner to comply with global reporting requirements.

Since 2001, Polaris has helped Life Sciences companies around the world create, implement, manage and automate their transparency reporting. These efforts not only reduce costs and risks, but increase efficiencies across the organizations. For information on Polaris’ solutions and how they can help you stay compliant with this and all global regulations, contact us.