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The Netherlands
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

To be reported to the Transparency Register between 14 January 2019 and 31 May 2019 for publication in July.

Authority

CGR (followed by members of other organizations, see details)

Who Must Report

Members of CGR (pharmaceutical companies)

Covered Recipients

Healthcare professionals (HCPs, i.e., persons qualified to prescribe or supply prescription-only medicinal products) and healthcare institutions
MEDICAL DEVICE

Report Due Date

To be reported to the Transparency Register between 14 January 2019 and 31 May 2019 for publication in July.

Authority

GMH (followed by members of Diagned, FHI, Firevaned, Holland Health Tech, Indent, Gain, Nefemed and VGT + KNMG, NVZ and NFu)

Who Must Report

Medical device companies that are GMH members (see above)

Covered Recipients

HCPs, HCP associations and patient organizations
• HCPs with a “BIG number”
• Organizations with a “KvK number”

Pharmaceutical Companies

What is reported:

  • Service agreements
  • Agreements regarding hospitality
  • Sponsorship agreements
  • Agreements for the support of patient organisations
Authority Details

The Foundation for the Code for Pharmaceutical Advertising (CGR) followed by members of the following organizations:

  • Nefarma (Association for Innovative Medicines in The Netherlands)
  • Bogin (Association of the Dutch Generic Medicines Industry)
  • Neprofarm (Association of the Pharmaceutical Industry for Self-Care Medicines and Healthcare Products)
  • KNMG (The Royal Dutch Medical Association)
  • KNMP (The Royal Dutch Pharmacists Association)
  • V & VN (The Dutch Nurses Association)
  • NAPA (The Netherlands Association of Physician Assistants)
  • CBD (The Dutch Association of druggists)

How to Report

The financial relationships can be reported in three ways: (See disclosure template link in Resources)

  1. Manual registration via the portal
  2. One-time upload using an Excel template* in CSV format (using list separators) via the portal
  3. Link to the XML web service

The Transparency Register must be provided with the following information on these financial relationships:

  • Company’s identification number (issued by the Healthcare Transparency Register)
  • Beneficiary’s registration number (BIG / UDN / Chamber of Commerce number)
  • Beneficiary’s email address (for notifying the beneficiary)
  • Number of the type of contract (information on type of contract)
  • Amount (in whole numbers, in euros)

Note

The Healthcare Transparency Register Foundation (Stichting Transparantieregister Zorg) was set up at the behest of CGR, the Dutch Foundation for the Code for Pharmaceutical Advertising, in 2012 with the aim of providing insight into the financial relationships between HCPs and the pharmaceutical industry. The Healthcare Transparency Register Foundation keeps a central register where the general public can find information on certain financial relationships between healthcare providers and organisations and pharmaceutical companies. The register was expanded to include the financial relationships between vets and the veterinary pharmaceuticals industry in 2014 and, as of 2016, the relationships between healthcare providers and the medical devices industry.

This link leads to the search page with which you can check the Transparency Register using the healthcare provider’s name or ‘BIG’ number (the registration number for individual healthcare providers; see www.bigregister.nl) or the name or Chamber of Commerce number of the healthcare organization, in combination with the place where it is located.

Medical Device Companies

What is reported:

Companies must report financial relations with recipients who have a total TOV sum for the calendar year exceeding 500 euros:

  • Remuneration of services
  • Sponsorship of projects or activities other than meetings, between:
    • HCPs listed in the BIG Register in the category “doctor”(except general practitioners); including those in collaboration with institutions
    • Suppliers of medical devices

How to Report

Use the disclosure template at: http://www.transparantieregister.nl/nl-NL/Voor-bedrijven

Disclosures can be presented in one of three ways:

  1. Manual registration via the portal
  2. One-time upload using an Excel template* in CSV format (using list separators) via the portal
  3. Link to the XML web service

The following information must be published:

  • Nature of the interaction and the calendar year in which the interaction was carried out
  • Supplier’s name and branch address and/or Chamber of Commerce registration number
  • For service agreements: the HCP’s personal details and the total amount of the fee; (if applicable) the details (name, branch office and/or Chamber of Commerce registration number) of the collaboration of HCPs
  • For sponsorship agreements: the details (name, branch office and/or Chamber of Commerce registration number) of the collaboration
    HCPs will have the ability to review the data one month prior to its being published.

Note

The Healthcare Transparency Register Foundation (Stichting Transparantieregister Zorg) was set up at the behest of CGR, the Dutch Foundation for the Code for Pharmaceutical Advertising, in 2012 with the aim of providing insight into the financial relationships between HCPs and the pharmaceutical industry. The Healthcare Transparency Register Foundation keeps a central register where the general public can find information on certain financial relationships between healthcare providers and organisations and pharmaceutical companies. The register was expanded to include the financial relationships between vets and the veterinary pharmaceuticals industry in 2014 and, as of 2016, the relationships between healthcare providers and the medical devices industry.

This link leads to the search page with which you can check the Transparency Register using the healthcare provider’s name or ‘BIG’ number (the registration number for individual healthcare providers; see www.bigregister.nl) or the name or Chamber of Commerce number of the healthcare organization, in combination with the place where it is located.

Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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