Zambon Netherlands Methodology for Disclosure of Financial relations

Zambon Netherlands is the Dutch based wholy owned subsidiary of Zambon S.p.A. which is an Italian Headquarters pharmaceutical company.  Zambon Netherlands is a member of  the industry association for the Dutch branches of innovative pharmaceutical companies, ‘Nefarma’. This association takes part in The Foundation for the Code for Pharmaceutical Advertising ("the CGR"). The rules of CGR governing the relationship between the industry and healthcare professionals closely follow the EFPIA code (European Federation of Pharmaceutical Industries and Associations) to which Zambon S.p.A. belongs to.

On 1 January 2012, the CGR1 implemented new rules on the disclosure of financial relations. These rules require that arrangements be made for the disclosure of service and sponsorship relationships agreed between pharmaceuticals companies and healthcare professionals, partnerships of healthcare professionals and institutions which employ healthcare professionals. Disclosure is compulsory if the healthcare professional, partnership or institution in question receives more than € 500 (in money or in kind) from a pharmaceutical company in any calendar year.

The rules stipulate that disclosure is to take place each year following the year-end by means of a single centrally held transparency register. In principle, the pharmaceutical companies are responsible for reporting financial relationships to the transparency register. If a healthcare professional has entered into a financial relationship with a pharmaceutical company based abroad, the obligation to register it lies with the healthcare professional. Financial relationships effectuated in any year and which exceed the € 500 limit in total must be entered in the central register at the start of the following year.

Disclosure takes place in a central transparency register, set up in collaboration with the Ministry of Health, Welfare and Sport. The management of the register is entrusted to an independent foundation (Stichting Transparantieregister Zorg).
The public may consult the transparency register through the internet (www.transparantieregister.nl). The data are searchable by the name of the recipient, i.e. the name of the healthcare professional, partnership or institution. Entering the name will produce a summary of the reported financial relationships which the party in question has had with pharmaceutical companies.

For the sake of clarity of registration and accurate linking of data, a reliable database is crucial. The transparency register is entitled to use the Individual Healthcare Professions (BIG) register of the government, which provides a guarantee of accuracy in registering personal data and compiling the central register.

The register has the following reporting structure:

1. The name of the healthcare professional, partnership or institution concerned;
2. The name of the pharmaceutical company concerned;
3. The nature of the financial relationship;
4. The amount;
5. The year to which the relationship relates.

Name of the recipient: in order to be able to “match” the names of healthcare professionals, a unique number must be used. As indicated above, the BIG number is used for healthcare professionals. For partnerships and institutions (legal persons), their registration numbers with the Chamber of Commerce are used.

Name of the pharmaceutical company: the name of the pharmaceutical company which registers as a sponsor. If a professional has entered into a financial relationship with a pharmaceutical company abroad and reports the relationship him/herself, the company name submitted by him/her will be entered.

Nature of the relationship: the reporting party will be asked to classify the financial relationship in question according to one of the following categories:

  • Consultancy services
  • Advisory board services
  • Services for non-interventional research outside the scope of the Dutch law on medical research in humans
  • Expenses
  • Other services
  • Sponsorship of meeting
  • Other sponsorship

The amount: Amounts are submitted in whole euros.  In the case of service provision by a healthcare professional, only the fee (excluding VAT and expenses) is to be registered. In case of sponsorship agreements, the full sponsorship amount is to be submitted. If as part of an agreement with a partnership or institution, personal services are rendered by a healthcare professional, this relationship must be registered separately, stating the fee received for these services. In such a case, therefore, certain sums of money must be submitted twice: the total contract value in the name of the partnership or institution and the fee for the personal service provision in the name of the healthcare professional concerned.

The transparency rules apply not only to monetary reimbursements but also to reimbursements in kind. Reimbursements in kind must be submitted at their equivalent monetary market value.

The year: Financial relationships effectuated in any year and which exceed the € 500 limit in total must be entered in the central register at the start of the following year. Reporting takes place at the start of the year following completion of the service and/or sponsorship.

Data Protection Law: The Healthcare Transparency Register uses the `BIG-register' for information on healthcare professionals. This has been reviewed and approved by the Dutch Data Protection Agency.

Research and Development Transfers of Value
There has been no Transfer of value for Research and Development by Zambon Nederland in 2015.

About the Transparancy Register

The Transparency Register Foundation (Stichting Transparantieregister Zorg) was established in 2012 at the initiative of the Foundation for the Code of Pharmaceutical Advertising (Stichting Code Geneesmiddelen Reclame, CGR; CGR website) for the purpose of providing insight into financial relationships between healthcare providers and pharmaceutical companies. Stichting Transparantieregister Zorg manages a central database which can be used by the public to consult data on certain financial relationships between pharmaceutical companies and physicians, healthcare providers, partnerships of healthcare professionals and institutions which employ healthcare professionals. Transparency is of importance in other branches and occupational groups as well. Therefore Stichting Transparantieregister Zorg has been established independently of the CGR. There is a great likelihood for the foundation to manage and publish financial relationships from other branches and occupational groups in the future as well. During the first quarter of 2014, financial relationships between veterinarians and veterinary pharmaceutical companies will be added to the register. 

Stichting Transparantieregister Zorg is managed by an indepedently operating secretary (Mrs. mr. J. Galjaard), who operates under supervision of a supervisory board consisting of the participating sector organizations (Mr. dr. L. Wigersma representing the KNMG, Mr. drs. A.M.J.A. Duchateau representing the KNMP, Mr. dr. M.A. Dutrée representing Nefarma and Mr. drs. P.F. Bongers representing Bogin). The foundation constructed a central database with a web portal with financial support of the Dutch Ministry of Health, Welfare and Sports. KNMG Opleiding & Registratie processes reports concerning financial relationships made to the transparency register.
Stichting Transparantieregister Zorg processes the data on pharmaceutical companies and healthcare providers and –institutions by order of CGR. For more information on rules and regulations with regard to transparency, please visit the CGR website: Stichting Code Geneesmiddelenreclame
The CGR Rules of Conduct Disclosure Financial Relationships include the obligation to physicians, pharmacists, nurses and physician assistants on the one hand and pharmaceutical companies on the other to report data on service, consultancy and sponsorship relationships to the register. Agreed upon is the fact that in the first instance pharmaceutical companies report to the register the financial relationships they entered within the Netherlands. If there is a financial relationship with a pharmaceutical company abroad and an actively in the Netherlands operating physician, healthcare provider or –institution, the obligation to report the register lies with the physician, healthcare provider or –institution.

1. The Foundation for the Code for Pharmaceutical Advertising ("the CGR") is a self-regulatory organisation, in which the following participating umbrella organizations take part:

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)