Frequently asked questions
Transparency Register for financial relationships in healthcare
Questions and answers (Q&A)
1. Why is there a transparency register for financial relationships in healthcare?
In the past it became apparent that misunderstandings could arise with respect to the objectives of financial relationships between healthcare professionals, healthcare institutions and pharmaceutical companies. Therefore, in 2009 the then acting Minister of Health Ab Klink initiated the establishment of a transparent system of financial relationships between healthcare professionals, healthcare institutions and the pharmaceutical industry. He was inspired by the American initiative that led to the Sunshine Act; whereby all the money and goods received by a doctor from a pharmaceutical company have to be made public. At that time there was a preference for self-regulation by the parties involved. The CGR took this on and in 2011 and in close consultation with stakeholders drew up a code of conduct to establish a system ensuring transparency. Ultimately, everyone should be able to gain insight into the relevant relationships that exist between healthcare professionals, healthcare institutions and the pharmaceutical industry.
2. Why do healthcare professionals or healthcare institutions and pharmaceutical companies actually work together?
Pharmaceutical companies and researchers work together with healthcare professionals and healthcare institutions because exchanging knowledge and skills leads to new and better medicines and treatments that benefit everyone. The pharmaceutical companies pay the healthcare professionals and healthcare institutions for their work (for example advising). The Healthcare Transparency Register ensures that these financial transactions are made available for inspection to anyone.
3. Which financial relationships are made public by the register?
The Healthcare Transparency Register ensures insight into the financial relationships that are stated in contracts, such as:
•
Services
A physician or healthcare professional can for example give a lecture or presentation, or write a medical-scientific piece for which he or she receives remuneration from a pharmaceutical company.
• Sponsorship
A pharmaceutical company can for example provide financial support for a project or a particular piece of research in exchange for acknowledgment in the relevant publications.
4. Can a healthcare professional with ties to the pharmaceutical industry be independent?
Yes. By choosing a treatment the physician will always act in the best interest of the patient, in line with scientifically established guidelines.
5. Do all healthcare providers and pharmaceutical companies participate?
All healthcare professionals, healthcare institutions and pharmaceutical companies that are affiliated with the following participating umbrella organizations take part in the register:
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)
NVZ (The Netherlands Association of Hospitals)
NFU (The Netherlands Federation of University Medical Centres)
OMS (The Netherlands Order of Medical Specialists)
LHV (The Netherlands National Association of General Practitioners)
A small number of healthcare providers and pharmaceutical companies are not affiliated with one of the above organisations. They have been, and are explicitly invited to voluntarily report any financial relationships. They may contact us using the contact form (
http://www.transparantieregister.nl/Contact)
6. Is participation by physicians in conferences, symposia etc. that are sponsored by pharmaceutical companies also registered?
No, this not necessary because there are already existing rules guaranteeing autonomy. Conferences and other forms of hospitality fall under the policy guidelines and related norms regarding inducements. These are regulated separately by the policy guidelines regarding inducements of the ministry of Health, Welfare and Sport (VWS) and the Pharmaceutical Advertising Code, which is drawn up by the CGR These are enforced by the CGR and the IGZ.
7. Can I also search by company?
It is not possible to search the Healthcare Transparency Register by company. The purpose of the register is to provide transparency of financial relationships of healthcare professionals and healthcare institutions.
8. This transparency register covers The Netherlands. What about across the border and foreign cases?
The register focuses on the registration of financial relationships between healthcare professionals or healthcare institutions and pharmaceutical companies operating/active in The Netherlands. These relationships must be reported to the register. It may concern financial relationships with a Dutch or a foreign pharmaceutical company. Financial relationships that do not relate to Dutch-based healthcare professionals or healthcare institutions are not included in the register.
9. Is the privacy of healthcare providers sufficiently guaranteed?
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.
10. Why is there a €500 limit per calendar year?
The healthcare industry is no different from normal businesses when it comes to exchanges of small gifts for special occasions the administrative burden would be too great if all such small gifts had to be registered, and it was therefore decided to limit the register to substantial financial relationships only.
11. Which authority monitors compliance with the rules?
The CGR is responsible for enforcing compliance.
12. What happens if the financial relationships are not reported or if the rules are not respected?
The enforcement of the code is based on complaints and signals that have been sent to the CGR. On the basis of a complaint or a signal the CGR will investigate whether there is indeed a case of noncompliance. When the CGR finds that the code has not been respected, measures can be taken, including an order to comply, a reprimand and publication. In addition to this, the umbrella organization affiliated with the CGR can take action against a member who does not comply with the code.
13. No entries are mentioned for my doctor. Does this mean that he/she does not have any financial relationships with the pharmaceutical industry?
Yes, that is to say at that particular moment there were/are no financial relationships known at the Healthcare Transparency Register. Nevertheless, there could be relationships that are not on the Healthcare Transparency Register, because they are related to something other than providing a service. For example, doctors may perform research in collaboration with pharmaceutical companies. See the website for what is and what is not registered on the Transparency Register.
(
http://www.transparantieregister.nl/Wat-wel-en-niet-geregistreerd)
14. When do the data concerning a relationship have to be registered?
The relationships must be disclosed within three months following the year in which payment took place. The information will remain on the register for three years at which point the information will be removed.
15. My doctor also sells medicines. Why doesn't this appear in the register?
The sale of medicines and the eventual profits made from this are considered normal business transactions, which fall outside the norms of inducement. They also fall outside the financial relationships covered by the register.
(See
http://www.transparantieregister.nl/Wat-wel-en-niet-geregistreerd)
16. My doctor is doing research on a particular medicine. I do not see this in the register. How can that be?
Clinical research is made public via the CCMO Trial Register
(See
https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm)
17. Can the register guarantee the elimination of improper influencing?
The essence of the Healthcare Transparency Register is to ensure transparency of financial relationships between healthcare professionals or healthcare institutions, other healthcare professionals, healthcare institutions on the one hand and pharmaceutical companies on the other. The openness is to ensure that improper influencing comes to light, if there are signals to that effect. Physicians and companies alike want to prevent the erosion of the autonomy of doctors and other healthcare professionals to act. The cooperation between healthcare professionals, healthcare institutions and industry to establish this Healthcare Transparency Register through self-regulation shows that openness is highly valued by all parties involved.
18. If a doctor has many ties to the pharmaceutical industry, what does that say?
As such nothing, because there can be good reasons for this. What is important is that his/her independent judgement is not compromised. A doctor may have many contacts with the pharmaceutical industry because of his or her specific knowledge or skills. There will be specific reasons in every individual case. Ask your doctor if you would like to know more about this.
19. There are so many different websites for regulations in healthcare. Why aren't these all in one place?
The website for the Healthcare Transparency Register Foundation is specifically designed to provide transparency of financial relationships between healthcare professionals or healthcare institutions and pharmaceutical companies. The rules governing healthcare professionals or healthcare institutions and pharmaceutical companies may be found in part in the law, in part at the various umbrella organizations, and in part at the Pharmaceutical Advertising Code Foundation. These various parties refer to each other, so that all the information is easily located.
20. Who checks whether all the information is registered in the transparency register?
The Healthcare Transparency Register Foundation verifies that all submitted information is complete. In addition to this, each of the professionals concerned has to check that the information is complete.
21. Are there similar registers in other countries?
No, not yet. There are other countries where transparency regulations exist for the relationships between pharmaceutical companies and healthcare providers. However, that this information can be accessed at a single central register is, as far as we know, unique to The Netherlands. In The United States, for example, work is in progress to develop a similar register.
For healthcare professionals or healthcare institutions and pharmaceutical companies
1. I am not affiliated with one of the participating umbrella organisations, but I would like to report to the Healthcare Transparency Register. How do I do that? Please contact us using the contact form: http://
www.transparantieregister.nl/nl-NL/Contact
2. What information is actually published in the Healthcare Transparency Register? The following information is included in the Healthcare Transparency Register: The name of the professional concerned, professional association (such as scientific society, partnership, etc.) or institution. The name of the company concerned. The nature of the financial relationship (consultancy, advisory board, speaker, research, sponsorship or other). The total amount or fees paid in that year.
3. How do I know what has been reported and what can I do if I do not concur with an intended report?
The information reported by a company is forwarded on to the relevant healthcare professionals or healthcare institutions. This is done using the system healthcare professionals and healthcare institutions are familiar with and which is also used for tracking accreditation points. If a doctor does not agree with the report then he or she can indicate this. The underlying agreement is then requested and its content takes precedence. Institutions also have the opportunity to react to an intended disclosure by notifying a contact person. It is recommended that a company provide the name of a contact person for the particular institution to be included on the register.
4. What if the Chamber of Commerce number of the healthcare professional or healthcare institution is unknown?
Companies only have to report payments made to registered Chamber of Commerce numbers (CC numbers). The register links the information from the institution or the partnership. The CC numbers can be obtained from the Chamber of Commerce. If a CC number is unknown, then it is not possible to include the information on the register. The Healthcare Transparency Register Foundation identifies the number of these cases and subsequently provides a suitable solution.