With the recent publication of the French Decree on Transparency (based on the legal requirements of the French law of December 29th, 2011) it seems relevant to analyse the Dutch self- regulatory approach to the public disclosure of interactions between pharmaceutical companies, healthcare professionals (HCPs) and healthcare organisations (HCOs).
For some countries, such as France, the United States or Slovakia, the transparency process comes from a regulatory approach. For other countries, such as Holland, the process is based on a system of self-regulation.
The Dutch initiative grew from a statement by the Health Minister, who declared in 2009 that, rather than impose transparency rules onto pharmaceuticals companies, it would be better in a first instance to let the stakeholders develop their own self-regulation code. This led to the elaboration of the “Code of Conduct on Transparency of Financial Relationships”.
The Code has a high degree of legitimacy for the following reasons:
- It has been developed by the stakeholders
- It guarantees their implication
- It has been approved by the Administration
- The Administration gave its financial support for the elaboration of the computer register
The self-regulation project was developed in 2010 and 2011 and involved all stakeholders: pharmaceutical companies, healthcare authorities, healthcare professionals, patients, healthcare organisations and politicians. It led to the creation of a computerised database managed by the Transparency Register Foundation. This foundation was created from the Foundation for the Code of Pharmaceutical Advertising, which manages the Dutch self-regulation Code.
The register establishes the publication of service contracts and partnerships between pharmaceutical companies and HCPs and HCOs. Publication involves the monetary amount of the contract or the partnership, as well as the name of the beneficiary and of the recipient and is mandatory for amounts over 500€.
The project, whose objective is to publish all the payments made in 2012, was finally launched the same year. The deployment schedule is detailed below:
- November 2012: pharmaceutical companies conducted tests
- December 2012: preparation of the data’s publication
- Half January 2013: pharmaceuticals companies entered the final data into the database
- February 2013: HCPs & HCOs controlled the data
- March 2013: a final control was conducted
The register was made public on April 1st on the following web address: http://transparantieregister.nl/
Contracts are organised as follow:
- Consultancy Services
- Advisory Board Services
- Speaker Services
- Non-interventional Study Services
- Other services
- Meeting Sponsorship
- Project Sponsorship
It is important to note that the database relies on a unique identification system of 350,000 Dutch healthcare professionals, thanks to a code attributed by the Administration available in the ‘BIG-register’ (https://www.bigregister.nl/en/aboutthebigregister/).
The data will be available on the website for three years. The public will be able to search an HCP or an HCO with their identification number. However, it has been decided that the public will not be able to search for individual pharmaceutical companies. HCPs, HCOs and pharmaceutical companies are given unique identifiers to access the register and information related to them.
The register is updated annually:
- By pharmaceutical companies
- By HCPs who are asked to publish contracts signed with foreign pharmaceutical companies for international events
This separation of responsibilities is justified by the fact that the pharmaceutical companies based in Holland do not always have access to the amounts received by healthcare professionals abroad.
There are three main figures of interest for this first disclosure:
- 50 pharmaceutical companies published their data
- Contracts/Partnerships published represent 30 million euros
- 2/3 of HCPs and 1/3 of HCOs are concerned by the publication
Thus, Holland has become the second European country to publish the healthcare industry’s data for payments made to HCPs and HCOs, after the UK (whose first publication was in March 2013). The Dutch example is interesting because it consists of a detailed publication on a unique website. For this reason it is close to the approach chosen by French legislators.