betransparent.be: transparency in the interest of the patient

Started as autoregulation

The industry and the healthcare professionals attach great importance to transparency in all of their dealings.  Such relationships are already regulated by legislation and by different codes of ethics, but in the interest of greater transparency concerning their interaction, a joint, central transparency platform, accessible to the public has been developed in 2015 by the industry in close collaboration with several associations from the healthcare sector.

The betransparent.be platform is a new, autoregulation initiative in the healthcare sector. Its aim is to encourage and ensure transparent relations between the industry and the healthcare professionals and organisations. betransparent.be in fact lists, in a very clear and simple way, remunerations between the industry and the healthcare professionals and organisations, in the interest of the patient.

Companies affiliated to the platform published on a voluntary basis the premiums and benefits they made to the benefit of organisations or professionals in the healthcare sector.

Grown into a legal obligation

As an important step towards an even greater transparency, the transparency obligation was given, on the initiative of the Minister of Social Affairs and Healthcare, Maggie De Block, a legal anchoring in the Belgian Sunshine Act.

This legal transparency obligation imposes pharmaceutical and medical devices companies, both Belgian and foreign, to document and annualy disclose on the platform Betransparent.be the premiums and benefits that they granted directly or indirectly to healthcare professionals, healthcare organisations or patient associations as from 1 January 2017 .

In this way, you are in a position to verify a.o. which financial transactions were carried out between your healthcare organisation or professional and companies. The first publication based on the Sunshine Act will take place in 2018 and will concern the premiums and benefits granted in 2017.

It goes without saying that good relations between companies and your healthcare organisation or professional is crucial:

  • This relationship generates a mutual exchange of information which encourages and renders possible the development of medicinal products and medical devices intended to improve the quality of life.
  • It is important that your healthcare professional be correctly informed concerning new and existing medicinal products and medical devices in order to be able to guarantee the very best care and treatment. Companies play an important role in this domain.
  • Healthcare professionals, in return, can provide important information to companies in sharing their practical experience concerning medicinal products or medical devices.

The integrity and the independence of healthcare professionals are central aspects

However crucial they may be, relations with the pharmaceutical or medical devices industry must in no way affect adversely the independence of your healthcare professional or organisation. In order to guarantee this independence, companies took the initiative to be transparent about their interactions with healthcare organisations and professionals.

The integrity of decisions made by your healthcare professional concerning the starting, continuing or ceasing of a specific medical treatment is one of the pillars of our healthcare system. For several years now, society has shown an increasing interest in the nature of relationships between the pharmaceutical or medical devices industry and healthcare actors: the public calls for increasing transparency and, on the one hand, confirmation that relations are not having a negative impact on therapeutical decisions whilst, on the other hand, that the healthcare professional’s decision to prescribe a drug or medical device is based solely on clinical criteria and has as its only aim the best interest of the patient.

Publication of transfers of value

Transfers of value

What is being disclosed nominatively on betransparent.be?

  • Fees, payments and reimbursements of costs for services and consultancy granted to healthcare organisations, healthcare professionals or patient organisations,
  • Contributions to the costs of the organisation of or participation to scientific manifestations (such as registration costs and travel and subsistence costs) granted to healthcare organisations, healthcare professionals orpatient organisations,
  • Donations and grants that support healthcare granted to healthcare organisations,
  • Financial or other support granted to patient organisations.

Because this is a legal obligation, there is no need for consent from the healthcare professionals concerned to disclose their data. However, they must be informed beforehand by the companies about the processing of their data.

What is being disclosed aggregated on betransparent.be ?

At an aggregated level, so without mentioning the identity of the healthcare professional or organisation concerned and without further details, the premiums and benefits granted in the framework of scientific research will be disclosed. This includes a.o. premiums and benefits granted in the framework of clinical trials.

Summary

When and how long?

Premiums and benefits are made public at the end of June following the calendar year in which they were granted.

The first disclosures were made on a voluntary basis:

  • For premiums and benefits granted in 2015 (disclosure in 2016), only the companies members of pharma.be were concerned.
  • For premiums and benefits granted in 2016 (disclosure in 2017), only the companies members of pharma.be, beMedTech or Febelgen were concerned.

The Sunshine Act applies for the first time to premiums and benefits granted in the calendar year 2017. These will be disclosed at the end of June 2018 on betransparent.be. By way of derogation, an additional term is granted for premiums and benefits related to veterinary medicinal products. These will only be subject to the Sunshine Act as of January 1, 2018, with a first publication in June 2019.

The disclosed data will be publicly available for public consultation in the Transparency Register for three years. Then they are removed.

You may not find a particular healthcare professional or organisation in the register. This may have several reasons:

  • the concerned person / organisation has not received any premiums or benefits from to the pharmaceutical or medical device industry,
  • the concerned person / organisation has received premiums or benefits from the pharmaceutical or medical devices industry but of a nature other than those to be nominatively disclosed (i.e. in the context of scientific research where there is no personal publication).

In addition, not being referenced on betransparent.be does not mean that a healthcare professional is not engaged in continuing medical education. In fact, even if costs of attendance at scientific manifestations are often sponsored by the industry (within the strict observance of current legislation and code of practice requirements), this may however not always be the case. Healthcare professionals may also fund themselves in continuing medical education.