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Posts Tagged ‘Transparency’

Healthcare Transparency Register concept law

May 14, 2019

The Netherlands 

On 30 April 2019, the concept text for the Healthcare Transparency Register law was presented for consultation. With this concept law, the obligation for suppliers of medicines and medical devices to report financial relationships with healthcare professionals and patient organizations to the Healthcare Transparency Register becomes legally anchored.  

The concept law anticipates the evaluation of the Healthcare Transparency Register that is currently being carried out by the Institute for Rational Use of Medicine. The results of this evaluation are expected by the end of this summer. 

The Healthcare Transparency Register Foundation will study the concept law and involve it in the results of the evaluation.

Source 

The Mdeon Code of Ethics has been updated

October 19, 2018

Belgium

The main reason for the update of the Mdeon Code of Ethics is to align it with the Sunshine Act. Simultaneously, the Practical Guidelines of the code have been adapted as well.

The two major changes are:

  1. Adaptation of the chapter on the transparency obligation according to the Sunshine Act (Chapter 1 of Title 3 of the Law of 18 December 2016 on various health provisions).
  2. Adaptation of the Practical Guidelines related to Article 3 of the Code of Ethics according to the caselaw applied by the Visa Office for 10 years, in particular the fact that the sponsorship of scientific training courses should always aim at continued medical education of the healthcare professionals. This means that it should therefore always be possible to combine the training course with the exercise of their profession without interrupting it for a long time. Long-term scientific training courses (i.e. more than three weeks) can therefore not be sponsored by the industry (e.g. fellowship of several months, additional year of study) since these are no scientific events within the meaning of article 10 §2 of the Law concerning medicines.

The 2018 version of the Code of Ethics and Practical Guidelines can be found on the Mdeon website.

Mdeon’s recognition as transparency platform

August 31, 2017

On 22 August 2017, the Royal Decree of 31 July 2017 was published in the Belgian Official Journal. This Royal Decree confirms the recognition of the non-profit-making association Mdeon to perform the transparency tasks that were entrusted to the FAMHP. Mdeon is now officially authorized to manage the transparency platform betransparent.be as described in the Sunshine Act, and is thus responsible for the management of the annual disclosures of premiums and benefits that were granted from pharmaceutical and medical devices companies directly or indirectly to healthcare professionals, healthcare organizations or patient associations.

Mdeon’s recognition has been granted for an indefinite period.

Implementation of the Sunshine Act: the Royal Decree is published!

June 23, 2017

Hot news: The Royal Decree (RD) that implements the Sunshine Act is published today, June 23rd 2017! We summarize the most important changes compared to the current practice on betransparent.be, which was solely based on the Deontological Codes of the industry associations as there was no legal basis yet.

As from now, besides Rx medicines and medical devices, also over-the-counter (OTC) medicinal products are in scope and will need to retro-actively comply with this RD for all transfers of value made since January 1st 2017. In addition, as the definition of a healthcare professional (HCP) in this RD has slightly changed, with the inclusion of veterinarians, the Sunshine Act is applicable to the business of veterinary medicines as well. However, animal health companies get an exemption from this obligation for one year and will only disclose as from 2018.

Furthermore, transfers of value made by a pharmaceutical company for the benefit of a HCP must be disclosed in name of the HCP, even if the HCP acts from a legal entity (NV/SA or bvba/sprl).

Indirect transfers of value (through a third party, congress organizer or a hospital) have to be disclosed in name of the final beneficiary HCP. This is no change, but in practice, this was hard to comply with for many pharmaceutical companies. This responsibility is now being shifted to the third party who will need to inform the pharmaceutical or medical device company of the identity of the final beneficiary and the exact amount he/she received. This information must be provided to the company at the latest on December 31st of the reference year.

As you know, transfers of value to patient organizations were to be made publicly available on the company’s website. According to this RD, however, these transfers of value need to be included in the transparency report.

Transfers of value must be disclosed in the year of the financial transaction, even if this year differs from the year that the services were provided.

And last but not least, an extra month was added to finalize the transparency report! Disclosure has to be made available at the latest on the 31st of May of the year following the financial transaction.

In conclusion, this RD clarifies several grey zones in transparency but also transforms a deontological commitment into a strict legal obligation!

Increased transparency

June 20, 2017

CGR

In the Netherlands, 58.2 million euros have been reported to the Healthcare Transparency Register for 2016 which is a 13% increase in comparison with last year. For the fifth year in a row, transparency between pharmaceutical industry, healthcare professionals, healthcare organizations and patient organizations is increased.

One of the reasons for this increase is the expansion of the Register to distributors of medical devices (ca. 2 million euros). The additional increase is due to the incremental cooperation between healthcare organizations as well as the cooperation between healthcare professionals and pharmaceutical companies.

Collaborations between parties have to be disclosed along with the payments that are associated with it to the Healthcare Transparency Register. The purpose of the Register is to make relationships between healthcare professionals and healthcare organizations more transparent. Moreover, it is publicly available on the internet.