Draft Government Decision on Ensuring the Transparency of the Healthcare System was Published

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A draft Government Decision on ensuring the transparency of the healthcare system was published on 7th of October 2016, on the website of the Ministry of Health. The Romanian version of the draft Government Decision is available here.

According to the draft order

  • the public hospitals

and

  • the private hospitals which have concluded agreements with the National Health Insurance Houses or which use the public patrimony

are bound to declare, among others:

  • the sponsorships, the payment of the investigators handling the clinical trials, and any other kind of transfers of value received by professionals from the medical system having contractual relationships , from manufacturers, marketing authorization holders or distributors of medicinal products or medical devices, as well as associations or foundations or other nongovernmental organizations funded by such;
  • clinical trials conducted within the respective hospital.

Moreover, the draft Government Decision stipulates that the manufacturers, marketing authorization holders and distributors of medicinal products and medical devices, as well as the associations, foundations or other nongovernmental organizations funded by such must comply with the transparency mechanism for the following actions:

  • the sponsorships, the payment of the investigators handling the clinical trials, and any other kind of transfers of value received by professionals from the medical system, professional organizations, patient organizations and any other kind of organization which conduct activities related to the human health, medical or pharmacy assistance.
  • clinical trials, funded and conducted within the Romanian healthcare system.

According to the information available on the website of the Ministry of Health, any interested party can make proposals for the amendment of the draft Government Decision. Proposals must be submitted via e-mail, to the following address propuneri@ms.ro, until 17 October 2016.

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