« back to GLOBAL TRANSPARENCY PAGE

Bulgaria
transparency obligations overview

Latest update: 29 November 2018 | Important Notes
PHARMACEUTICAL

Report Due Date

Annually, not later than 6 months after the end of the reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

ARPharM

Who Must Report

Members of the Code

Covered Recipients

Healthcare professionals (HCPs) or healthcare organizations (HCOs)
MEDICAL DEVICE

Report Due Date

Annually, not later than 6 months after the end of the reporting period. Each reporting period covers full calendar year, starting on 1 January and ending 31 December.

Authority

MedTech (BAMDE)

Who Must Report

Members of MedTech

Covered Recipients

Healthcare organizations

Pharmaceutical Companies

What is reported:

  1. Transfers of value to a healthcare organization in any amount related to any of the categories set forth below:

    • Donations and grants to healthcare organisations
    • Contribution to costs related to events, through healthcare organisations or third parties, including sponsorship to healthcare professionals to attend events, such as:
      1. Registration fees;
      2. Sponsorship agreements with healthcare organisations or with third parties appointed by a healthcare organisation to manage an event
      3. Travel and accommodation (to the extent governed by Article 9 of the Code of Ethics)
    • Fees for service and consultancy fees. These include transfers of value resulting from or related to contracts between a Member Company and a healthcare organization under which the HCO provides any type of services to a Member Company or any other type of funding not covered in the previous categories. Fees and expenses involved and agreed to in the written agreement covering the activity will be disclosed as two separate amounts.
  2. Transfers of value to an HCP:

    • Contribution to costs related to events, including
      1. Registration fees
      2. Travel and accommodation
    • Fees for service and consultancy fees. These include transfers of value resulting from or related to contracts between Member Companies and healthcare professionals under which such HCPs provide any type of services to a Member Company or any other type of funding not covered in the previous categories. Fees and expenses involved and agreed to in the written agreement covering the activity will be disclosed as two separate amounts.

How to Report

“For consistency purposes, disclosures pursuant to this Code will be made using a structure set forth in Annex 1, reflecting the requirements of this Code.”
“Disclosure shall be made in accordance with Article 15 on the website of the Member Company, a link to which shall be published on a dedicated information website in Bulgarian http://transparencybg.org/, to which there is unrestricted and public access.”

Resources

CODE FOR DISCLOSURE OF TRANSFERS OF VALUE BY PHARMACEUTICAL COMPANIES TO HEALTHCARE PROFESSIONALS AND HEALTH ORGANIZATIONS (1 January 2014), link 27 January 2018: RPharM_Disclosure_Code_Final.pdf

Medical Device Companies

If applicable (e.g. if your company is a member of MedTech or an industry association that is a member of MedTech): kindly refer to ‘Europe – Medical Device Companies’ for the summary in line with the MedTech Europe Code of Ethical Business Practice.

The Bulgarian Association of Medical Devices Entrepreneurs (BAMDE) is the face of the medical technology industry in Bulgaria. Established on 16 February 2006. It represents approximately 40 companies operating in Bulgaria — almost all major world producers. BAMDE is a member of MedTech.

How to Report

An example of the template can be found in annex II of the following source:
MedTechEurope_Code_of_Ethics.pdf
Disclosures shall be made on the EthicalMedTech website (ethicalmedtech.org) unless the Member Company is already bound by national laws, regulations or professional codes as regulated in Section 1.2 Applicability of these Disclosure Guidelines.

Resources

MedTech Code:
MedTechEurope_Code_of_Ethics.pdf
Link to MedTech Code currently published on MedTech website:
http://www.medtecheurope.org/legal-and- compliance/code
Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

Disclaimer:

The information contained in this website is for general information purposes only. The information is provided by MediSpend and, while we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.

In no event will MediSpend be liable for any loss or damage including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.

Through this website you may be able to link to other websites which are not under the control of MediSpend. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Every effort is made to keep the website up and running smoothly. However, MediSpend takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.