On November 26, 2013 the Association of Research- based Pharmaceutical Manufacturers in Bulgaria (ARPharM) adopted the Code for Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Health Organizations. The new Code requires from the beginning of 2016 all members of the organization to publicly disclose their financial relationships with healthcare professionals and health organizations. Thereby ARPharM joined the initiative of the European Federation of Pharmaceutical Industries and Associations, which adopted its Disclosure Code in June 2013.
Codes for disclosure are intended to introduce greater transparency on the interactions between the pharmaceutical companies and healthcare professionals. This cooperation is based on the exchange of scientific information between healthcare professionals and industry to provide the best possible treatment to patients. Adherence to high ethical standards in these relationships is a must. Pharmaceutical industry aims to ensure these standards by achieving a maximum degree of transparency as to keep relations industry – healthcare professionals well understood and appreciated by the health authorities and the public.
The Disclosure Code requires each company to document and disclose on its website:
- Names of healthcare professionals and healthcare organizations that have received payments or other transfers of value.
- The amounts of value transferred and relations to which it relates, such as congress fee, travel and accommodation, consultancy fees.
Companies are obligated to disclose annually transfers of value, each reporting period
covering a full calendar year (“Reporting Period”). The first reporting period will be the
calendar year 2015.
Time of disclosure
Companies are obligated to make disclosures not later than 6 months after the end of the
The disclosures shall be made by each Member Company within 6 months after the end
of the relevant Reporting Period.
The information disclosed shall be required to remain in the public domain for a minimum
of 3 years after the time such information is first disclosed in accordance with Article 14,
unless for each case:
- a shorter period is required under Bulgarian law or regulations for data privacy or
- the consent of the recipient, related to the specific disclosures and required under
Bulgarian law is revoked.
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 www.arpharm.org or on a dedicated
information website in Bulgarian, to which there is unrestricted and public access.
Applicable National Code. Disclosures shall be made pursuant to the national code of the
country where the Recipient has its physical address. If a Member Company is not resident
or does not have a subsidiary or an affiliate in the country where the Recipient has its
physical address, the Member Company shall disclose such Transfer of Value in a manner
consistent with the national code to which it is subject.
Language of disclosure
Disclosure shall be made in Bulgarian.
Documentation and retention of records
- Each Company shall document all Transfers of Value required to be disclosed and maintain the relevant records of the disclosures made under this Code for a minimum of 5 years after the end of the relevant Reporting Period, unless the consent of the recipient for the disclosure of the transfer of value, including disclosure of their private data, is revoked.
- The contract between the Company and the Recipient, including Transfer of value subject to disclosure, contains clauses stipulating the consent of the recipient to be disclosed for transfer of value under this Code.
- Companies have to renegotiate existing contracts for transfer of value to the Recipient, in order to bring them in line with the requirements of Article 17, paragraph 2 above.
For further information, refer to: