A new ARPIM Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals (HCP) and Healthcare Organisations (HCO) was published in Dec 2013. The new code is applicable from 1st January 2015.
Applicability of the Code
The Code governs disclosures regarding certain interactions with HCPs and HCOs. It is intended that this Code shall apply to interactions with HCPs and HCOs to the same extent as the existing HCP Code and PO Code. Therefore, this Code applies to Member Companies, including:
- Members: research-based pharmaceutical companies, developing and manufacturing medicinal products for human use, operating in Romania – called members;
- Separate, affiliate entities belonging to the same multinational company – which could be the parent company (e.g. the headquarters, principal office, or controlling company of a commercial enterprise), subsidiary company or any other form of enterprise or organization – shall be deemed to constitute a single company, and is as such committed to compliance with the ARPIM Codes.
The Code sets out the minimum standards which ARPIM considers must apply to all Member Companies (as per the ARPIM HCP/HCO Disclosure Code).
The Code is not intended to apply to Transfers of Value the disclosure of which is already provided for under, or that are otherwise regulated by, the PO Code (as per the ARPIM HCP/HCO Disclosure Code).
ARPIM Non-member companies that decide to voluntarily implement this Code shall comply with all of the provisions of this Code (as per the ARPIM HCP/HCO Disclosure Code).
Form of Disclosure
Annual Disclosure Cycle: Disclosures shall be made on an annual basis and each reporting period shall cover a full calendar year (the “Reporting Period”). The first reporting period shall be the calendar year 2015 (as per Article 2.01 of the ARPIM HCP/HCO Disclosure Code).
Time of Disclosure: Disclosures shall be made by each Member Company within 6 months after the end of the relevant reporting period and 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 2.04, unless, in each case,
- a shorter period is required under applicable national data privacy or other laws or regulations, or
- the Recipient’s consent relating to a specific disclosure, if required by applicable national law or regulation, has been revoked.