Joana Kuci -

The transparency of transfers of value declared by pharmaceutical companies is crucial for maintaining trust and integrity within the healthcare sector.

Pharmaceutical companies affiliated with Farmindustria/EFPIA, including its subsidiaries, affiliates, and other entities within the same Group, are required to disclose transfers of value. These transfers encompass direct or indirect economic transactions, whether monetary or non-monetary, conducted for promotional purposes or in relation to the development and marketing of prescription drugs for human use. Such values may be disclosed individually or in aggregate form.

 

Exemptions from the publication requirement apply to transfers of value associated with over-the-counter (OTC) drugs, as well as those pertaining to promotional items, meals, drinks, and medicine samples.

 

The publication of transfer of value data must occur annually, with reference to the preceding year’s data, by June 30th of the subsequent year.  Each pharmaceutical company is obliged to publicly disclose, the amount of transfers of value conducted in the previous year towards:

  • Healthcare Professionals (HCPs),
  • Healthcare Organizations (HCOs),
  • Patients’ Associations and Patient Experts,
  • Research and development expenses.

 

The data regarding transfers of value must be disclosed in the State where the recipient resides.

When a company does not have a subsidiary or affiliate in the country where the recipient resides, the providing company is still obligated to disclose transfer of value data. This disclosure must comply with the regulations stipulated in the State Code of Conduct applicable to the recipient’s domicile.

 

The disclosed information must remain publicly accessible for at least 3 years from the date of publication. Companies are also required to maintain documentation supporting the published data for at least 5 years, either in physical or electronic format.

 

Regulatory Pharma Net assists companies with data analysis, guideline implementation, and adherence to deadlines for transfers of value disclosure. The deadline for compliance with the deontological code is approaching and we stand ready to provide support!

 

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