Transparency reporting obligations under Code confirmed
It took over 6 months of negotiations between the ACCC and Medicines Australia, but the ACCC has finally granted authorisation for the 18th edition of the Medicines Australia Code of Conduct (Code) for 5 years. Our previous report, in relation to the ACCC's initial concerns with the Code, is available here.
Under the 18th edition of the Code, member companies are required to report transfers of value made to individual healthcare professionals (HCP) from 1 October 2015 by publishing details of the transfer, including the recipient's name and practice address on their websites.
The issue about whether member companies are required to obtain the HCP's informed consent to the disclosure of their personal information has also been resolved.
For transfers of value between 1 October 2015 to 1 October 2016, member companies are required by the Code to obtain informed consent from the HCP before they can disclose his/her personal information. Without consent, member companies can still engage a HCP and fulfill their obligations under the Code by reporting aggregate transfers of value without disclosing the HCP's personal information.
From 1 October 2016 onwards, member companies are required to take appropriate steps to ensure that the HCP reasonably expects that his/her personal information will be disclosed. Member companies are not permitted to make transfers of values to a HCP if those steps are not taken.
In total there are 6 different types of reporting obligations under the Code, some of which will phase out over the next 6 months while others will be introduced. With the 18th edition now authorised, member companies have certainty about the nature of their reporting obligations over the next few years and will now need to ensure collection of the correct information to comply with the new obligations.