In April, we notified you that the Association of the British Pharmaceutical Industry (ABPI) had released guidance that 2019 data would be submitted and disclosed in the aggregate in an effort to ease the burden on healthcare professionals to review the data during the initial stages of the COVID-19 pandemic.
ABPI has published the 2019 aggregated data, but is now requesting companies "disaggregate" their data and disclose at the individual level. Reports with disaggregated 2019 transfers of value are to be submitted by 31 July 2020. Disaggregated data refers to the individual disclosures for recipients who provided consent for standard disclosure.
The submission portal will be open for companies to submit from Monday 20 July to Friday 31 July at 14:00 GMT.
ABPI also asked companies to confirm that the already published 2019 aggregate data is up to date. The aggregate data will remain published until the official disaggregated data is made available to the public.
Recently the National Organization for Medicines (EOF) announced that the deadline for 2019 local EOF disclosure was moved up from September 30, 2020 to June 30, 2020. No change has been noted for the local submission process.
On May 29, 2020, the Colombia Ministry of Health and Social Protection announced that companies will now be able to submit data that was missed from the report due in March 2020. The Registry of Transfers of Value of the Health Sector (“RTVSS”) will be open from June 1-30, 2020 to submit the late data.
In light of COVID-19, the Healthcare Transparency Register Foundation (Stichting Transparantieregister Zorg) has announced that the transparency reporting deadline for 2019 reporting has been extended from 1 June 2020 to 15 June 2020. No change has been noted for the submission process to the transparency register.
The Association of the British Pharmaceutical Industry (ABPI) hosted a webcast to discuss the latest guidance for 2019 transparency disclosures. Their decision has been made to only publish aggregate data on the Disclosure UK portal. Companies are advised to submit all healthcare professional (HCP) and healthcare organization (HCO) data in aggregate, along with research and development. The only exception is joint working arrangements, which will be provided in methodological notes. ABPI will provide an amended, temporary data template for companies to submit 2019 data.
Here are next steps for your consideration:
Recently, the Irish Pharmaceutical Healthcare Association (IPHA) shared more information regarding consent trends and reporting in light of COVID-19. Guidance shared from IPHA differs from the direction ABPI has taken by asking companies to continue individual disclosure where appropriate consent has been captured. Therefore, no changes are asked to be made due to COVID-19 for 2019 data.
Here are the key takeaways:
PwC has a team of experienced compliance professionals ready to support your transparency program needs!
Feeling overwhelmed with activities leading as we enter into the critical reporting season? We hear you! PwC has a global team of trusted advisors that can support you and your team navigate through the complexity of reporting. Please reach out to us to start the conversation.
Principal, Pharmaceutical and Life Sciences Transparency Leader, PwC US
Director, Requirements Lead, PwC US
Partner, Pharmaceutical & Life Sciences, PwC US