We strive for openness and honesty in all aspects of our business and are committed to full disclosure of clinical trial data and the initiatives and organisations that we fund in line with the requirements of our industry.
Transfers of Value
Shionogi operates in Europe via Shionogi B.V. a private limited liability company formed under Dutch law, Shionogi GmbH in Germany, Shionogi S.r.l in Italy and Shionogi SLU in Spain.
Data on Transfers of Value (ToV) from Shionogi Europe to Healthcare Professionals (HCPs) and Healthcare Organisations (HCO) and methodology available can be found on the following links:
France (La France) _ External website link
United Kingdom (UK)_ External website link
Others (European countries where Shionogi does not have a local presence) are disclosed here.
Shionogi Europe disclosure methodology
The below describes the methodology we use to include or exclude Transfers of Value (ToV's) from Shionogi in our disclosures.
The definition of a ToV includes direct and indirect ToV, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development and sale of a prescription only medicine (POM) exclusively for human use. Direct ToVs are those made directly by Shionogi for the benefit of a Recipient. Indirect ToVs are those made on behalf of Shionogi for the benefit of a Recipient, or those made through a Third Party (e.g. a meetings and events agency) and where the Shionogi knows or can identify the Recipient that will benefit from the Transfer of Value.
What payments do we disclose?
• Fees for service and related expenses, Donations, Grants, Sponsorships to HCOs and financial support to Patient Organisations (POs), ToVs related to travel (e.g. flight ticket), accommodation (e.g. hotel room cost) and registration fees, will be included in the calendar year in which we executed the actual payment or reimbursement in our financial systems.
• In case of payments through a third party, our payment date to the third party is used as the determining factor to allocate the payment to the related calendar year.
Our aim is to have an efficient and fast processing of payment data, but whilst we update our systems, payment information could sometimes become available only after the date of publishing. We are striving to improve this situation and will monitor actual occurrences.
How do we report ToVs related to multi-year contracts?
• In these cases, we use a split payment approach, so the total value is transferred in multiple, separate payments over time.
• Each of these separate payments will be included in the calendar year in which we executed the actual payment or reimbursement in our financial systems.
Is VAT included?
• All payments (e.g. fees for service, Donations, Grants, Sponsorships and other financial support), are reported exclusive of VAT.
• All TOVs from services or products (e.g. flight ticket, hotel room, …) are reported gross, so inclusive of VAT where it is applicable
How are different currencies handled?
• All values reported are in local currency, i.e. the currency of the country in which disclosure is made.
• For TOVs that were originally made in non-local currency, a conversion to local currency is made and exchange rate details can be provided on a case by case basis.
Are TOVs made by non-EFPIA based Shionogi companies reported?
• TOVs to any HCP/HCO/PO of a country where our Shionogi affiliate is member of the national EFPIA association will be reported in their country of residence, regardless of which Shionogi company organized and/or made the TOV.
• TOVs to any HCP/HCO/PO of a country in EFPIA remit where Shionogi doesn’t have an affiliate will be available here.
What is reported in case of partial meeting attendance/cancellation?
• Only costs related to the partial participation are reported. Costs of cancellation prior the event are not reported as they do not constitute a value transfer to its recipients.
What is reported in case the TOV is made to/through a third party?
• In case an HCP is contracted and paid through an HCO (Health Care Organization) that the HCP is part of, we will disclose the TOV (Service Fee) on the HCO that received the TOV, subject to local code differences.
What is included in the aggregate disclosure section of the EFPIA reporting template? (for countries where consent is required)
• The HCP’s aggregate section of the Disclosure reporting template contains the total value per cost type that was transferred to HCPs that have chosen not to be disclosed individually.
• According to individual privacy rights, consent to individual disclosure can be withdrawn by HCPs, in which case disclosure is made on an aggregate basis. We apply Consent or withdrawal of consent per HPC for all TOV on a per-activity basis
• Partial Consent: As Shionogi collects consent on a per-activity basis. Where recipients of transfers of value have decided to disclose as an individual in some activities and aggregate in others, the amount attributable to all transfers is disclosed on an aggregate basis.
What address do we show in the EFPIA report?
• We will display the HCP/HCO/PO address available in our contract with HCP/HCO/POs that we have in our database at the time of the reporting.
R&D TOV reporting
• We report by country and as one annual total amount in aggregate basis, for all R&D TOVs to HCPs/HCOs
• R&D TOVs are TOVs to HCPs or HCOs related to the planning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good Laboratory Practice); (ii) clinical trials (as defined in Directive 2001/20/EC); or (iii) non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study
• Non-interventional retrospective studies are reported in HCO individual section of the EFPIA report.
What do if you have identified an error in your ToV(s) disclosed by Shionogi
· Please contact us via firstname.lastname@example.org to request review and correction.
• We rely on a manual data entry from internal and external resources to record relevant data and finally report it. The information reported in this submission reflects our good faith and best efforts to comply with the requirements of the EFPIA Code but we are striving to improve by the use of automated systems and standardised processes. Should we, despite our best efforts to ensure accurate reporting, fail to include complete and correct information in our submission, we will appropriately investigate and address in case of erroneous information.
Shionogi GroupClinical Trial Data Transparency Policy
Clinical Trial Data
Shionogi understand the benefit of ensuring clinical trial data is shared with healthcare providers, patients, and the general public.
In accordance with the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) principles on clinical trial data sharing, we are committed to reviewing requests from researchers for access to clinical trial protocols, patient-level clinical trial data and study-level clinical trial data. In addition, we will ensure that synopses of clinical study reports for medicines that have been granted marketing authorisations, after the authorisation process has concluded, are made publically available.
Given that we have a UK establishment located in the UK, these measures must support the current requirements in the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. The ABPI stipulate that current and future trials must be registered within 21 days of enrolling the first patient, and results must be published within one year of marketing authorisation or one year from completion for marketed products.
NP-EU-NP-0101 dop May 2020