模块6：价值转移的披露

What, Why, Howto comply with Disclosure of Transfers of Value WHAT(definition) HOW(Key rules to follow) WHY(rationale) Why does disclosure matter? What is Disclosure? Who must disclose Collaboration between pharmaceutical industry andHCPs, HCOs and POs contributes to betteroutcomes for patients. These partnerships have ledto major advances in healthcare by helping toprevent disease, improve diagnosis, and developinnovative treatment options. Disclosure is the publication by EFPIA membercompanies of transfers of value provided toHealthcare Professionals (HCPs) and Healthcare All EFPIA members, and companies that aremembers of national trade associationsrepresented within EFPIA, even if they are notdirect EFPIA members. This includes most majorpharmaceutical companies operating acrossEurope. EFPIA Member Companies also disclose supportprovided to Patients Organisations (POs). While the relationships are already governed bystrict rules, transparency further strengthens publicconfidence and demonstrates the value that suchcollaborations bring to patients and society. What is the deadline? Disclosure must be published within 6 monthsafter the end of the reporting year (i.e. by 30 Juneeach year) and remain publicly available for 3years. Transparency builds public trust by enablingpatients, payers and regulators to assess whetherfinancial relationships between industry andhealthcare professionals could influence prescribingor clinical decisions. Transfers of value include: •Donations & grants,•Sponsorship agreements including registrationfees and travel and accommodation,•Fees for services (speaking, consulting, Who benefits from disclosure? Individual data Patients, healthcare community, regulators and thepublic all benefit from disclosure through greatertransparency and a better understanding of howindustry collaborations support medical research,education and patient care. As per the GDPR, named disclosure of HCPsrequires a legal basis to name an HCP–eitherindividual consent or legitimate interest.Companies must have a documented process. At the same time, disclosure benefits thepharmaceutical industry by demonstrating itscommitment to transparency, accountability andethical engagement. DisclosureReal life scenarios Q1: A pharma company pays an HCP’sfee to attend an international advisoryboard. Does this need to be disclosed? Q2: A pharma company provides anunrestricted educational grant to amedical society. Must this be disclosed? A:Yes, but aggregate disclosure applies.The companymay still engage and compensate the HCP. However, thetransfer of value must be captured in the aggregate (non-named) total for the reporting year. The HCP's lack of consentmust be documented in the company's records. Alternatively,the company may use an alternative legal basis to disclose,e.g. legitimate interest which does not require consent. If thislegal basis is to be used, the HCP must be informed prior to A: Yes,allfees for services paid to HCPs—includingadvisory board participation, travel, and accommodation—are transfers of value and must be disclosedindividually (by name, with the HCP's consent) or inaggregate if consent is not obtained and another legal A:Yes,grants and donations to HCOs and POs must bedisclosed. The company should record the name of theorganisation, the purpose of the grant, and the monetaryvalue—even when the grant is unrestricted and no Q4:A pharma company sponsors a third-partyevent, and the third party is responsible forindicating the particular HCPs by name who willbe invited, should the indirectToVto theseHCPs be disclosed? Q6:How should disclosure be managed where theRecipient gives consent for travel &accommodation costs related to a consultancy tobe disclosed but does not consent for the Q5:Does the system cover all paymentsto healthcare professionals at anindividual level? A:A pharma company must not allow 'cherry picking' ofwhatToVsto disclose by a recipient as this has thepotential to mislead on the scale or nature of the A:Yes.If the third party uses some of the receivedsponsorship to invite HCPs that they select or to hireHCPs as speakers for that congress and the pharmacompany does not know the names of the HCPs, theToVmust be disclosed under the category 'Sponsorship'naming the recipient HCO if the third party is an HCO ora non HCO third party acting on the HCO behalf. activities are disclosed in aggregate. For the purposes of thedisclosure, these activities are defined as transfers of value toHCPs or HCOs related to the planning or conduct of:• non-clinical studies (as defined in OECD Principles on Good If a Recipient gives only partial consent to any aspect ofdisclosure e.g., the recipient does not allow disclosure ofall categories or of allToVs, allToVsmade to thatRecipient should be disclosed in the aggregate category, • clinical trials (as defined in Directive 2001/20/EC); or• non-interventional studies that are prospective in nature andthat involve t