disclosures of Transfers of Value: Summary of methodology
1. Astellas’ commitment
1.1 Astellas is a member company of the European Federation of Pharmaceutical Industries and Associations (“EFPIA”). The EFPIA Disclosure Code 2014 (the “EFPIA Disclosure Code” [available here - https://www.efpia.eu/media/24302/3a_efpia-hcp-code-2014.pdf] requires all member companies to document and disclose certain Transfers of Value they make, directly or indirectly, to or for the benefit of, Healthcare Professional (“HCPs”) or Healthcare Organisations (“HCOs”) (“Disclosures”). The EFPIA Code is implemented in the Netherlands by the Code of Conduct for Pharmaceutical Advertising (“CGR code”).
1.2 Astellas discloses all Transfers of Value to HCPs and HCOs in accordance with its commitment to the EFPIA Disclosure Code and the and the Code of Conduct for Pharmaceutical Advertising (“CGR code”) in Netherlands.
1.3 This note summarises the methodologies used by Astellas in preparing Disclosures in compliance with the EFPIA Disclosure Code.
2.1 The EFPIA Disclosure Code defines the following terms:
“Healthcare Organisation (HCO)”: A healthcare, medical or scientific association or organisation (e.g., a hospital, clinic, foundation, university or other teaching institution or learned society) whose business address, place of incorporation or primary place of operation is in Europe; or an organisation through which one or more HCPs provide services. This can also include a self-incorporated company set up by a HCP where the recipient is not the sole director of the company.
“Healthcare Professional (HCP)”: A member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his/her professional activities, may prescribe, purchase, supply, recommend or administer a medicinal product and whose primary practice, principal professional address or place of incorporation is in Europe.
“Research and Development (R&D)”: HCP/HCO transfers of value that relate to the planning and conduct of:
Non-clinical studies (as defined in OECD Principles on Good Laboratory Practice);
Clinical trials (as defined in Directive 2001/20/EC);
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. This also includes investigator sponsored research (ISRs).
o Non-interventional studies that are retrospective in nature have also been included within aggregate disclosure for R&D in this reporting year; this has been included within the self-certification submitted to EFPIA for 2017.
“Transfer of Value (ToV)”: Direct and indirect transfers of value (in payments or kind, or otherwise made) in connection with the development or sale of prescription-only medicinal products for human use whether for promotional services or otherwise.
3. TRANSFERS OF VALUE
3.1 Astellas discloses Transfers of Value to HCPs and HCOs that relate to research and development in the aggregate figure. These include expenses associated with clinical trials, non-clinical studies, non-interventional studies and investigator sponsored research.
3.2 Astellas will disclose transfer of values only if a HCP/HCO actually receives the benefit of the transfer. For example, Astellas will not disclose a transfer relating to a flight intended to be taken by a HCP in relation to a fee for service contract if the HCP does not in fact take the flight, even if a cost is incurred by Astellas. On the other hand, Astellas will disclose a Transfer of Value if the HCP incurred the cost of the flight he/she was going to take and was directly reimbursed by Astellas,
4. Country of Disclosure
4.1 Astellas discloses Transfers of Value based on the HCP/HCO’s principal place of practice. If the HCP/HCO operates in more than one country, Astellas will select one country to be the principal place of practice and disclose Transfers of Value in that country.
5.1 Astellas discloses Transfers of Value to HCPs and HCOs who operate in the Netherlands in Euros. Where Transfers of Value are made in a currency other than Euros, the amount will be converted into Euros using an annual exchange rate. Amounts disclosed in Euros may therefore vary slightly from the exact amount paid in the local currency.
6.1 Astellas discloses all Transfers of Value it makes between 1 January and 31 December of one year by 30 June of the following year. A Transfer of Value is made when the transfer is complete (e.g., on payment date or transfer of value date). For example, if a contract is signed on 1 October 2016 but the payment is made on 1 January 2017, the Disclosure will be published by end June 2018.
6.2 Disclosures must remain in the public domain for a minimum of three years and Astellas will document all Disclosures and retain the records for at least eleven years.
7. Multi-year contracts
7.1 Where a contract for any Transfer of Value listed in Section 4, runs for more than one year, Astellas will record Transfers of Value relating to that contract in the year the Transfer of Value was made (which may be different to the year in which the contract was agreed).
8.1 Where possible, Astellas discloses the full amount of all Transfers of Value exclusive of VAT. In some instances for indirect transfers of value, VAT may not be separable, in these cases; VAT has been included in the disclosure amount.
8.2 Transfers of Value to HCPs reflect fair market value, taking into account the nature of services rendered, the amount of time spent, and the knowledge and expertise of the HCP.
8.3 Where Astellas makes a Transfer of Value to a HCP indirectly via a HCO, it discloses such transfer only once.
8.4 Transfers of Value made by Astellas, irrespective of where the Astellas entity is located (e.g. transfers of value made by Astellas entities outside of the Netherlands are included in the Disclosure report for the Netherlands.