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”). Luxembourg is not member of EFPIA but the EFPIA Code is implemented in the APL Code of Deontology [available here – http://www.apl-pharma.lu/docs/pages/transparence/code-2015.pdf].
1.2 Astellas discloses all Transfers of Value to HCPs and HCOs in accordance with its commitment to the EFPIA Disclosure Code and the APL Code of Deontology Chapitre 5bis.
1.3 This note summarises the methodologies used by Astellas in preparing Disclosures in compliance with the EFPIA Disclosure Code implemented in the Luxembourg Code of Deontology.
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.
2.2 The categories of ToVs referred to in this methodology statement are in line with the terminology used in the EFPIA code. The titles of these categories may vary to the terminology used in the template prescribed in Luxembourg by the APL Code of Deontology.
3. Data Privacy
3.1 Astellas fully supports the principles of transparency and abides by data privacy law. Data privacy law requires Astellas to obtain permission from individual HCPs prior to disclosing individual Transfers of Value to them. Astellas makes every effort to obtain, and maintain a record of, the necessary permissions. Astellas’ approach for HCP consent is ‘all in’ or ‘all out’. In other words, the consent decision is not specific to a transaction or activity but applicable to the HCP for all transfers of value and a ‘yes’ decision is effective until withdrawn. HCP data will be removed or amended from the publication on the Company’s webpage/regulatory platform and/or our database or other platforms as soon as reasonably practicable from the date the HCP’s decision to withdraw consent is communicated to us. We can also send a follow-up message to individual HCPs to confirm the effective date of the withdrawal, while reminding them of our mutual commitment to the EFPIA Disclosure Code and the Deontological Code of the APL (Luxembourg Pharmaceutical Association), Chapter 5bis, and ask them if they want the consent to become effective from a certain date x or for all public records (already published/published in the past) based on the withdrawal date.
3.2 Where HCPs do not give permission to such individual Disclosures, Astellas discloses the total amount of all Transfers of Value in the relevant category as an aggregate figure.
3.3 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 seven years.
4. TRANSFERS OF VALUE
4.1 Astellas discloses the following Transfers of Value it makes to HCOs:
Donations : Funding (or benefits in kind) provided to HCOs for unspecified use.
Grants : Funding or support provided to HCOs in response to a request to support a specific activity that provides educational benefit or enhances patient care.
Sponsoring for attendance at congresses or educational events: Costs related to the sponsoring of HCOs for the organisation of congresses and/or secretariat support in exchange for benefits for the company during an event (e.g. exhibit space, hosting of a symposium, stands, advertising through programmes or banners and rental of rooms or catering services in case of payment on behalf of an HCO). This may also include activities such as preceptorships, where expenses are paid to HCOs for arrangement of educational events.
Fees: Transfers of Value that are fees for service resulting from or related to contracts between companies and institutions, organizations or associations of Healthcare Professionals under which such institutions, organizations or associations provide any type of services to a company or any other type of funding not covered in the previous categories. Fees and Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts, under the ‘Fees’ and the ‘Related expenses agreed in the fee for service or consulting contract’ categories.
4.2 Astellas discloses the following Transfers of Value it makes to HCPs:
Congress and educational event registration fees : Expenses related to the registration of a HCP to attend a congress or educational event.
Travel: Expenses related to the provision of travel to HCPs in relation to a fee for service contract (e.g. , rail travel, taxi travel, flights, reimbursement of private car miles) or to their attendance at a congress or educational event. Where travel expenses are required for the provision of a fee for service, these will be disclosed in the category of ‘Related expenses agreed in the fee for service or consulting contract’. Where there is no provision of services and they relate to contribution costs of a congress or educational event, they will be disclosed in the category of ‘Travel and accommodation’.
Accommodation : Expenses related to the provision of overnight accommodation of HCPs in relation to a fee for service contract or to their attendance at a congress or educational event. These will be disclosed in the category of ‘Related expenses agreed in the fee for service or consulting contract’ where they are required for the provision of expert advice and a fee for service. Where there is no provision of services and they relate to contribution costs of a congress or educational event, they will be disclosed in the category of ‘Travel and accommodation’.
- Fees: Transfers of Value paid to Healthcare Professionals to provide services to Astellas. These may include advisory board services, speaker services or other consulting services. Fees and Transfers of Value relating to expenses agreed in the written agreement covering the activity will be disclosed as two separate amounts, under the ‘Fees’ and the ‘Related expenses agreed in the fee for service or consulting contract’ categories. When Wi-Fi is included in the total cost of the accommodation expenses, it will be recorded in this category.
- Advisory committee services: Fees paid to HCPs under contract to attend a closed meeting with Astellas to provide expert advice on potential developments and improvements to enhance the quality of health care and on the developments regarding patients within a specific area of treatment. These costs will be recorded under the category “Fees”.
- Speaking services: Fees paid to HCPs that are contractually bound to provide speaking services (e.g. during a congress, a symposium or an internal training) by or on behalf of Astellas, or issuance of training materials on behalf of Astellas. These costs will be recorded under the category “Fees”.
- Consultancy services: Fees paid to HCPs under contract for performing other consultancy services to Astellas (e.g. medical writing, revision of materials or video shoots). These costs will be recorded under the category “Fees”.
4.3 In respect of each Transfer of Value described above, Astellas will disclose details 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.
4.4 Astellas records R&D-related value transfers made to HCPs and HCOs in the aggregate figure. According to Astellas, R&D-related value transfers include:
- Fees for investigators/sites: Fees paid to an HCP/an HCO for the services of investigators and for the study sites to support the conduct of a company-sponsored trial.
- Registration of the investigator for the meeting, travel and accommodation costs: Costs related to registering an HCP for attendance at an R&D-conference for investigators, including travel and accommodation costs.
- Cost for the on-site staff: Costs paid to an HCO in connection with nurse fees, the junior or independent investigator/R&D-related costs not included in the fees per patient.
- Services of advisory committees, consultancy services, accommodation, travel: Fees and costs paid in connection with research and development for company-sponsored trials.
- Services for expert meetings: Fees paid to an HCP/an HCO under contract to attend meetings of experts in the area of research and development (e.g. boards of clinical trial directors, selection boards) for company-sponsored trials.
- Data Safety Monitoring Boards (DSMB): Fees paid to HCPs/HCOs under contract for their involvement with the DSMB (e.g. safety monitoring, study integrity) for company-sponsored trials.
- Ethics/approval of the competent authorities, pharmaceutical costs, laboratory services, and insurance related to clinical trials: Fees paid to an HCO for supporting a company-sponsored trial.
- Investigator-sponsored research: Fees and costs paid to an HCO for a clinical trial sponsored by a third party, when the investigator independently approaches Astellas to request support for his study.
4.5 Where Astellas makes a Transfer of Value to a HCP indirectly via a HCO, it discloses such transfer only once.
4.6 Where services for Astellas are rendered by an HCP on behalf of an HCO (for example, Astellas enters into a service contract with an HCO and the services are provided by the HCO’s employee), the associated fees and expenses paid by Astellas to the HCO are disclosed as Transfers of Value made to the HCO. This is the case unless Astellas can confirm that the HCP received a benefit from the Transfer of Value, either directly from Astellas or via the HCO, (e.g., fees paid to the HCP in connection with the services he/she rendered and/or reimbursement of any related expenses the HCP incurred), in which case Astellas discloses those Transfers of Value as being transfers to the HCP. Where Astellas can identify the HCP and know that the HCO will make the full Transfer of Value to the HCP on Astellas’ behalf, the Transfer of Value is disclosed as being a Transfer of Value to the HCP.
4.7 Where services are provided by a self-incorporated company set up by a HCP and the HCP is not the sole director of the company, Astellas will consider the recipient as an HCO and disclose the Transfer of Value to the HCO.
5. Country of Disclosure
5.1 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.
6.1 Astellas discloses Transfers of Value to HCPs and HCOs operating in Luxembourg 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.
7.1 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.
8. Multi-year contracts
8.1 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).
9.1 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.
9.2 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.
9.3 When Astellas is party to a co-promotion agreement, Astellas discloses only Transfers of Value made by Astellas.
9.4 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 Luxembourg) are included in the Disclosure report for Luxembourg.