DISCLOSURES OF TRANSFERS OF VALUE: SUMMARY OF METHODOLOGY
1. ASTELLAS’ COMMITMENT
1.2 Astellas discloses all Transfers of Value to HCPs and HCOs in accordance with its commitment to the EFPIA Disclosure Code and the ARPharM: Code of Ethics in Bulgaria.
1.3 This note summarises the methodologies used by Astellas in preparing Disclosures in compliance with the EFPIA Disclosure Code.
2.1 The ARPHARM: Code of Ethics defines the following terms:
• “Healthcare Organisation (HCO)”: Any health organization, or medical or scientific organization or association (regardless of its legal or organization form), such as a hospital under the Act for hospitals, or foundation, university or other educational institution, or professional or scientific society (with the exception of patient organizations according to the Code for PO), whose registered office, place of incorporation or primary place of business in Bulgaria, or in which one or more healthcare professional provide services.
• “Healthcare Professional (HCP)”: HCP is any of the following medical doctors, doctors of dental medicine, master pharmacists, nurses, midwives, medical laboratory technicians, paramedics and doctor‘s assistants, assistant-pharmacists 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 Bulgaria.
• “Transfer of Value (ToV)”: Direct and indirect transfers of value (in payments or kind, or otherwise made) in connection with the development and sale of prescription-only medicinal products for human use whether for promotional services or otherwise.
• “Research and Development (R&D)”: HCP/HCO transfers of value that relate to the planning and conduct of
o Medical Research under the Health Act;
o Clinical trials; in accordance with the Law on Medicinal Products for Human use;
o 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 research purposes. 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.
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 Bulgaria by the ARPharM.
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.
3.2 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.
3.3 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.
3.4 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.
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 to support research and development.
• 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.
• Congress and educational event sponsorship: Expenses related to the sponsorship of HCOs as congress organisers and/or secretariats & third parties on behalf of HCOs in exchange for corporate benefits at an event (e.g., booth space, hosting of a symposium, stands, advertising on programmes or banners and room hire or catering if paid 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. Where they 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’.
• 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.
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 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.
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 who operate in Bulgaria in Lev (BGN). Where Transfers of Value are made in a currency other than BGN, the amount will be converted into BGN using an annual exchange rate. Amounts disclosed in BGN 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 disclose 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 Bulgaria are included in the Disclosure report for Bulgaria.
9.5 When the grant/donation consists of supplying a drug to an HCO (instead of a financial payment direct to the HCO) Astellas ascribes a monetary value to the cost of drug as it would be, if HCO had purchased the drug and disclosed this value.