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Methodology note regarding the implementation of the disclosure according to the Pharma Cooperation Code for the disclosure period
I. Data Privacy
Bayer is requesting consent from all HCPs [and HCOs] to disclose their transfers of value before starting an interaction leading to these transfers of value. If this consent is given, the corresponding transfers of value are individually disclosed, i.e. the recipient is mentioned by name. Otherwise, the information is presented in the form of an aggregate disclosure.
Our report is generally available for a period of three years. We will amend the report accordingly, if required for specific (e.g. legal) reasons.
II. General Questions
Transfers of value to international organizations based in Switzerland and focused on non-profit activities in the healthcare sector, such as the WHO, UNHCR and ICRC, are exempted from the duty of disclosure under the Pharma Cooperation Code (PCC). Further information on the societal engagement of Bayer in this field can be found on our website.
Transfers of value made by a local Bayer affiliate to a healthcare professional or organization with primary practice in a different European country will be reported by our affiliate which is based in that country.
Under the Pharma Cooperation Code, ToV are only covered in connection with prescription-only medications. In practice, however, such ToV may relate to a group of products made up of a combination of prescription-only and non-prescription pharmaceuticals and other products.
Healthcare professionals are invited to a scientific event, where results of a clinical trial related to a prescription-only medicine are presented. At the same time, information on over-the-counter medicines in the same therapeutic area is provided.
As long as transfers of value are not exclusively connected to over-the-counter medicines or medical products – which are not in the scope of the Pharma Cooperation Code - Bayer will disclose such transfers of value in full.
This question may arise in various situations:
1) A healthcare professional agrees with Bayer during one reporting period to appear as a guest speaker at an event, the flights are already booked during this period, but the event itself takes place in the following reporting period.
2) A sponsorship for a specialist training is granted in one reporting period, but the training only takes place in the next reporting period.
3) A speaker is engaged for an event at the end of one reporting period, but the invoice is received and the honorarium is paid in the next reporting period.
4) An HCP enters into a long-term consultancy contract with Bayer, which lasts for 18 months.
We will publish ToV in accordance with the following rules:
In case of activities within a short, defined timeframe (e.g. congresses or other scientific events), the start date of this activity is decisive. In case of long term activities, the posting date of the relevant invoice at Bayer determines the reporting period. Donations are always reported in the reporting period in which they are made.
Should an invoice for an activity taking place within a short, defined timeframe not be received in time to include the transfer of value in the report, the amount will be disclosed in the following report.
For the examples mentioned, these are the results:
1) As the event is an activity within a short, defined timeframe, all related transfers of value will be reported in the reporting period, in which the event takes place. Only if invoices (e.g. for the honorarium) are received too late to be taken into account for payment, the corresponding payment will be disclosed in the subsequent reporting period.
2) As the specialist training is a short term activity within a defined timeframe, the ToV related to it will be reported in the reporting period, in which the event takes place. Only if invoices (e.g. for the honorarium) are received too late to be taken into account for payment, the corresponding payment will be disclosed in the subsequent reporting period.
3) As the speaker is engaged for a specific event, the transfer of value will be reported in the reporting period in which the event took place. Only if invoices (e.g. for the honorarium) are received too late to be taken into account for payment, the corresponding payment will be disclosed in the subsequent reporting period.
4) As the consultancy contract is a long term activity, the relevant transfers of value under this agreement will be reported in the period, in which the individual invoices are received by Bayer.
In the event that our reporting rules should change, meaning that a ToV which would have been disclosed in the later reporting period under the previous regulations, would, under the amended regulations, be disclosed in the earlier reporting period, we will still disclose the ToV in the later reporting period. This means that any changes to our intern methodology will not result in any failure to disclose details of any ToV subject to a disclosure requirement.
This situation may arise, for example, if Bayer concludes a consultancy agreement with a doctor which has a three year term and which comprises a total consultancy fee of CHF 3,500.
In this case, we will disclose the individual honorarium based on the date when Bayer received the respective invoices. Details depend on the specific contract with the consultant (e.g. what services are provided in which time period, which specific amounts are foreseen for these services, etc.).
We will generally publish ToV details on an individual basis in accordance with the Pharma Cooperation Code. If an individual ToV can be allocated pro rata to the relevant organizations, these shares will be published under the name of the respective organization.
If such an allocation is not possible, we will assume that each organization receives an equal share and will publish this accordingly.
Contract, respectively Clinical Research Organizations, are contract research institutes which act as a service provider for companies in the pharmaceutical industry and who provide clinical study planning and execute clinical trials in return for payment.
We will not generally publish details of any ToV granted to any CRO whose services we retain. However, the exception is if:
• the CRO is comprised of healthcare professionals or has links to a medical institution (like a university hospital or a publicly-run organization). In this case, the CRO is considered to be a healthcare organization and details of any ToV granted to it will be published by us in accordance with the general rules.
• the CRO is used to indirectly grant ToV to healthcare professionals (so-called "pass-through costs"). In this case, we will publish the ToV in accordance with the general rules. As a rule these are usually ToV in the area of R&D which are disclosed as an aggregated amount.
ToV granted to universities and other educational establishments are not in scope of the Pharma Cooperation Code per se. We will only publish details of such ToV in the event that they indirectly find their way to a healthcare organization, such as a university hospital, or one or more healthcare professionals. In this case, we will publish the details of those ToV under the name of the university or other educational establishment to which they were granted.
In the event that we become aware that a ToV granted by us to a third party has been passed on to healthcare professionals or organizations, or those persons have benefited from such, we will generally publish the details of these ToV under the name of the relevant healthcare professional or organization. Our contractual arrangements with third parties include the obligation to report the relevant data to us in the necessary level of detail. The third parties are also obliged to ensure that such information transfer is in line with applicable data privacy laws.
III. Concrete Questions on the Report
A sponsorship under the Pharma Cooperation Code is any agreement, where Bayer grants a transfer of value for an event, a scientific project or similar in exchange for a reasonable consideration (for example a mention as sponsor).
Bayer will publish the entire sponsorship amount agreed in the underlying sponsorship contract. The sponsorship amount is determined based on the fair market value for the advertisement opportunities obtained.
We classify any event (e.g. conventions, conferences, symposia etc.) with a focus on providing medical or scientific information and serving to further the medical training of healthcare professionals as a scientific and specialist training event.
We will generally publish the payment of attendance fees for an event as a ToV to the relevant healthcare professionals in the section devoted to 'registration fees'. The total amount of such fees assumed during the reporting period will be published for each individual healthcare professional.
Such fees can also be reported under the name of a healthcare organisation, for example if Bayer supports the participation of a certain number of physicians working at a hospital and the hospital chooses the participants. In such case, the hospital is seen as the recipient of the ToV.
Bayer reports the payment of any travel and accommodation costs that are not related to services or Research & Development activities in this category. This includes, for example, costs for flights, train, taxi and hotel costs.
If travel is organized through an external travel agency, the administrative costs of that travel agency will not be reported. Such travel agency is contractually obliged to provide us with the information, so that it is possible to report on each individual participant.
In Switzerland the HCP him/herself bears a third of the training cost, i.e. this amount will be deducted before disclosure. The HCP's deductible is therefore not included in the disclosure.
If a scientific event (convention, conference, symposium etc.) is organized by an event agency and the event has a clear relevance to a HCO, we will disclose details of the ToV under the name of the related HCO, regardless of whether the agency or the organization is a direct beneficiary. As a general rule, we report the entire sponsorship amount. If we receive specific information that only a limited amount is transferred to the HCO, we will report only this amount.
If ToV are related to the area of ‘R&D’, we disclose these as aggregated amounts, i.e. without naming the beneficiary. The total amount of all ToV in the area of ‘R&D’ will be shown in the report as an aggregate amount.
Basic research is usually targeted at either developing new products or relates to a specific product and is intended to extend its scope of use. We therefore disclose ToV in the area of basic research as a rule under the category ‘R&D’.