Transfers of Value to Healthcare Professionals

Data Disclosure



In accordance with the EFPIA Disclosure Code and its national implementation through the Austrian association of the pharmaceutical industry (Pharmig) Bayer discloses transfers of value connected to the development and commercialization of prescription-only human pharmaceuticals to healthcare professionals and healthcare organizations.

The disclosed data include transfers of value in four main categories:

Categories Transfers of value:
Healthcare Professionals


Healthcare Organizations
Donations and grants Whether monetary or other
Events
  1. Registration fees
  2. Travel & accommodation
  1. Sponsorship
  2. Registration fees (if applicable)
  3. Travel & accommodation
Services and consultancy
  1. Fees
  2. Related expenses agreed in the contract (including, for example, travel, accommodation & registration fees)
Research and development Fees, travel & accommodation, and other related expenses that are covered in connection with the service

 

Learn More About our Disclosure Methodology

The general rules of the EFPIA Disclosure Code and the transparency rules of the Pharmig-Code of Conduct apply to all member companies and all companies will disclose transfers of value made to healthcare professionals and healthcare organizations in a pre-defined format. However, some details of the reporting methodology are left for the individual companies to decide in order to allow the necessary flexibility to adjust to the internal processes. This methodology note allows you to understand how Bayer in is documenting and disclosing the relevant information.

Methodology Note regarding the implementation of the EFPIA Disclosure Code, locally transposed by the “PHARMIG-Code of Conduct”.

Preamble

We at Bayer are convinced that close cooperation with and continuous education of healthcare professionals are key to achieving better outcomes for the patients we strive to help. We are committed to transparency regarding how healthcare professionals (HCPs) and healthcare organizations (HCOs) are compensated by us for the time and expertise they provide. When collaborating with medical experts, we comply with applicable laws and regulations, which regulate the relationship between the pharmaceutical industry and healthcare professionals, e.g. laws of the health system and codes of conduct designed by the industry, and fully respect the independence and integrity of these professionals.

 

As a member of the Association of the Pharmaceutical Industry in Austria (“PHARMIG”) we feel obliged to make the nature and extent of our cooperation with healthcare professionals understandable and transparent. For this purpose the PHARMIG has amended its code of conduct accordingly (Article 9). This code is designed to ensure that even the impression of potential conflicts of interest is avoided. By making the cooperation between the industry and the medical community more transparent, the general public can gain a better understanding of the high importance and value of this cooperation.

 

Healthcare professionals are doctors, pharmacists and other natural persons that are members of the medical, dental, pharmacy or nursing professions or other persons who, in the course of their 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. This also includes employees of public bodies, sick funds or other payers, who are in charge of prescribing, purchasing or administering drugs or are deciding about reimbursement.

 

In order to make the nature and the extent of the interaction between the pharmaceutical industry and healthcare professionals and organizations more transparent, Bayer will document and disclose all Transfers of Value in scope of the PHARMIG-Code of Conduct, dated July 1, 2015, which it makes, directly or indirectly, to the benefit of HCPs or HCOs. The reporting period is always a full calendar year and the report will always be published until end of June of the following year.

The purpose of this methodology note is to allow any person accessing the report to understand how Bayer is documenting and disclosing the relevant information in line with the PHARMIG-Code of Conduct. It shall especially explain the details of the data collection and reporting methodology.

If in doubt about the duty to disclose a specific Transfer of Value, our company will always aim for full disclosure. Only if a Transfer of Value is clearly out of scope of the Disclosure Code, it will not be included in the published report. This methodology note is structured as follows: Based on a specific question, we will explain in detail, how Bayer handles disclosure of Transfers of Value to HCPs and HCOs according to the PHARMIG-Code of Conduct.

I. Data Privacy

Legal Background
The Disclosure Code requires that information made available to the public shall remain available for at least three years from the date of its disclosure.

 

Methodology
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. At the end of this period we will remove the respective personal data from our publicly accessible websites.
Regardless of any consent or revocation of consent to publication on our website, we will retain personal data for a period of 6 years after the end of each reporting period. Personal data may also be retained longer if needed for legal requirements and / or due to the data retention and deletion rules applicable to the original processing purposes (e.g. performance and execution of a contract).

Methodology
In order to comply with the obligations under the Disclosure Code, Bayer AG in Leverkusen (Germany) maintains a central transparency database in which all Transfers of Value to Healthcare Professionals and Organizations made by Bayer and by third parties on behalf of Bayer are recorded. In addition, this personal data is compared with comparable, publicly available data disclosed by other pharmaceutical companies; this includes an analysis of the consent rate in regards to competitor, therapeutic area and total amount and type of Transfers of Value. This helps to avoid inappropriate payments and to promote ethically appropriate cooperation with Healthcare Professionals and Organizations.

 

The following categories of personal data are collected:

  • Contact information: We process the name, practice or business address and contact details;
  • Transfers of Value: We process the specific amount of the Transfers of Value that a recipient receives - directly or indirectly - from us or other Bayer Group companies. This includes in particular the following Transfers of Value:
    • Transfers of Value granted in connection with scientific events including admission and attendance fees, travel costs and costs for overnight accommodation;
    • Fees for services rendered and consulting provided and reimbursement of expenses;
    • Transfers of Value related to research and development;
  • Additional Information: We also collect information regarding the timing and evaluation of the Transfers of Value (such as contracts, payment documents, etc.).

 

The processing of personal data for the purpose of operating a central transparency database, as well as the corresponding analyses thereof, is based on the legal justification that the processing is necessary for the pursuit of our legitimate interests. We consider our interests as legitimate and appropriate to justify the processing of personal data as we must comply with our obligations under the Disclosure Code. Analyzing the total amount of Transfers of Values per reporting period as well as comparing it with similar data disclosed by other companies helps to avoid inappropriate payments and to promote ethically appropriate cooperation with Healthcare Professionals and Organizations.

 

The centrally processed data will be published on a publicly accessible website in order to comply with the requirements of the Disclosure Code. The publication of data under the name of the recipient is solely based on the consent of the recipient.

 

Data privacy rights:
Recipients of Transfers of Values have the right to request information about their personal data, to request the correction, deletion or restricted processing of personal data, to object to a processing as well as the right to data portability. In addition they have the right to file a complaint with a data protection authority. They may at any time with future effect revoke their consent without affecting the lawfulness of the processing before revocation.

 

For questions with respect to data privacy, we have provided a contact form. You can also contact our company data protection officer at the following address: Group Data Protection Officer, Bayer AG, 51368 Leverkusen, Germany.

II. General questions

Example
This sort of situation includes those cases where our local affiliate in Italy concludes a consultancy agreement with an Austria-based HCP and pays a honorarium for the services provided.

 

Methodology
Transfers of Value made by a local affiliate to a Healthcare Professional or Organisation with primary practice in a different (European) state will be reported by our affiliate which is based in this country. In the examples given above, the Transfer of Value will be reported by our Austrian legal entity. We will publish the information on a central website for any country where we do not have an affiliate. The same rules apply, if a local affiliate in a non-European country grants a Transfer of Value to a Healthcare Professional or Organisation with primary practice in a European state.

Examples
A doctor based in Austria receives funding from us to take part in a healthcare convention in the US and the attendance fee is paid in US dollars. A physician with primary practice in the UK is acting as a speaker for an event in Italy. The flight is booked by our Italian legal entity and is paid in euros.

 

Methodology
All Transfers of Value specified in our report will be denominated in euros. If the original payment was not made in euros, we will convert the amount according to the principles of proper accounting. Please refer to question 9 regarding the definition of the date, we consider as the transfer of value date.

Legal background
According to Ordinance 2/2014 of the PHARMIG Board on Article 9 of the PHARMIG-Code of Conduct (Transparency) all published Transfers of Value -figures are net values (excluding taxes and/or fees).

 

Methodology
Bayer will report all Transfers of Value as net amounts, excluding VAT.

Legal Background
Under the Disclosure Code, Transfers of Value are only covered in connection with prescription-only medications. In practice, however, such Transfers of Value may relate to a group of products made up of a combination of prescription-only and non-prescription pharmaceuticals and other products.

 

Example
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.

 

Methodology
As long as Transfers of Value are not exclusively connected to over-the-counter medicines or medical devices – which are not in scope of the Disclosure Code -, Bayer will disclose such transfers of value in full.

Example
This situation may arise in various situations:

  1. A Healthcare Professional agrees 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 an event is granted in one reporting period, but relates to an event taking 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. A Healthcare Professional enters into a long-term consultancy contract with Bayer, which lasts for 18 months.

 

Methodology
We will publish Transfers of Value in accordance with the following rules:

 

In case of short term activities within a 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 determines the reporting period. Donations are always reported in the reporting period where they are made.

 

Should an invoice for a short term activity not be received in time to include the Transfer of Value in a report, the amount will be disclosed in the following report.

 

For the examples, this methodology leads to the following results:

  1. As the event is a short term activity, all related Transfers of Value will be reported in the reporting period, in which the event takes place.
  2. As the event is a short term activity, the sponsorship will be reported in the reporting period, in which the event takes place.
  3. As the speaker is engaged for a specific event, the payment will be reported in the reporting period, where the event took place. Only if the invoice is received too late, reporting will be postponed until the next reporting period.
  4. As the consultancy contract is a long term activity, the Transfers of Value under this agreement will be reported in the period, in which the individual invoices for specific activities are received.

 

In the event that our reporting methodology should change, meaning that a Transfer of Value which would have been published in the latter reporting period under the previous regulations would, under the amended regulations, be published in the earlier reporting period, we will continue to publish Transfers of Value in the latter reporting period. This means that any changes to our methodology will not result in any failure to publish details of any Transfer of Value subject to a publication requirement.

Example
This situation may arise, for example, in the event that we conclude a consultancy agreement with a doctor which has a term from 1 July 2015 to 31 December 2018 and which attracts a total consultancy fee of EUR 3,500, which is paid in several tranches.

 

Methodology
In such case, we will disclose the individual payments based on the date, when we receive the respective invoices. Details depend on the contract with the consultant (e.g. what services are agreed for which time period, which amounts are foreseen for these services, etc.)

Methodology
We will generally publish Transfers of Value on an individual basis in accordance with the Disclosure Code. If an individual Transfer of Value can be allocated pro rata to the relevant organisations, these shares will be published under the name of the respective organisation.

 

If such an allocation is not possible, we will assume that each organisation receives an equal share and will publish this accordingly.

Background
Contract / clinical research organisations are research organisations which provide clinical study planning and execution services to companies in the pharmaceutical sector in return for payment.

 

Methodology
We will not generally publish details of any Transfers of Value granted to any CROs whose services we retain. However, we will report Transfers of Value, if:

  • the CRO is comprised of healthcare professionals or has links to a medical institution (like a university hospital or a publicly-run organisation). In such case, the CRO is considered to be an organisation and details of any Transfer of Value granted to it will be published by us in accordance with the general rules.
  • the CRO is used to indirectly grant Transfers of Value to healthcare professionals ("pass-through costs"). In such case, we will publish these Transfers of Value in accordance with the general rules.

Methodology
We will publish details of such Transfers of Value in the event that they find their way to a healthcare organisation, such as a medical university, or one or more healthcare professionals. In such case, we will publish the details of each of those Transfers of Value under the name of the university or other educational establishment to which they were granted.

Methodology
In the event that we become aware that Transfers of Value granted by us to a third party have been passed on to healthcare professionals or organisation, or those persons have benefitted from such, we will generally publish the details of each of those Transfers of Value under the name of the relevant healthcare professional or organisation. Our contractual arrangements with third parties include the obligation to report the relevant data to us in the necessary level of detail. Our contract partners are also obliged to ensure that such information transfer is in line with applicable data privacy laws.

Legal Background
It is not necessary under the Disclosure Code to allocate Transfers of Value paid in the form of transport costs for a group of healthcare professionals to individual healthcare professionals within that group. For example, only the total amount of the costs for a bus shuttle for a group of healthcare professionals would be published and would not be broken down according to the particular individuals involved.

 

Methodology
Bayer will publish costs for group transportation as an aggregated amount (without mentioning the individual Healthcare Professionals), if the identification of individual participants is not feasible due to organizational reasons.

III. Questions on the report

Example
It is possible in this case that the donation will be made to a hospital or clinic as a whole or to a department or unit within that institution, such as the oncology unit.

 

Methodology
In the event that the donation is clearly intended for a specific department or unit within a hospital and this department is a legal entity in its own right, we will publish details of the donation and give the name of the department. In the event that the donation is made to the hospital as a whole, or if the department is not a legal entity in its own right, we will publish the donation under the name of the hospital.

Legal background
A sponsorship under the Disclosure Code is any agreement, where Bayer grants a Transfers of Value in exchange for advertisement opportunities at an event. Under the Disclosure Code, only events organized by or on behalf of an HCO are in scope of the reporting obligations.

 

Methodology
We 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.

Methodology
We classify events (e.g. conventions, conferences, symposia etc.) that exclusively serve to provide medical or scientific information or to further the medical training of healthcare professionals, as scientific and educational events.

Methodology
We will generally publish the payment of attendance fees as a Transfer of Value 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 for a healthcare organisation, e.g. 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 Transfer of Value.

Methodology
We report the coverage of any travel and accommodation costs for HCPs and HCOs 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, which transfers of value have actually been provided to individual participants.

Methodology
If an event (convention, conference, symposium etc.) is organised by an events agency and the Transfer of Value is paid to that agency, but the event has a clear relevance to a HCO, we will generally publish details of such Transfers of Value under the name of the related HCO. As a general rule, we report the entire sponsorship amount.

Methodology
Internal events are defined as events organized by Bayer itself. Bayer does not charge attendance feed for its own events, therefore no Transfer of Value takes place in this regard. In the event that we assume the travel and accommodation costs for those persons attending our internal events, details of such will be published specifying the name of the relevant healthcare professional in the category provided for this purpose (provided that we have received the necessary consent).

Legal background
Service and consultancy fees are due under corresponding service and consultancy agreements. We understand these to be any Transfers of Value granted in exchange for any kind of service, which is not covered by another reporting category.

 

Methodology
Under the category service and consultancy fees, we record any Transfer of Value, which is granted in exchange for services provided by an HCP or HCO. As the expertise of HCPs and HCOs is absolutely crucial to advance science and patient care, services provided by experts will be remunerated at fair market value.

 

Generally, fees for services are honoraria paid for services like speaker engagements or consultancy. If services provided are connected to activities in scope of the category “Research and development”, the fees will also be reported in that category.

Legal background
In terms of Transfers of Value falling under the category "service and consultancy fees", the data record template provides for any expenses reimbursed being published in addition to and separately from the fee itself. These expenses generally include travel and accommodation costs.

 

Methodology
We will publish all expenses related to services in this section. Please note: In some cases, only expenses may be reported for an HCP, because no fee is paid in exchange for the services.

Methodology
In the event that the Transfers of Value relate to Research and Development activities, we will only publish the total amount of Transfers of Value without specifying the name of the recipient.

Methodology
In terms of the category "Research and Development", we will only publish those Transfers of Value relating to "regulatory necessary" studies. These are any studies which are required in order to obtain approval for a pharmaceutical product or for post-marketing surveillance. We consider this to include the planning and implementation of non-clinical studies (in accordance with the OECD Principles on Good Laboratory Practice), Phase I to IV clinical studies (pursuant to Directive 2001/20/EC) and non-interventional studies. We also include those studies which are necessary to demonstrate the additional benefit of a pharmaceutical product and to demonstrate or maintain that the expenses involved should be reimbursed.

Methodology
As generally basic research is targeted at either developing new products or relates to a specific product and is intended to extend its scope of use, we will publish the total value of Transfers of Value under the category "Research and Development". If we conduct basic research unconnected to the development of new or enhancement of existing products, which is general in nature, we will generally publish it under the category "service agreements" rather than under "Research and Development". In the event, however, that we support basic research in the form of donations to a university hospital, for example, we will publish the corresponding Transfers of Value under the category "monetary donations / donations in kind".