Methodology note regarding the implementation of the disclosure according to the Pharma Cooperation Code for the disclosure period

We at Bayer are convinced that close cooperation with doctors and supporting further training of healthcare professionals is key to achieving better outcomes for patients. In line with our values 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. In collaboration with healthcare professionals and healthcare organizations, we comply with applicable laws and sectorial guidelines such as the code of conduct of scienceindustries, and respect the independence and integrity of healthcare professionals and healthcare organizations.

 

As a member of scienceindustries, we welcome making the nature and scope of our collaboration with healthcare professionals and healthcare organizations understandable and transparent for the general public. For this reason, scienceindustries has developed the Pharma Cooperation Code (PCC), the code of conduct for the pharmaceutical industry in Switzerland about the cooperation with experts and patient organizations. This code is based on the regulations of the European Code, the Disclosure Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA). These codes are designed to ensure that even the impression of potential conflicts of interest are avoided and to improve the understanding of the general public as to the high importance and the need for cooperation of pharmaceutical companies with healthcare professionals. Included in the term 'healthcare professionals' are doctors and pharmacists based in Europe and all members of the medical, dental, pharmaceutical or other healthcare professions as well as any other people who prescribe or use medicines for human use within the scope of their professional activities or those who lawfully trade in them.

 

In implementing the Pharma Cooperation Code (PCC; status July 2015), we disclose all transfers of value, that we either directly or indirectly make to the benefit of healthcare professionals and healthcare organizations. A reporting period is a calendar year and we always publish the report every June in the following year.

 

The current methodological notes explain how we collect and disclose the transfers of value in terms of the Pharma Cooperation Code. In particular we want to clarify the underlying methodology and show with specific questions how we deal with them within the framework of disclosure. If there are doubts about the disclosure of a specific transfer of value, in the interests of transparency we assume that the transfer generally has to be disclosed. Only if a transfer of value is clearly out of the scope of the disclosure code, then 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 using explanations or examples the way in which we handle the requirements of the Pharma Cooperation Code (PCC) for the respective reporting year.

I. Data Privacy

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.

II. General Questions

Example

A "cross-border" interaction is always present when the Transfer of Value (ToV) is accorded in a country other than the country in which the HCP or HCO has its main principal practice address, office or headquarters. For example, this sort of situation includes those cases where our local affiliate in Italy concludes a consultancy agreement with a Swiss-based HCP and pays an honorarium for the services provided.

 

Methodology

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. In the example given above, the transfer of value will be reported by our Swiss organization. If there is no affiliate located in that country, we will publish the information on our central website.

 

The same rules apply, when a Bayer affiliate outside Switzerland, respectively an EFPIA area, grants a transfer of value to a healthcare professional or organization in Switzerland, respectively in an EFPIA country.

Examples

A doctor based in Switzerland receives funding from us to take part in a healthcare convention in the USA and the attendance fee is paid in US dollars.

 

A doctor with primary practice in the UK is acting as a speaker for a training event in Italy. The flight is booked by our Italian affiliate and is paid in Euros.

 

Methodology

In the Swiss report we reveal all ToV exclusively in Swiss francs. If the original ToV was not made in Swiss francs, we will convert it into Swiss francs.

 

In the first example, we would convert the congress attendance fee to Swiss francs. In the second example, we would convert the costs of the flight into British pounds and publish this sum.

Legal background

In principle, according to Pharma Cooperation Code, the amounts can be published as gross or net figures, i.e. either including or excluding VAT.

 

Methodology

Bayer will reveal all transfers of value as net amounts, excluding VAT.

Legal background

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.

 

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 products – which are not in the scope of the Pharma Cooperation Code - Bayer will disclose such transfers of value in full.

Example

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.

 

Methodology

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.

Example

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.

 

Methodology

In this case, we will disclose the individual honorarium based on the date when Bayer received the respective invoices (see also question 9). 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.).

Methodology

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.

Background

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.

 

Methodology

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.

Methodology

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.

Methodology

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

Legal background

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).

 

Methodology

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.

Methodology

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.

Methodology

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.

Methodology

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.

Methodology

Bayer discloses all ToV that HCPs and HCOs receive. If cancellation costs occur due to a 'no-show' and Bayer partly covers the costs, then these ToV are disclosed.

Methodology

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. This can happen, for example, if the HCO has out-licensed the name of a traditional event and is only receiving a certain percentage of sponsorship amounts as licence fees.

Methodology

Internal training events are defined as events organized by Bayer itself. Bayer does not charge attendance fees for its own events, therefore no transfer of value needs to be disclosed in this regard. In the event that we assume the travel and accommodation costs for participants 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 (assuming consent is given).

Legal background

Service and consultancy fees underlie corresponding service and consultancy agreements. Bayer understands 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. 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. Honoraria paid for services like speaker engagements or consultancy contracts fall into this category. If services provided are connected to activities within the framework of the category 'Research & Development', the fees will also be reported in this category.

 

In individual cases, sponsoring contracts can also be concluded with HCPs when they organize scientific events for professionals. Since scienceindustries has not planned any category for that, Bayer reports these ToV in the category 'Contributions to the cost of events'.

Legal background

If Bayer refunds other expenses in connection with service and consultancy fees, for example travel and accommodation costs, these costs will also be disclosed in the category 'Services and consultancy fees'.

 

Methodology

Bayer publishes all expenses that are related to provision of services in the category 'Services and consultancy fees'. It may happen that only expenses are reported in the name of a HCP, not however fees. This is because in some cases no fee for the service was claimed.

Methodology

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.

Methodology

In terms of the category 'R&D', we will only publish those ToV 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. Concretely, this includes in particular 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 as defined in the Pharma Cooperation Code. We also include in this category 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

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’.

 

If we conduct basic research unconnected to the development or further development of new or existing products, we will generally publish it under the category 'Services and consultancy fees' rather than under 'R&D'.

 

In the event, however, that we support basic research in the form of therapeutic legally permissible donations to a university hospital or a foundation, for example, we will disclose the corresponding ToV under the category 'Monetary donations/donations in kind'.

L.CH.COM.BHC.06.2017.0490-DE/EN/FR