METHODOLOGY NOTES

PUBLICATION OF VALUE TRANSFERS TO HEALTH CARE PROFESSIONALS, HEALTH CARE ORGANIZATIONS AND PATIENT ORGANIZATIONS

The purpose of this statement is to help readers understand how Azanta has derived and calculated the amounts for transfer of value to health care professionals (HCPs), health care organizations (HCOs) and patient organizations (POrgs).

Introduction to the publication and purpose of this statement
According to the European Federation of Pharmaceutical Industries and Association (EFPIA) Code of Publication, there should be greater transparency between pharmaceutical companies, HCPs, HCOs and POrgs. Hence, Azanta publishes once a year financial support to HCPs, HCOs and POrgs on its website.

A healthy collaboration between the pharmaceutical industry and HCPs, HCOs and POrgs is in the patients’ best interest. EFPIA’s publication code was introduced to protect the integrity of this relationship and is a step towards greater transparency to enhance trust between the pharmaceutical industry, the health sector and the society across Europe.

In Europe, all companies transferring values to HCPs, HCOs or POrgs must publish a note with a brief description of the methods used to prepare the publication and identify the individual categories of value transfers.

Azanta publishes all value transfers to HCPs, HCOs and POrgs in accordance with the EFPIA Code of Conduct.

The term “value transfer” means any direct or indirect transfer of value, whether in the form of cash, in kind contributions or otherwise, and whether the purpose is promotional or otherwise, in connection with the development or sale of drugs. A direct transfer of value is made directly from a company in favor of a recipient. An indirect transfer of value takes place on behalf of a company in favor of a recipient or through an intermediary, and where the company knows or can identify the recipient benefiting from the value transfer.

For non-monetary value transfers, an estimate of the corresponding value for the recipient is provided.

Definitions:

Health Care Professional
Any natural person who works as a doctor, dentist, pharmacist or nurse or any other person who, in connection with his or her professional activities, may prescribe, purchase, supply, recommend or submit a medicinal product and whose primary practice, primary business address or home is located in Europe. In case of doubt, the definition of HCP includes the following: (i) any official or official of an authority or other organization (in the public or private sector) who may prescribe, purchase, supply or administer medicinal products, and (ii) any member of staff of a member company whose primary job is to act as a HCP, except from x) all other employees of a member company and y) a wholesaler or distributor of pharmaceutical products.

In connection with publications, Azanta considers all employees in a national, public health service or any private health care provider as an HCP, regardless of their professional status. In addition, Azanta considers any registered or qualified HCP to be included in the scope of the disclosure, regardless of the status of their national public health service. Retired HCPs are thus covered by its coverage, including academic staff offering clinical services and support.

Any employee of Azanta whose primary occupation is an HCP is covered by this publication. Value transfers to this group will, therefore, be disclosed, including their salaries from Azanta.

Health Care Organization
Any legal entity i) which is a health, medical or research association or organization (irrespective of its legal or organizational form), such as a hospital, clinic, fund, university, educational institution or company (except POrgs covered by the EFPIA Patient Organizations Code) whose business address, registered office or principal place of business is located in Europe, or ii) through whom one or more POrgs provide services.

Patient Organization
POrgs are defined as not-for-profit organizations (including the umbrella organizations to which they belong), mainly composed of patients and/or caregivers, that represent and/or support the needs of patients and/or caregivers.

Other relevant decision-makers
Other relevant decision-makers include, in particular, bodies with a national health service, which may in any way affect the management, consumption, prescription, sale, recommendation, purchase, delivery or use of any medicinal product but which are not HCPs.

Value transfers to other relevant decision makers are disclosed along with value transfers to HCPs.

Azanta collectively designates HCPs, HCOs, POrgs and other relevant decision makers as health consumers.

Donations and grants
Donations and grants are understood to mean donations and grants (cash, in kind, or otherwise) to institutions, organizations, or associations of HCPs and/or HCPs or researches. Grants are awarded for the purpose of achieving a specific objective, but for which the specific activities required to achieve this objective have not yet been established. Grants are only permitted if: (i) they are granted for the purpose of supporting treatment or research; (ii) they are documented and registered by the donor / subsidiary; and (iii) they do not constitute an incentive to recommend, prescribe, purchase, supply, sell or provide specific pharmaceutical products. Donations and grants for individual HCPs are not allowed.

Data protection and consent
Azanta fully adheres to the concepts of transparency and data protection. According to the Data Protection Act, all pharmaceutical companies and hence Azanta must obtain the consent of individual HCPs prior to the disclosure of personal data such as individual value transfers to them by name.

Azanta agrees only with an HCP, another relevant decision-maker or HCO if they consent to the disclosure of their data, either in aggregated or individual form. Azanta does not enter into an agreement with HCPs who refuse to comply with the principle of transparency. Please note that HCPs are entitled at any time to opt out of individual disclosure and revoke their consent, and Azanta must comply with their wishes.

Whenever Azanta enters into an agreement with an HCP or HCO for a pre-determined collaboration (e.g., project work, meetings, events, grants or consultancy fees), the agreement provides a clear indication of the agreed form of publication (i.e. accepted by) the HCP/HCO. Azanta seeks to obtain consent to publish value transfers to an HCP or HCO for each transaction or collaboration covered by the agreement. This means that the same HCP or HCO for the same publication year can opt out of individual disclosure of certain value transfers (through individual disclosure) and aggregated for others (through aggregated disclosure).

If no permission has been obtained or the individual HCP has refused to give consent on an individual basis, Azanta will report the total cost as an aggregate figure. For the sake of transparency, Azanta seeks to obtain consent for the publication of all its value transfers on an individual level, so that a new consent is sought for each new collaboration or project.

Research and Development (R&D)
All payments to HCPs and HCOs in connection with research and development are published as an aggregate figure under R&D value transfers. Costs associated with these clinical trial activities are also included in the aggregate amount.

For the purposes of publications, in the case of research and development value transfers, transfers to an HCP or HCO planning to make are understood:

  • non-clinical studies (as defined in the OECD principles of good laboratory practice)
  • clinical trials (see definition in Directive 2001/20/EC)
  • non-intervention studies with a forward-looking perspective involving the collection of data from or on behalf of individuals or groups of HCPs specifically for the purposes of the studies concerned

Since clinical research organizations are not considered as HCOs by Azanta, any value transfer from the clinical research organization to the HCP or HCO is reported as part of the aggregated disclosure.

Transactions

Transaction date relative to date of service delivery
Azanta processes and reports value transfers from the time of payment to the health consumer, i.e. the transaction date, and not from the time of delivery of the service, for the co-operation or the actual event. This means that there may be cases where value transfers published in the current year are transferred to the following year.

Value transfers are always paid after the conclusion of the agreement, however, except for grants (see definition). Grants are paid before the actual event takes place or the purchase to which the grant is granted is carried out.

Multi-annual contracts management
In the same spirit as in the above paragraph, where projects run for several years, Azanta reports the amount paid relevant to the year in which the individual parts of the payment have been made. A project that runs over two calendar years and includes several individual value transfers during this period is subject to two coherent disclosures (i.e. one for each calendar year showing the value of the transfer made in that calendar year).

VAT
Consultancy fees and salaries are not subject to VAT and refundable local taxes.

Expenses related to an event or meeting (travel, housing and taxi) may be subject to VAT or subject to local taxes and charges.

If an amount is taxable, the VAT is the national VAT rate in the country where the expense is incurred, i.e. 25% in Denmark.

Currency and exchange rate management
The values stated in the publication are expressed in local currency, i.e. DKK for Danish data.

Payments to charity and third party
An HCP who has provided a service to Azanta may occasionally request to be paid by the charity or a third party. Azanta does not normally allow this practice and the disclosure is made as granted to the HCP concerned when the contract is concluded between Azanta and the HCP who provided the service and who has received the transfer of value. It is up to the HCP to transfer the payment to charity or a third party of his choice, and any subsequent transaction is beyond Azanta’s control.

Azanta regularly concludes agreements with advertising agencies and PR agencies for services related to its business, and an HCP can enter into an agreement to provide a service to Azanta. Azanta publishes any value transfer to that HCP made by agencies as if the payment had been made directly by Azanta to that HCP.

Payments to health care organizations for services provided by individual health care professionals
An HCO may occasionally request that benefits provided by its HCP be covered by an agreement concluded through the HCO concerned and not directly with the individual HCP. In that case, Azanta enters into an agreement that a named HCP must provide the services and the transfer of value will be published, stating the name of the HCP concerned. Any “administration fee” charged by the HCO is published as a fee for a benefit provided to that HCO. If the HCP does not receive additional payment for the benefit (e.g. because he or she is presenting at a meeting within normal working hours), the full amount paid by Azanta as provided to the HCO as a fee for a benefit is disclosed.

Private companies and charities
In the case of an HCP who runs a private company or a partnership or a charity organization for his or her own income, value transfers to the relevant organization in the publication will be stated as a direct payment to the HCP in question.

Grants for education

Grants for independent companies

Independent companies that carry out medical education projects can request Azanta to sponsor or fund their work. In that case, Azanta has no influence on the content of the project and does not necessarily know whether and, if so, which HCP has agreed. Value transfers are published as provided to the HCO.

Grants and donations
If Azanta receives an application for a grant or a donation to an HCO as an aid to its employees’ participation in medical or scientific meetings (i.e., which may include contributions to enrollment fees or travel and stay), the related value transfers are disclosed as provided to the HCO, unless the application is linked to named persons. If the application is linked to a named HCP, the publication is made as if the named employee had received the value transfer directly.

If Azanta does not know the name of the HCPs who receive the aid, the grant is exported as granted to the HCO that submitted the application.

Contributions to meetings
Azanta publishes all payments to medical associations and HCOs related to meetings. This includes direct funding such as sponsorship fees or building an exhibit stand, as well as indirect support such as access to a logistics agency or entry fees, travel and subscription fees. Expenses for participation in meetings organized by a medical association is also disclosed and details of these transfers of value appear from the relevant entry.

Dietary expenses are not subject to disclosure, as payment thereof is subject to strict industry guidelines. Diets may occasionally be included if it has not been possible to specify the costs for these if they are included in a lump sum that includes other costs to be disclosed.

Azanta provides support to HCO’s participation in medical and scientific meetings. If the cost is not specified for each participant (e.g., the cost of a bus transporting a group of HCOs from the airport to the conference venue), the total cost is allocated to everyone who has received support.

Cross-border payments
Azanta has subsidiaries in more countries in the European Union
Value transfers made by an Azanta unit are disclosed in the relevant disclosure form, and amounts paid to the HCP are stated in the correct local currency.

Common marketing projects
If Azanta markets a product with another pharmaceutical company, Azanta reports value transfers made directly from its own bank accounts and entered in the company’s accounts as part of its regular business activities. Value transfers made by the marketing partners are published separately by these organizations. The division of responsibilities regarding transparency and publication must be clearly stated in the contractual partner agreements.

For further interest in Azanta’s specialty pharma products or investigational cancer products, please contact your local representative or Azanta’s head office.

Find representative