Purpose of this document

This document explains the methodological approach of A. Menarini GmbH (hereinafter referred to as "A. Menarini") with regard to the disclosure of benefits and collaborations with healthcare professionals (HCPs), healthcare organisations (HCOs) and patient organisations (POs). The aim is to set out the principles of open and transparent collaboration. The report includes key definitions, the scope of disclosed activities and the basic elements of the data collection and reporting process.

1. Introduction

As a member of scienceindustries and signatory to the Pharmaceutical Cooperation Code, A. Menarini is committed to transparency in its co-operation with HCPs, HCOs and POs in accordance with all relevant local transparency requirements.

Collaboration between healthcare professionals and healthcare organisations has always been a driver for progress in patient care and the development of innovative therapies. HCPs and HCOs provide the pharmaceutical industry with valuable, independent clinical and therapeutic expertise. As the primary point of contact for patients, HCPs also contribute significantly to the understanding of therapy outcomes and patient management, thus promoting patient-centred product development and improved care.

HCPs and HCOs should be appropriately rewarded for the expertise and services they provide to pharmaceutical companies. The Pharma Cooperation Code ensures accuracy and transparency regarding the scope and value of these collaborations and thus strengthens trust between the pharmaceutical industry, the medical community and patients.

A. Menarini's policies are consistent with the objectives of the Pharmaceuticaql Cooperation Code, which is to promote ethical and transparent interactions with the healthcare community. Our interactions are governed by the A. Menarini Code of Business Practice, the Code of Conduct and global standards that require integrity in all business activities and strictly prohibit the granting or accepting of improper benefits.

The preparation of the annual transparency report is an important obligation for A. Menarini and an opportunity to reaffirm our commitment to the values and principles of the Local Pharmaceutical Cooperation Code, the EFPIA Code and other relevant transparency requirements.

2. Definitions

2.1. Recipient

2.1.1. HCP - Health Care Professional

Includes doctors, dentists, pharmacists (in practice, hospital or retail), chemists and persons authorised to prescribe, dispense or use medicinal products for human use in accordance with Swiss therapeutic products legislation.

2.1.2. HCO - Health Care Organisation

Refers to institutions, organisations, associations or other groupings of HCPs that provide healthcare services, advice or related services (e.g. hospitals, clinics, foundations, universities, scientific societies, professional associations, group practices, networks of doctors).

2.1.3. PO - Patient Organisation

Defined as non-profit legal persons/entities (including umbrella organisations) with a primary focus on patients and/or their carers, which represent and/or support their needs and have their registered office or main place of activity in Switzerland.

2.2. Types of benefits (ToVs)

2.2.1. Donations and grants

Refers to unpaid support to legitimate organisations (HCOs) for medical/scientific education, research, health systems or disaster relief (financial or non-financial). This includes earmarked donations and support contributions to promote educational initiatives for HCPs, medical/scientific research, partnerships as well as earmarked donations and support contributions to charitable POs (monetary or in-kind donations).

Written agreements define the scope of all donations and support contributions granted within this framework.

2.2.2. Sponsoring of specialised events

Includes the financial or non-financial support of legitimate organisations (HCOs) for the medical/scientific education of external stakeholders and the organisation/hosting of educational/scientific events (including independent congresses) in return for a defined service.

The aim is to improve the scientific/pedagogical quality and/or logistical support within an appropriate framework in accordance with A. Menarini's ethical principles.

Written sponsorship agreements define the purpose and use of the funds in detail. Sponsorship can cover various activities. Donations are issued directly to the HCO or a third party commissioned by it and disclosed to the ultimate beneficiary HCO.

2.2.3. Registration Fees

Refers to the support of HCOs or HCPs in covering registration fees for selected independent congresses and other educational/scientific events to promote continuing medical education. Where possible, payments are made directly to the relevant organiser.

Support can be provided up to a maximum of two thirds of the total costs, with the remaining third or costs being borne by the HCO or HCP themselves. For HCPs in training, the contribution towards their own costs can be reduced to one fifth.

2.2.4. Travel & Accommodation

Includes support for HCOs or HCPs to cover travel and accommodation costs to attend selected independent congresses and/or educational events organised by A. Menarini and other educational/scientific events to promote continuing medical education. This coverage includes air, rail, hotel, taxi and other travelling expenses. Costs for group transport are summarised; if the identity of the HCPs is known, a detailed breakdown by HCP is provided.

Support is provided up to a maximum of two thirds of the total costs, with the remaining third or costs being borne by the HCO or HCP themselves. For HCPs in training, the contribution towards their own costs may be reduced to one fifth.

2.2.5. Fees for services and consulting as well as related expenses

HCPs/HCOs/POs can be remunerated for services rendered in return for a market-based fee if there is a corresponding business need and proven qualification. This may include lectures, training, medical writing, data analysis, development of educational materials, general consulting, third party conference services, retrospective non-interventional studies and participation in market research (with known identity and compensation/travel reimbursement).

Within the framework of written agreements, related expenses (flights, train, hire car, tolls, parking fees, taxi, bus, hotel, visa) can be paid or reimbursed on presentation of appropriate receipts (direct payment to the provider or reimbursement on presentation of receipts).

2.2.6. Research and development (R&D)

All grants in connection with the planning and execution of prospective non-clinical, clinical and non-interventional studies conducted by A. Menarini or on its behalf by clinical research organisations are reported in aggregated form.

3. Scope of disclosure

3.1. Affected products

A. Menarini sells prescription medicines, non-prescription medicines, dietary supplements and medical devices. The disclosure is limited, as far as a clear delimitation is possible, to prescription medicines.

3.2. Deductible HCP / HCO

In the reported support contributions to HCOs and HCPs for participation in events organised by A. Menarini with a duration of more than half a day or in the support of HCPs for participation in selected independent congresses and other educational/scientific events to promote continuing medical education, the required co-payments of the participants of one third (one fifth for HCPs in training) are deducted from the disclosed total costs.

3.3. Excluded ToVs

• Hospitality costs: Food and beverages at events organised by A. Menarini are not subject to disclosure pursuant to Article 24.3.7 of the Pharma Cooperation Code. However, if they are an integral part of event/sponsorship contributions paid by A. Menarini to HCOs, they are recognised under "Contributions to event costs".
• Information/educational materials and medical aids: In accordance with Article 24.3.3 of the Pharma Cooperation Code, the supply of directly medically/pharmaceutically relevant materials with a direct benefit for patient care is not disclosed.
• Logistics costs: Costs for events organised by A. Menarini (room rental, technology, personnel) are excluded from disclosure. However, travel/accommodation costs or speakers' fees for HCP participants are included in the corresponding categories.
• Drug samples: The supply of drug samples is not subject to disclosure and is not recorded.
• Donations to non-profit organisations: Donations to organisations that are not HCOs are exempt from disclosure.

3.4. Time of data collection

Grants are generally recognised and published at the time the service is rendered, regardless of the date of payment.

In the case of multi-year contracts, however, the payment date is used as the basis and only allocations from the respective reporting year are taken into account.

3.5. Type of disclosure

A. Menarini's cooperation with HCPs and HCOs is exclusively project-related and based on cooperation agreements with a defined service duration. These contracts contain disclosure clauses as standard. The consent of the HCP and HCO to disclosure is therefore obtained on a project-by-project basis and the reports are made in each case in relation to the HCO or HCP.

The HCPs and HCOs listed by name in the report have consented in writing to the disclosure of the amounts. Individuals or organisations that did not agree to the disclosure of the pecuniary benefits and amounts for which no consent to disclosure could be obtained are shown in aggregated form.

Services in connection with studies or scientific research projects are generally disclosed on an aggregated basis.

3.6. Direct ToVs

The direct recipient is the natural or legal person whose bank account receives the payment. Direct donations are recorded via the project lists and dossiers, transferred to the A. Menarini transparency reporting system, assigned to the corresponding EFPIA category and reported.

Direct contributions made by Menarini Group companies outside Switzerland to HCPs/HCOs in Switzerland are recorded manually and uploaded to the local transparency reporting system (see point 3.9.).

3.7. Indirect ToVs

• R&D activities by third parties: If a third party commissioned by A. Menarini provides grants to HCPs/HCOs as part of research and development activities, these are recognised in aggregate under the "R&D" category, provided the activities meet the R&D definition.
• Via other third parties: If an HCO commissions third parties to organise an event and the HCO ultimately benefits from the grant, disclosure is made to the HCO. In the case of events for several HCOs without a clear allocation, the value is divided equally.
• Agreements with other pharmaceutical companies: All benefits received from A. Menarini as part of an agreement are disclosed if the HCP or HCO has a contractual relationship with A. Menarini and the benefits flow directly from A. Menarini to the HCPs or HCOs. If there is only a contract with the pharmaceutical company as part of a co-sponsorship, A. Menarini expects disclosure by the partner company.
• Travel organisation by third parties: If A. Menarini commissions third parties to organise travel and accommodation for HCPs (as part of services or event support), disclosure will be made to the HCP. Agency fees are exempt from disclosure as they do not constitute benefits to HCPs/HCOs.

3.8. Benefits for partial participation or cancellation

In the event of non-attendance or cancellation of an event, the obligation to report associated costs (e.g. hotel cancellations) does not apply. In the case of partial participation, only the services actually received or provided will be reported.

3.9. Cross-border activities

A. Menarini records and reports group-wide benefits to HCPs, HCOs and POs headquartered in countries that have implemented the EFPIA Code and/or other cross-border transparency requirements. The country of disclosure is based on the main practice address (HCPs) or registration address (HCOs). Disclosure is made locally via the website of the respective subsidiary or a separate platform in accordance with national regulations.

4. Special considerations

4.1. Independent HCPs

Sole proprietorships of HCPs are treated as HCPs but are subject to the disclosure consent requirement. Self-employed persons who are not registered as legal entities are treated as individual HCPs.

4.2. Sponsorship contributions to hospitals and universities

In the case of sponsorship contributions to hospitals and universities for training and services, the invoicing organisations are disclosed. In the case of sponsorship of universities and comparable organisations, only support contributions for projects with a direct medical connection are disclosed.

5. Consent management

5.1. Obtaining consent

A. Menarini endeavours to ensure a high degree of transparency in individual disclosures while complying with the relevant data protection regulations. The collaboration agreements contain standard consent clauses for disclosure, the status of which is continuously monitored and updated.

5.2. Revocation of consent

Consent to disclosure can be revoked in writing at any time. Benefits for which consent has been withdrawn will continue to be disclosed as an aggregated amount, but traceability to the individual recipient is excluded in this case.

5.3. Partial consent

According to the EFPIA Code, partial consent to disclosure is not acceptable. If consent is only partially given, the last answer applies to all transactions in the respective reporting year.

5.4. Requests from recipients

Enquiries or disputes will be dealt with locally. HCPs/HCOs are requested to contact their local contact person in the event of incorrect data. A. Menarini undertakes to clarify and, if necessary, republish the corrected data within 30 days.

6. Value added tax (VAT)

The amounts shown in the report are exclusive of VAT.

7. Currency / exchange rate

If a payment is made in a currency other than the Swiss franc, the monthly average exchange rate of the Swiss Federal Tax Administration is used for conversion.

8. Time, period and place of disclosure

The data for the respective reporting year is made available on the company website in the following year by 30 June at the latest. Disclosure is made for the full previous calendar year.

9. Duration and visibility of the data on the disclosure platform

The disclosed data remains visible on the platform for a period of three years. The published data is stored for a total of ten years and then deleted in accordance with the applicable data protection guidelines.

10. Disclosure of payments to patient organisations

In accordance with national regulations, donations to patient organisations and membership of patient organisations have been disclosed in detail for several years in a separate report on the company website.