METHODOLOGY FOR PUBLISHING BENEFITS

FROM CROSS PHARMACEUTICALS P.C. TO HEALTHCARE PROFESSIONALS (HCPs)
AND SCIENTIFIC HEALTHCARE ORGANIZATIONS (SHOs)

1. INTRODUCTION

Disclosure by Cross Pharmaceuticals P.C. of benefits in accordance with the provisions of Article 66 par. 7a of Law 4316/2014 (Government Gazette A 270), according to which "Every Pharmaceutical Company must publish by name on its website and on the special website of the National Organization for Medicines (EOF), no later than six months after the end of each calendar year, any benefit it provides to third-party healthcare professionals and scientific healthcare organizations [...] in relation to the promotion of prescription medicines" publishes on its website the attached list of benefits provided to Recipients, HCPs, and SHOs during the calendar year 2024 (Reference Period).

This website publishes the benefits provided by Cross Pharmaceuticals P.C. to Healthcare Professionals (HCPs) and Scientific Healthcare Organizations (SHOs) for the period from 01/01/2024 – 31/12/2024.

The purpose of this Methodological Note is to analyze and provide clarifications regarding the content and logic followed by Cross Pharmaceuticals P.C. when disclosing benefits in accordance with Law 4316/2014 (Article 66, paragraph 7).

Disclosure Objectives:

  • Further Enhancing Transparency and Professional Ethics and Responsibility

  • Ensuring clarity in the cooperation between HCPs/SHOs & pharmaceutical companies

  • Responding to society's growing demand for greater transparency and integrity

We expressly note that this disclosure of benefits to Healthcare Professionals was formulated in accordance with Opinions Nos. 5/2016 and 2/2017 of the Data Protection Authority, the content of which restricts nominal disclosure, at promotional conferences aimed at the commercial promotion of prescription medicines, as well as in accordance with the relevant announcement by the EOF, which was published on the EOF website and reads as follows:

Audit of compliance with Law 4316/2014 on the disclosure of benefits

Athens, 03/04/2024

In accordance with the principles of sound administration, good faith, and the protected legitimate expectations of those subject to public authority, which govern the exercise of the powers of public bodies, it is emphasized to those required to publish benefits on their website and on the EOF website, that the deadline set out in paragraph 7 of Article 66 of Law 4316/2014 (A' 270) is binding, i.e. “no later than six months after the end of each year,” and no freedom to amend it is granted.

Therefore, the reporting service for expenditure and accounting for the year 2023 will accept submissions via the EOF Online Application for Scientific Conferences until 30/06/2024 at 23:59. Furthermore, any relevant information sent by email or through the General Secretariat of the EOF will not be taken into account or evaluated.

Each party liable is urged to pay close attention to the fact that, after the expiry of the above deadline, the Agency will carry out checks on compliance with paragraph 7 of Article 66 of Law 4316/2014 (A' 270) and will impose the penalties provided for in the above law in order to protect the public interest.

The President of the National Organization for Medicines
Evangelos Manolopoulos
Professor of Pharmacology, Democritus University of Thrace, Faculty of Medicine

2. SCOPE OF APPLICATION

2.1 CATEGORIES OF RECIPIENTS

The recipients of this Disclosure Form are Healthcare Professionals (HCPs) and Scientific Healthcare Organizations (SHOs) who have received benefits from Cross Pharmaceuticals P.C. and whose main activity, professional headquarters, or place of residence or domicile is located in Greece. In particular:

2.1.1 Healthcare Professionals
Any natural person exercising the medical, dental, pharmaceutical or nursing profession or any other person who, in the course of his or her professional activity, may prescribe, dispense or administer a medicinal product. In order to avoid confusion, the term “Healthcare Professional” includes: (i) any executive or employee of a government agency or other organization (either public or private) who is able to prescribe, dispense, or administer pharmaceutical products; and (ii) any employee of the Company who is a HCP and whose primary professional activity consists of providing healthcare services. The following are excluded from the latter category: (a) all private doctors who provide ongoing services to the Company under an employment contract, mandate or project contract; and (b) wholesalers or distributors of pharmaceutical products.

2.1.2 Scientific Healthcare Organizations
An SHO is defined as any legal entity: (i) which is a health, medical, or scientific association (scientific society or professional association) or a healthcare organization (regardless of its legal or administrative form), such as a hospital, clinic, institute, university or other educational institution or company of any form (e.g. NGO) funded by pharmaceutical companies (except for patient associations); or (ii) through which one or more healthcare professionals provide healthcare services, including private primary healthcare providers (P.D. 84/2001, Government Gazette 70/Α/10.4.2001)

2.2 CATEGORIES OF BENEFITS

A benefit is defined as any transfer of goods and rights, whether in return for payment for services rendered or as a subsidy for educational activities - continuing education. This includes direct or indirect payments, whether in cash, in kind, or otherwise, made for promotional or other purposes in connection with the development and sale of generic or reference medicinal products exclusively for human use. Direct payments are those made directly by a PC to the benefit of a Recipient Indirect payments are those made on behalf of a PC to the benefit of a Recipient, where the identity of the PC is known or can be identified by the Recipient.

2.2.1 Benefits to Healthcare Professionals related to:

a) Participation in Events

  • Registration fees

  • Travel expenses

  • Accommodation expenses

b) Remuneration for consulting and other services
Remuneration arising from or related to contracts between Cross Pharmaceuticals P.C. and HCPs under which services are provided such as:

  • Education/training

  • Counselling Seminars

  • Speeches/Lectures

  • General consulting services

2.2.2 Benefits to Scientific Healthcare Organizations related to:

  • Donations (donations and grants to SHOs which support science, technology, medicine, healthcare, research, or education) and which have been completed (i.e., invoiced and paid to the recipient) within the reporting year.

  • Expenses related to scientific and/or educational events organized by SHOs for the training of Healthcare Professionals. For the expenses referred to in this paragraph, the date of provision shall be deemed to be the last day of the event.

  • Other sponsorships (e.g., website support)

When a third company is the organizer of a conference and acts on behalf of an SHO, Cross Pharmaceuticals P.C. will disclose the grant in the name of the SHO beneficiary, even if the payment is made to the third company.

2.2.3 Benefits for Research and Development
There will be aggregated disclosure of expenses related to the conduct of (i) non-clinical studies, (ii) clinical studies, and (iii) prospective non- interventional studies.

2.2.4 EXEMPTIONS FROM THE DISCLOSURE REQUIREMENT

  • Benefits related exclusively to Non Prescription Medicines (NPM).

  • Items of negligible value, directly related to medical practice.

  • Food & Beverages

  • Benefits related to the purchase and sale of medicines.

3. DISCLOSURE OF FINANCIAL INFORMATION

3.1 Currency

All amounts are expressed in euros (€). In cases where payments have been made in foreign currency, the exchange rate prevailing on the date of invoicing has been used for conversion into national currency.

3.2 VAT and Other Taxes

The benefits disclosed include, where applicable, Value Added Tax, Income Tax Withheld, any deductions in favor of ELKE/ELKEA/YPE/third parties and other charges, as evidenced by the relevant legal documentation.

4. PUBLICATION TIME

Information relating to transfers of value to HCPs. and SHOs is published on an annual basis. All data are recorded throughout the year and published no later than the end of the following year's semester. Access to the data will remain unrestricted for three years.

5. PUBLICATION FILE

The file is published today, 27/06/2025, on the website of CROSS PHARMACEUTICALS P.C. (http://www.crosspharma.gr) for the year 2024, in accordance with the law.