TRANSPARENCY 

UNDERSTAND THE TRANSPARENCY FRAMEWORK FOR THE SCIENTIFIC AND HEALTHCARE WORLD

RECORDATI operates in accordance with the highest compliance standards required by the pharmaceutical sector, and as a member of Farmindustria (the National Association of Pharmaceutical Companies, part of the European Federation of Pharmaceutical Industries and Associations (EFPIA)), it implements and applies the provisions of the association’s Code of Ethics to ensure maximum propriety in relations between industry and the scientific and healthcare world.

The following provides all information needed to understand the transparency framework regarding so-called “Transfers of Value” made by RECORDATI in respect of Healthcare Operators and Healthcare Organisations during the last three years. For further information on the applicable Codes of Conducts. Please refer to the following link:

EFPIA Code – Farmindustria Code 

COLLABORATION BETWEEN PHARMACEUTICAL COMPANIES AND THE MEDICAL AND SCIENTIFIC WORLD

This collaboration is essential for the development of important knowledge on the efficacy of treatments, the evolution of diseases, treatment compliance and the appropriateness of using certain drugs.

Ensuring this important exchange for the benefit of research and patients requires medical education initiatives and ongoing training, as well as other activities such as scientific information and clinical trials, which need investments and resources provided by pharmaceutical companies.

The resources made available for these initiatives, which are already subject to rigorous codes and regulations, are published in response to growing demand for transparency, which pharmaceutical companies wholeheartedly support.

THE VOLUNTARY FRAMEWORK ON TRANSPARENCY

The Farmindustria Code of Ethics, which implements the EFPIA Code of self-regulation, requires that every year all member pharmaceutical companies must publish Transfers of Value made to Healthcare Operators and Healthcare Organisations, relating to the development and marketing of prescription drugs for human use.

WHAT ARE TRANSFERS OF VALUE

Transfers of Value are defined as any direct or indirect form of support or contribution (in accordance with the terms of Legislative Decree 219/06 governing pharmaceutical advertising in Italy) that each pharmaceutical company provides within the scope of medical and scientific promotion, whether to Healthcare Operators (doctors, pharmacists, nurses and other persons who, within their professional activities, may prescribe, dispense, acquire or administer a medicinal product) or to Healthcare Organisations (hospitals, universities, medical and scientific associations, research institutes, patient associations and/or other institutional bodies from the scientific community).

THE DIFFERENT TYPES OF TRANSFERS OF VALUE:

Transfers of Value are considered as costs incurred by pharmaceutical companies for:

a) the participation of Healthcare Operators in courses and congresses, as part of training and refresher programmes (Continuing Medical Education – CEM), authorised in advance (according to Legislative Decree 502/1992 supplemented by Legislative Decree 229/1999) by AGENAS (the Italian National Agency for Regional Healthcare Services on behalf of the Ministry of Health) and by AIFA (the Italian Medicines Agency) and certified by accredited operators in the national territory;

b) professional consultancy tasks that are principally conducted within the scope of training projects;

c) study grants or contributions to support awareness-raising and training activities carried out by patient associations;

d) costs related to the performance of clinical trials conducted with the support of healthcare facilities located in the country.

RESEARCH AND DEVELOPMENT COSTS

Also in application of the Farmindustria Code of Ethics and in relation to the EFPIA Code of self-regulation, each pharmaceutical company is required to publish all Transfers of Value to Healthcare Organisations for the planning and implementation of:

(i) non-clinical studies (as defined by the OECD Principles of Good Laboratory Practice);

(ii) clinical trials (as defined in Directive 2001/20/EC);

(iii) prospective observational studies referred to under point 4.4 of the Farmindustria Code of Ethics, involving the collection of patient data by individual Healthcare Operators or groups of Healthcare Operators.

The Recordati Group invests a substantial portion of its revenues in research and development activities at the national and international level, through public or private healthcare facilities.

The Transfers of Value published here relate exclusively to the Italian territory and are those provided to healthcare organisations.

COMPLIANCE OF THE COMPANY’S ACTIVITIES WITH NATIONAL AND INTERNATIONAL REGULATIONS AND CODES OF ETHICS:

All of RECORDATI’s interactions with Healthcare Operators and Healthcare Organisations are conducted in full compliance with laws in force and the provisions of the Farmindustria Code of Ethics.

RECORDATI believes that the application of voluntary transparency provisions adds to and complements the existing, complex system of control aimed at ensuring the highest standards of ethics and legality.

RECORDATI is strongly committed to conducting its own business activities in a transparent, honest
and ethical manner.

The company has its own Code of Ethics accessible via this page and it has adopted an Organisational, Management and Control Model pursuant to Legislative Decree 231/2001 and a group Anti-Corruption Model aligned with relevant international laws (such as the Anti-Bribery Act in the United Kingdom, the Foreign Corrupt Practices Act in the United States and the Ley Organica in Spain, etc.)

TRANSPARENCY AND PRIVACY:

Application of the voluntary framework on transparency must ensure compliance with the existing Privacy Law (Regulation (EU) 2016/679 (“GDPR”), as well as Legislative Decree No. 196/2003 as amended by Legislative Decree No. 101/2018 (the “Privacy Code”)) to safeguard the processing of personal data. The Privacy Law requires all pharmaceutical companies to secure the consent of each Healthcare Operator before publication of the Transfers of Value by name. If a Healthcare Operator denies consent for publication of its own data, RECORDATI is required by its code of ethics to publish these Transfers of Value in aggregated form.

METHODOLOGICAL NOTE AND DISCLAIMER:

Finally, please find below a few references to enable the correct interpretation of the Transfers of Value.

All payments (e.g. donations and sponsorships) are reported net of VAT. Withholding tax (if applicable) is included. All Transfers of Value resulting from services (e.g. airline tickets, hotel rooms, etc.) are reported gross and therefore include VAT.

In order to ensure compliance with the Privacy Law, the data published may not be indexable on search engines (e.g. by typing the first and last name of the Healthcare Operator into Google, it must not be possible to retrieve details of the Transfers of Value from Recordati S.p.A.’s website).

Transfer of Value

Working Together 

Farmindustria and Transparency 

Farmindustria code of ethics

Efpia Code 

Efpia self-certification

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