Transparency report

Technical methodology note

Introduction

Having society's trust in it as a company is a key value for Diater. We are therefore committed to publishing information on the relationships between Diater and all the healthcare professionals and organisations we work with.

The pharmaceutical industry works to continuously improve patients' quality of life and increase life expectancy, promoting the general well-being of patients and quality healthcare. It is necessary for companies to invest part of their profits in Research and Development projects which contribute to the development of new drugs, as well as new therapeutic indications for drugs. This requires close collaboration between the pharmaceutical industry and healthcare professionals and organisations.

In order to ensure complete transparency in the relations between the pharmaceutical industry and healthcare organisations, as well as their members, as of 2014 the industry has voluntarily made new commitments in terms of transparency. To this same end, as of January 2016, with the aim of increasing trust in the pharmaceutical industry, it has been decided to release information on any transfers of value made, regardless of the nature and level of the relations with the healthcare organisations and professionals.

The information published covers all transfers of value made to healthcare professionals and healthcare organisations in the form of donations, training activities, provision of services and research and development corresponding to the previous year. This information will be updated retrospectively on an annual basis and may be freely accessed through the websites of the different companies.

For more information about this initiative, visit the website www.codigofarmaindustria.es.

Scope

Healthcare professionals and healthcare organisations play a very important role in today’s society. They bring their knowledge and clinical experience, which is often shared with the pharmaceutical industry for the purpose of improving patients' quality of life. From this relationship between healthcare professionals and the pharmaceutical industry transfers of value arise.

In order to increase trust in the pharmaceutical industry, the industry has decided to publish information about the nature and level of said relations.

Therefore, Diater is committed to publishing an annual account of any transfers of value to healthcare professionals or healthcare organisations under the previously established terms, as well as its level of investment in R&D. This information will be freely available through its website, always on a retrospective basis.

Glossary of terms

• Healthcare Organisation (HO): any legal person or entity (i) that is a medical or scientific association, healthcare institution (regardless of its legal or organisational structure) such as hospitals, clinics, foundations, universities and other academic entities, scientific societies or (ii) through which one or more Healthcare Professionals provide services.
• Patient Organisation: non-profit organisation—including the umbrella organisations to which they belong—formed mainly by patients and/or their carers which represents and/or supports the needs of the patients and/or their carers.
• Healthcare Professional (HP):any member of the medical, dental, pharmaceutical, nursing, or podiatry professions, any other person legally considered as a member, or any other person who, in the exercise of their profession, could carry out or condition the activities of prescribing, purchasing, supplying, dispensing or administering medicinal products for human use.
• Recipient: Healthcare Professionals or Healthcare Organisations that exercise their professional activity in Spain or whose principle management office or place of incorporation is in Spain.
• Donation: act by which a company (donator) donates, free of charge, an amount of money or an asset or service (donation in kind) to a third party (recipient), who accepts it. In some cases, the term 'grants' (earmarked donations) is used to refer to those cases in which the provision or service is for the purpose of the recipient achieving a certain objective, implementing a project or performing an activity. Under no circumstances shall the donor obtain or request any compensation from the recipient.
• Scientific-professional meetings: any meeting, conference, congress, lecture, symposium, in-person or distance learning course, or any other similar activity (including, but not limited to, expert meetings, visits to manufacturing plants and research facilities, as well as training meetings for researchers related to the conduct of clinical trials and observational studies with medicinal products) that are organised or sponsored by one or more pharmaceutical companies or under their control (hereinafter "meeting(s)").
• Relationship: activities carried out, organised or sponsored by a pharmaceutical company, or company under their control – subsidiaries, foundations, associations, institutions, agencies, third-party suppliers, etc. – which may lead either directly or indirectly to collaborations, support and/or compensation of any type in favour of a third party.
• Research and Development: activities associated with the design or implementation of preclinical studies, clinical trials and post authorisation studies.
• Medicinal products for human use: any substance or combination of substances presented as having properties for treating or preventing diseases or which can be used in humans or administered to humans with the aim of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis.
• Promotion: any activity carried out, organised or sponsored by a pharmaceutical company or company under its control (subsidiaries, foundations, associations, institutes, agencies, etc.) aimed at promoting, directly or indirectly, the prescription, dispensing, recommendation, sale or use of its medicinal products for human use.
• Transfer of value: any direct or indirect payment or compensation in cash, in kind or any other form, regardless of its end purpose.
  • Direct: when it is the pharmaceutical company that directly provides this to a specific recipient.
  • Indirect: when it is a third party (suppliers, agents, partners or subsidiaries—including foundations—acting on behalf of the company, who provides this to a recipient and the latter identifies or can identify the company.

Compilation of information to be published and identification of the recipients

Compilation and processing of information Compilation of information

All information to be published is collected through internal sources based on management control and administrative/accounting computer tools.

The processing of data obtained has been categorised according to the table defined for this purpose, taking into account its nature and its aim.

Healthcare professionals with whom Diater has performed transfers of value have been given a Transparency Information Document to fill in and return, wherein the professional confirms they have been informed that their data will appear individually, as well as their full name, address, town or city and ID number. These data have then been set out in accordance with the characteristics of the table defined for their publication.

Transfers of value from the pharmaceutical company to healthcare professionals and healthcare organisations in the form of meetings, sponsorships and other collaborations are obtained using a data management tool which guarantees their details.

Date used for compilation and publication (multi-year contracts)

The delivery and compilation of these Information Documents, wherein each Healthcare Professional declares that they have been informed of said individualised publication, continues to be constantly updated, incorporating new HP Information Documents that had not been reported.

VAT and other tax aspects

In order to have a single criterion, both the information processed and the date of compilation of the data was that stated in the official books for expenditure, i.e. the tax base of the same. This is the financial year (January to December) of the year in which the publication refers to.

Unique identifiers

Both the healthcare professionals and healthcare organisations with which we work have a unique identification number in all the company's computer systems.

Identifications of the recipients Clearly defined recipient (residence)

Using the signed healthcare professional Transparency Information Documents with which we have carried out any type of transfer of value, a file has been created with the specific data for each one, containing the information required to create the file to be published. An identification code is also included which makes it possible to link the tax data with the corresponding transfers of value.

Transfers of value to HPs through HOs

Transfers of value carried out to healthcare professionals through healthcare organisations are clearly identified by (their name and) a record wherein the relationship between the healthcare organisation and the healthcare professional is indicated. In cases of contributions to Scientific Activities, the Society involved is also included.

Any transfer of value related to research and development is taken into account as a global amount, expressly referring to the direct clinical trial data or collaboration expenses and services with universities and healthcare organisations, directly or through their foundations, of projects carried out during the period concerned.

Categories of transfers of value

Donation ans grants to healthcare organitations

Donations and grants to organisations, associations or foundations made up of healthcare professionals who provide healthcare as well as research services are taken into account within the transfers of value referred to in the published annex.

The purpose of making said donations is to establish a collaboration with the clinical research carried out in healthcare and research services, between the different specialist departments, in the interest of improving the quality of life of the patient.

Diater guarantees that said donations or subsidies do not constitute an incentive when it comes to prescribing, purchasing, selling or administering medicinal products.

None of the donations made by Diater are to healthcare professionals as individuals; the recipient is always a healthcare organisation, association or foundation.

Collaboration in scientific and professional meetings

Collaboration in scientific meetings, is understood as collaboration in meetings and organisation of events of a purely scientific nature. In these meetings Diater collaborates in different ways, without any involvement in activities of a recreational nature, engaging exclusively on a scientific/professional level, as established in the Pharmaceutical Industry Code of Good Practices.

The degree of collaboration goes from registering professionals for a course or for a regional, national or international congress, as well as covering the travel or accommodation expenses of the different attending healthcare professionals, i.e. hospitality; to the organisation of a medical-scientific meeting, and lastly the sponsorship of meetings organised by third parties.

Hospitality in professional meetings, is provided to a reasonable degree, never exaggerated or disproportionate.

The scientific objectives are the focal point of the organisation, and collaboration is limited to the strictly necessary logistical resources.

Provision of services

Pharmaceutical companies require advisory services from medical professionals in order to carry out their research and development tasks. Thus, Diater must contract healthcare professionals to provide consultancy or advisory services such as: presentations in meetings (including giving a talk or moderating), training activities, expert meetings, etc. That is to say, services which involve payment and/or travel and/or accommodation and/or maintenance expenses derived from the activity.

They are contracted for the purpose of collaborating in healthcare services, research, teaching, training, or organising professional or scientific meetings.

Research of development

The improvement in the quality of life of the patient, life expectancy and continuous improvement in terms of health, comes from the development of new drugs and the discovery of new therapeutic indications through R&D clinical trials carried out by the pharmaceutical industry.

For this purpose, Diater allocates part of its annual profits to clinical studies carried out in humans, with the purpose of determining clinical pharmacological effects, detecting possible adverse reactions originating from the administration of the drug, as well as studying the absorption, distribution and metabolism of an investigational medicinal product in order to determine its safety and efficacy.

Personal data protecction

Compliance with applicable personal data protection standards (rights to access, rectification, erasure or objection)

In accordance with Regulation (EU) 2016/679 of April 27 on Data Protection (GDPR), Diater holds information that, in some cases, is confidential and/or includes personal data. Diater constantly ensures the correct storing, protection and ethical and legal use of said information in order to avoid the negative impact of the information being revealed to parties who should not have knowledge of it, of the information being inaccurate or incomplete, or of it not being available when required, affecting the protection of the privacy of the personal data.

Furthermore, it has the relevant security document covering everything relating to this information.

Considering the continuous evolution of information systems, the security document intends to provide a stable framework, while also being flexible in terms of new computing and organisational requirements. For this, the parts that may vary over time are structured in annexes, making them easier to update. Those parts which only affect medium or high level files are shaded to make them easier to identify.

Access of HPs and HOs to their information

Once all transfers of value have been published, any healthcare professional who has received transfers of value from Diater may, in any case, exercise their rights of access, rectification, erasure (right to be forgotten), restriction of processing, portability and objection provided for in the Regulation by writing to Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A., Avda. Gregorio Peces Barba, nº2, Leganés (Madrid), or by email to dpogrupo@grupodiater.com, attaching a copy of their ID and indicating “Transfers of value” as the reference.

For clarification, the rights consist of:

Access: The right of the data subject to obtain information about their own personal data being processed, as well as available information about the origin of said data and any communications sent or planned.

Rectification: The right of the affected party, upon justification and provision of appropriate documentation, to have data that is found to be inaccurate or incomplete modified.

Erasure (right to be forgotten): Right of the data subject to obtain the erasure of personal data concerning him or her without undue delay.

Restriction: Right of the affected party to obtain the restriction of processing from the data controller when the conditions established in the Regulation are met

Portability: The right of the data subject to transmit personal data from one data controller to another without hindrance.

Objection: The data subject has the right to prevent the individual processing of his or her personal data in cases where the HP gives consent for aggregate publication and the data has been published individually.

Regarding the right to object, in accordance with the provisions of the Spanish Data Protection Agency in its report of 22 April, it should be noted that, as an exception, if a healthcare professional, through this right, can justify to the pharmaceutical company that there are well-founded and legitimate reasons related to a specific personal situation, which means that the weighting rule is reversed and the legitimate interest of the pharmaceutical company in such publication does not prevail in that particular case, the pharmaceutical company, after evaluating this request, could exclude the data of this healthcare professional from the individual publication, instead of publishing aggregate data.

The HP will have the right to file a complaint with the AEPD (Agencia Española de Protección de Datos [Spanish Data Protection Agency]), the competent authority in matters of data protection.

Right of Access:

The concerned party has the right to request and obtain information about their personal data included in the files.

When exercising the right of access, the concerned party will be able to opt for one or several of the following file consultation systems, provided that the configuration or material implementation of the file allows it:

• Visualisation on screen.
• Letter, copy or photocopy sent by email, certified or otherwise.
• Fax.
• Email or other electronic communication systems.
• Any other system which is suitable in terms of the configuration and material implementation of the files offered by people responsible for them.

As the party responsible for the files, Diater will respond to the access request within a maximum period of one month from receipt of the request. If an express response to the access request has not been provided after one month, the request will be understood to have been rejected and a claim may be submitted.

Opposition can be exercised through a request to Diater. Diater will make a decision within a maximum period of ten days from receipt of the request. After the expiration of the period with no response to the request, the concerned party may lodge the relevant claim.

Reference documents

In order to increase the reference information on the Pharmaceutical Industry Code of Good Practices, and particularly article 18.0 of said Code, relating to the Transfer of Relations in the Pharmaceutical Industry, we provide a series of weblinks regarding this subject.

www.codigofarmaindustria.es

www.efpia.eu

www.transparency.efpia.eu

Legal notice

Diater uses a combination of automated systems, standardised internal procedures and manual data input, through internal and external resources, with the objective of compiling the relevant information, for subsequent publication on its website.

The information published reflects and strengthens compliance with the provisions of Article 18 of the Farmaindustria Pharmaceutical Industry Code of Good Practices.

In the event that, despite our best efforts to ensure the publication faithfully reflects the transfers of value carried out, we have not included correct and complete information, we undertake to investigate the matter and give an adequate response if the information shown is not completely correct.

The information published on this website according to the requirements of the Code will only be used in order to comply with the requirements of the Ethical Code. Said data will not be used as a reference by the tax authorities.

The publication of this data responds to the transparency obligations derived from the Pharmaceutical Industry Code of Good Practices

The publication of the information does not generally enable those who access the website to carry out additional processing of the data of the professionals, such as crossing it with information published on other associated websites

he company has adopted security measures in order to prevent the indexation of the information through search engines.

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