1.0 INTRODUCTION.-

Relying on 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 relationships on which we publish information are the basis for good research and scientific training. Transfers of value through relationships between the industry and healthcare professionals and organisations are essential for a better understanding of the different pathologies and treatments of diseases. Therefore Diater is committed, as part of the pharmaceutical industry, to implementing this measure.

2.0 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 laboratories is committed to publishing an annual account of any transfers of value to healthcare professionals or healthcare organisations in 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.

3.0 GLOSSARY OF TERMS.-

• 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 service to a third party (recipient), who accepts it. It will be considered as final in those cases in which the provision 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.
• Events: any promotional meeting, scientific/professional meeting, congress, conference, symposium, day, on-site or distance training course, or any other type of similar activity, which is organised or sponsored by a pharmaceutical company or is under their control.
• 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.
• Healthcare Organisation (HO): non-profit organisation 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.
• 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 laboratory that directly carries it out in favour of a specific recipient.
  • Indirect: when it is a third party (suppliers, agents, partners or subsidiaries – including foundations – acting on behalf of the company, who carry it out in favour of a recipient and the latter identifies or can identify the company.

4.0 COMPILATION OF INFORMATION TO BE PUBLISHED AND IDENTIFICATION OF THE RECIPIENTS.-

4.1 COMPILATION AND PROCESSING OF INFORMATION

4.1.1 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.

The healthcare professionals with those that Diater has performed transfers of value have been given an informed consent form to fill in and return, where the professional agrees for their information to appear individually and or in aggregated format, as well as their full name, address, town or city and ID number. This data was then set out in accordance with the characteristics of the table defined for their publication.

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

4.1.2 DATE USED FOR COMPILATION AND PUBLICATION (multi-annual contracts)

The delivery and compilation of CI where each HP authorises its publication in individual or aggregated format has been carried out throughout 2015

4.1.3 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.

4.1.4 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.

4.2 IDENTIFICATION OF THE RECIPIENTS

4.2.1 CLEARLY DEFINED RECIPIENT (residence)

Using the signed informed consent forms from the healthcare professionals 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.

4.2.2 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 where 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.

5.0 CATEGORIES OF TRANSFERS OF VALUE.-

5.1.1 DONATIONS AND SUBSIDIES TO HEALTHCARE ORGANISATIONS

Donations and subsidies to organisations, associations or foundations formed 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 Laboratories are to healthcare professionals as individuals; the recipient is always a healthcare organisation, association or foundation

5.1.2 COLLABORATION IN SCIENTIFIC AND PROFESSIONAL MEETINGS

Collaboration in scientific meetings, is understood as the collaboration in meetings and organisation of events of a purely scientific nature. In these events Diater Laboratories 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 event, and lastly the sponsorship of meetings organised by third parties.

Hospitality in professional meetings, 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.

5.1.3 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 events.

5.1.4 RESEARCH AND 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 laboratories 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.

6.0 PERSONAL DATA PROTECTION.-

6.1.1 COMPLIANCE WITH APPLICABLE PERSONAL DATA PROTECTION STANDARDS (ARCO Rights)

Diater has information which, 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 inexact 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 safety document covering everything relating to this information.

Considering the continuous evolution of information systems, the safety document indents 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 the medium or high level files are shaded to make them easier to identify.

6.1.2 ACCESS OF HPs AND HOs TO THEIR INFORMATION

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.

If there is no personal data for the concerned party, this should also be communicated within the same period.

In the event of a favourable decision, access will be provided within a period of ten days following notification of the decision.

Diater may refuse access to personal data when the right is exercised in a period of less than twelve months and no legitimate interest of the concerned party is accredited, and when the request is submitted by someone other than the concerned party.

RIGHTS OF RECTIFICATION AND CANCELLATION

If the personal data of the concerned party is inexact or incomplete, inadequate or excessive, they will be able to send a request to the people responsible for the file to rectify or, where applicable, cancel the data.

The rights of rectification or cancellation will be accepted by Diater within ten days. If the rectified or cancelled data has been previously disclosed, Diater will notify the concerned party of the rectification or cancellation within the same period, so that the latter may adjust the data in their own files.

The rectification request should state the incorrect data and the correction that should be made, and should be sent along with documentation to support the rectification request, unless the request depends exclusively on the consent of the concerned.

In the cancellation request, the concerned party should indicate whether it withdraws the consent previously granted, where this is applicable, or if on the other hand it is a case of wrong or inexact data, in which case the supporting documentation should be provided. Cancellation will not be allowed when it may damage the legitimate interests of the concerned party or third parties or when there is an obligation to conserve the data.

If, once a request for rectification or cancellation is submitted, Diater considers that it is not suitable to agree to the request, it will communicate this fact and give reasons for its decision within a period of ten days following receipt of the request, so that a claim may be submitted. If an express response to the request has not been provided after ten days, the request will be understood to have been rejected and a claim may be submitted.

Cancellation requires the physical deletion of data, and it will not be sufficient to these effects to have a logical mark or maintain another alternative file in which the removed data is recorded. In the event that is decided to cancel the data but it is not possible to physically delete it, either for technical reasons or because of the procedure or format used, those responsible for the file will block the data in order to impede its processing or use.

However, an exception is made for situations in which the data has been collected or recorded by fraudulent, unfair or unlawful means, in which case the cancellation of the same will always involve the physical destruction of the data.

RIGHT OF OPPOSITION

Opposition may apply in with those cases in which the consent of the concerned party is not necessary for processing their data and, provided that there is no law which states the contrary, the concerned party may oppose its processing when there are founded and legitimate motives. Opposition may also apply regarding files whose aim is advertising and attracting clients and when the purpose of the treatment is to adopt a decision related to the concerned party and based only on the automated handling of their data.

Opposition can be exercised through a request to Diater Laboratories. Diater Laboratories 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.

The concerned party has the right not to be subjected to a decision with legal implications over them or which significantly affects them, which is only based on the automated handling of data intended to asses certain aspects of their personality, such as their job performance, creditworthiness, reliability or conduct.

However, the concerned party will be subject to such ruling when the decision has been adopted within the framework of the exercise of a contract on the request of the concerned party, provided that they are granted the possibility of presenting any information they consider appropriate in order to defend their right or interest.

PERIODS

The laboratory has a period of ten working days to respond to the request by the HP to exercise their rights of rectification, cancellation and opposition. The laboratories will find a way to fit this in with their published information updates, so that, if for technological questions it cannot be done within 10 days, a response will be given to the HP indicating the date (as soon as possible) on which the corresponding website will be updated.

Specific situations:

• Death of a healthcare professional: if any of their heirs request the cancellation of the public data, this will be granted.
• Retirement of a healthcare professional: in the case the healthcare professional ceases their activity due to retirement, the data will not be cancelled, unless the right to opposition is exercised because there are relevant circumstances.
• Data published more than 3 years previously: the healthcare professional can request the cancellation of the data. The handling of the data would be unnecessary. However, laboratories will erase data after 3 years of publication as standard.

7.0 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.org

www.efpia.eu

www.transparency.efpia.eu

8.0 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.”

“The laboratory has adopted security measures in order to prevent the indexation of the information through search engines.”