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Methodological note and report on transparency for 2015
Our society requires that the pharmaceutical industry has the capacity to make the best possible drugs available. To achieve this goal, it is necessary to invest in research and development, which inevitably requires close collaboration with health organizations and professionals.
Since 2014, the pharmaceutical industry has voluntarily assumed new commitments in relation to transparency, and as of 2016 all the laboratories that have subscribed to the Pharmaceutical Industry Code of Good Practices have taken the initiative to publish the transfers of value to health professionals and health organizations made in the form of donations, training activities, the provision of services and research and development during the previous year on their respective websites.
The publication of this information is aimed at increasing the transparency of the relationships existing between the pharmaceutical industry and health professionals and organizations.
It is essential that these partnerships are transparent and that the Company is confident that they obey the need to develop new medicines, for a constant updating of health professionals, for their application to clinical practice and to the common objective of attending to patients in the broadest sense.
Health professionals contribute their expertise and independent point of view, derived from their clinical and professional experience, which they share with the pharmaceutical industry and other health professionals in order to promote improved patient care. These services are critical to the industry and help in the design and to shape the activities it conducts.
For further information on this initiative, consult www.codigofarmaindustria.org
AIM OF THIS INITIATIVE
The aim of this initiative is none other than to generate credibility and confidence in the pharmaceutical industry as a whole, as well as in the interactions between pharmaceutical companies and health professionals and organizations.
To this end, the initiative:
- promotes the transparency of such interactions, especially when they give rise to payments or transfers of value,
- provides information on the scope and nature of these interactions, and
- helps identify and understand how, among other aspects, such interactions are necessary for the development of new medicines and to ensure the rational use of the same.
WHAT DOES IT CONTRIBUTE?
To patients and the general public: information regarding the various forms of collaboration existing between laboratories and health professionals and organizations, as well as on the added value they represent and contribute to the Company.
To health professionals and organizations: enables the quantification of the important role played by pharmaceutical companies in areas such as research and development and continuous medical training.
To researchers: indicates which part of the total investment in research and development carried out by laboratories is devoted to remunerating researchers and research centres.
To pharmaceutical laboratories: accredits their commitment to collaboration and continuous improvement, the legitimate need for such interaction and underlines their interest in the observance of the strictest ethical principles of professionalism and responsibility.
WHAT INFORMATION DOES IT INCLUDE?
It includes the transfers of value made by the pharmaceutical company to health professionals and healthcare organizations in the concept of:
- Donations (applicable only to healthcare organizations).
Example: Donation of scientific books to a public hospital.
- Training activities and scientific-professional meetings, detailing whether the transfer of value is intended to cover:
a) The sponsorship of the activity (applicable only to healthcare organizations).
b) Registration fees.
c) Travel and accommodation.
Example: collaboration for attendance at the annual congress organized by a scientific society.
- Provision of services, detailing whether the transfer of value is intended to cover:
b) Expenses related to the provision of these services.
Example: the hiring of a healthcare professional to provide advisory or consultancy services to the laboratory on a particular subject.
- Research and development.
HOW IS THE INFORMATION PUBLISHED?
In compliance with the provisions of Organic Law 15/1999 of December 13, Protection of Personal Data (LOPD), pharmaceutical laboratories request the express, prior consent of the healthcare professionals in order to carry out the individualized publication of their data.
Transfers of value made to those health professionals who do not give their express consent are published in aggregated form for each concept, providing the following information:
- annual aggregate amount
- number of healthcare professionals whose information is published in aggregate form, and
- a percentage representing the number of health professionals who have received transfers of value from the laboratory for this concept during the year.
Transfers of value made to healthcare organizations are published individually, as the Organic Law on Protection of Personal Data in Spain does not apply to legal entities. Data relative to research and development are published in aggregated form, reflecting a single amount per laboratory.
The fact that the amount published in Research and Development does not match the amount reflected in other areas is because this section only includes payments under the concept of R&D to healthcare professionals and healthcare organizations unaffiliated to REIG JOFRE. Following this criterion, the expenditure on internal personnel, materials, equipment and patents has not been included, for example.
WHEN IS THE INFORMATION PUBLISHED?
The laboratories have committed to publish this information on their website no later than June 30, 2016, and to update it with the transfers of value that occur each year.
COLLECTION OF INFORMATION
All data published by REIG JOFRE has been subject to the information process that ensures compliance with the applicable obligations under Article 18 of the Pharmaceutical Industry Code of Good Practice.
The information will be publicly available for a minimum period of 3 years as of its publication, unless a shorter period is legally established or the transferee revokes their consent and the revocation is legally binding for our laboratory. Furthermore, the documentation justifying and proving the published transfers of value will be maintained for a minimum period of 5 years following the completion of each applicable period, unless a shorter period is legally established.
In the case of contracts of more than one year, the proportion for each calendar year shall be assigned.
All published amounts are net, thus excluding taxes.
Transfers of value made annually on an individual basis to each healthcare professional or healthcare organization will be combined and a single amount published for each healthcare professional or individual healthcare organization. The breakdown will only be available for consultation, where appropriate, by the healthcare professional or individual healthcare organization, the supervisory bodies of the Code or the competent authorities.
Information that cannot be published individually for legal reasons shall be published in aggregate form.
In accordance with the provisions of Articles 5 and 6 of Law 15/1999 of December 13, on Personal Data Protection (LOPD), the transferees must individually, freely and voluntarily, give their consent to the publication of their data and the information relative to transfers of value. In the event of their opting not to grant such consent, the tacit consent arising from the contractual relationship, which enables the laboratory to publish the information in aggregate form, shall apply.
The consent shall be express and shall be obtained individually in writing for each act or, to the contrary, it may be agreed that general consent shall be granted once for all the collaborations between the laboratory and the transferee. The consent may be revoked at any time.
It must be borne in mind that the revocation of consent is not retroactive and, as such, it will not affect previously-signed contracts which remain in effect at the time of revocation. In such a case, the data will remain public for 3 years as of its publication, in accordance with the provisions on revocation of consent in Article 17 of Royal Decree 1720/2007 of 21 December, which approves the Regulations implementing Law 15/1999 of 13 December on the protection of personal data.
The transferee may exercise the rights of access, rectification, cancellation and opposition in relation to the data (ARCO rights).
COMPLIANCE WITH THE CODE
REIG JOFRE uses a combination of automated systems, standardized procedures and manual data entry, by means of internal and external resources, to gather the relevant information and to proceed with its subsequent publication. The information published reflects our good faith and best efforts to comply with the provisions of Article 18 of the FARMAINDUSTRIA Pharmaceutical Industry Code of Good Practices. In the event of our having failed to include accurate and complete information, we undertake the corresponding investigation and provide a quick and appropriate response.