Sistema de Autorregulación
Self-Regulation System
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Lisini
Self-regulation aims at strengthening trust in the activity of industry and, from the point of view of the commitments taken by companies, it can even go beyond what is established by law or, at least, identify and anticipate potential regulation lines.
Self-regulation promotes the continuous improvement of standards of behavior in a much more agile way, detecting them as the dialogue with stakeholders advances, as opposed to the logical rhythms involved in the incorporation of adaptations or improvements through legislation.
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Farmaindustria members, as well as EFPIA members and those companies that, not being a member, have voluntarily signed off the Code of Practice (affiliates), commit themselves and are compelled to respect its provisions in their promotional activities and in their relationships with patient organisations, healthcare organisations, healthcare professionals and any other person who, in the practice of his/her professional activity, may carry out or determine the activities of prescribing, buying, distributing, dispensing or administrating a medicine.
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Lisini
Self-regulation aims at strengthening trust and credibility in the pharmaceutical industry.
Self-regulation is thus a response to an internal reflection of industry (commitment with ethical and responsible behaviour to guarantee sustainability of the companies and win the trust of society) and shows the capacity of industry to tend to the external demands of a modern society in constant evolution in matters of transparency (disclosure of relationships and activities carried out with other agents of the sector).
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Lisini
The Code of Practice for the Pharmaceutical Industry is the basis of the self-regulation system of the pharmaceutical industry in Spain and it establishes standards of behaviour and control mechanisms that govern and guarantee that the promotion of prescription-only medicines and the relationship with healthcare organisations, healthcare professionals and patient organisations is carried out in a professional and responsible manner.
Farmaindustria adopted the Spanish Code of Practice for the Pharmaceutical Industry with the aim of guaranteeing that the information made available to healthcare professionals within the framework of promotion of medicines is complete, accurate and objective, as well as ascertaining that the relationships between industry and healthcare professionals are carried out respecting the highest ethical standards.
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Lisini
The Code covers: promotion of prescription-only medicines; relationship with healthcare organisations and healthcare professionals and relationship with patient organisations.
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Within scope are all methods of promotion, including the press and direct mail and online advertising, activities of company delegates, sponsorship of professional or scientific meetings attended by healthcare professionals, the use of the Internet and audiovisual materials, as well as the offering of medical samples, informational or educational materials and items of medical utility.
Also within its scope are all forms of interaction between pharmaceutical companies and healthcare professionals, both those derived from research agreements (clinical trials and studies) and those belonging to other types of agreements (collaboration, consulting, etc.), as well as the donations and grants to healthcare organisations.
As of 2016, pharmaceutical companies disclose, in addition to their collaborations with patient organisations, the transfers of value made to healthcare organisations and healthcare professionals.
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Lisini
After establishing the provisions, industry has also worked in the creation of control mechanisms, independent and autonomous of its internal management:
- The control of compliance with the provisions established in the Code belongs to the Surveillance Unit, the Code of Practice Committee and the Jury of Autocontrol.
- The Surveillance Unit of the Pharmaceutical Industry, independent and autonomous, holds different functions, among them, to monitor application of the Code, advise and train.
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To answer the first question, yes, in complying with the Code. The Surveillance Unit acts in a preventive manner, watching over what the Code establishes regarding actions, terms and conditions in which these relationships must be carried out.
The final use of the transfers is supervised by the companies themselves, following their internal procedures.
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The Surveillance Unit and the laboratories subject to the Code. Additionally, our system is an open self-regulation system, which means that any third party not subject to the Code can voluntarily issue a complaint through the self-regulation system.
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