The new code of good practice of Farmaindustria for 2021

Farmaindustria, the trade association that includes most research-based pharmaceutical companies established in Spain, has recently published on its website the long-awaited new version of its Code of Good Practice, which regulates the promotion of prescription medicines and the interactions of the pharmaceutical industry with healthcare professionals, healthcare organisations and patient organisations, and which already constitutes a true reference for the sector, given that the applicable legal framework has been in force for more than 25 years, with practically no substantial modifications.

This new version of the Farmaindustria Code, which will come into force on 1 January 2021, maintains the structure and general lines of the 2016 version currently in force, but it also introduces important new features in areas such as the digital environment, relationships with the media or the provision of services by healthcare professionals, which are deemed a risk area by the Code of Practice Surveillance Unit, given the interaction that they entail with such professionals, and therefore they have been regulated in a very specific manner, establishing new control and supervision obligations which must be observed before contracting with healthcare professionals and organisations.

Without aiming to be exhaustive and cover each of the modifications introduced by the new Code, we can highlight the following new features, which, in our opinion, are the most relevant:

a) Services provided by healthcare professionals and organisations

Perhaps the main new feature of the new Code is the inclusion of the so-called “Guidelines and criteria for action in relation to services provided by healthcare professionals or healthcare organisations” which introduces for the first time criteria and guidelines for action in relation to services contracted with healthcare professionals and healthcare organisations.

Although the Code maintains as a general criterion for the contracting of healthcare professionals that the company should ask itself whether it would be willing to inform the public of the details of the project in order to decide whether it should be carried out, the aforementioned Guide aims to establish measures to guarantee the freedom of prescription of healthcare professionals, and to this end, it introduces multiple guidelines and particular and very specific criteria according to the typology of service. In this regard, the Guide establishes specific criteria for clinical cases (which includes competitions of clinical cases, libraries of clinical cases and compilation of clinical cases at the request of a third party), expert meetings and advisory boards, training projects and publications, and it also introduces a battery of specific questions that companies should be able to answer affirmatively before contracting with health professionals.

In practice, the new Code requires companies to introduce limits and controls on the recruitment of healthcare professionals and healthcare organisations, such as setting annual limits on the total number of professionals recruited on a paid basis, on the number of times that the same professional is recruited on a paid basis and on the maximum amount that the same healthcare professional may receive for the provision of services.

The new Code also clarifies certain specific conditions for contracting this type of service, such as the existence of a legitimate need, the criteria for the selection of professionals, the number of professionals who can be recruited and the remuneration of these professionals according to fair market value.

In short, it establishes certain guidelines and criteria for the recruitment of healthcare professionals or healthcare organisations that companies must be able to specify and embody in their internal policies and procedures in order to comply with the new requirements of the new Code regarding interactions with healthcare professionals and healthcare organisations.

b) The digital environment and the use of social networks

The new version of the Code further developts the regulation of the digital environment, especially with regard to the use of social networks, which is quite understandable given the digital transformation the sector has undergone in recent years, a phenomenon that has only increased with the COVID-19 pandemic.

In this regard, new obligations are added for companies with respect to the implementation of guides and internal rules of conduct for employees and third parties, such as the requirement to expressly specify the legal prohibition of publishing or sharing content that could be deemed an act of promotion of prescription medicines to the general public, adding other obligations such as the obligation to carry out training for employees to prevent them from sharing, linking, publishing or commenting on content that is inappropriate, either because of its style or its tone.

The liability of companies for the content reproduced in relation to meetings organised or sponsored by them is also reinforced, having to take measures to prevent its dissemination through social networks and other channels when such dissemination could be deemed an act of promotion of prescription medicines to the public, having to, for instance, inform healthcare professionals and employees attending these events clearly and unequivocally to this effect, without prejudice to the safeguards that must be included in the documentation and contracts signed with the speakers and attendees for this purpose.

Finally, it is clarified that in the case of virtual training activities or scientific-professional meetings, a type of activity that is clearly on the rise as a result of the pandemic, it is not appropriate to offer any hospitality, whether the events are organised by the company or by third parties.

c) Providing information and interactions with the media

Another relevant new feature of the new Code can be found in one of its annexes, the third one, which introduces the new “Guide to communications and media relationships on prescription medicines“, a definitely long-awaited guide, as there was no specification in the current Code on how to report news or how to interact with the media.

This Guide provides a set of criteria and guidelines on the reporting on medicines and on how to conduct media relationships, thus strengthening the framework for the provision of information.

It aims to clarify when information communications can be made, establishing that they must be linked to a relevant or reportable event, such as the discovery of a new innovative molecule, the development of a new treatment or the approval or decision on the price and reimbursement of a medicine, also covering in detail the different ways in which such information can be transmitted, either in the written form, through information materials, or orally.

Furthermore, the means by which this information can be referred to, as well as the relationships and agreements that can be established with the media by companies, are clarified.

d) Materials and publications for patient organisations

The new Code also clarifies several aspects in relation to the materials and publications that can be provided to patient organisations, stating that these can be related to the health of patients, to specific diseases, to hygienic measures or to healthy habits, and should serve to help patients better understand the development of their disease and improve their quality of life.

These materials, which in any case should be formative or informative, should visibly include several messages, warning that their content cannot replace the diagnosis made by a healthcare professional, that they should go to the latter to resolve any doubts regarding their content and that the materials are of an informative nature, so the reader should not undergo treatment or follow advice without first contacting a healthcare professional, and it should also be clear in these materials that the pharmaceutical companies is sponsoring them.

e) The exceptional self-evaluation procedure

Finally, the new Code also includes a novel self-assessment procedure, for those cases in which companies, due to the review and audit processes to which they are subject, detect or become aware of activities or practices carried out by the same company that might be contrary to the Code.

In these cases, and provided that a complaint procedure has not already been initiated for the same facts, the company may submit a written statement detailing the activities it has carried out that may be contrary to the Code, acknowledging the possible infringement and proposing a penalty and the corrective measures that the company would be willing to take. In this regard, the Code of Practice Supervision Unit will issue a report, taking this into account as a mitigating circumstance, and the file will be continued within the framework of a mediation procedure.

All in all, this new version of the Farmaindustria Code is a further step in the effort of Farmaindustria to ensure that the conduct of companies in their areas of activity is ethical, professional and responsible and, from a practical point of view, it necessarily requires that all companies that are members of Farmaindustria or adherents to the Farmaindustria Code carry out an immediate adaptation of all their internal policies and working procedures (SOPs), in particular in the field of interactions with healthcare professionals and healthcare organisations and relationships with the media, as well as in regard to guidelines of conduct and rules on the digital environment.