Industria Farmacéutica

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The Pharmaceutical Industry Code of Best Practices(the “Code”) on promoting prescription medicines, relations between pharmaceutical companies and healthcare professionals, and patient organizations came into effect on January 1, 2021.

The reform, coordinated by the Autocontrol and Farmaindustria associations, replaces the 2016 code and addresses the need to update the principles, values and rules for action envisaged in the Code, particularly in the digital environment. The aim is, therefore, to ensure that the daily practice of operators in the sector is aligned with them, particularly with the current trend towards digitalization.

We highlight some of the developments in the Code that are likely to have a greater impact on the pharmaceutical industry.

a) The Code does not affect activities that do not promote prescription medicines (to which the Code does not apply).

However, it does define the concept of “information activities,” i.e., those that do not promote prescription medicines, which include the delivery of scientific articles or summaries that do not contain elements (e.g., printouts, recordings, phrases or trademarks) that may suggest that their nature is not informative, or the delivery of information on a company’s research lines mentioning the active ingredient and its properties.

b) How should data, tables or graphs be used in study-based materials? To avoid their use causing confusion, misleading or being construed as exaggeration, the Code establishes that this information must be “faithfully” reproduced (replicating the content of the original source without exclusions, additions or highlighting). Including a warning that it has been prepared or adapted by the company does not release it from this requirement.

c) What about the digital environment? The Code establishes that companies must develop internal guidelines specifying the legal prohibition to publish or openly share content that could constitute promotion of prescription medicines to the general public.

It also provides the following clarifications:

  • It obliges pharmaceutical companies to train their employees to avoid sharing, linking, posting or commenting inappropriate content on their personal social media, regardless of whether they are public or private (e.g., making comments on competitors’ products or off-label promotion).
  • It advocates a broad definition of “digital environment,” referring to  current digital media or supports and those developed in the future.
  • It makes pharmaceutical companies responsible for the content reproduced during meetings they chiefly sponsor or organize; they must take adequate measures to avoid its disclosure via social media or any other channel, media or support, if that dissemination could directly or indirectly constitute promotion of prescription medicines to the general public. These measures include clearly and categorically informing the healthcare professionals and employees in attendance (e.g., in the documentation or agreements signed).
  • Regarding access to website content, the previous version of the Code envisaged that people accessing it should state that they are healthcare professionals “authorized to prescribe or dispense medicines,” while access would now be limited to healthcare professionals “authorized to receive that promotion,” therefore, restricting access to this content.

d) What about scientific or professional meetings? The Code clarifies that, in online meetings, no type of hospitality should be offered (e.g., compensation for attending meetings, social events or accommodation).

Given their characteristics, online meetings organized or sponsored by pharmaceutical companies may be communicated to Farmaindustria’s Ethical Supervisory Unit.

The Code also provides that companies established in Spain and belonging to corporate groups located abroad are responsible for ensuring that related companies that perform promotional activities and connect with healthcare professionals comply with the Code when they take place: (i) in Spain with professionals, regardless of their country of practice; and (ii) with professionals practicing in Spain, regardless of where the promotional and connection activities take place.

e) Do pharmaceutical company employees have responsibility? In activities performed online, pharmaceutical companies and their employees must comply with and respect the Code and the applicable law. The Code specifically refers to compliance with data protection regulations.

f) As a supplementary rule for relations between pharmaceutical companies and patient organizations, the Code insists that the content, wording, design and characteristics of materials provided to patients must clearly confirm their main purpose and aim: being a support tool for patients.

They must also include visible messages stating that they are publications for guidance and information purposes, and that their content does not replace a diagnosis, and patients should consult their healthcare professional if they have any questions.

Finally, in the case of sponsored materials, they must expressly identify the sponsoring company. That company will be liable for any breaches.

g) As a supplementary rule, the Code includes the “Guidelines for action in communications and relations with the media regarding prescription medicines” (Annex III). These guidelines aim to provide recommendations and criteria on the information activity and how to perform it, to make it possible to distinguish the activities of an informative nature from those whose purpose is promotional.

The different elements covered by these guidelines are particularly significant.

Although we will take a closer look at it in a subsequent blog post, we should mention that, before the reform comes into effect, most of the conflicts in the sector revolved around whether particular materials related to prescription medicines were informative or could be described as promotional.

In view of potential proceedings at Farmaindustria—and subsequently, before the Autocontrol Board—in which those materials could be branded as promotional, it could be questioned whether the dissemination of the materials misled or deceived the recipients or constituted surreptitious advertising, and even publicity of prescription medicines to the general public, as envisaged in the Code.

h) As a supplementary rule, the Code includes the “Guidelines presenting criteria for action in relation to the services provided by healthcare professionals or health organizations” (Annex IV). These guidelines aim to preserve these professionals’ freedom of prescription and ensure their independent action when caring for each patient.

i) Finally, new questions and answers are added on interpreting the Code (no. 7, 12, 13, 82, 83, 88 and 89 of Annex V).

Taking into account the wide range of developments in the reform, it can only be expected that pharmaceutical companies in the sector that have assented to the Code (and, in general, the whole industry) will take note of all the clarifications and adapt their internal processes, guidelines and protocols. In any case, we will keep an eye out for potential developments, guidelines or interesting cases as the roll-out of this Code extends.

Authors: Adaya Esteban and Raúl Pérez

This post is also available in: Español

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adaya.esteban@cuatrecasas.com

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raul.perez@cuatrecasas.com