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In brief

Last October the Spanish association of pharmaceutical companies “Farmaindustria” approved its new Code of Good Practice for the Pharmaceutical Industry, which replaces and repeals the previous edition of October 2016. The new Code will come into force as of 1 January, 2021. The new Code of Good Practice introduces a number of important new features. As for the text of the Code, the following changes are noteworthy:


1.  Scope of the Code:

  • The distinction between information and promotion is highlighted. On this regard, a Guide to action on communication for medicinal products subject to medical prescription and media relations is included as Schedule III.
  • The Guide sets out criteria to ensure that any communications about medicinal products subject to medical prescription are informative. There is the principle of newsworthiness to determine if a communication is informative or promotional. The Guide also outlines different criteria depending on whether the information is conveyed in writing or an audiovisual format  or orally.
  • Lastly, the Guide includes some ethical rules on relations with the media, as well as a general set of actions to be taken in matters relating to providing information.

2. Digital environment (complementary rules to art. 8):

  • The obligation to notify users that a website is for healthcare professionals is replaced by an obligation to implement a system to verify or state that users are healthcare professionals.
  • The Code introduces the obligation for pharmaceutical companies to create guidelines and internal rules of conduct in connection to the information that is shared and based on the medium, format or channel used to that end. These guidelines and internal rules will:
  1. be addressed to employees but also to third parties acting on behalf or in representation or under the control of pharmaceutical companies;
  2. specify that openly publishing or sharing content that may be classed as promoting medicinal products subject to medical prescription to the general public is prohibited;

An obligation is also introduced to train employees to avoid them placing inappropriate content on their personal social networks.

  • In relation to  meetings, the new Code provides for measures to be taken to avoid any dissemination on social networks that could result in promoting medicinal products subject to medical prescription to the general public. Companies must inform healthcare professionals and employees attending the meeting in a clear manner, and they may include safeguards in the documentation and/or contracts signed with the speakers and attendees.

3. Scientific and professional meetings (art. 11):

  • For training activities or scientific-professional meetings that are carried out virtually or online, whether organised/sponsored primarily by the company or organised by third parties, it is forbidden to “offer any type of hospitality (social events, travel, accommodation and/or meals)” (Article 11.1).
  • For meetings that are part of projects that have already been disclosed by the pharmaceutical companies, the pharmaceutical companies will be not have to communicate those meetings in advance, under a new principle of non-duplication (Articles 11.8 and 35.1). In addition, it is stated that training courses or meetings carried out virtually are subject to voluntary rather than mandatory disclosure.

4. Services provided by healthcare professionals or health organizations (art. 16):

  • Regarding the hiring of health professionals for advisory or consulting services, the threshold number of health professionals hired for a project above for which there is a prior disclosure requirement is reduced from 20 to 10.
  • Pharmaceutical companies are obliged to set annual limits on the total number of healthcare professionals hired on a paid basis; and/or on the number of times the same healthcare professional can be hired on a paid basis; and/or on the maximum amount to be received per healthcare professional.
  • The criteria to be taken into account by pharmaceutical companies before contracting healthcare professionals or health organizations are developed in the Guide and criteria for action in relation to services provided by healthcare professionals or health organizations attached as Schedule IV to the Code. In addition, the guidelines are individualized as per the type of project: clinical cases, meetings of experts or advisory boards, training projects or publications.

5. Working with patient organizations (Art. 17):

  • Contracting patient organizations is prohibited when this is linked or related to their participation in a promotional event for a medicinal product subject to medical prescription (art. 17.7.g).
  • With regard to meetings with patient organizations, the Code goes further, by establishing when hospitality is deemed to constitute leisure and/or entertainment and is contrary to the Code, aligning these requirements with those applicable to meetings with healthcare professionals. It also establishes the same prohibition for offering hospitality for meetings held virtually or online (Article 17.8).
  • In terms of distributing materials or publications, they should be presented in such a way that their objective and purpose of educating and informing those patients affected by a disease is crystal clear, highlighting that they do not replace a medical diagnosis and are informative in nature with regard to a disease or quality of life (complementary rules).

6. Self-assessment procedure (Article 32.3):

  • Exceptionally, the Code provides for a self-assessment or self-reporting procedure. The legal representative of a pharmaceutical company that has detected any irregularities in the framework of a review or audit may provide a self-assessment report to the Deontological Supervision Unit stating: the activities/practices carried out by the pharmaceutical company, the potential breach committed, evidence available and sanction proposal and the corrective measures to be adopted.
  • The notice sent to the Deontological Supervision Unit will only be deemed at the most as a mitigating circumstance within the mediation or sanctioning proceeding.
Author

Montserrat Llopart has extensive experience in the areas of pharmaceutical and medical devices law, as well as competition, acquisitions and commercial law. She is currently the coordinator of the healthcare practice in the Baker McKenzie Barcelona office. Montserrat is also the chairman of the Healthcare Law Steering Committee of the Firm in Europe, Middle East and Africa (EMEA). Montserrat was awarded "Best Lawyer of the Year 2018" for Healthcare in Spain by the American group Best Lawyers. She was also named by Iberian Lawyers as one of the most inspirational female lawyers in 2018 in Spain and Portugal (InspiraLaw Top 50 Women List).