Regulatory and compliance

The new Code of Best Practices 2021

Published on 25th Feb 2021

After Spain adopted, in 1991, the European Code of Practice for the Promotion of Medicines, the Code of Best Practices of the Pharmaceutical Industry has been reviewed in several occasions to adapt it to the industry's new requirements. Its most recent version came into force on 1 January 2021, and it includes a new set of additional rules with novelties on the promotion of prescription-only medicines, specially highlighting the digital environment and of social networks.

On 1 January 2021, the Code of Best Practices of the Pharmaceutical Industry (the "Code of Best Practices") came into force, replacing the current 2016 code. Its main novelties are the following:

Operating in a digital environment:

The new version of the Code of Best Practices significantly reinforces pharmaceutical companies' obligations on the use of digital communication channels and social networks, including new obligations concerning the application of conduct rules and guidelines directed to their employees, setting out action guidelines on how to responsibly behave in the digital environment.

The Code of Best Practices requires that said guidelines shall include the legal prohibition of publishing or openly sharing content that could be regarded as promotion of prescription-only medicines to the general public in their internal guidelines, as well as other obligations such as the obligation to train their employees to ensure that they do not share, link to, publish or discuss on their social media profiles (private and/or public) any inappropriate content, either in style or tone, concerning prescription-only medicines (i.e. comments about competitor's products or off-label promotion).

Laboratories and pharmaceutical companies will be held responsible for the content reproduced during any meetings they organize or promote. They must take the necessary steps to avoid revealing any contents that could, directly or indirectly, promote medicinal products to the general public and include the necessary safeguards into any agreements entered into with speakers and attendees, and any related documents, clearly stating the prohibition of disclosing such content.

Services provided by healthcare professionals and/or healthcare organizations:

Annex IV is included into the Code of Best Practices under the header «Practical Guidance and criteria concerning services provided by Healthcare Professionals or by Healthcare Organizations». This Annex includes standards and guidelines related to the hiring of services of healthcare professionals and healthcare organizations based on the type of service they provide (i.e. clinical cases, advisory boards, training projects, publications, etc.).

The Guidance considers, among others, the need for companies to establish annual limits on the total number of healthcare professionals with remunerated contracts, on the number of engagements on which the same healthcare professional is given a remunerated contract and on the maximum remuneration paid to the same healthcare professional for the provision of the services. Likewise, companies should consider aspects such as the "legitimate need" for contracting a service (such as training needs) and if the foreseen remuneration it could constitute an inducement to recommend, purchase, supply, prescribe, sell or administer a given medicine of the company by a healthcare professional.

Patient organizations and transparency:

Any publications or materials which are intended to patients or patient organizations concerning patient health, specific diseases, hygiene-healthcare measures or healthy lifestyle must serve to help patients to better understand their diseases and to improve their quality of life.
Their content and wording must clearly show their main goal and shall become a support and informative material for patients affected by a particular disease and must include a warning standing that their content cannot substitute the diagnosis performed by a healthcare professional (whom in any case shall be contacted in event of any query) and shall be considered as explanatory guidance. The sponsorship of such materials by a company shall be clearly reflected therein.

Self-assessment procedure:

Additionally, the Code of Best Practices includes, under Title II - Rules of Procedure of the Control Bodies - an innovative exceptional procedure for those cases in which pharmaceutical companies, as a result of their review and internal audit processes, identify practices that may be contrary to said Code of Best Practices.

It is mainly envisaged that a laboratory, as long as it is not yet involved in a formal complaint with regards to the same facts, could self-incriminate before the Code of Practice Surveillance Unit ("CPSU") and, in exchange, benefit from a lesser classification of its infringement. To these effects, the laboratory shall (i) provide a detailed breakdown of the activities infringing the Code of Best Practices, including evidence; (ii) expressly acknowledge the violation; and (iii) formulate a proposal on the applicable sanctions and corrective measures. Afterwards, the CPSU will issue a report, taking into account the former as a mitigation circumstance and the case will be subject to mediation.

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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