Spain – Championing the Ethical and Responsible Use of Real World Data

RWE 201 – Spain – Championing the Ethical and Responsible Use of Real World Data


Farmindustria Code of Conduct:

In 2022, the Spanish Data Protection Agency (AEPD) gave its stamp of approval to the Farmaindustria “Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance.” These self-regulation standards focus on clinical studies involving medicines and are designed to help study sponsors understand the appropriate application of data protection regulations.

Support for Real-World Data and Evidence

This code of conduct acknowledges the significance of real-world data (RWD), which covers a broad spectrum of patient health information sourced from routine clinical practice, patients’ records, and even data acquired from wearable devices. Real-world evidence derived from this data is pivotal for observational studies with medicinal products. Such studies are instrumental in identifying the therapeutic effects of drugs, understanding adverse reactions, and gaining insights into medicine usage patterns without disrupting conventional clinical procedures.

Key Provisions from the Code of Conduct:

  1. Data Protection Impact Assessment (DPIA): Before the commencement of any clinical research, a thorough DPIA must be undertaken. This ensures that the data processing activities associated with the research are assessed for potential risks to participants’ rights and freedoms. If the assessment indicates high, unmitigated risks, relevant data protection authorities must be consulted prior to starting the research.
  1. Consent Stipulations: For any intended reuse of a participant’s data, a legitimate basis in line with data protection laws is mandatory. If the reuse involves coded data, it might not necessitate new consent, provided that certain regulatory stipulations are met, including robust security measures and a commitment to prevent re-identification.
  2. Broad Consent: Given the dynamic nature of clinical research, where full identification of data processing purposes might be challenging, participants can be approached for broad consent. This allows their data to be used for broader areas of investigation related to the original study. However, it’s imperative to keep participants informed, respect data protection principles, and secure necessary authorizations.

The comprehensive code of conduct provides clarity on various terminologies, from “patient’s records” to “trusted third party” and underscores the obligatory nature of the code for entities that choose to adhere. By fostering a standardized approach to data protection in clinical research, the code champions the ethical and responsible use of RWD, promoting transparency, trust, and advancing the field of medicine.

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