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In brief

The European Medicines Agency (EMA) has published an artificial intelligence workplan to 2028, setting out new strategy on its use. The aim of this workplan is to benefit public health through boosting the opportunities of artificial intelligence in different health fields.


In more detail

On 18 December 2023, the EMA published a workplan on Artificial Intelligence (AI) that includes a multitude of actions between 2023 and 2028. In this sense, the aim is to have a collaborative strategy to maximize the benefits of AI without falling into the risks that its use entails.

Taking into account the implications of AI in different areas of the healthcare sector, the EMA has focused its efforts on four dimensions that should contribute to improving the understanding and use of AI in a responsible way. The proposed workplan will be subject to future modifications as this technology evolves.

The key dimensions of the EMA workplan can be summarized as follows:

  • Guidance, policy and product support: It aims to support the development of AI in the life cycle of medicinal products. In this regard, it is envisaged that guidance and orientations will be approved in areas such as pharmacovigilance or the use of large language models. Moreover, preparations for the entry into force of the AI Law and the creation of an observatory to monitor it are foreseen for the second half of 2024.
  • AI tools and technology: Multiple objectives are envisaged for 2024, including ensuring compliance with data protection regulations; implementing guidance to support communication through generative AI together with the implementation of language models as assistants. In addition, a survey and the publication of a policy on the capabilities of Network Tools are also foreseen.
  • Collaboration and training: During 2024, it is foreseen to enhance collaboration on AI understanding and application by, among other measures, working with international partners specialized in AI, the creation of the AI Special Interest Area and the creation of an extended platform for the Digital Academy on AI and data analytics.
  • Experimentation: Multiple experimentation cycles, guided by technical deep dives, are foreseen between 2024 and 2027, along with the definition of guiding principles for the responsible use of AI. Furthermore, the network’s research priorities will also be defined.

Through this workplan, the EMA takes a solid step forward in terms of integrating AI into its procedures and into the life cycle of medicinal products, which will undoubtedly be a milestone in terms of data collection and decision-making that may affect human health.

For more information, please click on this link to read the full IA workplan of the EMA. In case you need individual advice for your company, please contact our team of experts in this field.

Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

David Molina is a Senior Associate in Baker McKenzie, Barcelona office.

Author

Damià Triay is an Associate in Baker McKenzie, Barcelona office.

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