The pharmaceutical industry is one of the most heavily regulated sectors in the world. From the research of a new drug to its commercialization, every step must comply with strict rules set by health authorities to ensure the safety and efficacy of products (European Medicines Agency [EMA], 2023). Additionally, each country and institution has its own rules and requirements, further complicating compliance. These requirements form what is known as pharmaceutical compliance.
In recent years, the emergence of automation and artificial intelligence (AI) has generated significant interest: what if certain compliance tasks could be automated? What if we could speed up our processes in the same way that factory automation has significantly increased production? This promises time and reliability gains but also raises questions about associated risks.
What Is Compliance?
In the pharmaceutical field, compliance encompasses the obligations that companies must meet: good manufacturing practices, rigorous controls, regulation of product promotion, traceability of clinical trials, pharmacovigilance, etc. (Agence Nationale de Sécurité du Médicament et des produits de santé [ANSM], 2023). These rules aim to protect patients while ensuring that products on the market are safe, effective, and properly used. For example, in France, any advertisement for a drug must be validated by the ANSM to ensure it is clear, honest, and compliant with authorized indications (ANSM, 2023).
Why Automate These Processes?
Automation can bring several major benefits:
- Saving time: software can analyze hundreds of pages in minutes.
- Reducing human errors: by standardizing checks, omissions or approximations are avoided (Gartner, 2022).
- Freeing up time for experts: they can focus on complex or strategic cases.
- Continuous monitoring: tools can automatically detect deviations or regulatory changes (EMA, 2023).
- Facilitating audits: every action can be traced and documented.
The EMA acknowledges that AI can help process large volumes of data more quickly, potentially bringing drugs to market faster without compromising safety (EMA, 2023).
What Are the Limits and Risks?
Automation should not replace healthcare and compliance professionals. Here are the main limits to keep in mind:
- Bias: if an algorithm is trained on incomplete data, it can make mistakes or be unfair (CNIL, 2023).
- Loss of human control: we should not leave everything to machines. The GDPR prohibits purely automated decisions if they have a significant impact on a person (CNIL, 2024).
- Lack of medical context: software does not always understand the subtleties of a scientific document. It may incorrectly reject or approve content.
- Data quality: if the analyzed data is erroneous or outdated, the results will be incorrect.
- Data security: automation involves handling a lot of sensitive information. Cybersecurity must be strengthened to prevent leaks (Gartner, 2022). Additionally, automation and AI can also facilitate the spread of false scientific publications, whether generated intentionally or by error, thereby compromising the reliability of evidence used in medical decisions (Else, 2023).
Key Takeaways
Automating pharmaceutical compliance opens up opportunities to simplify procedures, increase efficiency, and better meet regulatory requirements. However, it must be used judiciously. Human oversight remains essential, and each tool must be tested, regulated, and continuously improved.
For healthcare companies, the proper use of automation is an opportunity: not to shirk their responsibilities, but rather to strengthen them with tools better suited to current challenges.