In the pharmaceutical industry, compliance has become a fundamental pillar to ensure that all operations are carried out with integrity, ethics and transparency in order to position itself solidly in the market.

As this is such a relevant sector for public health, ensuring that all activities are carried out in accordance with the highest legal and ethical standards not only protects companies, but also strengthens the trust of patients, institutions, physicians and society in general.

In recent years, compliance in the pharmaceutical industry has led to a transformation in the organizational cultures of the companies that lead the industry. The Chief Compliance Officer and the Ethics Committees have become indispensable figures within organizations that prioritize compliance, ensuring that all business activities are carried out in compliance with ethical principles and the law.

A few years ago, the inclusion of compliance clauses in contracts, such as data protection, codes of ethics and anti-corruption regulations, generated numerous discussions between the parties involved. However, today, this is no longer a topic of debate. Compliance has become global and it is indisputable that these types of clauses must be present to ensure regulatory and ethical compliance at an international level.

Looking ahead to 2025 and beyond, the industry will continue to work on developing effective compliance programs that will enable them to be in line with international regulations.

When it comes to personal data, the adoption of the General Data Protection Regulation (GDPR) in Latin American countries has increased. Pharmaceutical companies must redouble their efforts to ensure the protection of patients’ personal data and comply with international standards. The increasing digitalization and use of big data in research and development makes rigorous management of personal data mandatory to avoid sanctions and maintain public trust.

The fight against corruption will continue to be a priority in the industry. Companies must implement and constantly update their compliance programs to prevent corrupt practices, always keeping in mind the internationally referenced provisions, such as the FCPA and the UK Bribery Act.

A gradual recovery in M&A activity is expected next year, driven by the improvement in financial markets and the strategic need for companies to transform and expand. Compliance will continue to play a fundamental role in these types of transactions, mitigating risks and ensuring that they are carried out efficiently and in accordance with the law.

There is no doubt that support from new technologies will be key to achieving effective compliance programs. Specifically, in regards to:

Risk detection and prevention: AI and machine learning enable the analysis of big data to identify unusual patterns that could signal compliance risks. This effectively prevents fraud and illicit activities.

Process Automation : Repetitive and administrative tasks, such as document review and compliance verification, can be automated, increasing efficiency and helping to reduce the margin for human error.

Informed Decisions: AI systems offer detailed analysis in real-time, facilitating decisions based on accurate and up-to-date data. This is vital for regulatory compliance in a dynamic business environment.

The implementation of AI will not only generate help for companies, but also significant challenges. It is essential to ensure transparency in this type of automated processes and to comply with the regulations and standards in this area, which will be constantly changing due to the dynamics involved.

In 2025, compliance in the pharmaceutical industry will continue to evolve to meet new challenges and comply with stricter regulations. A strong compliance program will not only avoid sanctions, but will also improve the reputation of companies and strengthen stakeholder trust.

It is crucial for pharmaceutical companies to maintain a proactive and continuous approach to regulatory compliance, adapting to changing regulations and leveraging new technologies to detect and prevent risks. By doing so, they will not only contribute to a more ethical and transparent business environment, but will also ensure equitable access to medicines, reaching more patients and reducing costs.

By Vanessa Malcolm, Head of Legal Department at Megalabs.