The European Union is currently working intensively on a comprehensive reform of EU pharmaceutical law ("pharmaceutical package"). The aim is to modernize the framework conditions for research, development, and market access, reduce bureaucracy, improve security of supply, and strengthen Europe's competitiveness.
The European Commission made its first move on the pharmaceutical package in April 2023. At the beginning of June 2025, the European Council agreed on a common position and is now ready for negotiations with the European Parliament.
Even though the pharmaceutical package does not provide for any changes to labor law regulations, there are labor law implications for employers in the pharmaceutical, biotech and clinical research industries, which they should already be preparing for.
We have summarized the most important labor law implications below.
Personnel planning and qualifications
Accelerated approval procedures and stricter regulatory requirements mean that companies need highly qualified personnel in the areas of regulatory affairs, quality assurance, pharmacovigilance, and environmental compliance at short notice. This can lead to staff shortages, especially for specialized professionals. Employers should therefore invest in training and continuing education in good time and consider flexible contract arrangements to cope with project-related "peaks."
Employment contracts and contract design
The pharmaceutical package provides incentives for certain approval strategies in some cases - for example, if a drug is made available in all member states. This may have an impact on remuneration systems and target agreements. Employers should ensure that bonus and incentive models in this regard are legally compliant and, for example, clearly define how regulatory milestones are incorporated into individual remuneration.
Compliance and documentation requirements
The pharmaceutical package increases the requirements for documentation, environmental compatibility, and reporting obligations, for example in the event of supply bottlenecks. This results in additional tasks for employers, which must be clearly regulated under labor law and assigned to employees. In this context, employers should also check whether existing works agreements on working hours, overtime, and on-call duty need to be adjusted.
Location selection and outsourcing
In order to take advantage of regulatory benefits, it may make sense for companies to locate certain studies or production steps within the EU. At the same time, outsourcing to external service providers remains an important factor. Employers must keep in mind their labor law responsibilities for quality, safety, and co-determination, especially in cross-border projects.
Co-determination and restructuring
New regulatory requirements may lead to necessary organizational adjustments, such as the expansion of licensing or compliance departments or even restructuring. In this context, the co-determination rights of existing works councils must be taken into account at an early stage. Employers should seek dialogue with existing works councils in good time and prepare the necessary documents, such as works agreements, in order to implement the necessary adjustments in the best possible way.
Conclusion
The pharmaceutical package has far-reaching implications that also affect labor law. Employers in the pharmaceutical, biotech and clinical research industries should adapt their HR strategies in good time, review existing contractual provisions, strengthen compliance, and observe co-determination rights. Employers who act in a prepared manner will not only ensure regulatory compliance but also competitiveness in an increasingly dynamic market environment.
We are happy to assist you with any questions you may have about the labor law implications of the pharmaceutical package and its implementation.
