By: Natasha Allen
As the January 2025 deadline for the EU Health Technology Assessment (HTA) Regulation approaches, companies in the oncology and cell and gene therapy sectors must act quickly to ensure they’re prepared for the new regulatory environment. The shift to a more streamlined and collaborative approach across EU member states presents both opportunities and challenges, particularly when it comes to ensuring compliance. Here are the top five things your company needs to know—and do—to stay ahead.
1. Understand the Joint Clinical Assessment (JCA) Process
The cornerstone of the EU HTA Regulation is the Joint Clinical Assessment (JCA). This collaborative process involves evaluating the clinical effectiveness and safety of new therapies across multiple member states. What does this mean for your company?
Key Action: Ensure your team fully understands the JCA process and timelines. This includes compiling a comprehensive report that aligns with both national and EU-level requirements. Early preparation is critical. Read the official document outlining the EU HTA Regulation.
2. Anticipate Increased Workload and Address Resource Constraints
One of the biggest challenges for companies will be managing the increased workload that comes with compiling JCA Reports. This requires meticulous coordination across regulatory affairs, clinical development, medical affairs, and biostatistics. Additionally, many organizations may face resource constraints, including limited budgets or expertise to handle the heightened demands.
Key Action: Review your current staffing structure. Do you have enough team members in critical roles to handle the additional burden? If not, consider outsourcing specific tasks or partnering with specialized organizations to help bridge the gap. Taking proactive steps now can prevent operational bottlenecks later.
3. Strengthen Leadership with Regulatory and Technological Expertise
The complexity of the new regulation requires leaders who can not only manage the day-to-day compliance demands but also strategically navigate the evolving regulatory landscape. Strong, forward-thinking leadership is essential for success.
Furthermore, companies that integrate technology into their compliance strategies will have a significant edge. Digital tools can streamline processes and enhance collaboration across departments.
Key Action: Assess your current leadership team’s expertise in regulatory affairs and technology. If you lack leaders with a deep understanding of the EU HTA environment and the digital tools that can support compliance, consider bringing in external experts or recruiting individuals with proven experience in these areas.
4. Prioritize Data Privacy and Cross-Functional Collaboration
Success under the EU HTA Regulation will depend heavily on how well different departments within your organization can collaborate. Siloed operations will slow down your ability to meet deadlines and ensure compliance.
Additionally, as companies will be sharing sensitive patient data across multiple member states, ensuring the highest standards of data privacy and security will be critical to mitigating risks.
Key Action: Foster a culture of collaboration by encouraging regular cross-functional meetings and project management practices that promote transparency. Leaders should prioritize breaking down silos, while also ensuring robust data protection measures are in place to secure sensitive information throughout the JCA process.
5. Partner with Specialized Executive Search Experts
Finding top talent in fields like regulatory affairs, medical affairs, and biostatistics is becoming increasingly competitive, especially with the increased demand for experts who can navigate the JCA process. Having the right executive recruiting partner can give you an edge.
Key Action: Engage with a top executive search firm that understands the nuances of the EU regulatory landscape. These partners can help you identify talent, assess candidates, and create onboarding programs to ensure new hires are ready to contribute immediately.
The January 2025 deadline will arrive quickly, and companies that fail to prepare risk falling behind. By taking these steps—understanding the JCA, addressing workload, investing in leadership, promoting collaboration, and partnering with the right talent experts—you can ensure your organization is ready to tackle the challenges of the EU HTA Regulation head-on.
