#BIOSPAIN2023Interview | "One of the objectives of the EU HTA is to increase cooperation among the member states and their HTA agencies"

Access to innovative medicines in Europe continues to be one of the major pending issues, especially considering the significant differences observed between countries. In recent years, we have witnessed the development of a series of regulations that have had a strong impact on access to innovative medicines in Europe. One of them is the European Union Health Technology Assessment Regulation (EU HTA), aimed at addressing uneven access across the EU, among other goals. 

To delve deeper into the implications that the EU HTA Regulation has on access to innovative medicines in Europe, we spoke with Chus Castillo, Partner Consulting Iberia from Alira Health, the Gold Sponsor of BIOSPAIN 2023, an international flagship event for the biotechnology sector.

AseBio.  What are the changes that are impacting market access for innovative products right now? 

Chus Castillo. Two examples of major regulatory changes underway in the EU both impact market access. The first is the EU HTA, which requires that pharma, biotech, and MedTech companies submit a clinical dossier at the EU level for new products beginning in 2025. This presents a major challenge to healthcare companies focused on innovation. 

The other regulatory challenge is the proposed EU Pharmaceutical Package. This revision of the 2006 European Commission (EC) regulation is under review by the EC and the European Parliament. If adopted, the new regulations would have a disruptive impact on manufacturers because they include significant changes to market protections and would increase the administrative and clinical burden.

AseBio. Why is the new EU HTA Regulation so important?

Chus Castillo. Traditionally, every country in the European Union (EU) has conducted their own HTA of a new health technology to determine its value at a national or sometimes regional level. The specific HTA agencies consider cultural, social, economic, and systems issues within the context of its country or region. The result is a variety of inconsistent HTA-related activities, duplication of efforts, and uneven patient access across the EU. The new EU HTA regulation aims to address these challenges by creating a common EU HTA.  

AseBio. What changes as a result of the EU HTA Regulation? 

Chus Castillo. Manufacturers must submit a clinical dossier for a joint clinical assessment (JCA) at the EU level beginning in 2025. Member states will then take the JCA into consideration when conducting their own HTA. They can ask manufacturers to conduct additional clinical and non-clinical studies if needed. Member states will still have the final say on the value of a new technology and for pricing and reimbursement. 

AseBio. What are the main advantages it includes?

Chus Castillo. Among the EU HTA’s goals are to increase cooperation among member states and their HTA agencies. The plan is to reduce duplication of efforts across member states, align HTA tools and methodologies, and establish common criteria for information, while setting the stage for the long-term sustainability of EU HTA cooperation. The hope is to ensure high quality work, clear timelines, and greater transparency. The most significant impact on patients will come from increased access equity across the member states; at least, that is the goal.

AseBio. How will this regulation improve access to innovative medicines?

Chus Castillo. One of the key goals of EU HTA is to improve patient access across the EU, bringing valuable new treatments to patients who need them regardless of what country they live in. Manufacturers, however, have concerns about the additional level of approval, the new requirements, and the administrative burden.

AseBio. What will BIOSPAIN 2023 add to the understanding of the new regulatory framework?

Chus Castillo. In our panel on “New EU Regulations: Overcoming Challenges to Deliver Cell Therapies to Patients in Need,” the experts will discuss the impact of both the EU HTA Regulation and the Clinical Trials Regulation. Both new frameworks were created with the goal of deepening cooperation and creating more regulatory harmonization in the EU. The question is, will the additional requirements imposed by these regulations stifle innovation and slow patient access to new medicine? We look forward to a lively discussion of these issues with our panellists, representing patients, pharmas, biotech start-ups, and hospitals, and hope the audience comes with many questions.