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Accelerating Demand-Driven tools for pediatric innovation adoption - A collaborative roadmap for Europe

Periodic Reporting for period 1 - Add4Kids (Accelerating Demand-Driven tools for pediatric innovation adoption - A collaborative roadmap for Europe)

Reporting period: 2024-01-15 to 2025-03-14

ADD4KIDS addresses the gap in European pediatric healthcare innovation adoption, driven by barriers like complex regulatory pathways, limited market size, and high perceived risks. Demand-driven policy instruments such as Public Procurement of Innovation (PPI), Pre-Commercial Procurement (PCP), and Social Impact Bonds (SIBs) are underutilized in paediatrics, exacerbating the problem.

The project seeks to optimize European demand-driven innovation instruments (DDI) in paediatrics, creating a coordinated action plan to promote innovation adoption. This includes engaging stakeholders from government, industry, academia, and civil society to integrate innovations into healthcare systems, making them more accessible and scalable.

The key objectives of ADD4KIDS are:

• Identify Financing Instruments: Assessing existing DDIs and their applicability to paediatrics.
• Stakeholder Engagement: Analyze challenges faced by key stakeholders in adopting paediatric innovations.
• Development of a European Action Plan: The project aims to create a collaborative framework for cross-border collaboration to adopt DDIs.
• Raise Awareness: Inform stakeholders about the potential of demand-driven innovation tools

The expected impact of ADD4KIDS includes:

• Provide valuable insights into the challenges and needs of paediatric healthcare, guiding future research and policy decisions
• Optimize financial resources and foster market investment in paediatric innovations.
• Improve children’s quality of life through accessible healthcare innovation that directly addresses their health needs.

In the long term, ADD4KIDS will create an inclusive and sustainable innovation ecosystem to reduce inequalities in paediatric healthcare across Europe.
ADD4KIDS has addressed barriers to DDI adoption in paediatrics, through three main activities.

Situational Analysis & Data Gathering (WP1) analysed existing DDI and identified key regulatory, financial, and structural barriers through surveys and stakeholder interviews.

Key outcome: The Europe Paediatric Innovation Adoption Situation Report, as a solid evidence base.

Challenges Analysis and Solution Framework Generation (WP2) addressed WP1 challenges by developing targeted solutions with 9 stakeholder Working Groups, resulting in a Solution Framework and White Paper with policy recommendations.

Key outcome

Actionable recommendations on policy alignment, financing mechanisms, and procurement processes. Co-creation of the White Paper, shared with EU institutions (EMA), offering strategic proposals shaping future pediatric innovation frameworks.

European Action Plan for Fast-Tracking Innovation Adoption (WP3) developed a comprehensive plan to expedite pediatric innovation adoption throughout Europe, including capacity-building and business acceleration programs.

Key outcomes

Establishment of a collaborative Pan-European Network of stakeholders committed to adopting paediatric innovation. European Action Plan that serves as a strategic tool for accelerating the adoption of paediatric innovations across Europe. Development of capacity-building programs and business acceleration initiatives to support the adoption process.
ADD4KIDS has made significant progress in advancing paediatric healthcare innovation by promoting demand-driven instruments like PPI, PCP, and SIBs, which remain underutilized despite their potential.

Through capacity-building and business acceleration programmes, the project has supported 37 key partners, including 24 stakeholders with no prior experience in demand-driven instruments. It has helped them understand and implement these instruments effectively, ultimately accelerating the adoption of paediatric innovations and enabling quicker market access for start-ups.

Another key achievement of the project is the development of a European Action Plan to fast-track the adoption of innovative paediatric solutions. The plan aims to equip the paediatric ecosystem with tools to foster innovation, attract private funding, and empower healthcare providers and patients. At the macro level, the project is focused on reducing healthcare inequalities across Europe and fostering international collaboration, particularly with countries like Canada, Japan, and South Korea.

The project’s impact spans scientific, economic, and societal levels. A Theory of Change (ToC) methodology was developed to address paediatric challenges, optimize resources and create a sustainable market, fostering ecosystem collaboration and improving child health outcomes across Europe.

Further research and pilot projects are needed to validate these approaches in real-world settings. Key priorities include strengthening financing mechanisms, aligning business models with procurement, and clarifying regulatory pathways. Expanding DDI adoption internationally requires policy harmonization and cross-border partnerships.
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