Asociácia inovatívneho farmaceutického priemyslu/Association of Innovative Pharmaceutical Industry
AIFP/AIPI
Support of economic, professional and legal interests of the Association’s members; protection of rights and justified interests of the Association’s members; support of the pharmaceutical industry in Slovakia.
ID: 030750745920-45
Lobbying Activity
Response to EU Life sciences strategy
16 Apr 2025
AIFP, a member of EFPIA, welcomes the European Commissions initiative to develop a robust EU Life Sciences Strategy to strengthen Europes competitiveness and close the innovation gap with global peers. The strategy must address challenges across the full value chain, deepen public-private collaboration, and reinforce the link between a thriving industry, world-class research and manufacturing, and equitable access to medicines. Amid geopolitical, societal, and climate challenges, a bold and coordinated EU approach is needed. Targeted policies supporting clinical research, SME funding, sustainable manufacturing, and streamlined market access can help Europe regain its edge, enhance economic and health security, and deliver innovations to patients. Governance should be supported by an EU Office for Life Sciences, accountable for strategy implementation. 1. Translating Innovation into Impact Despite Europes scientific excellence, it struggles to convert discoveries into transformative innovation. The strategy should: Strengthen globally competitive IP frameworks to attract R&D investment. Ensure robust funding for collaborative research in FP10 (successor to Horizon Europe), including public-private partnerships. Improve access to capital by: o Reforming pension fund rules to unlock private investment in high-risk ventures. o Reducing the cost of raising capital in EU stock markets. Invest in STEM education, upskilling and reskilling to build the workforce of the future. 2. Restoring Leadership in Clinical Research Europe has lost ~60,000 clinical trial places to other regions, weakening its global role in drug development. In Slovakia, there has been a slight increase in the absolute number of clinical trials; however, when considering the number of trials per capita, the country ranks among the lower end in Europe, according to an IQVIA analysis from October 2024." The strategy for restoring leadership should include: Streamline approvals for multi-country clinical trials to reduce delays. Ensure effective implementation of the EHDS and AI Regulation to enable data-driven innovation. Reinforce EMAs role in European and global regulatory convergence. A major barrier to competitiveness is the complexity of the EU regulatory framework. While the revision of pharmaceutical legislation is an opportunity, the strategy can deliver immediate improvements without further legislative change: Accelerate digital transformation of regulatory systems. Enable predictable use of all evidence types, including real-world data. Ensure regulatory authorities are sustainably resourced and agile. 3. Strengthening Europes Manufacturing Base With the U.S. and China attracting increasing biopharma investment, Europe must: Align environmental, chemical and animal welfare policy with open strategic autonomyensuring essential substances (e.g., PFAS, TiO2, talc) are not unduly restricted, risking medicine supply. 4. Timely & Equitable Access to Innovation To remain globally competitive, Europe must ensure faster, fairer access to innovation: Implement a workable HTA framework, with: Early dialogue between EU and national authorities to prevent duplication and delays. Predictability and scientific quality in joint clinical assessments. Develop value-based procurement guidelines that go beyond pricerecognising quality, sustainability, and supply security. Improve access through sustainable public pharmaceutical spending; short-term cost-containment undermines innovation. Foster structured high-level dialogue between industry, policymakers and health stakeholders to address access barriers. Conclusion: To restore Europes leadership in life sciences, the EU Life Sciences Strategy must be anchored in competitiveness, investment, and innovation. A forward-looking policy agenda will secure Europes role as a global hub for medical research, sustainable manufacturing, and equitable access to transformative treatments.
Read full responseResponse to Health technology assessment - Joint clinical assessments of medicinal products
28 Mar 2024
The success of the EU HTA Regulation is contingent on the ability of the system to deliver high-quality JCA reports which provide added value to national decision-makers. As such, the JCA process needs to: - facilitate early engagement with the health technology developer (HTD), to ensure a timely and optimally informed start of the process and to enable the systematic exchange of relevant information with the HTD; - to provide all participants with the necessary information and evidence for the scoping and assessment; - guarantee sufficient time for HTDs to conduct the relevant analyses required for preparing and finalizing their clinical evidence submission dossier; - allow assessors sufficient time to review the JCA dossier and to develop a high-quality JCA report. We are concerned about several glaring shortcomings in this draft JCA implementing act, especially regarding the workability of the JCA process, where it undermines the capacity of the HTD (from SMEs and biotech to larger pharmaceutical companies) to provide a good quality submission to the assessors and co-assessors. Several reasons drive this concern: the unbalanced time allocation between scoping and submission stages, the absence of visibility on the submissions scope coupled with the expected size/complexity of the assessment scope driven by a mechanistic need to satisfy all needs of all Member States and the lack of meaningful participation of the HTDs at key steps of the process. We believe that the draft JCA implementing act can set the path towards a successful EU JCA system if it recognizes the role of the key stakeholders in the process and enables a rebalancing of workload in line with respective remits and obligations. In practice, this means that: - The assessment scope should be finalized within 90 days of the start of the JCA procedure and the HTD should have at least 135 days to prepare a high-quality submission dossier. - The HTD should have the opportunity to leverage all relevant information, evidence, and knowledge as a key input into the definition of the assessment scope. - The HTD should have an opportunity to meet and discuss with the assessor/co-assessor its views on the draft assessment scope. - The HTD should have visibility on the draft assessment scope proposed by the assessor/co-assessor as well as on the PICO survey responses from Member States (in an anonymized manner) at the earliest possible stage, to be able appropriate time to submit a high-quality submission response.
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