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Miller International Knowledge

MIK

At Miller International Knowledge (MIK), we redefine excellence in the realms of legal consulting, compliance, and sustainability.

Lobbying Activity

Response to A European Strategy for AI in science – paving the way for a European AI research council

21 May 2025

Miller International Knowledge (MIK) welcomes the Commissions ambition to build a cohesive European AI strategy for science. We particularly appreciate the goal to democratise access to AI infrastructure, promote interdisciplinary collaboration, and accelerate responsible innovation. However, we urge the Commission to embed digital equality, scientific integrity, and ethical AI governance as foundational components of this strategy. Drawing from MIKs legal and ethical work in H2020 and Horizon Europe projects, and from the global insights of BCCEs Digital Equality Working Group, we propose the following priorities: 1. Center Ethical, Transparent, and Inclusive AI-by-Design The strategy must go beyond access and productivity. It should: Require AI ethics-by-design principles in all funded scientific projects (bias mitigation, explainability, human oversight). Support interdisciplinary research on the social and legal implications of AI in science, including data sovereignty, algorithmic bias, and intellectual property. Fund AI literacy and critical awareness training, especially among early-career researchers and underrepresented groups. 2. Operationalise Digital Equality in Scientific AI Equitable access is not guaranteed by infrastructure alone. MIK and BCCE call for: Targeted investment in women-led and minority-led research teams, particularly in STEM and AI fields. Accessibility standards for AI tools to ensure usability for persons with disabilities. Gender-disaggregated and diversity-sensitive monitoring of Horizon Europe funding distribution in AI-related science projects. 3. Reinforce Scientific Integrity and Open Science AI must not compromise scientific transparency. We recommend: Mandating open access to training data and AI models developed with public funds, aligned with the FAIR and CARE principles. Establishing independent oversight mechanisms to audit and evaluate scientific foundation models for reproducibility and integrity. Ensuring that high-risk AI systems in science fall under compliance pathways of the EU AI Act, especially those used in medical, climate, or public policy research. 4. Build an Inclusive, Multi-Stakeholder European AI Research Council If the strategy aims to lay the foundation for such a body, it must reflect broad representation: Include legal scholars, ethicists, civil society, and equality bodies alongside scientists and engineers. Embed citizen science and participatory foresight methods in the roadmap development to ensure responsiveness to societal needs. Safeguard against capture by dominant market players and ensure small institutions have a voice. 5. Align Monitoring With Equality and Fundamental Rights Standards MIK welcomes the planned use of quantitative and qualitative evaluation. To improve it: Include digital equality impact assessments as a standard in Commission-led evaluations of AI in science. Connect indicators to the European Pillar of Social Rights, SDG 5 (gender equality), SDG 9 (infrastructure, innovation), and SDG 10 (reduced inequalities). 6. Support Global Standards and Scientific Cooperation The EU has a unique role in promoting science diplomacy through responsible AI. MIK recommends: Coordinating with UNESCOs Recommendation on the Ethics of AI and OECD AI principles. Supporting low- and middle-income country researchers with EU co-funded AI science capacity programmes. Conclusion To realise the EUs vision of scientific excellence and strategic autonomy, the AI in Science Strategy must be grounded in equity, integrity, and public accountability. Miller International Knowledge and the BCCE Digital Equality Group remain available for consultation and would welcome the opportunity to contribute to working groups shaping this important initiative.
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Response to Gender Equality Strategy 2026-2030

21 May 2025

In response to the European Commissions Call for Evidence Title of Initiative: 20262030 Gender Equality Strategy Date: 23rd March 2025 Organisation: Miller International Knowledge (MIK) Type of organisation: Independent legal and ethical advisory organisation Website: https://miller.international Miller International Knowledge (MIK) welcomes the initiative to shape a forward-looking 20262030 Gender Equality Strategy. Based on our experience in Women 20 (W20), the European Women Lawyers Association (EWLA), and the Deutscher Juristinnenbund (djb), we highlight five priority areas for action: 1. Countering Anti-Gender Backlash W20 experience shows anti-equality movements increasingly use formal complaints and legal actions to stall progress. The EU must anticipate and counter these tactics by: Establishing an EU-level mechanism to protect gender equality institutions and actors from harassment (e.g. SLAPPs). Providing legal resources for civil society and public institutions under threat. 2. Legal Enforcement and Harmonisation EWLA has observed gaps in the enforcement of gender equality law across Member States. We recommend: A Gender Equality Legal Scoreboard to assess compliance with Articles 153 and 157 TFEU and the Equal Pay Directive. Stronger linkage between gender equality benchmarks and EU funding/infringement procedures. 3. Addressing Fiscal Disincentives and Structural Barriers DJBs analysis of tax and pension systems in Germany shows that existing fiscal regimes often discourage womens full economic participation. We urge: Gender impact assessments of national tax and benefit systems. Prioritisation of reforms to part-time work laws, pension gaps, and employment precarity. 4. Making Intersectionality Operational While intersectionality is cited as a guiding principle, its implementation remains inconsistent. MIK proposes: Mandatory collection of disaggregated data by gender, ethnicity, disability, and migration status. Gender-responsive budgeting and outcome tracking at EU and Member State levels. 5. Justice and Access to Remedies Access to legal protection remains uneven. We recommend: An EU Gender Justice Fund to support survivors of violence and discrimination. EU-funded training for judges and prosecutors on gender-sensitive justice, in line with the Istanbul Convention. Monitoring and Transparency MIK supports the use of the Gender Equality Index, SAAGE, and Eurostats Social Scoreboard. However, we call for: Annual publication of Member State progress with input from feminist legal networks. Open consultation with EWLA, djb, and W20 representatives in the strategys implementation phase. Global Dimension The EU should promote its internal gender equality standards in trade and foreign policy by: Including enforceable gender equality clauses in trade agreements. Supporting gender-transformative international partnerships aligned with the SDGs. Conclusion The Gender Equality Strategy must move beyond aspirations to legal and structural commitments. As a legal and ethical advisory organisation, MIK stands ready to contribute to further consultations and implementation.
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Response to Evaluation of the Good Laboratory Practice (GLP) Directives

23 Mar 2025

Feedback from Miller International Knowledge (MIK) As an interdisciplinary organization focused on legal compliance, ethics, and responsible innovation in science and technology, Miller International Knowledge (MIK) welcomes the opportunity to provide input on the evaluation of Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice (GLP). MIK supports the initiative to ensure the effectiveness, efficiency, coherence, and relevance of these Directives within the evolving regulatory and scientific landscape. 1. Effectiveness and Relevance MIK agrees that the core objectives of the GLP Directivesnamely the assurance of high-quality, reliable, and fraud-resistant dataremain highly relevant. However, their effectiveness is increasingly challenged by the complexity of new testing methods, such as AI-supported toxicity prediction, in vitro and in silico techniques, and alternative non-animal models. We encourage the Commission to consider how the Directives can better integrate innovative approaches, while still ensuring data quality and regulatory robustness. 2. Coherence and Alignment with OECD Principles Given the close alignment with the OECD Council Acts and annexes, MIK recommends that the revision pay special attention to ensuring semantic consistency while avoiding excessive legal fragmentation at EU level. Particular attention should be given to harmonizing the terminology and interpretation of GLP across Member States, which currently shows discrepancies and risks undermining the internal market. 3. Implementation and Legal Transposition As a compliance-focused organization, MIK notes that the legal transposition of the GLP Directives across Member States has led to heterogeneous implementation practices, notably in the number and role of national monitoring authorities, the frequency of inspections, and the scope of enforcement powers. A comparative legal analysis should not only describe transposition differences but assess their impact on legal certainty and cross-border equivalence of data. 4. Cost-Benefit and Administrative Burden From a compliance burden perspective, we underline the need for simplification measures, especially for SMEs and smaller test facilities. Certification processes and reporting requirements could be streamlined through digital tools, standardized templates, and mutual recognition mechanismswithout compromising quality. The cost-benefit analysis should incorporate indirect compliance costs, including training and documentation, which are significant for smaller actors. 5. Data Transparency and Ethics MIK encourages the integration of ethical and data governance dimensions into the evaluation framework. This includes clarity around data ownership, protection of proprietary methods, and greater transparency of GLP-compliant studies used in public policy. Furthermore, we believe the evaluation should consider the ethical implications of GLP practices in global supply chains, particularly where data are generated in third countries and submitted to EU regulatory bodies. 6. Recommendations for Future Policy Strengthen coherence and reduce regulatory fragmentation through updated, consolidated guidelines with direct cross-referencing to OECD materials. Promote digitalization of compliance tools and facilitate reporting obligations for smaller actors. Encourage uptake of alternative testing methodologies by revising GLP requirements to acknowledge and guide their integration. Introduce capacity-building measures to support consistent implementation across Member States, especially for inspection authorities. Consider including a sustainability dimension, evaluating how GLP can contribute to or align with broader EU policy objectives such as the European Green Deal.
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Response to EU Life sciences strategy

23 Mar 2025

In response to the European Commissions Call for Evidence Title of Initiative: A Strategy for European Life Sciences Date: 23rd March 2025 Organisation: Miller International Knowledge (MIK) Type of organisation: Independent legal and ethical advisory organisation Website: https://miller.international/ 1. About MIK Miller International Knowledge (MIK) is a cross-disciplinary legal and ethical consultancy working at the intersection of innovation, regulation, and responsible governance. Our expertise spans compliance advisory, data protection, regulatory foresight, and ethics monitoring in high-impact research and technological sectorsparticularly in health, biotechnology, AI, and education. We actively contribute to the European Research and Innovation ecosystem through our participation in numerous Horizon 2020 and Horizon Europe projects. These include, among others: DivAirCity (ethical framework and data governance for inclusive urban innovation), Path2Integrity (integrity education and research culture), iRISE (inclusive innovation ecosystems, with special focus on life sciences), IP4OS (intellectual property strategy and open science), Impact EdTech (digital education and ethics-by-design), and Re-Wiring (ethics and technology for democratic resilience). This extensive project portfolio gives us both strategic insights and practical experience in designing and implementing legal and ethical safeguards in frontier research and innovation. 2. Key messages We welcome the European Commissions strategic initiative and share the goal of making Europe a global leader in life sciences. Our feedback focuses on four critical enablers of success: regulatory coherence, responsible innovation, compliance capacity building, and societal trust. 3. Our contributions to the strategy A. Regulatory Simplification and Legal Coherence We recommend a risk-based review of the EUs regulatory framework for life sciences to reduce complexity for innovators, particularly start-ups and SMEs. We offer support in mapping and analyzing overlaps in EU and national legislation, particularly where convergence with AI, health data, and biotechnology is occurring. MIK can contribute to the legal foresight component of the strategy, identifying how upcoming technological shifts may interact with existing rules. B. Ethical, social, and legal alignment of innovation We encourage integration of ethics-by-design in biotech and life science research funding streams. MIK has practical experience in evaluating data governance models, informed consent frameworks, and public trust in AI-enabled health and genomics. We recommend that the strategy support the creation of multidisciplinary ethical oversight structures, especially for emerging applications such as synthetic biology or bio-AI. C. Skills and Capacity Building for Compliance MIK is developing training content for legal and ethical risk awareness in innovation teams. We propose contributing to the development of EU-wide compliance training modules for life sciences professionals (e.g., SMEs, research centres, regulators). Our team is prepared to collaborate on upskilling initiatives related to Horizon Europe and future R&I missions. D. Supporting the Uptake of Innovation MIK can contribute to frameworks that promote regulatory clarity, enabling translation of R&I outcomes to market applications. We support a compliance-support hub for early-stage companies in biotech and health innovation, especially those navigating MDR, AI Act, GDPR, and sectoral norms. 4. Recommended Actions for the Life Sciences Strategy 1. Embed legal and ethical foresight into Horizon Europe missions related to health, agri-food, and digital life sciences. 2. Develop a compliance support infrastructure for research actors and SMEs (toolkits, helpdesks, and peer mentoring). 3. Promote the inclusion of ethics advisors in EU-funded projects as standard practice. 4. Address regulatory fragme
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Meeting with Ann-Sofie Ronnlund (Cabinet of Commissioner Ekaterina Zaharieva)

17 Mar 2025 · - Best practices identified by the IP4OS project for EU research and innovation knowledge valorisation policies - Untapped potential of scientific data, for digital and AI applications