BioLawLaPaLooZa: Mauritz Kop on Hippocratic Quantum and the End of Stable Records at Stanford Law School

At BioLawLaPaLooZa, the annual law-and-biosciences conference convened at Stanford Law School by Henry T. "Hank" Greely and co-hosted with the Journal of Law and the Biosciences, Mauritz Kop delivered a talk that fused two strands of his recent work: the biomedical-ethics argument of his Harvard-published Hippocratic Quantum project and the security lens of his NATO Strategic Communications advisory work. It was his third appearance at the gathering, which builds on his earlier BioLawLaPaLooZa remarks.

The past is not yet stable

Kop's organizing line was that "the past is not yet stable." Rather than treating the quantum threat as a future event, he argued that today's authenticated, confidential records are contingent on a cryptographic transition still under way: adversaries can harvest encrypted data now and decrypt it once a Shor-capable machine factors the large integers beneath RSA. Confidentiality, in this reading, must be defended retroactively as well as prospectively—making the migration to post-quantum cryptography, for hospitals and biobanks, a clinical duty rather than an IT preference. The point reframes a familiar threat model: the danger is not only what a future machine will decrypt, but what is being copied and stored today against that day.

Four classical principles, recomputed

The talk recast the four principles of biomedical ethics—autonomy, beneficence, non-maleficence, and justice—for a quantum register. Quantum does not replace them, Kop said; it changes what applying them requires. Autonomy comes to demand data sovereignty and a credible right not to know as quantum-AI systems build finer probabilistic patient models. Dual-use simulators that design therapeutics can also lower the barrier to designing pathogens, which is where his LSI test—least trade-restrictive, security-sufficient, innovation-preserving—supports tiered disclosure over blanket secrecy. And the justice problem is a widening one: the quantum divide, he warned, may prove steeper than the digital divide.

The X-Ray City and a constitution for medicine

Widening the lens, Kop described civic-scale quantum gravimetric and magnetic sensors moving from the laboratory toward infrastructure pilots—able, from public rights-of-way, to resolve subsurface and interior spaces, and so to reach into the privacy of the home. He calls this prospect the X-Ray City, and said he had told NATO it needs a Hippocratic Quantum posture of its own. He closed with a "quantum constitution for medicine" in four standards of care: quantum-safe encryption, sovereignty over patient digital twins, human oversight in the loop, and tiered disclosure under the LSI test. The premise the room had not heard before, he suggested, was simply that the past itself is not yet settled.

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Academics, Healthcare, Stanford RQTHenry Quentir1 mei 2026Mauritz Kop, Stanford RQT, Healthcare, Ethics, Quantum Governance, Quantum Technology, Stanford Law School, Hippocratic Quantum, BioLawLapalooza, Hank Greely, Post-Quantum Cryptography, LSI Test, Quantum-AI, Petrie-Flom Center

Mauritz Kop Consults Amgen on Quantum-Biomedical Discovery

Invited by Howard Chang—the physician-scientist who led a renowned genomics laboratory at Stanford and now serves as Senior Vice President, Global Research, and Chief Scientific Officer at Amgen—Mauritz Kop consulted with Amgen's research organization on quantum-biomedical discovery: a disciplined exchange of ideas about where quantum methods can genuinely improve the way medicines are found.

An invitation from Amgen's chief scientist

The conversation paired deep biology with quantum strategy and governance. Its anchor was the Hippocratic Quantum approach Kop published at Harvard: accelerate discovery with quantum and quantum-classical methods, but under guardrails medicine itself would prescribe—validation, privacy, security, and patient trust from the first experiment. The same translational seriousness ran through the responsible-quantum lecture and workshop Kop gave at SandboxAQ.

Six use cases, one discipline

From computational chemistry for de novo discovery and lead optimization, through protein structure and selected omics analytics, metabolism and toxicity simulation, blood-brain-barrier hypotheses validated in organoid and lab-on-a-chip systems, operational optimization, and a watchlist for quantum neural networks—every candidate use case answers to the same rule: benchmark hard against strong classical baselines from day one, and let the evidence decide which pilots earn the next dollar.

Guardrails before hype

The strategy's quiet half is security and governance: a post-quantum cryptography roadmap for long-lived patient and research data, vendor diversification across qubit modalities, trade-secret and IP protection, and standards alignment. What the exchange was about, in the end, is decision quality—smarter discovery pipelines, better-protected data, and medicines that reach patients sooner.

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Healthcare, Quantum Technology, MedicineHenry Quentir3 maart 2026Mauritz Kop, Stanford RQT, Quantum Governance, Healthcare, Post-Quantum Cryptography, Amgen, Hippocratic Quantum, Quantum Medicine, Drug Discovery, Biomedical Discovery

Harvard Law Publishes Hippocratic Quantum: The Ethics of Biomedical Discovery in the Quantum Age

Cambridge, MA, February 25, 2026—Harvard Law’s Petrie-Flom Center has published Mauritz Kop’s new article, Hippocratic Quantum: The Ethics of Biomedical Discovery in the Quantum Age:https://petrieflom.law.harvard.edu/2026/02/25/hippocratic-quantum-the-ethics-of-biomedical-discovery-in-the-quantum-age/

The article advances a proposition that is becoming increasingly difficult for health lawyers, policymakers, and biomedical innovators to ignore: as quantum technologies begin to enter biomedical discovery, the decisive challenge is no longer only scientific capability, but rather governance. In Kop’s account, quantum-enabled medicine should not be understood as a distant or speculative frontier that can be regulated later, once the engineering settles. It should instead be approached as a present-tense quantum governance problem, one that already implicates patient confidentiality, data integrity, cyber resilience, export controls, supply chains, and the geostrategic value of biomedical knowledge.

The article’s answer is not a new morality, but a more demanding implementation of an existing one: quantum medicine requires a Hippocratic framework that is technical enough for engineers, legal enough for regulators, and concrete enough for hospitals and pharmaceutical firms, yet flexible enough to let innovation breathe and encourage the crucial public-private investment necessary to advance allied quantum capabilities.

Five examples of quantum-enabled biomedical innovations

To ground this institutional view, one must consider the specific technological capabilities currently transitioning from theoretical physics to applied biomedicine. Five feasible vectors of innovation illustrate the breadth of this shift. In the domain of quantum computing, hybrid classical-quantum algorithms are emerging to optimize complex drug discovery pipelines and process large-scale genomic datasets. In quantum sensing, technologies such as diamond nitrogen-vacancy magnetometry enable ultra-sensitive, room-temperature mapping of neurological and cardiac activity. For quantum simulation, researchers are utilizing qubit-based systems to model molecular interactions and drug-target binding affinities with high accuracy, aiming to reduce reliance on extensive physical wet-lab screening. Within quantum imaging, techniques leveraging entangled photons permit the high-resolution visualization of cellular structures at lower light intensities, thereby mitigating phototoxicity in living tissues, benefitting medical diagnosis. Finally, in quantum networking, the deployment of quantum key distribution protocols offers a mechanism to cryptographically secure the transmission of sensitive multi-omics data across distributed hospital and research architectures.

From legal-ethical framework to Quantum-ELSPI

The Harvard article is best read as part of a longer intellectual trajectory. An early expression of that project appeared in March 2021 in the Yale Journal of Law & Technology, in Establishing a Legal-Ethical Framework for Quantum Technology: https://yjolt.org/blog/establishing-legal-ethical-framework-quantum-technology

That Yale piece argued that quantum technologies were moving from hypothetical ideas to commercial realities, and that law and policy should not wait for full technical maturity before building governance tools. It proposed a culturally sensitive legal-ethical framework for applied quantum technologies, drawing on AI governance and nanotechnology’s ELSI tradition while recognizing the distinct physical characteristics of quantum systems. Crucially, it also insisted that ethical aspiration must be accompanied by practical mechanisms for monitoring, validation, and life-cycle risk management. In retrospect, many of the themes that now reappear in Hippocratic Quantum were already visible there: the concern for human-centered design, the call for risk-based governance, and the insistence that ethics without institutionalization would be inadequate.

Why quantum medicine changes the governance question

The new Harvard article narrows the focus to biomedicine, but in doing so it sharpens the stakes. Biomedical discovery is not simply another application area. It is a setting in which long-lived and highly sensitive data, bodily integrity, public-health interests, commercial incentives, and geopolitical competition intersect. Quantum technologies matter here not because they promise speculative disruption, but because they may incrementally and then materially improve specific tasks: hybrid quantum-classical computational chemistry, de novo molecular design, lead optimization, selected toxicity and metabolism modeling, and perhaps aspects of high-fidelity sensing, simulation, and networked quantum computation. The issue, then, is not whether every promise will be realized immediately. It is whether institutions are preparing now for the forms of capability that are already foreseeable.

A Harvard-facing research arc

This Harvard publication also extends a longer Harvard-facing research arc across AI, health law, and responsible quantum governance. That arc includes:

The Right To Process Data For Machine Learning Purposes In The EU (Harvard JOLT) https://jolt.law.harvard.edu/digest/the-right-to-process-data-for-machine-learning-purposes-in-the-eu
Towards Responsible Quantum Technology (Harvard Berkman Klein) https://cyber.harvard.edu/publication/2023/towards-responsible-quantum-technology
EU And US Regulatory Challenges Facing AI Health Care Innovator Firms (Harvard Petrie-Flom) https://petrieflom.law.harvard.edu/2024/04/04/eu-and-us-regulatory-challenges-facing-ai-health-care-innovator-firms/
A Brief Quantum Medicine Policy Guide (Harvard Petrie-Flom) https://petrieflom.law.harvard.edu/2024/12/06/a-brief-quantum-medicine-policy-guide/
How Quantum Technologies May Be Integrated Into Healthcare: What Regulators Should Consider (Stanford Law) https://hls.harvard.edu/bibliography/how-quantum-technologies-may-be-integrated-into-healthcare-what-regulators-should-consider/

Seen in this broader context, Hippocratic Quantum brings together early legal-ethical framing, responsible quantum governance, healthcare regulation, and geopolitical analysis into a single biomedical governance argument.

The article has also been featured by The Quantum Insider, which highlighted its central argument that quantum medicine’s promise must be matched by stronger privacy and governance safeguards: https://thequantuminsider.com/2026/02/27/analysis-quantum-medicines-promise-raises-new-privacy-and-governance-risks/

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A Brief Quantum Medicine Policy Guide: What Regulators Should Consider for Quantum and AI in Precision Medicine

As quantum technology and artificial intelligence move toward precision medicine, regulators face a problem they have not yet built tools for. A Brief Quantum Medicine Policy Guide—published on the Harvard Petrie-Flom Center's Bill of Health blog by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht, and I. Glenn Cohen, and cross-posted with the Stanford Center for Responsible Quantum Technology and the European Commission's European AI Alliance—is a concise map of the use cases, the overlapping legal regimes, and what agencies such as the FDA and EMA should consider. It is a companion to the team's longer treatment of how quantum technologies may be integrated into healthcare, and continues the collaboration later reflected in Kop's work consulting Amgen on quantum biomedical discovery.

Quantum use cases in healthcare

The guide sorts second-generation quantum medicine by domain. Quantum computing and simulation could accelerate de novo drug discovery by modeling molecular interactions, speed genome sequencing, and assist protein-folding prediction; quantum sensing could deliver continuous high-precision vital-sign monitoring, precision laser therapy, and earlier retinal diagnostics; post-quantum cryptography and quantum key distribution could secure patient data in line with HIPAA and GDPR. A recurring thread is the semiconducting quantum dot, whose ability to cross the blood-brain barrier opens possibilities in oncology imaging, targeted drug delivery, and neurodegenerative-disease research. Throughout, the authors keep the claims proportionate, marking many applications as early-stage or theoretical.

A fragmented regulatory map

There is no quantum-specific medical-device law in either the EU or the US. European devices fall mainly under the Medical Devices Regulation, with the EU AI Act and data laws in supporting roles, while CE marking is slowed by a shortage of Notified Bodies versed in AI or quantum. US devices may sit within the existing FDA framework—potentially including the Software-as-a-Medical-Device pathway—alongside HIPAA, the FTC, and standards such as ISO 13485. The guide's first practical counsel is for manufacturers to engage agencies early.

What regulators should build next

The guide names four changes: evaluation protocols attuned to quantum behaviors; risk-management frameworks that protect human subjects from quantum unpredictability; clinical-trial guidelines tailored to quantum devices; and interoperability standards. It then proposes a three-part architecture—ex-ante regulatory sandboxes for quantum-AI devices, ex-durante expert subcommittees, and an ex-post registration database—framed by ten guiding principles, from promoting quantum literacy to fostering institutional plasticity in bodies like the FDA and EMA. The throughline is a standards-first, anticipatory posture: prepare the institutions before the technology arrives, and balance innovation against patient safety rather than choosing between them.

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Law, Ethics and Policy of Quantum & AI in Healthcare and Life Sciences published at Harvard, Stanford and European Commission

A collaborative research initiative by scholars from Stanford, Harvard, and MIT, published by the Petrie-Flom Center at Harvard Law School, the Stanford Center for Responsible Quantum Technology, and the European Commission, delves into the complex regulatory and ethical landscape of integrating quantum technologies and artificial intelligence (AI) into the healthcare and life sciences sectors. This series of policy guides and analyses, authored by an interdisciplinary team including Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht, and I. Glenn Cohen, offers a comprehensive examination of the transformative potential and inherent challenges of this technological convergence.

Regulating Quantum & AI in Healthcare and Medicine: A Brief Policy Guide

This body of research, examining the entangled legal, ethical, and policy dimensions of integrating quantum technologies and AI into healthcare, is articulated across a series of publications in leading academic and policy forums. These works collaboratively build a comprehensive framework for understanding and navigating the future of medicine. A related policy guide was also published on the European Commission's Futurium platform, further disseminating these findings to a key international policymaking audience. The specific publications include:

1. A Brief Quantum Medicine Policy Guidehttps://blog.petrieflom.law.harvard.edu/2024/12/06/a-brief-quantum-medicine-policy-guide/

2. How Quantum Technologies May Be Integrated Into Healthcare, What Regulators Should Considerhttps://law.stanford.edu/publications/how-quantum-technologies-may-be-integrated-into-healthcare-what-regulators-should-consider/

3. EU and US Regulatory Challenges Facing AI Health Care Innovator Firmshttps://blog.petrieflom.law.harvard.edu/2024/04/04/eu-and-us-regulatory-challenges-facing-ai-health-care-innovator-firms/

4. Regulating Quantum & AI in Healthcare: A Brief Policy Guidehttps://futurium.ec.europa.eu/en/european-ai-alliance/document/regulating-quantum-ai-healthcare-brief-policy-guide

by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht & I. Glenn Cohen

Forging the Future of Medicine: A Scholarly Perspective on the Law, Ethics, and Policy of Quantum and AI in Healthcare

The research posits that the fusion of AI with second-generation quantum technologies (2G QT)—which harness quantum-mechanical phenomena like superposition and entanglement—is poised to revolutionize precision medicine. This synergy of quantum computing, sensing and simulation with artificial intelligence promises hyper-personalized healthcare solutions, capable of tackling intricate medical problems that lie beyond the grasp of classical computing. The potential applications are vast, spanning from accelerated drug discovery and development workflows and enhanced diagnostic imaging to rapid genome sequencing and real-time health monitoring. For instance, quantum simulations could model molecular interactions to create more effective pharmaceuticals, while quantum dots may offer novel platforms for targeted cancer therapies and treatments for neurodegenerative conditions by overcoming the blood-brain barrier.

However, the authors caution that these groundbreaking advancements are accompanied by significant ethical, legal, socio-economic, and policy (ELSPI) implications. The emergence of Quantum Artificial Intelligence (QAI), Quantum Machine Learning (QML), and Quantum Large Language Models (QLLM) is expected to amplify these ELSPI concerns. The dual-use nature of these technologies, such as their potential application in gain-of-function research, necessitates a principled and human-centric governance approach.

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Academics, Artificial Intelligence, European Law, American Law, Stanford, Harvard, Medical Devices, Medicine, HealthcareMauritz Kop6 december 2024quantum, AI, healthcare, medicaldevices, law, ethics, policy, governance, regulation, medicine, EMA, FDA, Harvard, Stanford, Mauritz Kop

Stanford Center for Law and the Biosciences: BioLawLaPaLooZa 2023-2024

For those deeply engaged in the intricate intersections of law, life sciences, and ethics, Professor Hank Greely’s annual BioLawLaPaLooza at Stanford Law School stands as an intellectual cornerstone. It is a vibrant, informal, yet deeply substantive gathering that brings together leading scholars to test new ideas, debate emerging challenges, and build the collaborative bridges essential for navigating our complex technological future. As a speaker and the photographer for the 2023 and 2024 editions, Stanford Center for Responsible Quantum Technologie Founder Mauritz Kop had the distinct pleasure of documenting and participating in these vital conversations. This post offers a reflection on and tribute to these remarkable events, which serve as a testament to the foresight and community-building spirit of Stanford’s Center for Law and the Biosciences.

The Center for Law and the Biosciences (CLB): A Foundation for Interdisciplinary Dialogue

Before delving into the events themselves, it is essential to understand the institution that makes them possible. The Stanford Center for Law and the Biosciences (CLB), under the direction of Hank Greely, has long been a preeminent academic hub for exploring the legal and ethical quandaries posed by advances in the life sciences. Alongside the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard University, directed by Professor I. Glenn Cohen, the CLB stands as one of the world's leading institutions in this domain. The Center's mission is to foster interdisciplinary research, educate the next generation of leaders in law and science, and inform public policy on topics ranging from genetics and neuroscience to reproductive technologies and AI in healthcare.

The CLB's history is marked by influential scholarship, a distinguished roster of fellows and faculty, and a commitment to public engagement. Its fellowship program has proven to be a successful launchpad, with former fellows frequently securing positions as professors and becoming influential scholars in their own right. Its publications consistently shape academic discourse and provide critical guidance to policymakers. BioLawLaPaLooza is the embodiment of the Center’s mission, creating an environment where complex ideas can be presented and scrutinized in a collegial, fast-paced format. The event’s structure—short, sharp presentations followed by engaged discussion—ensures a breadth and depth of intellectual exchange that is both rare and invaluable.

The Journal of Law and the Biosciences: A Premier Scholarly Venue

Further extending the intellectual ecosystem of which the CLB is a part is the Journal of Law and the Biosciences (JLB). As the first peer-reviewed academic journal focused on the intersection of law and the life sciences, JLB serves as the premier venue for scholarship in this field. It is a co-publication of Duke University, Harvard University Law School, and Stanford University, published by Oxford University Press. The journal's leadership reflects the collaborative and interdisciplinary spirit of the field, with Editors-in-Chief Professor Nita Farahany (Duke), Professor I. Glenn Cohen (Harvard), and Professor Hank Greely (Stanford). Many of the scholars who present their nascent ideas at BioLawLaPaLooza are also contributors to and readers of the journal, highlighting the symbiotic relationship between the conference and the formal academic literature. https://academic.oup.com/jlb

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Harvard Petrie-Flom publishes EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Harvard Law School's Petrie-Flom Center has published EU and US Regulatory Challenges Facing AI Health Care Innovator Firms on its Bill of Health blog—an op-ed co-written by lead author Suzan Slijpen, Mauritz Kop (Founder of the Stanford Center for Responsible Quantum Technology), and senior author I. Glenn Cohen, who directs the Center. It examines why firms building artificial intelligence for medicine face such a tangled compliance map, and what a better one might look like.

Two regulatory philosophies, one transatlantic market

The piece sets Europe's cross-sectoral instinct against America's sectoral one. An AI medical product entering the EU must answer to the Medical Device Regulation, the GDPR, and a sweeping digital rulebook that now includes the EU AI Act and the coming European Health Data Space. In the United States, by contrast, coverage is patchy by design: HIPAA reaches only certain entities and data, and the FDA regulates medical AI only where it fits an existing category. Each model has genuine merits and genuine blind spots, and a firm selling on both shores must satisfy both at once.

Where the law strains hardest

The authors are clearest on the cases that resist tidy rules. Adaptive algorithms that keep learning after deployment make it hard to say when a model has changed enough to need fresh review—an area where the FDA's 2023 predetermined-change-control guidance points a constructive way forward. Generative AI overtook the EU AI Act mid-negotiation, unsettling how foundation models are treated under a rulebook drafted before they arrived. And at the material frontier sit quantum- and AI-driven devices, with their export controls, fragile supply chains, dual-use questions, and intellectual-property and security concerns—the bridge from this op-ed to Kop's broader work on the quantum technology governance frontier. The lesson the authors draw is procedural as much as substantive: regulators must understand the tempo of the technology they govern, or risk writing rules that are obsolete before they bind.

Toward a workable middle ground

Rather than crowning a winner, the authors propose a mixed horizontal-vertical approach: keep the precautionary care for patient safety, keep the permissionless capacity to innovate, and tailor the result to the economic realities of health care—from clinical-trial costs to market licenses. Regulation that is sensible, practical, and sector-specific, they argue, serves innovators and patients alike; anything less is rendered ineffective fast. Readers tracking Kop's longer arc on responsible technology can also follow his AIRecht scholar profile, where the through-line from AI in medicine to the law and ethics of the quantum age is laid out across a decade of work.

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Quantum Trials: An FDA for Quantum Technology

What if the United States regulated emerging quantum technology the way it regulates new medicines? That is the provocation at the center of Quantum Trials: An FDA for Quantum Technology, a Stanford Law School working paper by Alexandra Waldherr, I. Glenn Cohen, and Mauritz Kop, posted as a preprint and first presented at the 2023 Stanford Responsible Quantum Technology Conference. The paper proposes a phased, documentation-driven pipeline for second-generation quantum technology, modeled on the FDA's clinical-trials regime.

A phased pipeline for quantum

The framework maps the FDA's four stages onto quantum research and development. Phase I captures a theoretical idea or laboratory proof-of-concept in a concise technical one-pager; Phase II adds a proof-of-principle validation with an ethical checklist; Phase III is a confirmatory stage whose findings are condensed into a Summary of Quantum Characteristics for regulatory assessment; and Phase IV follows the authorized technology through its public lifecycle, with failure reports and audits. Throughout, "efficacy" is reread as technical innovation and "safety" as the absence of unresolved ethical and legal concerns. A binding registry ties the phases together, serving regulators, engineers, educators, and the public from one shared record.

SEA TURTLE and the registry-first first step

Over the phases sits the SEA TURTLE checklist—a six-point barometer distilling the Ten Principles for Responsible Quantum Innovation and the broader Responsible Quantum Technology paradigm into a quick test of whether a technology is both innovative and responsibly developed. Its "SEA" element names a commitment to Safeguarding, Engaging, and Advancing quantum technology, society, and humankind. The authors are realistic about the political capital a full "FDA for Quantum" would demand, so they single out one immediate, low-cost step: making the registration of quantum developments mandatory by law, in the spirit of the legislation that produced clinicaltrials.gov. A standardized registry, they argue, gives regulators the evidence they need to balance underregulation against overregulation.

Why the analogy matters for governance

The deeper argument is structural. A young, dual-use, exponentially developing field is better served by an evidence-generating, phased pipeline than by either premature prohibition or laissez-faire. The same logic animates the authors' work on law, ethics, and policy of quantum and AI in healthcare and the ethics of biomedical discovery in Hippocratic Quantum. The paper does not claim the drug-approval analogy is settled; it invites the physics community to test its feasibility and the legislative branch to adopt, evaluate, and refine it. As an opening move in the design of quantum-specific regulatory institutions, it is less a verdict than a carefully argued invitation.

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Quantum Technology, Healthcare, ReguleringHenry Quentir12 maart 2024Mauritz Kop, Quantum Technology, Quantum Governance, Regulation, Policy, Healthcare, Ethics, Stanford RQT, I. Glenn Cohen, Quantum Trials, FDA, Clinical Trials, SEA TURTLE, Medical Devices, Alexandra Waldherr

Mauritz Kop Fellow at Inter-CeBIL Harvard Cambridge Copenhagen

Harvard-Cambridge-Copenhagen, Sept 15, 2023 — Mauritz Kop has accepted a position as an Inter-CeBIL Fellow at the prestigious Novo Nordisk Foundation Copenhagen-Cambridge-Harvard Inter-CeBIL Programme for International Collaborative Bioscience Innovation & Law. In this role, Kop will focus his research on Advanced Medical Computing, Artificial Intelligence (AI) and Quantum Technologies within the life sciences ecosystem.

About the Inter-CeBIL Programme

The Inter-CeBIL Programme is a world-leading research hub dedicated to identifying and tackling the most significant legal and regulatory barriers to health and life science innovation. The initiative fosters robust knowledge networks to provide tailored legal and regulatory support to patients, researchers, businesses, and incubators, with the ultimate goal of ensuring that health and life science innovations can safely and effectively reach patients and markets.

This international collaboration brings together top-tier academic institutions to drive progress in healthcare and biotechnology. The program is a joint effort between the Centre for Advanced Studies in Bioscience Innovation Law (CeBIL) at the University of Copenhagen, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the University of Cambridge, among other key partners. The program is led by a distinguished team, including Professor Timo Minssen as the Founding Director of CeBIL at the University of Copenhagen, Professor I. Glenn Cohen who leads Harvard Law School’s contribution, and Professor Mateo Aboy who leads the Cambridge part.

Key Research Areas

The Inter-CeBIL Programme centers its research on three key "grand challenges":

1. Advanced Medical Computing: Focusing on Artificial Intelligence (AI) and Quantum Technologies (QT).

2. Pandemic Preparedness & Anti-Microbial Resistance (AMR).

3. Sustainable Innovation & Biosolutions: Encompassing eco-systems, drug R&D, drug regulation, and data infrastructures.

Focus on Key Area 1: Advanced Medical Computing, AI & Quantum Technology

This key research area addresses the increasingly critical role of advanced computing in the life sciences and medical sectors. Algorithms are becoming fundamental building blocks in a wide range of medical devices, digital health technologies (DHTs), and drug discovery tools (DDTs). The use of advanced computing, including AI/ML and quantum computing (QC), holds immense potential benefits for the life sciences, drug discovery, and medical sectors. These advancements also raise significant legal, ethical, governance, and regulatory issues that the program aims to address.

In his capacity as an Inter-CeBIL Fellow, Mauritz Kop will contribute his deep expertise in quantum-AI, its governance, and its legal-ethical implications to this key research area, helping to navigate the complex challenges and opportunities presented by these cutting-edge technologies.

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Safeguards for accelerated market authorization of vaccines in Europe

by Suzan Slijpen & Mauritz Kop

This article has been published by the Stanford Law School ‘Center for Law and the Biosciences’, Stanford University, 15 March 2021. link to the full text: https://law.stanford.edu/2021/03/15/safeguards-for-accelerated-market-authorization-of-vaccines-in-europe/

Download the article here: Slijpen_Kop_Manufacturing Licenses and Market Authorization Vaccines EU-Stanford Law

The first COVID-19 vaccines have been approved

People around the globe are concerned about safety issues encircling the accelerated introduction of corona vaccines. In this article, we discuss the regulatory safeguards for fast-track market authorization of vaccines in Europe. In addition, we explain how the transmission of European Union law into national Member State legislation works. We then clarify what happens before a drug can be introduced into the European market. We conclude that governments should build bridges of mutual understanding between communities and increase trust in the safety of authorized vaccines across all population groups, using the right messengers.

Drug development normally takes several years

Drug development normally takes several years. The fact that it has been a few months now seems ridiculously short. How is the quality and integrity of the vaccine ensured? That people - on both sides of the Atlantic - are concerned about this is entirely understandable. How does one prevent citizens from being harmed by vaccines and medicines that do not work for everyone, because the admission procedures have been simplified too much?

The purpose of this article is to shed a little light upon the accelerated market authorization procedures on the European continent, with a focus on the situation in the Netherlands.

How a vaccine is introduced into the market

In June 2020, the Dutch government, in close cooperation with Germany, France and Italy, formed a Joint Negotiation Team which, under the watchful eye of the European Commission, has been negotiating with vaccine developers. Its objective: to conclude agreements with drug manufacturers at an early stage about the availability of vaccines for European countries. In case these manufacturers are to succeed in developing a successful vaccine for which the so-called Market Authorization (MA) is granted by EMA or CBG, this could lead to the availability of about 50 million vaccines (for the Netherlands alone).

Who is allowed to produce these vaccines?

Who is allowed to produce these vaccines? The Dutch Medicines Act is very clear about this. Only "market authorization holders" are allowed to manufacture medicines, including vaccines. These are parties that have gone through an extensive application procedure, who demonstrably have a solid pharmaceutical quality management system in place and have obtained a pharmaceutical manufacturing license (the MIA, short for Manufacturing and Importation Authorisation). This license is granted after assessment by the Health and Youth Care Inspectorate of the Ministry of Health, Welfare & Sport (IGJ) – by Farmatec. Farmatec is part of the CIBG, an implementing body of the Ministry of Health, Welfare and Sport (VWS). The M-license is mandatory for parties who prepare, or import medicines.

Masterclass 'Juridische Aspecten van AI & Data’

De 2,5 uur durende masterclass 'Juridische Aspecten van AI & Data' bij TNO verschafte de cursisten duidelijkheid over de regels voor data delen, privacy en gegevensbescherming, alsmede juridisch en economisch eigendom van informatie. We behandelden onderwerpen variërend van de bescherming van intellectueel eigendom op het AI-systeem, de software, hardware en apps, clearance van data tot het anticiperen op de aanstaande AI & Data Governance wetten van de Europese Commissie.

Multidisciplinair Panel voor Verantwoord Data Delen

Dezelfde middag vond er vanuit het TNO gebouw een online seminar plaats speciaal voor startups, onder leiding van Anita Lieverdink, Senior Orchestrator of Innovation at TNO, Directeur van TekDelta en Program Manager van de Werkgroep Startps & Scaleups van de Nederlandse AI Coalitie.

AIRecht managing partner Mr. Kop nam als juridisch expert deel in het panel dat ging over verantwoord data delen. Het was goed om deel te nemen aan dit multidisciplinaire panel en samen met onze collega's oplossingen te verkennen voor het versneld en verantwoord delen van gegevens. Het is cruciaal en urgent om belemmeringen voor de inzet van benevolente AI weg te nemen en organisaties begeleiding te bieden die rechtszekerheid en vertrouwen in de snelle introductie van deze veelbelovende transformatieve technologie aanmoedigt!

Juridische Cursussen van AIRecht

Onze cursussen ‘AI en Recht – Juridische aspecten van AI, Machine Learning en Data’ bieden een compleet overzicht van de juridische facetten van kunstmatige intelligentie, big (structured/labelled en unstructured, raw) data en de verschillende typen machine learning (supervised, unsupervised, deep reinforcement, transfer, federated). De invalshoek is breed: van beschermen idee tot en met marktintroductie van het product. Cursusdoel is het wegnemen van juridische obstakels voor innovatie. Onderwerpen die hierbij aan de orde komen zijn privacywetgeving, het maximaliseren van uw IP-portfolio (intellectueel eigendom), normering, standaardisering (interoperabiliteit) en certificering (CE mark, keurmerken, conformiteit), het stimuleren van internationaal zakendoen, en het realiseren van (training)data delen op basis van EU regelgeving, licenties, toestemmingen en rechtsgeldige contracten. Maatwerk is mogelijk.

De workshops en masterclasses zijn cross-disciplinair en verbinden de ontwikkeling en toepassing van technologie met geldend nationaal en EU recht.

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Dit zijn de waarborgen bij de versnelde marktintroductie van vaccins

Deze column is gepubliceerd op platform VerderDenken.nl van het Centrum voor Postacademisch Juridisch Onderwijs (CPO) van de Radboud Universiteit Nijmegen. https://www.ru.nl/cpo/verderdenken/columns/waarborgen-versnelde-marktintroductie-vaccins/

De eerste COVID-19 vaccins zijn in zicht

Veel mensen maken zich zorgen over de versnelde introductie van coronavaccins. "Begrijpelijke vragen, begrijpelijke zorgen. Gelukkig is de werkelijkheid een stuk genuanceerder", zegt jurist Suzan Slijpen. In dit artikel gaat zij in op de waarborgen bij de versnelde marktintroductie van vaccins.

De eerste COVID-19 vaccins zijn in zicht. Met effectiviteitsmarges van waarschijnlijk 55% tot 95% gloort er eindelijk licht aan de horizon. Het RIVM bereidt de vaccinatiestrategie alvast voor, zodat er snel geschakeld kan worden als het moment daar is.

Het ontwikkelen van geneesmiddelen duurt normaal enkele jaren

Het ontwikkelen van geneesmiddelen duurt normaal enkele jaren. Dat er nu sprake is van enkele maanden lijkt absurd kort. Hoe zorgt men ervoor dat deze middelen veilig zijn? Dat mensen - aan beide kanten van de Atlantische Oceaan - zich hier zorgen over maken is geheel terecht. Hoe voorkom je dat burgers schade oplopen doordat de vaccins en medicijnen toch niet voor iedereen blijken te werken, omdat de toelatingsprocedures te veel zijn versoepeld?

Hoe een vaccin op de markt wordt gebracht

De Nederlandse regering heeft in nauwe samenwerking met Duitsland, Frankrijk en Italië een Joint Negotiation Team gevormd dat onder leiding van de Europese Commissie onderhandelt met vaccinontwikkelaars. Doel: in een vroeg stadium met producenten afspraken maken over de beschikbaarheid van vaccins voor de Europese landen. Als deze producenten erin slagen om een succesvol vaccin te ontwikkelen waarvoor de zogenaamde Market Authorization (MA) wordt verleend door EMA danwel CBG, zou dat tot een beschikbaarheid van zo’n 50 miljoen vaccins (enkel en alleen al voor Nederland) kunnen leiden.

Wie mogen deze vaccins produceren?

Wie mogen deze vaccins produceren? De Geneesmiddelenwet is er heel duidelijk over. Alleen ‘vergunninghouders’ mogen geneesmiddelen, waaronder vaccins, produceren. Dit zijn marktpartijen die een uitvoerige aanvraagprocedure hebben doorlopen, aantoonbaar beschikken over een gedegen farmaceutisch kwaliteitsmanagement systeem en die - na toetsing door de Inspectie voor de Gezondheidszorg (IGJ) - een zogenaamde F-vergunning (fabrikantenvergunning) hebben verkregen van Farmatec. Farmatec is onderdeel van het CIBG, een uitvoeringsorgaan van het ministerie van Volksgezondheid, Welzijn en Sport (VWS). De F-vergunning is verplicht voor partijen die geneesmiddelen bereiden, doen bereiden of invoeren.

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