Quantum Technology Impact Assessment (EU AI Alliance, European Commission)

Brussels, 20 April 2023—The emergence of powerful new capabilities in large AI models, such as Generative Adversarial Networks (GANs), underscores the critical need to continuously improve and update technology impact assessment tools, ensuring they keep pace with rapid technological development. As defined in recent scholarship, technology impact assessment is the systematic process of monitoring and determining the unintended, indirect, or delayed societal impacts of a future technological innovation. Crucially, it is also about capitalizing on opportunities and enabling responsible innovation from the outset.

An article by Stanford Law’s Mauritz Kop on this topic is also featured on the European Commission's Futurium website.

Shaping the Quantum Innovation Process

Quantum Impact Assessments (QIAs) are emerging as vital practical tools to facilitate the responsible adoption of quantum technologies. There are several related approaches to this assessment: (1) interactive QIA, which seeks to influence and shape the innovation process; (2) constructive QIA, where social issues guide the design of the technology from its earliest stages; and (3) real-time QIA, which connects scientific R&D with social sciences and policy from the start, before a technology becomes locked-in.

Often taking the form of codes of conduct, best practices, roadmaps, and physics de-risking tools, QIA instruments can be used by governments, industry, and academia. These soft law toolsallow stakeholders to explore how current technological developments affect the world we live in and to proactively shape the innovation process toward beneficial, societally robust outcomes.

Exploratory Quantum Technology Assessment

Implementing interdisciplinary, expert-based QIAs can help raise awareness about the ethical, legal, socio-economic, and policy (ELSPI) dimensions of quantum technology, including quantum-classical hybrid systems. For instance, QIAs cultivate a deeper understanding of the potential dual-use character of quantum technology, where beneficial applications (such as quantum sensing for medical diagnostics) can exist alongside potentially harmful ones (such as the same sensors being used for autocratic surveillance).

Building on the foundational work of the 2018 AI Impact Assessment developed by ECP | Platform voor de InformatieSamenleving chaired by Prof. Kees Stuurman, this work presents a prototype of a QIA instrument: the Exploratory Quantum Technology Assessment (EQTA). This pioneering initiative was made possible through a collaboration between the Dutch Ministry of Economic Affairs & Climate Policy, Quantum Delta NL (QDNL), and ECP. The EQTA will be presented by Eline de Jong and Mauritz Kop at the inaugural Stanford Responsible Quantum Technology Conference in May 2023.

Guidance for Responsible Quantum Technology Implementation

The EQTA provides a comprehensive, practical step-by-step plan that encourages stakeholders to initiate a dialogue to clarify which ethical, legal, and social aspects are important in the creation and application of quantum systems and their interaction with classical technologies. This structured approach helps make the use of quantum technology—as well as the data and algorithms that power it—more transparent and accountable from an early stage.

Looking forward, establishing a risk-based legal-ethical framework in combination with standardization, certification, technology impact assessment, and life-cycle auditing of quantum-driven systems is crucial to stewarding society towards responsible quantum innovation. Mauritz Kop’s research group has written more on this framework in their seminal article Towards Responsible Quantum Technology (Harvard).

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Mauritz Kop Consults Senator Mark Warner on AI & Quantum Technology Policy

Washington D.C., January 4, 2022—As the United States Congress grapples with the complex challenges of regulating artificial intelligence and quantum technology, leading policymakers are seeking expert guidance to inform a robust and forward-thinking national strategy. On January 4, 2022, Mauritz Kop, a distinguished scholar in the field of technology law and governance, was consulted by the legal team of U.S. Senator Mark Warner (D-VA) to provide strategic insights on both AI and quantum technology policy.

This consultation highlights the growing recognition in Washington of the need for deep, interdisciplinary expertise to navigate the geopolitical, economic, and security dimensions of these transformative technologies. Senator Warner's team reached out to Kop based on his influential scholarship, including his extensive work at Stanford on the EU AI Act and the need for a strategic democratic tech alliance, his advisory role for the European Commission led by Ursula von der Leyen on the AI Act and Data Act, and his foundational article in the Yale Journal of Law & Technology proposing a comprehensive legal-ethical framework for quantum technology.

Senator Mark Warner: A Leader on Technology and National Security

Senator Mark Warner's engagement on these issues is both significant and timely. As the Chairman of the Senate Select Committee on Intelligence, he is at the forefront of addressing the national security implications of emerging technologies. His work involves overseeing the U.S. Intelligence Community and ensuring it is equipped to handle the threats and opportunities of the 21st century, where technological competition with nations like China is a central concern.

The Senate Select Committee on Intelligence has a broad mandate that includes analyzing intelligence on the technological capabilities of foreign powers and assessing the vulnerabilities of U.S. critical infrastructure. Senator Warner has been a vocal proponent of developing a national strategy for AI and quantum to maintain the United States' competitive edge and to ensure that these technologies are developed and deployed in a manner consistent with democratic values. This consultation with Mauritz Kop reflects the Senator's commitment to drawing on leading academic research to shape sound, bipartisan policy.

AI Policy: A Transatlantic, Risk-Based Approach that Lets Innovation Breathe

A key focus of the consultation was Kop's analysis of the European Union's AI Act. His Stanford publications argue for a balanced, pro-innovation regulatory model that can serve as a blueprint for international cooperation. Good governance and sensible legislation should incentivize desired behavior and simultaneously create breathing room for sustainable, beneficial innovation to flourish.

Quantum Governance: Establishing a Legal-Ethical Framework

The discussion also delved into the governance of quantum technology, drawing on Kop's seminal work in the Yale Journal of Law & Technology. Recognizing that quantum is rapidly moving from the theoretical to the practical, he stressed the urgency of establishing a legal-ethical framework before the technology is widely deployed and locked-in.

The consultation with Senator Warner's office represents a critical intersection of academic scholarship and high-level policymaking. As the United States charts its course in the era of AI and quantum, the insights provided by experts like Mauritz Kop are invaluable in ensuring that the nation's strategy is not only competitive but also responsible, ethical, and firmly rooted in democratic principles.

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Beyond IP Innovation Law: The Bigger Picture

Intellectual property is a powerful driver of innovation—but it is not the only one. In Beyond IP Innovation Law: The Bigger Picture, posted as a preprint and forthcoming in the European Media, IP & IT Law Review (MR-Int), Mauritz Kop argues that a serious innovation policy for the Fourth Industrial Revolution must reach past exclusive rights toward a fuller toolkit: prizes, grants, antitrust, commons-based production, open innovation, and a vital public domain.

Sustainable innovation law beyond IP

The essay frames "sustainable innovation law" as the interface between creativity, technology, society, and law—combining information law, antitrust, consumer protection, and fundamental rights with AI, machine learning, big data, quantum computing, CRISPR-Cas9, and virtual reality. Its test is normative: innovation counts as sustainable only when it is ethical and social, economically beneficial, conducive to well-being, and supportive of the environment. Once IP loses its monopoly on the policy imagination, a longer menu of incentive mechanisms—competitions, subsidies, tort law, market regulation, R&D tax incentives—comes into view, and choosing among them becomes the real task of the lawmaker.

Why AI can do without IP incentives

Applied to artificial intelligence, the argument is pointed: the classical justifications for IP are weak when applied to AI, and AI "can do without IP incentives," with narrow exceptions such as a medical AI system whose costly clinical trials might warrant patents or, equally, public subsidy. Human authorship and inventorship remain the normative anchor, and machine output that crosses an "autonomy threshold" should fall into the public domain under a model Kop calls Res Publicae ex Machina. The essay also presses for broad text-and-data-mining freedom—even an articulated right to process data for machine learning—so that training datasets, a prerequisite for supervised learning, do not become an IP chokepoint. This complements his theoretical and empirical work on quantum computing and intellectual property law.

A horizontal-vertical innovation architecture

Because incentives and risks vary by sector and by technology, the paper proposes a horizontal-vertical design: horizontal core rules for all 4IR technologies, plus vertical, risk-based regimes organized around a "pyramid of criticality" from low risk at the base to existential risk at the top. The calibration is physics-aware—an open posture may suit AI, while quantum technology warrants more ab initio control given its potential anthropogenic risks, a precautionary tilt Kop develops further in his work on ethics in the quantum age. Written against the European Commission's April 2021 draft AI Regulation, the essay reads that proposal as a "North Star" and urges that safety norms, interoperability standards, and the Trustworthy AI doctrine be embedded directly into the design of technology, monitored through life-cycle impact assessments. The bigger picture, in short, is an innovation law built for purpose—not the reflexive extension of twentieth-century IP.

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Quantum Computing and Intellectual Property Law

Berkeley Technology Law Journal, Vol. 35, No. 3, 2021

New Stanford University Beyond IP Innovation Law research article: “Quantum Computing and Intellectual Property Law”.

By Mauritz Kop

Citation: Kop, Mauritz, Quantum Computing and Intellectual Property Law (April 8, 2021). Berkeley Technology Law Journal 2021, Vol. 35, No. 3, pp 101-115, February 8, 2022, https://btlj.org/2022/02/quantum-computing-and-intellectual-property-law/

Download the article here: Kop_QC and IP Law BTLJ

Please find a short abstract below:

Intellectual property (IP) rights & the Quantum Computer

What types of intellectual property (IP) rights can be vested in the components of a scalable quantum computer? Are there sufficient market-set innovation incentives for the development and dissemination of quantum software and hardware structures? Or is there a need for open source ecosystems, enrichment of the public domain and even democratization of quantum technology? The article explores possible answers to these tantalizing questions.

IP overprotection leads to exclusive exploitation rights for first movers

The article demonstrates that strategically using a mixture of IP rights to maximize the value of the IP portfolio of the quantum computer’s owner, potentially leads to IP protection in perpetuity. Overlapping IP protection regimes can result in unlimited duration of global exclusive exploitation rights for first movers, being a handful of universities and large corporations. The ensuing IP overprotection in the field of quantum computing leads to an unwanted concentration of market power. Overprotection of information causes market barriers and hinders both healthy competition and industry-specific innovation. In this particular case it slows down progress in an important application area of quantum technology, namely quantum computing.

Fair competition and antitrust laws for quantum technology

In general, our current IP framework is not written with quantum technology in mind. IP should be an exception -limited in time and scope- to the rule that information goods can be used for the common good without restraint. IP law cannot incentivize creation, prevent market failure, fix winner-takes-all effects, eliminate free riding and prohibit predatory market behavior at the same time. To encourage fair competition and correct market skewness, antitrust law is the instrument of choice.

Towards an innovation architecture that mixes freedom and control

The article proposes a solution tailored to the exponential pace of innovation in The Quantum Age, by introducing shorter IP protection durations of 3 to 10 years for Quantum and AI infused creations and inventions. These shorter terms could be made applicable to both the software and the hardware side of things. Clarity about the recommended limited durations of exclusive rights -in combination with compulsory licenses or fixed prized statutory licenses- encourages legal certainty, knowledge dissemination and follow on innovation within the quantum domain. In this light, policy makers should build an innovation architecture that mixes freedom (e.g. access, public domain) and control (e.g. incentive & reward mechanisms).

Creating a thriving global quantum ecosystem

The article concludes that anticipating spectacular advancements in quantum technology, the time is now ripe for governments, research institutions and the markets to prepare regulatory and IP strategies that strike the right balance between safeguarding our fundamental rights & freedoms, our democratic norms & standards, and pursued policy goals that include rapid technology transfer, the free flow of information and the creation of a thriving global quantum ecosystem, whilst encouraging healthy competition and incentivizing sustainable innovation.

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Democratic Countries Should Form a Strategic Tech Alliance

Stanford - Vienna Transatlantic Technology Law Forum, Transatlantic Antitrust and IPR Developments, Stanford University, Issue No. 1/2021

New Stanford innovation policy research: “Democratic Countries Should Form a Strategic Tech Alliance”.

Download the article here: Kop_Democratic Countries-Strategic Tech Alliance-Stanford Law

Exporting values into society through technology

China’s relentless advance in Artificial Intelligence (AI) and quantum computing has engendered a significant amount of anxiety about the future of America’s technological supremacy. The resulting debate centres around the impact of China’s digital rise on the economy, security, employment and the profitability of American companies. Absent in these predominantly economic disquiets is what should be a deeper, existential concern: What are the effects of authoritarian regimes exporting their values into our society through their technology? This essay will address this question by examining how democratic countries can, or should respond, and what you can do about it to influence the outcome.

Towards a global responsible technology governance framework

The essay argues that democratic countries should form a global, broadly scoped Strategic Tech Alliance, built on mutual economic interests and common moral, social and legal norms, technological interoperability standards, legal principles and constitutional values. An Alliance committed to safeguarding democratic norms, as enshrined in the Universal Declaration of Human Rights (UDHR) and the International Covenant on Civil and Political Rights (ICCPR). The US, the EU and its democratic allies should join forces with countries that share our digital DNA, institute fair reciprocal trading conditions, and establish a global responsible technology governance framework that actively pursues democratic freedoms, human rights and the rule of law.

Two dominant tech blocks with incompatible political systems

Currently, two dominant tech blocks exist that have incompatible political systems: the US and China. The competition for AI and quantum ascendancy is a battle between ideologies: liberal democracy mixed with free market capitalism versus authoritarianism blended with surveillance capitalism. Europe stands in the middle, championing a legal-ethical approach to tech governance.

Democratic, value-based Strategic Tech Alliance

The essay discusses political feasibility of cooperation along transatlantic lines, and examines arguments against the formation of a democratic, value-based Strategic Tech Alliance that will set global technology standards. Then, it weighs the described advantages of the establishment of an Alliance that aims to win the race for democratic technological supremacy against disadvantages, unintended consequences and the harms of doing nothing.

Democracy versus authoritarianism: sociocritical perspectives

Further, the essay attempts to approach the identified challenges in light of the ‘democracy versus authoritarianism’ discussion from other, sociocritical perspectives, and inquires whether we are democratic enough ourselves.

How Fourth Industrial Revolution (4IR) technology is shaping our lives

The essay maintains that technology is shaping our everyday lives, and that the way in which we design and utilize our technology is influencing nearly every aspect of the society we live in. Technology is never neutral. The essay describes that regulating emerging technology is an unending endeavour that follows the lifespan of the technology and its implementation. In addition, it debates how democratic countries should construct regulatory solutions that are tailored to the exponential pace of sustainable innovation in the Fourth Industrial Revolution (4IR).

Preventing authoritarianism from gaining ground

The essay concludes that to prevent authoritarianism from gaining ground, governments should do three things: (1) inaugurate a Strategic Tech Alliance, (2) set worldwide core rules, interoperability & conformity standards for key 4IR technologies such as AI, quantum and Virtual Reality (VR), and (3) actively embed our common democratic norms, principles and values into the architecture and infrastructure of our technology.

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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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Artificiële Intelligentie, Auteursrecht, AVG / GDPR, Bedrijfsrecht, Big data, Blockchain, Computer Vision, Data delen, Data processing, Deep Learning, eHealth, Entertainment en Kunst, Ethics, Ethiek, Europees recht, Farmaceutica, Grondrechten, Food Feed Agri, Healthcare, High Tech Industrie, Innovation, Informatierecht, Intellectual Property, Intellectueel Eigendom, Internationaal Zakendoen, Licenties, Machine Learning, Medical Devices, Ondernemingsrecht, Policy, Privacywetgeving, Productontwikkeling, Regulering, Standardization, Wetgeving, Workshops, Cursus, MasterclassMauritz Kop7 februari 2021AIRechtNL AIC, TNO, TekDelta, Startups & Scaleups, Kunstmatige Intelligentie, Juridisch, Workshop, Masterclass, Data delen, Expert panel, Europees recht, AI ecosysteem Nederland, Training Datasets, machine learning, JAVB Bedrijvendesk, AIRecht, Mauritz Kop, Stanford Law School, internationaal zakendoen, AVG, GDPR, Intellectueel Eigendom, Ethiek, Privacy, Trustworthy AI, AI Impact Assessment, Algoritmen, Aansprakelijkheid, Grondrechten, Data altruisme, legal sandboxes, Standaardisering, Certificering, CE Marking, Keurmerk, Conformiteit, Contractenrecht, Arbeidsrecht, Licenties, Cursus AI & Recht

Distributiecontracten, Online Verkoop en de Mededingingswet

Onze cliënten stellen ons regelmatig vragen over distributiecontracten, mededinging en online verkoop. Wat moet er eigenlijk allemaal in een distributieovereenkomst staan? Heb ik inkoopvoorwaarden nodig? Bestaat er zoiets als onbegrensde contractvrijheid? En hoe maak ik afspraken met mijn dealernetwerk, zonder dat consumentenrechten worden geschonden? Afspraken die eerlijke concurrentie en marktwerking eerbiedigen?

Wat moet er in een distributiecontract tussen producent en distributeur staan?

Fabrikant en dealer dienen juridisch valide afspraken te maken over de details van de distributie van producten. Die afspraken maken we schriftelijk, op papier dus, en leggen we neer in een distributieovereenkomst. De details zijn uiteraard afhankelijk van de branche, de industrie of de economische sector waarin producent, distributeur of wederverkoper werkzaam zijn, en van de omvang van hun marktaandeel. Ook is het van belang of verkoop aan de consument online in een webwinkel, of offline in een fysieke winkel plaatsvindt of beide.

Groothandel in consumentenelektronica, distributie en wederverkoop

Stel, een groothandel (danwel een fabrikant of producent) specialiseert zich in de verkoop van consumentenelektronica. Zij maakt daarbij gebruik van een distributieketen van door haar geselecteerde wederverkopers. Verkoop vindt plaats via de fysieke winkels van distributeurs, maar tevens online, via webshops. De groothandel is marktleider in het betreffende segment.

Contractvrijheid tussen partijen

Bij het maken van schriftelijke afspraken geldt het beginsel van contractvrijheid tussen partijen. Daarbij gaat het om de rechtsverhouding tussen partijen. Maar deze afspraken dienen natuurlijk ook fair te zijn richting derden, zoals consumenten en de concurrentie. Marktbederf dient te worden voorkomen. Indien er sprake is van een marktaandeel, of een de facto monopolie, dan kunnen voorschriften uit dwingende Europese en Nederlandse wetgeving inzake mededinging, zoals artikel 101 VWEU en artikel 6 van de Mededingingswet (Mw), in de weg staan aan deze contractvrijheid. Een en ander is echter afhankelijk van alle omstandigheden van het geval.

Wat doet de Autoriteit Consument en Markt (ACM)?

De Autoriteit Consument en Markt (ACM) ziet er op toe dat consumentenbelangen worden beschermd, en dat bedrijven op een eerlijke manier met elkaar concurreren. De ACM biedt informatie aan ondernemers over het verkopen van producten en diensten aan consumenten, en richtsnoeren over concurrentie, marktwerking en eerlijke samenwerking tussen bedrijven. Denk aan gedragsregels omtrent prijsafspraken, kartelvorming, concurrentie met overheden, fusies, overnames en joint ventures, maar ook aan regels voor samenwerking tussen ondernemers op het gebied van duurzame innovatie en maatschappelijk verantwoord ondernemen. De ACM heeft als missie om spelregels voor bedrijven en consumenten -waaronder ieders rechten en plichten- te geven en te handhaven op het gebied van concurrentie en marktwerking en als zodanig bij te dragen aan een gezonde economie.

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Bedrijfsrecht, Contractenrecht, Europees recht, Innovation, Intellectueel Eigendom, Internationaal Zakendoen, Juridisch Advies, Leveringsvoorwaarden, Ondernemingsrecht, MededingingMauritz Kop25 januari 2021AIRechtdistributiecontract, online verkoop, Mededingingswet, contractvrijheid, dealernetwerk, producent, fabrikant, importeur, consumentenrechten, eerlijke concurrentie, marktwerking, Autoriteit Consument en Markt (ACM), checklist distributieovereenkomst, software, consumentenelektronica, fysieke winkel, webshop, wederverkoop, prijserosie, free rider, distributieketen, marktaandeel, verkoopbeperkingen internet, verticale prijsbinding, kartelvorming, internationale mededingingsregels, Europese Commissie, WTO, OESO, unfair competition law, antitrust law, platformclausule, duurzame innovatie, handelspraktijken, jurist, rechten en plichten, economie, agentuurovereenkomst, principaal, handelsagent

Een Juridisch-Ethisch Kader voor Quantum Technologie

Een bewerkte versie van deze bijdrage 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/we-nederland-voorbereiden-kwantumtoekomst/

Nederland moet zich voorbereiden op de toepassing van kwantumtechnologie, zegt jurist en Stanford Law School Fellow Mauritz Kop. Op het gebied van regulering, intellectueel eigendom en ethiek is er nog veel werk aan de winkel.

De Quantum Age roept veel juridische vragen op

Het gedrag van de natuur op de kleinste schaal kan vreemd en contra-intuïtief zijn. Hoe kunnen beleidsmakers de toepassingsgebieden van kwantumtechnologie, zoals quantum computing, quantum sensing en het quantum internet op een maatschappelijk verantwoorde manier reguleren? Dienen ethische kwesties een rol te spelen in regulering? De Quantum Age roept veel juridische vragen op.

Hoe kunnen we kwantumtechnologie reguleren?

Regulering van transformatieve technologie is een dynamisch, cyclisch proces dat de levensduur van de technologie en de toepassing volgt. Het vraagt om een flexibel wetgevend systeem dat zich snel kan aanpassen aan veranderende omstandigheden en maatschappelijke behoeften.

De eerste regelgevende stap om te komen tot een bruikbaar juridisch-ethisch kader is het koppelen van de Trustworthy AI-principes aan kwantumtechnologie. Die vullen we vervolgens aan met horizontale, overkoepelende regels die recht doen aan de unieke natuurkundige eigenschappen van quantum. Aan deze horizontale kernregels voegt de wetgever tenslotte verticale, industrie- of sectorspecifieke voorschriften toe. Die verticale voorschriften en gedragscodes zijn risk-based en houden rekening met de uiteenlopende behoeftes van economische sectoren waar het duurzame innovatiestimuli betreft. Zo ontstaat een gedifferentieerde, sectorspecifieke benadering aangaande incentives en risks.

Bewustwording van ethische, juridische en sociale aspecten

Een belangrijk onderdeel van het synchroniseren van onze normen, waarden, standaarden en principes met kwantumtechnologie is het creëren van bewustwording van de ethische, juridische en sociale aspecten ervan. De architectuur van systemen die zijn uitgerust met kwantumtechnologie moet waarden vertegenwoordigen die wij als samenleving belangrijk vinden.

Vooruitlopend op spectaculaire doorbraken in de toepassing van kwantumtechnologie is de tijd nu rijp voor regeringen, onderzoeksinstellingen en de markt om regulatoire en intellectuele eigendomsstrategieën voor te bereiden die passen bij de power van de technologie.

Nederland moet zich voorbereiden op een kwantumtoekomst, want die komt eraan.

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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.

Meer lezen

Regulating Transformative Technology in The Quantum Age: Intellectual Property, Standardization & Sustainable Innovation

Stanford - Vienna Transatlantic Technology Law Forum, Transatlantic Antitrust and IPR Developments, Stanford University, Issue No. 2/2020

New Stanford cutting edge tech law research: “Regulating Transformative Technology in The Quantum Age: Intellectual Property, Standardization & Sustainable Innovation”.

Download the article here: Kop_Regulation Standardization Innovation Quantum Age-Stanford Law

Quantum technology has many legal aspects

The behavior of nature at the smallest scale can be strange and counterintuitive. In addition to unique physical characteristics, quantum technology has many legal aspects. In this article, we first explain what quantum technology entails. Next, we discuss implementation and areas of application, including quantum computing, quantum sensing and the quantum internet. Through an interdisciplinary lens, we then focus on intellectual property (IP), standardization, ethical, legal & social aspects (ELSA) as well as horizontal & industry-specific regulation of this transformative technology.

The Quantum Age raises many legal questions

The Quantum Age raises many legal questions. For example, which existing legislation applies to quantum technology? What types of IP rights can be vested in the components of a scalable quantum computer? Are there sufficient market-set innovation incentives for the development and dissemination of quantum software and hardware structures? Or is there a need for open source ecosystems, enrichment of the public domain and even democratization of quantum technology? Should we create global quantum safety, security and interoperability standards and make them mandatory in each area of application? In what way can quantum technology enhance artificial intelligence (AI) that is legal, ethical and technically robust?

Regulating quantum computing, quantum sensing & the quantum internet

How can policy makers realize these objectives and regulate quantum computing, quantum sensing and the quantum internet in a socially responsible manner? Regulation that addresses risks in a proportional manner, whilst optimizing the benefits of this cutting edge technology? Without hindering sustainable innovation, including the apportionment of rights, responsibilities and duties of care? What are the effects of standardization and certification on innovation, intellectual property, competition and market-entrance of quantum-startups?

The article explores possible answers to these tantalizing questions.

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Shaping the Law of AI: Transatlantic Perspectives

Stanford-Vienna Transatlantic Technology Law Forum, TTLF Working Papers No. 65, Stanford University (2020).

New Stanford innovation policy research: “Shaping the Law of AI: Transatlantic Perspectives”.

Download the article here: Kop_Shaping the Law of AI-Stanford Law

The race for AI dominance

The race for AI dominance is a competition in values, as much as a competition in technology. In light of global power shifts and altering geopolitical relations, it is indispensable for the EU and the U.S to build a transatlantic sustainable innovation ecosystem together, based on both strategic autonomy, mutual economic interests and shared democratic & constitutional values. Discussing available informed policy variations to achieve this ecosystem, will contribute to the establishment of an underlying unified innovation friendly regulatory framework for AI & data. In such a unified framework, the rights and freedoms we cherish, play a central role. Designing joint, flexible governance solutions that can deal with rapidly changing exponential innovation challenges, can assist in bringing back harmony, confidence, competitiveness and resilience to the various areas of the transatlantic markets.

25 AI & data regulatory recommendations

Currently, the European Commission (EC) is drafting its Law of AI. This article gives 25 AI & data regulatory recommendations to the EC, in response to its Inception Impact Assessment on the “Artificial intelligence – ethical and legal requirements” legislative proposal. In addition to a set of fundamental, overarching core AI rules, the article suggests a differentiated industry-specific approach regarding incentives and risks.

European AI legal-ethical framework

Lastly, the article explores how the upcoming European AI legal-ethical framework’s norms, standards, principles and values can be connected to the United States, from a transatlantic, comparative law perspective. When shaping the Law of AI, we should have a clear vision in our minds of the type of society we want, and the things we care so deeply about in the Information Age, at both sides of the Ocean.

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