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”.

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/

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.

Read more at the Stanford Center for Law and the Biosciences!

Read more on manufacturing licenses, fast track procedures and market authorization by the European Medicines Agency (EMA) and the EC, harmonisation and unification of EU law, CE-markings, antigenic testing kits, mutations, reinfection, multivalent vaccines, mucosal immunity, Good Manufacturing Practices (GMP), pharmacovigilance, the HERA Incubator, clinical trials, compulsory vaccination regimes and continuous quality control at Stanford!

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