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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Voeding en Genexpressie

De invloed van voedsel op onze genen

Voeding is een essentieel onderdeel van ons bestaan. Niet verwonderlijk dus dat we er dagelijks mee bezig zijn. In toenemende mate is er aandacht voor het terugdringen van overgewicht en de daar uit voortvloeiende gezondheidsrisico’s. In deze context wordt er grensverleggend onderzoek gedaan naar de exacte relatie tussen voeding en gezondheid.

Is het precieze effect van voedingsmiddelen en drinkwaar op een persoon bijvoorbeeld afhankelijk van diens genetisch materiaal, diens genen? En is voeding van invloed op onze genen? En lopen we straks allemaal met een personalized nutrition app met individueel dieetadvies in onze telefoon?

Juridische aspecten en relevante wetgeving

De uitkomsten van wetenschappelijk voedingsonderzoek zijn ook vanuit juridisch oogpunt interessant, nu dat potentieel zou kunnen leiden tot de ontwikkeling van ‘novel foods’ en een uitbreiding van het huidige behandelspectrum bij diverse stofwisselingsaandoeningen. Daarbij kan ook gedacht worden aan de ontwikkeling van analytische tools en medical devices die het mogelijk maken om onderzoek uit te voeren en behandelingen te optimaliseren. In al die gevallen is het zaak om goed op de hoogte te zijn van relevante Europese wet- en regelgeving, de Warenwet of de Wet op de Geneeskundige behandelingsovereenkomst.

Voedingswetenschapper dr. Inge van Bussel geeft in onderstaand kennisartikel een zeer interessante inkijk in de wereld van voeding en genexpressie.