Corporate, Commercial & Regulatory

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Van Bael & Bellis advises multinational clients on corporate, commercial and regulatory issues in the EU and Belgium.

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Recent publications

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    • 18/01/2021
    • Articles

    Belgium – Publication of Law on Medical Devices

    The Belgian Official Journal publishes today (i.e., 18 January 2021) the Law of 22 December 2020 on medical devices (Wet van 22 december 2020 betreffende medische hulpmiddelen / Loi du 22 décembre 2020 relative aux dispositifs médicaux – the Law). The Law implements in Belgium (i) Regulation (EU) 2017/745 of 5 April 2017 on medical devices (the MDR); and (ii) chapter IV of Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices, i.e., the chapter on notified bodies. Following its adoption by the federal Chamber of Representatives’ Committee for Public Health and Equal Opportunities on 8 December 2020, the Law was adopted in plenary session on 17 December 2020. The adopted text is identical to that of the Bill which the federal Government submitted to the Chamber of Representatives on 29 September 2020. For a discussion of the Law, we refer to our news alert of 3 December 2020 (see, Van Bael & Bellis Life Sciences News Alert of 3 December 2020). Subject to exceptions, the Law will enter into force on 26 May 2021, i.e., on the currently scheduled date of entry into force of the MDR.

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    • 08/01/2021
    • Articles

    German Government prohibits Chinese acquisition under foreign direct investment rules

    On 2 December 2020, the German Government prohibited on public security grounds the sale of the German Institut für Mobil- und Satellitenfunktechnik (“IMST”), a specialist in satellite and communications technologies, to Addsino, a subsidiary of State-owned defence group China Aerospace Science and Industry Corp (“CASIC”). This is only the second time that the German Government has decided to prohibit a transaction on the basis of the Foreign Trade and Payments Ordinance, and is technically the first prohibition to take effect as the first transaction had been abandoned once it became clear that the prohibition was imminent.

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    • 06/01/2021
    • Articles

    Covid-19 Vaccine Moderna® Is Second Covid-19 Vaccine Recommended by European Medicines Agency for Use in European Union

    The European Medicines Agency (EMA) issued today its recommendation that the European Commission (the Commission) should grant a conditional marketing authorisation for the vaccine Covid-19 Vaccine Moderna®, a medicine developed by Moderna which will be indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older (see, attached press release). The Commission is expected to give its approval shortly, possibly still today, paving the way for an expansion of existing vaccination programmes in the European Union. The recommendation follows a similar recommendation given on 21 December 2020 for Comirnaty®, a vaccine developed by BioNTech and Pfizer (see, Van Bael & Bellis Life Sciences News Alert of 21 December 2020). As is the case for Comirnaty®, Covid-19 Vaccine Moderna® contains a molecule called messenger ribonucleic acid (mRNA) which harbours instructions for making the spike protein which is characteristic of the SARS-CoV-2 virus and allows the virus to enter the human body’s cells. The vaccine thus causes the recipient’s body to recognise and produce the spike protein temporarily which, in turn, will activate the person’s immune system and cause it to produce antibodies and activate white blood cells to attack it. The person’s immune system is thus readied for an attack with the genuine SARS-CoV-2 virus and defend the body against it. The EMA made its recommendation on the basis of placebo-controlled clinical trial data involving 30,000 people. Efficacy was calculated in around 28,000 persons and showed a significant 94.1% reduction in the number of symptomatic Covid-19 cases in persons who were given the vaccine compared with persons from the control group who received a dummy injection. These strong results applied irrespective of pre-existing risk-enhancing conditions such as chronic lung disease, heart disease or diabetes and regardless of age (18 and up), gender, race or ethnicity. The marketing authorisation awarded to Covid-19 Vaccine Moderna® will be conditional in that the marketing authorisation holder will be required to continue providing results from the ongoing main trial which is scheduled to last two years. Additional trials will seek to gain fresh information regarding the length of protection afforded, the level of protection created against severe Covid-19 infections and the degree of protection established for the benefit of specific groups, including immunocompromised patients, children, and pregnant women. Further research will also focus on the vaccine’s ability to prevent asymptomatic cases. Other checks will result from the application of the EU’s safety monitoring plan for Covid-19 vaccines and from the risk management plan for Covid-19 Vaccine Moderna®.

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