News & Insights

  • 01/09/2020
  • News

Van Bael & Bellis opens London office

We are delighted to announce that Van Bael & Bellis has opened its London office today after receiving regulatory approval from the Solicitors Regulation Authority of England and Wales. Our new office focuses on international trade and customs law, UK and EU competition law, public international law and investment treaty arbitration.

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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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    • 12/01/2021
    • News

    Investment Protection Implications of the EU-UK Trade and Cooperation Agreement (TCA)

    On 24 December 2020, the European Union (“EU”) and the United Kingdom (“UK”) agreed a Trade and Cooperation Agreement (the “TCA”), with provisional application from 1 January 2021. Title II of Part Two, Heading One (Trade) of the TCA includes provisions relating to “services and investment”. Yet, the provisions are minimal. In respect of investment protection, the TCA is more notable for what is out than what is in. This Client Alert provides our short analysis of the TCA’s investment protection provisions. It considers and discusses the TCA’s implications for EU-UK investors and what steps should now be taken by investors to maintain international protection for EU-UK investments. Please click on the link below to read our Client Alert on this topic.

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    • 11/01/2021
    • News

    The impact of Brexit on Trade Defence Instruments

    On 24 December 2020, the European Union (“EU”) and the United Kingdom (“UK”) concluded a “Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part” (“EU-UK Trade and Cooperation Agreement” or “TCA”). The TCA was ratified by the UK on 31 December 2020. The EU started to apply the TCA on a provisional basis on 1 January 2021. The European Parliament and the European Council of Ministers will have to ratify it by the end of February 2021. The TCA defines the specific terms of the relationship between the EU and the UK, following the end of the transition period, which was governed by the Withdrawal Agreement, and therefore the departure of the UK from the EU Single Market (comprising the free movement of persons, goods, services and the freedom of capital) and the EU customs union. The TCA establishes a free trade area between the EU and the UK by ensuring no tariffs or quotas on trade in goods that have preferential origin of either party. However, as of 1 January 2021, the EU and the UK form two distinct markets each governed by its own rules, including those relating to trade defence instruments (TDIs). Please click on the link below to read our client alert on the topic.

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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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    • 06/01/2021
    • News

    New partner for London office of leading Brussels law firm Van Bael & Bellis

    Following the successful launch of its new London office earlier in the year, Van Bael & Bellis is expanding its UK team with the appointment of Skadden Counsel, Nicholas Lawn, as a partner and Head of International Dispute Resolution in London. Nicholas specialises in international arbitration and litigation. His practice focuses in particular on investment arbitration and he has extensive experience advising both multinational corporations and sovereign States in relation to international disputes across a broad range of highly-regulated sectors including telecoms, energy, pharmaceuticals and mining. He has regional expertise in relation to disputes connected to Central and Eastern Europe and South Asia.

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