Samuel Hall focuses on EU competition law as well as EU regulatory law. 
Before joining Van Bael & Bellis, Samuel worked in the Brussels and London offices of a well-known international law firm advising mainly on EU and UK competition law issues, gaining particular experience in the pharmaceuticals sector. During his time as a trainee in London, Samuel also gained valuable experience of pharmaceutical patent litigation. Samuel has also worked as a research assistant at the University of Sheffield.


English, German


  • BPP Law School, London, Postgraduate Diploma in Legal Practice, 2017
  • University of Sheffield, Bachelor of Laws (European and International Law), 2015
  • University of Vienna, Erasmus programme, 2014
  • Bucerius Law School, Germany, Exchange Programme in International and Comparative Business Law, 2013

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Solicitor, England and Wales 

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    • 11/06/2021
    • Articles

    Belgium - Constitutional Court Rejects Challenge to Statutory Medicine Shortage Rules, Including Export Restrictions

    The Constitutional Court dismissed on 10 June 2021 the action which the Belgian Association of Parallel Importers and Exporters, several other parties active in the parallel trade in medicines, and pharmacists in the Democratic Republic of the Congo and Rwanda (the Applicants) had brought to obtain the annulment of Articles 2, 3 and 4 of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (Wet van 20 december 2019 tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Loi du 20 décembre 2020 modifiant diverses législations, en ce qui concerne les pénuries de médicaments – the Law). The Constitutional Court had already rejected a request for suspension of the same provisions (see, Van Bael & Bellis News and Insights of 20 July 2020). Yesterday’s judgment (see, attachments) focused on the powers given by statute to the government to establish a procedure for the creation of a temporary limitation or prohibition of the exportation of medicines that are unavailable on the Belgian market. The Applicants relied on the European free movement of goods principles but also on several provisions of Belgian law to challenge these restrictions. However, the Constitutional Court considered the contested rules justified in that they permit the government to counter situations in which medicine supplies to Belgian patients are no longer guaranteed. The Constitutional Court distinguished the new rules, which will be applied on a case-by-case basis following an assessment of the causes and nature of the particular shortage afflicting a specific medicine, from the blanket export prohibition imposed on wholesaler-distributors which it struck down in 2019 (see, Van Bael & Bellis Life Sciences News and Insights of 19 July 2019 and 17 October 2019). As the Constitutional Court has allowed the challenged statutory medicine shortage rules to stand, the question arises when the government will come up with the requisite implementing rules. Pressed on the subject in Parliament, the Minister of Social Affairs and Public Health indicated back in February 2021 that these proposed rules are under review, but he did not give a timetable for their adoption. Four months later, it is still not clear when they will become law.

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    • 31/05/2021
    • Articles

    Medical Devices - Free Market Access between European Union and Switzerland Given Blow

    Regulation (EU) 2017/745, the new Medical Device Regulation (MDR), started to apply on 26 May 2021, more than four years after its adoption in April 2017. However, this important step in the development of the regulatory framework governing medical devices coincided with a shrinking of the internal market for these products as trade in medical devices between the European Union (EU) and Switzerland became subject to more red tape. This is because the chapter covering medical devices of the EU – Switzerland Mutual Recognition Agreement (MRA) has not been updated to reflect the application of the MDR (see, the attached European Commission Notice to Stakeholders – the Notice). The failure to modernise the MRA is ironic, because both sides have tightened their requirements with respect to medical devices, mainly to improve safety and increase regulatory oversight. Even though the regulatory adjustments to EU and Swiss medical device rules are thus largely comparable, reciprocal free market access has fallen by the wayside because of the EU’s insistence that no piecemeal regulatory adaptations in areas of mutual interest will be made as long as the parties do not agree on an overarching Institutional Framework Agreement (IFA). Negotiations in pursuit of the IFA started in 2014, but were terminated by Switzerland on 26 May 2021, which thus added further complications to an eventful day. The EU and Switzerland apparently anticipated these developments and, based on a proposal submitted by the European Commission, have tried to work out transitional arrangements for the MRA, including a grace period until 2024, but these talks failed as well. The consequences for the EU-Swiss trade in medical devices are devastating as Switzerland exports more than EUR 4.5bn worth of medical devices to the EU, while it imports over EUR 2.4bn. Even though this trade will not dry up, it will become harder to sustain. Similarly, investment decisions, primarily those directed at Switzerland, may also be affected. Industry will have to contend with additional expenses because the trade facilitating measures of the MRA no longer apply. Market surveillance will also be adversely affected. And new regulatory burdens will emerge. For its part, Switzerland has put in place measures to mitigate these negative effects. For example, the measures will ensure the equivalence of the Swiss rules governing medical devices to those of the EU. Additionally, importers in Switzerland will be given time to appoint an authorised representative, adjust labelling, carry out registrations with Swissmedic, the Swiss regulatory authority, and effect specific publications. Conversely, there are no transitional rules that apply to importers in the EU. As a result and as explained in the Notice, since 26 May 2021, these businesses are required to: • ensure that medical devices are certified by an EU conformity assessment body if such a certification is dictated by the applicable conformity assessment procedure; • designate an EU authorised representative; • observe the rules governing the registration and labelling of products.

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    • 07/05/2021
    • Articles

    Pharmaceuticals – Dealing in Uncertain Times – The Article 22 Merger Procedure

    With the Commission’s publication of Guidance on its expanded use of the Article 22 merger review procedure, and its immediate use against the Illumina / Grail transaction, pharmaceutical companies face a new world where any acquisition of a small biotech or company with key technology could now face a merger control investigation and potentially a prohibition. So what can pharmaceutical companies do in these uncertain times… Background In recent years, the European Commission has expressed concerns that large companies in the pharmaceutical and tech sectors are conducting “killer acquisitions” of new entrants or smaller competitors that fall below the revenue thresholds for merger review. In order to address this concern, the Commission expanded the use of Article 22 of the Merger Regulation in a manner that would effectively empower the Commission to review any transaction. Under Article 22, any national competition authority (on its own motion or following encouragement by the Commission or by interested parties) may refer a transaction to the Commission, even if the transaction does not meet EU or national merger thresholds. Further, such a review process can be triggered even after the closing of the transaction. For companies in the pharmaceutical sector, this means that transactions involving a biotech or other company with little revenue could still be subject to a merger clearance process, even after closing, and could potentially result in a prohibition or required changes. Dealing in Uncertain Times Identifying At-Risk Transactions While the Commission has issued guidance concerning the characteristics of transactions that may be caught, companies operating in the pharmaceutical sector will not find much comfort, as the characteristics will fit many transactions in the sector. These characteristics include transactions involving a target (i) with turnover/revenue that does not reflect its actual or future competitive potential or that is significantly lower than the consideration being paid to the seller, (ii) that is an important innovator or is conducting potentially important research, (iii) has access to competitively significant assets (such as raw materials, infrastructure, data or intellectual property rights), and/or (iv) provides key inputs/components. Pharmaceutical companies therefore are largely left to assess for themselves the practical risk of a transaction being subject to the expanded Article 22 procedure, taking into account possible challenges by competitors, customers, payors or suppliers, or an investigation initiated by a competition authority. Particular care is recommended for any transactions that could be politically sensitive or important to national health authorities or payors, which are more likely to be pursued by the competition authorities. The Illumina / Grail transaction provides a good example, as the case concerns next-generation gene testing for cancer, a topic that is important to the Commission’s Beating Cancer Plan. Negotiating Contractual Protections Deal terms will need to address this new risk of an Article 22 referral and merger review process, including the possibility of a decision imposing conditions or prohibiting the transaction. These terms will also need to address the possibility that a review could be initiated up to six months post closing, or even longer if the transaction raises serious competition law concerns. Informal Consultation with the Commission? The European Commission has indicated that it may be willing to provide informal guidance to parties concerning whether the transaction would likely be caught by the Article 22 procedure. However, as any guidance would be non-binding, the parties would only get very little legal certainty in the best scenario. For this reason, the main benefit from an informal consultation would arise where a transaction could raise substantive issues or is likely to be reviewed, in which case a pro-active approach would allow the parties to present their case and avoid that the authorities only hear from parties seeking to block the deal. Make the Transaction “Known” to National Authorities? Where a notification is not required in a Member State, the EU Merger Regulation specifies that national competition authorities may only refer the transaction to the Commission if the referral occurs within 15 working days from when the transaction is “otherwise made known” to the authority. This rule creates the opportunity for the parties to informally notify relevant national authorities of the transaction (so that the transaction is “made known” to the authority), and then await expiry of the 15-day period before closing the deal. Through such a step, the parties may achieve additional comfort that the transaction would not later face referral and review by the Commission after closing. However, the use and effect of such an informal notification remains untested, and may not be beneficial for all transactions. Currently, the law is not clear concerning what information would have to be provided to an authority for the transaction to be “made known”, and prevent a later referral after the expiry of the 15-day period. Further, the parties may incur significant costs and legal fees notifying authorities in all relevant countries. For these reasons, parties might instead choose to proceed without any informal notification or consultations, particularly where the transaction does not raise any significant substantive competition law issues and therefore is unlikely to face any later decisions requiring remedies or the unwinding of the deal. Influencing Whether the Commission Will Pursue an Article 22 Request The Commission’s Guidance indicates that the parties will be notified “as soon as possible” where a referral request is being considered. Parties to a transaction may therefore have a brief opportunity for informal submissions to the Commission and national authorities, seeking to convince the authority that the transaction does not merit referral. However, in light of the very short timelines available to the authorities to decide whether to refer a transaction, any opportunity for submissions and consultation would be very limited, and such measures are only likely to have an impact for simple transactions with no significant competition law concerns. Procedure if the European Commission Accepts the Referral If the Commission accepts a referral, the parties will be required to notify the transaction and the resulting review of the transaction will be largely governed by the standard EU merger review rules and procedures. As an exception, the “stand-still” obligation on the parties will only apply if the transaction has not already been implemented on the day on which the Commission informs the parties of a referral request from a national authority. New Opportunities for Third-Parties to Challenge Transactions While the expanded use of the Article 22 procedure creates significant risks for merging parties, it creates opportunities for competitors or other parties interested in challenging transactions. The European Commission’s guidance specifically welcomes third parties to “contact the Commission or the competent authorities of the Member States and inform them of a concentration that, in their opinion, could be a candidate for a referral under Article 22 of the Merger Regulation.” Suffice it to say, this creates a significant opening for any interested party to raise issues and introduce additional uncertainty for the parties seeking to complete or implement a transaction, even after closing.

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