Corporate, Commercial & Regulatory

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    • 24/10/2019
    • News

    Gábor Báthory speaks at the European Federation of Pharmacy Chains’ 1st International Conference on the future of pharmacy care

    On 17 October 2019, Van Bael & Bellis counsel Gábor Báthory spoke at the 1st International Conference on the future of pharmacy care organized by the European Federation of Pharmacy Chains in Prague. Topics covered at the conference included current issues and challenges of the European pharmacy sector such as ownership, quality, education of pharmaceutical professionals and innovation. Gábor's presentation discussed pharmacy ownership, with a focus on remedies available under EU Law against national restrictions on pharmacy ownership. Other speakers included Johan Wallér, CEO of the Swedish Pharmacy Association, Max Müller, Member of the Board at DocMorris, Europe’s largest internet pharmacy, Daniel Horák, CEO of Dr.Max, the largest pharmacy network in Slovakia and the Czech Republic, Peter Pažitný, Executive Director of the “CEE Health Policy Network” and former health policy advisor to various Ministers of Health of Slovakia, the Czech Republic and Hungary, and Tomas Sebek, Co-founder and Partner of uLékaře.cz, the Czech Republic’s leading virtual hospital. The Panel was moderated by Martin Dočkal, the founder and owner of APATYKÁŘ, the largest pharmacy website in the Czech Republic.

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    • 19/09/2019
    • News

    Belgium – Cannabis for Medical Use – Update

    As a follow-up to the Van Bael & Bellis Life Sciences Newsflash of 12 March 2019, please find below the latest on medical cannabis in Belgium. • Following the publication on 20 May 2019 of the Law of 7 April 2019 “amending the provisions on the provision of scientific and technical advice by the Federal Agency for Medicines and Health Products and on the financing of the Federal Agency for Medicines and Health Products as well as the establishment of a cannabis office’’, which provides the statutory basis for a Cannabis Office and the controlled cultivation and commercialization of cannabis in Belgium, we are still waiting for the publication of detailed implementing rules in the form of (a) Royal Decree(s). This may still take some time as there is yet a coalition to be formed for a new federal government following the national elections of 26 May 2019. The current caretaker government does not have the powers to adopt the requisite Royal Decree(s).

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  • The quality of the advice is great - we have been asking some complex questions and they have given clear and to-the-point advice and have been very proactive in providing alternative solutions.

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  • Van Bael & Bellis has ‘impressive knowledge of dispute resolution, including mediation’. The firm is notable for its strong regulatory and administrative law contentious practice as well as its impressive life sciences sector presence.

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  • They are very responsive, and experienced in pharma and compliance-related matters. They always indicate the timelines of the work they do and keep the client informed on the status of the work.

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Recent publications

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    • 05/11/2019
    • Articles

    Dutch Competition Authority Will Clarify Guidelines on Joint Purchasing of Medicines

    The Dutch competition authority announced yesterday that it would clarify its 2016 guidelines on the joint purchasing of medicines (“Leidraad gezamenlijke aankoop geneesmiddelen voor de medisch-specialistische zorg” - https://www.acm.nl/sites/default/files/old_publication/publicaties/15959_leidraad-gezamenlijke-inkoop-geneesmiddelen-voor-medisch-specialistische-zorg-2016-06-22.pdf – the “Guidelines”). It did so in response to an assessment of the Guidelines carried out by “Strategies in Regulated Markets”, a consultancy (the “Assessment” – see attached). The Guidelines were designed to encourage the joint purchasing of medicines by a range of hospitals, a group of insurers or a combination of hospitals and insurers. They are supposed to offer a safe haven for specific forms of cooperation on the buying side of medicines. According to the Assessment, the Guidelines have increased the dynamics of oligopolistic medicine markets but have also added a layer of complexity to cooperation. As a result, the net effect of the Guidelines on competition in such markets is limited. By contrast, the Guidelines have had a larger impact, including price reductions, on monopolistic medicines. Conversely, the Guidelines had no stimulating effect on the market for medicines in full competition, because these markets work well and joint purchasing of such medicines has existed for decades. On this basis, the Assessment advocates for a broader safe haven which will bolster competition in the markets where the mechanics of competition are still imperfect. For example, the Assessment recommends the possibility for buyers to exchange more information regarding medicines. Additionally, the Assessment identifies non-competition related obstacles to the efficient buying of medicines. These include the fact that there is still no consensus on the switching of patients between therapeutically equivalent medicines. Similarly, buyers do not have reliable information on the relevant costs of the medicines which they procure.

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    • 04/11/2019
    • Articles

    Medicine Shortages - The Netherlands To Create "Iron Stock" Of Medicines

    The latest European country to announce measures to tackle medicine shortages is The Netherlands. Minister of Medical Care Bruno Bruins announced this morning the creation of what he referred to as an “iron stock” (“ijzeren voorraad”) of medicines that would cover five months of supplies (see, attached press release). The stock would include all medicines available on the Dutch market and would be built up gradually from 2020 onwards. It is expected to reach completion in 2022. The system will require a range of agreements among suppliers, wholesalers, pharmacists and payers on both operational and funding issues. Some of these arrangements will give rise to competition law scrutiny. For example, the Minister anticipates the parties “better to predict the demand for medicines in order to match supply and demand optimally”. The new rules will be laid down in a policy measure that will be overseen by the Inspection for Medical Care and Youth (“Inspectie Gezondheidszorg en Jeugd”). The Minister estimates the cost of the iron stock to amount to approximatively EUR 25 million. The press release does not indicate whether this is a one-off or a recurring expense. Finally, Minister Bruins once more advocates for a European approach to some of the medicine shortage problems. Echoing a proposal made by the French government (see, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019), he suggests that the production of specific “crucial medicines” and pharmaceutical ingredients should return to Europe.

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    • 29/10/2019
    • Articles

    Spanish Competition Authority Extends Investigation against Producers of Radiopharmaceuticals

    The Spanish competition authority, “Comisión Nacional de Los Mercados y la Competencia” (“CNMC”), today decided to extend an investigation involving radiopharmaceuticals to two additional defendants, GLO Holdco S.C.A. and Novartis Groupe France S.A.(see, attached press release of 29 October 2019). These are the parent companies of respectively Curium Pharma Spain S.A. (“Curium”) and Advanced Accelerator Applications Ibérica S.L.U. (“AAA”), firms that had already been targeted by, first, dawn raids (see, attached press release of 9 November 2018) and, later competition proceedings (see, attached press release of 11 February 2019). A number of executives of these firms are also the subject of proceedings which are based on both European and Spanish competition law. Curium and AAA stand accused of colluding to share the market, fix prices and exchange business-sensitive information on the Spanish market for the production and sale of radiopharmaceuticals used in positron emission tomography (“PET”) nuclear imaging. This infringement allegedly took place between 2014 and at least November 2018. Additionally, AAA is suspected of having abused a dominant position on the market for PET radiopharmaceuticals by hindering third-party market entry between 2017 and, again, at least November 2018. This latest move is another manifestation of the very active enforcement policy of the CNMC in the pharmaceutical sector (see e.g., Van Bael & Bellis Life Sciences Newsflashes of 25 April 2019 and 27 May 2019). The approach of the CNMC thus forms part of a broader Europe-wide pattern involving intense competition scrutiny of the industry.

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