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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  • 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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    • 23/08/2019
    • Articles

    Portugal Latest EU Member State to Tackle Medicine Shortages and Regulate Parallel Trade in Medicines

    In Portugal, an amending decree-law of 16 August 2019 which entered into force on 19 August 2019 seeks to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. That obligation involves the duty to ensure a continuous supply of medicines. It prohibits abusive or discriminatory practices such as directly or indirectly refusing to fulfill medicine orders or applying differing deadlines. The new decree-law reinforces the public-service obligations for pharmaceutical companies to ensure that medicines make it to wholesalers who have a duty of their own to supply pharmacies and other retailers. Those who hold a marketing authorisation must constantly monitor their stock positions and communicate possible shortages both to the other stakeholders and Infarmed, the Portuguese health agency. The decree-law also clarifies the dual role of wholesalers which have to (i) supply the domestic market; and (ii) operate as logistical service providers. Furthermore, the new decree-law makes an attempt to limit parallel trade by precluding wholesalers from selling medicines to other countries or other distributors, unless they have first made sure to supply the domestic market. Finally, the amendments bolster the ability of Infarmed to enforce the new rules. A communication which Infarmed issued to publicize the new rules is attached. Portugal thus becomes the latest EU member state to tackle medicine shortages and interfere with parallel trade in medicines. It is expected that the new European Commission which will start operations at the end of the year will also address this issue.

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    • 19/08/2019
    • Articles

    Belgium - Medicine Shortages - New Development

    At the end of July 2019, Febelco and PharmaBelgium-Belmedis, two wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur – “WSD”), and the National Association of Wholesaler-Distributors (NVGV/ANGR) filed with the Constitutional Court (“CC”) a petition for annulment of Article 3, 2° of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet van 7 april 2019 tot wijziging van de Wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft/Loi du 7 avril 2019 modifiant la Loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (see attached excerpts from the list of pending CC cases). Pursuant to Article 3,2°, WSD are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WSD; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see Van Bael & Bellis Life Sciences Newsflashes of 8 May 2019 and of 17 May 2019).

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    • 05/08/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 07

    The July 2019 issue of our Belgian Business Law newsletter reporting on the latest developments in a range of areas, including competition, data protection, intellectual property and labour law.

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