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Van Bael & Bellis authors EU chapter of Chambers Life Sciences Guide 2019

  • 16/04/2019
  • News

Van Bael & Bellis authored the EU chapter of Chambers & Partners Life Sciences guide which was recently published online. Part of the Global Practice Guides series, the Life Sciences guide provides expert legal commentary on the key regulatory issues for businesses in the life sciences sector. The EU chapter was authored by Van Bael & Bellis partners Peter L’Ecluse and Catherine Longeval, counsels Koen T’Syen and Thibaut D’hulst and associates Melody Moodley and Margot Vogels.

The EU chapter can be accessed in full here. The full Life Sciences guide can be accessed here.

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    • 17/05/2019
    • Articles

    Belgium - Medicine Shortages - New Developments

    On 14 May 2019 the head of the Federal Agency for Medicines and Health Products (“FAMHP”), Xavier De Cuyper, sent a letter to all stakeholders in the pharmaceutical supply chain explaining his organisation’s view on the effects of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (the “Letter” - see attached). The Letter has since been published on the FAMHP website.   The Law of 7 April 2019 introduces a range of measures to reduce medicine shortages in Belgium (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019). The Letter focuses on the practical consequences of the specific rule that limits the categories of customers to which a wholesaler (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) is allowed to supply. These groups of potential customers are (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules. As a result, WS with a public service WS status will no longer be able to sell medicines abroad.   The Letter highlights what FAMHP considers to be the following practical effects: Suppliers will no longer be able to refuse supplies to WS with a public-service WS status who will have to meet their public-service obligations in Belgium at all times and for that purpose require reliable and uninterrupted sources of medicines. The Letter stresses that FAMHP will monitor and enforce the supply obligation.  WS with a public-service WS status can no longer sell abroad. To the extent their owners want to continue pursuing export activities, these will have to act through a distinct legal entity that will require a separate WS licence. FAMHP will also monitor the obligation imposed on WS with a public-service WS status only to supply the limited categories of customers defined by law. The status of community pharmacists and hospital pharmacists does not change. Holders of marketing authorisations are required to report the unavailability of specific medicines. Additionally, WS with a public-service WS status and pharmacies are urged to report medicines that as a practical matter are not available even though they do not feature on the dedicated website of medicines reported as unavailable by the marketing authorisation holders.   The Letter addresses the status of ordinary WS only in passing (for example, by indicating – as noted – that ordinary WS will still be able to engage in export activities). In reality, the role and status of ordinary WS does not change under the Law of 7 April 2019.

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    • 08/05/2019
    • Articles

    Belgium - Medicine Shortages | Wholesaler-Distributors Curtailed

    Today’s Belgian Official Journal contains the text of the “Law of 7 April 2019 modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft / Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (the “Law”). The Law (i) allows the concept of “temporary cessation of supply of medicines” to be determined by Royal Decree; (ii) allows the Minister to make recommendations of suitable therapeutical alternatives in case of temporary shortages of specific medicines; (iii) allows wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) only to supply specific categories of clients, namely (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules; and (iv) imposes particular shortage-related obligations on parallel traders which previously only applied to the marketing authorisation holders. The Federal Agency for Medicines and Health Products has already announced implementing rules that will define the unavailability of a medicine and the period within which the orders of a WS with a public-service WS status will have to be supplied ( NL / FR ) The statutory limitation of the authorised categories of clients of WS with a public-service WS status (which are all based in Belgium and service the Belgian market) is designed to ensure the steady supply of medicines to the Belgian market and, conversely, cut down on exports that threaten public health. Under specific conditions, that limitation will not apply to medicines earmarked for clinical trials. To be sure, unlike WS with a public-service WS status, marketing authorisation holders and regular wholesalers will still be able to sell abroad. Lastly, the Law implements European rules that combat the trade in falsified medicines by creating criminal sanctions for specific violations of Regulation 2016/161 which lays down safety features for the packaging of medicines for human use.

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    • 02/05/2019
    • Articles

    Bulgaria and Cyprus Also To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    The European Medicines Agency (“EMA”) announced on 30 April 2019 that the US Food and Drug Administration (“FDA”) just added Bulgaria and Cyprus to the list of EU Member States able to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US. As a result, Bulgaria and Cyprus now form part of the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. There are at present 24 EU Member States whose inspection results can replace those of the FDA. Conversely, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017. It is expected that the MRA will be operational in all EU Member States on 15 July 2019. The EMA updated its Questions & Answers document on the impact of the MRA: https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-30-april_en.pdf.

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