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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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    • 05/09/2019
    • News

    Medicines Cooperation - Sweden to Join International Horizon Scanning Initiative

    On 4 September 2019, the Dutch Minister for Medical Care, Bruno Bruins, announced plans for Sweden to join the impending International Horizon Scanning Initiative (“IHSI”) (see, attached press release). IHSI, which is expected to start in October 2019, is a form of international cooperation that seeks to identify innovative medicines before they reach the market. It will inform decision-making on treatment and budgets in the participating countries. IHSI is just one example of a broader trend of expanding international cooperation on medicines in a range of areas and in varying geographical constellations. Last month, Minister Bruins had already announced that Canada would also become a member of IHSI (see, Van Bael & Bellis Life Sciences Newsflash of 18 July 2019). When airing the intentions of Sweden, Minister Bruins expressed the hope that IHSI would be able to begin operations with 10 member countries. Other known aspiring members include Belgium, Ireland, Luxemburg and The Netherlands.

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Recent publications

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    • 17/09/2019
    • Articles

    Leadiant Fights Perception that Price for CDCA is Excessive

    Leadiant is involved simultaneously in administrative proceedings and in a public relations struggle to justify its pricing for chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”). In Europe, the number of these patients is thought to be in a range between 200 and 250. Leadiant secured orphan medicine status for CDCA in December 2014 after it succeeded in demonstrating the significant benefit of CDCA over existing treatments of CTX. However, by Leadiant’s own acknowledgement, the list price of CDCA “appears to be high” especially when that price is compared with that of an old medicine with the same active substance indicated for the treatment of cholesterol gallstones. As a result, Leadiant has come under fire from various political leaders, healthcare regulators and competition authorities on account of the allegedly excessive prices which it charges for CDCA (see, Van Bael & Bellis Life Sciences Newsflashes of 9 September 2019, 9 April 2019, and 12 February 2019). Leadiant has now taken the unusual step of making publicly available a letter which it sent to the Dutch Minister of Medical Care, Bruno Bruins, following talks over the price of CDCA (the “Letter” – see attached Dutch-language original and English translation). The Letter sets forth Leadiant’s arguments in favour of the current price of CDCA in The Netherlands, but also highlights Leadiant’s willingness to continue the discussions in hopes of finding an “acceptable price” and thus securing what Leadiant describes as “access to an innovative medicine”. In the Letter, Leadiant makes the following points: • CDCA is a new medicine that should be distinguished from the old medicine with the same active substance for a different therapeutic indication. It faced much more exacting hurdles to secure a marketing authorisation than did the marketing authorisation holder of the old medicine many years ago. • Leadiant was able to show the significant benefit of CDCA over other forms of treatment of CTX. • Leadiant invested significant amounts in retrospective studies that demonstrated the safety and efficacy of CDCA (The European Medicines Agency actually indicates that the marketing authorisation for CDCA results from a hybrid application which relied in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. Additionally, the marketing authorisation was granted “under exceptional circumstances” which implies that Leadiant was unable to provide comprehensive data on the efficacy and safety under normal conditions of use). • Leadiant was required to modernise the active substance master file for the active pharmaceutical ingredient at the heart of CDCA. • Leadiant created a European patient registry which just became operational and is designed to monitor the benefits and safety of the medicine and thus make up for the insufficient data available at the time the marketing registration was granted. • Leadiant committed to developing a paediatric formulation which will specifically cater to the needs of 30 to 60 patients in the EU. • Lastly, Leadiant strongly disputes the public health benefits of a pharmaceutical preparation that was touted in The Netherlands as a possible alternative to CDCA. The Letter should be understood as an attempt by Leadiant to demonstrate its bona fides and operate as a reliable partner of the health authorities in the interest of patients. Time will tell whether that attempt is successful.

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    • 13/09/2019
    • Articles

    Romania - Ministry of Health Announces Plan to Limit Export of 127 Medicines

    The Romanian Ministry of Health announced today that it would suspend the exportation of 127 medicines for a period of 6 months that would end on 31 March 2020 (see, attached). The suspension is subject to the outcome of a public consultation. According to healthcare specialists, the targeted medicines all run an increased risk of shortage and are indicated for the treatment of cancer patients and transplant recipients. The Ministry expects the proposed measure to pass muster under EU law but will notify it to the European Commission. In the past, the Commission has already given its blessing to targeted export restrictions in Poland, Romania and Slovakia that were considered to be “justified, reasonable and proportionate to ensure a legitimate public interest” (see, Van Bael & Bellis Life Sciences Newsflash of 17 May 2018). According to the Commission, seeking to avoid medicine shortages qualifies as a legitimate public interest. Conversely, the Belgian Constitutional Court recently suspended a statutory rule that had precluded wholesaler-distributors (i.e., wholesalers entrusted with specific public service obligations) from selling to any party other than fellow wholesaler-distributors, community pharmacists and specific hospitals on the grounds that such a mesure constitutes an unjustified restriction of the free movement of goods across Member State borders (see, Van Bael & Bellis Life Sciences Newsflash of 19 July 2019).

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    • 11/09/2019
    • Articles

    Stella Kyriakides Commissioner-Designate for Health

    Stella Kyriakides, a member of the Cypriot parliament, a trained psychologist and a forceful advocate of patient rights (she is a past President of Europa Donna, the breast cancer patient group), has been entrusted with the health portfolio by Ursula von der Leyen, the President-elect of the incoming European Commission. Like the other designated Commissioners, Ms. Kyriakides’ appointment still has to be approved by the European Parliament, but with her colleagues she is expected to take up her position in November 2019.

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