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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Latest news

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    • 05/04/2019
    • News

    Van Bael & Bellis assists the retail industry in securing an injunction by the European Commission suspending Slovakia’s tax on the food retail sector

    On 2 April 2019, the European Commission opened an in-depth investigation into a tax on the food retail sector in Slovakia over concerns that the way in which the tax is structured gives some retailers a selective advantage over their competitors, thus involving State aid in breach of EU rules. At the same time, the Commission issued an injunction requiring Slovakia to suspend the application of the measure until the Commission has concluded its assessment under EU State aid rules. The complaints giving rise to the Commission’s afore-mentioned decisions were lodged in December 2018. Van Bael & Bellis counsel Gábor Báthory assisted the retail industry in this matter. Further details on this case can be found here.

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    • 29/03/2019
    • News

    Fifteen Member States Sign Agreements for Supply of Pandemic Influenza Vaccines under Umbrella of Joint Procurement Agreement

    On 28 March 2019 the European Commission announced that 15 EU Member States and the Commission signed framework contracts with the pharmaceutical firm Seqirus for the supply of pandemic influenza vaccines to 30 contracting authorities in these Member States in the event of an influenza pandemic (https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/ev_20190328_memo_en.pdf). The agreements will run for at least 4 years and are subject to a possible extension of 2 more years. Under the agreements, Seqirus will not only supply vaccines but will also reserve part of its weekly manufacturing capacity and will be paid in return an annual preparedness fee. The agreements were concluded under the Joint Procurement Agreement (“JPA”), a framework established on the basis of Article 5 of Decision 1082/2013/EU tackling serious cross-border threats to health. A similar set of agreements was entered into in 2016 to organise the joint procurement of botulinum anti-toxin. A further series of agreements to expand the vaccine coverage is under preparation. Additional joint procurement procedures for diphtheria anti-toxin, tuberculin and Bacillus Calmette–Guérin (“BCG”) vaccines, and personal protective equipment are under consideration. The JPA was conceived of to improve the state of preparedness of Member States for serious cross-border threats to health, ensure equal treatment of patients affected and increase the buying power of Member States when anticipating emergency situations.

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Recommendations

  • 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 patiently try to understand the mentality of people in different cultures and pay full respect to that. This attitude is rare in a highly expert world. We are fully satisfied with their practice and the results therefrom.

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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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Van Bael & Bellis is well known for its client-centred approach, commitment to excellence, exceptional client service and personalised attention.

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Recent publications

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    • 20/05/2019
    • Articles

    Medicine Shortages - Growing Pressure on European Commission To Take Action in Next Legislative Cycle

    On 17 May 2019, a broad group of organisations representing patients, consumers, healthcare professionals and public health advocates called on the European Commission to investigate medicine shortages and take appropriate action that complements the work undertaken by a joint task force of the heads of national medicine agencies and the European Medicines Agency (“EMA”) (see annex 1 - letter addressed to European Commissioner responsible for Health and Food safety Vytenis Andriukaitis and the Director General for Health and Food Safety, Anne Bucher). The initiative comes ahead of the European elections at the end of May 2019 which will create a new European Parliament but will also trigger the designation of a freshly composed European Commission. The letter advocates action “during the next legislative period”. The letter reflects the position of heavyweight organisations such as the European Association of Hospital Pharmacists which, in November 2018, published the results of a pan-European survey (1,666 responses from 38 countries) on medicine shortages in the hospital sector and listed the major challenges to be tackled (annex 2). It is the latest voice in a growing chorus of calls from various sectors in favour of action at the European level. For example, in early April 2019, the European Society for Medical Oncology, published its own set of “recommendations for the 2019-2024 legislative cycle”, including the adoption of legislation for early notification requirements for medicine shortages and the creation of catalogues of shortages (annex 3). Earlier, in February 2019, France’s pharmaceutical trade association Leem came out in favour of increased cooperation between national and European regulators to tackle what it described as a sharp increase in the number of medicines at risk of shortages (annex 4). According to Leem, in 2008 companies reported to the French medicines regulator ANSM 44 medicines of major therapeutic interest at risk of or experiencing shortages. That number grew to 538 in 2017. Leem attributes the shortages to an expanding global demand coupled with insufficient production capacity, as well as changes in production chains, controls and regulatory obligations. It supports an EU-wide effort to monitor shortages and also recommends a boost in the EU-based production of active pharmaceutical ingredients. Additionally, Leem backs improvements to hospital public procurement mechanisms and to the exchange of information between the various stakeholders in the medicine supply chain. Leem’s proposals follow in large part the findings of a report which the French Senate released in October 2018. The pressure on the incoming European Commission to put medicine shortages high on its list of priorities is considerable and is thrown into sharp relief by Member State initiatives such as that of Belgium which try and address medicine shortages at the local level (see, Van Bael & Bellis Life Sciences Newsflashes of 8 and 17 May 2019).

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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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    • 14/05/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 04

    The April 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. Please click below to read the issue.

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