News & Insights

You have searched for:
    • 14/10/2021
    • Articles

    European Commission Proposes to Delay Application of Regulation on In Vitro Diagnostic Medical Devices

    The European Commission (the Commission) published today a proposal for a Regulation delaying the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) by three to five years, depending on the risk involved in the devices concerned (Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices – the Proposal; see, attached copy). The IVDR was set to take effect on 26 May 2022. Referring to the extraordinary circumstances created by the COVID-19 pandemic and the resulting delay in the designation and work of notified bodies under the IVDR, the Proposal stresses that immediate action is necessary to avert a “significant disruption in the supply of in vitro diagnostic medical devices on the market both for health institutions and for the public” (p. 2). To date, only six notified bodies have been designated under the IVDR. Moreover, these six notified bodies are established in only three countries (France, Germany and the Netherlands). Extending the existing transitional period for devices covered by a valid certificate issued under the current in vitro diagnostic medical devices Directive (Directive 98/79/EC) by one year, the Proposal provides that these devices can continue to be placed on the market or put into service until 26 May 2025. Furthermore, the Proposal introduces tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. For these devices, the length of the transitional period will depend on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices will benefit from a transition period until 26 May 2027, whereas higher risk devices (class D and class C devices) will only have a transition period until, respectively, 26 May 2025 and 26 May 2026. The Proposal responds to a widespread call for delayed application of the IVDR. This call is not new though. As early as in April 2020, the European trade association for the medical devices sector, MedTech Europe, warned that “even before the COVID-19 pandemic, very little progress had been achieved yet, to get the new IVDR regulatory system ready” and that “since the present COVID-19 outbreak, the IVDR implementation progress has come to a total halt” (see, Van Bael & Bellis Life Sciences News and Insights of 24 April 2020).

    Download PDF
    • 11/10/2021
    • Articles

    EU Clinical Trials Regulation - EMA Publishes Clinical Trial Information System Go-live Plan

    On 8 October 2021, the European Medicines Agency (EMA) provided an update on the progress in the development and preparations for the ‘go-live’ of the Clinical Trial Information System (CTIS) on 31 January 2022. EMA also published a 12-page CTIS go-live plan summarising the key steps remaining before the launch of CTIS (the Plan; see, attached copy). According to EMA and the Plan, CTIS is currently being extensively tested to identify any potential remaining stability issues. A key priority in preparing CTIS for launch is ensuring that the sponsor workspace is fully functional. Once this has happened, the workspace for health authorities will be finished, followed by the public portal. Other priorities are to set up a dedicated helpdesk for CTIS users and to prepare materials for “extended stakeholder training”. These materials will complement the existing training materials already issued by EMA, including online training modules and a sponsor handbook (see, Van Bael & Bellis Life Sciences News and Insights of 9 August 2021). Further preparations are also necessary to allow for clinical trial safety reporting and monitoring as included in the initial scope of CTIS activities. The Plan provides for all of the outstanding matters a chart with a timeline for their implementation. In the first quarter of 2022, EMA will publish a follow-up plan focusing on the activities post 31 January 2022 which will cover post go-live releases, CTIS operation and maintenance, continued training offerings and stakeholder support and interaction. CTIS is the cornerstone for the application of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014). Comprising an EU Portal and EU Database, CTIS will ensure a single-entry point for the submission of data and information relating to clinical trials by sponsors, evaluation and supervision by Member State health authorities, and access to publicly available data and information relating to clinical trials by the public (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021 and Van Bael & Bellis Life Sciences News and Insights of 9 August 2021).

    Download PDF
    • 11/10/2021
    • Articles

    Belgium, Ireland, and The Netherlands Jointly Agree under Aegis of Beneluxa Initiative to Reimburse Zolgensma®

    On 8 October 2021, Belgium, Ireland, and The Netherlands announced that they had reached an agreement with Novartis Gene Therapies (Novartis) regarding the reimbursement of Zolgensma® (onasemnogene abeparvovec), a gene therapy medicinal product that was designated as an orphan medicine and is indicated for the treatment of two specific types of Spinal Muscular Atrophy (SMA) (see, attached press release). SMA is the most common genetic cause of mortality in infants and affects nerve cells that cause general muscle weakness. Infants with SMA typically do not survive more than two years. For its part, Zolgensma® is known as the world’s priciest medicine, but the press release does not address the price reductions which Novartis is understood to have consented to in order to secure reimbursement in the three countries. The agreement was reached under the aegis of the Beneluxa initiative, a collaborative effort of Austria, Belgium, Ireland, Luxemburg, and The Netherlands designed to expand patient access to high quality and affordable medicines. Under the Beneluxa initiative member governments pursue joint activities in the areas of (i) horizon scanning; (ii) Health Technology Assessment; (iii) the sharing of information; and (iv) pricing and reimbursement. The arrangement with regard to Zolgensma® is the first agreement governing the price and reimbursement of a medicine involving 3 countries. The previous one only applied to two countries, Belgium and The Netherlands, but, interestingly, related to Biogen’s Spinraza® (nusinersen), a medicine also indicated for the treatment of specific SMA conditions (see, Van Bael & Bellis Life Sciences News & Insights of 12 July 2018). Zolgensma® will qualify for reimbursement in Ireland with immediate effect. In The Netherlands, the medicine will be reimbursable on 1 November 2021, while Belgium will reportedly follow suit on 1 December 2021.

    Download PDF
    • 29/09/2021
    • Articles

    European Commission Launches Public Consultation on Reform of Pharmaceutical Legislation

    On 28 September 2021, the European Commission (the Commission) launched a public consultation that probes for stakeholders’ views on the reform of the pharmaceutical regulatory framework. The consultation will run until 21 December 2021 and marks a new milestone in a long-running debate regarding the future of pharmaceutical regulation. The Commission shaped that debate by presenting its Pharmaceutical Strategy for Europe (see, Van Bael & Bellis Life Sciences News Alert of 26 November 2020 and Van Bael & Bellis News and Insights of 2 April 2021). However, events such as the Covid-19 pandemic equally played a significant role in defining the hot button issues on which the Commission is now seeking views. The Commission’s questionnaire (attached) addresses a range of topics, including : • the performance of current EU rules; • unmet medical needs; • incentives for innovation (data and market protection, but not intellectual property protection); • antimicrobial resistance; • novel products (with questions touching on the borderline between medicines and other health products; the use of “regulatory sandboxes” which allow for policy experimentation; adaptive regulatory frameworks; and an early dialogue between the various regulators); • improved patient access to medicines (with issues such as obligatory pan-European market launches and limitations on market withdrawals); • enhanced market functioning (e.g., by increasing biosimilar competition); • repurposing of medicines; • security of medicines supply (covering issues such as the reporting of shortages; mandatory safety stocks; and the compulsory diversification of supply chains); • quality and manufacturing; and • environmental risk.

    Download PDF
    • 20/09/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 8

    The August 2021 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.

    Download PDF
    • 17/09/2021
    • Articles

    European Commission Launches European Health Emergency Preparedness and Response Authority

    On 16 September 2021, the European Commission (the Commission) decided to establish the European Health Emergency Preparedness and Response Authority (HERA) which will seek to prevent, detect, and respond to health emergencies and will complement the work carried out by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). However, unlike these autonomous agencies, HERA will be created as a Commission service, headed by a Director-General, and will therefore remain under its control. As such, it will form an important part of the emerging European Health Union (see, Van Bael & Bellis Life Sciences News & Insights of 30 June 2021, 19 February 2021, and 12 November 2020). According to Article 2 of the Commission Decision establishing HERA, the new service will be given a range of tasks, including assessing health threats and ensuring directly or indirectly the research, development, production, procurement, distribution, stockpiling and knowledge building in relation to what are referred to as “medical countermeasures” (MCM). MCM are products used to face serious health threats and include antibiotics, chemical antidotes, diagnostic tests, medical equipment, personal protective equipment, therapeutics and vaccines. In addition to the decision establishing HERA, the Commission also tabled a proposed Regulation “on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”. While HERA will be a Commission service, its board will consist of one representative of each Member State. In a move unlikely to meet with a warm welcome, the European Parliament will only be invited to designate an observer to the HERA board and will thus be placed on an equal footing with several specialised EU agencies and bodies. HERA will rely on a budget of EUR 6 billion from the current Multiannual Financial Framework for the period covering 2022-2027, but other EU programmes will also make contributions, thus causing the total European support to reach an estimated EUR 30 billion. The Commission points out that the project’s firing power will even be larger as a result of additional Member State initiatives and private sector ventures. The attached extensive documentation includes a (i) Commission press release; (ii) Commission questions and answers file; (iii) Commission Communication on the subject; (iv) annex to the Communication; (v) Commission decision establishing HERA; and (vi) proposed Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.

    Download PDF
    • 10/09/2021
    • Articles

    Belgium Prepares to Implement Regulation (EU) 2019/6 on Veterinary Medicinal Products

    Earlier this week, Belgian plans for implementing Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC (the Vet Reg) were made partially publicly available pursuant to the notification procedure governing possible technical barriers to trade provided for by Directive (EU) 2015/1535. This Technical Regulation Information System or “TRIS” procedure allows both the European Commission and the EU Member States to review before their adoption technical regulations which Member States intend to introduce for products and Information Society services. The TRIS procedure thus created a mechanism to increase the likelihood that the proposed texts are compatible with EU law, including the Internal Market principles. The European Commission’s TRIS platform now displays the text of a draft Law governing veterinary medicinal products (“Voorontwerp van Wet betreffende diergeneesmiddelen”/“Avant-projet de loi sur les médicaments vétérinaires” – the Draft Vet Law – see, attached Dutch and French versions) which will be submitted to Parliament and is intended to apply on 28 January 2022, the date of application of the Vet Reg. As a Regulation the Vet Reg is directly applicable in EU Member States and, theoretically, does not require national implementation. However, as was the case for many Regulations across diverse fields of law, implementing measures also proved necessary for the Vet Reg. Accordingly, the Draft Vet Law contains an extensive set of detailed rules and provides for the prospect of even more elaborate implementing rules that will be enacted by Royal Decree. The Draft Vet Law regulates a set of important issues, including clinical trials with veterinary medicinal products; marketing authorisations; post marketing authorisation measures; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; publicity; inspection, supervision and criminal penalties; administrative settlements; and the processing of inspection data. As a result of the Draft Vet Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications.

    Download PDF
    • 02/09/2021
    • Articles

    Belgium - Bill Facilitating Biosimilar Market Entry in Hospital Channel

    Member of Parliament Nawal Farih submitted in June 2021 a private member’s bill which seeks to facilitate market entry by biosimilar medicines (Bill 2157K001 – Wetsvoorstel tot wijziging van de Wet betreffende de verplichte verzekering voor geneeskundige verzorging en uitkeringen gecoördineerd op 14 juli 1994, met het oog op een financieel toegankelijker geneesmiddelenbeleid binnen de ziekenhuizen/Proposition de loi modifiant la loi relative à l’assurance obligatoire soins de santé et indemnités coordonnée le 14 juillet 1994, afin que les hôpitaux mènent une politique des médicaments qui les rende financièrement plus abordables - the Bill, see attachment). The Bill became publicly available just a few weeks ago. Ms. Farih expects a larger uptake of biosimilars in hospitals to make biological medicines more accessible for patients and, more plausibly, to create additional savings on the health budget. The Bill is predicated on the finding that the biosimilar uptake in Belgian hospitals is still low and that this is attributable to a deficient application of the public procurement rules which most hospitals in Belgium are supposed to abide by. On that basis, the Bill proposes to: • Oblige hospitals to have the biological reference product and the biosimilar product form part of the same subdivision (perceel/lot) in any given request for proposals. • Oblige hospitals to issue a call for tenders within 90 calendar days following the entry into force of reimbursement conditions for a new biosimilar. This obligation will come into play even if the hospital at issue has a pending contractual obligation to procure the reference biological product or another competing biosimilar medicine. • Oblige hospitals to start a new procurement regime within 60 calendar days following the receipt of offers in response to a request for proposals. • Limit the duration of any new supply agreement to 24 months, with the possible option, subject to conditions, to extend the agreement for a further 12 months. • Guarantee the equal treatment of the reference biological products and the biosimilars. A model request for proposals may be established by Royal Decree. • Create rules that will exempt hospitals from the application of the new procurement rules for biological products as soon as the biosimilars obtain a specific share of the market for a given active substance. The Bill was prompted by a study published by the Christian sick-fund, one of Belgium’s major healthcare payors. While the Bill is a private member’s initiative, it may still gain traction, either autonomously or as part of a wider governmental initiative to promote biosimilars, which is one of the policy objectives of the current federal government.

    Download PDF
    • 27/08/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 7

    The July 2021 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.

    Download PDF

Showing 1-9 of 673 insights

View more
Keep updated Sign up for VBB insights

Be the first amongst your peers to get the latest publications and insights.