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    • 14/01/2020
    • Articles

    Advocate General Confirms Validity of EU Standard Contractual Clauses

    Advocate General Henrik Saugmandsgaard Øe recently delivered his opinion in the Facebook Ireland and Schrems case, (also known as the Schrems II case). The Advocate General states that the validity of the Commission Decision approving standard contractual clauses for the transfer of personal data (SCCs) cannot be called into question. At the same time, the Advocate General indicated that controllers and supervisory authorities have an obligation to suspend transfers on the basis of SCCs if the obligations contained in the clauses cannot be guaranteed under the laws of the data importer. Please click below for a short client memorandum on these guidelines.

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    • 14/01/2020
    • Articles

    OECD Makes Recommendations for Improvement of Performance-Based Managed Entry Agreements for Medicines

    The Organisation for Economic Co-operation and Development (“OECD”) published a health working paper (the “Paper”) authored by Martin Wenzl and Suzannah Chapman that offers recommendations for the use of performance-based managed entry agreements in OECD countries and EU Member States (see, attached). The Paper reflects the results of a review of managed entry agreements (“MEAs”) carried out in 2018 and 2019. MEAs are arrangements between healthcare payers and pharmaceutical firms that provide for the reimbursement of generally new health technologies, including medicines, while controlling the financial impact of that reimbursement and keeping price concessions confidential. These financial agreements are thus tools for achieving patient access to medicines while managing uncertainty. A further group of MEA’s, far less common than these purely financial agreements, are performance-based contracts. Both financial MEA’s and performance-based MEA’s can be assessed either at the level of individual patients or at that of a given population. The Paper indicates that the experience with performance-based MEA’s is both limited and mixed. This is in large part due to the dearth of available information as few countries have formally assessed their experience with performance-based MEA’s. The Paper therefore relies on limited public sources and a number of expert interviews. Only Belgium and Sweden had independent evaluations conducted by third parties. The tentative conclusion of the Paper is that performance-based MEA’s have made only a limited contribution towards reducing uncertainty regarding product performance. This is why the Paper makes recommendations for good practices that make it more likely for performance-based MEA’s to reach their objectives. These are: i. to use performance-based MEA’s strategically and in the wider context of information derived from the use of other instruments such as horizon-scanning; ii. to identify uncertainties and design the performance-based MEA’s to address such uncertainties; iii. to create a governance framework that ensures transparency of process and guarantees that results are actually acted upon; iv. to ensure an appropriate level of transparency of content, even though some parts of the MEA’s, such as prices, may have to remain confidential. The Paper points out that countries could benefit from sharing information but very little information is at present published or shared. Still, the Paper cites approvingly a number of collaborative initiatives of the European Medicines Agency such as the EU-wide framework on patient registries or the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.

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    • 13/01/2020
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 12

    The December 2019 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.    Click below to view and download the issue

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    • 10/01/2020
    • Articles

    MEP Cindy Franssen Raises Important Questions Regarding Medicine Shortages in European Union

    Member of the European Parliament Cindy Franssen submitted to the European Commission (the “Commission”) a series of interesting questions regarding medicine shortages (see, attachment). Broadly, the questions probe for (i) possible violations of Directive 2001/83/EC if pharmaceutical firms “caus[e] shortages [of medicines] on the basis of commercial decisions”; (ii) the measures which the Commission plans to take to tackle shortages; and (iii) the proposals which the Commission intends to put forward in order to enhance local production of medicines. While some of these questions exhibit bias against the pharmaceutical industry, they are likely to prompt important answers from the Commission in relation to (i) the public service obligation associated with supplying medicines as contained in Article 81 of Directive 2001/83/EC; (ii) the initiatives which the Commission will take to address medicine shortages (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019 and Van Bael & Bellis Life Sciences Newsflash of 11 September 2019); and (iii) calls made in various circles to make sure that the production of key pharmaceutical ingredients is moved to Europe (see for example, Van Bael & Bellis Life Sciences Newsflash of 9 July 2019).

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    • 06/01/2020
    • Articles

    Grand-Duchy of Luxembourg - Creation of National Medicines Agency

    The Council of Government of the Grand-Duchy of Luxembourg approved on 20 December 2019 a draft bill that provides for the creation of a national medicines agency which will be known as "Agence luxembourgeoise des médicaments et des produits de santé" (« ALMPS ») (see attached press release). As its name suggests, ALMPS will be responsible for a range of products, including pharmaceuticals, medical devices, cosmetics, food supplements and other health products. As a result, Luxembourg will cease to be one of the few European countries without a medicines agency that is separate from the executive branch of government. According to the press release, once operational, ALMPS will be in a better position to cope with a range of public health issues, including health risk management, medicine shortages and universal access to medicines. Additionally and significantly, ALMPS will also be given an economic remit in that it will facilitate and preserve investment in the life sciences sector (the press release expressly mentions the biotechnology industry). ALMPS is supposed to achieve that goal by creating legal certainty in the form of a regulatory framework which will be “precise” and “administered efficiently” and will govern activities such as production, commercialisation and clinical trials.

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    • 24/12/2019
    • Articles

    EU General Court Backs European Commission in Refusal to Approve Schizophrenia Medicine

    Please find attached short comments on a judgment which the EU’s General Court handed down on 19 December 2019. The judgment confirms the broad discretionary powers of the European Commission and the European Medicines Agency when handling a request for marketing authorisation of a medicine under the centralised procedure.

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    • 23/12/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 11

    The December 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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    • 20/12/2019
    • Articles

    Belgium - Medicine Shortages

    On 19 December 2019, the federal House of Representatives adopted bill 55K229 modifying various laws to tackle medicine shortages (Wetsvoorstel tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Proposition de loi modifiant diverses legislations, en ce qui concerne les pénuries de medicaments)(the Bill). As is the case in many countries across Europe, medicine shortages are thought to be a pressing health problem that requires urgent action. The Bill seeks to address at least part of that problem and is expected to be complemented by a range of Royal Decrees that should be in place by 31 January 2020. The Bill includes the following key features: • It tightens the notification requirement of temporary supply cessations. • It equates a partial supply with a temporary cessation of supplies that gives rise to notification. • Medicines that are affected by supply cessations may be made subject to a temporary export limitation or prohibition. A Royal Decree will determine detailed rules. The lawmakers are confident that a focused export restrictions procedure which results in narrow export limitations will pass muster under European law, unlike the blanket export ban which the Constitutional Court first suspended and later annulled earlier this year (see, Van Bael & Bellis Life Sciences Newsflash of 19 July 2019 and 17 October 2019). • Wholesalers with a public service obligation and pharmacists now benefit from a supply obligation in their favour of three working days. It is thought that this rule will counter the possible shortages resulting from the application of supply quota systems by pharmaceutical firms. • Any costs resulting from a temporary supply obligation will be borne by the marketing authorisation holder. The Bill seeks to avoid that such costs burden the patient or the social security budget. • If a medicine is not available, the pharmacist will have the right to replace that product with an alternative that has the same active substance, the same dosage, the same route of administration and the same frequency of administration. It will be possible for the prescribing physician to object against this form of substitution in a given case. The Bill will not be notified to the European Commission pursuant to Directive 2015/1535 which requires Member States to advise the Commission and other Member States of the technical regulations which they intend to introduce for products and for Information Society services before their adoption. By contrast, according to the Parliamentary works that accompany the Bill, the Royal Decree that will govern the export restrictions will probably be notified under that Directive. However, to the extent this is true, the deadline of 31 January 2020 for having the entire regulatory framework in place will not be met as a notification under Directive 2015/1535 implies a mandatory standstill period of at least 3 months. The Bill is expected to be signed into law and published shortly. It will enter into force 10 days following its publication in the Belgian Official Journal, with the exception of specific provisions that will start to apply at the latest on 31 January 2020.

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    • 09/12/2019
    • Articles

    Seven European Supply Chain Organisations Adopt Constructive Approach to Tackling Medicine Shortages

    In an unusual joint move, seven European organisations which represent a range of stakeholders in the medicine supply chain call for a dialogue with European and national authorities in hopes of finding solutions to prevailing medicine shortages (see, attached press release of 6 December 2019). The seven organisations take a stance on behalf of suppliers of innovative medicines, generic medicines, biosimilars, vaccines and over-the-counter medicines as well as wholesalers, parallel traders and pharmacists. They indicate to prefer a dialogue that creates results over an approach that involves “placing short term disproportionate requirements on manufacturers and supply chain stakeholders that could have opposite effects to the ones intended”. An example of such a short term and disproportionate requirement seems to be in the making in the Belgian federal house of representatives where a committee of legislators has already voted a first time in support of a measure that attempts to stamp out supply quota systems while paying little attention to a range of other possible causes of occasional shortages. The appeal of the European organisations comes ahead of a meeting of the European Employment, Social Policy, Health and Consumer Affairs Council on 9 and 10 December 2019. Health ministers will pursue avenues for strengthened cooperation to improve access to medicines (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019). Medicine shortages feature as a prominent topic under that umbrella. For their part, the seven organisations list a number of what they refer to as “root causes” of medicine shortages which include a list of factors of a regulatory, production, quality, economic and supply chain nature (see, attached position paper). Given the diversity of causes of medicine shortages, the solutions advocated by the seven organisations are equally multi-faceted. They express support for: • EU lines of communication which, in turn, imply pan-European cooperation, a European definition of what constitutes a shortage of medicines, a European reporting and monitoring system, the identification of high-risk medicinal products, and the creation of reasonable security measures, incentives and penalties; • Regulatory flexibility which involves a case-by-case approach to specific shortage situations; • Efficient use of the “repeat use” procedure which involves reliance on the mutual recognition procedure more than once for subsequent applications to other Member States in relation to the same medicinal product; • Incentives for essential low-price products; • A predictable and sustainable pricing and reimbursement environment; and • Adequate information to all stakeholders, including healthcare professionals, patients and suppliers of alternative products to those under scrutiny.

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