News & Insights

  • 23/05/2019
  • News

Van Bael & Bellis launches the sixth edition of its “EU Anti-Dumping and Other Trade Defence Instruments"

The definitive book on EU trade defence law appears in a fully updated sixth edition. As comprehensive in its coverage as its predecessors, this new edition of the Van Bael & Bellis book on “EU Anti-Dumping and Other Trade Defence Instruments” provides incisive analysis and critical commentary on all relevant aspects of the EU trade defence instruments as actually applied by the EU Institutions against the backdrop of WTO law. The book covers every issue likely to arise in any trade defence matter and examines the numerous cases decided under the EU anti-dumping, countervailing, safeguard and trade barriers regulations, including all of the following and more: • determining the dumping and injury margins; • rules for the determination of permissible adjustments; • clarification of the terms ‘significant distortions’ and ‘distortions on raw materials’; • determining the subsidy margin; • determining the causal link between dumping or subsidy and injury; • determining if “Union interest” calls for intervention; • examining the differences between anti-dumping and anti-subsidy legislation; • procedural rules applicable to complaints, initiation of proceedings, investigations, protective measures, reviews and refunds; • conditions for accepting an undertaking; • measures that may be taken to prevent ‘circumvention’ of anti-dumping or countervailing measures; • rules governing the standing of various interested parties before the European Courts; • allocation and administration of quantitative quotas; and • surveillance measures. As a detailed and practical commentary on the relevant aspects of the EU trade defence instruments as actually applied by the EU institutions in the light of WTO law, the sixth edition of this book remains without peer as a guide to EU trade defence law. To order a copy of the book from Kluwer, click on this link.

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    • 18/07/2019
    • Articles

    Transatlantic Cooperation on Medicines - Latest Developments

    A visit to Canada by the Dutch Minister for Medical Care, Bruno Bruins, has given rise to interesting news regarding international cooperation on medicine pricing. According to the attached press release of 17 July 2019, The Netherlands is spearheading an effort to have Canada sign up to the Beneluxa initiative on medicines (http://www.beneluxa.org/). Beneluxa is an international alliance for pharmaceutical policy composed of Austria, Belgium, Ireland, Luxembourg and The Netherlands. Medicine pricing is one of the pillars of Beneluxa along with other areas such as horizon scanning. A possible transatlantic contribution to Beneluxa by Canada would undoubtedly add considerable economic weight to the grouping and to the pricing negotations which it initiates. At the same time, it would create a further layer of technical complexity that may cause an already cumbersome organisation to become entirely unwieldy. Separately, Canada also wants to participate in the International Horizon Scanning Initiative (“IHSI”) in which countries from the Beneluxa group and others seek to identify innovative medicines before they reach the market. The initiative is supposed to inform decision-making on treatment choices and prepare members for tough budgetary discussions. An announcement on the countries that will participate in IHSI is scheduled for October 2019.

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    • 15/07/2019
    • Articles

    Belgium - Request for Premiums and Benefits by Hospitals from Suppliers of Medicines and Medical Devices in Public Procurement Proceedings

    The Federal Agency for Medicines and Health Products (“FAMHP”) has recently come out against hospitals requesting premiums and benefits from firms participating in tender proceedings for the supply of medicines and/or medical devices. According to FAMHP, that practice is not only prohibited by Article 81 of the Law of 17 June 2016 on Public Procurement, but may also run foul of Article 10 of the Law of 25 March 1964 regarding Medicines. At issue is the widespread practice indulged in by hospitals to ask prospective suppliers of medicines or medical devices to take care of unrelated goods and services such as the supply of educational materials and software for patient management or to pay for outreach activities organised by the hospitals. Article 81 of the Law of 17 June 2016 on Public Procurement provides in relevant part that the award criteria of a request for tenders should be connected to the subject of the public procurement procedure. For its part, Article 10 of the Law of 25 March 1964 regarding Medicines prohibits firms, subject to exceptions, from offering or providng benefits in cash or in kind to specific healthcare professionals and institutions in connection with the prescription, administration or supply of medicines or medical devices. Similarly, healthcare professionals and institutions are banned from soliciting or receiving such benefits. Based on a combined reading of these provisions, FAMHP maintains that it is not possible to offer or request free additional services with the supply of medicines or medical devices. According to FAMHP, additional services have to (i) come at a price; or (ii) and this is a puzzling addition, “have to present a cost which expressly forms part of the price of the goods”. Importantly, the services have to present a connection with the goods supplied. FAMHP indicates that this implies that outreach activities or additional software are “not admissible”. It adds that “free competition” should be guaranteed at all times and that a hospital should be able to justify the use of a specific award criterion. In other words, the hospital does not benefit from discretionary powers when crafting and then implementing a procurement procedure. Attached are a circular letter of FAMHP on the subject as well as an opinion delivered earlier this year by the committee for public procurement, an advisory body, which informed the point of view of FAMHP.

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    • 12/07/2019
    • Articles

    Slovakia Final Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    Slovakia has become the 28th and final EU Member State to be given the powers to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US (see attached press release). On 11 July 2019, the US Food and Drug Administration (“FDA”) confirmed Slovakia’s status under the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. For their part, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017. Pursuant to the MRA, the EU and the US now fully recognise inspections of manufacturing sites for human medicines carried out in each other’s territories. Separately, the batch testing waiver existing under the MRA will also start to apply. As a result, qualified persons in pharmaceutical firms based in Europe will no longer be required to carry out the quality controls when these have already been run in the US. The EU and US will continue implementation work for the MRA in hopes of extending its scope to a range of additional products, including veterinary medicines, human vaccines and plasma derived medicinal products.

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    • 09/07/2019
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 06

    The June 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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    • 09/07/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 06

    The June 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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    • 09/07/2019
    • Articles

    France Presents Plan To Tackle Medicine Shortages and Adds Sense of Urgency to European Discussions

    Agnès Buzyn, the French Minister for Solidarity and Health, presented on 8 July 2019 a four-year plan to tackle medicine shortages in France (see, annex). The plan is the latest move in what is gradually becoming a wave of new rules and policy initiatives across Europe to fight the lack of availability of specific medicines. The plan reflects a four-pronged approach that includes the following measures: 1. Increased transparency and enhanced channels of communication between all stakeholders, including individual patients and patient organisations 2. New strategies for preventing, mitigating and managing medicine shortages • Power for community pharmacists, subject to conditions, to substitute out-of-stock medicines of major therapeutical importance (“médicaments d’intérêt thérapeutique majeur “ – “MITM”); • Focus on antibiotics that run an out-of-stock risk; • Further development of management plans for out-of-stock medicines (“plans de gestion des pénuries” – “PGP”) and creation of enhanced management plans for medicines that have already faced supply problems (“PGP renforcé”); • Specific measures targeting hospitals and wholesaler-distributors. 3. Reinforced national coordination and increased European cooperation • Increased powers for regulator (“Agence nationale de sécurité du médicament et des produits de santé – “ANSM”) to tackle supply quota systems (“contingentements”) and to import substitute medicines, including competing products; • Powers for specific public institutions to stock and distribute MITMs; • Pursuit of European rules, including definitions of key concepts such as medicine shortage and medicines of major therapeutical importance; • Advocacy in Europe of European or French production of key pharmaceutical ingredients and medicines; • Increased focus on joint procurement of essential vaccines; • Exchange of information between Member States on medicines hit by shortages. 4. Modified institutional architecture • The new plan will be implemented and steered by a “Comité de pilotage” (“COPIL”) and supported by a task force composed of representatives of the various competent ministries. ANSM will also be given a more prominent role. The French plan is certain to be met with close attention in France and abroad as it plays into the often expressed and at times overstated fears of supply disruption of medicines. Following repeated similar statements by other policy makers and interested parties (see e.g., Van Bael & Bellis Life Sciences Newsflash of 28 June 2019), the plan is certain to catapult this issue on the list of top health priorities of the incoming European Commission.

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    • 08/07/2019
    • Articles

    European Union Task Force Publishes Guidance Tackling Medicine Shortage Issues

    A European Union task force set up to address medicine supply problems published on 4 July 2019 two documents on the subject as follows: • Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders in the Union (EEA) (“Document 1” - attached); and • Good practice guidance for communication to the public on medicines’ availability issues (“Document 2” - attached). The task force was established by the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies (“HMA”), with representatives from the European Commission and national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the Good Manufacturing Practices/Good Distribution Practices Inspectors Working Group, the Working Group of Communication Professionals (“WGCP”) and the European Surveillance Strategy Working Group (“ESS WG”). Document 1 offers guidance to the pharmaceutical industry to facilitate the detection and early notification of medicine shortages to competent authorities. The guidance is based on a common EU definition of the term ‘shortage’ which is said to occur when supply does not meet demand at a national level. In that definition, the notion of supply refers to the total volume of stock of the individual medicinal product that is placed on the market by the Marketing Authorisation Holder. Demand relates to the request for a medicinal product by a healthcare professional, veterinarian or patient in response to a clinical need. On the basis of this definition, Document 1 explains the issues that form the subject of notification; the party responsible for the notification; the time of notification; the bodies that should be notified; and the information which a notification should cover. Document 1 also contains a handy proposed template for shortage notification. The guidance and template will be implemented in a pilot phase which is currently scheduled to start in the last quarter of 2019. Document 2 is addressed to EU national competent authorities and EMA and lays out principles and examples of good practices for communication on shortages to the public, including patients and healthcare professionals. The guidance is based on a survey carried out by the task force in all EU Member States to collect information on how issues related to shortages and availability of medicines are measured and communicated to the public. Significantly, in presenting the guidance, EMA described medicine shortages as a “a key public health priority for the EU network”. At the same time, EMA also acknowledged that medicine “[s]hortages and availability problems are complex with no quick solutions”.

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