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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    • 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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    • 09/09/2019
    • Newsletters

    VBB on Competition Law, Volume 2019, No. 08

    The August 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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    • 09/09/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 08

    The August 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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    • 09/09/2019
    • Articles

    Belgium - Minister of Economic Affairs Uses Price Regulation Powers against Leadiant's CDCA

    Minister of Economic Affairs Wouter Beke took action against pharmaceutical firm Leadiant and, making use of his price regulation powers, reduced the price of chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”). CDCA was designated as an orphan medicine in December 2014, but its active substance is no longer patented and has been used for many years as an inexpensive treatment for cholesterol gallstones. In a press release (see attached, only the Dutch version is available), the Minister says that he lowered the price of what would seem to be a presentation of 100 tablets of 250mg of CDCA Leadiant to EUR 3,653.25 ex factory, while Leadiant had sought a price of EUR 14,000 ex factory. The presentation at issue covers the treatment of CTX during approximately one month. The Minister has also urged the Belgian Competition Authority (“BCA”) to review as a matter of priority the alleged abuse of a dominant position of which Leadiant might be guilty. The case before the BCA results from a complaint filed by consumer organisation Test-Aankoop/Test-Achats earlier this year (see, Van Bael & Bellis Life Sciences Newsflashes of 9 April 2019 and 11 February 2019). Additionally, the Minister called on the European Commission to review the rules governing orphan medicines. However, that call is superfluous as an assessment of these rules has already been under way for quite some time (see, Van Bael & Bellis Life Sciences Newsflash of 18 October 2018) and the outcome of this exercise is expected to be high on the agenda of the incoming European Commission.

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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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    • 30/08/2019
    • Articles

    Comparison of Regulatory Outcome of EMA and FDA New Medicine Marketing Applications (2014-2016)

    Officials of the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”) published a study on the regulatory outcome of 107 new medicine marketing applications submitted to both agencies in the period 2014 – 2016 (the “Study”* – see attached). The Study shows that there was a high rate of convergence between the decisions on marketing approvals of both agencies. The decisions upon first submission and review presented the same regulatory outcome for 91.5% of the applications (98 cases out of 107). That impressive figure rose to 98% as a result of resubmitted and reexamined applications (105 cases out of 107). Only two medicines, namely corifollitropin alfa and ataluren, were the subject of discordant marketing authorisation decisions. The Study also reveals that the broad alignment between the agencies on medicine approvals coexists with some variation in type of marketing authorisation. In addition, some concordant approval decisions exhibited differences in the approved indication. The divergent outcome upon first submission and review in the 9 cases referred to above were due to a difference in conclusions regarding efficacy (3 out of 9 medicines) and more disparate reasons such as dissimilarities in the submitted clinical data; and differing conclusions about the strength of evidence in support of safety or an applicant’s compliance with good manufacturing practices. According to the Study, the therapeutic areas that stood out from the perspective of outcome divergence were oncology and hematology. It is hoped that EMA and FDA officials will carry out similar studies in years to come as these may inform future policy decisions. *M. Kashoki, Z. Hanaizi, S. Yordanova, R. Vesely, C. Bouygues, J. Llinares and S. Kweder, “A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance and Why”, Clinical Pharmacology and Therapeutics, July 2019.

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    • 23/08/2019
    • Articles

    Portugal Latest EU Member State to Tackle Medicine Shortages and Regulate Parallel Trade in Medicines

    In Portugal, an amending decree-law of 16 August 2019 which entered into force on 19 August 2019 seeks to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. That obligation involves the duty to ensure a continuous supply of medicines. It prohibits abusive or discriminatory practices such as directly or indirectly refusing to fulfill medicine orders or applying differing deadlines. The new decree-law reinforces the public-service obligations for pharmaceutical companies to ensure that medicines make it to wholesalers who have a duty of their own to supply pharmacies and other retailers. Those who hold a marketing authorisation must constantly monitor their stock positions and communicate possible shortages both to the other stakeholders and Infarmed, the Portuguese health agency. The decree-law also clarifies the dual role of wholesalers which have to (i) supply the domestic market; and (ii) operate as logistical service providers. Furthermore, the new decree-law makes an attempt to limit parallel trade by precluding wholesalers from selling medicines to other countries or other distributors, unless they have first made sure to supply the domestic market. Finally, the amendments bolster the ability of Infarmed to enforce the new rules. A communication which Infarmed issued to publicize the new rules is attached. Portugal thus becomes the latest EU member state to tackle medicine shortages and interfere with parallel trade in medicines. It is expected that the new European Commission which will start operations at the end of the year will also address this issue.

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    • 19/08/2019
    • Articles

    Belgium - Medicine Shortages - New Development

    At the end of July 2019, Febelco and PharmaBelgium-Belmedis, two wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur – “WSD”), and the National Association of Wholesaler-Distributors (NVGV/ANGR) filed with the Constitutional Court (“CC”) a petition for annulment of Article 3, 2° of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet van 7 april 2019 tot wijziging van de Wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft/Loi du 7 avril 2019 modifiant la Loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (see attached excerpts from the list of pending CC cases). Pursuant to Article 3,2°, WSD are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WSD; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see Van Bael & Bellis Life Sciences Newsflashes of 8 May 2019 and of 17 May 2019).

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