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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    • 17/10/2019
    • Articles

    Clinical Trials | New Regulatory Developments

    The European Commission (the EC) has been active in the field of clinical trials lately. New Site Suitability Template On 15 October 2019, the EC published a new “Site Suitability Template” that sponsors of clinical trials can use as part of their application dossier. Although the template was developed for use under the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR), which, as you know, has yet to take effect, the EC emphasises that “this template is also relevant under Directive 2001/20/EC and may be used in advance of the Regulation applying”. It is clear that it will still take some time for the CTR to enter into force. During the latest meeting of the European Medicines Agency's Management Board (the EMA Board), it became apparent that it is currently too early for the EMA Board to even consider the timing of the audit of the CTR’s underlying IT systems (i.e., the EU Clinical Trials Portal and EU Database) (see here, p. 2). Yet, the entry into force of the CTR is contingent on an audit of the EMA Board confirming that the EU Clinical Trials Portal and EU Database are fully functional. Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products Yesterday, the EC published guidelines on Good Clinical Practice (GCP) specific to Advanced Therapy Medicinal Products (ATMPs). The guidelines describe the GCP requirements that are specific to clinical trials conducted with ATMPs. They complement the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines on Good Clinical Practice (ICH-GCP), which are of general application. In case of discrepancies, the EC guidelines prevail.

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    • 17/10/2019
    • Articles

    Belgian Competition Authority Imposes Second Fine on Professional Organisation of Pharmacists in Less Than Six Months

    On 15 October 2019, the Belgian Competition Authority (“BCA”) again took formal steps against the professional organisation of pharmacists (“Orde der Apothekers”/ “Ordre des pharmaciens”) (the “PO”) (see, attached press release of 16 October 2019). First Decision In a first decision, the BCA imposed a fine of EUR 225,000 on PO. This sanction comes less than six months after that same body was in May 2019 at the receiving end of another fine of EUR 1 million on account of exclusionary measures thwarting the development of MediCare-Market (see, Van Bael & Bellis Life Science Newsflashes of 5 June 2019 and 24 June 2019). This time, the BCA found that several provisions of the PO’s Code of Ethics and two of its communications unduly restricted the ability of pharmacists to advertise their business and non-pharmaceutical products, both online and offline. In its current version, the Code of Ethics forbids any “solicitation” of patients. The BCA found this to be “almost identical” to a ban on advertising. The BCA also took issue with two PO communications of 2014 and 2017 prohibiting pharmacists from using Google AdWords or social media to advertise their products. Although the advertising of medicines is regulated in Belgium, no such regulation applies to non-pharmaceutical products. These provisions of the Code and these two communications therefore had as their very object the restriction of competition. Interestingly, the BCA specified that “it did not have any objections concerning medicines” as advertising prescription medicines to end users is forbidden by law and advertising over the counter medicines is strictly regulated. Compared to its May 2019 decision, the BCA imposed a modest fine of EUR 225,000. The BCA only fined the PO for its communications preventing pharmacists from using Google AdWords or social media to advertise non-pharmaceutical products, not for the infringements included in the Code of Ethics. Having regard to the principle that decisions must be adopted within a reasonable time, the BCA explained that the infringements included in the Code of Ethics had been investigated since 2010 and should therefore not give rise to a fine. As a result, the fine was based on the sole turnover of pharmacists for their online sales of non-pharmaceutical products. Moreover, since the PO accepted to settle the case, it obtained a 10% reduction of the fine in exchange for its acknowledgment of the infringement and its waiver of the right to appeal this decision. The PO also offered commitments to the BCA, which were mentioned as a reason for the BCA not to impose any fine for the infringements included in the Code of Ethics. These commitments were examined by the BCA in a separate decision. Second Decision In this second decision, the BCA decided to close the investigation partially without imposing a fine after PO offered to (i) adopt a new Code of Ethics allowing advertising and the solicitation of patients, also through paying referencing services and social media, by the end of 2019; (ii) adopt a commented version of the Code of Ethics complementing the Code of Ethics on advertising and commercial practices, which should notably distinguish between medicines and other products, by the end of 2019; (iii) review the commented version of the Code of Ethics on a regular basis with regard to the decisional practice of disciplinary bodies of the PO and to assess the need to review the Code of Ethics at least every five years; and (iv) make accessible to members on its website an anonymised version of the disciplinary decisions adopted pursuant to the provisions of the new Code of Ethics. The BCA considered that these commitments were sufficient to remedy the flaws which it had identified and therefore made them binding on the PO. Contrary to the settlement procedure followed in the context of the first decision, when the BCA closes a case further to commitments received from the parties, it does not reach any final decision on the existence of an infringement. As a result, while the infringements contained in the first decision are now considered established, the BCA’s preliminary objections included in the second decision are not confirmed. In the second decision, the BCA blamed the PO for allowing disciplinary bodies to use specific provisions of its Code of Ethics as a basis for sanctioning pharmacists not only for their advertising activities, but also for offering significant rebates to patients. The BCA’s initial view was that this restriction on rebates amounted to “indirectly imposing a minimum price” for both medicines and non-pharmaceutical products sold in pharmacies. Since the BCA decided to accept the PO’s commitments, it did not take a final view on the merits of these initial objections. Remarkably, the BCA only “partially” closed the investigation further to the commitments offered by the PO. This seems to imply that the BCA is still investigating certain practices of the PO. It cannot therefore be ruled out that the BCA should adopt yet another decision regarding the PO in the coming months or years.

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    • 16/10/2019
    • Articles

    Italian Competition Authority Opens Investigation Against Leadiant over Allegedly Excessive Medicine Pricing and Other Abusive Conduct

    On 15 October 2019, the Italian Competition Authority carried out on-site inspections at the premises of Leadiant in Italy and, with the help of local competition authorities, in Germany and the United Kingdom (see, attached press release and decision). Leadiant is the marketing authorisation holder of chenodeoxycholic acid Leadiant (“CDCA”) which is 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 has been known for decades as a cure for cholesterol gallstones as well. Leadiant stands accused of (i) excessive pricing; (ii) foreclosing the market for “home brew” versions of CDCA produced in hospital pharmacies; and (iii) indulging in delaying and obstructionist tactics when negotiating high prices with AIFA, the Italian medicines agency. All of these alleged practices would constitute an abuse of dominant position in breach of Article 102, Treaty on the Functioning of the European Union. Leadiant has been in the crosshairs of competition authorities, healthcare regulators and political figures for quite some time. For example, its pricing practices for CDCA are under review in Belgium and The Netherlands (see, Van Bael & Bellis Life Sciences Newsflash of 9 April 2019, 9 September 2019 and 17 September 2019) and possibly also in Spain. Additionally, these practices formed the subject of questions in the European Parliament addressed to Commissioner for health and food safety Vytenis Andriukaitis (see, Van Bael & Bellis Life Sciences Newsflash of 11 February 2019). The Italian Competition Authority plans to finish its investigation by 31 October 2020.

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    • 15/10/2019
    • Articles

    Czech Republic Latest Member State to Tackle Medicine Shortages

    At the beginning of October 2019, the Czech Republic notified to the European Commission (the “Commission”) a series of proposed measures to tackle medicine shortages (see, attached notification). The notification, based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, should allow the Commission and other Member States to offer their view on the compatibility of the proposed measures with EU pharmaceutical law and with the free movement of goods principle. The Czech Republic contemplates adopting the following measures to ensure that reimbursed medicines remain available to patients: • the possibility to import medicines subject to shortages, even if the formal requirements for importing are not satisfied and as long as the quality and safety of the medicines are not compromised; • new authorisation requirements for the export of predefined medicines whose export restrictions are justified; • the establishment of an emergency medicine ordering system that benefits pharmacies; and • the possibility to change temporarily the maximum price and the reimbursement basis of a medicine that is in short supply. The move is part of a wider trend that sees Member States try and respond to medicine shortages.

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    • 10/10/2019
    • News

    Andreas Reindl speaks at GCR’s 2nd Annual IP, Antitrust & Innovation Conference in Brussels

    On 8 October 2019, Van Bael & Bellis partner Andreas Reindl participated in a panel session on digital platforms, data, innovation and market power at GCR’s 2nd Annual IP, Antitrust & Innovation Conference in Brussels. The panel discussed competition law issues in the world of digital platforms, covering recent EU and national cases involving Booking,com, Google, Amazon and Facebook as well as ongoing competition policy debates. The other panel members were Miguel Perez Guerra, Senior Competition Counsel, Google, Pinar Akman, Professor of Competition Law & Director of Centre for Business Law and Practice, University of Leeds, and Karen Jelgerhuis Swildens, Senior Legal and Competition Counsel of Booking.com. The panel was moderated by Paul Lugard, Baker Botts.

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    • 10/10/2019
    • Articles

    Belgium - Medicine Pricing | Avastin-Lucentis

    On 9 October 2019, there was a second debate in federal parliament on the status and role of Avastin and Lucentis in opthalmological care (see, attached parliamentary proceedings). As was the case the preceding day in the plenary session of the federal Parliament (see, Van Bael & Bellis Life Sciences Newsflash of 9 October 2019), the new debate in the committee for health and equal opportunities was again tense and offered a platform for intervening members of parliament to publicise known positions that are highly critical of the approach adopted by the Minister of Social Affairs and Public Health towards Roche and Novartis and of the pharmaceutical industry in general. For her part, the Minister firmly defended her policy explaining that (i) she had received expert advice against establishing the reimbursement of Avastin in the off-label indication for the treatment of wet age-related macular degeneration (“AMD”); and (ii) she had ensured, by concluding a Managed Entry Agreement with Novartis, that the price for the treatment of AMD with Lucentis would be equivalent to that of a hypothetical treatment of AMD with Avastin. Several members of parliament advocated further hearings with representatives of the agencies involved in this file, including the Federal Agency for Medicines and Health Products, the Commission for the Reimbursement of Medicines and the Belgian Competition Authority (“BCA”). In response to these requests, a hearing with the BCA, which received a complaint alleging anticompetitive arrangements between Lucentis and Novartis, will take place at an as yet unspecified date under the aegis of the committee for economic affairs. The debate promises to be interesting as it will afford the BCA the opportunity to explain its scrutiny of the pharmaceutical sector which it has earmarked as a priority industry for supervision. This is reflected in recent events, including the request of the Minister of Economic Affairs to the BCA to review the pricing practices of Leadiant (see, Van Bael & Bellis Life Sciences Newsflash of 9 September 2019) and the unannounced inspections earlier this week seeking to ferret out allegedly anticompetitive conduct hindering the market development of biosimilar products in the hospital channel (see, Van Bael & Bellis Life Sciences Newsflash of 8 October 2019).

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    • 09/10/2019
    • Articles

    Belgium - Medicine Pricing | Avastin-Lucentis and Related Matters

    The prices of medicines took again centre stage during the plenary session of Tuesday 8 October 2019 of the federal Parliament (see attached). At issue were specifically the prices and reimbursement status of Lucentis (Novartis) and Avastin (Roche). Five members of parliament wanted to learn why the Minister of Social Affairs and Public Health (the “Minister”) had failed to rely on a possibility which the Court of Justice of the European Union (“CJEU”) expressly created in November 2018 to reimburse the off-label use of a medicine for budgetary reasons (see, Van Bael & Bellis Life Sciences Newsflash of 21 November 2018). Under the approach proposed by the members of parliament at issue and endorsed by the CJEU, Avastin would be reimbursed for the treatment of the eye-condition wet age-related macular degeneration (“AMD”) while it has no therapeutic indication for the treatment of that condition. Avastin would thus function as a replacement for Novartis’ significantly more expensive Lucentis which does benefit from a therapeutic indication covering AMD. For its part, Avastin only has a marketing authorisation for a range of unrelated oncology indications. In her response, the Minister explained that she had managed to secure beneficial reimbursement conditions for Lucentis by concluding a Managed Entry Agreement (“MEA”) whose financial conditions are confidential. Additionally, the Minister defended her medicines policy of the last few years which was based on budgetary prudence, rewards for innovation and international cooperation among payers. However, this response did not satisfy the members of parliament who had raised the Avastin/Lucentis matter. They engaged in broadsides against Novartis, the wider pharmaceutical industry, the Belgian Competition Authority (which allegedly failed to investigate a competition complaint against Novartis and Roche) and the Minister. They promised further fireworks in a fresh debate on Avastin/Lucentis in the parliamentary committee for health and equal opportunities scheduled on Wednesday 9 October 2019 as well as during hearings on innovative expensive medicines which will take place in November 2019.

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    • 08/10/2019
    • Newsletters

    VBB on Belgian Business Law, Volume 2019, No. 09

    The September 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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    • 08/10/2019
    • Articles

    Belgian Competition Authority Carries Out On Premise Inspections of Pharmaceutical Firms

    The Belgian Competition Authority (“BCA”) just published a press release indicating that it is currently carrying out inspections at the premises of unspecified pharmaceutical firms which are suspected of hindering the market entry of biosimilar rivals of established medicines (see, attached press release in three language versions). The BCA will inquire whether any such firm violated applicable competition rules, including Articles 101 and 102, Treaty on the Functioning of the European Union and the equivalent provisions of Belgian law.

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