News & Insights

  • 27/06/2022
  • News

The European Commission adopts the new Vertical Block Exemption Regulation (VBER) alongside new Guidelines on Vertical Restraints (VGL)

On 1 June 2022, the new Vertical Block Exemption Regulation (“VBER”) and Guidelines on Vertical Restraints (“VGL”) took effect. These introduce a number of important changes to the application of the EU competition rules to a wide range of vertical agreements affecting all sectors of the economy. In these VBB Insights, we analyse in detail the most important changes and their potential impact on market participants.

Read more
    • 04/07/2022
    • News

    Stockholm SCC Tribunal declines jurisdiction in ECT arbitration based on intra-EU objection

    For the first time ever, on 16 June 2022, an arbitral tribunal in Green Power Partners K/S SCE and SCE Solar Don Benito APS v The Kingdom of Spain (SCC Arbitration V (2016/135) held that it had no jurisdiction to hear the claims of two Danish investors against Spain based upon the intra-EU jurisdictional objection.

    Download PDF
    • 04/07/2022
    • News

    European Commission’s new approach to enforcement of sustainability chapters in FTAs

    On 22 June 2022, the European Commission published a communication on “The power of trade partnerships: together for green and just economic growth”, which sets out a new approach to promoting green and just growth through trade agreements. Given that many of the EU trade agreements already include commitments in the field of trade and sustainable development (TSD), the European Union aims to strengthen the implementation and enforcement of those commitments. In particular, the European Union will now seek to extend the application of the standard State-to-State dispute settlement procedure to the TSD chapters in its trade agreements and to impose trade sanctions in case of non-compliance.

    Download PDF
    • 30/06/2022
    • News

    The International Procurement Instrument: a new trade policy tool promoting reciprocity in access to international public procurement and concession markets

    Access of Union economic operators, goods or services to public procurement and concession markets from third countries as well as the elimination of restrictive public procurement practices in third countries remains an important policy objective of the European Union (Union). On 23 June 2022, the Union therefore adopted the International Procurement Instrument (IPI). The general objective of the IPI is achieving reciprocity by opening third-country public procurement and concession markets and improving market access opportunities for Union economic operators, goods or services. The present newsflash provides a synopsis of the set of rules of the IPI that shall soon enter into force.

    Download PDF
    • 28/06/2022
    • News

    Joanna Redelbach and Tetyana Payosova recognised by The Best Lawyers 2023

    Van Bael & Bellis is pleased to announce that our senior associates, Joanna Redelbach (Brussels) and Tetyana Payosova (Geneva), have been recognised in the 2023 edition of The Best Lawyers in Belgium and The Best Lawyers in Switzerland respectively. Joanna and Tetyana are recognised for their work in Trade Law. Since it was first published in 1983, Best Lawyers® has become one of the most respected guides to the legal profession globally, publishing its annual survey based on peer-review.

    Read more
    • 28/06/2022
    • News

    Isabelle Van Damme appointed by the European Commission to the arbitrators and TSD experts lists of candidates

    On 23 June 2022, the European Commission published its appointment of Isabelle Van Damme to the “List of Candidates for Appointment as Arbitrators and TSD Experts”. The European Commission will use this list to make proposals for the appointment of arbitrators and trade and sustainable development (TSD) experts in specific cases or for pre-agreed lists (rosters) under relevant bilateral trade agreements with third countries. The list was prepared in line with the European Commission’s adherence to the Equal Representation in Arbitration Pledge. Further information is available here.

    Read more
    • 27/06/2022
    • Articles

    Spanish Competition Authority Set to Continue Excessive Pricing Probe Against Leadiant

    On 15 June 2022, the Spanish competition authority (Comisión Nacional de los Mercados y la Competencia – CNMC) rejected the appeal by Leadiant Biosciences SpA, Leadiant Biosciences Ltd, Leadiant GmbH and Sigma Tau Arzneimittel GmbH (together, Leadiant) against the decision of the Competition Directorate of the CNMC of 3 March 2022 to discontinue the settlement negotiations with Leadiant aiming to terminate the abuse of dominance probe which the CNMC launched against Leadiant on 22 December 2020 for alleged excessive pricing of chenodeoxycholic acid (CDCA) (see, Van Bael & Bellis Life Sciences Insights and News Alert of 22 December 2020). CDCA is an orphan medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder. In support of its appeal, Leadiant submitted that the Competition Directorate had violated Article 47 of the Spanish competition law (Law 15/2007, 3 July 2007) by rejecting its proposed commitments and ending the settlement procedure. More precisely, Leadiant argued that the Competition Directorate had infringed its rights of defence and had caused it irreparable harm, which are two possible grounds of appeal under Article 47 of the Spanish competition law. First, regarding the alleged infringement of Leadiant’s rights of defence, the CNMC held that the Competition Directorate had, in fact, provided Leadiant with a sufficiently detailed and reasoned explanation as to why it rejected the proposed commitments. Hence, Leadiant’s rights of defence had not been violated. Second, regarding its alleged irreparable harm, Leadiant argued that this harm would result from a violation of Article 47(1)(b) and (e) of Law 30/2015, 1 October 2015, which regulates the common administrative procedures in the Spanish public sector. Pursuant to these provisions, a decision is void if it was adopted by an authority which is not competent or if the procedure followed is not the adequate one for that decision. However, the CNMC disagreed with Leadiant, holding that the Competition Directorate was competent and had complied with all applicable legal requirements. Consequently, the CNMC concluded that the Competition Directorate’s decision was not void, had not ignored Leadiant’s right of defence and had not caused irreparable harm. This implies that the CNMC will continue its excessive pricing probe against Leadiant. A final decision is expected before August 2023. Leadiant’s pricing practices have already been fined in the Netherlands (see, Van Bael & Bellis Life Sciences Insights and News Alert of 20 July 2021) and Italy (see, Van Bael & Bellis Life Sciences Insights and News Alert of 1 June 2022), whilst they are being investigated in other Member States including Belgium (see, Van Bael & Bellis Life Sciences Insights and News Alert of 9 September 2019).

    Download PDF
    • 24/06/2022
    • News

    Andrzej Kmiecik moderates panel on Dual Distribution and Information Exchange in Brussels at Informa's Vertical Restraints and Distribution conference

    On 22 June 2022, Van Bael & Bellis partner Andrzej Kmiecik moderated the panel session on “Dual Distribution including Information Exchange», at the Informa conference on Vertical Restraints and Distribution held in Brussels. Other members of the panel were Paul Bridgeland (European Commission), Anselm Rodenhausen (Zalando) and Kayvan Hazemi-Jebelli (Computer & Communications Industry Association: CCIA). Topics covered included the revised rules on dual distribution, information exchange in a vertical context, and the treatment of hybrid and other platforms under the new vertical restraints regime. More information on the conference can be found [PLEASE INSERT LINK].

    Read more
    • 23/06/2022
    • Articles

    Belgian Government Think-Tank Publishes Study on Compulsory Licensing for Expensive Medicines

    On 14 June 2022, the Belgian Health Care Knowledge Centre (KCE), a research institute funded by the federal government, published a study discussing “Compulsory Licensing for Expensive Medicines” (the CL Study). The CL Study was commissioned by the Committee for Health and Equal Opportunities of the federal Chamber of Representatives which is reviewing bill 55K407 that seeks to expand the existing system of compulsory licensing for patented medicinal products in the interest of public health (Article XI.38(1) Code of Economic Law). The publication of the CL Study preceded by a few days the adoption of an intellectual property waiver for Covid-19 vaccines by the Twelfth Ministerial Conference of the World Trade Organisation (see, Van Bael & Bellis Life Sciences News and Insights of 20 June 2022) and was almost immediately welcomed in Parliament by the Minister of Social Affairs and Public Health. While the compulsory licensing of pharmaceutical patents is therefore clearly a trending topic, the CL Study is strikingly cautious in making policy recommendations. This is because compulsory licensing for expensive medicines not only raises questions of principle but also of practical implementation. Additionally, high medicine prices are generally the result of increasingly complex technological innovations. The CL Study therefore advocates a comprehensive approach that considers the entire regulatory framework, not just patent law, and is in favour of calibrated measures that do not jeopardise the benefits of the current system which seeks to encourage and reward innovation. That is a crucial concern for a country such as Belgium which hosts a thriving ecosystem of pharmaceutical and biotechnological research, development, clinical trials and production facilities. Additionally, the incentives for innovation encompass a range of measures covering patent law, know-how, data and market exclusivity, and targeted rules that stimulate the development of orphan and paediatric medicines. Lastly, the CL Study fully recognises the difficulties associated with defining an excessive price for medicines. It notes that the excessive pricing cases brought by European competition authorities all involve off-patent medicines (for a recent example with regard to Leadiant, see, Van Bael & Bellis Life Sciences News and Insights of 1 June 2022). On this basis, the CL study makes the following policy recommendations: • Compulsory licensing should not be an end, but rather a means to bring down prices in exceptional circumstances. • EU Member States should coordinate any initiatives to impose compulsory licensing in specific cases. • Adaptations to the current rules governing exclusivity and data access could be envisaged but require careful consideration. • In Belgium, the exchange of expertise between pricing and reimbursement authorities and the Belgian Competition Authority should be improved. • There is always scope for a more robust pricing and reimbursement policy and increased cooperation at EU and international level. • The patent exemption for pharmacists should be optimised. • Universities and public research institutions should apply “socially responsible licensing conditions”. • Collaborative models for patent licensing should be encouraged.

    Download PDF

Showing 1-9 of 1683 insights

View more
Keep updated Sign up for VBB insights

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