News & Insights

  • 22/03/2021
  • News

Van Bael & Bellis awarded excellent rankings in Chambers Europe 2021

Van Bael & Bellis is pleased to see that its award-winning Life Sciences practice has gained well-earned recognition with a Band 1 ranking by Chambers & Partners, and, while the firm has once again been awarded top rankings for its renowned Competition and International Trade teams, its Corporate M&A team continues to be ranked among the top independent firms in Brussels by Chambers Europe 2021 whose results were recently published online. Sixteen partners are named in the 2021 edition for their expertise in their chosen practice area. Competition team (Band 2): Chambers Europe 2021 recognizes the firm’s strong offering of both EU Competition and domestic Belgian competition law noting as strengths: behavioural antitrust matters (cartels and abuse of dominance), handling significant appeals against Commission decisions, follow-on damages claims, strategic advice on lawsuits filed in multiple EU jurisdictions, advising major multinational companies on compliance matters and merger control. Clients say: One client simply describes the team as “outstanding in competition law advice.” Another stresses that “the firm has a good team of very knowledgeable people who go deep” into competition topics. International Trade/WTO team (Band 1): “Outstanding practice with a tremendous reputation for work opposing the imposition of trade remedies by the EC, acting for an impressive range of clients”, the team supports “European companies in investigations carried out by the EC and other trade authorities across the world”. Key partners are also well known for their presence in WTO proceedings. The team handles diverse customs matters, including disputes with national customs authorities and CJEU referral cases concerning the application of customs law in complex cases. Additional strength in sanctions compliance topics and litigation is also noted. Clients say: "They have huge experience and technical knowledge of the processes," adding: "Whenever we had questions, we could reach out to them and they were immediately answered." "Listening to everyone's requests and accepting the opinions of others is the strength of Van Bael & Bellis." "The cooperation is very uncomplicated, they are flexible and always on time." Life Sciences (Band 1): Prominent domestic life sciences practice advising an impressive roster of international biotechnology and pharmaceutical companies on interactions with the Belgian regulator and Belgian interpretation of EU legislation. Assists clients including public sector clients with a range of regulatory work relating to clinical trials, product distribution and market entry. Further represents clients in contentious matters before the Belgian courts relating to market authorisations and reimbursement concerns, as well as licence agreements and product liability. Clients say: A client enthuses that the team’s service is “fast and the lawyers advise you on how to proceed in the best interest.” Another client praises the team’s responsiveness, underlining that “the moment you contact them you can be sure you will have an immediate reaction.” Corporate M&A (Band 3): The “reactive and client-minded” Michel Bonne heads the “solid” Corporate M&A team which advises on a broad range of corporate mandates, including auction sales, acquisitions and corporate restructurings and represents private equity houses and venture capital investors. Clients say: One client highlights the team’s “quality of deliverables and the way they supported us through the negotiations,” adding that the team is “able to focus on what matters from a commercial standpoint.” Another client attests that the lawyers are “very responsive and proactive, trying to keep things going and keeping the ball rolling even when the other party was not very reactive,” adding that it was a “very smooth experience.”

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    • 12/04/2021
    • Newsletters

    VBB on Competition Law, Volume 2021, No. 3

    The March 2021 issue of our newsletter, VBB on Competition Law, which covers major developments in competition law at both the European Union and Member State levels.

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    • 12/04/2021
    • Articles

    European Union and South Korea Conclude Adequacy Talks

    On 30 March 2021, the European Commission and the Republic of Korea successfully concluded their negotiations on adequacy. An “adequacy finding” will enable free and safe data flows from the European Union to South Korea. The conclusion of the negotiations allows the European Commission to adopt an “adequacy finding” under Article 45.3 of the GDPR, confirming that South Korea’s Personal Information Act (PIPA) provides a comparable level of protection of personal data to European data protection laws. Such an “adequacy finding” will cover both private and public sector data controllers established in South Korea. The negotiations on adequacy were initiated in the context of the Free Trade Agreement that was concluded between the European Union and Korea. Within the framework of these negotiations, South Korea has enacted a series of reforms to its data protection laws. For instance, South Korea committed to implementing additional safeguards to protect European citizens’ personal data (e.g., introducing the concept of “pseudonymised information”, as well as the “purpose limitation” principle) and streamlined South Korea’s data protection regulatory authorities to one authority, while previously data protection breaches and issues were handled by multiple agencies. These new rules will be binding on companies importing data from the European Union and enforceable by South Korea’s Personal Information Protection Commission (PIPC). The European Commission will now launch the procedure for the adoption of a formal adequacy decision. This involves obtaining an opinion from the European Data Protection Board and approval by a committee composed of representatives of the EU Member States. Once the formal decision has been adopted, personal data can flow freely from the EU Member States to South Korea without any further safeguards or authorisations such as binding corporate rules and contractual clauses.

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    • 09/04/2021
    • Articles

    Conclusion of Pharmaceutical Pricing Investigation in Austria

    On 2 April 2021, the Austrian competition authority accepted commitments and closed its case concerning pricing strategies alleged to unlawfully hinder entry by generic competitors. More specifically, the pricing strategies in question involved special offers to hospitals of below-cost prices or free products, with higher prices charged for supply to community pharmacies. The attached note provides a summary of the case.

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    • 02/04/2021
    • Articles

    European Commission Starts Revising Pharmaceutical Legislation and Publishes Evaluation Roadmap and Inception Impact Assessment

    Earlier this week, the European Commission (the Commission) started the process of revising the general pharmaceutical legislation – Directive 2001/83/EC and Regulation (EC) 726/2004 - which it labels as one of the flagships of the Pharmaceutical Strategy for Europe (PSE) (see, Van Bael Bellis Life Sciences News Alert of 26 November 2020). Both the general public and the stakeholders are invited to submit their views on the “Combined Evaluation Roadmap/Inception Impact Assessment” (see, attachment). The Commission is seeking contributions on the broad range of issues covered by the PSE such as (i) unmet medical needs in areas outside the scope of the rules governing rare diseases and paediatric medicines; (ii) unequal access to affordable medicines; (iii) new technologies, including genomic sequencing, genome editing, artificial intelligence and medication based on genetically modified organisms; (iv) simplification of applicable rules and procedures; (v) vulnerable supply chains, security of supply and shortages; (vi) competition issues, including the role played by generics and biosimilar products; (vii) incentives designed to stimulate innovation; and (viii) antimicrobials. This initial public assessment started on 30 March 2021 and will end on 27 April 2021. A more thorough public consultation featuring targeted questions will be held in the fourth quarter of 2021. The Commission plans to propose draft legislation one year later in the fourth quarter of 2022.

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    • 02/04/2021
    • Articles

    USTR - 2021 National Trade Estimate Report on Foreign Trade Barriers - Assessment of European Pharmaceutical Markets

    The United States Trade Representative published on Wednesday 31 March 2021 her National Trade Estimate Report for 2021 on Foreign Trade Barriers (the Report; see, attachment). The Report defines trade barriers as “government laws, regulations, policies, or practices that protect domestic goods and services from foreign competition, artificially stimulate exports of particular domestic goods and services, or fail to provide adequate and effective protection of intellectual property rights” (Report p. 1). The Report says to cover significant barriers, regardless of whether they are consistent or inconsistent with international trading rules. As in previous years, the Report focuses extensively on foreign trade and investment barriers for the pharmaceutical industry in Europe (Report, pages 178 and following; pages 185 and following of PDF file). In a familiar lament, the Report decries “several Member State policies affecting market access for pharmaceutical products, including non-transparent procedures and a lack of meaningful stakeholder input into policies related to pricing and reimbursement, such as therapeutic reference pricing and price controls” (Report, p. 178). According to the Report, the lack of transparency and of “due process” gives rise to uncertainty and unpredictability for investment in these markets and is liable to undermine innovation (Id.). The Report cites the “clawback system” as a particularly pernicious system from an investment perspective. It requires pharmaceutical firms to return to the government a specific percentage of the amount spent by Member States over budgetary limits. The report identifies and targets various clawback systems in Member States such as Belgium, Greece, Hungary, Italy, and Romania. The Report also takes issue with inconsistent and lengthy time limits for pricing and reimbursement decisions, even though these procedures are supposed to be limited as a result of the application of the long- standing “pricing and reimbursement transparency” Directive 89/105/EEC. Furthermore, the Report keeps a watchful eye on the patent systems of overseas countries, both in general terms and in their application to the pharmaceutical system. This is why the Report expresses concern over the apparent disregard for patent protection in certain pricing and reimbursement decisions in Italy (Report, p. 179) and maintains earlier criticism of the EU manufacturing and stockpiling waivers, in effect since 1 July 2019, which introduced exceptions to the Supplementary Protection Certificate, the extended patent protection for active substances of medicines (Report, p. 206; see, Van Bael & Bellis Life Sciences News Alert of 13 June 2019).

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    • 01/04/2021
    • Articles

    Court of Justice of European Union Dismisses Appeals By Lundbeck and Others Against Citalopram Pay-for-Delay Patent Settlement Agreements

    The Litigation Chamber of the Belgian Data Protection Authority prohibited a controller from passing on personal data obtained in breach of data protection rules to its legal counsel. The Litigation Chamber did not issue a fine, but the decision serves as a clear message that further processing of such unlawfully obtained personal data, even in the context of legal proceedings, is prohibited. Please click below for a Client Alert on this decision.

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    • 31/03/2021
    • Articles

    Italian Highest Administrative Court Refers Avastin/Lucentis Case for Second Time to Court of Justice of European Union

    We are pleased to present a note on the questions which the Consiglio di Stato, Italy’s highest administrative court, presented earlier this month to the Court of Justice of the European Union (CJEU) in the Avastin – Lucentis case which Hoffmann-La Roche and Novartis have now been litigating in various courts and before several competition authorities around Europe for a considerable period of time. This newest procedural development marks the second time that the Italian court asks the CJEU for help. While the questions lie at the intersection of Italian procedural law and European law, the parties hope to revive what seems to be a losing battle over the off-label use of Avastin® and its interchangeability with Lucentis®, another, more expensive medicine that was specifically authorised for that use.

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