News & Insights

  • 29/06/2021
  • News

Van Bael & Bellis awarded triple ISO certification as an Integrated Management System

Van Bael & Bellis is pleased to announce that the firm has been awarded the ISO 9001, ISO 22301 and ISO 27001 certificates. This achievement demonstrates the firm’s dedication to ensuring compliance with the highest standards of cybersecurity, business continuity and quality management. Van Bael & Bellis is the first European law firm that has obtained all three certificates thereby showing once again the firm’s commitment to providing optimal legal services to its clients. Van Bael & Bellis Managing Partner Philippe De Baere commented: “Meeting our client’s needs has always been our top priority. Clients expect not only that we provide them with the best legal advice but also that they can trust that their data are secure and our systems are robust. ISO certification offers them the confidence that we have in place the systems and processes necessary to ensure the efficiency, resilience and security of our services.” The external auditing of our implementation of these standards was conducted by Brand Compliance B.V. who presented us with certificates of recognition on 28 June 2021. For further information please contact Thibaut D’hulst _____________ About the ISO Standards 1. ISO 9001:2015 The Quality Management Standard ISO 9001:2015 is based on seven quality management principles that can be used by top management to lead an organization towards improved performance. It is the world’s foremost quality management standard, used by hundreds of thousands of organizations in over 170 countries around the globe. It sets out the essential requirements for a practical and effective quality management system (QMS) which is, in essence, a system for minimising risk and maximising opportunity. ISO 9001 sets out seven key principles of quality management: • Customer focus • Leadership • Engagement of people • Process approach • Improvement • Evidence-based decision making • Relationship management These seven principles are not auditable, but are fundamental attributes of any quality management system. ISO 9001 is based on the PDCA cycle – Plan-Do-Check-Act – and its key elements are: • Establishing the quality management system • Documenting the system • Implementing the system • Reviewing the results • Maintaining the system • Improving the system. 2. ISO 27001:2017 Implementation of Information Security Management System The worldwide international standard for information security: ISO 27001 sets out the auditable specification for an information security management system (ISMS). An ISMS is a set of policies, procedures, processes and systems that manage information risks, such as cyber attacks, hacks, data leaks or theft. The standard adopts a best practice approach and helps organizations manage their information security by addressing people, processes and technology. Certification to the standard is recognized worldwide as an indication that an organization has put in place an ISMS aligned with information security best practice, enabling it to avoid the potentially devastating financial losses caused by data breaches, and helping to protect information in line with regulatory requirements such as the EU General Data Protection Regulation (GDPR). This standard is a framework that helps organizations “establish, implement, operate, monitor, review, maintain and continually improve an ISMS”. It helps businesses become more productive through, for instance, clearly setting out who is responsible for information risk. It ensures that the systems organizations put in place are effective, reliable and auditable. In so doing, the certification to the standard protects and enhances an organization’s reputation. 3. ISO 22301:2019 Business Continuity ISO 22301 is the international standard for implementing and maintaining effective business continuity plans, systems and processes. This standard specifies requirements to implement a management system that allows an organization not only to deal with disruptions to business when and howsoever they arise, but also reduce the likelihood of their occurrence through enhancing an organization’s resilience.

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    • 03/08/2021
    • Articles

    Brussels Court of Appeal Upholds Attachment Order against Kazakhstan

    On 29 June 2021, the Brussels Court of Appeal (the Court of Appeal) handed down a judgment in which it upheld a protective attachment order over more than USD 500 million worth of assets, owned by Kazakhstan, and held with the Brussels subsidiary of the Bank of New York Mellon (the BNYM). Background The proceedings before the Belgian courts result from the efforts of two Moldovan investors (Anatolie and Gabriel Stati (the Investors)) who seek to enforce an arbitral award handed down in their favour in 2013. The arbitral tribunal (chaired by Karl-Heinz Böckstiegel) had found Kazakhstan liable for a harassment campaign against the Investors which ultimately resulted in a violation of the Energy Charter Treaty provisions on Fair and Equitable Treatment. As a result, the arbitral tribunal had ordered Kazakhstan to pay USD 508 million to the Investors as compensation for the damage suffered. In the absence of voluntary payment from Kazakhstan, the Investors sought a protective attachment order from the Brussels Court of First Instance in 2017 enabling them to freeze assets owned by Kazakhstan held with BNYM pending the outcome of the proceeding leading to the recognition and enforcement of their arbitral award in Belgium. The protective attachment order was obtained in ex parte proceedings (i.e., without notice to Kazakhstan). However, upon notice of the attachment order, Kazakhstan lodged a third-party opposition (tierce opposition / derdenverzet) challenging the validity of the protective order. After the Brussels Court of First Instance dismissed the third-party opposition, Kazakhstan appealed that decision before the Court of Appeal.

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    • 29/07/2021
    • Articles

    Analysis – New Excessive Pricing Cases in the UK and NL – Major Developments or More of the Same?

    Over the past two weeks, the competition authorities for the UK (“CMA”) and the Netherlands (“ACM”) have imposed significant fines for unlawful excessive pricing of medicines, accelerating the recent trend in Europe of pharmaceutical companies facing prosecution and sanctions for significant price increases. Background On 15 July 2021, the UK CMA imposed fines of £155 million on Accord-UK (previously Auden Mckenzie / Actavis) for price increases of more than 10,000% on hydrocortisone tablets after they were de-branded and fell outside the UK NHS price regulations. The CMA also imposed additional fines of £111.5 million for cartel agreements entered into when other parties threatened to enter the market. On 20 July 2021, the NL ACM imposed fines of approximately €20 million on Leadiant Biosciences for charging higher prices on chenodeoxycholic acid (CDCA) after it successfully received orphan medicine status and regulatory exclusivity. On 29 July 2021, the UK CMA imposed fines of over £100 million on Advanz and its private equity owners (HgCapital and Cinven) for price increases of more than 6000% on liothyronine tablets. New Developments or More of the Same? NEW – Prosecution of excessive pricing during regulatory exclusivity. While past excessive pricing cases, as well as the two new cases in the UK, all involve products for which any patent or regulatory exclusivity had expired, the case in the Netherlands concerns the pricing of a product for which Leadiant held valid regulatory exclusivity under the orphan drugs regulations. While the Dutch competition authority took pains to emphasize that any innovation by Leadiant was minimal (as CDCA was previously available for many years), this case nevertheless represents an additional step by competition authorities, demonstrating that they are also willing to prosecute strategies involving large price increases and limited innovation. NEW - Highest ever fines. The fines issued in these cases are the highest fines ever imposed on pharmaceutical companies by the UK and Dutch competition authorities, indicating that the authorities in these countries consider such excessive pricing to be as serious an infringement as cartel conduct. NEW – Specific requirements when negotiating prices. The Dutch decision includes the legal standard the ACM expects to be met by dominant pharmaceutical companies when negotiating prices. Specifically, such companies have a responsibility of “active engagement” and to negotiate “effectively and seriously” with health insurers and other relevant public authorities, and ultimately “not to charge and collect an excessive price”. NEW - 1800% and 250% price increases allowed? In the case in the Netherlands, the price of CDCA increased from €46 to €14,000. However, only Leadiant’s last price increase (of 350% in 2017) was held to be an infringement, while Leadiant’s prior price increases of 1800% in 2009 and 250% in 2014 were not sanctioned. Potential explanations are that Leadiant was not dominant before receiving exclusivity in 2017 or that Leadiant’s prior price increases were justified by the costs it incurred to gain regulatory approval. SAME - Compliance with regulations is not an infringement, but it is also not a valid defense. The ACM does not allege that Leadiant unlawfully obtained an orphan designation for CDCA, or that the necessary price increase to cover the costs for the registration is unlawful. However, the ACM also does not appear to accept that Leadiant’s compliance with the orphan regulations and the associated “reward” of regulatory exclusivity empower Leadiant to freely set its prices in its discretion, and does not justify the last 350% price increase implemented in 2017. SAME – Comparisons with prices in other countries is also not a valid defense. Consistent with the approach of the European Commission and Italy in the Aspen case, the ACM did not appear to accept Leadiant’s argument that the list price set it the Netherlands is “the lowest in the EU” as a defense against a finding of excessive pricing. NEW – Authorities not deterred by losses in prior cases. The UK CMA’s prior high-profile case against Pfizer and Flynn for excessive pricing of phenytoin sodium capsules was annulled on appeal. Despite this high profile rebuke – with the CMA being criticised for, among other things, misapplying the legal test for excessive pricing and failing to properly evaluate evidence adduced by the parties – the CMA and ACM appear undeterred in the pursuit of cases involving significant price increases on medicines.

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    • 29/07/2021
    • Articles

    UK CMA continues crack down on excessive pricing of medicines

    On 29 July 2021, the UK Competition and Markets Authority (“CMA”) imposed fines totalling more than £101 million on Advanz Pharma and previous owners, Cinven and HgCapital, for charging excessive and unfair prices for liothyronine tablets – a treatment for hypothyroidism (see Press Release). In line with most recent excessive pricing cases, this new decision concerns a drastic increase in the price of a genericised medicine that could not be justified by increased costs, investments or innovation. During its investigation, the CMA uncovered Advanz’s strategy of identifying genericised medicines subject to no (or limited) competition and substantial barriers to new entry. After acquiring the rights to such medicines, Advanz would “de-brand” the medicines in order to avoid applicable price regulations. Using this strategy, Advanz Pharma was able to increase the price of liothyronine tablets by more than 6,000% between 2009 and 2017. As a result, NHS spending on liothyronine tablets increased from approximately £2.3 million in 2009 to above £30 million in 2016. Liothyronine tablets were ultimately placed on the NHS “drop list”, leaving patients with the option of either ceasing use of the treatment or having to purchase the treatment at their own expense. This new decision by the CMA follows hot on the heels of its £260 million fine on Auden Mckenzie and Actavis (now Accord-UK) for charging excessive prices and concluding anticompetitive market sharing agreements in relation to the supply of hydrocortisone tablets (for further information see our previous updates: (1) CMA fines hydrocortisone tablet suppliers over GBP 260 million; and (2) Analysis – New Excessive Pricing Cases in the UK and NL – Major Developments or More of the Same?).

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    • 23/07/2021
    • Newsletters

    VBB on Belgian Business Law, Volume 2021, No. 6

    The June 2021 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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    • 23/07/2021
    • Articles

    CMA fines hydrocortisone tablet suppliers over GBP 260 million

    On 15 July 2021, the UK Competition and Markets Authority (“CMA”) imposed fines of more than GBP 260 million on the hydrocortisone tablet suppliers, Auden Mckenzie and Actavis (now named Accord-UK) for charging excessive and unfair prices and for paying potential rivals to remain out of the market (see Press Release). CMA Chief Executive, Andrea Coscelli, referred to the CMA’s findings as “without doubt some of the most serious abuses […] uncovered in recent years.” Excessive and Unfair Pricing The CMA found that Auden Mckenzie and Actavis charged excessive and unfair prices for 10mg and 20mg hydrocortisone tablets between 2008 and 2018 (Actavis took over Auden Mckenzie’s hydrocortisone tablet business in 2015 and is therefore liable for its conduct before that date). The CMA found that the parties had increased the price of the tablets by more than 10,000% compared to the price that had been charged for the original branded version of the tablets. More specifically, in April 2008, the price of a single pack of 10mg tablets was 70p and a pack of 20mg tablets was GBP 1.07; by March 2016, the prices had risen to GBP 88 and GBP 102.74, respectively. In supplying a de-branded version of the hydrocortisone tablets, the parties were able to exploit the fact that it is only the original, branded version of a drug which is subject to price regulation. In theory, the prices of de-branded medicines should be kept in check by the onset of competition between competing generic suppliers. However, in this instance – and to some extent due to the conduct of the parties (see Market Sharing below) - such competition did not, in fact, materialise. This created the space for the parties to drastically hike the price of their products. The total fine imposed by the CMA for the charging of excessive and unfair prices was GBP 155 million. Market Sharing The CMA also found that Auden Mckenzie concluded anticompetitive market sharing agreements with Waymade and AMCo (now known as Advanz Pharma). Pursuant to these agreements, Auden Mckenzie made monthly payments to Waymade and AMCo in return for their commitment to refrain from introducing their own generic hydrocortisone tablets to market. In total, over the duration of the agreement, AMCo received GBP 21 million and Waymade received GBP 1.8 million. The CMA fined Auden McKenzie/Accord-UK and Allergan (as its former parent company) a further GBP 66 million for its part in the market sharing agreement. AMCo/Advanz Pharma and its former parent, Cinven, were fined a total of GBP 43 million, and Waymade was fined GBP 2.5 million.

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    • 20/07/2021
    • Articles

    Dutch Competition Authority Imposes Fine of Almost EUR 20,000,000 on Medicine Supplier Leadiant on Account of Excessive Pricing

    The Dutch competition authority, Autoriteit Consument & Markt (ACM), announced on Tuesday that it imposed a fine of EUR 19,569,500 on Leadiant which was found guilty of an abuse of dominant position by charging excessive prices for chenodeoxycholic acid Leadiant (“CDCA”), a medicine indicated for the treatment of patients afflicted with cerebrotendinous xanthomatosis, a rare metabolic disorder (“CTX”)(see, attached press release and summary of decision in Dutch and English versions). In December 2014, Leadiant secured orphan medicine status for CDCA after it had succeeded in demonstrating the significant benefit of CDCA over existing treatments of CTX. Over time, Leadiant had managed to obtain a list price for CDCA of EUR 14,000 for a pack of 100 capsules (or EUR 153,300 per patient per year), a price far higher than that of an old medicine with the same active substance indicated for the treatment of cholesterol gallstones (EUR 46 for a similar pack). ACM considered Leadiant’s price for CDCA to be excessive because it was, according to ACM, both “exorbitantly high and unfair”. ACM’s finding that the price for CDCA was exorbitantly high followed from an analysis of Leadiant’s costs, investments and revenues associated with the product as well as the risk that the product could fail. ACM reached the conclusion that the “CDCA project was characterised by low costs in comparison with the revenues, low risks, and a very high return”. ACM specified that it had considered the “reasonable” rate of return of 15%. ACM’s finding that the price for CDCA was also unfair came in spite of the orphan medicine designation of CDCA. According to ACM, Leadiant did not innovate and CDCA did not present any therapeutic added value over other CDCA-based medicines. Even on the safety and efficacy front, the contribution of CDCA had been minimal as the active substance had been prescribed and administered for decades. Leadiant maintained that it had always been open to price discussions, but for ACM there were no indications that Leadiant had ever been willing to entertain the possibility of a non-excessive price. According to ACM, Leadiant had failed to “negotiate effectively or seriously with health insurers and the ministry [of health, welfare and sport]”. Leadiant has come under competition scrutiny in several countries, including Belgium, Italy and Spain, but ACM was the first to fine it (see, Van Bael & Bellis Life Sciences News and Insights of 11 February 2019, 9 April 2019, 9 September 2019, 17 September 2019, 16 October 2019, 29 June 2020, 3 November 2020, and 22 December 2020). The decision against Leadiant also marks the first time ACM issued a fine to tackle excessive medicine pricing.

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    • 14/07/2021
    • News

    Gabriele Coppo, Mats Cuvelier and Elyse Kneller participate in seminar on export control compliance

    On the first of July, Gabriele Coppo, Mats Cuvelier and Elyse Kneller spoke at a seminar, co-hosted by Van Bael & Bellis, on key compliance risks for companies exporting military goods and dual-use items, including intangible technology transfers. Their presentation also covered international and European regulatory initiatives related to corporate and social responsibility duties affecting trade. The seminar was part of a meeting of the Belgian Security and Defence Industries (“BSDI”), the national trade association bringing together companies in the defence, aerospace, (cyber-) security sectors. The seminar was the first in-person event BSDI had organized in more than a year, providing the VBB team with an eager and engaged audience.

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    • 14/07/2021
    • News

    Brussels Court Issues Judgment against Belgian Federal and Regional Governments in Climate Change Litigation

    On 17 June 2021, the French-speaking Brussels Court of First Instance (Franstalige rechtbank van eerste aanleg te Brussel / Tribunal de première instance francophone de Bruxelles; the Court) handed down its judgment in the so-called “Klimaatzaak” case, in which it found that the federal government as well as the governments of the three regions (i.e., Flanders, Wallonia and Brussels) breached Article 1382 of the Belgian Civil Code on tort liability and Articles 2 and 8 of the European Convention on Human Rights (the ECHR) by failing to take the necessary measures to limit the adverse effects of climate change on the country’s population. On 27 April 2015, the environmental non-profit association “Klimaatzaak” representing 58,000 Belgian citizens (the claimants) filed a lawsuit against the Belgian federal government as well as against the governments of the three regions, alleging that these authorities breached their general duty of care and the citizen’s human rights by failing to implement their commitments in terms of fighting climate change. In its judgment, the Court first addressed the admissibility of the claim brought by the claimants. It held that the 58,000 Belgian citizens showed a personal and direct interest in the legal action in view of the real threat of climate change and of its present and future adverse consequences on the daily lives of citizens in Belgium and elsewhere. In addition, the Court considered that the non-profit association “Klimaatzaak” had an independent personal and direct interest in the legal action in accordance with its statutory object, clearly aimed at combating climate change. On the merits, the Court considered that both the federal government and each of the governments of the three regions were individually liable for failing to implement their climate obligations. The Court based its reasoning on three findings. First, Belgium showed mixed results in terms of reducing greenhouse gas emissions (the GHG emissions) and therefore failed to meet international, European and national GHG emissions reduction targets. More specifically Belgium failed to comply with: • international targets laid down in the 2012 Doha Amendment to the Kyoto Protocol to the United Nations Framework Convention on Climate Change of 1997; • European targets set out in the Decision No 406/2009 of the European Parliament and of the Council of 23 April 2009 on the effort of Member States to reduce their greenhouse gas emissions; • internal targets that Belgian authorities have set for themselves. In addition, experts projected that Belgium will also not meet the targets for 2030 set by the EU Regulation 2018/842 of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030, even if additional internal policies were implemented. Second, the Belgian authorities failed to implement a strong climate governance. In particular, the Court considered that since climate policy is a competence shared between the federal government and the governments of each of the three regions, these entities should have taken appropriate coordinated actions to ensure that their climate obligations were met. Third, the Court noted that Belgium received repeated warnings from the European Union concerning its failure to meets its climate commitments. These findings, together with the fact that the Belgian authorities had full knowledge of the risks of climate change on the country’s population led the Court to conclude that neither the federal government, nor the governments of the three regions acted with the degree of care and diligence required by Article 1382 of the Belgian Civil Code. In addition, the Court considered that the same authorities breached the claimants' rights to life and right to privacy enshrined in Articles 2 and 8 of the ECHR. In that respect the Court stressed that the authorities did not take appropriate measures to prevent the risks and adverse consequences of climate change on the claimants’ life and privacy. The Court nonetheless rejected the claimants’ request for an injunction to further reduce the GHG emissions by 48% (or at least by 42%) in 2025, by 65% (or at least by 55%) in 2030, and by 100% in 2050. In particular, it found that whilst it could be determined that the federal government and the government of the three regions were liable for breach of their legal obligations, the principle of separation of powers did not allow the Court to intervene in political decisions and set specific GHG emission reduction targets. The claimants communicated their intention to appeal this part of the judgment before the Brussels Court of Appeal and to bring the case before the European Court of Human Rights.

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    • 09/07/2021
    • News

    Andreas Reindl discusses the proposed new VBER and Vertical Guidelines during Law Leaders Europe Conference organised by GCR

    On 13 July 2021, Van Bael & Bellis Partner Andreas Reindl will participate in a panel titled “Vertical restraints – everything new or business as usual” at GCR’s Law Leaders Europe Conference. The panel will provide the first opportunity to discuss key elements of the proposed new VBER and Vertical Guidelines that the European Commission published on Friday, 9 July 2021. [we can insert here the link to the webpage where the documents would be published] The other panel speakers are Tone Oeyen, Freshfields Bruckhaus Deringer, Matthias Eisenbarth, Anheuser-Busch InBev, Alexis Walckiers, E.CA Economics, and Helen Gornall, De Brauw Blackstone Westbroek You can find further information on this link.

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