英国法院认定法庭拒绝CMA苯妥英决定有误
SOURCE / GOV.UK-CMA Updates · Tribunal was “wrong” to reject CMA phenytoin decision, says Court
原文
Tribunal was “wrong” to reject CMA phenytoin decision, says Court
完整原文
<div class="govspeak"><p>The <a href="https://www.gov.uk/cma-cases/investigation-into-the-supply-of-pharmaceutical-products#court-of-appeal-judgment">judgment from the Court of Appeal</a> (Court) comes after the Competition Appeal Tribunal (CAT) set aside the <a href="https://www.gov.uk/government/news/70-million-in-fines-for-pharma-firms-that-overcharged-nhs">Competition and Markets Authority’s (CMA) 2022 decision</a> and made its own findings against the parties.</p> <p>In re-making the decision, the CAT concluded – as the CMA had – that Pfizer and Flynn abused their dominant positions by charging excessive prices for phenytoin sodium capsules between 2012 and 2016. It also imposed almost identical fines on the firms to those issued by the CMA, totalling £69 million. However, it said there were flaws in the CMA’s analysis, and replaced the CMA’s reasoning with its own.</p> <p>Following appeals to the Court from both Pfizer and Flynn, and the CMA’s own appeal, the Court has now rejected the CAT’s approach in its entirety. It fully upheld the CMA’s appeal against the CAT setting aside the CMA’s decision, and found that the CAT had “misread, or mischaracterised, the CMA’s decision on critical issues”, and was “wrong” to set it aside.</p> <p>The judgment states:</p> <blockquote> <p class="last-child">The CAT found errors in the [CMA’s] Decision which, on a fair reading, the CMA did not make…</p> </blockquote> <p>Adding that:</p> <blockquote> <p class="last-child">… the CAT failed to engage with, or mischaracterised, the CMA’s decision on critical issues…</p> </blockquote> <p>In addition, the Court rejected the CAT’s finding of bias in the CMA’s approach, saying:</p> <blockquote> <p class="last-child">… the CAT was wrong to find that the CMA predetermined the outcome… and examined the evidence in a biased and selective way…</p> </blockquote> <p>And:</p> <blockquote> <p class="last-child">The CMA set outs its analysis at great length in the Decision. We can detect nothing in the CMA’s analysis of prices over time which indicates, or is relevant to, a finding of bias.</p> </blockquote> <p>In relation to Pfizer and Flynn’s appeals, the Court concluded that, “the CAT’s remade decision was vitiated by procedural unfairness” and went on to set aside the re-taken decision. It concluded also that, because the CAT was wrong to set aside the CMA’s decision, it had no basis to remake the decision.</p> <p>Now, the Court will consider further submissions from the parties before deciding whether to reinstate the CMA’s decision, including fines.</p> <p>Juliette Enser, Executive Director of Competition Enforcement, said:</p> <blockquote> <p class="last-child">This is an important judgment from the Court of Appeal. Phenytoin is a vital drug relied on by thousands to prevent life-threatening seizures, and the CMA found that these companies exploited their positions to charge the NHS excessive prices. The judgment confirms the Competition Appeal Tribunal was wrong to set aside the CMA’s decision – recognising that our findings were based on a fair and robust assessment of the evidence. We will now make submissions to the Court in advance of its further ruling.</p> </blockquote> <h2 id="case-background">Case background</h2> <p>After reassessing part of its case following a remittal from the CAT, the CMA imposed fines of approximately £70 million, in 2022, on Pfizer and Flynn – £63,300,000 and £6,704,422 respectively – for breaching competition law. It found that both firms had used their positions as the dominant suppliers in the UK market to charge excessive and unfair prices for phenytoin sodium capsules over a 4-year period.</p> <p>The CMA’s decision found that between 2012 to 2016, Pfizer’s prices rose by 780-1,600%. The company supplied the drug to Flynn, which then sold the capsules to wholesalers and pharmacies at prices significantly above its own costs. The combination of the prices imposed by Pfizer and Flynn resulted in prices between 2,300% and 2,600% higher than those previously charged for the drug. This illegal behaviour led to NHS annual costs for phenytoin capsules increasing from £2 million in 2012 to approximately £50 million the following year. </p> <p>In November 2024, the CAT agreed with most of the drug firms’ grounds of appeal, finding against the CMA in a number of areas, including its approach to calculating a ‘reasonable rate of return’, its assessment of unfairness, and aspects of its procedure.</p> <p>However, it concluded the firms had infringed competition law and imposed similar fines, with a small – 1% – reduction to Pfizer’s penalty.</p> <p>Today, the Court of Appeal has found that the CAT was wrong to set aside the CMA’s decision.</p> <p>For more information, see the <a href="https://www.gov.uk/cma-cases/investigation-into-the-supply-of-pharmaceutical-products">Phenytoin sodium capsules</a> case page.</p> <h2 id="email">Email</h2> <ul> <li>For general public: <a href="mailto:general.enquiries@cma.gov.uk">general.enquiries@cma.gov.uk</a> </li> <li>For media: <a href="mailto:press@cma.gov.uk">press@cma.gov.uk</a> </li> </ul> <h2 id="telephone-numbers">Telephone numbers</h2> <ul> <li>For media: 020 3738 6460</li> <li>For media – out of hours: 020 3738 6878</li> </ul> <h2 id="opening-hours">Opening hours</h2> <p>Monday to Friday, 9am to 5:30pm. On <a href="https://www.gov.uk/bank-holidays">bank holidays</a>, or outside of working hours, media can call the out of hours number or use the media email address above.</p> </div>
归纳
英国高等法院裁定，竞争上诉法庭在拒绝英国竞争与市场管理局（CMA）关于抗癫痫药物苯妥英钠定价的决定时存在错误。CMA此前认定制药公司辉瑞和飞利浦-田边滥用市场支配地位，对苯妥英钠胶囊收取过高价格，违反竞争法。竞争上诉法庭曾推翻该决定，但法院现已撤销其裁决，并将案件发回重审。该判决强调了对药品定价监管的司法立场。
点评
英国法院确认 CMA 对制药公司过高定价的监管权限，强化药品滥用市场支配地位认定的司法标准。
法律视角点评
AI 生成 · 人工审核核心关切
英国法院确认 CMA 对制药公司过高定价的监管权限，强化药品滥用市场支配地位认定的司法标准。
实务启示
中国药企应警惕反垄断法下不公平高价风险，提前构建定价合规体系以避免类似执法行动。