<p>，/PRNewswire/ -- Zentiva，作为一家领先的欧洲高质量和经济实惠药品制造商，回应了欧洲联盟普通法院关于城市污水处理指令（UWWTD）的决定，重申当前形式的 UWWTD 对欧洲基本药品的安全供应构成重大风险。</p>
<p>在指令通过后，尽管 16 个欧盟成员国提出了重大担忧，Zentiva 于 2025 年提起法律诉讼，请求撤销该指令，以保障依赖这些药品的患者的安全供应。</p>
<p>最近的裁决澄清了法院对欧盟法律下法律地位的解释。裁决认为 Zentiva 及其他仿制药和专利到期药品制造商并不被视为受到个别影响，因此没有直接的司法途径来挑战该指令——尽管其对行业及我们在欧洲供应的药品的影响是真实且显著的。重要的是，法院并未评估案件的实质内容——包括 UWWTD 下的扩展生产者责任（EPR）计划是否与欧盟法律兼容，或成本模型是否可行、合理或安全以确保药品供应的连续性。</p>
<p>Zentiva 首席执行官 Steffen Saltofte，同时也是欧洲药品协会的会长表示：<em>&#34;UWWTD 指令已获批准，并已进入实施阶段。其基础是多次被科学证明错误的评估，但它要求制药和化妆品行业承担至少 80% 的污水处理费用，尤其是在第四处理阶段。从一开始，我们就知道这对专利到期药品行业来说是不可行的。我们的价格大多受到监管，专利到期药品的每日剂量价格在几分钱的范围内。我们根本无法承担这些费用。&#34;</em></p>
<p>如果不进行修正实施，该指令可能会使许多基本药品的生产在经济上不可持续。结果将直接影响所有欧盟成员国的患者，减少可负担治疗的获取，并增加药品短缺的风险。最终，患者将为此付出代价。</p>
<p>法院的裁决并未解决这些长期存在的问题——它未能处理指令的实质内容及其实际影响，进一步强调了在全面实施之前需要进行政治和政策层面的修正，以避免造成伤害。</p>
<p>仿制药行业占所有发放药品的 70%，以及 90% 的关键药品。如果不采取进一步措施，该指令以当前形式被转化为 27 个国家的国家立法，很可能会导致大规模短缺。</p>
<p>Saltofte 进一步评论道：<em>&#34;作为一家欧洲公司的首席执行官和欧洲药品协会的会长，代表专利到期药品行业，我不会坐视这一切发生。我们将继续坚持必须共同开发的解决方案——而不是孤立进行，也不是在没有行业的情况下进行。这一问题需要所有利益相关者齐聚一堂，暂停实施，在欧盟层面进行修复，并以可行的方式在欧洲重新启动——确保清洁水而不危及依赖这些药品的欧洲人民的医疗保健的可用性、可及性和经济性。&#34;</em></p>
<p><strong>接下来需要发生什么</strong></p>
<p>该指令已被通过并进入国家实施阶段，使得政治领导和对话比以往任何时候都更加紧迫。</p>
<p>Zentiva 呼吁：</p>
<ul>
<li>在欧盟层面暂停当前 UWWTD 的实施，允许欧盟机构、成员国、水务运营商、患者、医疗系统和行业进行包容性对话，</li>
<li>进行新的独立研究，作为对指令必要修复的一部分，基于可靠的科学、比例原则和现实世界的医疗经济学，评估对药品的可用性、可及性和经济性的影响，</li>
<li>以可行的形式重新启动该指令，确保提供清洁水而不危及患者在欧洲的药品可用性、可及性和经济性。</li>
</ul>
<p><strong>关于 Zentiva</strong></p>
<p>Zentiva 为所有世代提供健康和福祉，专注于开发、生产和交付高质量、经济实惠的药品，服务于超过 40 个国家的 1 亿多人。Zentiva 拥有四个全资制造基地和广泛的外部制造合作伙伴网络，以确保供应安全。Zentiva 雇佣了超过 5400 名独特人才，大家团结在一起，致力于每天依赖我们药品的人们。请访问我们的网站 www.zentiva.com</p>
<p>Logo - https://mma.prnewswire.com/media/2660891/5369762/Zentiva_Logo.jpg</p>
<p>来源 Zentiva</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjIzJk5ld3NJdGVtSWQ9TE45MzEzNCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMjMwNjA0UFJfTkVXU19VU1BSX19fX19MTjkzMTM0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjIzJk5ld3NJdGVtSWQ9TE45MzEzNCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMjMwNjA0UFJfTkVXU19VU1BSX19fX19MTjkzMTM0"/></p>

广发中证香港创新药(QDII-ETF)

天弘国证生物医药ETF

医疗业 ETF - Vanguard

<p>捷恩特（Zentiva），一家欧洲制药公司，呼吁暂停实施城市污水处理指令（UWWTD），因为该指令可能对基本药物的供应构成风险。欧盟普通法院裁定捷恩特在法律上没有资格挑战该指令，这可能导致专利到期药物的成本增加。捷恩特的首席执行官强调，需要一种协作解决方案，以确保医疗保健的可获得性和可负担性，同时保持清洁水标准。该公司呼吁进行新的研究，并重新启动该指令以解决这些问题</p>

<p>, /PRNewswire/ -- Zentiva, a leading European manufacturer of high–quality and affordable medicines, responds to the decision of the General Court of the European Union concerning the Urban Waste Water Treatment Directive (UWWTD) reiterating that the UWWTD, in its current form, poses a significant risk to the secure supply of essential medicines in Europe.</p>
<div class="lb-trans"><p>，/PRNewswire/ -- Zentiva，作为一家领先的欧洲高质量和经济实惠药品制造商，回应了欧洲联盟普通法院关于城市污水处理指令（UWWTD）的决定，重申当前形式的 UWWTD 对欧洲基本药品的安全供应构成重大风险。</p>
</div><p>Following the adoption of the Directive, despite major concerns raised by 16 EU Member States, in 2025 Zentiva filed a legal action to request annulment of the Directive to safeguard the secure supply of essential medicines for the patients who depend on them every day.</p>
<div class="lb-trans"><p>在指令通过后，尽管 16 个欧盟成员国提出了重大担忧，Zentiva 于 2025 年提起法律诉讼，请求撤销该指令，以保障依赖这些药品的患者的安全供应。</p>
</div><p>The recent decision clarifies how the Court interprets legal standing under EU law. It concludes that Zentiva and other generic and off–patent medicine manufacturers are not considered individually affected, and therefore do not have a direct judicial route to challenge the Directive - even though its impact on the sector and on the medicines we supply across Europe is real and substantial. Importantly, the Court did not assess the substance of the case - including whether the Extended Producer Responsibility (EPR) scheme under the UWWTD is compatible with EU law or whether the cost model is workable, proportionate, or safe for securing the continuity of medicine supply.</p>
<div class="lb-trans"><p>最近的裁决澄清了法院对欧盟法律下法律地位的解释。裁决认为 Zentiva 及其他仿制药和专利到期药品制造商并不被视为受到个别影响，因此没有直接的司法途径来挑战该指令——尽管其对行业及我们在欧洲供应的药品的影响是真实且显著的。重要的是，法院并未评估案件的实质内容——包括 UWWTD 下的扩展生产者责任（EPR）计划是否与欧盟法律兼容，或成本模型是否可行、合理或安全以确保药品供应的连续性。</p>
</div><p>Zentiva CEO, Steffen Saltofte, who is also President of Medicines for Europe, stated: <em>&#34;The UWWTD Directive has been approved and is already in the implementation phase. Its foundation is an assessment that has been scientifically disproven multiple times, yet it obliges the pharmaceutical and cosmetics industries to cover at least 80% of the costs for wastewater treatment in the fourth treatment stage. From the very beginning, we knew this was not feasible for the off–patent medicine industry. Our prices are mostly regulated, and the price for a daily dosage of an off–patent medicine is in the cent range. We simply cannot absorb these costs.&#34;</em></p>
<div class="lb-trans"><p>Zentiva 首席执行官 Steffen Saltofte，同时也是欧洲药品协会的会长表示：<em>&#34;UWWTD 指令已获批准，并已进入实施阶段。其基础是多次被科学证明错误的评估，但它要求制药和化妆品行业承担至少 80% 的污水处理费用，尤其是在第四处理阶段。从一开始，我们就知道这对专利到期药品行业来说是不可行的。我们的价格大多受到监管，专利到期药品的每日剂量价格在几分钱的范围内。我们根本无法承担这些费用。&#34;</em></p>
</div><p>If implemented without correction, the Directive may render many essential medicines economically unsustainable to produce. The result would directly affect patients across all EU Member States, reducing access to affordable treatments and increasing the risk of medicine shortages. Ultimately, patients would pay the price.</p>
<div class="lb-trans"><p>如果不进行修正实施，该指令可能会使许多基本药品的生产在经济上不可持续。结果将直接影响所有欧盟成员国的患者，减少可负担治疗的获取，并增加药品短缺的风险。最终，患者将为此付出代价。</p>
</div><p>The Court outcome does not resolve these long–standing issues - it leaves the substance of the Directive and its practical impact unaddressed, reinforcing the need for a political and policy–level correction before full implementation causes harm.</p>
<div class="lb-trans"><p>法院的裁决并未解决这些长期存在的问题——它未能处理指令的实质内容及其实际影响，进一步强调了在全面实施之前需要进行政治和政策层面的修正，以避免造成伤害。</p>
</div><p>The generics industry counts for 70% of all dispensed medicines, and 9 out of 10 critical medicines. If no further measures are taken and the Directive in its current form is transposed into national legislation across 27 countries, it is highly likely to lead to massive shortages.</p>
<div class="lb-trans"><p>仿制药行业占所有发放药品的 70%，以及 90% 的关键药品。如果不采取进一步措施，该指令以当前形式被转化为 27 个国家的国家立法，很可能会导致大规模短缺。</p>
</div><p>Saltofte further commented: <em>&#34;As the CEO of a European-based company and President of Medicines for Europe, the representation of the off-patent medicine industry, I will not sit back and watch this happen. We will continue to insist on a solution that we must develop together - not in silos, and not without industry. This issue requires all stakeholders at one table to pause the implementation, repair it at EU level, and relaunch it in a workable way across Europe - ensuring clean water without jeopardizing the availability, accessibility, and affordability of healthcare for the people in Europe who depend on these medicines every day.&#34;</em></p>
<div class="lb-trans"><p>Saltofte 进一步评论道：<em>&#34;作为一家欧洲公司的首席执行官和欧洲药品协会的会长，代表专利到期药品行业，我不会坐视这一切发生。我们将继续坚持必须共同开发的解决方案——而不是孤立进行，也不是在没有行业的情况下进行。这一问题需要所有利益相关者齐聚一堂，暂停实施，在欧盟层面进行修复，并以可行的方式在欧洲重新启动——确保清洁水而不危及依赖这些药品的欧洲人民的医疗保健的可用性、可及性和经济性。&#34;</em></p>
</div><p><strong>What needs to happen next</strong></p>
<div class="lb-trans"><p><strong>接下来需要发生什么</strong></p>
</div><p>The Directive has been adopted and is entering national implementation, making political leadership and dialogue more urgent than ever.</p>
<div class="lb-trans"><p>该指令已被通过并进入国家实施阶段，使得政治领导和对话比以往任何时候都更加紧迫。</p>
</div><p>Zentiva calls for:</p>
<div class="lb-trans"><p>Zentiva 呼吁：</p>
</div><ul>
<li>A pause in the current implementation of the UWWTD at EU level, allowing an inclusive dialogue of EU institutions, Member States, water operators, patients, healthcare systems and industry,</li>
<li>Conduct new independent studies, as part of a necessary repair of the Directive, based on sound science, proportionality and real world healthcare economics, to assess the impact on the availability, accessibility and affordability of medicines,</li>
<li>A relaunch of the Directive in a workable form that delivers clean water without jeopardising the availability, accessibility and affordability of medicines for patients across Europe.</li>
</ul>
<div class="lb-trans"><ul>
<li>在欧盟层面暂停当前 UWWTD 的实施，允许欧盟机构、成员国、水务运营商、患者、医疗系统和行业进行包容性对话，</li>
<li>进行新的独立研究，作为对指令必要修复的一部分，基于可靠的科学、比例原则和现实世界的医疗经济学，评估对药品的可用性、可及性和经济性的影响，</li>
<li>以可行的形式重新启动该指令，确保提供清洁水而不危及患者在欧洲的药品可用性、可及性和经济性。</li>
</ul>
</div><p><strong>About Zentiva</strong></p>
<div class="lb-trans"><p><strong>关于 Zentiva</strong></p>
</div><p>Zentiva provides health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe and beyond. Zentiva has four wholly-owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. Zentiva employs more than 5,400 unique talents, bonded together by a commitment to the people who depend on our medicines every day. Visit us at www.zentiva.com</p>
<div class="lb-trans"><p>Zentiva 为所有世代提供健康和福祉，专注于开发、生产和交付高质量、经济实惠的药品，服务于超过 40 个国家的 1 亿多人。Zentiva 拥有四个全资制造基地和广泛的外部制造合作伙伴网络，以确保供应安全。Zentiva 雇佣了超过 5400 名独特人才，大家团结在一起，致力于每天依赖我们药品的人们。请访问我们的网站 www.zentiva.com</p>
</div><p>Logo - https://mma.prnewswire.com/media/2660891/5369762/Zentiva_Logo.jpg</p>
<div class="lb-trans"><p>Logo - https://mma.prnewswire.com/media/2660891/5369762/Zentiva_Logo.jpg</p>
</div><p>SOURCE Zentiva</p>
<div class="lb-trans"><p>来源 Zentiva</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMjIzJk5ld3NJdGVtSWQ9TE45MzEzNCZUcmFuc21pc3Npb25fSWQ9MjAyNjAyMjMwNjA0UFJfTkVXU19VU1BSX19fX19MTjkzMTM0" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=LN93134&amp;Transmission_Id=202602230604PR_NEWS_USPR_____LN93134&amp;DateId=20260223"/></p>

06:04 ET Zentiva 要求欧盟层面暂停 UWWTD，以确保药品的供应