执行主任在欧洲药品管理局（EMA）女性健康多方利益相关者研讨会上的演讲
正文 · 中文译文
以实际发言为准（发布文本基于事先准备的讲稿。发言过程中可能略有差异） 感谢大家线上线下同步参会。 欢迎出席欧洲药品管理局（EMA）的首届女性健康多利益相关方研讨会。我知道有些人远道而来参加。 在数据、研究、疾病预防和诊断方面。女性比男性寿命更长，但平均而言，她们有更多生命时间处于较差的健康状况，且健康结局更差。 令人震惊的是，我们多年来一直知道这一点：我们知道，在基于性别的差异方面，我们的认识存在空白；我们知道，女性在临床研究中的代表性历来不足，影响她们的一些治疗方法可能并未充分反映她们的具体需求。 影响大量女性患者的疾病、病症和健康状况未被充分认识。本应伴随科学突破而来的创新和投资，往往未能实现。 让我震惊的是，我们似乎不知何故已经接受了这一现状，仿佛对此无能为力。作为一名女性，也是六个姐妹之一，我觉得这极其令人震惊。 今天我还想和大家分享的另一件令人震惊的事是：就在六年多前，在我于欧洲议会参加执行主任职位听证会时，EMA的同事们为我做了非常出色的准备。我以为自己对每个问题都胸有成竹，但有一个问题我回答不上来，那就是：“EMA打算在女性健康方面做些什么？” 今天，这个房间里汇聚了一批独特的专家、科学家、患者、医疗专业人员、监管机构和行业代表，他们深切而独到地理解我们试图通过本次活动解决的问题。 我们都相信，必须采取行动来缩小这一差距。推动变革所需的专业知识、经验和想法都汇聚在这个房间里。 我们希望创新药物能更快地惠及女性，我们也需要帮助打破阻碍女性健康领域创新成果惠及所需患者的壁垒。 这意味着需要更多的研究、更好的诊断和更好的治疗选择。 我现在看到了明显的势头。在欧洲层面，欧洲议会妇女权利与性别平等委员会（FEMM Committee）正在强调女性健康的重要性，而且，医疗保健首次作为一项行动内容被明确纳入欧盟委员会《2026—2030年性别平等战略》。 去年通过的欧盟“安全心脏计划”重点关注性别特异性风险、女性早期检测，以及减少心血管护理中的不平等。 在欧洲药品管理局（EMA），我们已经采取了重要措施。我们正在监测临床试验的代表性，并发布针对性的指导——我们在必要时要求调整剂量和添加警告，并且正在加强妊娠期和哺乳期安全用药方面的工作。 重要的是，这是我们与国际合作伙伴共同开展的工作。 我们也在更好地利用真实世界数据，以了解女性中的药物使用和疾病模式。我们正在加强与利益相关者的对话，并扩大国际合作。 本次研讨会旨在支持进展，我们在此与您一起为下一步工作做出贡献。 我们的目标是强调我们网络中正在为女性健康所做的贡献，评估差距与挑战，探索有助于加快这一进程的机遇和行动。 我的愿景是，我们在离开本次研讨会时，能拥有一份包含切实可行、可衡量行动的路线图，帮助我们在这一任务上取得进展。 我们将把成果写入一份公开报告，总结主要发现、经验教训以及为推进欧盟女性健康而拟议的下一步措施。 这不仅仅是监管机构单独行动，也不仅仅是医生、研究人员、患者或行业单独行动。女性健康领域的进展显然太慢，需要所有人参与。 女性健康状况改善具有明确的经济效益。 对子宫内膜异位症等疾病的更好诊断将减少不孕并发症，并对医疗保健系统产生经济影响。 女性更健康地长寿，孕妇获得更好的治疗，不仅减少痛苦，而且减轻医疗保健系统的压力。 归根结底，这是要建立一个确保公平、一致、高质量监管和全民医疗保健的系统。 这在我完成任期之前是我的个人优先事项。这也是欧洲药品管理局（EMA）的优先事项。 我在开场时说过，女性仍然缺失。你们为本次研讨会所作的贡献有助于弥合这一缺口，从而建立一个更加均衡的体系，该体系既尊重女性在我们研究工作中的独特性，又为她们提供更好的药物获取途径和健康结果。 我非常感谢你们今天的参与。这对我们所有人意义重大。 药物研发中缺失的女性：欧洲药品管理局（EMA）的变革路线图（2026年9月30日） 女性健康多利益相关方研讨会（2026年9月28日至29日）
正文 · 英文原文
Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery) Thank you for joining us both online and in the room. Welcome to EMA’s first women’s health multistakeholder workshop . I know some of you have travelled from far away to participate. In data , in research , in prevention and diagnostics of diseases. Women live longer than men but on average spend more of their lives in poorer health and have worse health outcomes. And the shocking thing is, we have known about this for years: we’ve known that gaps exist in our understanding of sex-based differences, we’ve known that women are historically underrepresented in clinical research, that some treatments affecting them may not fully reflect their specific needs. Diseases, illnesses and health conditions that affect larger numbers of women patients are under-recognised. Too often, the innovation and investment that should follow scientific breakthroughs fail to materialise. What shocks me is that we somehow seem to have accepted this. As if there was nothing we could do about it. And as a woman, and one of six sisters, I find that incredibly shocking. And one of the other shocking things I want to share with you today is just that just over six years ago at my hearing in the European Parliament for the post of Executive Director, I had been brilliantly prepared by the colleagues in EMA. I thought I knew the answer to every question, and there was one question that I couldn't answer, and that was: ‘What was EMA going to do about women’s health?’ In this room today is a unique gathering of experts, scientists, patients, healthcare professionals, regulators and industry representatives who understand intimately and uniquely the need we are trying to address through this event. We all believe something must be done to close the gap. The expertise, experience and ideas needed to drive change are all here in this room. We want innovative medicines to reach women faster and we need to help break down the barriers that prevent innovation in women's health from reaching the patients who need it. This means more research, better diagnosis and better treatment options . I see a clear momentum now. At European level, the importance of women’s health is being highlighted through the European Parliament’s FEMM Committee, and, for the first time, healthcare is explicitly included, as an action item, in the European Commission’s Gender Equality Strategy 2026-2030. The EU Safe Hearts Plan adopted last year places a strong focus on sex-specific risks, early detection in women, and reducing inequalities in cardiovascular care. At EMA, we have taken important steps. We are monitoring clinical trial representation and issuing targeted guidance - we are requiring tailored dosages and warnings where necessary, and we are stepping up work on the safe use of medicines during pregnancy and lactation . Importantly, this is work we are doing with our international partners. We are also making better use of real-world data to understand medicine use and disease patterns in women. We are strengthening dialogue with stakeholders and expanding our international collaboration. This workshop is designed to support progress, and we are here, with you, to contribute to the next steps. Our goal is to highlight the contribution being made in our network towards women’s health, take stock of the gaps and challenges, explore opportunities and actions that will help speed up the process. My ambition is that we leave this workshop with a roadmap of practical, measurable actions that help us on this task. We will capture the outcomes in a public report summarising key findings, lessons learned and proposed next steps to advance women’s health in the European Union. This is not about regulators acting alone, nor about doctors, researchers, patients or industry acting alone. Progress is clearly too slow in women’s health and it requires everyone on board. Better health for women has clear economic benefits. Better diagnosis of diseases such as endometriosis will reduce infertility complications and also have an economic impact on health care systems. Women living longer in better health, better treatments for pregnant women not only reduce suffering but reduce pressure on healthcare systems . Ultimately, this is about building a system that ensures fair, consistent, and high-quality regulation and healthcare for all. This is a personal priority for me before I finish my mandate. And this is a priority for EMA. I began by saying that women are still missing. The contributions you make to this workshop can help close that gap, leading to a more balanced system that respects the uniqueness of women in our research work and provides them with better access to medicines and health outcomes. I am very grateful for your participation today. It means a lot to all of us. Women are missing from medicines development: EMA’s roadmap for change (30/09/2026) Multistakeholder workshop on women’s health (28-29/09/2026)