歐洲藥品安全:Polpharma集團呼籲緊急行動




波爾法馬集團支持歐盟緊急措施以確保藥物獲取及加強歐洲的藥品主權

作為「歐洲藥品協會」的成員,波爾法馬集團與行業內的領先企業聯合,向所有27個歐盟成員國的首相和衛生部長發出公開信,呼籲緊急政策行動,通過一個針對藥品的五點行動計劃,以保護患者、促進生產並確保公平競爭。

這封信由來自整個歐洲專利藥物行業的首席執行官和高級管理人員簽署,重點強調以下幾點必要性:

1. **加速實施歐盟藥品法規,特別關注以下幾點:**

– 保持目前的11年監管專屬期,以避免不必要的健康支出。
– 加強和統一Bolar例外條款,確保仿製藥和生物類似藥在專利保護到期後能立即上市,從而為患者提供更快的獲取途徑,並為健康系統節省開支。

美國關稅的威脅不應成為擴大歐洲知識產權保護的理由,因為目前的保護已是全球最慷慨的。任何延長保護期的措施都將對公共健康預算造成負擔,並無法阻止生產轉移至海外,這一點已被多家原廠商指出。信中還強調,2024年歐盟國家在僅五種暢銷藥品上的支出達到200億歐元。根據原廠商對15種分子提出的延長申請(13至18年),模擬顯示健康預算的成本將在200億至1000億歐元之間。

2. **避免有害的法規重疊,例如在關於城市污水處理的指令(UWWTD)中,若不進行修改,將無意中干擾藥物供應並增加患者的成本。**

例如,僅在荷蘭,糖尿病藥物二甲雙胍的成本預計將上升高達875%,而抗生素阿莫西林的成本將上升高達400%。

3. **通過《關鍵藥物法》(Critical Medicines Act, CMA)等倡議支持關鍵藥物的生產,該法應與行業和健康安全的目標保持一致。**

目前98%的專利投資流向美國,僅有1%流向歐盟。

波爾法馬集團的首席執行官馬庫斯·西格表示:「歐洲現在必須行動,以保護其患者和藥品主權。仿製藥行業在歐洲進行投資,但我們也需要一個穩定、具競爭力和促進創新的環境,以便繼續這樣做。這個五點行動計劃是一個務實而緊迫的藍圖,以確保必需藥物的可獲取性、可負擔性和在歐洲的生產。」

波爾法馬集團將繼續致力於與歐盟機構和國家政府合作,建立一個有韌性、可持續和以患者為中心的歐洲藥品生態系統。

這篇文章強調了波爾法馬集團對於歐洲藥品市場的關注,尤其是在當前全球供應鏈面臨挑戰的背景下。藥品的可獲取性和價格問題不僅影響患者的健康,也影響整個公共健康系統的可持續性。波爾法馬集團的行動計劃不僅是對當前政策的回應,也是對未來藥品市場發展的前瞻性思考。隨著全球醫療需求的增長,如何在確保藥物可獲取的同時,保持生產的可持續性,將是未來政策制定者需要面對的重要課題。

以上文章由特價GPT API KEY所翻譯及撰寫。而圖片則由FLUX根據內容自動生成。

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