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主席 我們有請農業部的房間署跟食藥署吧有請杜署長 江署長"},{"start":19.7,"end":35.059,"text":"好 謝謝那我想今天早上其實已經聽到就是說我們這個辦法會註銷那我先簡單問一句那這個因為我看到新聞上面也有講說我們好像也有在新的辦法在討論了對不對好 那我想要先確認幾個事情因為我們之前這個爭議其實真正的關鍵在於說"},{"start":38.963,"end":53.373,"text":"其實不是申請有多複雜啦也不是門檻有多高啦其實就是後面的出貨行政作業太複雜啦程序太複雜因為呢人用藥轉為動物用藥之後的貼標制度到目前為止這一塊其實並沒有被真正的解決"},{"start":58.171,"end":73.498,"text":"所以人用藥之所以要貼標最主要就是要做用途區隔跟流向管理也就是避免誤用在人身上同時讓主管機關可以掌握藥品的流向問題就是在於這整個制度忽略了一個最基本的問題就是GMP的制度"},{"start":78.537,"end":100.383,"text":"這邊跟委員報告一下我們現在藥廠當然是Pick GMP的藥廠我們針對這個貼標轉換成我們現在的動物保護用藥的過程當中如何協助他貼標在貼標的過程其實我們會跟農業部這邊協作不一定要在Pick GMP廠內做貼標我們可能是在盤商可能是在經銷商能夠去確實來做這件事情跟藥廠溝通這件事情嗎這件事情我們"},{"start":103.824,"end":128.419,"text":"在新的制度持續的把這件事情能夠確立下來因為最後的方式的話還需要有很多stakeholder的溝通所以這邊我們持續會做的好我了解喔因為我想這個我不太確定是多久已經有溝通啦但是因為這是我們最近這段時間跟藥商這邊來了解了他們提到的問題其實是在這裡啦就是這個異地貼標對大家來說難度實在是非常的高所以"},{"start":129.219,"end":155.295,"text":"就是說他們也有提出一個解方既然你們也非常清楚了就是說大家的期待就是說我們不要選擇成本這麼高也這麼不符合實務的管制方式我們可以透過中盤來做標示分流甚至搭配流向申報或是記錄機制來達到同樣的管理目的那這樣子呢可以避免藥廠因為GMP批次出貨整批改標所產生的高成本"},{"start":156.656,"end":180.181,"text":"那也能夠維持藥品的流向可溯及性甚至更貼近食物流通的運作方式那這個看起來剛從您的回答裡面也是你們雙方都已經同意了往這個方向來努力對嗎對的謝謝委員的提示也是整個的方向這樣子對能夠貼近使用端能夠取得方便性以及在藥商供應的時候他們也可以完成我們的標示的辨識性"},{"start":182.65,"end":203.859,"text":"我想我還是會覺得說我們在整個處理的過程之中我們應該有行政怠惰因為這件事情其實如果更早之前我們了解為什麼藥商來登記這麼少的時候就應該要積極來協助而不是等到現在這個時候才來想這個辦法再來就是說我們新的辦法會不會從負面表列的方式來處理呢"},{"start":204.779,"end":228.395,"text":"這也是大家非常關注的因為其實最主要是說我們對於一些基本的胃藥工具像是ECC的針頭來說或者是脫水常用的乳酸鄰隔試液與忽略針或者是兔子等特殊寵物要用的這個優利酥保濕型點眼液這基本上在現在的藥局不管是連鎖的社區藥局他通通都領不到他通通都買不到所以"},{"start":229.255,"end":248.334,"text":"大家就會期待說我們是不是可以像多數國家一樣是採取負面表列的方式或是類似的制度也就是原則性開放例外限制並搭配受益的專業判斷跟事後管理而不是全面的事前限制所以我想了解我們新的方法新的辦法是不是也可以往這個負面表列的方式來努力呢"},{"start":249.919,"end":274.507,"text":"這邊跟委員做一些說明的確委員這邊做了非常完整的一些說明那以美歐日三個區域來提的話管理機構在美歐其實是分別是FDA跟EMA可是在日本的話其實就像我們類似台灣我們是其實很多是跟日本制度比較近一方面是後生勞動一方面是農林水產省的一個人一個是動物"},{"start":275.347,"end":291.707,"text":"那採取的方式供藥的部分其實是藥局或者藥商都是採取雙軌制對於正面表現負面表現的部分我們看到日本其實是原則上面規範如果沒有替代用藥那獸醫師會做判斷所以我們目前對動保用藥"},{"start":292.828,"end":310.8,"text":"也經過就我們了解是雙方做一些溝通之後也跟我們的獸醫師能夠確立哪些是需要的能夠進入我們的所謂的動保用藥目前是偏向這樣負面表列這個部分我們持續在這個部分我們會針對這個部分去思考"},{"start":311.513,"end":327.285,"text":"好 我想部長可能要補充 對嗎好 我來直接把這個做一點原則性的因為在動保法的第四條第二項談到是藥物就是當動物用的藥物不足的時候由人用藥物這邊公告去使用"},{"start":327.885,"end":350.64,"text":"那藥物包含了醫材跟藥品那從醫材的角度來看這個選擇性太多我們沒有辦法正面表列做不了所以醫材的部分應該採用負面表列它的這個風險管理程度也比較低就只要針對一些非常高風險的去排除就好但是藥品的部分"},{"start":351.22,"end":373.813,"text":"那涉獵的風險度就比較高裡面有很多是麻醉藥啦很多管制藥抗生素等等的那可能初步還是用正面表列那麼會比較安全性的管理所以大概可以採取這樣的方式來思考因為它這個法裡面把這個藥物兩個通通框進來了醫材跟藥品都框進來了"},{"start":374.073,"end":384.273,"text":"好 了解 那我想問一下就是說因為這個畢竟還是希望可以傾聽第一線的聲音所以我想了解的是說我們現在有沒有規劃大概什麼時候會來找我們相關的不管是收費師團體"},{"start":387.035,"end":409.144,"text":"對 公會來討論這樣子謝謝委員因為這個新的辦法嘛 大家都非常關注對 這個註銷公告然後公告了以後那我們也會同步來討論 擬定這個草案當我們凝聚了這個草案內容以後那獲可以後 我們大概就會全國開始來溝通進行宣講然後收集大家的意見"},{"start":410.104,"end":431.784,"text":"對 是全國開說明會還是座談會 因為這兩樣說明會比較是我公告你 我告訴你什麼所以我們應該是座談會吧 座談會的形式收集大家的意見大概是什麼時候呢 有沒有預計的時程表如果我們雙方都對這個草案 我們也預定說如果達成共識的話 看給我們"},{"start":433.325,"end":458.822,"text":"還是要一段時間啦 可能幾個月的時間 可能三個月好 那我們兩個月之後再來關注一下你們的進度好不好因為大家都非常關注這件事情那最後一件事情就是說我上個禮拜在這個農業部的諮詢的時候也有特別提到啦就是有關於生動物在取得藥物的時候難度非常的高畢竟相對的距離還是很遙遠畢竟在像野灣所在的台東池上想光取得人物的用藥都非常的困難"},{"start":459.762,"end":482.47,"text":"所以我是希望 那他們上禮拜其實也有那個林業署的同仁也有出席相關的會議所以我也是希望說在我們考量這個辦法的時候也要邀請我們野生動物相關的救傷團體林業署來去聆聽他們的聲音因為也許他們的困境又比我們想像來得更高 可以嗎已經納進來了 對 他們的意見都已經納進來了"},{"start":484.591,"end":492.028,"text":"對 但是因為接下來還要開相關的座談會嘛這個都是一定要邀請他們的好嗎 謝謝好 謝謝好 謝謝詹雅琳委員的資訊"}],"gazette":[{"speaker":"張委員雅琳","start":"2026-04-15T14:21:36.972000+08:00","guessed":false,"end":"2026-04-15T14:21:41.304000+08:00","text":"主席，我請農業部防檢署與食藥署。","quality":0.786},{"speaker":"主席","start":"2026-04-15T14:21:42.407000+08:00","guessed":false,"end":"2026-04-15T14:21:43.631000+08:00","text":"請杜署長、姜署長。","quality":0.857},{"speaker":"張委員雅琳","start":"2026-04-15T14:21:49.921000+08:00","guessed":false,"end":"2026-04-15T14:21:59.773000+08:00","text":"今天早上其實已經聽到這個辦法會註銷，那我也先簡單問一句，我看到新聞提及也有新的辦法在討論了，對不對？","quality":0.935},{"speaker":"張委員雅琳","start":"2026-04-15T14:21:59.954000+08:00","guessed":false,"end":"2026-04-15T14:22:01.916000+08:00","text":"那麼我想先確認幾件事情。","quality":0.818},{"speaker":"張委員雅琳","start":"2026-04-15T14:22:02.837000+08:00","guessed":false,"end":"2026-04-15T14:22:22.373000+08:00","text":"之前爭議的真正關鍵其實不在於申請有多複雜，也不是門檻有多高，就是後端出貨的行政作業太複雜、程序太複雜，因為人用藥轉為動物用藥之後的貼標制度這一塊，到目前為止其實沒有真正解決，對吧？對嘛！","quality":0.859},{"speaker":"張委員雅琳","start":"2026-04-15T14:22:27.531000+08:00","guessed":false,"end":"2026-04-15T14:22:37.756000+08:00","text":"人用藥之所以要貼標，最主要就是為了作用途區隔與流向管理，也就是避免誤用在人身上，同時讓主管機關可以掌握藥品的流向。","quality":0.925},{"speaker":"張委員雅琳","start":"2026-04-15T14:22:39.737000+08:00","guessed":false,"end":"2026-04-15T14:22:42.478000+08:00","text":"但是整個制度忽略了最基本的問題，就是GMP制度，對嗎？","quality":0.875},{"speaker":"姜署長至剛","start":"2026-04-15T14:22:47.537000+08:00","guessed":false,"end":"2026-04-15T14:22:53.019000+08:00","text":"這邊跟委員報告一下，藥廠當然要是PIC/S GMP藥廠。","quality":0.8},{"speaker":"姜署長至剛","start":"2026-04-15T14:22:53.019000+08:00","guessed":false,"end":"2026-04-15T14:23:08.083000+08:00","text":"我們針對貼標轉換成動保用藥的過程中如何協助業者貼標，在貼標的過程中我們會跟農業部協作，不一定要在PIC/S GMP廠內貼標，可能是在盤商、可能在經銷商，都能夠確實做這件事。","quality":0.899},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:08.083000+08:00","guessed":true,"end":"2026-04-15T14:23:09.083000+08:00","text":"後續有跟大家溝通這件事情嗎？","quality":0.077},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:08.383000+08:00","guessed":false,"end":"2026-04-15T14:23:08.883000+08:00","text":"有跟藥廠溝通這件事情嗎？","quality":0.909},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:08.883000+08:00","guessed":true,"end":"2026-04-15T14:23:09.883000+08:00","text":"還是這幾天才溝通？","quality":0.125},{"speaker":"姜署長至剛","start":"2026-04-15T14:23:09.363000+08:00","guessed":false,"end":"2026-04-15T14:23:22.870000+08:00","text":"我們會在新的制度持續地將這件事情確立下來，因為最後方式還需要與很多stakeholder溝通，這是我們會持續做的。","quality":0.889},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:23.150000+08:00","guessed":false,"end":"2026-04-15T14:23:23.570000+08:00","text":"好，我了解。","quality":1},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:24.731000+08:00","guessed":false,"end":"2026-04-15T14:23:35.678000+08:00","text":"我不確定多久以前有溝通，但是我們在最近這段時間向藥商了解，他們提到的問題其實是在這裡，就是異地貼標這件事情對大家來說難度實在非常地高。","quality":0.857},{"speaker":"張委員雅琳","start":"2026-04-15T14:23:37.219000+08:00","guessed":false,"end":"2026-04-15T14:23:59.192000+08:00","text":"所以他們也提出一個解方，既然你們也非常清楚了，大家的期待就是不要選擇成本這麼高、也這麼不符合實務的管制方式，而是可以透過中盤作標示、分流，甚至搭配流向申報、記錄機制，達到同樣的管理目的。","quality":0.964},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:00.233000+08:00","guessed":false,"end":"2026-04-15T14:24:11.257000+08:00","text":"這樣可以避免藥廠因為GMP批次出貨、整批改標所產生的高成本，也能夠維持藥品的流向可溯及性，甚至更貼近實務流通的運作方式。","quality":0.964},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:11.957000+08:00","guessed":false,"end":"2026-04-15T14:24:18.039000+08:00","text":"從您剛剛的回答看起來，你們雙方都已經同意往這個方向努力，對嗎？","quality":0.75},{"speaker":"姜署長至剛","start":"2026-04-15T14:24:18.039000+08:00","guessed":false,"end":"2026-04-15T14:24:29.161000+08:00","text":"對，謝謝委員的提示，這也是整個方向，這樣最能貼近使用端取得方便性，以及藥商在供應時也可以完成標示的辨識性。","quality":0.938},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:31.650000+08:00","guessed":false,"end":"2026-04-15T14:24:47.497000+08:00","text":"我還是覺得在整個處理過程中應該有行政怠惰情形，因為就我們了解，對於這件事情，在更早之前、藥商登記這麼少的時候就應該積極協助，而不是等到現在這個時候才想辦法。","quality":0.861},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:48.977000+08:00","guessed":false,"end":"2026-04-15T14:24:52.839000+08:00","text":"再來，新的辦法會不會以負面表列方式處理呢？","quality":0.947},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:53.779000+08:00","guessed":false,"end":"2026-04-15T14:24:54.900000+08:00","text":"這也是大家非常關注的。","quality":1},{"speaker":"張委員雅琳","start":"2026-04-15T14:24:55.660000+08:00","guessed":false,"end":"2026-04-15T14:25:31.548000+08:00","text":"最主要的原因是基本的餵藥工具──以1cc針筒、脫水常用的乳酸林格氏液與蝴蝶針，或者兔子等特殊寵物用的優麗舒保濕型點眼液來說，基本上，在現在的藥局或社區連鎖藥局統統都領不到、統統都買不到，所以大家就期待是不是可以像多數國家一樣，採取負面表列方式或類似制度，也就是原則性開放、例外限制，並搭配獸醫的專業判斷跟事後管理，而不是全面事前限制。","quality":0.818},{"speaker":"張委員雅琳","start":"2026-04-15T14:25:31.688000+08:00","guessed":false,"end":"2026-04-15T14:25:37.314000+08:00","text":"所以我想了解，新的方法、新的辦法是不是也可以往負面表列方式努力呢？","quality":1},{"speaker":"姜署長至剛","start":"2026-04-15T14:25:38.919000+08:00","guessed":false,"end":"2026-04-15T14:25:40.500000+08:00","text":"跟委員作一些說明。","quality":0.875},{"speaker":"姜署長至剛","start":"2026-04-15T14:25:41.300000+08:00","guessed":false,"end":"2026-04-15T14:26:03.487000+08:00","text":"的確，委員做了非常完整的說明，提到美、歐、日三個區域的話，管理機構在美歐分別是FDA跟EMA，可是在日本其實就類似臺灣，我們其實有很多制度是跟日本比較近，一方面涉及厚生勞動省，一方面涉及農林水產省，因為一邊是人，一邊是動物嘛！","quality":0.832},{"speaker":"姜署長至剛","start":"2026-04-15T14:26:05.288000+08:00","guessed":false,"end":"2026-04-15T14:26:09.834000+08:00","text":"至於採取的方式，供藥者其實有藥局或藥商，都採取雙軌制。","quality":0.833},{"speaker":"姜署長至剛","start":"2026-04-15T14:26:10.555000+08:00","guessed":false,"end":"2026-04-15T14:26:34.316000+08:00","text":"關於正面表列與負面表列，我們看到日本其實是原則上規範，如果沒有替代用藥，那麼獸醫師會判斷，所以就我們了解，對於動保用藥也是經由雙方作一些溝通，並且跟獸醫師確立哪些是需要的、能夠進入動保用藥，目前是偏向這樣。","quality":0.851},{"speaker":"姜署長至剛","start":"2026-04-15T14:26:34.316000+08:00","guessed":false,"end":"2026-04-15T14:26:39.780000+08:00","text":"針對負面表列這部分，我們會持續思考。","quality":0.75},{"speaker":"張委員雅琳","start":"2026-04-15T14:26:41.033000+08:00","guessed":false,"end":"2026-04-15T14:26:42.154000+08:00","text":"部長可能要補充，對嗎？","quality":1},{"speaker":"石部長崇良","start":"2026-04-15T14:26:42.815000+08:00","guessed":false,"end":"2026-04-15T14:26:46.017000+08:00","text":"我直接作一點原則性的說明。","quality":0.75},{"speaker":"石部長崇良","start":"2026-04-15T14:26:47.438000+08:00","guessed":false,"end":"2026-04-15T14:26:56.265000+08:00","text":"動保法第四條第二項談到的是藥物，當動物用藥物不足的時候，由人用藥物公告使用。","quality":0.971},{"speaker":"石部長崇良","start":"2026-04-15T14:26:57.305000+08:00","guessed":false,"end":"2026-04-15T14:27:17.718000+08:00","text":"而藥物包含醫材跟藥品，從醫材的角度來看，選擇性太多，沒有辦法正面表列、做不了，所以醫材應該採用負面表列，其風險管理程度也比較低，只要針對一些非常高風險者加以排除就好。","quality":0.933},{"speaker":"石部長崇良","start":"2026-04-15T14:27:18.479000+08:00","guessed":false,"end":"2026-04-15T14:27:36.689000+08:00","text":"但是藥品涉及的風險度就比較高，裡面有很多是麻醉藥、也有很多是管制藥、抗生素等等，初步可能還是要用正面表列，比較符合安全性的管理，所以大概可以採取這樣的方式思考。","quality":0.877},{"speaker":"石部長崇良","start":"2026-04-15T14:27:38.010000+08:00","guessed":false,"end":"2026-04-15T14:27:43.073000+08:00","text":"法律裡是把兩類藥物統統匡進來了，包括醫材跟藥品。好。","quality":0.609},{"speaker":"張委員雅琳","start":"2026-04-15T14:27:43.594000+08:00","guessed":false,"end":"2026-04-15T14:27:56.735000+08:00","text":"那我想問一下，畢竟還是希望你們可以傾聽第一線的聲音，所以我想了解現在有沒有規劃、大概什麼時候會找相關各方討論，不管是獸醫師團體或公會等等？","quality":0.828},{"speaker":"張委員雅琳","start":"2026-04-15T14:27:58.576000+08:00","guessed":false,"end":"2026-04-15T14:27:59.336000+08:00","text":"因為這是新辦法嘛！","quality":0.875},{"speaker":"張委員雅琳","start":"2026-04-15T14:27:59.436000+08:00","guessed":false,"end":"2026-04-15T14:28:01.917000+08:00","text":"大家都非常關注。","quality":1},{"speaker":"杜署長麗華","start":"2026-04-15T14:28:02.198000+08:00","guessed":false,"end":"2026-04-15T14:28:07.960000+08:00","text":"對，在公告註銷公告以後，我們也會同步討論、明定草案。","quality":0.818},{"speaker":"杜署長麗華","start":"2026-04-15T14:28:08.960000+08:00","guessed":false,"end":"2026-04-15T14:28:18.144000+08:00","text":"在我們凝聚草案內容、獲可以後，大概就會開始在全國溝通、進行宣講，蒐集大家的意見。","quality":0.857},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:19.265000+08:00","guessed":false,"end":"2026-04-15T14:28:22.287000+08:00","text":"要在全國開說明會還是座談會？都……","quality":0.786},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:23.769000+08:00","guessed":false,"end":"2026-04-15T14:28:27.432000+08:00","text":"說明會比較像是要公告、告訴你某事，所以應該是座談會吧？","quality":0.833},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:27.852000+08:00","guessed":false,"end":"2026-04-15T14:28:30.855000+08:00","text":"以座談會的形式蒐集大家的意見，對不對？是。","quality":0.667},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:30.855000+08:00","guessed":false,"end":"2026-04-15T14:28:31.756000+08:00","text":"那大概是什麼時候呢？","quality":0.889},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:31.916000+08:00","guessed":false,"end":"2026-04-15T14:28:32.877000+08:00","text":"有沒有預計時程表？","quality":1},{"speaker":"杜署長麗華","start":"2026-04-15T14:28:34.418000+08:00","guessed":false,"end":"2026-04-15T14:28:44.327000+08:00","text":"我們預定，如果我們雙方對這個草案達成共識的話，還是需要一段時間，可能是幾個月。","quality":0.829},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:44.327000+08:00","guessed":true,"end":"2026-04-15T14:28:45.327000+08:00","text":"幾個月？","quality":0},{"speaker":"杜署長麗華","start":"2026-04-15T14:28:44.827000+08:00","guessed":false,"end":"2026-04-15T14:28:45.187000+08:00","text":"可能3個月，至少法案……","quality":0.5},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:46.148000+08:00","guessed":false,"end":"2026-04-15T14:28:49.810000+08:00","text":"好，那兩個月之後再關注一下你們的進度好不好？","quality":1},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:50.090000+08:00","guessed":false,"end":"2026-04-15T14:28:51.851000+08:00","text":"因為大家非常關心這件事。","quality":0.909},{"speaker":"杜署長麗華","start":"2026-04-15T14:28:51.851000+08:00","guessed":true,"end":"2026-04-15T14:28:52.851000+08:00","text":"好，我們儘量。","quality":0},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:52.232000+08:00","guessed":false,"end":"2026-04-15T14:28:52.812000+08:00","text":"最後一件事情。","quality":1},{"speaker":"張委員雅琳","start":"2026-04-15T14:28:53.893000+08:00","guessed":false,"end":"2026-04-15T14:29:07.822000+08:00","text":"我上禮拜在對農業部質詢時也特別提到，野生動物取得藥物難度非常高，畢竟相對距離還是很遙遠，像是野灣所在的臺東池上鄉，光是想取得人用藥都非常困難。","quality":0.894},{"speaker":"張委員雅琳","start":"2026-04-15T14:29:09.682000+08:00","guessed":false,"end":"2026-04-15T14:29:30.770000+08:00","text":"上禮拜林業署同仁也出席了相關會議，所以我希望在考量這個辦法的時候，也要邀請野生動物救傷相關團體、林業署，聆聽他們的聲音，也許他們的困境又比我們想像得更高，可以嗎？","quality":0.959},{"speaker":"杜署長麗華","start":"2026-04-15T14:29:30.770000+08:00","guessed":false,"end":"2026-04-15T14:29:31.450000+08:00","text":"已經納進來了、他們的意見都已經納進來了。","quality":1},{"speaker":"張委員雅琳","start":"2026-04-15T14:29:33.591000+08:00","guessed":false,"end":"2026-04-15T14:29:38.763000+08:00","text":"對，但是你們接下來還要開相關座談會，而他們都是一定要邀請的，好嗎？好。謝謝。","quality":0.844},{"speaker":"主席","start":"2026-04-15T14:29:40.407000+08:00","guessed":false,"end":"2026-04-15T14:29:41.008000+08:00","text":"謝謝張雅琳委員的質詢。","quality":0.7},{"speaker":"主席","start":"2026-04-15T14:29:41.508000+08:00","guessed":true,"end":"2026-04-15T14:29:46.365143+08:00","text":"鍾佳濱委員、鍾佳濱委員、鍾佳濱委員不在。","quality":0},{"speaker":"主席","start":"2026-04-15T14:29:46.665143+08:00","guessed":true,"end":"2026-04-15T14:29:49.522286+08:00","text":"接著請郭昱晴委員質詢。","quality":0}]}},"supported_relations":[],"relations":[]}