学 術 研 究 ABS ツールキット IV-C 遺 伝 資 源 利 用 研 究 のための 事 前 情 報 に 基 づく 同 意 (PIC) 見 本 ABS 学 術 対 策 チーム 森 岡 一

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1 学 術 研 究 ABS ツールキット IV-C 遺 伝 資 源 利 用 研 究 のための 事 前 情 報 に 基 づく 同 意 (PIC) 見 本 ABS 学 術 対 策 チーム 森 岡 一

2 内 容 はじめに... 3 事 前 の 情 報 に 基 づく 合 意 (PIC)の 取 り 方 マニュアル... 5 フィリッピン 標 準 研 究 提 案 インド 生 物 資 源 伝 統 的 知 識 アクセス 許 可 申 請 FORM I インド 研 究 結 果 海 外 商 用 目 的 移 転 許 可 申 請 FORM II インド 知 的 財 産 権 出 願 許 可 申 請 FORM III インド 生 物 資 源 伝 統 的 知 識 第 三 者 移 転 許 可 申 請 FORM IV ブータン 王 国 のアクセス 許 可 申 請 ブータン 王 国 遺 伝 資 源 と 関 連 する 伝 統 的 知 識 アクセス 申 請 ブータン 王 国 生 物 資 源 及 び 関 連 する 伝 統 的 知 識 第 三 者 移 転 許 可 申 請 ブータン 王 国 知 的 財 産 権 出 願 許 可 依 頼 申 請 マレーシアサラワク 州 生 物 資 源 アクセス 収 集 研 究 許 可 申 請 アフリカユニオン 伝 統 的 知 識 同 意 契 約 ウガンダ 共 和 国 事 前 の 情 報 に 基 づく 同 意 申 請 南 アフリカ 共 和 国 バイオ 探 索 許 可 申 請 南 アフリカバイオ 探 索 研 究 標 準 輸 出 許 可 申 請 カメルーンリンベ 動 植 物 園 共 同 研 究 覚 書 (PIC) ブラジル 非 商 用 研 究 用 遺 伝 遺 産 アクセスと 輸 出 標 準 許 可 申 請 ブラジル 非 商 用 研 究 用 遺 伝 遺 産 アクセスと 輸 出 特 別 許 可 申 請 GEF プロジェクト 事 前 情 報 に 基 づく 伝 統 的 知 識 アクセス 承 認 (PIC) 標 準 申 請... 87

3 はじめに 生 物 多 様 性 条 約 第 15 条 第 5 項 に 遺 伝 資 源 の 取 得 の 機 会 が 与 えられるために は 当 該 遺 伝 資 源 の 提 供 国 である 締 約 国 が 別 段 の 決 定 を 行 う 場 合 を 除 くほか 事 前 の 情 報 に 基 づく 当 該 締 約 国 の 同 意 を 必 要 とする と 規 定 されている この 項 目 では 4 つの 重 要 な 条 件 が 入 っている 一 つは 所 得 の 機 会 (アクセス) 許 可 が 必 要 なのは 遺 伝 資 源 が 対 象 であり 生 物 資 源 ではないということである 次 に 提 供 国 が 別 段 の 決 定 を 行 う 場 合 を 除 くため 提 供 国 が 別 段 の 決 定 を 行 って いるかどうか 確 認 する 必 要 がある 次 に 事 前 の 情 報 に 基 づくという 決 まりが あり 研 究 活 動 を 行 う 前 に 同 意 をとることが 必 要 である 最 後 に 提 供 国 の 同 意 という 点 である 提 供 国 の 同 意 であって 提 供 国 研 究 者 の 同 意 ではない 提 供 国 の 同 意 を 与 える 機 関 は 権 威 ある 当 局 (Competent National Authority)と 呼 ばれている 一 般 的 に 同 意 のことを Prior Informed Consent (PIC と 略 )とよば れているが 多 くの 提 供 国 の 場 合 許 可 (Permit)を 呼 ぶ 場 合 が 多 い 同 意 を 与 える 権 威 ある 当 局 は 提 供 国 の 制 度 によって 異 なる 一 か 所 が 許 可 を 与 える 国 もあれば 多 くの 政 府 系 機 関 に 権 限 を 移 譲 している 場 合 もある また 研 究 内 容 によっても 異 なるので 提 供 国 の 情 報 提 供 機 関 (National Focal Point) に 問 い 合 わせることが 必 要 となる PIC 取 得 で 課 題 となるのは 申 請 書 の 中 身 と 審 査 期 間 である 多 くの 申 請 書 では 研 究 目 的 に 従 い 提 供 国 内 での 活 動 のためのアクセス 許 可 と 遺 伝 資 源 の 国 外 移 動 の 許 可 その 他 の 許 可 ( 特 許 出 願 など)がある したがって 目 的 に 合 わせ て 取 得 すべき PIC は 異 なる 提 供 国 内 で 研 究 を 行 い 収 集 したサンプルを 日 本 に 移 動 させる 場 合 は アクセス 許 可 と 国 外 移 動 許 可 の2つが 必 要 となる また 特 許 出 願 等 を 考 える 場 合 にはそのための 許 可 も 必 要 となる PIC は 政 府 機 関 が 与 えるものなので 制 度 を 作 っている 国 では 決 まった 標 準 書 式 を 用 いる 場 合 が 多 い 許 可 申 請 に 必 要 な 書 類 として 研 究 計 画 書 や 素 材 移 転 契 約 書 利 益 配 分 契 約 書 など 共 に 申 請 人 の 身 元 能 力 資 金 等 を 示 す 書 類 が 必 要 になる 場 合 がある したがって 許 可 申 請 に 必 要 な 書 類 をよく 精 査 する 必 要 がある インドでは 許 可 を 入 手 してから 契 約 を 行 う 順 序 になっているが そ の 他 の 国 では 提 供 国 内 の 当 事 者 との 契 約 が 最 初 に 行 い その 契 約 書 を 申 請 書 類 に 添 付 する 形 式 が 多 い ここでは PIC 制 度 を 整 備 したいくつかの 国 の 発 行 している 標 準 書 式 を 掲 載 し

4 ている 制 度 を 整 備 していない 国 の 場 合 であっても 標 準 形 式 を 用 いることは 有 用 であると 考 えられるが まず 提 供 国 の 情 報 提 供 機 関 で 確 認 することが 最 も 重 要 である PIC の 具 体 的 取 得 手 順 について 各 国 毎 にまとめたクイックリファレンスチャ ートを 作 成 する そのため 本 書 では 許 可 申 請 の 書 式 のみをまとめている 今 後 提 供 国 では 制 度 整 備 が 行 われ 本 書 で 記 載 した 書 式 が 最 終 版 でなくなる 可 能 性 が 高 い したがって 実 際 に PIC 許 可 申 請 する 場 合 本 書 の 書 式 をそのまま 使 う 前 に 最 新 書 式 がないかチェックすることが 必 要 である

5 事 前 の 情 報 に 基 づく 合 意 (PIC)の 取 り 方 マニュアル 事 前 の 情 報 に 基 づく 合 意 (PIC)の 取 得 について 基 本 的 方 法 を 示 す PIC は 提 供 国 によって 異 なる 場 合 がある また 詳 細 に 取 得 方 法 を 示 していない 場 合 もあ る そのため ここに 掲 載 する 基 本 方 法 を 基 に それぞれの 国 の 要 求 される 事 項 に 従 って 修 正 することが 望 ましい ここでは 南 アフリカ 共 和 国 の 規 則 である Commencement of on Bioprospecting, Access and Benefi-sharing Regulations 2008 を 参 考 として 例 示 する ステップ1 申 請 に 必 要 書 類 の 準 備 提 供 国 で 申 請 書 類 の 形 式 が 決 まっている 場 合 はそれに 合 わせる 1. 研 究 計 画 書 2. PIC 申 請 書 バイオ 探 索 研 究 申 請 単 独 またはバイオ 探 索 研 究 と 輸 出 許 可 申 請 の 両 方 3. 素 材 移 転 契 約 書 4. 利 益 配 分 契 約 書 5. 確 認 に 必 要 な 証 拠 書 類 遺 伝 資 源 に 付 随 する 伝 統 的 知 識 および 伝 統 的 知 識 保 持 者 6. 申 請 人 を 同 定 するのに 必 要 な 証 明 書

6 ステップ1-1 遺 伝 資 源 情 報 の 考 察 と 整 理 1. 利 用 する 遺 伝 資 源 の 同 定 で 考 察 する 項 目 l 遺 伝 資 源 か 外 来 種 か l ヒト 由 来 か l ペット 鑑 賞 植 物 関 連 か l 国 内 各 種 法 令 のふくまれないこと l 素 材 の 起 源 を 示 す 証 拠 収 集 2. 付 随 する 伝 統 的 知 識 の 有 無 ステップ1-2 研 究 内 容 の 明 確 化 1. 非 営 利 研 究 か 営 利 研 究 の 可 能 性 は 2. 特 許 出 願 の 可 能 性 はあるか 3. 栽 培 化 繁 殖 遺 伝 子 解 析 などの 可 能 性 ステップ1-3 研 究 計 画 書 の 作 成 上 記 考 察 を 含 む 通 常 の 研 究 計 画 内 容 以 外 に 必 須 とな る 項 目 1. 研 究 成 果 はどのように 予 想 するか 2. 特 許 化 の 可 能 性 商 用 研 究 への 移 行 の 可 能 性 利 益 見 通 しなどの 明 記 3. 環 境 保 全 への 影 響 効 果 4. 提 供 国 への 利 益 配 分 の 実 態 予 想 5. 報 告 の 約 束 報 告 の 形 態

7 ステップ1-4 PIC 申 請 書 類 の 作 成 注 意 : 提 供 国 内 でのみバイオ 探 索 研 究 を 行 う 場 合 はバイオ 探 索 研 究 用 の PIC 申 請 を 行 う 収 集 した 試 料 を 日 本 に 持 ち 帰 り 研 究 を 行 う 場 合 はバイオ 探 索 研 究 用 PIC と 輸 出 許 可 証 の 両 方 を 申 請 する 提 供 国 の 規 則 の 確 認 を 要 する 1. バイオ 探 索 研 究 用 の PIC 申 請 法 人 名 申 請 者 名 その 他 の 申 請 者 その 他 の 協 力 者 プロジェクト 主 催 者 プロジェクト 資 金 提 供 者 用 いる 遺 伝 資 源 情 報 種 類 量 採 取 地 など その 他 必 要 な 認 可 書 提 供 者 への 情 報 開 示 状 況 提 供 者 情 報 伝 統 的 知 識 の 有 無 ( 告 示 文 献 情 報 ) 伝 統 的 知 識 開 示 状 況 ( 先 住 民 等 からの 開 示 文 献 デー タベース 情 報 ) 伝 統 的 知 識 保 有 者 である 先 住 民 社 会 との 利 益 配 分 契 約 利 益 配 分 契 約 の 紛 争 解 決 手 段 プロジェクト 提 案 目 的 利 益 方 法 期 間 環 境 保 護 報 告 義 務 成 果 予 想 採 取 サンプルの 破 棄 方 法 など 添 付 資 料 参 加 者 の 身 分 証 明 書 の 写 し その 他 の 認 可 書 の 写 し サイン 入 り 素 材 移 転 契 約 書 と 利 益 配 分 契 約 書 の 写 し

8 1. 遺 伝 資 源 輸 出 許 可 書 作 成 輸 入 者 情 報 その 他 の 規 制 書 類 ( 植 物 検 疫 ワシントン 条 約 規 制 等 ) 輸 出 の 理 由 2. 素 材 移 転 契 約 書 (MTA) 完 成 事 前 に 提 供 関 係 者 と 合 意 し サインしたものが 必 要 3. 利 益 配 分 契 約 書 (MAT) 事 前 に 提 供 関 係 者 と 合 意 し サインしたものが 必 要 5. 確 認 に 必 要 な 証 拠 書 類 遺 伝 資 源 に 付 随 する 伝 統 的 知 識 の 内 容 を 示 した 書 類 伝 統 的 知 識 保 持 者 から 入 手 した PIC の 写 し 6. 申 請 人 を 同 定 するのに 必 要 な 証 明 書 パスポートの 写 し 大 学 在 籍 証 明 書 資 金 提 供 証 明 書 など ステップ2 申 請 書 の 提 出 権 威 ある 当 局 と 呼 ばれる 政 府 省 庁 に 提 出 す る 権 威 ある 当 局 は 提 供 国 の 国 内 法 令 規 則 等 に 記 載 されている ステップ3 受 付 申 請 書 に 不 備 がないかチェックする 受 領 書 と 申 請 受 付 ナンバーを 発 行 ステップ4 申 請 料 の 支 払 い

9 規 定 に 従 い 申 請 料 を 支 払 う 申 請 料 の 額 は 規 則 参 照 その 時 申 請 受 付 ナン バーを 記 載 する ステップ5 委 員 会 審 査 申 請 料 受 領 確 認 申 請 審 査 委 員 会 へ 送 付 ( 審 査 委 員 会 は 定 期 的 に 開 催 されるが 頻 度 は 多 くない) 審 査 委 員 会 で 審 査 他 省 あるいは 該 当 地 方 当 局 への 照 会 追 加 質 問 資 料 請 求 ステップ6 決 定 審 査 委 員 会 の 決 定 PIC 発 行 担 当 省 ( 環 境 省 が 多 い)への 推 薦 状 発 行 ステップ7 担 当 省 審 査 担 当 省 での 審 議 審 査 基 準 l 提 供 者 の 権 利 が 確 保 l 素 材 移 転 契 約 が 締 結 l 利 益 配 分 契 約 が 締 結 l 申 請 研 究 が 環 境 保 全 に 貢 献 l 申 請 研 究 が 経 済 に 貢 献 l 申 請 研 究 が 科 学 に 貢 献 ステップ8 大 臣 決 裁

10 担 当 大 臣 決 裁 認 可 証 の 発 行 許 可 条 件 の 明 示 ステップ9 研 究 実 施 PIC 認 可 証 の 受 領 許 可 条 件 の 確 認 遺 伝 資 源 利 用 計 画 の 実 行 定 期 的 な 報 告

11 フィリッピン 標 準 研 究 提 案 RESEARCH PROPOSAL FORMAT Academic Commercial 1. Project Title 2. Project/Research Objectives Places of Collection Projected date of implementation and reason 4. Bioresources and quantity (if possible) (indicate live or dead specimen specify if by-products or derivatives) 5. Methodology (use separate sheet if necessary) 6. Manner data to be gathered (recorded, photographed, video, collected, observed, etc.) and format (notes, specimens, photographs, etc.)

12 7. Anticipated intermediate and final destination of bioresources, etc. 8. How bioresources obtained are to be used initially (i.e. national collection) subsequently (e.g.) drug exploitation, field guide preparation, etc.) 9. Description of funding support with budget (use separate sheet if necessary) 10. Analysis of the research of foreseen impact on biological diversity. 11. Detailed description of immediate compensation anticipated. 12. Detailed description of long-term compensation anticipated. 13. List of in-country entities likely to receive compensation enumerated in # 11 and reasons (logical and legal)

13 インド 生 物 資 源 伝 統 的 知 識 アクセス 許 可 申 請 FORM I Application form for access to Biological resources and associated traditional knowledge Part A 1. Full particulars of the applicant Name: Permanent address: Address of the contact person / agent, if any, in India: Profile of the organization (personal profile in case the applicant is an individual). Please attach relevant documents of authentication): Nature of business: Turnover of the organization in US$: 2. Details and specific information about nature of access sought and biological material and associated knowledge to be accessed Identification (scientific name) of biological resources and its traditional use: Geographical location of proposed collection: Description / nature of traditional knowledge ( oral / documented): Any identified individual / community holding the traditional knowledge: Quantity of biological resources to be collected (give the schedule): Time span in which the biological resources is proposed to be collected: Name and number of person authorized by the company for making the selection: The purpose for which the access is requested including the type and extent of research, commercial use being derived and expected to be derived from it: Whether any collection of the resource endangers any component of biological diversity and the risks which may arise from the access: 3. Details of any national institution which will participate in the Research and Development activities.

14 4. Primary destination of accessed resource and identity of the location where the R&D will be carried out. 5. The economic and other benefits including those arriving out of any IPR, patent obtained out of accessed biological resources and knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs 6. The biotechnological, scientific, social or any other benefits obtained out of accessed biological resources and knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs 7. Estimation of benefits, that would flow to India/ communities arising out of the use of accessed bioresources and traditional knowledge. 8. Proposed mechanism and arrangements for benefit sharing. 9. Any other information considered relevant. Part B Declaration I/ we declare that: Collection of proposed biological resources shall not adversely affect the sustainability of the resources; Collection of proposed biological resources shall not entail any environmental impact; Collection of proposed biological resources shall not pose any risk to ecosystems; Collection of proposed biological resources shall not adversely affect the local communities;

15 I/we further declare the Information provided in the application form is true and correct and I /We shall be responsible for any incorrect / wrong information. Place Signed Date Name Title

16 インド 研 究 結 果 海 外 商 用 目 的 移 転 許 可 申 請 FORM II Application for seeking prior approval of National Biodiversity Authority for transferring the results of research to foreign nationals, companies, NRI`s, for commercial purposes. 1. Full particulars of the applicant 1. Name 2. Address: 3. Professional profile 4. Organizational affiliation (Please attach relevant documents of authentication): 2. Details of the results of research conducted 3. Details of the Biological resources and /or associated knowledge used in the research. 4. Geo-graphical location from where the biological resources used in the research are collected 5 Details of any traditional knowledge used in the research and any identified individual /community holding the traditional knowledge 6. Details of institution where R&D activities carried out. 7. Details of the individual / organization to whom the research results are intend to transfer. 8. Details of economic, biotechnological, scientific or any other benefits that are intended, or may accrue to the individual /organization due to commercialization of transferred research results. 9. Details of economic, biotechnological, scientific or any other benefits that are intended, or may accrue to the applicant seeking approval for transfer of results of research.

17 10. Details of any agreement or MOU between by the proposed recipient and applicant seeking approval for transfer of results of research. Declaration I/we declare the Information provided in the application form is true and correct and I /We shall be responsible for any incorrect / wrong information. Signed Place Name Date Title

18 インド 知 的 財 産 権 出 願 許 可 申 請 FORM III Application for seeking prior approval of National Biodiversity Authority for applying for Intellectual Property Right 1. Full particulars of the applicant i. Name ii. Address: iii. Professional profile iv. Organizational affiliation (Please attach relevant documents of authentication): 2. Details of the invention on which IPRs sought 3. Details of the Biological resources and /or associated knowledge used in the invention. 4. Geo-graphical location from where the biological resources used in the invention are collected 5. Details of any traditional knowledge used in the invention and any identified individual /community / holding the traditional knowledge 6. Details of institution where Research and Development activities carried out. 7. Details of economic, biotechnological, scientific or any other benefits that are intended, or may accrue to the applicant due commercialization of the invention. Declaration I/we declare the Information provided in the application form is true and correct and I /We shall be responsible for any incorrect / wrong information.

19 Signed Place Name Date Title

20 インド 生 物 資 源 伝 統 的 知 識 第 三 者 移 転 許 可 申 請 FORM IV Application form for seeking approval of National Biodiversity Authority for third party transfer of the accessed Biological resources and associated traditional knowledge. 1. Full particulars of the applicant ii. iii. iv. i. Name Address: Professional profile Organizational affiliation (Please attach relevant documents of authentication): 2. Details of the biological material and traditional knowledge accessed. 3. Details of the access contract entered (Copy to be enclosed) 4. Details of the benefits and mechanism / arrangements for benefit sharing already implemented. 5. Full particulars of the third part to whom the accessed material / knowledge is intended to transfer. 6. The purpose of the intended third party transfer. 7. Details of economic, social, biotechnological, scientific or any other benefits that are intended, or may accrue to the third party due to transfer of accessed biological material and knowledge. 8. Details of any agreement to be entered between the applicant and the third party. 9. Estimation of benefits that would flow to India/ communities arising out of the third party transfer of accessed biological resources and traditional knowledge

21 10. Proposed mechanism and arrangements for benefit sharing arising out of the proposed third party transfer. 11. Any other relevant information Declaration I/we declare the Information provided in the application form is true and correct and I /We shall be responsible for any incorrect / wrong information. Signed Place Name Date Title

22 ブータン 王 国 のアクセス 許 可 申 請 Access/collection permit This access/collection permit is issued by the Ministry of Agriculture, Royal Government of Bhutan pursuant to the Biodiversity Act and the Rules. 1. Details of the Applicant Name of the applicant (organization): Nationality: Permanent Address: 2. This permit shall be applicable within the area and for the biological resource specified below. Collection sites/area: Type of Biological resource/tk: 3. Duration of collection. Start date: End date:. 4. Reference No. of the letter of grant of access. 5. Validity of the permit shall be for the duration specified in number 3 and any collection activity beyond the stipulated duration shall be prohibited. Sign: Seal:.. Head of the National Biodiversity Center/Authorized Agency

23 ブータン 王 国 遺 伝 資 源 と 関 連 する 伝 統 的 知 識 アクセス 申 請 Application for Access to Biological/biochemical resources and/or associated TK Part A: Description of the Applicant & Access Activity 1. Details of the Applicant: a) Name: b) Permanent Address: c) Address of the contact person/agent if any in Bhutan: d) Profile of the organization (personal profile in case the applicant is an individual with relevant documents) e) Identity and responsibilities of all entities and individual persons who will be involved in the activities for which access authorization is requested. f) A valid PIC reference number (a copy of the valid PIC) 2. A description of the applicant(s) technical and financial capability to conduct the activities for which access authorization is requested. a) Annual turnover of the organization in Nu/US dollars. b) Equipments and laboratories relevant to the activity. c) Description of all previous biological/biochemical resource collection activities in Bhutan or elsewhere. d) Provide complete information about existing or proposed contracts between the applicant and any third party relating to the use of any information and products resulting from the access activity. PART B: Project Proposal 3. The project proposal shall among other things include the details and specific information about nature of access sought, and biological material and associated knowledge to be accessed. a) Identification (scientific name) of Biological resource and its use. b) Geographical location of proposed collection. c) Description/nature of traditional knowledge (oral/documented) d) Any identified individual/community holding the traditional knowledge e) Quantity of biological resources to be collected with schedule. f) Provide information on the arrangements made within Bhutan to facilitate

24 the collection mission. g) Time span in which biological resources is proposed to be collected. h) Purpose for which access is requested including the type and extent of research, mechanism for sharing of results, commercial use being derived and expected to be derived from it and any other benefits anticipated. i) Whether any collection of the resource endangers any component of biological diversity and the risks which may arise from the access. j) Indicate the work plan and time frame within which the project is to be completed. k) The information included in the Access Application Form including Project/research proposal shall be in sufficient detail to enable the relevant authorities to make a decision whether to grant or refuse Access. 4. Provide information on: a) the primary destination of the resources and any expected subsequent destinations of the resources. b) intended distribution/sharing of the accessed resources and list actual or potential beneficiaries. 5. Details and responsibilities of collaborating national institution/s, scholars, scientists, students, farmers and farmer groups in Bhutan in the field mission and/or its follow-up activities. 6. The economic and other benefits including those resulting from any Intellectual Property rights (IPR) and patent obtained out of accessed biological resources and knowledge that are intended, or may accrue to the applicant or to the country that he/she belongs. PART C: DECLARATION I/we declare that the information in the application form is true and correct, and I/we shall be responsible for any incorrect/wrong information. Signature Name Title Date & place

25

26 ブータン 王 国 生 物 資 源 及 び 関 連 する 伝 統 的 知 識 第 三 者 移 転 許 可 申 請 Application form for seeking approval for third party transfer of the accessed Biological resources and/or associated Traditional Knowledge. 1. Full particular of the applicant (a) Name: (b) Address: (c) Professional profile: (d) Organization affiliation (please attach relevant documents of authentication) 2. Details of the biological material and/or traditional knowledge 3. Details of the contract/user agreement entered (Copy to be enclosed) 4. Details of the benefits and mechanism/arrangements for benefit sharing already implemented. 5. Full particulars of the third party to whom the accessed materials and/or knowledge is intended to transfer. 6. The purpose of the intended third party transfer. 7. Details of economic, social, biotechnological, scientific or any other benefits that are intended, or may accrue to the third party due to transfer of accessed biological material and knowledge. 8. Details of any agreement to be entered between the applicant and the third party. 9. Estimation of benefits that would flow to Bhutan/communities arising out of the third party transfer of accessed biological resources/biochemical resources and/or associated traditional knowledge. 10. Proposed mechanism and arrangements for benefit sharing arising out of the proposed third party transfer.

27 11. Any other relevant information Declaration I/we declare the information provided in the application form is true and correct and I/we shall be responsible for any incorrect/wrong information. Signature. Name. Title. Place :. Date :

28 ブータン 王 国 知 的 財 産 権 出 願 許 可 依 頼 申 請 Application for seeking prior approval for applying for intellectual Property Right 1. Full particulars of the applicant a) Name: b) Address: c) Professional profile: d) Organizational affiliation (Please attach relevant documents of authentication) 2. Details of the invention on which IPRs are sought 3. Details of the Biological resources and/ or associated knowledge used in the invention 4. Geo-graphical location from where the biological resources used in the invention were collected. 5. Details of any traditional knowledge used in the invention and any identified individual/ community holding the traditional knowledge. 6. Details of institution where Research and Development activities carried out. 7. Details of economic, biotechnological, scientific or any other benefits that are intended, or may accrue to the applicant due commercialization of the invention. Declaration I/we declare the Information provided in the application form is true and correct and I/We shall responsible for any incorrect/ wrong information. Signature Name Title

29 Community Biodiversity Traditional Knowledge Documentation 1. Prior Informed Consent at Individual/Community Level The (name of the Community/individual) agrees to document traditional knowledge associated with biological/biochemical resources. Understanding that this will help in reducing the erosion of knowledge, and will preserve and protect the knowledge of the.(community/individual) and the nation as a whole to be passed on to our future generations, we herein consent the Authorized Agency to document the TK in accordance with the procedure provided in the Rules. Dzongkhag:. Geog:. Village.. Village Representative Signature (tshokpa):. Name of the Tshokpa. Authorized Government Agency Representative Signature Name of the Authorized Agency representative Seal of the government office applying for the consent letter Date

30 マレーシアサラワク 州 生 物 資 源 アクセス 収 集 研 究 許 可 申 請 APPLICATION FOR A PERMIT (Form SBC-RA/1) Access, Collection and Research on Biological Resources in Sarawak Application No.: THIS APPLICATION SHOULD BE TYPEWRITTEN Project Title : Name of Applicant : Name of Researcher(s) : Please tick (/) which is applicable. For further information please refer to Sarawak Biodiversity Regulation, Research on Biological Resources Collection and Research on Protected Resources Export on Biological and Protected Resources Sale of Protected Resources Research on Ethnobiological Note: Please ensure that all information is provided in order to avoid administrative delay. Please send completed research application form in BOTH soft and hard copies SARAWAK BIODIVERSITY CENTRE KM20 Jalan Borneo Heights, Semengoh, Locked Bag 3032, Kuching, Sarawak, Malaysia Tel: Fax: or

31 Part 1 ORGANISATION PROFILE This part consists of information on the organization in which the applicant is affiliated to. All fields MUST be completed by the applicant. Commercial organizations are ALSO required to complete Attachment 1. Name of Organization Registered Address Correspondence Address Business Address (if applicable) Tel. No Fax No. Website Date of Registration Establishment No. Summary of the organization s core business Contact person for further information the organization Part 2 INFORMATION ON THE APPLICANT AND RESEARCHER(S) This part must be completed by the applicant and EACH researcher/team member involved in the project. PHOTOGRA PH

32 Part 2a Personal Details Name Sex Date of birth Place of birth Citizenship IC/Passport No. Correspondence Address Permanent Address Contact Fax No. No. (Office) (Home) (Mobile) Occupation Designation Organization/Institu tion Department Purpose of Research (Ph.D, M.Sc etc) Field of Study Role(s) of Applicant/Researche r Names of accompanying Citizensh Ag Relationshi Occupation persons ip e p (accompanying members are not allowed to work or carry out research) Part 2b Supervision of Project Name of Research Supervisor/Advisor Address of Institution Occupation Designatio

33 Area(s) of Expertise Contact No. Fax No. n (Office) (Home) (Mobile) Part 2c Researcher s Educational Details & Professional Training Names of Institutions Year From To Qualificatio ns gained Major fields of Study Part 2d Related Research Experience in Sarawak Provide brief description of related research experience conducted in Sarawak, if any. Please include dates, description and details on publications related. Part 2e Related Research Experience outside Sarawak Provide brief description of related research experience conducted outside Sarawak. Please include dates, description and publication, if any. Part 2f Area(s) of Expertise & Special Qualifications Part 3 PROJECT INFORMATION This part needs to be completed only ONCE per application Part 3a Project Title Part 3b Project Classification e.g. botanical, zoological, microbiological, mycological, ethnobotanical, etc.

34 Part 3c Project Abstract Part 3d Project Background (a) rationale for the study (b) significance and benefits to Sarawak (in terms of the sustainable and environmentally sound use of biological diversity) Part 3e Project Objectives (i) (ii) (iii) Part 3f Proposed Work Schedule Please include Gantt Chart with expected starting and ending dates of research activities, dates of submission of draft and final reports

35 Part 3g Research Methodology This part is to be completed according to the outline as provided in the form. (i) Type of biological resources to be collected in terms of species, parts of organism and quantities (ii) Type of biological data to be collected (iii) The time of executing or carrying out the collection activities (iv) The place of executing or carrying out the collection activities (v) The methods of executing or carrying out the collection activities (vi) The local informants involved in the case of ethnobiological research (vii) The use(s) of the collected biological resources (viii) The plan for evaluation of the biological resources collected (ix) The final destination of the biological resources collected Part 3h Institution(s) Name(s) and address(es) of the Institution(s) in which the research/analysis will take place. Part 3i Expected Results and Programme Output Part 3j The anticipated and final destination of the information resulting from the access, collection and research Part 3k The anticipated uses of the information and end product Part 3l Financial Sponsor The financial sponsor must disclaim and waive all rights to any discovery or invention which may result from this project and any other activity pertaining to any biological resources of Sarawak. Please complete Attachment 2.

36 (i) Name (ii) Address (iii) Amount (iv) Terms and conditions of sponsorship Part 3m Permission To Enter Project Location Please specify the permit(s) number and attach a copy of the permit(s) from the relevant authority. For ethno-biological research please attach a copy of the Letter of Consent from the community leader. Part 3n Local Collaborator (If applicable) Collaborator is required to monitor, advise, facilitate and participate in the implementation of the research activities. Please complete Attachment 3. Statement by Applicant I confirm that the particulars given in this application are correct.

37 Date Signature of Applicant For Official Use Incomplete documentation Re-apply with amendments Action to be taken Comments/Remarks This application is approved/rejected by the Sarawak Biodiversity Council on. CEO/Secretary Sarawak Biodiversity Council Attachment 1 Name SHAREHOLDERS PROFILE (You may use a separate sheet if the space below is insufficient) Shareholder Shareholder Shareholder Shareholder Address Tel No. Fax No. address IC/Passport No. Citizenship Date of birth Place of birth

38 Position in the Organization Appointment date Qualifications No. of Shares * Please attach Audited Financial Report of the previous year.

39 BOARD OF DIRECTORS PROFILE (You may use a separate sheet if the space below is insufficient) Director Director Director Director Name Address Tel No. Fax No. address IC/Passport No. Citizenship Date of birth Place of birth Position in the Organization Appointment date Qualifications No. of Shares KEY STAFF S PROFILE (You may use a separate sheet if the space below is insufficient) Staff Staff Staff Staff Name Address Tel No. Fax No. address IC/Passport No. Race Citizenship Date of birth Place of birth

40 Position in the Organization Appointment date Qualifications No. of Shares Attachment 2 DECLARATION OF DISCLAIMER TO: Chief Executive Officer Sarawak Biodiversity Centre Project Title:.. Researcher:. I/We the undersigned hereby declare that I/we waive and disclaim all rights and interests whatsoever, to any discovery or invention arising from research, using the biological resources of Sarawak, carried out or undertaken by the above named researcher. Signed by:

41 Witnessed by: Signature: Signature: Name: Name: Designation:... Designation:... On behalf of:. (Name and seal of the Institution) Dated this on. day of

42 Attachment 3a STATEMENT OF UNDERTAKING BY THE LOCAL COLLABORATOR(S) TO: Chief Executive Officer Sarawak Biodiversity Centre Project Title: Researcher (Permit Holder): I, the undersigned, of... (full address), hereby declare that I agree to be the Local Collaborator in this research project and agree to abide and accept the responsibility as stipulated in the agreement to be signed between the researcher (permit holder) and the Sarawak Government. I also declare that I have obtained the approval of my institution to fulfill the obligations of

1. Sistema de serviço médico 医 療 サービスのしくみ

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