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| Guide of the Anti-Monopoly Committee of the State Council to Anti-monopoly in the Active Pharmaceutical Ingredients Field | | 國務院反壟斷委員會關于原料藥領域的反壟斷指南 |
| (No. 3 [2021] of the Anti-Monopoly Committee of the State Council, issued by the Anti-Monopoly Committee of the State Council on November 15, 2021) | | （國反壟發〔2021〕3號 2021年11月15日國務院反壟斷委員會印發） |
| Chapter I General Provisions | | 第一章 總 則 |
| Article 1 Purpose and basis | | 第一條 目的和依據 |
| This Guide is developed in accordance with the Anti-monopoly Law of the People's Republic of China (hereinafter referred to as the “Anti-monopoly Law”) and other applicable laws for the purposes of preventing and curbing monopolistic acts in the field of active pharmaceutical ingredients (APIs), further specifying market competition rules, maintaining the order of market competition in the API field, and protecting consumers' interests and public interest. | | 為了預防和制止原料藥領域壟斷行為，進一步明確市場競爭規則，維護原料藥領域市場競爭秩序，保護消費者利益和社會公共利益，根據《中華人民共和國反壟斷法》（以下簡稱《反壟斷法》）等法律規定，制定本指南。 |
| Article 2 Relevant definitions | | 第二條 相關概念 |
| (1) “APIs” means raw materials that satisfy the requirements of relevant laws and regulations on drug administration, that are used for the production of various drugs, and are active ingredients in drugs. For the purposes of this Guide, APIs include chemical APIs and traditional Chinese medicines. | | （一）原料藥，是指符合藥品管理相關法律法規要求、用于生產各類藥品的原材料，是藥品中的有效成份。本指南所稱原料藥包括化學原料藥、中藥材。 |
| (2) “Drugs” means substances used to prevent, diagnose and treat human diseases, and purposefully regulate human physiological functions with prescribed indications or major functional treatments, usages and dosages, including traditional Chinese medicines, chemical drugs and biological products, among others. | | （二）藥品，是指用于預防、診斷、治療人的疾病，有目的地調節人的生理機能並規定有適應症或者功能主治、用法和用量的物質，包括中藥、化學藥和生物制品等。 |
| (3) “API businesses” means the various types of enterprises that engage in API production and operation with the approval of relevant regulatory departments. | | （三）原料藥經營者，是指經相關監督管理部門批准，從事原料藥生產、經營的各類企業。 |
| (4) “API producer” means an enterprise that produces and sells APIs by such means as chemical synthesis, animal and plant extraction, and biotechnology with the approval of the relevant regulatory department. | | （四）原料藥生產企業，是指經相關監督管理部門批准，采用化學合成、動植物提取、生物技術等方式生產並銷售原料藥的企業。 |
| (5) “API distributor” means an enterprise that engages in API operation and sale rather than API production with the approval of the relevant regulatory department. | | （五）原料藥經銷企業，是指經相關監督管理部門批准，不生產原料藥，僅從事原料藥經營銷售的企業。 |
| (6) “Drug producer” means an enterprise that has obtained a drug production permit to produce and sell drugs with the approval of the relevant regulatory department. | | （六）藥品生產企業，是指經相關監督管理部門批准，取得藥品生產許可證，生產、銷售藥品的企業。 |
| (7) “Drug distributor” means an enterprise that has obtained a drug operation permit to engage in drug sale with the approval of the relevant regulatory department. | | （七）藥品經銷企業，是指經相關監督管理部門批准，取得藥品經營許可證，從事藥品經營銷售業務的企業。 |
| Article 3 Basic principles | | 第三條 基本原則 |
| Anti-monopoly law enforcement authorities shall conduct anti-monopoly regulation in the API field under the following principles: | | 反壟斷執法機構對原料藥領域開展反壟斷監管堅持以下原則： |
| (1) Fair competition on the market shall be protected. Market participants shall be treated equally, standardization and regulation shall be strengthened in accordance with the law, efforts shall be made to prevent and curb monopolistic acts in the API field, protect fair competition on the market, maintain the good order of competition, support the innovative development of API businesses, and enhance their international competitiveness. | | （一）保護市場公平競爭。堅持對市場主體一視同仁、平等對待，依法加強規範和監管，著力預防和制止原料藥領域壟斷行為，保護市場公平競爭，維護良好競爭秩序，支持原料藥經營者創新發展，增強國際競爭力。 |
| (2) Scientific and efficient regulation shall be conducted in accordance with the law. The basic systems, regulatory principles and analytical frameworks specified in the Anti-monopoly Law and relevant supporting regulations, rules and guides shall apply to market participants in the API field. Anti-monopoly law enforcement authorities shall, according to the specific circumstances of the cases in the API field, strengthen competition analysis and legal argumentation, constantly strengthen and improve anti-monopoly regulation, and make anti-monopoly law enforcement more pertinent and scientific. | | （二）依法科學高效監管。《反壟斷法》及有關配套法規、規章、指南確定的基本制度、規制原則和分析框架適用于原料藥領域市場主體。反壟斷執法機構根據原料藥領域案件具體情況，強化競爭分析和法律論證，不斷加強和改進反壟斷監管，增強反壟斷執法的針對性和科學性。 |
| (3) Attention shall be paid to protecting consumers' interests. Anti-monopoly law enforcement authorities shall severely crack down on the various API-related monopolistic acts, promote enterprises' enhancement of operation efficiency, maintain competitive prices on the market, guide and encourage API businesses to invest more resources in improving processes and enhancing quality and efficiency, and promote the effective supply of APIs and the stable supply of drugs, so as to protect the interests of consumers. | | （三）注重保護消費者利益。反壟斷執法機構嚴厲打擊各種類型的原料藥壟斷行為，促進企業提高運營效率，維護市場競爭價格，引導和鼓勵原料藥經營者將更多資源用于工藝改進、質量和效率提升，促進原料藥有效供給和藥品穩定供應，保護消費者利益。 |
| (4) Legal deterrence shall be continuously strengthened. Anti-monopoly law enforcement authorities shall continuously reinforce law enforcement in the API field, and impose heavier punishments in accordance with the law on those who knowingly and deliberately commit violations of the Anti-monopoly Law or take measures to evade investigation so as to strengthen legal deterrence, effectively curb monopolistic acts in the API field, and focus on improving the people's livelihood and well-being. | | （四）持續強化法律威懾。反壟斷執法機構持續加大原料藥領域執法力度，對明知有關行為違反《反壟斷法》故意實施或者采取措施規避調查的，依法從嚴從重作出處理，強化法律威懾，有效遏制原料藥領域壟斷行為，著力增進民生福祉。 |
| Article 4 Definition of relevant markets | | 第四條 相關市場界定 |
| The API industry chain covers such links as production, transportation and distribution and involves multiple business types, relevant commodity markets and geographical markets shall be defined under the general principles determined in the Anti-monopoly Law and the Guide of the Anti-monopoly Committee of the State Council on the Definition of Relevant Markets and specific analysis shall be conducted on a case-by-case basis in consideration of the features of the API industry. | | 原料藥產業鏈涵蓋生產、運輸、經銷等環節，涉及業務類型多樣，界定相關商品市場和地域市場需要遵循《反壟斷法》和《國務院反壟斷委員會關于相關市場界定的指南》確定的一般原則，同時考慮原料藥行業特點，結合個案進行具體分析。 |
| (1) Relevant commodity markets | | （一）相關商品市場 |
| The basic method for defining relevant commodity markets in the API field is substitution analysis. To define the relevant market in a particular case, demand substitution analysis may be conducted based on the API product features, quality standards, use and price, and other factors. Where necessary, supply substitution analysis may be carried out concurrently based on such factors as market access, production capacity, transformation of production facilities, and technical barriers. | | 原料藥領域相關商品市場界定的基本方法是替代性分析。在個案中界定相關市場時，可以基于原料藥的產品特性、質量標准、用途、價格等因素進行需求替代分析。必要時，可以同時基于市場進入、生產能力、生產設施改造、技術壁壘等因素進行供給替代分析。 |
| Depending on the specific circumstances, the relevant commodity market may be further subdivided into the API production market and API distribution market. | | 根據具體情形，可能需要將相關商品市場進一步細分為原料藥生產市場和原料藥經銷市場。 |
| Since APIs play a special role in the production of drugs, an API generally constitutes a separate relevant commodity market, which may be further subdivided according to the specific circumstances. If different types of APIs may substitute each other, it may be determined that several types of APIs constitute the same relevant commodity market in light of the specific circumstances. | | 由于原料藥對于生產藥品具有特殊作用，一種原料藥一般構成單獨的相關商品市場，並可能根據具體情況作進一步細分。如不同品種原料藥之間具有替代關系，可能根據具體情況認定多個品種原料藥構成同一相關商品市場。 |
| (2) Relevant geographical markets | | （二）相關地域市場 |
| The relevant geographical markets in the API field shall be defined by demand substitution and supply substitution analysis. Different countries have different qualifications and regulatory standards for API production and distribution. API businesses which produce and distribute APIs in China shall organize production according to the approved process, strictly abide by the Good Manufacturing Practice for Drugs and the Good Supply Practice for Drugs and ensure that the production and operation processes satisfy the statutory requirements; and API import shall be subject to the approval of the relevant regulatory department of China. Consequently, the relevant geographical market for API production and distribution shall generally be defined as the Chinese market. | | 原料藥領域相關地域市場界定采用需求替代和供給替代分析。不同國家關于原料藥生產、經銷的相關資質和監管標准不同。在中國生產、經銷原料藥，原料藥經營者應當按照核准的工藝組織生產，嚴格遵守藥品生產質量管理規範和藥品經營質量管理規範，確保生產和經營過程符合法定要求；進口原料藥需獲得中國相關監督管理部門批准。因此，生產、經銷原料藥的相關地域市場一般界定為中國市場。 |
| According to the characteristics and costs of the transport of different APIs, the geographical market for specific types of APIs may be defined as a certain territorial scope. | | 根據不同原料藥運輸的特點和成本，特定品種原料藥的地域市場可能界定為一定的地域範圍。 |
| Chapter II Monopoly Agreements | | 第二章 壟斷協議 |
| The Anti-monopoly Law prohibits businesses from entering into or implementing monopoly agreements. Chapter III of the Anti-monopoly Law and the Interim Provisions on the Prohibition of Monopoly Agreements shall apply to the determination of monopoly agreements in the API field. The monopoly agreements specified in Articles 13 and 14 of the Anti-monopoly Law shall be prohibited in accordance with the law, and monopoly agreements meeting the conditions set forth in Article 15 of the Anti-monopoly Law shall be exempted in accordance with the law. | | 《反壟斷法》禁止經營者達成、實施壟斷協議。認定原料藥領域的壟斷協議，適用《反壟斷法》第三章和《禁止壟斷協議暫行規定》。對《反壟斷法》第十三條、第十四條明確列舉的壟斷協議，依法予以禁止；對符合《反壟斷法》第十五條規定條件的壟斷協議，依法予以豁免。 |
| Article 5 Forms of monopoly agreements | | 第五條 壟斷協議的形式 |
| “Monopoly agreements in the API field” means the business's agreements, decisions or other acts in concert that preclude or restrict competition. Agreements or decisions may be made in written, oral or other forms. “Other acts in concert” means the essentially coordinated and concerted actions committed by undertakings through other means without explicitly entering into any agreement or decision, except for the price leadership and other parallel conduct of relevant businesses based on their independent expression of intention. | | 原料藥領域壟斷協議是指經營者排除、限制競爭的協議、決定或者其他協同行為。協議、決定可以是書面、口頭等形式。其他協同行為是指經營者雖未明確訂立協議或者決定，但通過其他方式實質上存在協調一致的行為，有關經營者基于獨立意思表示所作出的價格跟隨等平行行為除外。 |
| Article 6 Horizontal monopoly agreements | | 第六條 橫向壟斷協議 |
| Competing API businesses are prohibited from entering into any of the horizontal monopoly agreements with each other as set forth in Article 13 of the Anti-monopoly Law. The following conduct of an API business generally constitutes a monopoly agreement prohibited by Article 13 of the Anti-monopoly Law. | | 禁止具有競爭關系的原料藥經營者達成《反壟斷法》第十三條規定的橫向壟斷協議。原料藥經營者下列行為，一般會構成《反壟斷法》第十三條禁止的壟斷協議行為： |
| (1) An API producer determines through consultation with any other competing business the API production quantity, sales quantity, sales price, sales targets, and sales region, among others, through a joint production agreement, joint procurement agreement, joint sales agreement, joint bidding agreement, or other methods. | | （一）原料藥生產企業與具有競爭關系的其他經營者通過聯合生產協議、聯合采購協議、聯合銷售協議、聯合投標協議等方式商定原料藥生產數量、銷售數量、銷售價格、銷售對象、銷售區域等； |
| (2) An API producer communicates and coordinates the API sales price, production capacity and output, production and sales plan, and other sensitive information through any third party (such as API distributors and downstream drug producers), trade fairs, and industry conferences, among others. | | （二）原料藥生產企業通過第三方（如原料藥經銷企業、下游藥品生產企業）及展銷會、行業會議等溝通協調原料藥銷售價格、產能產量、產銷計劃等敏感信息； |
| (3) An API producer enters into an agreement with any other competing API business under which it will not produce or sell APIs and will receive compensation made by such an API business. | | （三）原料藥生產企業與具有競爭關系的其他原料藥經營者達成不生產或者不銷售原料藥、其他原料藥經營者給予補償的協議； |
| (4) An API distributor communicates and coordinates with any other competing API business on the procurement quantity, procurement targets, sales price, sales quantity and sales targets, among others. | | （四）原料藥經銷企業與具有競爭關系的其他原料藥經營者就采購數量、采購對象、銷售價格、銷售數量、銷售對象等進行溝通協調。 |
| Since there is no significant difference in competition analysis between the API field and other fields and industries in terms of horizontal monopoly agreements, this Guide does not provide substantiated provisions. | | 原料藥領域與其他領域和行業橫向壟斷協議在競爭分析方面並無顯著差別，本指南不再進一步細化。 |
| Article 7 Vertical monopoly agreements | | 第七條 縱向壟斷協議 |
| An API business is prohibited from entering into a vertical monopoly agreement set forth in Article 14 of the Anti-monopoly Law with the transaction counterparty. The following conduct of an API business generally constitutes a monopoly agreement prohibited by Article 14 of the Anti-monopoly Law. | | 禁止原料藥經營者與交易相對人達成《反壟斷法》第十四條規定的縱向壟斷協議。原料藥經營者下列行為，一般會構成《反壟斷法》第十四條禁止的壟斷協議行為： |
| ．．．．．． | | ．．．．．． |
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