Doing Business with the People\u27s Republic of China: The Role of Foreign Lawyers

This article describes the nature of a legal practice involving business transactions with entities in the P.R.C. and the role of the foreign, or non-national, lawyer in such transactions. Part I focuses on the increasing volume of Chinese legislation and international agreements affecting foreign trade and investment in the P.R.C., and the difficulties of keeping abreast of and interpreting this recent legislation. Part II examines the role of foreign lawyers in Chinese business transactions. It also discusses the need for competence in the Chinese language, practical problems encountered in practicing in the P.R.C., and the use of local Chinese counsel. Finally, in part III, this article examines the working relationship that has developed between foreign and Chinese lawyers

Mortality Among Adults With Cancer Undergoing Chemotherapy or Immunotherapy and Infected With COVID-19

Importance: Large cohorts of patients with active cancers and COVID-19 infection are needed to provide evidence of the association of recent cancer treatment and cancer type with COVID-19 mortality. // Objective: To evaluate whether systemic anticancer treatments (SACTs), tumor subtypes, patient demographic characteristics (age and sex), and comorbidities are associated with COVID-19 mortality. // Design, Setting, and Participants: The UK Coronavirus Cancer Monitoring Project (UKCCMP) is a prospective cohort study conducted at 69 UK cancer hospitals among adult patients (≥18 years) with an active cancer and a clinical diagnosis of COVID-19. Patients registered from March 18 to August 1, 2020, were included in this analysis. // Exposures: SACT, tumor subtype, patient demographic characteristics (eg, age, sex, body mass index, race and ethnicity, smoking history), and comorbidities were investigated. // Main Outcomes and Measures: The primary end point was all-cause mortality within the primary hospitalization. // Results: Overall, 2515 of 2786 patients registered during the study period were included; 1464 (58%) were men; and the median (IQR) age was 72 (62-80) years. The mortality rate was 38% (966 patients). The data suggest an association between higher mortality in patients with hematological malignant neoplasms irrespective of recent SACT, particularly in those with acute leukemias or myelodysplastic syndrome (OR, 2.16; 95% CI, 1.30-3.60) and myeloma or plasmacytoma (OR, 1.53; 95% CI, 1.04-2.26). Lung cancer was also significantly associated with higher COVID-19–related mortality (OR, 1.58; 95% CI, 1.11-2.25). No association between higher mortality and receiving chemotherapy in the 4 weeks before COVID-19 diagnosis was observed after correcting for the crucial confounders of age, sex, and comorbidities. An association between lower mortality and receiving immunotherapy in the 4 weeks before COVID-19 diagnosis was observed (immunotherapy vs no cancer therapy: OR, 0.52; 95% CI, 0.31-0.86). // Conclusions and Relevance: The findings of this study of patients with active cancer suggest that recent SACT is not associated with inferior outcomes from COVID-19 infection. This has relevance for the care of patients with cancer requiring treatment, particularly in countries experiencing an increase in COVID-19 case numbers. Important differences in outcomes among patients with hematological and lung cancers were observed

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study

Introduction: The multiorgan impact of moderate to severe coronavirus infections in the post-acute phase is still poorly understood. We aimed to evaluate the excess burden of multiorgan abnormalities after hospitalisation with COVID-19, evaluate their determinants, and explore associations with patient-related outcome measures. Methods: In a prospective, UK-wide, multicentre MRI follow-up study (C-MORE), adults (aged ≥18 years) discharged from hospital following COVID-19 who were included in Tier 2 of the Post-hospitalisation COVID-19 study (PHOSP-COVID) and contemporary controls with no evidence of previous COVID-19 (SARS-CoV-2 nucleocapsid antibody negative) underwent multiorgan MRI (lungs, heart, brain, liver, and kidneys) with quantitative and qualitative assessment of images and clinical adjudication when relevant. Individuals with end-stage renal failure or contraindications to MRI were excluded. Participants also underwent detailed recording of symptoms, and physiological and biochemical tests. The primary outcome was the excess burden of multiorgan abnormalities (two or more organs) relative to controls, with further adjustments for potential confounders. The C-MORE study is ongoing and is registered with ClinicalTrials.gov, NCT04510025. Findings: Of 2710 participants in Tier 2 of PHOSP-COVID, 531 were recruited across 13 UK-wide C-MORE sites. After exclusions, 259 C-MORE patients (mean age 57 years [SD 12]; 158 [61%] male and 101 [39%] female) who were discharged from hospital with PCR-confirmed or clinically diagnosed COVID-19 between March 1, 2020, and Nov 1, 2021, and 52 non-COVID-19 controls from the community (mean age 49 years [SD 14]; 30 [58%] male and 22 [42%] female) were included in the analysis. Patients were assessed at a median of 5·0 months (IQR 4·2–6·3) after hospital discharge. Compared with non-COVID-19 controls, patients were older, living with more obesity, and had more comorbidities. Multiorgan abnormalities on MRI were more frequent in patients than in controls (157 [61%] of 259 vs 14 [27%] of 52; p<0·0001) and independently associated with COVID-19 status (odds ratio [OR] 2·9 [95% CI 1·5–5·8]; padjusted=0·0023) after adjusting for relevant confounders. Compared with controls, patients were more likely to have MRI evidence of lung abnormalities (p=0·0001; parenchymal abnormalities), brain abnormalities (p<0·0001; more white matter hyperintensities and regional brain volume reduction), and kidney abnormalities (p=0·014; lower medullary T1 and loss of corticomedullary differentiation), whereas cardiac and liver MRI abnormalities were similar between patients and controls. Patients with multiorgan abnormalities were older (difference in mean age 7 years [95% CI 4–10]; mean age of 59·8 years [SD 11·7] with multiorgan abnormalities vs mean age of 52·8 years [11·9] without multiorgan abnormalities; p<0·0001), more likely to have three or more comorbidities (OR 2·47 [1·32–4·82]; padjusted=0·0059), and more likely to have a more severe acute infection (acute CRP >5mg/L, OR 3·55 [1·23–11·88]; padjusted=0·025) than those without multiorgan abnormalities. Presence of lung MRI abnormalities was associated with a two-fold higher risk of chest tightness, and multiorgan MRI abnormalities were associated with severe and very severe persistent physical and mental health impairment (PHOSP-COVID symptom clusters) after hospitalisation. Interpretation: After hospitalisation for COVID-19, people are at risk of multiorgan abnormalities in the medium term. Our findings emphasise the need for proactive multidisciplinary care pathways, with the potential for imaging to guide surveillance frequency and therapeutic stratification

Doing Business with the People\u27s Republic of China: The Role of Foreign Lawyers

This article describes the nature of a legal practice involving business transactions with entities in the P.R.C. and the role of the foreign, or non-national, lawyer in such transactions. Part I focuses on the increasing volume of Chinese legislation and international agreements affecting foreign trade and investment in the P.R.C., and the difficulties of keeping abreast of and interpreting this recent legislation. Part II examines the role of foreign lawyers in Chinese business transactions. It also discusses the need for competence in the Chinese language, practical problems encountered in practicing in the P.R.C., and the use of local Chinese counsel. Finally, in part III, this article examines the working relationship that has developed between foreign and Chinese lawyers

China Implements More Participatory Rulemaking Under Communist Party

China’s central government, the State Council, recently mandated a 30-day public notice-and-comment process for most government rulemakings and institutionalized other mechanisms that increase public participation and transparency in the rulemaking process throughout the country more generally. These new mechanisms—referred to collectively as the “Procedures”—were accomplished through amendments to two sets of State Council procedures that apply, respectively, to national administrative regulations (xingzheng fagui) issued by the State Council and to lower-level rules (guizhang) issued by the State Council departments and by local governments and their departments. The Procedures effectuate calls by the Chinese Communist Party (CCP) and the State Council to make rulemaking better reflect the will of the people and ensure higher quality regulation. Unexpectedly, the updates also codified requirements for CCP consultation and approval during the rulemaking process. The State Council issued the original version of the Procedures in 2001 to implement basic rulemaking provisions in China’s Legislation Law, which established the principle that the Chinese people should “participate in legislation through various channels.” The term lifa—legislation—covers not only lawmaking by the National People’s Congress (NPC) but also government rulemaking for legally binding State Council regulations—issued by the State Council—and rules—issued by ministries and provincial governments. Both original Procedures were revised in late 2017, with effect from May 1, 2018. The revised Procedures enhance public participation throughout the rulemaking process, which comprises four stages. The first stage involves preparing annual rulemaking plans. The Procedures now require the State Council to solicit public input on its annual plan for regulations, but this is optional for annual plans for issuing rules by State Council departments and local governments. In both cases, the finalized plans must now be made public. At the second stage, agencies designated as drafting units formulate initial drafts of regulations or rules. Both Procedures now require the drafting unit to publish most proposed regulations and rules and to solicit written public input for a minimum 30-day comment period. The comment-seeking obligation is not ironclad. The State Council must publish draft regulations for public comment, unless it decides not to. In the case of rules, drafting units must publish drafts for public input, unless drafts must be kept secret. Moreover, the comment period shall “in general” not be less than 30 days, but no examples are given of what exceptions to the 30-day rule might be. The foreign business community has long sought longer comment periods of at least 60 to 90 days to provide more time to translate drafts and obtain and translate input. The “not less than” language in both Procedures suggests that drafting agencies may provide longer than the minimum 30 days for drafts impacting foreign interests, but they do not specify such a possibility. The third stage involves an examination of proposed regulations by the Legislative Affairs Office (LAO) of the State Council or of draft rules by the relevant State Council department or local government or department. Under both Procedures, the LAOs should circulate drafts presented for examination throughout the government and to select outside organizations, experts, and citizens for comments. The LAOs may also decide to conduct a second round of public notice-and-comment. The fourth stage comprises the final decision and promulgation of the regulation or rule. The Procedures now also call for post-enactment assessment and “cleanup,” which may lead to a revision or repeal of a regulation that would be subject to the same rulemaking procedures. The Procedures provide additional avenues for expanded public participation. Public hearings are optional for draft State Council regulations, whereas they are now required for input on drafts of controversial rules. Some central ministries and many local governments have convened public rulemaking hearings for many years. The State Council never has, but the Procedures leave open that possibility. Both Procedures further codify recent practices of inviting outside experts, academic and research institutes, and social organizations to help draft or independently prepare “expert” drafts, to conduct “appraisal and consultation,” and to offer third-party assessments of drafts in various circumstances. Although the Procedures increase the overall transparency and responsiveness of China’s regulatory process, additional requirements, many of which are being implemented in practice, would further improve the process. These include: disclosing the public’s comments and transcripts of public hearings, appraisals, and other meetings; disclosing the advice of outside experts, institutes, and social organizations; providing feedback on how the public’s comments were considered; requiring and disclosing regulatory impact analyses of the proposed regulations and rules; and establishing online rulemaking dockets to collect related materials in a permanent record. The absence of a requirement to explain how the public’s input was considered is particularly disappointing, since the CCP and State Council have endorsed public comment feedback to ensure accountability. Under both Procedures, drafting agencies and LAOs must prepare explanations of the drafts they submit for review and decision, so preparing a public explanation of how the public’s input was considered should not require much extra effort. As for remedies, the Chinese public cannot challenge a regulation in the courts. The Procedures do provide, however, that members of the public can seek review by the NPC Standing Committee or State Council if they believe a regulation or rule is inconsistent with a superior law or regulation. Moreover, the public can sue the government for failure to comply with procedural requirements that infringed their lawful rights and interests. The Procedures do not, though, explicitly mention such a remedy, and it is unclear whether requirements like the 30-day comment period will be deemed sufficiently concrete to permit such challenges. Both Procedures also give the CCP a role in the rulemaking process. Previously, de facto CCP involvement in legislation was exercised pursuant to conventions and unpublished Opinions on Strengthening CCP Leadership over Legislation. The Opinions reportedly require that draft laws and regulations relating to political matters and major economic and social issues must first be deliberated by the Central Committee or the CCP organization at the same level as the drafting body. These principles of CCP approval have been written into both Procedures, which also require that regulations and rules implement the CCP’s line, policies, and decisions. CCP leadership may be intended more to ensure policy oversight than to interfere with what is becoming a more transparent and participatory rulemaking process. Insertion of the CCP into state law, however, is a disturbing trend that raises concerns about China’s rule of law project. Nonetheless, the gradual institutionalization of transparency and public participation in rulemaking represents progress along the road to modernizing the Chinese governance system

China’s Central Government Seeks to Rein in Regulatory Documents

As the Trump Administration seeks to pare back agency regulations, the Xi Administration in China is clamping down on guidance-type regulatory documents, frequently called “red-headed” documents due to the official letterhead on which they are issued. The U.S. business community in China has long complained about these directives, conservatively estimated to number in the millions, and their inconsistent enforcement. Even though red-headed documents frequently impact the public’s rights and obligations, they have not been required to go through the increasingly transparent rulemaking procedures that apply to legally binding regulations and rules adopted at all levels of the Chinese government. In May 2018, the Chinese State Council imposed a detailed set of requirements—the “Circular”—to govern the content and management of regulatory documents. In December 2018, the State Council mandated that agencies assess such documents’ legality prior to adoption. Moreover, the public may now ask Chinese courts to review the legality, under China’s Administrative Litigation Law, of regulatory documents that were the basis for a contested government action. Regulatory documents are a category of what are called “normative documents” (guifanxing wenjian). These include, when used in the term’s broad sense, both legislative documents and non-legislative documents. Legislative documents consist of laws adopted by the National People’s Congress or its Standing Committee as well as State Council “regulations” (xingzheng fagui) and central departmental and local government “rules” (guizhang). Non-legislative documents include decisions and orders issued by government agencies, which are referred to literally as administrative normative documents (xingzheng guifanxing wenjian) but translated here as “regulatory documents,” in line with the State Council’s current practice. The formulation and handling of legislative documents are governed by China’s Legislation Law. In contrast, non-legislative regulatory documents are not subject to the Legislation Law, even though they are considered generally binding. Regulatory documents are defined in the Circular as official documents, other than State Council regulations, decisions and orders, and departmental and local government rules, that are formulated by a government authority according to statutory powers and procedures, publicly issued, involve the rights and obligations of the public, and have a general binding force and applicability within a certain period of time. Regulatory documents may impact the public by imposing user fees, standards, and certification requirements. Some of these documents have been characterized as “bizarre” for exceeding the bounds of reasonable administration—such as by forbidding employees from taking a vacation—and the State Council has long sought to reduce the volume of and better manage regulatory documents. The Circular reflects the continuing struggle to manage regulatory documents. It mandates government agency compliance with its requirements through the use of language like “must” (bixu and yao) as opposed to “should” (ying), which is more typical of policy documents. “Significant” (zhongyao) documents must undergo five procedures that echo those required for rulemakings, although without comparable detailed procedural requirements: (1) assessment and appraisal of their necessity, feasibility and reasonableness; (2) widely soliciting the public’s opinions; (3) legality review; (4) collective deliberation and decision, to prevent arbitrary actions; and (5) public issuance as a condition of enforceability. Although “significant” is not expressly defined, public opinion solicitation is required for documents that involve the public’s “vital interests” or have a “major” (zhongda) impact on their rights and interests. When proposed documents impact major public interests, in-depth investigations and studies through such channels as forums, expert appraisal meetings, and site visits must be undertaken to adequately obtain input from stakeholders. The Circular prohibits government authorities from issuing, without a proper legal basis, regulatory documents that increase their own powers or reduce their statutory obligations. It likewise prohibits the issuance of documents that impair the lawful rights and interests of citizens, legal persons and other organizations or increase their obligations, or that infringe upon citizens’ personal, property, personality or labor rights. Business regulation is also explicitly addressed in the Circular. Governments may not, without legal authority, undertake to do any of the following: establish new licensing requirements, penalties or compulsory measures, or add conditions for licensing; require duplicative or unnecessary certification; impose measures that eliminate or restrict fair competition; intervene in or interfere with normal business production and activities; or establish market access and exit conditions. China’s new Foreign Investment Law specifies that regulatory documents relating to foreign invested enterprises must be formulated in accordance with the above requirements and published in a timely manner. A March 2019 State Council notice further urges central and local agencies to create a law-based, internationalized, and facilitative business environment by obtaining advice from affected enterprises, trade associations, chambers of commerce, and lawyers associations when drafting business-related regulatory documents. All regulatory documents must also undergo a review, numbering, and registration process, and they must be periodically re-examined—including at the request of the public. As circumstances change, they should be “cleaned up” (qingli) through amendment or repeal. For example, the State Council released an instruction last June to abolish by the end of 2018 all certification requirements based on regulatory documents. A further constraint on regulatory documents is afforded by the right, under the revised Administrative Litigation Law, to challenge them in court when concurrently seeking review of the legality of a government agency action based on such documents. This “incidental review” is an exception to the rule that Chinese courts do not have the authority to directly review the legality or reasonableness of State Council regulations, rules or regulatory documents. In such circumstances, China’s Supreme People’s Court (SPC), in a 2018 judicial interpretation of the revised Administrative Litigation Law, instructed Chinese courts to review the legality of regulatory documents if they exceed the drafting agency’s authority, did not comply with procedures including for publication, or otherwise violate the law. Furthermore, incidental review of regulatory documents is appropriate if the documents conflict with the provisions of higher-level laws, regulations, and rules, or, without a legal basis, increase the obligations, or reduce the lawful rights and interests, of the public. The introduction of incidental review of regulatory documents may help to gradually expand the scope of judicial review of Chinese agency action more broadly. For now, the State Council and the impacted public hope that the new requirements, bolstered by incidental judicial review, will curb the abusive aspects of regulatory documents and promote transparency and more law-based governance in China

China’s Central Government Seeks to Rein in Regulatory Documents

As the Trump Administration seeks to pare back agency regulations, the Xi Administration in China is clamping down on guidance-type regulatory documents, frequently called “red-headed” documents due to the official letterhead on which they are issued. The U.S. business community in China has long complained about these directives, conservatively estimated to number in the millions, and their inconsistent enforcement. Even though red-headed documents frequently impact the public’s rights and obligations, they have not been required to go through the increasingly transparent rulemaking procedures that apply to legally binding regulations and rules adopted at all levels of the Chinese government. In May 2018, the Chinese State Council imposed a detailed set of requirements—the “Circular”—to govern the content and management of regulatory documents. In December 2018, the State Council mandated that agencies assess such documents’ legality prior to adoption. Moreover, the public may now ask Chinese courts to review the legality, under China’s Administrative Litigation Law, of regulatory documents that were the basis for a contested government action. Regulatory documents are a category of what are called “normative documents” (guifanxing wenjian). These include, when used in the term’s broad sense, both legislative documents and non-legislative documents. Legislative documents consist of laws adopted by the National People’s Congress or its Standing Committee as well as State Council “regulations” (xingzheng fagui) and central departmental and local government “rules” (guizhang). Non-legislative documents include decisions and orders issued by government agencies, which are referred to literally as administrative normative documents (xingzheng guifanxing wenjian) but translated here as “regulatory documents,” in line with the State Council’s current practice. The formulation and handling of legislative documents are governed by China’s Legislation Law. In contrast, non-legislative regulatory documents are not subject to the Legislation Law, even though they are considered generally binding. Regulatory documents are defined in the Circular as official documents, other than State Council regulations, decisions and orders, and departmental and local government rules, that are formulated by a government authority according to statutory powers and procedures, publicly issued, involve the rights and obligations of the public, and have a general binding force and applicability within a certain period of time. Regulatory documents may impact the public by imposing user fees, standards, and certification requirements. Some of these documents have been characterized as “bizarre” for exceeding the bounds of reasonable administration—such as by forbidding employees from taking a vacation—and the State Council has long sought to reduce the volume of and better manage regulatory documents. The Circular reflects the continuing struggle to manage regulatory documents. It mandates government agency compliance with its requirements through the use of language like “must” (bixu and yao) as opposed to “should” (ying), which is more typical of policy documents. “Significant” (zhongyao) documents must undergo five procedures that echo those required for rulemakings, although without comparable detailed procedural requirements: (1) assessment and appraisal of their necessity, feasibility and reasonableness; (2) widely soliciting the public’s opinions; (3) legality review; (4) collective deliberation and decision, to prevent arbitrary actions; and (5) public issuance as a condition of enforceability. Although “significant” is not expressly defined, public opinion solicitation is required for documents that involve the public’s “vital interests” or have a “major” (zhongda) impact on their rights and interests. When proposed documents impact major public interests, in-depth investigations and studies through such channels as forums, expert appraisal meetings, and site visits must be undertaken to adequately obtain input from stakeholders. The Circular prohibits government authorities from issuing, without a proper legal basis, regulatory documents that increase their own powers or reduce their statutory obligations. It likewise prohibits the issuance of documents that impair the lawful rights and interests of citizens, legal persons and other organizations or increase their obligations, or that infringe upon citizens’ personal, property, personality or labor rights. Business regulation is also explicitly addressed in the Circular. Governments may not, without legal authority, undertake to do any of the following: establish new licensing requirements, penalties or compulsory measures, or add conditions for licensing; require duplicative or unnecessary certification; impose measures that eliminate or restrict fair competition; intervene in or interfere with normal business production and activities; or establish market access and exit conditions. China’s new Foreign Investment Law specifies that regulatory documents relating to foreign invested enterprises must be formulated in accordance with the above requirements and published in a timely manner. A March 2019 State Council notice further urges central and local agencies to create a law-based, internationalized, and facilitative business environment by obtaining advice from affected enterprises, trade associations, chambers of commerce, and lawyers associations when drafting business-related regulatory documents. All regulatory documents must also undergo a review, numbering, and registration process, and they must be periodically re-examined—including at the request of the public. As circumstances change, they should be “cleaned up” (qingli) through amendment or repeal. For example, the State Council released an instruction last June to abolish by the end of 2018 all certification requirements based on regulatory documents. A further constraint on regulatory documents is afforded by the right, under the revised Administrative Litigation Law, to challenge them in court when concurrently seeking review of the legality of a government agency action based on such documents. This “incidental review” is an exception to the rule that Chinese courts do not have the authority to directly review the legality or reasonableness of State Council regulations, rules or regulatory documents. In such circumstances, China’s Supreme People’s Court (SPC), in a 2018 judicial interpretation of the revised Administrative Litigation Law, instructed Chinese courts to review the legality of regulatory documents if they exceed the drafting agency’s authority, did not comply with procedures including for publication, or otherwise violate the law. Furthermore, incidental review of regulatory documents is appropriate if the documents conflict with the provisions of higher-level laws, regulations, and rules, or, without a legal basis, increase the obligations, or reduce the lawful rights and interests, of the public. The introduction of incidental review of regulatory documents may help to gradually expand the scope of judicial review of Chinese agency action more broadly. For now, the State Council and the impacted public hope that the new requirements, bolstered by incidental judicial review, will curb the abusive aspects of regulatory documents and promote transparency and more law-based governance in China

China Implements More Participatory Rulemaking Under Communist Party

China’s central government, the State Council, recently mandated a 30-day public notice-and-comment process for most government rulemakings and institutionalized other mechanisms that increase public participation and transparency in the rulemaking process throughout the country more generally. These new mechanisms—referred to collectively as the “Procedures”—were accomplished through amendments to two sets of State Council procedures that apply, respectively, to national administrative regulations (xingzheng fagui) issued by the State Council and to lower-level rules (guizhang) issued by the State Council departments and by local governments and their departments. The Procedures effectuate calls by the Chinese Communist Party (CCP) and the State Council to make rulemaking better reflect the will of the people and ensure higher quality regulation. Unexpectedly, the updates also codified requirements for CCP consultation and approval during the rulemaking process. The State Council issued the original version of the Procedures in 2001 to implement basic rulemaking provisions in China’s Legislation Law, which established the principle that the Chinese people should “participate in legislation through various channels.” The term lifa—legislation—covers not only lawmaking by the National People’s Congress (NPC) but also government rulemaking for legally binding State Council regulations—issued by the State Council—and rules—issued by ministries and provincial governments. Both original Procedures were revised in late 2017, with effect from May 1, 2018. The revised Procedures enhance public participation throughout the rulemaking process, which comprises four stages. The first stage involves preparing annual rulemaking plans. The Procedures now require the State Council to solicit public input on its annual plan for regulations, but this is optional for annual plans for issuing rules by State Council departments and local governments. In both cases, the finalized plans must now be made public. At the second stage, agencies designated as drafting units formulate initial drafts of regulations or rules. Both Procedures now require the drafting unit to publish most proposed regulations and rules and to solicit written public input for a minimum 30-day comment period. The comment-seeking obligation is not ironclad. The State Council must publish draft regulations for public comment, unless it decides not to. In the case of rules, drafting units must publish drafts for public input, unless drafts must be kept secret. Moreover, the comment period shall “in general” not be less than 30 days, but no examples are given of what exceptions to the 30-day rule might be. The foreign business community has long sought longer comment periods of at least 60 to 90 days to provide more time to translate drafts and obtain and translate input. The “not less than” language in both Procedures suggests that drafting agencies may provide longer than the minimum 30 days for drafts impacting foreign interests, but they do not specify such a possibility. The third stage involves an examination of proposed regulations by the Legislative Affairs Office (LAO) of the State Council or of draft rules by the relevant State Council department or local government or department. Under both Procedures, the LAOs should circulate drafts presented for examination throughout the government and to select outside organizations, experts, and citizens for comments. The LAOs may also decide to conduct a second round of public notice-and-comment. The fourth stage comprises the final decision and promulgation of the regulation or rule. The Procedures now also call for post-enactment assessment and “cleanup,” which may lead to a revision or repeal of a regulation that would be subject to the same rulemaking procedures. The Procedures provide additional avenues for expanded public participation. Public hearings are optional for draft State Council regulations, whereas they are now required for input on drafts of controversial rules. Some central ministries and many local governments have convened public rulemaking hearings for many years. The State Council never has, but the Procedures leave open that possibility. Both Procedures further codify recent practices of inviting outside experts, academic and research institutes, and social organizations to help draft or independently prepare “expert” drafts, to conduct “appraisal and consultation,” and to offer third-party assessments of drafts in various circumstances. Although the Procedures increase the overall transparency and responsiveness of China’s regulatory process, additional requirements, many of which are being implemented in practice, would further improve the process. These include: disclosing the public’s comments and transcripts of public hearings, appraisals, and other meetings; disclosing the advice of outside experts, institutes, and social organizations; providing feedback on how the public’s comments were considered; requiring and disclosing regulatory impact analyses of the proposed regulations and rules; and establishing online rulemaking dockets to collect related materials in a permanent record. The absence of a requirement to explain how the public’s input was considered is particularly disappointing, since the CCP and State Council have endorsed public comment feedback to ensure accountability. Under both Procedures, drafting agencies and LAOs must prepare explanations of the drafts they submit for review and decision, so preparing a public explanation of how the public’s input was considered should not require much extra effort. As for remedies, the Chinese public cannot challenge a regulation in the courts. The Procedures do provide, however, that members of the public can seek review by the NPC Standing Committee or State Council if they believe a regulation or rule is inconsistent with a superior law or regulation. Moreover, the public can sue the government for failure to comply with procedural requirements that infringed their lawful rights and interests. The Procedures do not, though, explicitly mention such a remedy, and it is unclear whether requirements like the 30-day comment period will be deemed sufficiently concrete to permit such challenges. Both Procedures also give the CCP a role in the rulemaking process. Previously, de facto CCP involvement in legislation was exercised pursuant to conventions and unpublished Opinions on Strengthening CCP Leadership over Legislation. The Opinions reportedly require that draft laws and regulations relating to political matters and major economic and social issues must first be deliberated by the Central Committee or the CCP organization at the same level as the drafting body. These principles of CCP approval have been written into both Procedures, which also require that regulations and rules implement the CCP’s line, policies, and decisions. CCP leadership may be intended more to ensure policy oversight than to interfere with what is becoming a more transparent and participatory rulemaking process. Insertion of the CCP into state law, however, is a disturbing trend that raises concerns about China’s rule of law project. Nonetheless, the gradual institutionalization of transparency and public participation in rulemaking represents progress along the road to modernizing the Chinese governance system