1. The scope and classification of soft law in the Chinese legal system

The question “what is soft law?” is universally controversial. Chinese scholars have thus, like scholars in other places, attempted to define the scope of soft law and have put forward different categorisations.

The multiple manifestations that soft law takes mean that delineating the boundaries of soft law is not an easy task. The concept proposed by Luo Haocai has attracted the attention and affirmation of many scholars. He considered that, in addition to hard law expressed in command-and-control measures and implemented by the state’s coercive force, the more extensive institutional arrangements in state law are soft laws. Such soft law includes the following four categories: (i) legal norms embodied within laws, regulations that describe legal facts, or which are demonstrative, hortative, enticing, promotional, consultative or guiding in nature; (ii) normative documents without legal effect legitimately created by public authorities; (iii) self-regulatory norms devised by various political organisations seeking to determine issues such as the exercise of power, participatory government and public political discourse; and (iv) self-regulatory norms created by various societal communities.Footnote ²

It should be noted that there exists a tendency to propose that all rules, other than hard law, that can restrict people’s behaviour are soft laws. This is what is sometimes called “Pan soft law” and includes customs, folk laws, ethics, religious rules, legal consciousness, legal culture and so on. On the one hand, this framing ignores the major premise that soft laws are posited as legal norms, and interferes with the scientific construction of soft law theory. On the other hand, the idea of Pan soft law relegates soft law to a “pocket concept”, which hinders soft law from obtaining its own independent value. However, just like the complex relationship between law and morality, soft law and other norms are not entirely distinct and unrelated, but the uniqueness of soft law is obvious in terms of its norm-making bodies, ways of creation, effect, means of implementation, significance and so forth,Footnote ³ and these features can be used to distinguish it from other social norms.

2. Academic engagement with soft law in China

At present, academic research on soft law in China focuses mainly on three aspects: network governance; regional collaborative governance; and the legal effects of soft law.

First, new situations arising from the implementation of the 2015 Chinese “Internet Plus” strategy pose great challenges to the governance of the state and society. For example, Ji Weidong has pointed out that artificial intelligence harbours great risks that may endanger legitimate interests and social order. Soft law may provide one way to govern artificial intelligence networks.Footnote ⁴ As a second example, soft law, rather than state law backed by coercive force, works better to solve the problems posed by technical and complex data governance.Footnote ⁵

Second, in areas such as environmental pollution and food safety, different administrative regional authorities govern through soft law instruments, such as signing administrative agreements, in a bid to provide both sides with flexible and predictable opportunities for interaction and cooperation, thus enhancing mutual trust.Footnote ⁶ Shi Youqi has noted that soft law in the form of regional administrative agreements is an innovative institutional mechanism that can break through the shackles of space and legal traditions, compensate for the lag, rigidity and institutional failure of hard law, balance diverse interests and demands, and enhance the effectiveness of regional governance.Footnote ⁷

Third, with the increasing number of different soft law instruments, the legal effect of soft law, as an important aspect of soft law theory, has gradually attracted more attention from scholars. Does soft law have legal effect(s)? Some Chinese scholars have suggested that, in contrast to hard law, soft law has a persuasive binding force that is ultimately derived from people’s consent and acceptance. The actual legal effects of soft law do not rely only on enforcement mechanisms of the administrative and judicial systems, but may also be realised through non-mandatory means such as incentives and guidance adopted by non-state actors.Footnote ⁸

In addition, other topical issues such as non-state actors’ key role in the application of soft law, the relationship between soft law and human rights protection, and the relationship between soft law and inner-party regulations have been discussed in detail by Chinese scholars interested in soft law, thus enriching the breadth and depth of soft law theory, responding to the practice of soft law application and promoting the realisation of good governance in China.

1. China’s hard law framework regarding the prevention and control of infectious diseases

After the 2003 SARS epidemic, China began to enact and revise legislation on the prevention and control of infectious diseases on a large scale. The Law on the Prevention and Control of Infectious Diseases, enacted in 2003, has become the basic law on the prevention and control of infectious diseases in China.Footnote ⁹ The Emergency Response Law, adopted in 2007, provides the legal basis for China’s response to emergencies including public health emergencies.Footnote ¹⁰ In addition, the government has enacted the Regulation on Emergency Response to Public Health EmergenciesFootnote ¹¹ and revised various administrative regulations such as the Administration Regulations on the Circulation of Vaccines and Vaccination.Footnote ¹² The relevant departments of the State Council have also revised departmental rules, such as the Measures for the Administration of Blood Stations and the Measures for the Administration of Disinfection, which are closely related to the prevention and control of infectious diseases, and formulated and revised relevant standards, including 18 standards related to the diagnosis of infectious diseases, and 12 standards for the control of hospital infections.Footnote ¹³

The provinces (ie autonomous regions and municipalities directly under the Central Government) have also, since 2003, successively issued a number of local regulations to further improve the prevention and control of infectious diseases.Footnote ¹⁴ Generally, China has established a comprehensive legal framework that can respond to major epidemics, including measures on infectious disease epidemic monitoring and early warning systems, reports and information disclosure, control measures for epidemics and medical treatment and prevention of infectious diseases. The laws, regulations and departmental rules to be followed in the prevention and control of major epidemics are mostly hard law norms.

2. The drawbacks of hard law in dealing with the coronavirus

Soft law and hard law are contrasting legal paradigms.Footnote ¹⁵ If the radical cause of the existence and rise of soft law in the field of international law lies in the lack of sovereignty, then, in the field of domestic law, the introduction of soft law does not stem from the lack of legislators with legislative capacity, but lies in the inherent deficiencies of hard law itself. In the context of the prevention and control of the COVID-19 pandemic, the drawbacks of the relevant hard law are mainly manifested in the following aspects.

3. The use of soft law in coping with COVID-19

Although there are still many controversies about the scope, legality and binding force of soft law,Footnote ¹⁹ it is an undeniable fact that soft law has been increasingly applied in the public governance of various countries. As discussed above, although China has a relatively complete hard law framework to combat infectious diseases, it was insufficient to cope with the challenge of the COVID-19 epidemic. The mix of the uncertainty that COVID-19 brings, the high reliance on scientific judgments, the flexibility necessary for emergency control and some other inherent deficiencies make hard law inadequate and inefficient in tackling the COVID-19 crisis. Against this background, it is unsurprising that public authorities at all levels in China have issued various non-mandatory soft law measures to guide administrative officials and encourage the public to cooperate in the prevention and control of the epidemic. Generally speaking, the use of soft law has made an important contribution to the scientific treatment of the novel coronavirus and helped prevent its spread.

The following section focuses on three soft law norms created in response to the COVID-19 situation in China, namely, the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia, the Guidelines for the Use of Masks, and the Guidelines on Resuming Work and Production Amidst Epidemic Control, and will analyse the specific form, function and disputes on the legality of these soft law measures.

1. The hard law legal basis of the Diagnosis and Treatment Protocol for COVID-19

Paragraph 3 of Article 51 of the Law on the Prevention and Treatment of Infectious Diseases stipulates that:

Article 37 of the Regulation on Responses to Public Health Emergencies stipulates that:

Therefore, in the face of newly discovered infectious diseases such as COVID-19, the applicable laws and regulations put obligations on the health administrative department of the State Council to formulate diagnosis and treatment protocols.

It should be pointed out that although the above provisions stipulate that medical agencies shall take necessary measures in accordance with the diagnosis and treatment requirements for infectious diseases, this does not mean that those provisions are legally binding. On the one hand, the legislation has not established the corresponding legal liability for violating this duty. On the other hand, the diagnosis and treatment protocol does not necessarily imply a specific behavioural requirement. From the point of view of medical agencies, medical staff and/or the public, the Diagnosis and Treatment Protocol does not have legally binding force; in other words, it is soft law.

The National Health Commission has promulgated eight editions of the COVID-19 Diagnosis and Treatment Protocol (trial). It should be pointed out that although the State Health and Health Commission promulgated the Pneumonia Diagnosis and Treatment Program for New Coronavirus Infection on 15 January 2020 (for trial implementation) and the Pneumonia Diagnosis and Treatment Program for New Coronavirus Infection on 18 January 2020 (for trial implementation), it is impossible to find these two versions via the website of the National Health and Health Commission. The full text is only circulated in an informal way on a limited number of medical websites. As a guidance document, it is a mix of scientific, political and policy considerations that reflects its adoption process. While medical experts lead the formulation of this Protocol and it is officially adopted by the administration, the general public holds strong opinions on what it should contain. It is worth emphasising that the Protocol is not compulsory and has no legally binding force. Nor does it directly set or change the rights, obligations and legal status of parties. It is clear that the Protocol should be regarded as best practice on medical treatment.Footnote ²¹ It is addressed mainly to public health administrators and medical professionals. There is no doubt that it has played an important role in the fight against COVID-19.^{Footnote 22}

2. The legal and practical effects of the Diagnosis and Treatment Protocols

To date, China’s National Health Commission has published eight versions of the Diagnosis and Treatment Protocol for COVID-19. The last version was published on 18 August 2020.Footnote ²³ Save for the first two versions, subsequent versions can be found on the official website of the National Health Commission.Footnote ²⁴ By way of overview, each of them contains the following nine aspects: background; etiological characteristics; clinical characteristics; case characteristics/diagnostic criteria; clinical classification; case finding and reporting; therapeutic regimen; discharge criteria; and infection control. With the spread of the COVID-19 epidemic and the accumulation of diagnosis and treatment experience, the content of the diagnosis and treatment protocol is becoming increasingly detailed, including a more accurate description of clinical characteristics, increasingly detailed diagnostic criteria and clinical classification, and continuous improvement of the recommended therapeutic regimen.

3. Legitimacy concerns and suggestions for improvement

During the process of formulation and revision of the Diagnosis and Treatment Protocol, many questions have been put forward. There are (at least) six areas where further clarification in relation to the Protocol would be useful. First, the nature or legal basis of the Protocol is unclear. Second, the institutions and disciplines of the experts involved in the formulation of the Diagnosis and Treatment Protocol are not officially disclosed. Third, formal participation channels are limited and many experts and doctors have no formal channels to express their opinions and suggestions. Fourth, there is no specific disclosure of the opinions and disputes in the formation of the Diagnosis and Treatment Protocol. In other words, medical personnel and the public know only how to do something, but they do not know why they should do it.

In order to further enhance the effectiveness of the Diagnosis and Treatment Protocols as soft law measures, the following procedural requirements should be emphasised in the future. First, the system of information disclosure and declaration of conflicts of interest for experts should be improved. It is recommended that, in the future, when publishing these protocols, the name, workplace and academic background of the experts who participate in their drafting or act as consultants should be disclosed, and it should be stated that the experts have no actual or potential conflicts of interest. This will help enhance the professional persuasiveness and acceptability of these protocols and help clarify the responsibilities of the experts. Second, more emphasis should be placed on the involvement of frontline medical worker experts drawing on their clinical experience, new scientific findings and advances accumulated in treatment practice. Third, the democratic nature of the participation process should be emphasised. At present, in the formulation of these protocols, most attention is paid to the quality and scientific nature of the rules, and to whether those rules constitute “sound science”. However, many administrative measures like these protocols not only contain judgments on the medical level but also imply judgments on various (and possibly competing) social values.

For example, the question of whether and how to use traditional Chinese medicine in fighting COVID-19 has caused much controversy. Those trained or experienced in Western medical expertise reject Chinese medicine, and vice versa. In addition, when selecting patients for clinical trials of vaccines, doctors also face ethical dilemmas. In the formulation of future Diagnosis and Treatment Protocols, it would be useful to follow the principles of democratic decision making, listen to the opinions of stakeholders, such as patients, the general public and professional organisations, and ensure that the public can participate in the formulation of Diagnosis and Treatment Protocols through various channels and forms.

1. The legal nature of the requirement to wear a mask

The first document from the central Chinese government on wearing masks as a response to COVID-19 was the “Guidelines for the Use of Masks for the Prevention of Novel Coronavirus Pneumonia” issued by the National Health Commission on 30 January 2020. The guidelines state:

It is important to note that this document is only a “guideline” to guide the protection of the public and reduce the risk of infection. In addition, its function, as indicated in the document, was only “for guidance to strengthen personal protection”.Footnote ²⁹ The guideline neither obliges the public to wear masks in all public places nor imposes sanctions for not wearing masks. In this sense, wearing masks when going out is not a hard law obligation with clear binding force, but only a soft law obligation providing guidance for the public for personal protection.

In addition to the guidelines for the use of masks issued by the National Health Commission, many local health commissions have issued similar guidelines reflecting the situation of local epidemics. According to these guidelines, wearing a mask when going outside is a recommendation, rather than a mandatory requirement. However, there are examples showing that entering public places without wearing masks will be punished as an illegal act. A typical example is the circular issued by the Health Commission of Guangdong Province on 26 January 2020, which states:

This document was later imitated by many local governments. Originally a soft law obligation, the requirement of wearing masks when going outside has been transformed into a mandatory obligation by many local governments, with the additional consequences of administrative penalties. Although there is no legal basis, this obligation has been generally observed in combating COVID-19.

2. The legality of the requirement to wear a mask

Whether or not an action is a punishable illegal action is essentially a question of whether the violated act provides for an administrative penalty. According to the Law on Administrative Penalty, only laws and administrative regulations can be accompanied by administrative penalties; and penalties involving restriction of freedom of persons can only be created by laws. Therefore, the soft law measure issued by the local governments cannot be accompanied by administrative penalties.

In practice, the legal basis for public security organs of the state to impose sanctions is Article 50 of the Public Security Administration Punishment Law, which stipulates:

If we consider carefully the wording of this provision, it can be seen that, in order to prevent the possible expansion of public power in the application of this article, the legislator emphasised that what citizens must fail to abide by must be “the decisions and orders issued by the people’s government in accordance with law under the state of emergency”, and that what they must obstruct must qualify as acts of “state officials performing their duties in accordance with the law”. In other words, the legality of the administrative order is the basis for the public security authorities to punish the alleged offender according to this provision.

However, neither the Law on the Prevention and Treatment of Infectious Diseases, the Emergency Response Law nor the Regulation on Responses to Public Health Emergencies set additional obligations for the public during an epidemic other than compulsory quarantine, isolation and treatment; nor do those laws authorise local authorities to take other tougher prevention and control measures beyond the requirements set by those laws. The fact that local authorities relied on lower-level soft law measures, elevating what was originally administrative guidance to a mandatory order with administrative penalties attached as a deterrent, is clearly inconsistent with the premise of the application of Article 50 of the Public Security Administration Punishment Law. In reality, some citizens went out without wearing masks, clashed with epidemic prevention workers and were held in administrative detention according to Article 50.Footnote ³¹ It should be noted that those offenders were eventually punished not only because they did not comply with the requirement to wear a mask but also because they had physical conflicts with epidemic prevention workers.

Although current legislation gives the local government broad authorisation in the form of vague and general language, it does not mean that the local government can impose at will harsh legal obligations on the public without a clear legal basis. The scope and legitimacy of necessary measures depend on the careful balance between the necessity of epidemic prevention and control and the legitimacy of restricting rights. In the absence of a clear basis in the hierarchically higher law, local governments cannot use this broad authorisation as a basis for setting universal mandatory obligations on the public.

3. Compliance with a soft law obligation to wear a mask

It can be seen from the above that statutory law does not impose a legal obligation to wear a mask when going out during the pandemic, nor does it set a specific legal liability for non-compliance with this obligation. Neither the Law on Administrative Penalty nor the Public Security Administration Punishment Law can serve as a legal basis for detaining people not wearing masks when going out. When the country is fighting against COVID-19, individuals are subject to additional obligations for the public good, and their rights are subject to additional restrictions. This does not mean, however, that public authorities can create unlimited obligations for citizens and elevate moral obligations to legal obligations, because the confusion this creates between moral and legal obligations can lead only to the continuous curtailment or even the total erosion of individual freedoms.Footnote ³²

At present, the pandemic situation is still challenging. Although the current applicable law does not establish a hard law obligation to wear a mask when going out, empirical evidence has demonstrated the positive impact of wearing a mask in preventing the spread of the novel coronavirus. In China, although there are a few places that ensure that people wear masks when going out (through the (illegal) enforcement methods just discussed), it appears that wearing masks when going out is still formally only a soft law obligation. Why do people generally wear a mask then? Given the limited law enforcement resources, it is not realistic to attribute the extensive compliance with this soft law obligation to the fear of legal sanctions. Despite the lack of legally binding force, the main reasons for the extensive compliance with the guidance on wearing a mask in China can be attributed to the following aspects: (i) large-scale social publicity has made people generally aware of the positive effect of wearing masks on the prevention of COVID-19, although the World Health Organization recommends that asymptomatic people should not be required to wear masks;Footnote ³³ (ii) under the “joint prevention and control” mechanism,Footnote ³⁴ the staff of social organisations at all levels, communities, shops, supermarkets, sports stadiums and other public places dissuade those not wearing a mask from going inside, which makes it almost impossible for those not wearing a mask to go anywhere; and (iii) the government has adopted a variety of measures to ensure the adequate supply of affordable masks in the market so that the public can easily purchase them.Footnote ³⁵

1. The formulation of Guidelines on Resuming Work and Production

On 21 February 2020, the joint prevention and control mechanism of the State Council issued the Guidelines for Enterprises and Institutions on Resuming Work and Production Amidst Epidemic Control.Footnote ³⁶ The guidelines mainly emphasise the responsibility of enterprises and institutions in epidemic prevention and control. The obligations set by the guidelines include the following aspects: (i) the need to strengthen the health monitoring of employees. Each employer is to monitor the temperature of employees who live in collective dormitories twice a day, summarise the health status of all employees, and report that information to the disease control department on a daily basis; (ii) the need to strengthen the prevention and control measures in workplaces, including registration of the entry and exit of personnel, regular disinfection of the workplace, reduction of staff gathering and collective activities, staggered dining, and remote office working; and (iii) the need to enhance anti-epidemic knowledge among employees. As part of this, employers are to guide employees to strengthen their own personal protection, including reducing unnecessary trips out and wearing masks in crowded places.

On 9 April 2020, the joint prevention and control mechanism of the State Council issued the Guidelines for Enterprises and Institutions on Resuming Work and Production Amidst Epidemic Control in Different Risk Areas Nationwide.Footnote ³⁷ They emphasised that enterprises and institutions in low-risk areas should be further promoted to the full resumption of work and production, and restore normal production and living order as soon as possible. At the same time, the Guidelines urged that high-risk and medium-risk areas should continue epidemic prevention and control measures and resume work and production in accordance with the requirements in relation to zoning and classification, precisely implement prevention and control policies, and coordinate the epidemic prevention and control work in enterprises and institutions, so as to restore the order of production and life in an orderly manner.

These two Guidelines provide a necessary policy basis for the adoption of epidemic prevention and control measures and the resumption of work and production throughout the country. However, judging by the issuing body, the process of adoption and the legal effects of the two Guidelines, it is obvious that they are not legally binding hard law norms, but rather soft law documents that have practical effects.

Despite the fact that these two Guidelines are soft law documents with no clear legal effect, they have played an important role in guiding the orderly resumption of work and production in various production and operation entities.

2. The general content of Guidelines on Resuming Work and Production

The Guidelines on Resuming Work and Production Amidst Epidemic Control issued in April require local authorities to adopt different prevention and control measures according to the geographic risk level of the epidemic. For low-risk areas, it is necessary to fully resume work and production; for medium- to high-risk areas, tailored measures should be devised and implemented to avoid a “one-size-fits-all” approach. This idea of resuming work and production in accordance with local conditions was particularly prominent and evident during the combat of the second wave of COVID-19 in Beijing in June 2020.

Based on the risk differences of different industries in the prevention and control of COVID-19, regions have adopted differentiated policies when issuing guidelines for the resumption of work and production. For example, the Guideline issued by Shanghai on 5 March 2020 clarifies that:

With regard to the conditions for the resumption of work and production, the guidelines do not set out explicit restrictions or prohibitions, except for a small number of industries with a large turnover and high risk. In order to facilitate the flexible application of measures by local authorities based on different risks, the guidelines set a large number of guiding norms. For example, on 4 March the General Office of the State Council issued a Notice on resuming work and production, which requires simplifying the procedures and conditions for doing so. For medium to high-risk areas, local governments shall, on the basis of meeting the requirements for epidemic prevention and control, formulate and publish unified and harmonised conditions for the resumption of work and production setting out the procedures, materials and time limits for each item.

3. The legality of the implementation of the Guidelines on Resuming Work and Production

As mentioned above, the two Guidelines are not legally binding, which means that they are not, in principle, capable of changing the conditions of administrative licensing in workplaces. However, in practice, due to strong public sentiment and political pressure, many local governments have set excessively stringent conditions for the resumption of work and production. As soft law norms, the guidelines are intended to provide scientific guidance for enterprises resuming work and production to prevent the spread of the epidemic, but in practice, many local governments, when implementing the measures stipulated in the Guidelines, have often transformed a soft law obligation into a hard law obligation, imposing obligations and responsibilities on enterprises without a legal basis. In fact, besides the shutdown of Wuhan, there is no clear legal basis for the shutdown of production in other areas. Local governments have acted based on the need to formulate emergency responses and paying attention to social stability pressures. Fearing the risk of the spread of the epidemic, local governments are still actively taking some overly strict anti-epidemic measures. Of course, during this particular period, few enterprises will directly challenge the legality of such measures through the relevant administrative or judicial mechanisms. Some news reports by the relevant media show, however, that the illegal setting of overly stringent conditions for resuming work and production has caused dissatisfaction among many business owners.Footnote ³⁹

The severe conditions set by local governments are not based on scientific evaluation but rather are an emotional response. In order to avoid legality risks, governments and public institutions at all levels should, on the one hand, respect the soft law nature of the guidelines and ensure that they do not illegally set excessively stringent epidemic prevention obligations for businesses without a legal basis. At the same time, governments and public institutions need to strengthen the scientific basis of the guidelines for the resumption of work and production and take targeted and flexible epidemic prevention measures to avoid a “one-size-fits-all” approach in view of the different epidemic prevention risks faced by different industries in the resumption of work and production.