Royal Decree-Law 21/2020 of 9 June on urgent prevention, containment and coordination measures to address the health crisis caused by COVID-19

OFFICIAL BULLETIN OF THE STATE No. 163 Wednesday 10 June 2020 Sec. I. Page 38723 I. GENERAL PROVISIONS HEAD OF STATE 5895 Royal Decree-Law 21/2020, of 9 June, on urgent prevention, containment and coordination measures to address the health crisis caused by COVID-19. I Since the World Health Organization declared the international emergency occasioned by the COVID-19 epidemic outbreak an international pandemic on 11 March 2020, the Council of Ministers, meeting in extraordinary session on Thursday 12 March, adopted the first urgent measures to address the spread of the pandemic, in particular Royal Decree-Law 7/2020 of 12 March, adopting urgent measures to respond to the economic impact of COVID-19. From that moment on, the legal framework for the pandemic response has been structured around two constitutional instruments: on the one hand, the declaration of a state of alarm and the measures adopted under it, and on the other, the adoption of successive royal decree-laws, fundamentally aimed at alleviating the consequences and negative effects that the pandemic and the containment measures adopted to control it are having in the socioeconomic sphere. In this regard, unlike other countries in our vicinity, our constitutional order provides, in Article 116 of the Spanish Constitution, for the declaration of a state of alarm under certain circumstances regulated in Organic Law 4/1981 of 1 June on states of alarm, exception and siege. By virtue of the authorization granted to the Government by said organic law and the factual scenarios provided for in its fourth paragraph, point b) ("health crises, such as epidemics and serious contamination situations") and d) ("situations of shortage of essential products"), the Government approved Royal Decree 463/2020 of 14 March, declaring a state of alarm to manage the health crisis situation caused by COVID-19. According to its own preamble, the measures provided for in this provision fall within the Government's decided action to protect citizens' health and safety, contain the progression of the disease and strengthen the public health system. This rule also included, in addition to measures limiting freedom of movement, which as the law provides remains conditional upon meeting certain requirements, a variety of containment measures in different areas, ranging from education and training, to commercial activity, cultural facilities, recreational establishments and activities, hospitality and catering activities, or places of worship and civil and religious ceremonies. Nevertheless, since the World Health Organization's classification as an international pandemic and the subsequent declaration of a state of alarm, the public health emergency occasioned by COVID-19 evolved, both nationally and worldwide, with enormous speed. This is an unprecedented health crisis of extraordinary scope and severity, both due to the extraordinary risk of contagion and the high number of affected citizens, with the consequent pressure on health services, as well as the high social and economic cost derived from the extraordinary containment and distancing measures adopted by various States. This evolution has required the adoption of successive additional measures to address the pandemic. Nevertheless, Article 6 of the aforementioned Organic Law 4/1981 of 1 June establishes that the duration and effects of the state of alarm may not exceed fifteen days, and that it may only be extended with the express authorization of the Congress of Deputies, which in this case may establish the scope and conditions valid during the extension. Therefore, given the rapid and devastating evolution of the pandemic, in order to guarantee the effective management of this health emergency, contain the spread of the disease and preserve and guarantee the response of the National Health System, the Government has requested authorization from the Congress of Deputies to extend the state of alarm up to six times, as well as the validity of the measures contained therein. The Plenary of the Congress of Deputies, in the sessions held on 25 March, 9 April, 22 April, 6 May, 20 May and 3 June 2020, agreed to grant the aforementioned authorizations to extend the state of alarm successively until 00:00 hours on 21 June 2020. Since the adoption of Royal Decree 463/2020 of 14 March, this provision and the measures contained therein, as well as those established in the successive royal decrees extending the state of alarm, have constituted the basic regulatory framework of the regulations adopted to address the emergency provoked by the pandemic. This legislation, in accordance with what was stated by the Constitutional Court, on the only occasion it had the opportunity to rule previously on the declaration of the state of alarm, in its Judgment 83/2016 of 28 April 2016, "(s)hould be understood that it is configured in our legal system as a decision or provision with the rank or value of law. And, consequently, it is endowed with a normative value comparable, by its content and effects, to that of laws and assimilable norms whose application may be excepted, suspended or modified during the state of alarm", without the "conclusion regarding the rank or value of the decree by which the state of alarm is extended" being "different in this case, moreover with the peculiarity that the extension decree constitutes an external formalization of the prior authorization of the Congress of Deputies". The legislation through which additional measures have been adopted under the state of alarm finds its legal basis in the authorizations contained in said provisions for this purpose in favor of the Ministers designated as delegated competent authorities to issue the orders, resolutions, provisions and interpretative instructions that, within the specific sphere of their action, are necessary to guarantee the provision of all services, ordinary or extraordinary, in order to protect persons, property and places, both generally and specifically for different areas. Obviously, the necessary containment measures adopted have had a very significant economic and social impact, as they have meant temporarily reducing economic and social activity, restricting mobility and paralyzing activity in numerous areas; with the consequent loss of income for workers and households, as well as for the different companies and sectors of the Spanish economy. Therefore, from the very beginning, economic and social measures have been adopted to guarantee the protection of families, workers and vulnerable groups; to sustain the productive and social fabric; and to mitigate the obvious harms generated by the health crisis through the adoption of a set of provisions articulated in different royal decree-laws aimed at mobilizing national resources for protection against these adverse effects, with special attention to the most vulnerable groups. In any case, following the publication of the Communication "Common European Roadmap for Lifting COVID-19 Containment Measures", presented on 15 April 2020 by the President of the European Commission and the President of the European Council, the different Member States of the European Union began planning the different phases that would allow the resumption of economic and social activities, so as to minimize any impact on people's health and not overload health systems, taking into account the guidelines of the World Health Organization. In that context, in light of the main available indicators, the experience acquired nationally, and best practices in other countries, by Agreement of the Council of Ministers of 28 April 2020, the Plan for the Transition towards a New Normality was approved, which conceives the lifting of containment measures in a gradual, asymmetric manner, coordinated with the autonomous communities and adaptable to necessary changes in orientation depending on the evolution of epidemiological data and the impact of the measures adopted. The Plan, which was submitted to the Congress of Deputies on 29 April 2020 in compliance with what is provided for in the sixth additional provision of Royal Decree 463/2020 of 14 March, has the fundamental objective of achieving, while maintaining the protection of public health as a fundamental reference, the gradual recovery of daily life and economic activity, minimizing the risk that the epidemic represents for the population's health and avoiding that the capacities of the National Health System can be overwhelmed. In application of said Plan, since the approval of Royal Decree 514/2020 of 8 May, extending the state of alarm declared by Royal Decree 463/2020 of 14 March, and in accordance with what is provided for in the authorization granted by the Congress of Deputies, the Minister of Health was enabled to agree, within the scope of his competence and upon proposal, if applicable, of the autonomous communities and the cities of Ceuta and Melilla, the progression of the measures applicable in a given territorial area, in view of the evolution of the health, epidemiological, social, economic and mobility indicators established in the Plan. In turn, Article 4 of the cited royal decree established that "(i)n the process of de-escalation of the measures adopted as a consequence of the health emergency caused by COVID-19, the Government may agree jointly with each Autonomous Community the modification, expansion or restriction of the units of action and the limitations regarding freedom of movement of persons, containment measures and those ensuring goods, services, transport and supplies, in order to better adapt them to the evolution of the health emergency in each autonomous community". By virtue thereof, and in application of the regulations issued on this matter by the Minister of Health, the different territories have been progressing through phases, in an asymmetric and gradual manner, with the consequent lifting and modulation of the different measures initially established in Royal Decree 463/2020 of 14 March, up to the present moment. For its part, Royal Decree 537/2020 of 22 May, extending the state of alarm declared by Royal Decree 463/2020 of 14 March, established in its Article 5 that "(t)he overcoming of all the phases provided for in the Plan for the De-escalation of Extraordinary Measures Adopted to Address the COVID-19 Pandemic, approved by the Council of Ministers in its meeting of 28 April 2020, will determine that the measures derived from the declaration of the state of alarm in the corresponding provinces, islands or territorial units cease to have effect". At the present moment, in which the entire national territory has reached at least phase II of the Plan, the current Royal Decree 555/2020 of 5 June, extending the state of alarm declared by Royal Decree 463/2020 of 14 March, declaring a state of alarm to manage the health crisis situation caused by COVID-19, in addition to maintaining the aforementioned provision, stipulates that the delegated competent authority for the adoption, suppression, modulation and execution of measures corresponding to phase III of the de-escalation Plan will be, in exercise of its competencies, exclusively the President of the autonomous community, except for measures linked to freedom of movement that exceed the scope of the territorial unit determined for each autonomous community. In addition, it is foreseen that the autonomous communities will be the ones that can decide, in accordance with health and epidemiological criteria, the overcoming of phase III in the different provinces, islands or territorial units of their community and that, consequently, the measures derived from the declaration of the state of alarm in their respective territories will cease to have effect. In this state of the de-escalation process and within the framework of these provisions, during the validity of this last extension, the aim is to conclude this process with the gradual lifting and definitive loss of effect of the measures in all territories if, as is foreseeable, all of them overcome all phases of the de-escalation process. Thus, the final de-escalation process of the containment measures has been synchronized with the maintenance of the state of alarm, so that the gradual and coordinated lifting of the same, as provided for in the Plan for the Transition towards a New Normality, would allow not compromising the achievement of the pandemic containment objectives set since the beginning of the health emergency occasioned by COVID-19. In this regard, the favorable evolution of the situation already recorded during the fifth extension must be highlighted. In view of the different indicators and parameters examined in relation to strategic health assistance capacities, epidemiological surveillance, containment of contagion sources and collective protection, the favorable progress in containing the pandemic and transmission chains now allows that, once the validity of the last extension expires and all phases of the de-escalation process have been overcome, the measures derived from the declaration of the state of alarm in the entire national territory cease to have effect. However, the current favorable evolution in containing the pandemic does not exempt public authorities from their duty to "organize and oversee public health through preventive measures and the necessary provisions and services" established in Article 43.2 of the Spanish Constitution to guarantee the right to health protection recognized in its first paragraph of this article. Therefore, although the effects of the pandemic have been notably controlled thanks to the containment measures adopted, its nature and unpredictable evolution, as well as "the current state of scientific research, whose advances are changing" and the "uncertainty so pronounced and difficult to calibrate from legal parameters" to which the Constitutional Court refers in its Order of 30 April 2020 (FJ 4), in relation to the forms of contagion and the spread of the virus, advise the adoption of a series of urgent prevention, containment and coordination measures, which allow continuing to face and control the pandemic, once the validity of the state of alarm expires and the measures derived from its adoption cease to have effect. In this sense, it is essential to distinguish between the expiration of the containment measures limiting freedom adopted during the validity of the state of alarm and its successive extensions to address the health emergency situation occasioned by COVID-19, and the health crisis itself, caused by the pandemic, which persists, although notably attenuated in our country, and whose overcoming has not yet been officially declared either nationally or internationally by the competent organizations and authorities. Therefore, given the possible risks that could arise from the automatic loss of validity of said measures for the favorable evolution in achieving the pandemic containment objectives, due to the emergence of new epidemiological outbreaks and new unidentified transmission chains that could compromise the guarantee of physical integrity and people's health and place available health resources under enormous assistance pressure again, from the perspective of the constitutional duty of public authorities to organize and oversee public health through preventive measures, the adoption of said preventive measures is urgent and necessary, until the end of the health crisis situation is officially declared. To this end, this royal decree-law responds by establishing a general duty of caution and protection that reinforces preventive behaviors throughout the population, and by adopting a series of urgent prevention, containment and coordination measures, aimed at guaranteeing the right to life and health protection while the health crisis occasioned by COVID-19 persists, once the validity of the state of alarm and the extraordinary containment measures, including those limiting freedom of movement, established under it, expire. Additionally, the scope and severity of this health crisis have revealed certain shortcomings in the regulation contained in our ordinary legislation, apart from the declaration of the state of alarm, to address health crises of this or similar nature. Therefore, it is also considered necessary to undertake a series of targeted modifications to health legislation so as to guarantee in the future the articulation of an effective and coordinated response by health authorities in the face of such crises. The urgent nature of these modifications is justified, on the one hand, by the current persistence of the crisis situation derived from the pandemic officially declared as such, and on the other, by its nature and unpredictable evolution, in the terms previously outlined, which advise the immediate modification of those provisions provided for in the legislation in force to address such situations, in order to guarantee greater effectiveness and coordination in the adoption of measures to face them, not only in the future, generally, but also at the present moment, given the contingency that the appearance of eventual community transmission outbreaks of COVID-19 would entail. To this end, these modifications will allow plans and strategies of action to be drawn up or activated to address health emergencies through the figure of "coordinated actions in public health". Likewise, it is intended to guarantee adequate coordination between health authorities and strengthen the functioning of the entire national health system in the face of health crises. II The royal decree-law is structured in seven chapters, 31 articles, six additional provisions, one repealing provision, eight final provisions and an annex. Chapter I, Articles 1 to 5, covers the general provisions, that is, the object and scope of application of the royal decree-law, the competent bodies, as well as the measures that must be adopted to avoid the generation of risks of COVID-19 disease spread. Likewise, the adoption of plans and strategies of action to address health emergencies is foreseen, through coordinated actions in public health, for the development of the different activities contemplated in the following chapters. Chapter II is integrated by Articles 6 to 16 and covers the maintenance of certain prevention and hygiene measures, such as the mandatory use of face masks in public roads, outdoor spaces and closed spaces of public use or open to the public, as well as in transport. Likewise, in this regard, the possibility that masks can be purchased individually at pharmacy offices is contemplated, which facilitates their access to the population. This measure, together with the modification established in the consolidated text of the Law on guarantees and rational use of medicines and medical devices, approved by Royal Legislative Decree 1/2015 of 24 July, allows access to masks to be carried out under non-abusive economic conditions. Likewise, this chapter contemplates the adoption of certain prevention measures in the work environment, such as the organization of workstations or the organization of shifts to avoid overcrowding, as well as the maintenance of basic prevention and hygiene measures in commercial establishments, social residential centers, hotels and tourist accommodations or in hospitality and catering activities, among others. In the sports field, for its part, the competence of the Higher Sports Council to apply these measures in certain professional competitions is recognized, once the organizer, the Ministry of Health and the autonomous communities have been heard; and depending on the concurrent circumstances and the necessary protection of athletes and the public. Chapter III, Articles 17 and 18, covers various provisions that enable the regulation of the offer of places and the volume of occupancy in passenger transport services by sea, rail and road, all of which are of state competence. Transport operators with a pre-assigned seat number must retain, at the disposal of public health authorities, the contact information of passengers for a minimum of four weeks, in order to carry out contact tracing. Likewise, the head of the Directorate General of Merchant Navy is enabled to order, upon proposal of the Ministry of Health, the adoption of sanitary measures for the control of ships, including cruise ships, that carry out international trips and navigate through territorial sea waters in order to enter Spanish ports. Chapter IV, Articles 19 to 21, contains measures relating to medicines, medical devices and products necessary for health protection. Among other aspects, it should be noted, in the matter of medicines, the need to give continuity to the measures of information supply, stocking and manufacturing of those considered essential for the health management of COVID-19. Likewise, to protect public health, their supply in health centers and services must be guaranteed, and this requires a distribution capable of covering consumption with