The GOVERNANCE of the health system with regard to COVID-19 relates to pandemic response plans and the steering of the health system to ensure its continued functioning. It includes emergency response mechanisms, as well as how information is being communicated, and the regulation of health service provision to patients affected by the virus.
Third Act for Protecting the Public in an Epidemic Situation of National Importance
On November 18, the federal Parliament and the Bundesrat passed the amendments to the Infection Protection Act laid out in the ‘Third Act for protecting the Public in an Epidemic Situation of National Importance’. The main goals are to provide legal support for coronavirus measures that have so far been issued by decree and to specify more precisely under which circumstances and preconditions protective measures can be taken to stem the spread of COVID-19.
The Act introduces a new paragraph that lists the possible protective measures that can be taken by state governments and authorities, such as distance requirements, restrictions on going out and social distancing requirements. The Act also aims to provide a legal framework for more targeted help for hospitals, more protection for high-risk groups and better support for working parents.
The Act aims to strengthen parliamentary decision-making. In this regard, the Federal Ministry of Health or the Federal Government can only issue specific corona ordinances on the basis of defined criteria and if the Bundestag (parliament) determines an epidemic situation of national scope. Thus, measures that involve restricting fundamental rights and freedoms must be tied to specific incidences (i.e. after the so-called 7-day incidence of 35 and 50 new infections per 100,000). Particularly serious restrictions imposed on fundamental rights, including the freedom of assembly, freedom to practice religion, confinement measures, and bans on access to care homes and facilities are tied to specific preconditions – for instance that other measures have not helped. Statutory ordinances of the federal states are to be justified and limited in time to four weeks, with the possibility of extension. As a consequence, restrictions e.g. on cultural venues due to the pandemic must be justified by the federal and state governments.
In addition, the Act includes a number of legal bases for additional measures:
• Insured persons should be entitled to protective masks if they belong to a risk group with a significantly increased risk of serious or fatal disease progression after infection with the coronavirus SARS-CoV-2
• With regard to protective vaccinations and tests, not only insured persons but also uninsured persons should be able to have a corresponding claim if an ordinance of the Federal Ministry of Health provides for this. The ordinance may also contain provisions on remuneration and accounting for the corresponding services.
• A digital entry declaration can be prescribed after a stay in risk areas to allow better traceability of quarantine compliance by the competent authorities
• New rules on loss of earnings: e.g. compensation claims for parents who cannot work because of childcare are to be extended and expanded until March 2021.
• Novel surveillance instruments at the Robert Koch Institute
• Use antigen tests and, if necessary, to be able to call up the capacities of the veterinary medical laboratories the Act to allow more flexibility
Overall, the Act takes the previous two acts to the next level and brings them into line with the current requirements in view of the pandemic, while taking into account new developments and findings.
Protection against Infection Act
Infection prevention and control in Germany is regulated by the Protection against Infection Act (‘Act on the Prevention and Control of Infectious Diseases in Man’) at national level that came into force in 2001. According to the Act, the Robert Koch Institute (RKI) advises competent authorities on measures for the prevention and detection of serious communicable diseases and the prevention of their spread and advises the supreme health authorities on measures involving more than one federal state. It collaborates with the respective competent Federal authorities, the competent Laender authorities, the national reference centres, other scientific establishments and professional societies as well as foreign and international organisations and authorities and executes co-ordinating functions within the framework of the European network for the epidemiological surveillance and control of communicable diseases.
The Protection against Infection Act (2001) can be found here: https://www.rki.de/EN/Content/infections/inf_dis_down.pdf?__blob=publicationFile
Act for Protecting the Public in an Epidemic Situation of National Importance
On March 28 2020, the “Act for Protecting the Public in an Epidemic Situation of National Importance” grants the Ministry of Health expanded but timely limited power. Among other things, the Federal Ministry of Health is now authorized to take measures regarding the provision of pharmaceuticals and medical devices, including narcotics, laboratory diagnostics, items of personal protective equipment and products for disinfection. The Ministry of Health can also strengthen personnel resources in the health care system, e.g. by authorizing health professionals to perform medical work if they are personally qualified to do so. The new competencies of the Federal Ministry of Health will expire on April 1, 2021, the "authorization to treat" for nurses and emergency paramedics will expire on January 1, 2021.
On March 4, 2021, the federal parliament extended the “Act for the Continuation for Protecting the Public in the Event of an Epidemic Situation of National Importance”, which would have expired on March 31, 2021, for three months until June 30, 2021. The law also extends the statutory ordinances on vaccination and the associated decisions on prioritization, test ordinance, entry ordinance, DIVI intensive register ordinance, as well as financial aid and flexible rules for care. In addition, these are summarized in the legal framework and no longer need to be extended individually. What is new in the current law is that it, among others, stipulates that in future the restrictions no longer have to be based only on the incidence, but that other key indicators can also be taken into account, such as the R-value and progress in vaccinations.
Pandemic Preparedness Plan
The German Influenza Pandemic Preparedness Plan was first published by the RKI in 2005 and was regularly updated, e.g. based on evidence collected in the 2009 influenza pandemic. The plan provides the basis for pandemic preparedness plans at regional (federal states) and community level. Based on the regional pandemic preparedness plans and the Protection against Infection Act, the individual Health Offices of the federal states are in charge of implementing most infection prevention and control (IPC) measures resulting in variation of measures within Germany. In general, federal authorities such as the RKI and authorities at community level (public health offices) execute their responsibilities in support of the federal and regional responses to a pandemic.
On March 4, the RKI extended the Influenza Pandemic Preparedness Plan in a supplement on COVID-19 for the handling of the pandemic. The supplementary plan aims to reduce morbidity and mortality, ensure treatment of infected persons, maintain essential public services and provide short and accurate information for decision-makers, media and public. The plan provides information on risk-assessment criteria, diagnostics, case definition, IPC, case-management, surveillance as well as communication regarding the COVID-19 crisis. The plan foresees three stages: containment, protection and mitigation.
Governance and steering bodies for the management of the crisis
Following the pandemic preparedness plans a crisis management was set up under leadership of the Ministry of Health and the Ministry of Interior, Building and Community. The RKI, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich Institute (PEI) provide scientific advice. The crisis management closely collaborates at international level (e.g. WHO, ECDC).
Since the outbreak of the pandemic in Germany, the federal government reorganised its chief executive body, the Federal Cabinet of ministers and chancellor which is since called ‘Corona Cabinet’. The small Corona Cabinet is meeting on Mondays under the leadership of the Federal Chancellor. It is made up of the Ministers of Defence, Finance, Interior, Foreign affairs, Health and the head of the German Chancellery. The composition of the small Corona Cabinet slightly differs from regular cabinet meetings, which continues to take place on Wednesdays and where all members of the Federal Government make decisions on upcoming projects of the cabinet schedule within the current legislative period. On Thursdays, the big Corona Cabinet meets. In addition to the small Corona Cabinet’s participants, all ministers responsible for the topics to be discussed are also invited to attend. For example, during debates over how to handle harvest season, the Minister of Agriculture would also be present.
A summary of the measures taken by the federal government until mid-April can be found in the document “Measures by the Federal Government to contain the spread of the COVID-19 pandemic and address its impacts”. It can be found here:
Health protection at work and schools
Generally, employers in Germany are obliged to protect their employees from infection by taking necessary measures. Legally, if the mandatory occupational safety and health regulations are not complied with (see also Section 6.1 Measures in other sectors: Economy), there is the option of stopping or refusing work, but each individual case has to be judged separately based on the specific situation. If the work represents a significant objective danger for the person in the high-risk group or at least a seriously objective reasoned suspicion of danger to body or health, workers have the right to exercise the so called right to refuse performance.
There is compulsory schooling in Germany. If a student belongs to a risk group, a medical certificate must be presented, which proves that it is currently not possible to go to school. A similar procedure is recommended if relatives from the child's household, such as parents or siblings, belong to a risk group. Though, there are different regulations in the federal states.