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Health Protection

Joseph Kuhn, Andreas Böhm

(last update 13 January 2015)


The term “health protection” comprises measures that serve to deflect dangers to the life and health of human beings; these are generally grounded in legal standards. Many of the delineations to the concept of health promotion are reflected in these two characteristics. Different from health promotion, health protection is based on  a pathogenetic approach (salutogenetic perspective). Further, health protection is characterized by obligations to act, that is, it may intervene in the personal privacy of individuals and limit the organizational autonomy of institutions. This makes a differentiated legal basis for these interventions absolutely necessary, something that is not true for health promotion.

Historically speaking, health protection was characterized by its connections to health/hygiene regulations. Measures of health protection were not originally introduced in order to protect the health of individuals, but rather to maintain public order, particularly with respect to outbreaks of epidemics. Regulations for fighting epidemics are some of the oldest measures of health protection known - present already in ancient times and in the Bible. A major surge in health regulations may be traced to the spread of the pest epidemics during the Middle Ages, for example, the introduction of quarantines and strict hygienic regulations.

The more explicit differentiation of health protection introduced during the Industrial Age as well as the attention paid to individual physical integrity that ran parallel to the rise of the middle classes, led to changes in the rationale behind health protection. No longer was the maintenance of public order the focal point, but rather the protection of individual health. From the history of health protection we learn why public health administration used to be part of Ministries of the Interior, which included (and sometimes still includes) the police system. Independent ministries of health are a relatively late phenomenon. The German Federal Ministry of Health, for example, was founded only in 1961.

In Germany the state has the constitutional obligation to enact measures protecting the health of its citizens. Accordingly, the life and health of the individual are to be protected under Article 2, Section 2 of the German constitution (“right to life and physical integrity”). The legislative power for that lies on the national level as well as with the individual federal states. In addition, there are now EU provisions that regulate many areas of health protection, from occupational safety to food safety. Article 168 (1) of the “Treaty on the Functioning of the EU (TFEU)” foresees that European policies ensure a “high level of health protection,” even if health policy making, the organization of health services and the delivery of health care remain within the responsibility of the individual member states (Art. 168 (7) TFEU).

Measures of health protection today affect nearly all areas of life. Examples are:

  • Occupational safety and health (workplaces, work materials and equipment, working hours, etc.)
  • Consumer health protection (safety of food, products, drugs, etc.)
  • Environmental health (emission control, radiation protection, grid and plant protection, industrial safety)
  • Infection control
  • Disaster management
  • Traffic safety
  • Monitoring of healthcare professions

The three following operational principles are applied (cf. Table 1):

Precautionary principle

Recognizing and deflecting dangers before they can cause damage.

Perpetrator principle

The responsibility for deflecting dangers lies wherever possible with the perpetrator.

Cooperative principle

Government agencies, perpetrators and other involved parties should work together to deflect dangers.

Table 1. Primary operational principles of health protection.

In order to illustrate these operational principles, five areas of health protection are discussed below by way of example: occupational safety, infection control, drinking water protection, food safety and hygiene, monitoring of drugs and medical products.

Occupational Safety and Health

According to Article 2 (1) of the German Occupational Safety Act (ArbSchG) from 1996, this term comprises “measures to prevent accidents at the workplace and work-related health risks, including measures to ensure humane working arrangements.” A number of further individual statutes concerning occupational safety and health address more specific areas, such as regulations concerning the organization of the workplace, handling of hazardous materials, working with heavy materials, the special protection of certain groups (pregnant women, adolescents, etc.) or the length and structure of work hours. Most regulations of occupational safety and other statutes are directed toward the employers, that is, at the operational level the employer is mainly responsible for ensuring proper occupational safety.

At the next higher level, the German occupational safety system is characterized by a dualistic approach, with state-sanctioned occupational safety and self-administered occupational safety by the providers of statutory accident insurance. The 7th volume of the Social Security Statute Book (SGB VII) lists the extensive responsibilities of the providers of statutory accident insurance for preventative measures, which go beyond compensation for work-related accidents and occupational diseases and also address work-related health risks. The framework for reaching agreements among the various stakeholders concerning common goals for occupational safety was defined in 2008 in the German Occupational Safety Act and in SGB VII as the “Joint German Occupational Safety and Health Strategy.”

The Occupational Safety Act demands a problem-oriented approach to modern occupational safety and health, that is, the employer has to identify health hazards present at the workplace, assess their relevance and determine whether and what corrective measures have to be taken (Art. 5 ArbSchG). This serves to keep employers, as means of addressing occupational safety, from concentrating solely on the observation of formal occupational safety regulations and ignoring the actual dangers in the workplace situation. For employees the Occupational Safety Act prescribes both rights and duties of participation.

An important regulation for organizing a company-wide occupational safety system may be found in the Occupational Safety Professionals Act of 1973, which prescribes that companies have to engage company physicians and other professionals to tend to matters of occupational safety. The Employers´ Liability Insurance Associations regulate the amount of time devoted to this in their Accident Prevention Regulations. In small businesses, because of the relatively low level of input required, there can major problems in the implementation of  the occupational safety and health regulations. Here new forms of maintaining occupational safety in small businesses are being implemented (e.g., the so-called “entrepreneur model”).

Today, international standards are playing an ever larger role in the further development of occupational safety and health, particularly those standards being prescribed by the EU for all member states. Beyond that,  research on occupational safety and health has also become very important, carried out by, among others, occupational medicine institutes at the university level, research institutes of the Liability Insurance Providers or other state-supported research facilities such as the Federal Institute for Occupational Safety and Health (BAuA).

Infection Control

The Infection Protection Law (IFSG) from the year 2000 had the goal of preventing the rise of communicable diseases, recognizing such infections as early as possible, and preventing their spreading.

Stakeholders

Tasks

Doctors in private practice/hospitals

Diagnosis, therapy, instruction, counseling, reporting of notifiable diseases to the public health offices, vaccinations

Laboratories

Reporting of notifiable diseases to the local health authorities

Local health authorities

Measures for recognizing, preventing and combating infectious diseases, instruction concerning proper hygienic behavior, determination of vaccination status and closing of vaccination gaps, inspection of drinking water, public pools and lakes, review of hygiene standard, e.g., in hospitals, nursing homes and other community facilities

Robert Koch Institute (RKI)

Developing concepts for infection control, counseling on demand of the higher-level federal health authorities, development of guidelines for protective health measures, evaluation of disease notification data, cooperation with the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO)

Table 2. Examples of stakeholders and their respective tasks in infection control.

Further important institutions involved in tasks related to infection control with a statutory foundation other than the Infection Protection Law, include the authorities responsible for food monitoring and veterinary supervision. Besides the actions listed, there is a range of possibilities for personal infection protection: immunizations for oneself and one´s children, compliance with hygiene rules and leading a healthy lifestyle, which strengthens our immune system.

Drinking Water Protection

The most important legal stipulations here are found in Sections 37-40 of the Infection Protection Law as well as in the separate Law on Drinking Water Supply (TrinkwV) from 2001, which serves to implement the EU regulations for drinking water in German law. The drinking water regulations concern, among other things, the demands made on water for human consumption (potable water), the obligations of companies/owners of water supply facilities, and the obligations and rights of health authorities as control body for this area.

Drinking water must be free of germs and pathogenic agents, fit for human consumption and pure (TrinkwV 2001). These demands are considered fulfilled when the delivery, preparation and distribution of water adhere to the generally accepted standards of modern technology and satisfy the chemical and physical limits/demands laid down by law. The quality of drinking water is assessed in the appropriate manner through self-checks by the companies/owners of the water supply facilities and by official supervision through the local health authorities. Provisions for cases in which these standards are not fulfilled are laid down in the TrinkwV. The new TrinkwV strengthens the role and increases the responsibility of the health authorities. Consumers must be informed of the quality of the water the water suppliers.

Food Safety and Hygiene

An increasingly important part of consumer health protection concerns the protection of foodstuffs, for example, matters referring to food-related infections, contaminants, residues (e.g., pesticides) and foreign matter or problematic ingredients. At the European level, in the year 2002 the basic EU regulation of food law (EU Act No. 178/2002) described the general principles of food law, the establishment of a European authority for food safety and other procedural matters (early-warning system, crisis management and emergencies). The so-called “Hygiene Package” of 2004 provides for three EU acts (VO [EU] No. 852/2004 - VO [EU] No. 854/2004), which among other things place specific demands on manufacturers. The primary responsibility for the safety of food and the compliance with the legal stipulations lies with the food producers/manufacturers, who are then controlled by the food-inspection authorities on a sample basis. The introduction of the VO [EU] No. 882/2004 brought uniform regulations for these official controls. An important instrument in this regard is the “Hazard Analysis and Critical Control Points” concept (HACCP concept), which sets down which critical points lie in the responsibility of the manufacturer during food production and how they are to be monitored. In this respect food safety follows a similar logic to that employed in the hazard assessment in occupational safety.

In December 2014 the Food Information Regulation (FIR) came into force, which harmonized the declaration of foodstuffs throughout Europe. Food information must explicitly ensure a “high level of protection of consumers’ health and interests” (Art. 3 Para. 1 FIR). Like the other parts of health protection, the official control of foodstuffs should not be oriented solely toward repressive acts (monitoring of compliance with regulations, initiation of legal procedures in cases of noncompliance and criminal prosecution), but also proactively provide counseling and assistance. The monitoring and policing rights granted in the European Food, Commodities and Feed Code from 2005 are delegated to each country´s respective authorities. At the level of regional and local public administration, this code is implemented by district and county as well as competent specialist authorities.

Monitoring of Drugs and Medical Products

Part of the field of health protection is devoted to the supervision of drugs (and blood-related products) and medical products in general. This part of consumer health protection is especially concerned with quality, efficacy and safety. New drugs must pass a central certification process of the European Medicines Agency (EMA). In Germany national certification is done by the National Institute for Drugs and Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul Ehrlich Institute (PEI). Monitoring tasks, including inspecting pharmaceutical companies, wholesale suppliers and hospital pharmacies, are implemented at the federal state level. The state authorities are also responsible for monitoring clinical tests and supervising the recall of poor-quality drugs including issuing warnings to the general public in cases that go beyond local interests. Together with the customs authorities, they also control the import of pharmaceuticals. This monitoring of drugs and medical products is financed jointly by the federal government (certification), the individual states (monitoring) and the pharmaceutical companies (fees for the certification and monitoring). Since 2004 the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) has assumed an important role in ensuring the high-quality provision of drugs within the statutory healthcare insurance system. This includes assessing evidence for the benefit of new drugs coming to market.

Developmental Tendencies and Problems

Germany has a very high level of health protection. Many areas are covered by legal regulations, and the responsibilities for monitoring and executing health-protection legislation are clearly defined. Well-qualified specialists are available, and the level of acceptance among the general public is high. Nevertheless, there are developments that will have repercussions in the coming years and need to be addressed. Here, four of these coming developments in detail:

  1. The globalization of the modern marketplace is also being felt in the field of health protection (global health). As a result the health protection system is increasingly being confronted with having to control and monitor products of companies from other countries with other legal systems. The authorities often lack the necessary legal and organizational qualifications to adequately fulfill this mission. Another aspect of globalization relevant to health protection lies in the fact that, because of the need for uniform economic and social conditions, international standards have to be adopted at the national level. In the future the goal is to orient the quality of health protection aspects along positive examples through benchmarking and not to “dumb it down”.
  2. The legal regulation of health protection is indispensable for those authorities charged with intervening, yet in some areas proper legislation is not present which limits the action radius. In other areas, however, there are a large number of regulations that may or may not be completely fathomed even by the specialists. In this case it is necessary to find a balance between a reliable legal foundation for health protection and a transparent and practical system of norms to enforce it. Along with that it is necessary to set up a higher level of control over the results and the entire system instead of legally monitoring a host of detailed processes. It is better to get the “generator of danger” involved from the very beginning in the responsibility for averting danger. The relationship between the health protection authorities and their clients thus becomes one characterized more by counseling and assistance than by monitoring and sanctioning.
  3. The transition from the goal of upholding public order to protecting health described at the beginning of this text implies a change away from direct averting of dangers to the assurance of the quality of products, procedures and life circumstances (Sustainability and Sustainable Health Promotion). Protection is no longer restricted to upholding minimum requirements in order to deflect an imminent danger. The development of consumer health protection is a good example of this. However, the more aspects of quality come at the forefront, the more difficult it becomes to enforce the respective laws and norms at the level of individual controls  and monitoring. This means finding and implementing new mechanisms of regulation.
  4. The reason for reorienting health protection from broadly based control and monitoring of all possible details to more systematic and system’s control and counseling lies not only in the logic mentioned, but also in the economic strictures imposed on public coffers. The reorganization of health protection is thus often accompanied by restrictions or cutbacks. The goal is to retain the quality of health protection while developing its structures further to meet future demands and in particular not to allow public health services to become a symbol of a new impoverished “night watchman” state in the 21st century.

References:
Bachmann W/Schiwy P, Das Grüne Gehirn - Sammlung von medizinisch-fachlichen Erläuterungen und Rechtsgrundlagen mit Kommentaren zu den Aufgaben des Öffentlichen Gesundheitswesens (Loseblattwerk in 4 Ordnern), Starnberg 2011.
Bundesgesundheitsblatt, published by BfArM, BgVV, BZgA, DIMDI, PEI und RKI, available online at
www.bundesgesundheitsblatt.de
Locher WG/Wildner M/Kerscher GF (Eds.), Der Öffentliche Gesundheitsdienst im internationalen Vergleich - Euregio Bodensee, Munich 2009.
Robert Koch-Institut, Statistisches Bundesamt (Ed.), Gesundheit in Deutschland, Berlin 2006, available online at
www.rki.de

Internet addresses:
www.baua.bund.de (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin)
www.bfr.bund.de (Bundesinstitut für Risikobewertung)
www.dguv.de (Deutsche Gesetzliche Unfallversicherung)
www.gda-portal.de (Gemeinsame Deutsche Arbeitsschutzstrategie)
www.rki.de (Robert Koch-Institut)

Links: Sustainability and Sustainable Health Promotion


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Federal Centre for Health Education (BZgA) / Maarweg 149-161 / 50825 Köln / Tel +49 221 8992-0 / Fax +49 221 8992-300 /
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The Federal Centre for Health Education (BZgA) is a specialist authority within the portfolio of the Federal Ministry of Health.