Combating multi-resistant hospital germs – 10-point plan

Combating multi-resistant hospital germs

Federal Health Ministry presents 10-point plan

On 23 March 2015, it was announced that a 10 point plan to tackle the spread of multi-resistant germs in hospitals was being presented by German Health Minister Gröhe – ini-tially only for inter-ministerial coordination within the German government. Implementation of the Federal Health Minister’s proposals is expected to result in significant legislative changes at national and state level, impacting particularly on hygiene and reporting standards in German hospitals.

 

Background

Increasing risk posed by multi-resistant pathogens
When over 30 patients in a German university hospital became infected with a pathogen resistant not to one but to four groups of antibiotics (acinetobacter baumannii) in early 2015, this refuelled the national discussion of the risk of contracting an (additional) infection as a result of hospital treatment. Internationally, there are also more and more re-ports of pan-resistant strains of pathogens that are even resistant to reserve antibiotics (the “last resort”). The example of acinetobacter baumannii ultimately makes clear how the existing risks already posed by multi-resistant pathogens are increasing further since many of them function as “genetic converters”, i.e. they absorb resistance genes, alter or rearrange them and then pass this volatile genetic material on to other strains of bacteria.

Experts also expect the spread of multi-resistant pathogens to become an ever increasing problem in German hospitals especially due to a continued rise in average patient age (and thus average susceptibility to infection) and an increase in the number of complex medical interventions (and thus the risk of developing a serious infection).

Combating (multi-resistant) pathogens in hospitals is ultimately important not only for those patients potentially affected but also for each of the hospitals affected as the question of how a germ was able to enter the hospital and whether or not this may be a basis for criminal charges is often a matter for investigation by public prosecutors.

Federal Health Ministry’s 10-point plan

Following the legislator’s endeavours at national and local state level to contain the problem and curb the spread of multi-resistant germs in hospitals with amendments to the German Act on the Protection and Control of Infectious Diseases (Infektionsschutzgesetz – IfSG) and the medical hygiene regulations in the individual German states, a renewed initiative is now being launched as the desired improvements failed to materialize.

Although the Health Minister’s (internal) 10-point plan has not yet been published and is initially only at the inter-ministerial coordination phase, a number of publicly accessible (coinciding) reports indicate the following key points:

• There are plans to investigate whether, prior to “foreseeable stays in hospital”, patients can be required to undergo a compulsory test for multi-resistant germs and be isolated until an infection has been ruled out (currently only possible in cases involving “risk patients” and certain pathogens).
• Stricter reporting obligations (especially where particularly dangerous pathogens are concerned) are to be introduced such that hospitals and healthcare institutions will be required to notify the competent authorities as soon as the first incidence of multi-resistant germs is identified.
• There are plans for healthcare institutions to be required to provide their staff with further training in antibiotic treatment and infection prevention, and the prudent handling of antibiotics will be increasingly important here as their improper or over-zealous use can increase the resistance of relevant pathogens.
• Focus on mandatory compliance with existing hygiene regulations and standards with escalation to the Robert Koch Institute (RKI) as a national expert institution.
• Patients are to have easier and faster access to information on hygiene and hygiene standards in hospitals and healthcare institutions (healthcare institutions will have to meet relevant information requirements including quality reports with an additional section in easily comprehensible language.
• Cooperation with the pharmaceutical industry is also to be intensified. With greater interaction between human and veterinary medicine, there are plans to create new incentives for developing new antibiotics to combat (currently) resistant pathogens and remove existing obstacles to innovation.
• With a view to international cooperation, Germany as part of its G7 presidency (G7 Summit 7/8 June 2015), will ultimately endeavour to promote the development of new antibiotics, test methods and alternative treatments.

Outlook

Legislative changes and their effects on the healthcare sector

As the number of infections in German hospitals is, to some extent, still well above the international average – for example, when compared to the Netherlands – this initiative by the Federal Health Ministry is certainly to be welcomed.

The 10-point plan is currently being discussed with other Federal ministries and (with regard to the expected impact on competences at local state level) with the local state health minis-tries. If a binding commitment is then reached on the above key points, significant legislative changes and the introduction of new legal obligations (administrative fines or even contractual penalties) will be necessary (which will primarily relate to the German Act on the Protection and Control of Infectious Diseases (IfSG) and the local state medical hygiene regulations). It remains unclear, however, in what form and within what timeframe it will then actually be possible to implement the current proposals.

It also remains unclear how the additional costs – which will undoubtedly arise – of meeting new obligations will be financed, and the view is likely to be expressed (not just by healthcare institutions) that these costs should be paid for out of public funds (within the meaning of the provision on the bearing of costs contained in Section 69 IfSG). The additional (staffing) costs could also be financed by special subsidies, such as the existing hygiene promotion programme set out in Section 4(11) of the German Act on Hospital Fees (Krankenhausentgeltgesetzes - KHEntgG) intended for the hiring of specialist hygiene staff.

From the perspective of pharmaceutical companies, the hope remains that the 10-point plan’s praiseworthy statements will be acted upon and that the development, manufacture and licensing of new drug products (in accordance with the German Medicines Act (Arzneimittelgesetz) and its regulations) is actually made easier. One of the greatest chal-lenges in this regard will also be the EU-wide coordination, consolidation and harmonization of the amended licensing regulations.

Finally, it is unlikely that the desired types of antibiotics with new mechanisms of action – which it will only be possible to research at additional cost, however – can be refinanced from the profits of the manufacturing pharmaceutical companies (as they will also often “only” be used as reserve antibiotics). Particular importance will therefore be attached to future research funding in the field of antibiotic resistance.