The excessive and improper use of antibiotics has led to an increasing incidence of bacterial resistance. In europe the yearly number of infections caused by multidrug resistant bacteria is more than 400.0, each year resulting in 25.0 attributable deaths. Early in the 20th century, bacteriophages were described as entities that can control bacterial populations.

Although bacteriophage therapy was developed and practiced in europe and the former soviet republics, the use of bacteriophages in clinical setting was neglected in western europe since the introduction of traditional antibiotics. Given the worldwide antibiotic crisis there is now a growing interest in making bacteriophage therapy available for use in modern western medicine. Despite the growing interest, access to bacteriophage therapy remains highly problematic.

In this paper, we argue that the current state of affairs is morally unacceptable and that all stakeholders pharmaceutical industry, competent authorities, lawmakers, regulators, and politicians have the moral duty and the shared responsibility towards making bacteriophage therapy urgently available for all patients in need. The excessive and improper use of antibiotics has led to an increasing incidence of bacterial resistance and a significant threat to human health 1. Yearly, more than 400.0 people are infected by multidrug resistant bacterial strains, often called x0201c superbugs x0201d 3 . Superbugs have a considerable economic impact: extra hospital costs and related productivity losses amount to more than 1.5 billion euros per year within the european union eu. In the united states us , infections with multidrug resistant bacteria cause 20 billion us$ in additional health care costs and 35 billion us$ societal costs annually 4 .

At the same time, it is becoming more and more difficult and expensive to develop new antibiotics as an adequate response to the phenomenon of multidrug resistance. Actually, very few new antibiotics are in the pipeline of the pharmaceutical industry at the moment 5 . Bacteriophages or x0201c phages x0201d are viruses that infect and replicate within specific bacteria without harming others. Although bacteriophage therapy hereafter bpt was developed and practiced in europe and the former soviet republics, the western world abandoned the use. This was mainly because at that time 1930s there was a lack of knowledge of what a bacteriophage really was a virus as well as the discovery of antibiotics. These molecules are well characterized chemical substances, relatively easy to produce in a well controlled fashion, initiating the golden age of antibiotics, the so called x0201c miracle drugs x0201d 6 . Given the worldwide antibiotic crisis, the existing and continued experiences build up in eastern europe and the former soviet republics combined with recent encouraging animal and human study results there is a growing interest for bpt in modern medicine and the agrobioindustry, a recognized potential reservoir for antibiotic resistant germs 1.

Despite this growing interest, introducing bpt in the western medical world remains highly problematic as a consequence of four main obstacles. First, historical clinical data about the safety and effectiveness of bpt are not considered proven and validated by european regulators. Second, given the substantial costs and investment in the development and marketing of conventional medicinal products by the pharmaceutical industry, there is in our actual pharmacoeconomic model an imperative demand for a strong intellectual property ip protection. Third, an efficient and effective bpt concept needs to be flexible and tailored to the patient 11. That requirement is not compatible with the usual timeframes years for the development and the marketing of conventional medicinal products 11. Rather, the regulatory framework for medicinal product development, as present in most countries, calls for drugs to have a fixed chemical composition.

Last fourth obstacle , uncertainty exists about the potential negative coevolutionary consequences of unlimited use of bpt 13 . In view of these obstacles, access to bpt for patients in need remains highly problematic as discussed earlier 12. Recently, henein emphasized that so far no bioethical bacteriophage therapy debate has been published. Indeed in 2011, an emerging strain of o104:h4 escherichia coli caused a serious outbreak of food borne haemolytic uremic syndrome and bloody diarrhoea in germany. Antibiotics were of questionable use and 54 deaths occurred, beside tens of clinical cases with lasting sequels 16. Several bacteriophage research groups had in their collection isolated candidate therapeutic bacteriophages that efficiently lyse the e.

The public health sector never asked for these phages during the outbreak and none of the scientific papers published during the outbreak mentioned bpt as a potential treatment. Nestl x0e9 research centre even offered their phage isolate to the german public health sector during the epidemic, but the proposal was apparently not addressed 20 . 21 addressed briefly the ethical aspects of bacterial drug resistance and phage therapy. The authors also highlighted the appeals for decisive changes in the policies governing the development of antimicrobials. Bacteriophages should be considered as a public good and the government should be responsible for their development and production. Thus, the development and introduction of new antimicrobials should not only be regulated by market forces 21 . The main purpose of this paper is not so much to fleece out these four main obstacles, nor to determine how an adequate regulatory framework for bpt might look like.

We here argue why there exists a moral need or duty to develop such a regulatory framework. The different actors in the field, mainly the industrial partners, politicians and regulators as well as consumers, urgently need to take up their responsibility in order to guarantee bpt accessibility for patients in need. What is more, when the costs of phage therapy and antibiotic therapy were compared, phages were approximately 50% cheaper than antibiotics. This means that a wider application of phage therapy could lead to substantial savings in healthcare costs and make antibacterial therapy accessible to those who otherwise cannot afford treatment 23 .

Given the above nonnormative specifications of bpt, the basic moral problem associated with bpt can be formulated as follows. Bpt, when used in a flexible tailor made, locally developed and sustainable manner, has the potential of saving thousands of lives every year 11. However, due to the above mentioned obstacles, access to that therapy remains highly problematic in the western world. How can we argue from a moral point of view that this situation is simply unacceptable? central to this moral problem are the preservation and restoration of the health and well being of the patient. Two basic underlying moral principles are relevant in this patient centred approach and will be further investigated in this paper.

The first is the principle of nonmaleficence, which implies the obligation not to inflict harm on another. The second principle is the principle of beneficence, which implies the obligation to prevent or to remove harm or the obligation to promote good 25 . The fact that efficacy of bpt has not yet been proven according to european regulatory standards is one of the obstacles that clearly suggests the moral relevance to investigate the principle of nonmaleficence in the context of bpt. Indeed, a patient has a right not to be subjected to a medical treatment or therapy that has not yet been rigorously tested for its effectiveness and possible health risks as is bpt.

The moral duty, however, not to subject a patient to a not yet approved therapy is not an absolute, but a prima facie duty. This means that under well defined, specific circumstances this duty not to subject someone to a not yet approved therapy can be set aside 26 . At this point in the argument, it is appropriate to introduce the notion of an x0201c ethically justified medical therapy x0201d ejmt. This is a medical therapy that has not yet obtained an official approval for its health effectiveness at least not according to western standards , and/or for which some doubts remain concerning possible health risks, but the use of which seems to be morally acceptable given the specific circumstances of the case at hand.