KEY MESSAGES: Ethical challenges with implementing prophylactic vaccines against human papilloma virus (HPV) Background: About 300 women get cervix cancer and about 100 die from cervix cancer every year in Norway. Cervic cancer is primarily caused by continuous infection with human papilloma virus (HPV), and over 120 strains of HPV have been identified. About 14 of these are are oncogenic. HPV-16 and HPV-18 can be found in about 70% of of the women with cervix cancer. Most HPV infections will cease by themselves, but where the infections persist, there is an increased risk for cellular changes. There exist vaccines against HPV 16/18, but there is yet no evicence that the vaccine is effective against cervical cancer. This has incited fierce debates on whether to introduce the HPV vaccine in national or statewide vaccination programs. This report aims at highlighting and discussing the moral aspects that are relevant for the decisionmaking process with regards to HPV vaccine. Method: The report uses a method developed for addressing ethical issues in health technology assessments (HTAs) that discusses central moral questions related to health interventions. The aim is not to give unequivocal answers to the questions, but rather to elucidate arguments and aspects that are important for decision makers and stake holders. Results: The potential utility of HPV 16/18 vaccination is considerable, but morally challenging, as the real impact of HPV vaccination on cervical cancer is not known, and the vaccine is costly. Vaccination is an intervention towards healthy people, calling for special attention, especially as there is conciderable uncertainty about its effects and side effects. It is challenging to assess future utility of potential prophylactic interventions against the utility of health interventions today. HPV vaccine of children is also challenging with respect to informed consent. Informing the public and potential persons to receive the vaccine appears to be a considerable challenge. Conclusion: HPV vaccination can potentially save 40 women from getting cervix cancer every year and 13 from dying, but there is no evidence for this, and vaccination is costly. That raises a series of morally challenging issues that are important to address when deciding whether to implement the vaccine or not (and how to implement it).

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