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Background: This paper analyses schemes to promote the authorisation of and reimbursement for orphan drugs., Methods: 8 countries - Australia, Canada, Germany, Great Britain, France, Netherlands, Switzerland, USA - were studied to compare specific regulations for orphan drugs regarding drug admission, health technology assessment (HTA), decision-making for reimbursement, and off-label and compassionate use. Information was obtained by reviewing published and grey literature. Expert interviews were also conducted., Results: The comparison of orphan drug legislation reveals that the EU and the USA offer the greatest incentives for the development of orphan drugs, whereas there is a tendency for Australia and Switzerland to profit from incentives in other countries. Although not explicitly stated, economic evaluation of orphan drugs takes the special circumstances for orphan drugs into account. In addition to common reimbursement practices, special schemes or programmes for the reimbursement of high-priced orphan drugs exist in all countries that were analysed. Therefore access to orphan drugs seems to be warranted. However, due to co-payments of 5%, the USA may form an exception., Conclusion: On the one hand, the use of special criteria for drug admission, HTA, and reimbursement promotes R&D for orphan drugs. On the other hand, high opportunity costs arise, because huge efforts are made for a minority of patients. A solution for this moral dilemma may be the application of "rule of rescue" or of "no cure, no pay" programmes., (© Georg Thieme Verlag KG Stuttgart · New York.)

The growing burden of chronic disease and the current nature of healthcare systems which are structurally ill-equipped to cater to the complex needs of patients with chronic conditions has led to governments and healthcare providers seeking alternative ways to improve patients own capacity to actively self-manage their chronic condition. In Australia, there has been a focus on patient education and self-management programs within the healthcare system to achieve this. These programs aim to empower patients through providing information and teaching skills and techniques to improve self-care and doctor-patient interaction with the ultimate goal of improving quality of life. Patient education and self-management programs have been supported through several national government initiatives and implemented within the healthcare setting. This paper describes the current position of patient education and self-management within the Australian healthcare system. It further describes a new collaboration project between an Australian and a German research team which aims at translating an assessment questionnaire used in Australia for the evaluation of self-management programs, the "Health Education Impact Questionnaire" ("heiQ"); this instrument is expected to be of significant use in the German rehabilitative system.