Biological Medicinal Therapy in terms of Respecting Patients’ Rights – Assessment of the Present Legal Status in Poland
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Introduction: Patients’ rights must be respected at every stage of therapy, including during biological drug therapy. For clinicians, it is key to be involved in the decision-making process with regard to the choices of medication and possible drug substitution. In Poland, the law encourages automatic drug substitution and does not recognise disparities in biological drugs. Aim: The main aim of the paper is to describe the present legal situation depicting the scope of autonomy of a hospitalised patient. Methods: An analysis was conducted of the Polish regulations, the doctrine and administrative decisions and European Medicines Agency guidance documents. Results: In Poland, patients who require therapy with advanced technologies such as biopharmaceuticals, may obtain access to a medicine within a special drug reimbursement programme in a hospital. Hospitals are supplied with the drugs necessary for drug therapy programmes via public procurement. This means that hospital procurement procedures decide which drug a patient will receive. It is not the decision of the health care provider. In view of this, the Polish Patient Ombudsman, in a decision confirmed by the Provincial Administrative Courts, pointed out that the selection of a drug for therapy should depend on current medical knowledge rather than on the result of a tender carried out by a hospital. Conclusions: Polish solutions based on the lack of an obligatory requirement to consult a substitution with a treating physician deviate from the standard practices followed in numerous EU countries and the US.
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