Browsing by Author "Lencioni, Isabella"

Innovative therapy (also ‘experimental therapy’) is a special form of medical care where traditional care methods are significantly modified or completely new and unproven methods are introduced. Recent examples of innovative treatments include the use of convalescent whole blood and blood plasma for the treatment of Ebola virus disease, face transplantations, and numerous gene therapies to combat different types of cancers. This thesis presents an analysis of the various categories of innovative therapy: innovative therapy on a named-patient basis, compassionate use, and off label use of medicines. The main components of the action, namely the innovative and therapeutic nature of the action, are also analysed. In a wider context of health care, innovative therapy is located somewhere between standard therapy and therapeutic research, yet it has to be distinguished from both: it is medical care in nature, but also has many similarities to medical research. The distinction between innovative therapy and medical research is at the centre of this research; the aim is to find some guiding aspects that will help to identify each action separately. Also the distinctive features compared to standard therapies will be surveyed; the line is not always clear between the innovative and the conventional therapies, either. Innovative therapy is crucial for the advancement of medicine, yet it also involves some problematic features that need to be acknowledged. That is why some propositions as to the legislation and the current oversight procedure are in order. This study will first examine the standing of innovative therapy in Finnish law and legislation, especially with regard to the distinction between innovative therapy and (therapeutic) research. Some recent case law will also be examined. The second part of the thesis will focus on the human rights principle called primacy of the human being, which demands that the interests and welfare of the human being shall prevail over the sole interest of society or science. This principle is secured in Article 2 of the Council of Europe Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. Another provision that is highly relevant for the scope of this research is Article 37 of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.