Masterarbeit

Benefit Assessment and Indication in Marketing Authorisation - Relevance for and Impact on Paediatric Research, Pricing, Reimbursement, Medical Therapy and Advertising ***

Dr. Andrea Rohrauer-Scherr (2016)

Summary
Language: English
Today many parties participating in the process between developing and applicating a medicinal product. Pharmaceutical entrepreneur, regulatory authorities, health insurances, physicians and patients are the most important ones. The interests of these parties conflict by nature. Pharmaceutical entrepreneurs aim to sell their products. Therefore, they use the tools of marketing – within the borders of the indication. Regulatory authorities have to ensure that patients receive safe and effective drugs with well defined authorised indications. Health insurances on the other hand have to find ways to cope with the costs of medicinal products – without burdening people with high insurance contribution rates. Physicians have the duty to choose the appropriate medicinal drug for a patient. The last link in this long chain is the patient who expects his physician to make all effort to maximise his wellbeing.
Since the drama caused by Contergan, legislators and regulatory authorities put a lot of effort into making drugs safer and reducing risks for patients. Consequently, the regulatory framework was improved during the last decades and drugs are only approved for well proven indications – which usually reflect the inclusion criteria of the studies. The indication of a medicinal product, as defined in section 4.1 of the SmPC of a drug, nowadays plays an eminent role for all contributors in the process between development and application of a drug. Therefore, the objective of this master thesis was to describe the interdependencies between the indication of a pharmaceutical drug, paediatric research, medical therapy, benefit assessment, reimbursement, pricing and drug advertising
Pages: 44