The Act on the Reform of the Market for Medicinal Products (AMNOG), effective January 1, 2011, transformed the pharmaceutical landscape by requiring proof of additional therapeutic benefits for new medicinal products. This legislation shifted the dynamics within the market, impacting costs and strategies for launching new drugs. The book explores the implications of this reform on the pharmaceutical industry and the resulting changes in market practices.
Bachelor Thesis from the year 2013 in the subject Health Science, grade: 1,4,
Neisse University Görlitz, course: V282129, language: English, abstract: The
Act on the Reform of the Market for Medicinal Products, which entered into
force on the 1st of January 2011, brought about a fundamental change in the
balance of power on the pharmaceutical market. This thesis therefore sets out
to answer the following question: What impact does the early benefit
assessment in the context of the Act on the Reform of the Market for Medicinal
Products have on the stakeholders of the healthcare system? To answer this
question, this work first presents the theoretical foundations of the law, of
the early benefit assessment and the bodies involved. It then takes stock of
the decisions taken to date before describing the impact on the selected
stakeholders. The following findings were reached: As the representative of
the statutory health insurance funds, the Central Federal Association of
Statutory Health Insurance Funds has gained in power and now decides, as a
member of the Federal Joint Committee, on the added benefit of a drug and,
depending on this decision, also on the future reimbursement rate.
Pharmaceutical companies, however, are losing clout and must comply with the
guidelines and assessments of the early benefit assessment. Patients stand to
gain and lose out from the early benefit assessment. They are the ones who are
ultimately dependent on the medicinal product and its improvement and benefit
from a proven benefit. However, they have no say in the early benefit
assessment procedure.
Die Bachelorarbeit untersucht die Auswirkungen des Arzneimittelmarktneuordnungsgesetzes auf die Akteure im Gesundheitswesen. Sie analysiert die Machtverschiebungen, wobei der GKV-Spitzenverband an Einfluss gewinnt, während Arzneimittelhersteller an Macht verlieren. Patienten profitieren von geprüften Nutzen, haben jedoch kein Mitspracherecht.
