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Fourth Week: Law and Ethic Concerns

At the beginning of this week, you will learn more about the regulation of the health sector, especially about the regulation of medical drugs. The registration of drugs, also known as product licensing, is an essential element of drug regulation. All medical drugs must be authorized before they can be put on the market and sold to patients. You will focus on European drug regulation, especially on procedures for approving drugs in Europe but also on comparisons between the U.S. and Europe.

Most of the value of new medicine products lies in the amount of invention, innovation, research, design, and testing. Companies have to invest enormous amounts of money to develop new drugs and medical devices as you will see on our business trips. Therefore, they depend on some kind of legal mechanism to recover their investments. Also companies who have spent a lot of time on planning and exploiting their ideas do not want to see these ideas used by business rivals. Therefore, during this part of the program you will discuss Intellectual Property Rights, such as patent protection which is an incentive for research and development of new medicines. This topic will be linked closely to the curriculum of the first and second part of the program.

Patents themselves and patent law play a big role in almost every company. First of all, you will learn about the basics of Intellectual Property law including historic treaties and agreements to understand how it emerged and adapted. You will explore the rights of patent owners, the duration of patents, the degree of international uniformity and the degree of effectiveness of patents in protecting and commercializing medical inventions.

Another component of the last part will relate Intellectual Property law to the issue of human rights. During the study of the linkage between those fields questions such as ‘Can it be considered human if a company does only focus on their return on investment instead of caring for seriously ill people who cannot afford expensive drugs?’ will be discussed.