BIOLAW AND BIOMEDICINE Intensive Course

Aim

This intensive course aims at providing specific knowledge about the law that governs the basic topics of modern Biomedicine nowadays in Europe. The lectures cover cutting-edge clinical applications and research activities focusing on challenging legal dilemmas in relevance, the importance of which attracts more and more the interest of a wide scientific and non-expert audience in the post-COVID era.

Triggering Questions

• What is the impact of law on advanced medical applications, particularly after the COVID-19 experience?
• Does legal regulation hold back the progress of clinical trials and the creation of novel therapies?
• Is it time for a common European regulation in IVF, after the Strasbourg Court’s judicial activism?
• Do we need more specific regulations on data protection in the era of medical “big data”, Precision Medicine, and Medical Genetics?
• Are there legal rules suitable for regulating artificial intelligence in Biomedicine?
• Is the existing legal framework on biomedical patents an “ally” in technological progress

Background information

Over the last decades, the impressive progress in Medicine and Life Sciences triggered an intense production of specific legal rules, covering the most important areas of clinical practice and biomedical research. For the first time, both the legal and the medical community need to be familiarized with the legal regulation which encompasses basic principles of medical ethics, like informed consent, beneficence, medical secrecy, and respect of human dignity.

The COVID-19 pandemic has been a critical challenge regarding the real impact and efficiency of that regulation, as several topics needed to be addressed under the view of public health protection. Issues related to clinical trials, handling of medical data, patenting / benefit-sharing, and compulsory vaccinations are largely discussed in legal and medical contexts yielding sensitive questions in relevance.

This intensive course intends to make known the basic elements of Biomedical Law in Europe, including international and EU legislation, as well as specific case-law. Lectures from European legal experts cover a wide range of topics, focusing on critical dilemmas with the expectation of a vivid interaction with the students.

Ideal for:

• Lawyers specialized in medical consulting and litigation
• Medical doctors, and health professionals
• Professional researchers in Medicine, Life-Sciences, and Social Sciences
• Managers, policy advisors in the pharma and health industry
• Civil servants and state managers involved in regulatory authorities (Clinical trials, IVF, data protection authorities)
• Administrative personnel of hospitals, clinics, laboratories, research facilities
• Students (Law, Medicine, Biology, Nursing, Sociology, Political Sciences)

Learning outcomes

Participants are expected to

• Demonstrate knowledge and understanding of the European Biomedical Law’s basic elements as expressed in the most critical topics of clinical practice and biomedical research
• Understand the vital role of regulation in Biomedicine as a crucial factor in scientific and technological progress ensuring the necessary support from society, in the light of “responsible science”