Executive Education

Biolaw and Biomedicine: Challenges of regulation in the post-COVID era

This intensive course aims at providing specific knowledge about the law that governs the basic topics of modern Biomedicine nowadays in Europe.

Online applications for this program are now closed. For help, please contact info@elgs.eu.

Biolaw and Biomedicine: Challenges of regulation in the post-COVID era

Program Executive Education

Language English

Duration 4 days

Running Period 22 - 26 November, 2021

Location(s) Online

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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”

General Lecture Courses

General Course I

“European Defense and Security”
Prof. Panayotis J. Tsakonas , National and Kapodistrian University of Athens, Greece

General Course II

“Judicial Review of Administrative Decisions”
Prof. Dr. Nilay Arat,Kadir Has University, Turkey

Special Lecture Courses

Special Course I

“Technologies and Innovation for Security and Defense: New Frontiers and EU Governance”
Prof. Maurizio Mensi, Italian National School of Administration-SNA, EESC Member

This course systematically examines the legal frameworks, regulatory mechanisms, and policy strategies governing the development, deployment, and oversight of critical technologies, such as communications infrastructures (terrestrial, satellite, and submarine), semiconductors, unmanned systems, and autonomous weapons. Particular attention is dedicated to the evolution of the EU legal landscape, the interaction between national security prerogatives and supranational harmonization, and the role of EU law in shaping binding standards. By addressing the legal, ethical, and strategic complexities associated with disruptive innovations, the program delineates how legal and regulatory responses are redefining the foundations of security and defence within Europe

Special Course II

“Judicial Review: Law, Politics and Courts as Political Actors”
Prof. dr Violeta Beširević, Union University Law School Belgrade

This course aims to introduce students to significant comparative judicial politics. The course will bring students up to speed on current theoretical and empirical developments concerning courts as political actors and their ability to bring about (desirable) social changes. By focusing on the number of countries and societies, judgments from several apexes, international and transnational courts, and legal analysis from a comparative perspective, students will be able to develop an understanding of the courts as political actors, to assess the strengths and weaknesses of legal versus other strategies for social change and to understand the importance of law in public policy.

Guest Lectures/Seminars

Topic TBC
Prof. Paul Craig Emeritus Professor of English Law, St. John’s College, Oxford University.

EGPL Reunion

Participation in the Annual Reunion of the European Group of Public Law (EGPL). The 2026 topic is “International Law, European Union Law, Constitutional Law”. During the EGPL Reunion the students of the Academy will perform in front of an EGPL jury a debate session in the format of the European Public Law Model EU Parliament. This session offers students a unique opportunity to step into the roles of European policymakers, debating critical European law and policy issues.

Summer Program’s European Public Law Model EU Parliament Debate!

This dynamic and engaging debate session forms part of the Academy Summer Program and is modeled after the “European Public Law Model EU Parliament”. Students will be assigned a fictitious case related to a pressing European issue. Training sessions will take place during the study program to prepare them for the final debate. Working in teams, students will deliberate on the case, draft resolutions and create position papers with the aim is to propose practical solutions to the issues at hand.

Key Details:

Task: Drafting a short position paper (max. 2 pages) outlining the main problems of the case and proposing solutions.
Format: Parliamentary-style debate with structured discussions and team collaborations.
Skills: Research, teamwork, drafting resolutions, public speaking, argumentation, and critical thinking.
Prepare to debate, learn, and challenge yourself in this exciting session!

Students are encouraged to bring a laptop in order to study relevant references and reading material including statistics, maps, reports, scientific articles and presentations used by the speakers.