General Course Information
1.1 Course details
| Course code: | LLAW6250 / JDOC6250 |
| Course name: | Regulation of Pharmaceutical Products and Medical Devices |
| Programme offered under: | LLM Programme / JD Programme |
| Semester: | Second |
| Prerequisites / Co-requisites: | No |
| Credit point value: | 9 credits / 6 credits |
1.2 Course description
The course is aimed at students seeking an understanding the legal and regulatory requirements that must be met before new drugs, vaccines, biologics or medical devices (generally referred to as therapeutic goods) may become accessible to the public. The global therapeutic goods market, heavily dominated by the pharmaceutical industry, is experiencing significant growth, with total global pharmaceutical revenue estimated at approximately USD 1.7 trillion to USD 1.99 trillion in 2024–2025 (not counting medical devices with artificial intelligence (AI) capability). The market is highly concentrated, with the United States (US) holding a commanding share of over 50% of the global pharmaceutical market, followed by China and Germany. For this reason, the course will focus on the regulatory requirements of key regulators like the US Food & Drug Administration, the National Medical Products Administration of the People’s Republic of China, and the European Medicines Agency. Additionally, the course will consider the important role that Hong Kong (specifically the Department of Health of the Government of Hong Kong SAR) has to play as a technological intermediary among these major markets.
Topics that will be covered in the course include international standards for clinical trials involving pharmaceutical and biopharmaceutical product, and medical devices (with focus on devices based on artificial intelligence or machine learning); direct human experimental and biomedical research involving human participants; ‘non-invasive’ epidemiological and other studies involving only the use of data; human tissue banking and biobanking; cohort studies; genomic research; the research use of ‘legacy’ diagnostic tissue or data collections; the sharing of personal, medical and genomic information (e.g. in electronic medical records), and through remote healthcare systems and applications in the Internet of Medical Things; public ‘diseases registries’ and the use of medical information for public health research purposes; the legal and ethical regulation of multi-centre and multi-jurisdictional collaborative biomedical research; data-mining and the implications of migration to large-scale national health records systems; human embryonic stem cell and induced pluripotent stem cell research; genome editing and gene therapy; and ethical and regulatory standards for governance of biomedical research at the institutional level (through Institutional Review Boards, or Human Research Ethics Committees).
Fundamental concepts such as the informed consent of subjects (at common law and under international clinical trial good practices) with particular emphasis on the consent given by or on behalf of minors, incompetent subjects and vulnerable populations, social value of the research, right to science, return of benefits to research subjects or affected populations, risk-benefit assessment, clinical trial designs and clinical equipoise will be considered, as along with the impact and requirements of national laws and regulations international guidelines. Certain aspects of property law (e.g. ownership of biological materials) and intellectual property law (scope of monopolistic rights over medicines) will also be considered.
The course seeks to help students understand and keep abreast of biotechnological developments and to enable them to identify ethical, regulatory and legal issues that are relevant to the pharmaceutical, biotechnology and medical device sectors, and to equip them with the basic language and vocabulary necessary to address these issues. To this end, students will be introduced to basic technical (i.e. medical or scientific) information that relates to the technology (e.g. AI-based medical software or gene therapy) considered in this course.
1.3 Course teachers
| Name | E-mail address | Office | Consultation | |
| Course convenor | Calvin Ho | TBA | TBC | By email |
Learning Outcomes
2.1 Course Learning Outcomes (CLOs) for this course
CLO 1 Describe and explain the differences between the relationships of physician-patient, and that of researcher-subject, with special attention to the conflict of interests which may arise where the physician also acts as researcher, and where the patient is also the subject, or the source of the tissue or data. Propose and describe measures for the management and resolution of such conflicts in specific settings, such as that of the registered physician who is at once a practicing clinician as well as a biomedical researcher in a research and teaching hospital.
CLO 2 Critically examine the ethical considerations and legal/regulatory requirements (such as the taking of consent from research subjects who are considered to be vulnerable) in different types of biomedical or health-related research, including tissue or biobanking, genomics and genome editing, clinical trials (both pharmaceutical products and vaccines, or biologics more broadly), pluripotent cells and medical device trials (inclusive of devices based on artificial intelligence or machine learning).
CLO 3 Critically and comparatively examine the regulatory approval processes (including emergency use authorisation) for pharmaceutical products, vaccines and other biologics, and medical devices (inclusive of devices based on artificial intelligence or machine learning).
CLO 4 Critically examine and analyse current international developments in the legal and ethical regimes for the sharing of medical and genetic information (in conventional and in emergent Big Data health research), as well as of tissue and genetic samples.
CLO 5 Consider differences in legal and regulatory requirements, as well as ethical good practices, in Hong Kong relative to leading scientific jurisdictions, with a view to understand trends in regulation and governance of biomedical research.
2.2 LLM and JD Programme Learning Outcomes (PLOs)
Please refer to the following link:
LLM – https://course.law.hku.hk/llm-plo/
JD – https://course.law.hku.hk/jd-plo/
2.3 Programme Learning Outcomes to be achieved in this course
| PLO A | PLO B | PLO C | PLO D | PLO E | PLO F | |
| CLO 1 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| CLO 2 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| CLO 3 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| CLO 4 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| CLO 5 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Assessment(s)
3.1 Assessment Summary
| Assessment task | Weighting | Feedback method* | Course learning outcomes |
| Class participation | 30% | 1 | 1, 2, 3, 4, 5 |
| Take home exam | 70% | 1 | 1, 2, 3, 4, 5 |
| *Feedback method (to be determined by course teacher) | |
| 1 | A general course report to be disseminated through Moodle |
| 2 | Individual feedback to be disseminated by email / through Moodle |
| 3 | Individual review meeting upon appointment |
| 4 | Group review meeting |
| 5 | In-class verbal feedback |
3.2 Assessment Detail
To be advised by course convenor(s).
3.3 Grading Criteria
Please refer to the following link: https://www.law.hku.hk/_files/law_programme_grade_descriptors.pdf
Learning Activities
4.1 Learning Activity Plan
| Seminar: | 3 hours / week for 11 teaching weeks |
| Private study time: | 9.5 hours / week for 11 teaching weeks |
Remarks: the normative student study load per credit unit is 25 ± 5 hours (ie. 150 ± 30 hours for a 6-credit course), which includes all learning activities and experiences within and outside of classroom, and any assessment task and examinations and associated preparations.
4.2 Details of Learning Activities
To be advised by course convenor(s).
Learning Resources
5.1 Resources
| Reading materials: | Reading materials are posted on Moodle |
| Core reading list: | TBA |
| Recommended reading list: | https://www.cambridge.org/core/books/cambridge-handbook-of-health-research-regulation/6C0BD8EA72887CE20B6EC348D1BF148C |
5.2 Links
Please refer to the following link: http://www.law.hku.hk/course/learning-resources/