Handbook home
Pharmaceuticals: Current Legal Issues (LAWS90183)
Graduate courseworkPoints: 12.5Not available in 2021
Please refer to the return to campus page for more information on these delivery modes and students who can enrol in each mode based on their location.
Overview
Fees | Look up fees |
---|
This subject will be delivered online in 2020 over the scheduled dates.
Pharmaceuticals provide fundamentally important medical treatments, saving lives and alleviating suffering, but they are also mired in controversy. Patients and governments struggle to meet rising costs, and have to deal with medical conditions for which there are still no effective drugs. Companies complain about heavy regulatory burdens and sagging profits. What is the role of law in mediating these tensions? Does it do so successfully?
The subject will not be limited to a single jurisdiction, but focusses on Australian and European law and draws widely on world events. It will be taught by Dr Kathleen Liddell, Director of the Centre for Law, Medicine and Life Sciences (Cambridge) who has more than 20 years’ experience in academia, legal practice, law reform, policy advice and ethical analysis. Significantly, the subject is not solely for practicing lawyers in health and medical law. It is also suitable for doctors, research scientists, policymakers, industry executives, patent attorneys, and pharmacists.
This subject follows a medicine’s journey from a scientific idea through to the marketplace, clinic and (occasionally) courtroom. Along the way, we investigate the major legal and ethical issues affecting pharmaceuticals, including:
- criteria for market approval
- regulation of clinical trials
- intellectual property incentives
- controversies with pricing and competition in high income and low income countries
- safety monitoring
- compensation for injuries
- experimental therapies
- off-label prescribing
- direct to consumer advertising
- counterfeit medicines
- the looming crisis of antibiotic resistance
- future challenges such as genomic and ‘precision’ medicine.
Intended learning outcomes
A student who has successfully completed this subject will:
- Have an advanced understanding of key issues in the legal regulation of pharmaceuticals and associated controversies.
- Have the cognitive and technical skills to critically evaluate relevant legal principles and controversies in this area of law.
- Be able to suggest and evaluate legal and other reforms that may be appropriate.
- Have advanced communication skills to convey complex information to specialist and non-specialist audiences; and to be an engaged participant in ongoing debates in the field.
Last updated: 30 January 2024
Eligibility and requirements
Prerequisites
None
Corequisites
None
Non-allowed subjects
None
Recommended background knowledge
Applicants without legal qualifications should note that subjects are offered in the discipline of law at an advanced graduate level. While every effort will be made to meet the needs of students trained in other fields, concessions will not be made in the general level of instruction or assessment. Most subjects assume the knowledge usually acquired in a degree in law (LLB, JD or equivalent). Applicants should note that admission to some subjects in the Melbourne Law Masters will be dependent upon the individual applicant’s educational background and professional experience.
Inherent requirements (core participation requirements)
The University of Melbourne is committed to providing students with reasonable adjustments to assessment and participation under the Disability Standards for Education (2005), and the Assessment and Results Policy (MPF1326). Students are expected to meet the core participation requirements for their course. These can be viewed under Entry and Participation Requirements for the course outlines in the Handbook.
Further details on how to seek academic adjustments can be found on the Student Equity and Disability Support website: http://services.unimelb.edu.au/student-equity/home
Last updated: 30 January 2024
Assessment
Additional details
- Class participation (10%);
and either - Take-home examination (maximum 6,000 words) (90%) (16 - 19 October)
or - Research essay (6,000 - 8,000 words) (90%) (25 November)
A minimum 75% attendance is a hurdle requirement. Note: hurdle does not apply when the subject is delivered online.
Last updated: 30 January 2024
Quotas apply to this subject
Dates & times
Not available in 2021
Additional delivery details
This subject has a quota of 30 students.
Enrolment is on a first come, first served basis. Waitlists are maintained for subjects that are fully subscribed.
Students should note priority of places in subjects will be given as follows:
- To currently enrolled Graduate Diploma and Masters students with a satisfactory record in their degree
- To other students enrolling on a single subject basis, eg Community Access Program (CAP) students, cross-institutional study and cross-faculty study.
Please refer to the Melbourne Law Masters website for further information about the management of subject quotas and waitlists.
Last updated: 30 January 2024
Further information
- Texts
Prescribed texts
Specialist materials will be made available via the LMS in the pre-teaching period.
- Links to additional information
- Available through the Community Access Program
About the Community Access Program (CAP)
This subject is available through the Community Access Program (also called Single Subject Studies) which allows you to enrol in single subjects offered by the University of Melbourne, without the commitment required to complete a whole degree.
Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.
Additional information for this subject
If required, please contact law-admissions@unimelb.edu.au for subject coordinator approval.
Last updated: 30 January 2024