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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: 2 December 2019