Dr Teresa Nicoletti is both a lawyer and PhD-qualified scientist with 25 years' experience in the health and life sciences sector. She has gained particular prominence in Australia as the leading lawyer in the regulation of medicinal cannabis (Federal and State).
Teresa's practice provides broad advice to clients across their businesses, and draws on her unique mix of commercial, regulatory, scientific and legal expertise to obtain the best outcomes for her clients. She represents clients regularly in dealings with the TGA, State and Territory health and food authorities, the APVMA, ACCC, HCCC, medical and pharmacy boards, AHPRA, VCAT and NCAT.
Teresa’s expertise includes:
- Therapeutic goods regulation (medicines, medical devices and biologicals)
- Regulation of medicinal cannabis (Federal and State)
- Regulation of cosmetics, foods, agrochemicals and industrial chemicals
- Reimbursement of pharmaceuticals, medical devices and medical services
- Commercial products supply and distribution
- Health disciplinary proceedings and medical malpractice
- Patent litigation, freedom to operate, oppositions, validity advice and term extensions
- Product liability, safety and recalls
- Industry Code of Conduct complaints and appeals
- Competition and Consumer law.
- Advising various companies on Commonwealth and State/Territory regulatory regimes for medicinal cannabis cultivation, production, manufacture and supply.
- Advice on the Federal and State regulatory regimes for patient access to medicinal cannabis products.
- Ongoing advice about the regulation of therapeutic goods, particularly the merits of decisions by the TGA; section 60 and AT appeals; ongoing advice about application of the legislation and guidelines; and proper administrative process.
- Advice to an originator company regarding price implications arising from the listing of a generic competitor, including advice on applicable statutory provisions and negotiations with the Department of Health to achieve a commercially acceptable.
- Advice to various originator companies in relation to alleged disclosures by the Department of Health of confidential information in risk-share deeds.
- Acting for an originator against a generic company alleging misleading and deceptive conduct in relation to various claims made in promotional material.
- Ongoing negotiation and drafting of commercial agreements for the supply and distribution of pharmaceutical products (3PL and 4PL).
Professional Memberships / Accreditation & Activities
- Leading Lawyer (Band 1), Life Sciences, Chambers Asia-Pacific.
- Recognised Lawyer, Life Sciences Practice, Biotechnology Law and Health & Aged Care Law, Best Lawyers in Australia.
- Recommended Lawyer, Intellectual Property, The Legal 500 Asia-Pacific Legal.
- Partner of the Year, Health, Lawyers Weekly Partner of the Year Awards, 2016 and 2017.
- Judging Panel’s Highly Commended Award, Women Lawyers Association of NSW Achievement Awards, 2017.