Pharmaceuticals and Life Sciences: Legal Issues
Pharmaceutical drug companies face pressure from many directions – a complex legal and regulatory landscape, pressure to preserve their intellectual property, compliance with strict privacy and advertising requirements, as well as ensuring that all their activities meet strict competition and consumer compliance. Spend a valuable half day exploring these advanced issues for pharmaceutical products at this unique and focused webinar specifically tailored to answer the legal needs of the industry. WEB219N25
Description
Attend and earn 3 CPD units in Substantive Law
This program is applicable to practitioners from all States & Territories
Chair: Alison Jones, Special Counsel, Corrs Chambers Westgarth
10.00am to 10,20am Opening Address
Presented by Elizabeth de Somer, Chief Executive Officer, Medicines Australia
10.20am to 11.20am Pharmaceutical Patents and the Industry’s Special Regulatory Features
From a leading lawyer with decades of experience in life sciences, learn how it all fits together.
- Helicopter overview of patents including hot topics Crown use, compulsory licensing and patent settlements
- Patent litigation the global multinational way
- Before action: who can sue, seeking undertakings in a demand letter, when to escalate
- Information sources and the TGA transparency regime
- Preliminary injunctions: proving irreparable harm and aligning with the business
- Final hearings, injunctions, damages, how it fits with the NHA, PBS
- Alternative options: administrative law, FOI, alternative dispute resolution (expert determination, mediation)
- Increased enforcement action by the TGA: infringement notices, penalties, negotiating with the TGA
- Protecting commercial confidentiality and maintaining privilege
Presented by Odette Gourley, Partner, Corrs Chambers Westgarth; Leading Contentious Intellectual Property Lawyer NSW and Recommended Intellectual Property Lawyer – Australia, Doyle’s Guide 2020
11.20am to 11.30am Break
11.30am to 12.30pm Competition Issues in Pharmaceutical Industry and Life Sciences
- Attending industry association meetings: anti-trust issues
- Exclusive dealing
- Resell price maintenance
- Distributor’s risk issues
- Competition and Consumer Act: important issues
Presented by Kirsten Webb, Partner, Clayton Utz; Recommended Competition Lawyer – Australia, Doyle’s Guide 2020
12.30pm to 1.30pm Advertising and Marketing Law Refresher and Update: Pharmaceuticals and Life Sciences
- Primer and refresher on specialist healthcare professional marketing and advertising law
- Hot topics and tips for achieving alignment with the business on advertising clearance
- Comparative advertising and substantiation issues: take outs from recent cases applied to prescription pharma and life sciences
- Misleading advertising to healthcare professionals: what is the guidance from the decided cases?
- Half-truths and unjustified implied messages: headline advertising, images and use of disclaimers
- Managing advertising risk on company controlled social media accounts and websites
- Unapproved medicines, misleading claims, and social Influencers
- COVID advertising claims and restricted representations in therapeutic goods advertising
- Managing IP and privacy risks, and high level overview of Australian privacy reforms
- Modern Slavery regulation
- Code complaints relating to promotional material for prescription medicines
- TGA’s role in advertising regulation including relationship with the ACCC, and TGA advertising enforcement action
Presented by Alison Jones, Special Counsel, Corrs Chambers Westgarth