Patrick Hopkinson is a Global Market Access expert with over 25 years’ experience. He is an independent consultant, founder and managing director of PHTA Consulting. He is a senior leader in the life sciences industry with extensive expertise gained from working across multiple functions in global pharmaceutical organisation’s at an executive leadership level. A former Vice President of Global HEOR at Bristol Myers Squibb he has a specialist focus in Market Access, HEOR, HTA Policy and RWE combined with extensive commercial experience including P&L responsibility. An HTA expert, he has delivered over 400 HTA submissions globally and in-market, overcoming HTA and Access challenges to optimise commercial performance. He has been a member of key access policy working groups at EFPIA, PhRMA and ABPI, plus he served as a NICE Appeal Panel member for 10 years. Previously he worked at GSK in Global and Country roles and as a Clinical Oncology Pharmacist in the UK NHS. Patrick is a thought leader and regular conference speaker.
Sponsored by RTI Health Solutions.
Starting January 13, 2028, orphan medicines will be required to undergo Joint Clinical Assessments (JCAs) as part of the EU Health Technology Assessment Regulation (HTAR). Manufacturers must prepare and submit JCA dossiers documenting the comparative efficacy and safety of their products against relevant comparators across EU member states. However, applying the same rigorous standards to orphan medicines as to other drugs presents unique challenges, including small patient populations, limited evidence, treatment variability, and high levels of uncertainty.
This panel will feature Victor Maertens, Government Affairs Director at EUCOPE and a leading expert in European policy and government affairs, Patrick Hopkinson an experienced representative from the pharmaceutical industry, and Sorrel Wolowacz, Vice President at RTI Health Solutions, who is an expert in innovative methods for demonstrating value in orphan medicines. The session will be moderated by Anne Heyes, Vice President at RTI Health Solutions.
The panelists will share insights from policy, patient advocacy, and industry perspectives on how they are preparing for these upcoming changes. They will discuss strategies for overcoming challenges associated with JCAs and highlight key advocacy efforts aimed at ensuring that the unique needs of orphan medicines are addressed under the new framework.
This session is essential for stakeholders seeking to navigate the evolving regulatory landscape while maintaining access to life-saving therapies for rare disease patients.
Sponsored by RTI Health Solutions.