The EU Pharma Package replaces the long-standing certainty of fixed-term RDP and market exclusivity with a more complex and ambiguous system of incentives linked to operational and product requirements. By conditioning additional exclusivities, the reform has introduced a significant new layer of uncertainty that will require companies to recalibrate proactively across IP, regulatory and broader corporate functions.
This session will examine the Pharma Package’s changes to RDP and market exclusivity, and discuss the implications of this marked departure from the status quo for legal strategy across the life sciences sector. Hear expert insights into how the new legislation will alter the complex interplay between your IP, regulatory and overall business strategies, and position your company to respond successfully to an era-defining shift in the European regulatory landscape.
- How feasible will it be for companies to meet the criteria for beyond-baseline extensions to regulatory exclusivities on pharmaceuticals?
- What does “unmet medical need” mean in a legal context? How will this be evaluated in practice?
- How are exclusivities and incentives changing for paediatric medicines, priority antimicrobials and orphan medicinal products?
- How feasible are the criteria for SPC extensions under the EU Biotech Act? How will they be assessed?
Alexander Natz
