By Hanna Roos, Oliver Browne and Robbie McLaren

How to thrive amid uncertainty? This was the question we explored at the 35th FT Global Pharmaceutical and Biotechnology Conference. Here are five key industry trends and corresponding practical legal tips to help companies stay protected and seize opportunities.

“Access”, Not “Excess”

The industry is facing pressure on pricing to expand access to crucial therapies in both developed and developing markets. Increasingly, regulators and legislators measure success not only by clinical breakthroughs, but also by how many patients end up receive a treatment. Regulators and legislators have begun to examine how pricing correlates with the cost of R&D, and the value that a treatment delivers. The UK Competition and Markets Authority’s recent £90 million fine for “excessive and unfair” pricing is an example of this increased scrutiny (for more information, please see our blog here). Such pressure has led to streamlined drug development and flexible pricing models linked, for example, to ability to pay. Regulators are adopting conditional approval mechanisms, which revisit therapeutic efficacy to ensure that drugs deliver “bang for the buck” before they are granted long-term marketing authorisation and/or purchase commitment.