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Healthcare artificial intelligence is a promising sector for PE investors that requires careful navigation, particularly given divergent regulatory approaches.

By Jon Fox, Frances Stocks Allen, Catherine Campbell, Tom Evans, and David Walker

PE funds invested more than US$14 billion in healthcare (including pharma) in 2019, up from US$3.5 billion in 2013, and interest is likely to grow further, given the global impact of COVID-19. In our view, the application of artificial intelligence (AI) to healthcare and pharma is of increasing importance, and is likely to bring new deal opportunities for PE investors.

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.

By Paul Davies, Elisabetta Righini and Rosa Espin

Shiny transparent capsule filled with colorful spheresOn 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment.

Concurrently, the EC launched a 12-week open public consultation to address the environmental pollution caused by human and veterinarian pharmaceutical substances.

Under the title “Strategic approach to pharmaceuticals in the environment”, the EC aims to implement Article 8c of Directive 2008/105/EC, as amended by Directive 2013/39/EU, according to which the strategic approach shall include proposals to improve the procedure for placing medicinal products on the market more effectively to reduce the environmental impacts of medicines. In addition, by September 2017, the EC shall propose measures at the EU and/or Member State level recommending the reduction of discharges, emissions, and losses of such substances into the aquatic environment.

This initiative aims to:

  • Identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them
  • Explore how to address the challenge of protecting the environment (and human health via the environment), while safeguarding access to effective and appropriate pharmaceutical treatments for human patients and animals, considering inter alia opportunities for innovation