Innovation on Prescription

Innovation on Prescription: A Critical Analysis of the Pharmaceutical Industry’s Concerns Over Drug Regulation and Delays

Agnieszka Marecka

The pharmaceutical industry’s concerns about excessive regulation and slow approvals hindering innovation are overstated. This essay argues that regulation is not inherently antagonistic to progress but functions as a mechanism of optimisation, balancing the protection of public health with the need for scientific advancement. While industry concerns often reflect frustrations with rising costs and lengthy timelines, the obstacles lie in systematic inefficiencies and regulatory capture, which distort incentives as well as hinder competition. The analysis draws on theories of regulatory capitalism and biopolitics to show how clear, predictable governance frameworks can cultivate public trust and encourage radical breakthroughs and innovation. Legal disputes, such as R v Medicines Control Agency ex parte Pharma Nord Ltd and Merck Sharp & Dohme v Licensing Authority, highlight how definitional ambiguities and extended exclusivity periods have slowed market access, supporting the argument that the procedural inefficiencies are at fault rather than regulation itself. Proposals such as risk-based regulation, adaptive licensing, and global harmonisation are identified as ways to streamline approval processes without compromising safety. Ultimately, regulation acts as a catalyst not a constraint for pharmaceutical progress.

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