For more than a decade, analysts of the pharmaceutical industry have argued that the conventional blockbuster model of drug discovery and development is unsustainable, despite many years of investment in new life science technologies. Explanations have included a failure of innovation capacity and low productivity, a focus on incremental rather than radical innovation, excessive regulatory barriers and a lack of venture capital investment. However, an alternative argument can be posed that the pharmaceutical innovation model has been remarkably resilient and multinational companies have been extremely robust in maintaining their market dominance.
If disruptive change in the pharmaceutical innovation model does become inevitable, it will be important to manage this change carefully if we are to ensure that continued medical benefits are delivered to patients. The key to achieving this is through the regulatory system, and any regulatory change must be accompanied by a good understanding of the subtlety and complexity of the interactions between regulation and innovation in the life sciences. Among other things, this will require a commitment to smart regulation that looks at the very nature of particular regulatory regimes and ensures that they are suitable for the emergent science, technologies and therapies that have the potential to transform healthcare and the industries that provide for it.
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