GSK chief backs a centralized European approval process

With European countries slamming the brakes on drug spending whenever possible, GSK chief Andrew Witty took the helm of the continent's pharma association calling for a "new dialogue" between the industry and government officials and cautiously backing a radical revamp of the European approval process.

Currently, developers have to gain the endorsement of the EMA prior to seeking marketing approval from the 27 countries in the EU, which assess a product's cost effectiveness. Witty, though, expressed support for a more centralized approach to a therapeutic review.

"There is a certain degree of appeal to having a rational evidence-based relative efficacy or effectiveness discussion once in Europe rather than having it 27 times and potentially answered 27 different ways," said Witty as he took the presidency of the European Federation of Pharmaceutical Industries and Associations. "Provided that didn't become a further reason to delay approval or access to the medicine, I think that is something that over time the industry could work towards."

Witty also wants a new regulatory approach to the drug industry in which industry executives and regulators can take a more collaborative approach to drug development. "Let's start looking at medicines expenditure as an investment. This will enable governments and industry to set a strategic agenda for health and pharmaceutical innovation. What matters is whether a medicine works, responds to patient needs and, if so, that it is rewarded," he said.

Unlike the U.S., where drug prices can float as high as the market will bear, Europe's central payer system gives government agencies extraordinary power to determine if a drug should be covered or not. The UK's NICE, for example, often takes a hard line on therapies with marginal health benefits and high costs. As a result, Witty and other biopharma chiefs want more regulatory input earlier on in the R&D process,so they can focus on new drugs that can gain widespread use.

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