Pharmalittle: Pharma trade group slams European Commission proposal; U.S. lawmakers demand FDA explain its approach to shortages

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A pharmaceutical industry trade group argues that a major rules overhaul proposed by the European Commission in April could cause Europe’s share of global research and development to contract by a third to 21% by 2040, translating to $2.15 billion per year in lost investment, Reuters writes. The European Federation of Pharmaceutical Industries and Associations says the commission has not conducted a competitiveness impact assessment and if the new rules become law, they would accelerate the negative innovation trend in the EU and hit small and medium-sized enterprises the hardest.

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Meanwhile, Novo Nordisk warned that it will accelerate its U.S. expansion at the expense of the European Union unless Brussels changes the plan to reform industry regulation, The Financial Times adds. Novo chief executive officer Lars Fruergaard Jørgensen said much of the company’s research was now done in Boston and “the journey of expanding in the U.S. would be further accelerated” if the EU implemented its new rules that would cut years of market exclusivity. Jørgensen argued the plan would create a “negative ecosystem.” The industry is concerned by a cut in the number of years of market exclusivity from 10 to eight years.

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