FILE PHOTO: Illustration photo shows various medicine pills in their original packaging in Brussels, Belgium August 9, 2019. - REUTERSPIX: Nov 6 - A major pharmaceutical rules overhaul, proposed by the European Commission in April, could see Europe’s share in global research and development contract by a third to 21% by 2040 translating to 2 billion euros per year in lost investment, industry group EFPIA said on Monday.
“Any changes to our incentives system would equally affect EU-based and foreign-based companies which bring medicines to the EU and, therefore, it would not put EU firms at a disadvantage,“ an EU Commission spokesperson said. The Commission said its proposal would reduce new medicine approval times to 180 days from 400 days. It also includes boosts for small and medium-sized enterprises such a longer period to get data protection in all 27 member states as well as fee reductions or waivers schemes and favourable regulation for rare disease medicines.
“If you chop off, one or two or three years of exclusivity, it’s the peak sales that you take away. When you launch a product, you have a negative profit contribution because you invest more in marketing, sales...it’s really easy the last few years that you recoup your investment,“ Jorgensen said.