One final push: EU pharma industry group demands competition check on incoming legislative overhaul

The Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) this morning called on the European Commission to ensure that it adequately assesses how its re-writing of the 20+-year-old pharma legislation, which is due to be released before the end of the month, damages the competitiveness of the pharma industry.

EFPIA’s opposition to the changes has lingered since the beginning, and its latest estimate is that the rewritten legislation could cost the industry €640 million ($688 million).

The high-level proposal, according to press leaks, seeks to level the playing field for accessing new medicines across member states, among other reforms. That would include requiring companies to intro their drugs evenly — so countries like Romania see the same access as others like Germany or France — or else lose two years of the 10 years companies currently enjoy without competition.

Only if a new drug is launched in all of the EU would a company then see those two years of exclusivity restored. An official proposal is expected on March 29.

“We very much welcome last week’s Communication on Long-term Competitiveness of the EU,” EFPIA director general Nathalie Moll said in a statement today. “For legislation that will shape our health, science, jobs and growth for the next 20 to 30 years, it is deeply concerning that no complete Competitiveness check has yet been made to assess the real impact the pharmaceutical legislation proposals will have on access to the latest treatments, jobs, R&D investment, academia, manufacturing and growth across Europe.”

Novo Nordisk CEO Lars Jorgensen similarly told Reuters earlier this month that Europe would lose out to the US and Japan for new R&D investments with the rewritten legislation. Stefan Oelrich, head of Bayer’s drugs business, also told the Financial Times in January that Europe was becoming “innovation unfriendly,” adding, “We are really shifting our commercial footprint and the resourcing of our commercial footprint much away from Europe.”

Modeling by Charles Rivers Associates (funded by EFPIA) shows the rewrite could amount to about €14 billion ($15 billion) in lost biopharma R&D investments per year.

“By 2040, China will have relegated Europe to third place as a destination for company life science investment,” an EFPIA spokesperson told Endpoints News. “A set of proposals designed to save Europe millions are going to cost Europe billions.”

The EC’s track record with rewriting medical product-related regulations isn’t in a stellar position at the moment, as implementation of the newly reformed medical device regulations has been pushed back to 2028 for some devices following shortage concerns (even as the new regs have officially been applicable since May 2021).

But Europe isn’t alone in trying to get more from its pharma industry. Both the US and the UK also have proposals and laws in various states of implementation that would do more to drive down the cost and prices of pharmaceuticals via negotiations and price setting.

Meanwhile, the EC’s impact report pointed to ways that the new pharma legislation would help industry via accelerating product development and authorizations in areas of unmet need, creating new incentives to develop new classes of antimicrobials, adding:

The economic benefits to the European pharmaceutical sector in terms of reduction of administrative burden will be further enhanced through the future-proofing of the legislation and new possibilities for accelerated product development. Regulatory flexibility to use improved evidence generation techniques throughout the lifecycle of a medicine through the possibility to use real word data and artificial intelligence (AI) applications for evidence generation with the possibility to adjust decisions based on new evidence.

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