European payer organizations and health technology appraisal (HTA) bodies have warned that the European Commission’s overhaul of the EU pharmaceutical legislation should not lead to faster marketing approval mechanisms. This would exacerbate existing problems for pricing and reimbursement decision makers caused by an increasing trend for regulatory approvals based on limited evidence, said speakers at a recent online event.
European HTAs And Payers On How To Tackle The Evidence Problem
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.

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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.