EU Changes Drug Rules After Court Ruling

A recent court ruling has highlighted significant flaws in the European Medicines Agency's (EMA) policy regarding the management of competing interests among its experts. The Court of Justice of the European Union (CJEU) found that the EMA's regulations, which have undergone multiple revisions since their inception in 2004, inadequately address situations where experts have ties to rival products. This ruling came in favor of French biotech firm D&A Pharma, which challenged the involvement of EMA experts with connections to competing drugs during the assessment of its medicine. The judgment specifically pointed out that one expert was consulting for several pharmaceutical products, while another was a lead investigator for a competing product under EMA review. This has raised concerns about the integrity of the EMA's evaluations, particularly for companies like PharmaMar, which claims its cancer drug Aplidin was unfairly rejected due to conflicts of interest among reviewers. Other drugs impacted by the ruling include Biogen/Eisai’s Alzheimer’s drug Leqembi and PTC Therapeutics’ Translarna for Duchenne muscular dystrophy. As the EMA reassesses Leqembi following the court's decision, the agency continues to grapple with the implications of its expert network. Currently, 4,122 experts are available to advise on drug marketing decisions, with 11 percent having direct industry links and 8 percent with indirect conflicts. The EMA's annual report indicates that 17 percent of its drug licensing committee members also have some connection to the pharmaceutical industry, raising ongoing concerns about potential biases in drug evaluations.