Policy & Regulation
Regulatory developments from the EU and the US are having widely felt effects on companies operating globally in both medtech and biopharma. The patents and pricing battle has engulfed the FDA and USPTO, while the impact of MDR and IVD regulation changes can be felt keenly for those in working in Europe.
Will scrutiny by the Centers for Medicare and Medicaid Services eventually lead to shifts in investment away from improving older drugs toward developing new products?
Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.
UK ministers are increasingly focusing on the need to improve uptake of new technologies in the National Health Service. Ambitious programs have been launched but implementing them effectively for lasting change in a delivery system under acute stress is a challenge of a different order.
The chances of reaching agreement on proposals to overhaul the EU pharma rules before the European Parliament elections in June 2024 are receding as disagreements emerge over key issues such as regulatory data protection and how to encourage antimicrobial R&D.