Working with its clients to ensure a successful outcome in terms of market access, Grove’s locally based consultants provide expert advice in three key areas:
Rafts of changes to the local regulatory system were introduced in 2015, with ‘more changes implemented in six months in 2015 than in the previous six years’. An aggressive clawback policy remains in place, and with this comes unpredictability with the knock-on effect being a lack of investment in innovation in the healthcare sector.
Despite regulatory change, the reimbursement system remains for many ‘incoherent’ and unstable. Instability is compounded by constant changes at ministerial level resulting in a complete lack of appropriate strategic planning.
The National Agency for Medicines and Medical Devices (NAMMD), the Ministry of Health and the National Health Insurance House (NHIH) play key roles in the market for pharmaceuticals, medical devices, food supplements and cosmetics. Understanding their individual and collaborative roles is of vital importance.
Navigating the local pricing and reimbursement system is a challenge for even the most experienced and robust manufacturer. New market entrants cannot begin to hope to get their own price and reimbursement strategies and submissions right without a watertight understanding of the reimbursement policy in Romania and the associated dynamics. With experienced locally based consultants, Grove can assist with: