Working with its clients to ensure a successful outcome in terms of market access, Grove consultants provide expert advice in three key areas:
Hungary has one of the most complex and comprehensive regulatory frameworks in Europe. The framework was developed within the context of the state-owned universal health insurance system (the OEP), financed through mandatory tax contributions from employers and employees.
The contributions fall well short of that needed, and despite the industry effectively compensating for this, the Hungarian healthcare system remains severely underfinanced. Proving the value of a new innovative therapy is becoming more and more important in an environment characterized by tight budgets.
Although the reimbursement system can be navigated with relative ease by some, those with a more complex case to present (new active ingredients, new indications or higher-level reimbursements) can find it a difficult and lengthy process. The Hungarian regulatory authorities are extremely thorough in their assessment of new applications and significant numbers of applications now require a final ministerial decision for approval.
Hungarian regulatory authorities are strict. It is no defense to claim ignorance, and delays, fines and cessation of activities can all be forced on a manufacturer failing to understand what is expected of it within the context of regulatory affairs.
The National Institute of Pharmacy and Nutrition (OGYEI) plays the key role in the market for pharmaceuticals, medical devices, food supplements and cosmetics.
The complex local environment for regulatory affairs demands a high level of understanding and commitment from potential new market entrants and those looking to develop their presence in the market further. Only with an in-depth understanding of the reimbursement policy in Hungary, can new market entrants hope to get their own price and reimbursement strategies and subsequent reimbursement application right. With experienced local consultants, Grove can assist with: