Working with its clients to ensure a successful outcome in terms of market access, Grove consultants provide expert advice in three key areas:
- Pricing and reimbursement
- Regulatory affairs (RA) support for local product launch, sales and marketing
- Pharma compliance
- Pharma quality assurance
PHARMA MARKET ACCESS HUNGARY – PRICING AND REIMBURSEMENT STRATEGY
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:
- Understanding the Hungarian pharmaceutical reimbursement policy
- Understanding Hungarian pricing regulations
- The development of appropriate pricing strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement application
- Reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS HUNGARY – REGULATORY AFFAIRS SUPPORT FOR LOCAL PRODUCT LAUNCH, SALES AND MARKETING
Beyond pricing and reimbursement, locally based consultants provide expert regulatory affairs support for local product launch, sales and marketing. This includes:
- Review of advertising, promotional and educational materials to meet local regulatory requirements
- Validation and submission of relevant materials to appropriate local agencies
- Provision of local management support required/relevant local databases
- Facilitation of direct communication with local healthcare professionals
MARKET ACCESS HUNGARY – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Experienced, well-connected local Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant Hungarian legislation and regulatory requirements.
Across key product areas of pharmaceuticals/medicines, medical devices and biologics, food and dietary supplements and cosmetics, areas in which Grove consultants provide regular input to ensure client compliance include:
- Local notifications and authorization support, for example reporting supplies and sales of medicinal products to the relevant national authorities
- RA support; production of SOPs for all services provided
- Clinical trials; covering services for local clinical trials Phase I to Phase IV and where clinical trials are taking place in the country within a global program – RA support, feasibility and site selection, clinical monitoring, local project management, PV and QA working to ISO 9008:2001
- Manufacturing; notably assistance in QA compliance
- RA consulting services to meet local distribution prerequisites
- Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
- Advertising, to ensure adherence to the Hungarian Code of Advertising Ethics, for example, and focused on product sector given specific regulations for medical devices, medicinal products and cosmetics, for example
- Data protection and GDPR
- Packaging and labelling, to include tracking safety labelling changes
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Food and dietary supplements