Market Access services
in Romania

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:

  • Pricing and reimbursement
  • Regulatory affairs (RA) support for local product launch, sales and marketing
  • Pharma compliance
  • Pharma quality assurance

PHARMA MARKET ACCESS ROMANIA – PRICING AND REIMBURSEMENT STRATEGY

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:

  • Understanding the local pharmaceutical reimbursement policy
  • Understanding pricing regulations
  • The development of appropriate pricing strategies
  • Access to key opinion leaders and healthcare decision makers
  • Translation of all related documentation
  • Reimbursement applications
  • Reimbursement status monitoring and maintenance
  • Timely follow up and communication with experts
  • Administrative support at all levels

MARKET ACCESS ROMANIA – 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 ROMANIA – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE

Experienced, well-connected Grove consultants are ideally positioned to be able to provide local regulatory affairs support to ensure client compliance in terms of relevant local 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 national authorities
  • RA support to meet EU serialization requirements
  • Manufacturing; NAMMD monitors good manufacturing practice and carries out regular inspections, imposing fines for non-compliance where it sees fit
  • 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, with NAMMD overseeing the advertising and promotional activities (including internet-related activities) carried out by MAHs, their employees and contractors, in relation the general public, patients and healthcare professionals
  • Data protection and GDPR; currently under review and expected to change significantly with regard to those marketing within the healthcare sector
  • Packaging and labelling; tightly regulated by NAMMD
Grove provides market access consultancy services across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements