Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Slovakia 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 – PRICING & REIMBURSEMENT STRATEGY
Under the control of the Ministry of Health, and also under continual review, healthcare in Slovakia is universally available within the context of a system of compulsory health insurance, a basic benefit package, a competitive insurance package and flexible pricing of health services.
The system remains relatively inefficient and quality levels are low.
With EU membership has come a more transparent pricing structure and Slovakian legislation delineates clear rules and timelines for price approval and reimbursement of drugs. Alongside this, over the past ten years the Ministry of Health has pushed cost-containment heavily within the reimbursement policy in Slovakia. While stricter rules for price referencing and the introduction of a new set of regulations for the setting of reimbursements has led to visible cost savings, an increase in parallel exports and drop in local availability of the drugs in question. The re-export of pharmaceuticals has been banned as a consequence.
As in other areas, the State Institute for Drug Control (SUKL) plays the key role in pricing and reimbursement in the market for pharmaceuticals, medical devices, food supplements and cosmetics.
The Slovakian regulatory environment requires careful navigation. Only with an understanding of local pricing and reimbursement policies, can new market entrants hope to get their own price and reimbursement strategies and subsequent pricing and reimbursement submissions right. With experienced local consultants, Grove can assist with:
- Understanding the local reimbursement policy
- The development of appropriate pricing strategies
- Access to key opinion leaders and healthcare decision makers
- Translation of all related documentation
- Reimbursement applications/submissions
- Pricing and reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
Administrative support at all levels
PHARMA MARKET ACCESS – 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, 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 SLOVAKIA – 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 legislation and local regulatory procedures.
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 and reporting all interactions between pharmaceutical companies and contacts within the healthcare sector
- RA support to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
- Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements must be met (with SUKL carrying out periodic inspections related to good manufacturing practice)
- RA consulting services to meet local distribution prerequisites (with SUKL responsible for periodic inspections related to good distribution practice)
- Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
- Advertising; compliance with the strict, comprehensive legislation introduced in 2001 covering all product areas within the wider healthcare market (overseen by SUKL for medicines advertising in print media and via the internet and the Public Health Service of the Slovak Republic and Regional Public Health Authorities for cosmetics and food and dietary supplements)
- 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