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 CZECH REPUBLIC – PRICING REIMBURSEMENT STRATEGY
Good logistics and increasing levels of transparency relative to that which existed historically, now characterize the Czech healthcare system. In part, this has been driven by recent changes to the reimbursement and healthcare purchasing systems implemented as part of a government drive to make the Czech public health insurance system more effective. However, the fact remains that the local pricing and reimbursement system remains complex and cumbersome.
Although challenging to navigate, the reimbursement system today is at least driven by clear bureaucratic procedures. With this, comes predictability.
With a unique referencing system and continual price pressures which afford manufacturers clear challenges, the local regulatory framework is noted for its ability to provide patients access to new medicines. This in itself, makes the market an attractive option for many.
While the Ministry of Health has some influence, it is the State Institute for Drug Control (SUKL) that plays the major role and is the interface with manufacturers as far as pricing and reimbursement are concerned within the market for medicines, medical devices, food supplements and cosmetics.
Only with an understanding of the reimbursement policy in the Czech Republic, 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 local pharmaceutical reimbursement system
- 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
- Pricing and reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS CZECH REPUBLIC –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 – 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 local legislation and regulatory requirements.
Across key product areas of pharmaceuticals/medicines/drugs/medicinal products, 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
- 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
- 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 (a complex area in the Czech market with the advertising framework underpinned by various Acts, Codes of Conduct and guidelines; strict regulations relate to the advertising of medicinal products, with less control applied to medical devices and cosmetics advertised to the general public; further change is expected)
- Data protection (compliance with the Act on Protection of Personal Data and fully harmonized in terms of legislation with the EU)
- Packaging and labelling, to include tracking safety labelling changes with packaging and labelling of medicinal products governed primarily by the Act on Pharmaceuticals, the Decree on the Registration of Pharmaceuticals, the Act on Packaging and the Act on the Regulation of Advertising (and all controlled by SUKL and the Ministry of Health)
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Food and dietary supplements