Working with its clients to ensure a successful outcome in terms of market access, Grove local 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 KAZAKHSTAN – PRICING AND REIMBURSEMENT STRATEGY
Currently, the Kazakh market for pharmaceuticals is divided roughly equally into two: state procurement (via regional and city health departments and the remaining share bought directly by hospitals) and retail sales.
October 2018 sees the introduction of a phased introduction of a pricing policy (prescription pharmaceutical products in October 2018, followed by OTC drugs in 2023). This should benefit suppliers across the healthcare market. The National Center of Expertise (Ministry of Health) will be responsible for overseeing the associated product approval and certification process which will be based on a list drawn up by healthcare authorities. Both medicines and medical devices are to be included in the process.
The introduction of a clear pricing policy in Kazakhstan follows the previous updating of its reimbursement policy which is, in turn, based on Guaranteed Volume of Free Medical Aid (GVFMA). Policy changes have resulted in both an increase in the number of drugs on the reimbursement list and a fall in the cost to the patient for the drugs involved. Tender processes are clear. Tender details are announced by September with decisions made by November. The process is administered by the Ministry of Health.
The increasingly transparent local regulatory procedures still require careful navigation. Only with an understanding of local reimbursement policies, can new market entrants hope to get their own reimbursement strategies and subsequent reimbursement submissions right. With experienced local 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 KAZAKHSTAN – 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 Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant national legislation and 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
- 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; regulated by the Law on Advertising in Kazakhstan; strict regulations related to advertising of medical treatment and pharmaceuticals; presentation of advertising in Kazakh and Russian languages
- Data protection, incorporating the PDP Law (personal data protection)
- Packaging and labelling, to include tracking safety labelling changes; ability to meet specific language requirements key
Grove provides market access consultancy services across the following product areas:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Biologics
- Cosmetics
- Food and dietary supplements
