Working with its clients to ensure a successful outcome in terms of market access, Grove Russian 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 RUSSIA – PRICING AND REIMBURSEMENT STRATEGY
Recognizing that improved regulation will positively drive development within the Russian healthcare sector, the regulatory authorities have worked hard to develop and introduce an appropriate regulatory framework. Within this, the Federal Drug Reimbursement Program now provides free access to over 250 pharmaceutical products for the most vulnerable in the Russian society.
With the market split between OTC and prescription pharmaceutical products, an Essential Drug List is maintained by the authorities, and pricing (maximum sale price/mark up) is strictly controlled. For all other products, suppliers are responsible for their own price setting.
As a member of the Eurasian Economic Union, there has been some regulatory harmonization across the countries involved. The reality is however, that the implementation of any regulatory issues pertinent to the healthcare market will take some time to take effect.
As in other areas, the Ministry of Healthcare of the Russian Federation (MINZDRAV) plays a key role in pricing and reimbursement procedures.
The relatively transparent local regulatory environment requires careful navigation given its complexity. Only with an understanding of the reimbursement policies in Russia, 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
- Support with the reimbursement application
- Reimbursement status monitoring and maintenance
- Timely follow up and communication with experts
- Administrative support at all levels
MARKET ACCESS RUSSIA – 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 guidelines
- 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 RUSSIA – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE
Experienced, locally based 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, 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, with the Federal Service on Surveillance in Healthcare and the Federal Anti-Monopoly Service responsible for supervising marketing activities regarding Russian healthcare professionals
- Advertising, with the advertising of pharmaceutical products driven both by legislation and also influenced by the Code of Practice of the Association of International Pharmaceutical Manufacturers (AIPM)
- Data protection; extensive Russian legislation requires careful consideration at all times
- 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