Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in the Lithuanian market 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 SERVICES LITHUANIA – PRICING AND REIMBURSEMENT STRATEGY
The National Drug Policy was approved in August 2017 in Lithuania. While the main aim of the policy is to ensure universal healthcare provision to all within the country, reducing patient co-payment is a key element and with this, pricing policies have been scrutinized. Although recent legislation has improved the transparency of the Lithuanian pharmaceutical market to a limited degree, the regulatory authorities still have work to do in getting to grips with eliminating fluctuations in supply caused by parallel exports.
The local reimbursement system continues to reflect inefficiency and poor management within the healthcare system as a whole. With a lack of health-related data, processing abilities and methodologies required, Lithuania is still some way from being able to implement an effective value- based reimbursement policy. The SMCA recognizes the failings, but it will take considerable time before there is real transparency and efficiency within the reimbursement system in the country.
The State Medicines Control Agency (SMCA) and the Ministry of Health both have key roles in the market for medicines, medical devices, food supplements and cosmetics.
New market entrants continue to find it a challenge to navigate reimbursement policies in the Lithuanian market. With experienced local consultants, Grove can assist with:
- Understanding the local pharmaceutical reimbursement policy
- Understanding local 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 – 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 legislation and regulatory requirements in Lithuania.
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
- Local 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 regulations and requirements
- 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
- Biologics
- Cosmetics
- Food and dietary supplements
