Our lawyers have extensive experience with regard to the drug reimbursement. Counsellor Oskar Luty and Counsellor Marcin Flak co-authored the first commentary on reimbursement rules that came into force in 2012.
For many years, our lawyers have been providing advisory services in market access issues, which includes for instance:
- assessing refundability chances of medical devices and preparing reimbursement applications,
- determining the pricing policy,
- negotiating applications before the Economic Commission of the Ministry of Health, including negotiating risk-sharing instruments,
- all regulatory matters related to the list of devices available on order (the so-called list under Article 38 of the Reimbursement Act)
- solving legal problems related to the reimbursement and trading in devices financed in the order mode (Article 38 of the Reimbursement Act), regarding the application of prices, advertising and promotional instruments, building information policy on the availability of reimbursable products, etc.,
- building an access strategy to public financing outside the reimbursement regime (guaranteed benefits, National Health Fund settlement products).