AOTMiT has been given new tasks. The regulations regarding the changes have been adopted.
The Sejm passed the government-prepared amendment to the Act on the Reimbursement of Medicines, Foodstuffs for Particular Nutritional Purposes and Medical Devices and the Act on Healthcare Services Financed from Public Funds.
259 MPs voted in favour of the bill, 4 voted against and 167 abstained.
The provisions contained therein implement the government's deregulation activities.
The Act adapts Polish law to European Union regulations on health technology assessment.
Previously, companies applying for reimbursement for a product or drug in Poland were required to conduct three HTA analyses: clinical, economic, and budget impact. These analyses had to be conducted separately in each member state, which entailed very high costs and extended the time it took for the technology to reach the market.
The new regulations introduce a uniform clinical analysis at the European level, which is intended to expedite reimbursement procedures. Patients will be able to benefit more quickly from therapies registered by the European Medicines Agency.
The amendment also assumes, among other things, that entities from the pharmaceutical industry will be able to submit applications for reimbursement and applications for an increase in the net selling price without a clinical analysis if the requirements specified in the Reimbursement Act are met.
The Agency for Health Technology Assessment and Tariff System will carry out tasks arising from the EU regulation on health technology assessment.
The bill will now go to the Senate.
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