Innovate and get refund!

Amendment of the reimbursement act

Innovate and get refund!

The Ministry of Health is preparing a new tool to support Polish pharmaceutical innovation:

This is the so-called reimbursed mode of development. It will be dedicated budget aimed to encourage entrepreneurs to invest in the development of Polish medicines and medical devices. It will be public fund, but separate from the money destined for drugs – explained Ewa Warmińska, Deputy Director of Drug Policy And Pharmacy Department in the Ministry of Health.

We belive in all ideas which will encourage companies to boost their R&D projects and develop the knowledge-based economy in Poland.

Beside the support for innovation, in the draft were such decisions of the amendment as:

  • facilitating reimbursement procedure of orphan medicines. In the procedure of acquiring the reimbursement decision for these kind of medicines, instead of an economic analysis, only price justification will be required.
  • introduction of „compassionate use” rule allowing application of medicine that has not been registered for patient who is not taking in a clinical trial.
  • publishing reimbursement lists every three months, not every two months, as it is now.
  • enabling reimbursement of registered medicinal products in direct import procedure, which are authorized, but are unavailable on the territory of Poland.
  • publishing the reimbursement application, which aims to strengthen transparency of the reimbursement procedure.
  • introduction of the possibility of quick removal of medicinal product from the reimbursement list, when this particular medicine does not fulfill any reimbursement criteria anymore.

Second quarter of the 2017 – this is the time when the amendment of the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices (the reimbursement act) is planned to be submitted.

During the BioForum 2017 we will debate this topic – come and hear first hand!