The list of legislative and programmatic work of the Council of Ministers includes the publication of a draft law amending the Law on reimbursement of medicinal products, foodstuffs intended for specific nutritional uses and medical devices and the Law on publicly funded health services. It is expected to be adopted in the fourth quarter of this year.
The last change Reimbursement Law introduces a number of significant changes to the scope reimbursement of medicines, foodstuffs for special nutritional purposes and medical devices. The new regulations aim to improve the reimbursement procedures process and to adapt national regulations to EU regulations, in particular to the Regulation of the European Parliament and of the Council (EU) of 15 December 2021 (the so-called common HTA). The changes are of great importance for patients, pharmacies and doctors, as well as for the entire pharmaceutical sector.
Changes to the Drug Reimbursement Law. Simplifying procedures
One of the main aspects of the change is: simplification of procedures related to reimbursement of medicines. The bill provides for:
- reducing requirements for drug reimbursement claims and determining the net sales price;
- introduction of new tasks for the Agency for Health Technology Assessment and Pricing (AOTMiT) and for the President of the Agency;
- adapt the regulations on clinical analyses of medicinal products already assessed at EU level, which will speed up the national reimbursement procedure.
These changes are intended to contribute to faster access for patients to modern medical technologies and medicines.
Reimbursement of medicines in a new way. Changes resulting from the Common ATS Regulation
The amendment adapts the provisions to EU regulations relating to joint health technology assessment (ATS). In connection with:
- medication and health technologies that have undergone a joint clinical assessment at European Union level will not require additional analyses at national level;
- when assessing reimbursement requests, the reports of joint clinical assessments published on the EU IT platform will be taken into account;
Agency for Health Technology Assessment (AOTMiT) will be required to include EU clinical evaluation reports in its analyses. Thanks to this, reimbursement procedures in Poland will become more transparent and effective.
Changes to the Reimbursement Act of 2024. What’s new for patients?
To patients The change potentially means a number of benefits, including:
- faster access to modern drug therapies because reimbursement procedures will be shortened;
- simplified integration process reimbursed medicineswhich have already been approved at EU level;
- greater availability of medicines used in the treatment of rare and ultra-rare diseases, thanks to the adjustment of the criteria for assessing reimbursement requests.
The change increases the chances of patients receiving effective treatment with modern therapies, especially in the case of difficult-to-treat diseases.
Reimbursement Law Amendment. What does this mean for pharmacies?
Pharmacies should also benefit from the changes introduced. Thanks to the new regulations:
- reimbursed drugs will be available on the market more quickly, which will allow pharmacies to better supply patients;
- procedures related to the provision of medicines will be simplified, which will affect their availability in pharmacies;
- pharmacies will be able to offer patients modern therapies that will be marketed more quickly thanks to simplified reimbursement procedures.
These changes will strengthen the competitiveness of pharmacies and increase their role in providing modern medicines to patients.
Changes to the Drug Reimbursement Act. How will this affect physicians?
For doctors amendment of regulations on reimbursement of medicines associated with:
- simplified access to modern subsidized medicines, which will be available without lengthy clinical analysis processes at national level;
- greater support in treating patients thanks to new medical technologies that will be reimbursed more quickly;
- easier treatment decisions thanks to joint clinical assessments carried out at EU level.
Doctors will be able to introduce modern therapies into clinical practice more quickly, which will improve the quality of patient care.
New refund regulations for 2024. Problems with interpreting the law
Let us remember that the previous changes Reimbursement Lawintroduced in autumn 2023 (the so-called DNUR), proved to be imprecise and caused numerous problems of interpretation. The Ministry of Health issued several explanatory statements to clarify ambiguities in the regulations. This is why new quick change (CABLE) aims to correct errors and remove ambiguities.
The main changes correcting the previous regulations include: removal of the algorithm for determining the quantity of the product, which proved to be problematic in practice. The Ministry also plans to eliminate the provision on the mandatory suspension of refund processes, which was too restrictive.
