Ordering Access to Therapy

• The Ministry of Health has prepared a draft amendment to eight laws, including the Pharmaceutical Law, concerning the financing of therapies.
• The changes are primarily aimed at patients who have exhausted their current therapeutic options.
• The draft provides for the continuation of treatment after the completion of the pre-registration access program for the drug.
• Patients would be able to submit and monitor applications for reimbursement of drugs imported from abroad through the Internet Patient Account.

The Ministry of Health proposes changes to eight legal acts, including the Pharmaceutical Law. The draft is in the preparation stage by the Ministry of Health, without specifying a date for adoption by the Council of Ministers (Easier access to therapy and continuity of treatment. The Ministry of Health proposes changes in therapy financing – Ministry of Health). The aim is to provide a more coherent and predictable treatment approach, especially for patients who have exhausted their current therapeutic options. Deputy Minister of Health Katarzyna Kacperczyk emphasized that the ability to access necessary therapy should not depend on whether a patient can raise funds from public collections.

Continuation of Treatment After Access Programs

The draft provides for securing the continuation of effective therapy after the patient’s participation in the pre-registration access program for the drug has ended. This concerns situations where a patient receives a drug before its formal registration, and after this stage, they should have the opportunity for further treatment. Details regarding the financing of such continuation have not yet been specified in the draft.

Digital Application Submission

The planned changes also include facilitating formalities. Patients would be able to submit applications for reimbursement of drugs imported from abroad and monitor their processing through the Internet Patient Account. This would apply to preparations not available in standard domestic circulation.

Safety and Fundraising

The Ministry emphasizes that the changes will also concern the safety of treatment. The Ministry does not intend to eliminate public fundraising but wants to introduce additional mechanisms that will expand the therapeutic options for patients.