The Ministry of Health (MZ) presented the assumptions of its draft act on individual reimbursement on Wednesday, 21 October. Deputy Minister Katarzyna Kacperczyk said that access to effective therapies should not depend on public fundraising campaigns.
The draft is an amendment to the Pharmaceutical Law and certain other acts, known as the individual reimbursement act. According to PAP, it is intended to streamline the fragmented funding routes for modern therapies and ensure patients continuity of treatment.
One system instead of several routes
Currently, alongside systemic reimbursement, there are: emergency access to drug technologies (RDTL), target import and sub-funds within the Medical Fund. Kacperczyk said the ministry wants to combine them into a coherent system so that patients do not lose access to therapies.
“We cannot make access to effective therapies dependent on public fundraising campaigns organised by patients or their relatives” — Deputy Health Minister Katarzyna Kacperczyk, according to PAP.
The deputy minister stressed that the focus is on therapies with justified, confirmed clinical value. Not every drug for which money is being collected will therefore automatically be included in the new system.
Six areas of the act
According to PAP, the draft will cover:
- the Pre-Registration Access Programme (PPD),
- treatment of rare diseases,
- target import, meaning easier access to medicines brought in from abroad,
- funding after PPD, so that an effective therapy continues until systemic reimbursement is granted,
- bridge financing of drug technologies, with an expert-based assessment of the application,
- reimbursement of target import.
RDTL is to be transformed into bridge access to drug therapies. The ministry assesses that the current mechanism has not always worked fairly. According to Kacperczyk, the procedure was available mainly in haemato-oncology, haematology, gastroenterology and cancers of the digestive system, while a large group of patients with other conditions were excluded.
Full digitisation of target import is also planned. Patients will be able to track the status of applications and reimbursement decisions in their Internet Patient Account (IKP). The draft amendment to the reimbursement act, published on the Chancellery of the Prime Minister (KPRM) website, provides, among other things, for submitting applications for individual reimbursement via the IKP.
Stage of work and cost sharing
This is the third element of a package of changes to drug policy, alongside the act on prescriptions and the amendment to the reimbursement act, which according to PAP will soon go before the Council of Ministers. The individual reimbursement draft has passed pre-consultations and is expected to move to formal public consultations shortly. According to the Puls Medycyny portal, pre-consultations began in early July and were to last 14 days.
Representatives of the Department of Drug Policy and Pharmacy noted that around 800 new therapies have entered the system since the previous drug policy was introduced. Even so, alternative routes continue to grow rapidly. The ministry wants to divide financial responsibility between pharmaceutical companies and the state budget so that patients are not “hostages to marketing”.
What this means
For now, nothing changes: these are assumptions of a draft, not binding law. The act must go through consultations, the government and parliament. Until then, RDTL and target import remain in force. Fundraising campaigns, such as the one for the glioma treatment of a participant of “Ślub od pierwszego wejrzenia” (Married at First Sight), will therefore remain the only option for many patients. Ultimately, the greatest gains could go to patients from fields not currently covered by RDTL, as well as people waiting for medicines imported from abroad, who will be able to track their application online. The draft does not ban fundraising; the ministry only declares that it wants to reduce the need to organise it.
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