Rare Disease Day: targeted import
Rare Disease Day draws attention to the challenges associated with access to specialist treatments. In the case of some orphan medicines and other treatments not commercially available in Poland, one of the mechanisms enabling treatment is targeted import.
In this article, you will learn:
- when a targeted import may be applicable
- What other early-access schemes are in place in Poland?
- how Urtica supports the achievement of import targets
- how e-Urtica supports the handling of enquiries about the availability of medicines
Rare diseases
Access to treatment as a systemic challenge
Although rare diseases affect small groups of patients, from the perspective of the healthcare system they represent thousands of individual cases in which the timing and availability of treatment are of crucial importance.
Orphan medicines and innovative treatments are not always commercially available in Poland – some are awaiting reimbursement decisions, whilst others have not been authorised for marketing in the country. In such situations, one of the mechanisms enabling treatment is targeted import.
Targeted import
When might it be used?
In practice, targeted imports most commonly concern orphan medicines used to treat rare diseases and innovative therapies awaiting reimbursement decisions. The application is prepared by a doctor, and once approval has been granted by the Minister of Health, the medicine may be imported by an authorised pharmaceutical wholesaler and delivered to the designated facility.
The procedure does not cover products for which marketing authorisation has been refused or withdrawn in Poland.
Targeted import may only be used once certain conditions have been met. These relate both to the availability of the product on the Polish market and to the clinical situation of the individual patient.
Not available in Poland
This medicinal product is not commercially available on the Polish market.
No registered equivalent
There is no registered equivalent of it.
Exhaustion of available treatment options
The available treatment options are inadequate or have been exhausted.
Registration in the country of origin
The product is registered in its country of origin.
The need for treatment for a specific patient
Its use is essential to save the life or health of a specific patient.
Access to treatment
Early access mechanisms
Early Access Programme
Compassionate use – when a manufacturer makes a medicine available prior to registration, usually as part of a multi-patient programme.
Emergency Access to Drug Technologies
RDTL – where a medicine has already been authorised for marketing but is not yet reimbursed, and the patient’s life or health is at risk.
Targeted import
A mechanism enabling the import of a product not commercially available in Poland, subject to certain conditions being met.
Urtica Support
Targeted import: from enquiry to delivery
If the required medicine is not commercially available in Poland, Urtica assists healthcare facilities with the targeted import procedure – from the initial enquiry right through to the safe delivery of the product.
Once a request has been submitted via the SOID system by a doctor or healthcare provider and approval has been granted by the Minister of Health, the patient has 60 days to designate a pharmacy that will undertake the targeted import and establish a partnership with an authorised pharmaceutical wholesaler.
The selected wholesaler then takes charge of organising the import of the medicine. This involves locating a foreign supplier and confirming availability, agreeing the terms of purchase, organising international transport, and ensuring that the quality standards are met and that the documentation is complete.
In the case of treatments for rare diseases, including the targeted import of orphan medicines, the wholesaler’s experience and efficient coordination of the process are crucial to the start of treatment.
e-Urtica
Digital support for checking the availability of medicines
The handling of enquiries regarding medicines not available on the domestic market has been integrated into the ‘Price Enquiries’ module on the e-Urtica portal.
Pharmacies, hospital pharmacy departments and other healthcare providers can, all in one place, submit an enquiry about the possibility of sourcing a product, provide data for analysis, attach documentation and monitor the status of their request.
In practice, an enquiry submitted via e-Urtica may initiate a procedure which will then be handled by a specialist team, in a tailored manner.
Digitalisation and collaboration
More effective coordination of access to treatment
The digitalisation of healthcare processes streamlines the organisation of activities relating to the availability of medicines. Tools such as e-Urtica.pl streamline communication, integrate documentation and support the coordination of individual stages, where response times and transparency are crucial.
In the case of rare diseases, organisational efficiency and effective cooperation determine how quickly a patient gains access to the necessary treatment. Access to treatment is a shared responsibility of the entire system – doctors, pharmacists, healthcare providers, pharmaceutical wholesalers and public authorities.
Urtica’s role is to support this process in a safe, compliant and operationally efficient manner.
FAQ
Import into Poland – frequently asked questions
Who can initiate a targeted import?
A request for a targeted import is prepared by a doctor, whilst the formalities are handled by a healthcare provider in collaboration with an authorised pharmaceutical wholesaler. Any user of the portal who is a healthcare professional may submit an enquiry regarding the possibility of importing a medicine using the Price Enquiry module.
Does targeted import apply only to orphan medicines?
No. Targeted import may cover both orphan medicines and other innovative therapies or products not authorised for marketing in Poland, provided there are no equivalents available on the market – subject to the approval of the Minister of Health.
Can a medicine imported under the targeted import scheme be reimbursed?
This is possible, but it requires separate authorisation from the Minister of Health. The Urtica team has experience in the field of targeted imports and shares its expertise on the reimbursement procedure.
How do you start the process on e-Urtica.pl?
Log in to the e-Urtica portal, go to the ‘Price Enquiries’ module and submit a request for a medicine not available in Poland using the form provided in the system or by email.