Special permits for individual patient basis use
Fimea may grant a special permit for a medicinal product that has no marketing authorisation in Finland to be released for consumption in individual cases for special therapeutic reasons.
The Medicines Decree (693/1987, 1184/2002 and 868/2005) (www.finlex.fi) only allows special permit in exceptional cases where no other treatment is appropriate or yields the desired effect.
Medicinal products subject to a special permit may be prescribed in accordance with the Decree of the Ministry of Social Affairs and Health on the prescription of medicines (1088/2010). The use of electronic prescriptions is not possible for the time being.
In outpatient care, the permission must be obtained for each individual patient. Health care institutions may apply for an institutional permit that pertains to several users of the medicine within the institution. A special permit for individual patient basis use is valid for one year, starting from the date of issue. It should be noted that the special permit is prescription-specific and that the prescription related to the special permit may be valid up to one year.
Account of special therapeutic reasons
The physician prescribing products subject to a special permit for individual patient basis use is required to supplement the special permit application with an account of the special therapeutic reasons for choosing the product concerned and why no products with a marketing authorisation can be used. The account must substantiate that the case is exceptional and that no other treatments are appropriate or yield the desired effect.
The attending physician is responsible for the treatment they prescribe.
When a special permit is applied for, it should be remembered that the product concerned has no marketing authorisation. The product may still be in a development stage or its marketing authorisation may have been revoked. This may be due to deficiencies in efficacy, safety or quality, or a changed perception of the therapeutic value and necessity of the product.
When prescribing a medicinal product without a marketing authorisation, the physician must take into account the fact that no national translation approved by the authorities is available of the summary of product characteristics or the package leaflet. For this reason, the physician prescribing the medicine may be unaware of the potential precautions for use.
When considering an individual treatment plan involving a medicinal product subject to a special permit for individual patient basis use, the physician concerned should update their knowledge of the product concerned as applicable.
When a medicinal product without a marketing authorisation is prescribed, account must also be taken of how the continuity of medicinal treatment can be ensured after the expiry of the special permit. A special permit for individual patient basis use is valid for one year, after which the preconditions for granting the permit will no longer necessarily be met if, for example, other alternative products with a marketing authorisation become available or the product is granted a marketing authorisation. No special permit is needed for releasing products with a marketing authorisation for consumption, and a special permit cannot be used as a means of resolving an issue with the availability of a product in a case where the marketing authorisation holder has not placed the product on the market in Finland.
Responsibility of the party releasing the product for consumption
The releasing party is responsible for ensuring the appropriateness of the application when submitting the application to Fimea. When a medicinal product is released for consumption under a special permit for individual patient basis use, the releasing party is required, for its part, to ensure that the user of the product is provided with sufficient information on the safe and correct use of the medicinal product concerned, along with storage and other relevant instructions.