Most of the medications sold in pharmacies in Iceland have marketing authorization from the Icelandic Medicines Agency, and they are available domestically because their marketing authorization holder (MAH) has decided to market them in Iceland. The marketing authorization (drug registration) is a prerequisite for marketing, which includes the publication of the drug in The Icelandic Medicine Price Catalogue and Icelandic Medicinal Product Information Database.
There are times, for various reasons, when a need arises for drugs that are not marketed in Iceland. In those cases, there are several options depending on the registration status of the drug.
Exemption drugs
Exemption drugs, with an approved maximum wholesale price and publication in the Icelandic Medicine Price Catalogue, are the most common solution for accessing drugs that are not marketed in Iceland. These drugs are usually prescribed through the doctor's prescription system, such as the Saga system.
Exemption drugs may either be drugs with marketing authorization in Iceland or elsewhere in the EEA, but have not been marketed domestically. Alternatively, they could be drugs without marketing authorization in the EEA, though this is rarer. In both cases, the doctor sends a request for an exemption to the Icelandic Medicines Agency, for example through the prescription system.
Clinical trials
When new drugs are being developed, for example, for diseases where there are few or no treatments, someone with the disease may be offered the opportunity to participate in a clinical trial, thereby gaining access to a developing drug.
Early access through specific programs
There are several terms in English and Icelandic for situations where patients are granted access to non-marketed drugs through defined programs. Examples include the Compassionate Use Program, Early Access Program, and Named Patient Program. These are sometimes confused with off-label use. New guidelines from the Icelandic Medicines Agency seek to clarify these differences, summarized as follows:
Compassionate Use (CU)
The Icelandic Medicines Agency is authorized to grant permission to offer drugs for compassionate use. These drugs do not have marketing authorization in the European Economic Area (EEA). Compassionate use involves making a drug available to a group of patients with a disease that causes long-term or serious disability, or a life-threatening disease that cannot be satisfactorily treated with a drug that has marketing authorization in the EEA. An application for centralized marketing authorization for the drug must either be in process, or clinical trials must have been authorized. Before the Icelandic Medicines Agency makes a decision on authorization, the opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) must be obtained. More details are in the guidelines.
Named Patient Program (NPP)
The NPP is based on a doctor's authorization to use non-marketed drugs, which is similar to the authority to prescribe exemption drugs as described in Article 12 of the Medicines Act. However, it should be noted that the prescription of exemption drugs without marketing authorization through the NPP, which are sometimes free of charge to patients and the public, is different from the traditional prescription of exemption drugs, as outlined in the guidelines. In these cases, the prescription is made through the "My Pages" section on the Icelandic Medicines Agency's website. The MAH or representative of the drug does not need to apply for permission from the Icelandic Medicines Agency for NPP as is required for compassionate use.
A common factor in these programs is crucial for patients. In both cases, CU and NPP, it is very important, before the program begins, to try to ensure that there will be no treatment interruptions for patients, for example, by reaching an agreement with the company (MAH or Agent) on the continued treatment of patients who have started treatment once the program ends. It cannot be assumed that the government will participate in the cost of treatment without approval of reimbursement or an agreement on the price of the drug, as per Regulation no. 1414/2020 on drug pricing and reimbursement participation.