Obligations of pharmaceutical companies in medicine shortages
Mitigation measures by pharmaceutical companies
When it becomes clear that a medicinal product will go into shortage, it is important to use the advance notice to respond and reduce the impact of the medicine shortage on patients and the healthcare system. Pharmaceutical companies can, among other things, use the following remedies:
Other package sizes, strengths or pharmaceutical forms
It is important to include with the medicine shortage report information on whether other package sizes, strengths or pharmaceutical forms can cover the shortage period.
Inform doctors, healthcare institutions and pharmacies in good time
Information must be provided in good time about medicinal products that are to be withdrawn from the market and medicinal products that are going into shortage, where the shortage is likely to affect patients. This applies in particular to essential medicinal products, widely used medicinal products and medicinal products that are the only ones of their kind on the market. This gives doctors the opportunity to respond, for example by changing treatment.
The reasons why the medicinal product is no longer available shall be stated, and guidance on remedies provided, as appropriate. It is also important to provide pharmacies with comparable information, among other things so that they can advise patients. Pharmaceutical companies must also publish the information on their website, e.g. on their backorder list.
Before medicinal products or individual packages are taken off the market, marketing authorisation holders must examine whether this would adversely affect vulnerable patient groups, such as children, and take measures so that patients' needs can be met.
Prevent knock-on effects
A medicine shortage can have knock-on effects, i.e. when one medicinal product with a large market share goes into shortage, there may be shortages of other comparable medicinal products on the market with a smaller market share.
To prevent this, it is important that pharmaceutical companies follow the information sent out by email by the Icelandic Medicines Agency (IMA) on anticipated medicine shortages and the information on medicinal products in shortage in the Medicinal Product Information (Sérlyfjaskrá), and take this information into account when purchasing medicinal products.
Shortage information can be found in the Medicinal Product Information (Sérlyfjaskrá). It is important to communicate the latest information on shortage dates to IMA and on the pharmaceutical companies' backorder lists.
Obtain a comparable medicinal product from another market
The pharmaceutical company reporting the shortage may try to obtain the same or a comparable medicinal product from other markets for the duration of the shortage. IMA may then grant an exemption from the requirement for Icelandic labelling on the packaging. If IMA grants approval, the benefit is that the negative impact of the medicine shortage on patients and the healthcare system is reduced. The medicinal product in shortage can then be prescribed, there is no need to prescribe an exempt medicine, and prescriptions for the medicinal product in shortage that were issued just before the shortage began can be dispensed.
Obtain an exempt medicine and apply for permission to change prescriptions
If none of the above remedies are effective, pharmaceutical companies may try to obtain an exempt medicine to replace the medicinal product in shortage.
If IMA approves a change, in pharmacies, of prescriptions for the medicinal product in shortage to a specific exempt medicine, the benefit is that the negative impact of the medicine shortage on patients and the healthcare system is reduced. The medicinal product in shortage can then be prescribed, there is no need to prescribe an exempt medicine directly, and prescriptions for the medicinal product in shortage that were issued just before the shortage began can be dispensed.
Price concessions for medicinal products that replace medicinal products in shortage
Pharmaceutical companies may apply for a higher price for medicinal products that resolve a medicine shortage. IMA's pricing rules state that where there is a serious problem concerning access to an essential medicinal product, a higher price may be requested, provided that the application is accompanied by a justification and cost data supporting the price applied for.
Special concessions, both turnover-related and relating to the mark-up percentage, also apply to exempt medicines that replace a marketed medicinal product in shortage.
Exemptions for the release of individual batches (GxP exemptions)
An exemption may be requested for the distribution of individual batches when they do not meet all the requirements of the marketing authorisation, for example:
Release of a batch with an older version of the package leaflet
Deviation from the specifications – quality defect
An application for exemptions for the distribution and sale of individual batches that do not meet all the requirements of the marketing authorisation must be completed.
Service provider
Icelandic Medicines Agency