What factors affect the availability of medicines?
The process of releasing a new medicinal product for patient use is a long one. Pharmaceutical companies are constantly developing new medicines, but only a fraction of them end up being used by patients. Availability of medicines is affected by several factors, such as:
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The product does not have marketing authorisation in Finland. Pharmaceutical companies may choose to not apply for marketing authorisation in markets that are too small to cover the product’s research and development, production and distribution costs.
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The product has marketing authorisation, but it has not been introduced to the Finnish market.
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The pharmaceutical company has stopped supplying the product to retailers on the market or its marketing authorisation has expired.
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The manufacturer has found that the product cannot qualify for marketing authorisation during the development process. For patients treated with a new pharmaceutical in a clinical trial, a situation like this will emerge as a supply shortage.
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Manufacturing facilities might fail to meet the requirements of good manufacturing practices, or clinical trials might fail to meet the requirements governing the reliability of the trial. In a situation like this, pharmaceutical regulatory authorities will take action to revoke the marketing authorisation or to remove the product from the market.
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Pharmaceuticals might also occasionally be unavailable due to temporary availability issues which are often caused by supply chain disruptions.
European pharmaceutical regulatory authorities work together in order to notify healthcare professionals of any availability issues affecting pharmaceuticals without delay to ensure patients get the treatment they need. Fimea also works together with the Finnish Food Authority, to notify veterinary surgeons of availability issues affecting veterinary medicines.
FimeaWeb Search can be used to check if a medicinal productl is available (on the market) in Finland and whether its marketing authorisation is valid. FimeaWeb Search also indicates whether a shortage has been reported for the medicine.