The group of biological medicines is rapidly developing and consists of a wide range of products that originate from biological systems. These include blood and blood-based products, plasma derivatives, vaccines, monoclonal antibodies, cells, tissues and organs from human and animal origin. This group also includes advanced therapy medicinal products such as gene, somatic and tissue engineered medicinal products.
Biological medicines have a complex nature and their “active ingredients” vary greatly. These “active ingredients” can be nucleic acid, proteins, growth factors and hormones and are intended to work in the human body. More complex biotechnological medicinal products consist of cells that are grown on scaffoldings or matrixes and planted into the organism to fulfil their function.
Blood, blood-based products and plasma derivatives play a vital role and are widely used within healthcare services. In accordance with Estonian legislation these are treated as medicinal products, with the exception that they do not require marketing authorisation. In Estonia, around 2.5% of the population aged between 16 and 65 donate blood. Estonia has 4 major blood centres and around 50,000 donations are collected annually.
Biological medicines based on cells, tissues and organs work on a principle that once transplanted into a recipient‘s body, they replace damaged cells, tissues and organs and re-establish lost functions.
Recent advances in science have resulted in the development of more complex biological medicines, such as gene, somatic and tissue engineered medicinal products. These are currently being investigated with the aim to restore, correct or modify physiological functions. Being at the cutting edge of innovation and offering hope against various diseases for which there are limited treatment options, these medicinal products have been subject to considerable interest and debate. Due to the novelty and technical complexity of handling advanced therapy medicinal products, specially tailored rules have been set out to ensure safe production and free movement within the European Union.