Kacper Szkalej

What Barriers Delay the Introduction of Derivative Medicinal Products Such as Generics and Biosimilars for Human Use? A Comparative Study of the Regulatory Framework of the European Union, the United Kingdom and Germany

Every medicinal product is subjected to a scrupulous examination before it can be authorized to be released on the market because whether or not it contains a previously unknown substance, there is at least the need to ascertain whether the product has the chemical composition which is claimed, that it can be used for the purpose for which it will be produced, that it exerts the claimed therapeutic effect, and that there are foreseeable side effects; in essence, that the product is safe and effective enough to be given to a human being. But this is only one view of how things should work in this environment.From a more commercially-oriented perspective it all comes down to maintaining a turnover and for that reason releasing the product as soon as possible while ensuring there is as little competition as possible. The authorization framework is equally pivotal because without an authorisation to place a medicinal product on the market a pharmaceutical company cannot do more than restrict its operations to internal research and development without proper prospects of gaining a return on the investments made, whether it is the innovator or the replicator. The work analyses the compromises that have been made to ensure a balance between patent protection, development and research on medicinal products and the public health sector, as well as how a workable marketing authorization framework for medicinal products can be sustained.