“estudio de la comercialización efectiva de medicamentós en españa y la influencia de la regulación del sistema de precios de referencia i otras disposicions de ámbito farmacéutico

Resumen

There are several causes which can affect the initial marketing authorisation conditions during a medicine’s lifecycle, and this can lead to an absence or a lack of supply. For instance, the existence of other competitors, new implementation of regulatory requirements, additional restrictions derived from pharmacovigilance, entries of generic medicinal products, or simply, a decrease in demand due to obsolescence. All of these circumstances ultimately affect marketing viability for certain products, leading to their disappearance from a market which is constantly changing. However, when this situation affects products that are still crucial for treating certain diseases, the lack of availability poses a conflict that has an effect on patients and healthcare professionals, reducing treatment options and damaging the pharmaceutical industry’s image because the MAH is blamed for the fact that the medicine can no longer be used by patients and health professionals. The fact that it is still necessary to guarantee the availability of certain products and, more precisely some presentations, denotes that further development of Spanish regulation seems necessary in order to ensure the commercialisation of these products with high healthcare interest but low economical interest. Spanish legislation refers to “medicinal products without commercial interest” (hereon in MPWCI) as those where there is an absence, or shortfall, of supply within the Spanish market, yet are still required to treat certain diseases or pathologies. In this thesis, the main aim is to answer whether there is a group of marketed products that could be considered MPWCI; a legal category of medicines described but not developed in Spanish legislation. An identification of these types of products is suggested, the description of their characteristics, the main causes that threaten their marketing viability and several considerations regarding the need to develop regulations for this matter in Spain.