Análisis del acceso a mercado del Alofisel un medicamento huérfano para la Enfermedad de Crohn

Sainz de Vicuña Cabeza, Santiago José (2020). Análisis del acceso a mercado del Alofisel un medicamento huérfano para la Enfermedad de Crohn. Proyecto Fin de Carrera / Trabajo Fin de Grado, E.T.S. de Ingeniería Agronómica, Alimentaria y de Biosistemas (UPM), Madrid.

Description

Title: Análisis del acceso a mercado del Alofisel un medicamento huérfano para la Enfermedad de Crohn
Author/s:
  • Sainz de Vicuña Cabeza, Santiago José
Contributor/s:
  • Corrionero Pérez, Ana
  • Benito Casado, Begoña
Item Type: Final Project
Degree: Grado en Biotecnología
Date: February 2020
Subjects:
Faculty: E.T.S. de Ingeniería Agronómica, Alimentaria y de Biosistemas (UPM)
Department: Biotecnología - Biología Vegetal
Creative Commons Licenses: Recognition - No derivative works - Non commercial

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Abstract

The objective of this study is to acknowledge the difficulties related with the access to the European market of biotechnology products, such as orphan medicaments. For that purpose, Alofisel, which treats for a specific symptom of the Crohn disease, the perianal fistula, will be used as example of orphan medicament. The method used will follow the next order: a descriptive review of the Crohn disease, prevalence, epidemiology, symptoms and treatments. Next, an examination of the formal process of access to the european market, by the theoretical studying of the different organizations and committees present at the European Union, Spain, regional and hospital in order to authorise the use of orphan’s medicaments. Following, a look at Alofisel process will be carry, in order to learn some of the good practices done, trying to achieve some data about the access to market. The conclusions drawn are the following: There are differences between access to medicines in the European and American frames. While American’s is organized into a single central organization, the FDA, and seeks client protection; the European presents a central body which is the one that authorizes the marketing of medicines throughout the European region, but gives freedom to the different states member to integrate them into their commercial frames. In Spain, the times of access to the market are quite long (approximately 20 months), especially if we compare them with other countries of the European Union such as Germany (3 months) and Sweden (6 months). These long times are due, in large part, to the number of committees and regulatory bodies present at the state, regional and hospital levels. This makes one wonder whether the current system is the most effective for the patient wellness and what we can do to improve it. A proposed solution could be to give flexibility to the financing and price process. This could speed up the entrance processes and decrease the times of access to the market. In relation with Alofisel, this is a novel therapy which uses mesenchymal stem cells (first in class) to treat serious fistulas in patients with Crohn’s disease whom previous disposable treatments have not taken effect. Its quick access to the market may be due to the decision of good strategic criteria, such as identifying a rare disease not covered need or developing a novel product with a clear benefit. Given the great investment in time and money required for the research and development of a drug and that the period of exclusivity granted by the patent only lasts 20 years, it is recommended that research groups and pharmaceutical companies know in detail how the entry access works of medicines and carry out complementary research to identify other factors to consider, such as strategic, commercial and existence or not of competitors, since this would be very useful for them.

More information

Item ID: 64473
DC Identifier: http://oa.upm.es/64473/
OAI Identifier: oai:oa.upm.es:64473
Deposited by: Biblioteca ETSI Agrónomos
Deposited on: 08 Oct 2020 07:07
Last Modified: 08 Oct 2020 07:10
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