Vaccines for minor use and minor species (MUMS)--industry's views.

Abstract

Over the past 30 years the importance of vaccines for minor use and minor species has changed for multinational animal health companies. The major reasons for this are being reviewed, with a particular focus on technical, financial and business aspects. Key regulatory obstacles to the development of new products for minor uses and minor species are identified, and examples of vaccines falling into the various categories are provided. A number of proposals are offered with the intention of resolving the medicines availability problem between all the stakeholders involved. Finally, based on the presented scientific and regulatory considerations, ideas are shared as to where the legal and economical framework would need to change to reach a viable solution.