Reintroducing Phage Therapy in Modern Medicine: The Regulatory and Intellectual Property Hurdles
Daniel De Vos, Gilbert Verbeken, Carl Ceulemans, Isabelle Huys and Jean-Paul Pirnay
from: Phage Therapy: Current Research and Applications (Edited by: Jan Borysowski, Ryszard Międzybrodzki and Andrzej Górski). Caister Academic Press, U.K. (2014)
Antibiotic resistance is a life-threatening problem worldwide and the industrial pipeline is dry. Other therapeutic options are needed and one of them is 'phage therapy'. Bacteriophages, phage in short, have proven to be effective in combating (multidrug-resistant) bacterial infections. However, legal obstacles and intellectual property rights are impeding the implementation of phage therapy in modern medicine and triggering ethical discussions. Worldwide, medicinal product regulations are directed towards standardized marketing authorization for 'classical' medicinal products. But phage are of a different nature than antibiotics on which most of our current regulation is based. Phage therapy is not covered by a specific regulatory pathway. Exceptions defined under the medicinal products legislation do not include the idea of phage therapy. Another hurdle is the Intellectual Property issue. Owning patents is essential in our current industrial economic model. But natural phages are evolving biological lifelike entities and thus difficult to cover by patents. In the future the adapted legal framework should allow the coexistence of a "sur-mesure" pathway beside a "prêt-à-porter" road. Taking into account the sustainability concept, all relevant safety measures and quality production controls, the "sur-mesure" pathway should enable the use of the most fruitful and efficiency based phage therapeutic approach at regional or hospital level read more ...