Małgorzata Sznitowska, Monika Lamparska-Przybysz

Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs
2022-07-15

Wide public access to effective and safe medicines has always been a priority for the Member States of the European Union, which was particularly noted during the Covid-19 pandemic. The European Commission has developed and adopted a Pharmaceutical Strategy which provides for actions to strengthen the competitiveness of generic and biosimilar medicines. The development of new generics and biosimilars is resource intensive and companies have a right to expect public support. So far, such support has been obtained in Poland almost exclusively for research on the development of original drugs. The risk of failure of an original drug development project is very high and very few such drugs are produced worldwide, and virtually no original drug has been developed in Poland, at least in the last four decades.

Companies receive support for innovative activities through competition procedures, based on the evaluation of a panel of experts. In order to support the development of generic medicines, it is essential that the innovation related to this category be properly understood by the experts evaluating R&D projects. The guidelines contained in the Oslo Manual 2018 recognized in the European Union are of key importance. This article presents the pitfalls that have so far influenced the inappropriate perception of innovation by the experts and the public. The following were indicated: mistakenly equating innovation with a patent and not with implementation, incorrect identification of an original drug with an innovative drug, mistakenly equating an innovative drug only with new or improved technology, and incorrect identification of innovation with a product and not, for example, with a process.

The characteristics that determine the innovativeness of generic drugs according to the definition of the Oslo Manual 2018 include affordability, meeting the needs of patients and the health care system, as well as improving medicines used in medical treatments. According to this definition, a new generic medicine may be innovative, as innovation should be defined as any implementation resulting in a significant economic and / or social impact, manifested on the one hand by meeting the needs of patients and, on the other, by increasing the competitiveness of companies that have taken the risk of developing innovative products. Other important benefits of generics innovation are the expansion of competencies at the interface between science and business, and the development of technological competencies.

Keywords: generic medicinal product, innovation, research and development.

© Farm Pol, 2022, 78(5): 263–267