Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs
Wide public access to the 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 strength...
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| Format: | Article |
| Language: | Polish |
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Polish Pharmaceutical Society
2022-07-01
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| Series: | Farmacja Polska |
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| Online Access: | https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2022%2F5%2F03_OG_Ocena_innowacyjnosci_n.pdf |
| _version_ | 1811262099502923776 |
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| author | Małgorzata Sznitowska Monika Lamparska-Przybysz |
| author_facet | Małgorzata Sznitowska Monika Lamparska-Przybysz |
| author_sort | Małgorzata Sznitowska |
| collection | DOAJ |
| description | Wide public access to the 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 the 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 a new or improved technology, and incorrect identification of an 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 competences at the interface between science and business, and the development of technological competences. |
| first_indexed | 2024-04-12T19:19:17Z |
| format | Article |
| id | doaj.art-3c099868148d40d9b32764af64968ddc |
| institution | Directory Open Access Journal |
| issn | 0014-8261 |
| language | Polish |
| last_indexed | 2024-04-12T19:19:17Z |
| publishDate | 2022-07-01 |
| publisher | Polish Pharmaceutical Society |
| record_format | Article |
| series | Farmacja Polska |
| spelling | doaj.art-3c099868148d40d9b32764af64968ddc2022-12-22T03:19:39ZpolPolish Pharmaceutical SocietyFarmacja Polska0014-82612022-07-0178526326710.32383/farmpol/152081152081Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programsMałgorzata Sznitowska0https://orcid.org/0000-0003-0866-0452Monika Lamparska-Przybysz1https://orcid.org/0000-0002-7296-7400Katedra Farmacji Stosowanej, Gdański Uniwersytet Medyczny, PolskaPolpharma, PolskaWide public access to the 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 the 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 a new or improved technology, and incorrect identification of an 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 competences at the interface between science and business, and the development of technological competences.https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2022%2F5%2F03_OG_Ocena_innowacyjnosci_n.pdfgeneric medicinal productinnovationresearch and development |
| spellingShingle | Małgorzata Sznitowska Monika Lamparska-Przybysz Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs Farmacja Polska generic medicinal product innovation research and development |
| title | Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs |
| title_full | Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs |
| title_fullStr | Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs |
| title_full_unstemmed | Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs |
| title_short | Evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the R&D support programs |
| title_sort | evaluation of the innovativeness of the domestic pharmaceutical sector projects within the framework of the r d support programs |
| topic | generic medicinal product innovation research and development |
| url | https://www.ptfarm.pl/download/?file=File%2FFarmacja+Polska%2F2022%2F5%2F03_OG_Ocena_innowacyjnosci_n.pdf |
| work_keys_str_mv | AT małgorzatasznitowska evaluationoftheinnovativenessofthedomesticpharmaceuticalsectorprojectswithintheframeworkoftherdsupportprograms AT monikalamparskaprzybysz evaluationoftheinnovativenessofthedomesticpharmaceuticalsectorprojectswithintheframeworkoftherdsupportprograms |