The pharmaceutical industry is one of the most publicly regulated activities. At the same time, although it is a competitive, thriving and global industry, it receives significant public support from supranational, national, public and private organisations. State aid is not specifically regulated in EU law. They mostly fall within the framework of aid for research and development. The application of these rules to the pharmaceuticals sector, however, has many peculiarities. Many aids are granted by the EU and are therefore not state aid. In addition, public regulations on the development and trade of medicines must be taken into account, as well as the difficulty of making certain notions of research and development commensurable with research on medicines. The public authorities can also support the pharmaceutical industry by purchasing research services and pre-purchasing medicines that are yet to be produced. These solutions were practised by the Union during the pandemic period to promote the development of vaccines. The expansion of the Union's supporting role in the production of medicines should perhaps also be matched by a better tailored aid discipline of the Member States.
L’industria dei medicinali è una delle attività maggiormente sottoposte a regolazioni pubbliche. Al contempo, pur trattandosi di un’industria competitiva, florida e globale, essa riceve significativi aiuti pubblici da parte di organizzazioni sovranazionali, nazionali, pubbliche e private. Gli aiuti concessi dagli Stati non hanno una disciplina specifica nel diritto UE. Essi ricadono per lo più nel quadro degli aiuti alla ricerca e allo sviluppo. L’applicazione di tali regole al settore dei farmaci ha però molte peculiarità. Molti aiuti vengono sono concessi dall’Unione europea e dunque non sono aiuti di Stato. Occorre poi tenere conto delle regolazioni pubbliche sullo sviluppo e sul commercio dei medici- nali e della difficoltà di rendere talune nozioni caratteristiche della ricerca e sviluppo commensurabili con la ricerca sui medicinali. I poteri pubblici possono sostenere l’indu- stria dei medicinali anche acquistando servizi di ricerca e pre-acquistando medicinali ancora da produrre. Queste soluzioni sono state praticate dall’Unione nel periodo della pandemia, per promuovere lo sviluppo dei vaccini. All’espandersi del ruolo di sostegno dell’Unione alla produzione dei medicinali, dovrebbe forse corrispondere anche una disciplina degli aiuti degli Stati membri meglio calibrata sul settore.
AIUTI DI STATO E INDUSTRIA DEI MEDICINALI
giuliano fonderico
2021-01-01
Abstract
The pharmaceutical industry is one of the most publicly regulated activities. At the same time, although it is a competitive, thriving and global industry, it receives significant public support from supranational, national, public and private organisations. State aid is not specifically regulated in EU law. They mostly fall within the framework of aid for research and development. The application of these rules to the pharmaceuticals sector, however, has many peculiarities. Many aids are granted by the EU and are therefore not state aid. In addition, public regulations on the development and trade of medicines must be taken into account, as well as the difficulty of making certain notions of research and development commensurable with research on medicines. The public authorities can also support the pharmaceutical industry by purchasing research services and pre-purchasing medicines that are yet to be produced. These solutions were practised by the Union during the pandemic period to promote the development of vaccines. The expansion of the Union's supporting role in the production of medicines should perhaps also be matched by a better tailored aid discipline of the Member States.File | Dimensione | Formato | |
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