Judgment_paragraph 62 · Novartis Europharm Ltd v European Commission (T-472/12)

62Article 10(1) of Directive 2001/83 — which provides for the possibility of derogating from the requirement laid down in Article 8(3)(i) of that directive to provide the results of pharmaceutical pre-clinical tests and clinical trials for the purpose of obtaining marketing authorisation for a medicinal product, if the applicant can demonstrate that the medicinal product that is the subject of the application is a generic of a reference medicinal product which has been authorised within the European Union and the regulatory data protection period has expired — seeks to reconcile, on the one hand, the provision of adequate protection for the research and development work undertaken by innovative pharmaceutical companies and, on the other, the wish to avoid excessive testing on humans and animals. Thus, according to recital 9 in the preamble to Directive 2001/83, ‘it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorisation for a medicinal product which is essentially similar to an authorised product, while ensuring that innovative firms are not placed at a disadvantage’, whereas recital 10 states that ‘there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause’.