Market Access Innovative Agreements Spain

Published on: December 12, 2020

In Spain, market access consists of two phases: (i) the granting of marketing authorisation by the regulatory authority (Spanish Medicines and Medical Devices Agency, “AEMPS”) or the registration in the AEMPS register of products authorised under the EU`s centralised procedure; and (ii) the Ministry of Health`s resolution on pricing and reimbursement (MOH). AEMPS also intervenes to some extent in the pricing and reimbursement procedure by issuing a therapeutic report on which THE MOH relies to decide on pricing and reimbursement. During 2017 (latest data available), 1,450 drug submissions were included in the provision of NHS9. A first business group deals with the interpretation of the conditions provided by Spanish law for the creation of reference price groups. In October 2019, the Spanish Audiencia Nacional had the opportunity to rule on an interesting case with regard to the creation of reference groups where there is no generic drug or biosimilar in Spain12. The applicant submitted that MOH had insufficiently created a reference price group with both submissions, since these submissions were in fact the same drug. The Court of Justice did not share this view and found that the creation of the group had been done correctly by the MOH, since the two presentations for reference pricing purposes had to be considered different products. The Court supported its position by stating that the two submissions had separate marketing authorizations and were marketed under different brands. The Court ignored the fact that the two submissions were part of the same global marketing authorization for data protection reasons. The verdict was appealed to the Supreme Court. A decision on the appeal has not yet been made. We believe that this judgment may be questionable from the point of view of the economic logic of the reference price system.

In this context, we believe that the reason why Spanish legislation considers that reference prices can appear without generics or biosimilars is that at the time of application of this reference price, there should be at least one product on the market that does not take into account the research efforts of the reference product, thus opening the door to competition on prices. , which does not depend on the costs of R D. In this regard, it can be argued that this openness to competition, which does not depend on the costs of research and development, does not occur in situations such as the one described in this case, where two product submissions are owned by the same company and are the result of the same company`s research and development efforts. We are awaiting the opinion of the Supreme Court on this matter. Payers expect the use of innovative price agreements to multiply in Europe. This consensus has been under threat since May 2019, when the General Manager of the Pharmacy issued a report stating that drugs for which a judgment was made expressly denying reimbursement cannot be paid by hospitals or regional authorities.