Aspects to be considered in the future regulation on public financing and prices of medicinal products

Drafting the new Royal Decree on financing and price of medicinal products is, without question, a complex process. The two documents to which we refer in this article bring valuable ideas that should be considered in future regulations.

Transparency

It is particularly convenient to talk about transparency. The Spanish National Commission for Markets and Competition (NCMC) points out in its Report that the procedure that is currently being followed for deciding about the inclusion of a product in the pharmaceutical coverage provides too much discretion to the decision on how the pre-selected criteria will be applied and the possible preference of some products over others.

In this regard, the NCMC criticizes the fact that the reasoned decisions of the prices fixed are not published. In our opinion, it would be convenient to at least ensure that those decisions are fully reasoned. So far, the only reasoning offered is a brief reference to an article of the Law. For instance, reimbursement is denied by simply pointing out that there are other therapeutic alternatives for the same diseases at a lower price or at lower cost per treatment. However, it is not explained which are these alternatives or how the cost of the treatment has been calculated in order to come to that conclusion, which may leave interested parties defenseless.

Europe, always Europe

On the other hand, the judgment in the Servier case recalls that the provisions of the Directive aim to ensure that any national measure controlling prices or public financing of medicinal products must meet the requirements set out by it. According to the Court, in order to ensure the effectiveness of the rule it is necessary that the interested parties are able to check that the decisions on this matters respond to objective criteria. Furthermore, the Court adds that the Directive seeks to obtain an overall picture of national agreements on price fixing, including all the criteria on which they are based. It also seeks to provide public access to such agreements for all the ones who intervene in the market of medicinal products.

In its judgment, the European Court recalls that the European Law requires for products coming from other Member States not to be discriminated against national medicinal products. In this regard, the NCMC noted in its Report that future regulations should review the reference of the contribution that medicinal products make to the gross domestic product, because it introduces in the system a “possible discriminations based on the origin of products coming from an uncertain trajectory”.