On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. Article 3(3) allows the government to implement certain economic measures with respect to medicines aimed at treating rare or infrequent diseases. The new measure is intended to encourage investment in the research, development, and subsequent marketing of orphan medicinal products and, therefore, guarantee its supply, which will hopefully result in better results for people suffering from rare or infrequent diseases.

According to the press release accompanying the Council of Ministers' meeting, this measure consists of ensuring that orphan medicinal products included within the Spanish National Healthcare System (SNS) portfolio enjoy a specific and separate economic regime from that governed by the reference price system, which is applicable to other medicinal products reimbursed by the SNS when their patent has expired.

The purpose of the reference price system is to make the pharmaceutical provision more efficient by containing the prices of medicinal products reimbursed by the SNS and encouraging the use of generics. In short, adjusting the price of medicinal products that have ceased to be an innovation because their patents have elapsed provides savings to the SNS. As a result, excluding orphan medicinal products from the reference price system – and therefore making them more attractive from a price perspective – encourages investment, development, and subsequent marketing of the same.

For an orphan medicinal product to be included in this new pricing scheme (about which information is presently unavailable), there must be no medicinal product with the same authorized indication reimbursed by the SNS. In that event, such orphan medicinal products must provide a significant clinical benefit.

We hope to have additional information in the coming weeks and expound upon on this significant agreement, which bears particular import for the orphan medicinal products industry.