On 13 January 2021, the Spanish National Commission for Markets and Competition (Comisión Nacional de los Mercados y la Competencia - CNMC) launched a public consultation in the framework of a study on the competition conditions in the commercialisation and wholesale distribution of medicines sector. The study focuses on medicines dispensed through high-street pharmacies, rather than medicines dispensed through hospital channels. This study is conducted as a continuation of the analysis carried out in study E / CNMC / 003/15 on the retail distribution market for medicines in Spain, published in October 2015.
The scope of the study could be very important due to its regulatory, business and competition implications. Although its title refers to the "commercialisation and wholesale distribution" of medicines dispensed in pharmacies, the main questions in the consultation do not refer to the distribution of those medicines as such, but to the key economic aspects, in connection with setting the prices of innovative medicines and their generics or biosimilars along with competition conditions in the market. Therefore, the study addresses aspects such as:
- the impact of the economic evaluation on the pricing of innovative medicines;
- the conditions for effective competition between innovative medicines and their generics or biosimilars, such as whether incentives are necessary for the latter or whether the relationship between the price of the innovative medicine and the initial price that is set for the generic or biosimilar is adequate;
- the advantages and disadvantages of both the reference price, a homogeneous grouping system and the selected pricing system; and
- the risk that high-value medicines will leave the market due to the lack of profitability upon the expiration of their patents.
Regarding the questions that actually refer to wholesale distribution and dispensation in high-street pharmacies, very important aspects are also included, among which the following are noteworthy:
- whether the distribution remuneration (the wholesale margin) is sufficient and possible alternatives to this system;
- advantages and disadvantages of a return system for the discounts obtained in the distribution chain (clawback) to the SNS; and
- the prohibition of the vertical integration of wholesalers and pharmacies and the exceptions (the “traditional” cooperatives).
Answers to the consultation can be sent by 12 February 2021.