The Ministerial Order No. SSI/1225/2014, which was approved on July, 10, 2014 and published in the Official State Gazette of Spain (BOE) on July , 15, 2014, (hereinafter “the Order”) develops the new reference price system for medicines which was put in place by Royal Decree 177/2014, dated March 21.
The Order has been approved by the Ministry of Health after a long prior deliberation process in which pharmaceutical laboratories have been involved and where they have raised their complaints and voiced their disagreement with the projected regulation, which has however eventually been enacted without major modifications.
The Order is of great importance since it directly affects the prices and the terms of public financing of the medicines by the National Health System “NHS”). It creates the “reference groups”, composed of branded or innovative medicines together with generic and biosimilar products having a similar active ingredient and identical way of administration, as contemplated by the Royal Decree, and it sets forth the reference price (the maximum amount of financing received by a medicine under the NHS) of each product included in a group. In setting those new groups and reference prices the Order implements the provisions of Royal Decree which sets forth the principles governing the creation of the reference groups (e.g. the medicines which are part of the group must be actually commercialized) as well as those governing the calculations of reference prices (e.g. calculation of reference price is made on the basis of the lowest cost/treatment/day of the products, there is a minimum threshold price of 1.6 euro, etc.)1.
One of the most controversial issues of the Order (and of the Royal Decree which sets forth the framework which the Order develops) has been the creation of reference groups for biosimilar medicines. Those groups receive the same treatment as generic medicines. Leaving aside the issues concerning the economic impact arising as a result of the creation of the groups in those cases where there is biosimilar product, the issues which have raised most criticism have been (i) that biosimilar medicines receive the same treatment that the generics for purposes of the creation of groups when in fact it is impossible to think about similarity in the active substance of biological products, (ii) the lack of parameters to determine a comparable defined daily dose for these biosimilar medicines and (iii) the non-interchangeability of the biosimilar medicines.
With regard to the argument on the interchangeability mentioned above, it should be noted that interchangeability is a feature required for medicines to be part a homogeneous group- “agrupación homogénea”-, but it is now not a legal requirement for creating a reference group (“conjunto de referencia”). In other words, unlike in the case of homogeneous groups, it is possible to include in the same reference group (“conjunto de referencia”) non interchangeable medicines, which are those medicines that could not be replaced by others for being dispensed to the patient.
An explanation for this different treatment between homogeneous groups and reference groups is that the two are not the same and each of them operates at different levels: the reference groups are set forth for the purposes of determining (and lowering) the maximum price to receive for medicines under public financing from the NHS. However, the reference price system is not relevant in order to the dispensing of medicines to patients: it is at the level of dispensation that operate now the homogeneous groups- “agrupaciones homogéneas” (groups of financed medicines, dispensed in pharmacies, having the same active principle, dose, contents, pharmaceutical form and method of administration, which are interchangeable). For those homogeneous groups there is a “lower price” determined by the authorities based on the lowest product price (which is revised every quarter) and thereafter there is the possibility for voluntary reduction of prices: with this system the decrease of prices is incentivized since the law also provides for dispensation obligations on the pharmacists in favor of the medicines of the homogeneous group having the lowest prices.
The configuration of the reference groups (“conjuntos de referencia”) is another controversial aspect of the Order. In this regard, it is claimed that the Ministry has configured some reference groups with medicines having different active substances, a configuration which would be contrary to Section 93 paragraph 2 of the Medicines Law (Law 93/2006) and Section 3 of the Royal Decree 177/2014, which provide that medicines of a same reference group must have the same active substance.
The result of the Order has been an important reduction in reference prices and as a result a pressure over the medicines prices, which as mentioned above must be lowered to reach the reference price.
Finally it should be mentioned that some claims have been brought by Pharmaceutical companies against the Order.
Initiative requiring the Government for a regulation for biological medicines
It is also worth noting that since the regulation about biological and biosimilar products currently in place is very partial and even sometimes contradictory, the Congress Health Commission approved in June a non-legal proposal calling on the Government to come up with a specific regulation in this matter.