On 14 July 2021, the Spanish Ministry for Health, Consumer Affairs and Social Welfare (Ministerio de Sanidad, Consumo y Bienestar SociaI) published the draft of the new Reference Price Order. The ministry must update the reference price of the medicinal products annually. This new draft updates the reference prices set forth in the previous orders, establishes new groups and removes those that do not meet all of the applicable requirements due to supervening causes. To be included in a specific reference group, medicinal products must have the same Level 5 ATC code and an identical administration route. Interested parties have 15 days to allege what they deemed convenient for their best interests. The deadline is 4 August 2021.
The ATC 5 criteria apply to this new order due to the amendment that entered into force on 1 January 2021 with respect to Article 98.2 of the revised text of the Law on Guarantees and Rational Use of Medicines and Medical Devices, as approved by Royal Legislative Decree 1/2015 of 24 July. It is well known that, up until this point, the reference pricing system consisted of groups of financed medicines (those meeting specific requirements) with the same active ingredient and the same route of administration. This legislative change was the result of a legal dispute between a number of laboratories and the Ministry of Health, which ended in victory for the laboratories. However, as the saying goes, “if you don’t like something, change it,” and this is precisely what the government did with this legislative modification.
The fact is that since 2014, the year in which the current reference pricing system was implemented, the Ministry of Health had already been creating reference groups based on ATC 5, rather than on the active ingredient as required by regulations (the prior wording of Article 98.2 of the law on guarantees). The rationale — a simple one — for creating the groups under ATC 5 was that more medicines would be included in the reference pricing system and, consequently, their price would be reduced. This is due to the fact that ATC 5 is a classification carried out by the World Health Organization for statistical purposes, in order to gauge consumption patterns, and is therefore not as precise as identifying the active ingredient, which is based on technical grounds. As it is more generic in nature, medicines with different active ingredients may be under the same ATC 5. Precisely for this reason, the World Health Organization itself advises against using ATC 5 for medicine financing purposes.
Every year, the various Price Orders created on the basis of ATC 5 are challenged by a number of laboratories affected by this incorrect application. Our team has represented several laboratories challenging Orders 2014 to 2018 (both included) on this point, which in all cases ended in rulings in their favor.
Given that the Ministry of Health lost the legal dispute, it had to rectify its position and the 2020 Order was the first to be drawn up in accordance with regulations, creating groups based on the active ingredient. Nevertheless, this new order has now been created again following the ATC 5 criteria, based on the legislative changes explained above.
For informational purposes, Schedule 1 of the draft includes reference groups of presentations of medicinal products sold via pharmacy offices; in particular, reference groups with numbers F1 to F460 are new reference groups. On the other hand, Schedule 2 includes reference groups of presentations of medicinal products for hospital use and in clinical packaging; in particular, reference groups with numbers P1 to P154 and S1 to S101 are new reference groups. In addition, Schedule 4 sets out the reference groups of medicinal products that have been deleted. Lastly, Schedule 7 determines the presentations of medicinal products that were effectively included in the benefits provided by the Spanish Health National System after 9 April 2021, defining the reference groups and the reference prices that will apply to them.
For further information, please contact Montserrat Llopart and Elisabet Cots of our Barcelona office.