The deadline to submit allegations is 27 September 2022

In brief

The Spanish Ministry for Health, Consumer Affairs and Social Welfare have published the Draft of the Reference Price Order of 2022 with the aim of updating the reference prices set forth in previous orders, establishing new groups and removing those that do not meet the applicable requirements. The deadline for interested parties to submit allegations is 27 September 2022.

In more detail

On 6 September 2022, 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 yearly update the reference price of the medicinal products. Therefore, this new Draft updates the reference prices set forth in the previous orders establishes new groups and removes those which do not meet all applicable requirements due to supervening causes. Note that in order to be included within a specific reference group, medicinal products included in such reference group must have the same Level 5 ATC code and identical administration route. Interested parties have fifteen working days to allege what they deem convenient for their best interests. The deadline is 27 September 2022.

Note that, as was the case with the previous Order, the ATC 5 criteria apply to this new Order due to the amendment 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. It should be pointed out that 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 former, but 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 the aforementioned Article 98.2 of the law on guarantees). The rationale - a simple one - for creating the groups under ATC 5, was that a higher number of 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 have been challenged by a number of laboratories affected by this incorrect application. Our team has represented several laboratories challenging Orders 2014 to 2019 (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, now this new Order, together with that of 2021, has been created again following the ATC 5 criteria, based on the legislative changes explained above.

For information purposes, a total of 30 new reference groups have been created. On the one hand, Schedule 1 of the Draft includes reference groups of presentations of medicinal products sold via pharmacy offices; in particular, reference groups with numbers F461 to F471 are new reference groups. On the other hand, Schedule 2 includes reference groups for presentations of medicinal products for hospital use and in clinical packaging; in particular, reference groups with numbers P154 to P171 and S102 are new reference groups. In addition, Schedule 4 sets out the 24 reference groups of medicinal products that have been deleted. Lastly, Schedule 7 determines the presentations of medicinal products that were effectively included within the benefits provided by the Spanish Health National System after 28 April 2022, defining the reference groups and the reference prices that will apply to them.