Royal Decree 1302/2018 of 22 October, amending Royal Decree 954/2015 of 23 October on the indication, use and authorisation for dispensing medicines and medical devices for human use by nurses (hereinafter, "Royal Decree 1302/2018"), was published in Spain's Official State Gazette on 23 October 2018.
Royal Decree 1302/2018 was enacted for the purpose of "clarifying the complexities of interpreting the respective responsibilities attributed to the professions subject to the application of Royal Decree 954/2015 of 23 October", raising the need for harmonious solutions vis-à-vis doctors and nurses "to guarantee patient safety and the continuity of care".
Concerning the latter purpose, Royal Decree 1302/2018 has re-worded the previously controversial Article 3, Section 2, by removing the need for the "prescribing professional to have first of all determined the diagnosis, prescription and clinical guidelines or protocol to follow" and enabling nurses to indicate, use and authorise the dispensation of prescription medicines as part of their professional activity.
However, the above is subject to (i) the clinical guidelines or protocols outlining the specific cases in which a doctor's approval is required prior to the nurse's indication, and (ii) the nurses obtaining the necessary accreditation, i.e. the new regulation requires them to hold a degree or diploma in nursing or be a qualified healthcare assistant or equivalent, evidencing a minimum of one year's experience or the completion of a conversion programme.
Regarding the procedure for nurses to obtain the above-mentioned accreditation, Constitutional Court Judgment no. 76/2018 of 5 July 2018 affirmed that the awarding of such authorisation for nurses to prescribe medicines and medical devices corresponds to the regional governments, while the criteria used to determine how they are accredited falls within the State's remit. Thus, Royal Decree 954/2015 specifies that the accreditation procedure is to be regulated by the regional governments as part of their decision-making authority.
The new Royal Decree also includes a series of transitional provisions relating to the deadline for implementing clinical guidelines or protocols and the procedures already in place. Against this backdrop, it states that "the clinical guidelines or protocols must be approved within two years from the entry into force of this Royal Decree". Meanwhile, "the nurses who have indicated, used and authorised the dispensation of medicines and medical devices for human use in view of the current regional legislation may continue to apply such guidelines and protocols under the terms established in said legislation through which they are permitted to do so".
As regards the advertising of prescription medicines to healthcare professionals, the fourth additional provision of the Royal Decree 954/2015 of 23 October regulation already stipulated that "the references and terms contained within this Royal Decree relating to the persons authorised to prescribe or dispense medicines should also be understood as referring to those able to indicate, use and authorise the dispensation of medicines (...) especially in relation to the advertising of medicines and medical appointments". This wording led to Farmaindustria (the National Trade Association for Spain's pharmaceutical industry) issuing Circular USD/03/16 abolishing the ban on advertising prescription medicines to said collective and assuming that the advertising of prescription medicines to nurses had passed an ethical review.
Nevertheless, from a legal perspective, the new regulation has failed to shed light on the uncertainty surrounding the interpretation of the mentioned provision, in particular which products it relates to and from when will it be possible to advertise prescription medicines to this group of professionals.
Within this context, it could be interpreted that the advertising of medicines to nurses is contingent on the approval of the corresponding clinical guidelines or protocols containing the list of medicines and groups of medication subject to indication, as well as to the subsequent regulatory developments as far as the regional governments' accreditation procedures are concerned. However, neither the objective pursued by the new regulation nor the regulatory progress in this regard – which attempts to foster collaboration across a plethora of disciplines to ensure truly comprehensive healthcare and "patient safety and the continuity of care" – back this notion, even less so when the purpose of the companies' promotional activities is to educate on the properties and method of administration of the medicines which, in essence, benefits the patient.
This article does not represent the professional opinion or legal advice of its author.