Some of these allegations come from the General Council of Physicians (CGCOM), which has presented a series of proposals to the Ministry of Health. Thus, the CGCOM points out that «this law should focus on medications and healthcare products and not on medical prescription,» as it believes that «crucial modifications are being introduced in the competencies of the different healthcare professions that deviate from the set objectives.»
Therefore, the CGCOM states that the current draft «not only would not improve the well-being of patients, but would also jeopardize their clinical safety.» Thus, they indicate that medical prescription «is not an administrative act» and, in their opinion, this draft «introduces confusion about who prescribes, supplies, dispenses, indicates, or authorizes a medication and dilutes the responsibility that should be clearly assigned to each professional.»
In this sense, the Medical and Practitioner Union of Madrid (SIME), affiliated with CSIT Unión Profesional, requests in its allegations to preserve medical prescription as a «specific and inherent» competence of medical personnel. Likewise, it proposes to condition any future authorization for non-medical prescription to a «specific normative development,» detailing the training requirements, protocols, and competency limits, «thus avoiding ambiguities and legal uncertainty.»
Additionally, SIME calls for the establishment of mechanisms for the periodic evaluation and supervision of medication use by non-medical personnel, involving multidisciplinary pharmacotherapy committees.
On the other hand, the Madrid Society of Family and Community Nursing (SEMAP) has proposed to establish a «specific and updated» competency framework for nurse prescription within a maximum period of 6 months. «It is requested to replace the Third Additional Provision with a Transitory Provision that clearly defines the prescribing framework of each professional category, including autonomous and collaborative prescription by nurses,» they emphasize.
Likewise, they request the recognition of nursing diagnosis and advocate for the elimination of the exclusive concept of medical diagnosis. They also demand to replace expressions like «medical prescription» or «physician» with «prescription» and «prescriber.»
Furthermore, the Federation of Pharmacy Associations of Catalonia (FEFAC) requests a review of the proposed pricing system, as well as a review of the current deductions system. They also call for the pharmacist to reserve the substitution capacity in dispensing, «as an accredited healthcare professional rather than the citizen.»
BIOSIM ALLEGATIONS
The Spanish Association of Biosimilar Medicines (BioSim) has conveyed a series of proposals to the Ministry of Health with the aim of ensuring that the regulations take into account the particularities of biosimilar medications.
BioSim requests the maintenance of biosimilar prescription by their commercial name, accompanied by their common name, which «allows the patient to identify the active ingredient they are using.» «As they are biological medications, this measure is essential to ensure treatment traceability and safety,» explains the Association.
The association has reiterated the importance of monitoring the prescription made by the doctor. «Biosimilar medications, due to their biological nature, are administered parenterally, and therefore require much more complex handling than an oral medication,» BioSim points out.
BioSim has also requested the elimination of Article 116 on the Selected Price System, considering that «the current wording represents an unpredictable and volatile scenario that could lead to supply problems. This system may mean that the same product is in different funding situations every six months, which will logically affect the consumption of the medication and therefore production forecasts.»
Other proposals presented by the Association relate to the exclusion of biosimilar medications from orphan drugs and those considered strategic from the reference price system.