MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
8.4 Cost-Benefit Analyses Previously, the methodology for determining price was quite clear and included cost-benefit analyses. How- ever, it is no longer clear, and it is also not currently clear whether the new administration will be open to exploring value-based proposals. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies The regulatory framework links the rules of prescrip- tion and dispensing with those of substitution at the point of sale. There are two scenarios for the private and public markets. • For the private market, the first rule is that prescrib- ing according to the active ingredient or generic name is mandatory, and that the use of the distinc- tive name or trade mark of the product is optional for health professionals. The second and perhaps most important rule is that if the prescription contains only the generic name, pharmacists are allowed to substitute the product. Conversely, if the product is prescribed under its distinctive name, then substitution at the point of sale is forbidden. • For the public market, although the basic rule structure is the same, there is no reference to the option of prescribing by trade mark – meaning that substitution is always allowed. At the same time, it has also been a long-held practice in the public sector to prescribe using the product code allocat- ed in the national compendium, which is based on the active ingredient as well. There are provisions allowing prescriptions to be made under different conditions, but the relevant institution would need to authorise such decisions, which is not common.
E-prescription is regulated by the applicable legal framework. However, some controversies over the technical requirements regarding healthcare profes- sionals’ e-signatures have hindered the full adoption of e-prescriptions throughout the ecosystem.
204 CHAMBERS.COM
Powered by FlippingBook