- The National Compendium of Health Supplies is the document that groups all drugs and healing materials authorized for use in Mexico.
- The new version has caused controversy because it eliminates the participation of the National Chamber of the Pharmaceutical Industry.
- Now the process to request the discharge of new medications could be longer.
During the past year, new regulations were issued for the listing of pharmaceutical products within the National Compendium of Health Supplies, formerly known as the Basic Table. These rules will directly impact the process for registering new medications.
The Compendium is the document in which medicines, healing material, instruments, medical equipment, diagnostic aids, nutrition supplies, homeopathic medicines, herbal medicines, acupuncture supplies, osteosynthesis material, endoprosthesis and functional aids are grouped, characterized and codified. Public institutions must adjust to this Compendium in order to provide the service to the population.
Modifications in the process to approve new medicines
The new regulation eliminates the participation of the National Chamber of the Pharmaceutical Industrya representative of the Ethics Council of the Pharmaceutical Industry and a representative of the National Chamber of Transformation Industries, together with other participants from the private sector, such as patient groups.
With this change, to include a new product, companies must submit: an analysis of the impact on the overall procurement budget and the maximum price for any sale to the public sector. In addition, an official communication issued by a hospital or public institution in the health sector, justifying the need to update the compendium.
“Some of the adjustments to the regulations will be of great help for institutions and companies related to the health sector. For example, economic analysis is relevant, as it will be of vital importance if innovative access models are offered. The maximum price is a necessary clarification, since the previous regulations only referred to ‘unit prices’ and did not clarify whether lower prices could be offered,” said Juan Luis Serrano, partner in the firm’s Life Sciences practice area. Sanchez Devanny.
Another requirement is that an innovative drug, despite being approved, must be submitted to a specific institution to start the inclusion process. In addition, with the new regulations, the obligation to hold an annual meeting of the commission and monthly meetings of its subcommittees is eliminated. However, this modification may cause delays in the approval process.
Similarly, two exceptions are established, in order to include supplies without adhering to the criteria of the supply evaluation guide, which are health emergencies, and when there are opportunities for priority acquisitions to address a health problem.
If the meetings of the Commission are held, they may be held virtually, it is also indicated that the compendium will be published every six months and the specific deadlines within a calendar year for submitting requests to update the compendium are eliminated. Applications can now be submitted at any time.
The initial request will be subject to a tacit affirmative response period of 15 days in relation to the supporting documents. This term does not imply an approval, just that the review process will take place.
Other recent settings
Health institutions may now request minor modifications, in the same way public institutions may acquire any supply of the compendium, according to their needs.
Although some changes will be beneficial for the population, others could cause delays and problems for pharmaceutical companies and health institutions. And therefore, they could result in litigation, as seen in the past, some examples of what has been presented are:
- Judicial challenges against denials of product inclusion, when based on budgetary considerations and not on the lack of technical information.
- Challenges against the inclusion of therapeutic alternatives.
- Challenges related to the differences between the national compendium and the specific forms of the institutions.
- Challenges related to medicines not included in the National Compendium.
These new rules are part of the various changes that the current government has made to modify the Health system.
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