Analyzing New National Health Supplies Compendium Laws

In Mexico, the process of access to innovative pharmaceutical products is subject to listing in the National Health Supplies Compendium (formerly named the Cuadro Básico). New regulations were issued in November 2022, which will impact the process of listing new products – and are thus highly relevant for  accessing departments in charge of  pharmaceutical products. In this article, we will look at the most relevant changes derived from these regulations.

1. The new regulations eliminate the participation of the National Chamber of the Pharmaceutical Industry, a representative of the Ethics Council of the Pharmaceutical Industry and a representative of the National Chamber of Transformation Industries, along with other participants of the private sector, such as patient groups. 

This change is in line with other decisions taken by the current federal administration where contact with private companies and associations has been severely limited. 

2. In order to include a new product, companies must now present:

• Analysis of impact to the overall budget for acquisitions.

• Ceiling price for any sales to the public sector.

• An official communication issued by a public hospital/institution of the health sector, justifying the need for the update of the compendium.

Economic analysis has always been relevant, and will be of paramount importance if innovative access models are offered.  The ceiling price is a needed clarification, since the prior rules only referred to “unitary prices” and did not clarify whether lower prices could be offered.

The last requirement is an additional step; it is not enough for an innovative drug to be approved, but companies must now present it to a specific institution in order to begin the process of inclusion.

3. The obligation to have a yearly meeting of the commission, and monthly meetings of its sub-committees is eliminated. This modification may cause delays in approval proceedings.

4. Two exceptions are established, in order to include supplies without adhering to the criterion in the guidelines for evaluation of supplies:

• Sanitary emergencies. 

• When there are opportunities for priority acquisitions in order to address a sanitary problem.

5. Commission meetings can formally take place remotely.

6. The Compendium will now be published bi-annually (as opposed to the former yearly basis). 

7. Specific time-periods within a set calendar year in order to present applications for update of the compendium are eliminated. Applications can now be filed at any time.

8. The initial application is subject to a 15-day tacit affirmative response period regarding supporting documents; this term does not imply an approval, but only that the review process will take place. 

9. Health institutions can now request minor modifications.

10. Participation of the National Center of Technological Excellence in Health is eliminated from the regulations. 

11. Public health Institutions can acquire any supply in the compendium, but are not obligated to acquire all supplies; the new regulations establish that they can acquire based on specific needs. 

We will now look at four different litigation scenarios that have taken place in the past and may happen again under the new regulations:

• Judicial challenges against refusals to include products.

As with any other administrative decision, determinations by the Commission refusing inclusion of new products – or eliminating existing ones – are subject to challenges. These challenges usually refer to cases where the refusal is based on budget considerations, and not where  technical information is lacking.

• Challenges against inclusion of therapeutic alternatives.

Article 41 of the Federal Acquisitions Law allows as an exemption to public tenders the acquisition of patented products where technically acceptable substitutions exist. This same principle has been used in the past to include biosimilar products, or others considered as therapeutic substitutes. 

These inclusions have been challenged by companies holding the marketing authorizations for the initial products. 

In similar fashion, challenges have been filed associated with the inclusion of products considered as invading patent rights. 

• Challenges related to differences between the national compendium and specific formularies of institutions.

In addition to the national compendium, institutions like the Mexican Institute of Social Security (IMSS) and the Institute for Social Security for Government Employees (ISSSTE) have specific formularies, which may not be coincident with the National Formulary.  Due to this, some patients have brought forth judicial actions to challenge refusal to provide a drug that is not included in a specific formulary.

• Challenges related to drugs not being included in the national compendium.

Judicial precedents in these cases have not ordered immediate acquisition: Under jurisprudence issued by the Supreme Court in 2020, a detailed analysis is required.  

In this jurisprudence, the Court reviewed a case where a patient had been prescribed by a private physician with a drug that was not included in the National Formulary, and the patient was refused the drug by a public institution.  

The Supreme Court granted a partial injunction, ordering physicians in the public institution to analyze the medical situation of the plaintiff and compare therapeutic alternatives in the Compendium to the prescribed drug.  

These new rules are part of the many changes that the federal government has made to modify the healthcare system. Close follow-up will be important to determine the outcome.