Specialized Medications: A New Era for Mexico’s Pharmacies?

Specialized medications are complex treatments used for rare, chronic, or serious diseases, such as cancer, HIV, multiple sclerosis, autoimmune diseases, and leukemia, among others. They are not only expensive, but they also require specialized logistics and careful handling.

Their main features include:

• Centralization in pharmacy chains, primarily due to the high cost of the medications.
• In some cases, a cold chain and strict storage are required to maintain specific temperatures, as any alteration in temperature can compromise a medication's effectiveness.
• Continuous clinical monitoring: Treatment is not simply dispensed; its effect and tolerance are constantly monitored.

What is a 'High Specialty Pharmacy?'

These are establishments with standard operating procedures for safeguarding and dispensing these types of medications:

• They ensure controlled storage when necessary (temperature, humidity).
• They offer timely follow-up on treatment adherence.
• Trained and certified traditional pharmacies are now participating in this market to the best of their ability, incorporating some of these lines.
• Previously, this market was solely for transnational companies. Today, it is opening up to the generic market and a variety of suppliers or distributors that help supply traditional pharmacies that previously did not participate in this market.
• They have a direct relationship with laboratories and distributors, offering their customers rapid access to quotes and competitive prices throughout the country.
• Some of these pharmacy chains carry a wide range of highly specialized medications, including treatments for conditions, such as cancer, multiple sclerosis, rheumatic diseases, and HIV.

How Are These Medications Regulated in Mexico?

Article 226 of the General Health Law establishes the official classifications of medications into six groups:

• Group 1 Narcotics (Controlled)
• Group 2 Psychotropic Substances (Controlled)
• Group 3 Psychotropic Substances (Controlled)
• Group 4 Sale of Prescription Drugs
• Group 5 Free Access
• Group 6 Free Access in Formally Established Locations

And according to the Pharmacopoeia Supplement:

• Pharmaceutical Specialties: preparations authorized by the Ministry of Health):
• Biotechnological: produced using molecular biotechnology techniques.

Many highly specialized medications fall into these categories, especially those that are biotechnological.

Legal Definition and Categorization

The Parliamentary Gazette of April 23, 2019, defines "highly specialized medications" as those that require specialized medical supervision, specific storage, and individualized dosages. Priority diseases include cancer in adults and children.

Additionally, these medications are often associated with cancer treatments that were part of the Catastrophic Expense Protection Fund. (This government fund has unfortunately been eliminated.)

Relevant Institutions 

Advanced Specialty Graduate Programs in Medicine (PAEM) require applicants to have already completed a specialty. These are offered at institutions such as the UNAM School of Medicine, the Salvador Zubirán National Institute of Medical Sciences and Nutrition (INCMNSZ), and the National Rehabilitation Institute, among others.

Regulatory Updates on Oncology Drugs

The National Compendium of Health Supplies, published by the Ministry of Health, records inclusions and modifications of relevant oncology drugs, for example:

• Pembrolizumab (immunotherapy) and Trastuzumab Emtansine (targeted therapy): major modifications in 2022.
• Durvalumab, Pemetrexed, and r-L-Asparaginase: updated in 2024.

This shows that these oncology treatments are officially regulated and considered part of the country's strategic supplies system.

Public Supply and Distribution

In March 2025, a severe shortage of cancer drugs was documented, leading to blockades and public outrage. The transition to IMSS-Bienestar resulted in reduced spending on cancer care (and other conditions), impacting timely care.

Despite efforts, there were also supply interruptions in hospitals, such as the Federico Gómez Hospital, which relied on a supplier that had breached contracts; although, on occasion, vincristine was supplied through new shipments.

Financing

Under the consolidated purchasing model for 2025-2026 for cancer treatments, the government will allocate about MX$123 billion (US$6.6 billion) for cancer treatments, which represents 20% of the total budget for medications and includes the purchase of 25.2 million units.

Opportunities in the Private Market

The growth of the network of private pharmacies and the offices adjacent to pharmacies is strengthening for well-known reasons: proximity, low cost of consultations, care for those in need of medical services, relatively shorter wait times than at the Mexican Social Security Institute (IMSS), and of course, the lack of medications for IMSS BIENESTAR beneficiaries. In the case of highly specialized medications, there is the possibility of expanding the supply in traditional pharmacies due to the number of generics already available and constantly approved by COFEPRIS, as well as the tools that pharmacies currently have, such as the VADEMECUM, which contains the most complete registry of molecules, with more than 4,700 formulas, and the registries authorized by COFEPRIS, which provide information to any purchasing department on pharmaceuticals in our country.