Regulatory Clarity Key to the Provision of Health Services

Q: What are the main shifts made by the federal administration regarding the acquisition of medicines in the public health sector?

A: This federal administration has implemented more substantial changes than any other administration in recent memory. These changes have focused on two main areas: the provision and acquisition of supplies and the provision of health services.

The first change was the decision to no longer work with distributors. All acquisitions of health supplies in Mexico are now made directly with manufacturers, either through bidding processes or direct sales. Before the change, those who participated in tenders were usually distributors, which were in charge of supplying hospitals, warehouses or distribution centers, as well as of collecting payment from the public sector for these procurement contracts. Now, the pharmaceutical industry is no longer working directly with distributors.

The acquisition process was separated into two. Some products would be acquired directly from manufacturers, while others would be acquired through a contract with the UN Office for Project Services (UNOPS). This office coordinates a bidding process to boost the number of participants by reaching out to companies that were not operating in Mexico but could offer their products to the Mexican government. In retrospect, the goal was not achieved. Over 90 percent of the products acquired were bought from the same Mexican companies that have had operations or plants in Mexico for several years.

Q: Regarding services, how have the recent changes impacted the way the public health sector works in Mexico?

A: The decision made to eliminate Seguro Popular led to significant changes because it was an insurer that funded health services at all the public institutions of the National Health Systems. INSABI, another administrative body that administers the existing health services, is very different. INSABI uses a model that is similar to IMSS. Its rules are also not very clear.

Q: How is medicine and supply distribution expected to change as INSABI assumes a new role in the system?

A: The reorganization has not been clear. The only way to achieve clarity is through regulations, laws or rules because it is the way our legal system provides transparency to the patient, letting them know which benefits they are entitled to. Each administrative reorganization causes changes and problems, generating delays in patient care on a daily basis.

Another problem involves patients filing lawsuits when denied medications that have either been approved by COFEPRIS or not been approved by the institution but have been approved by foreign regulators. In these cases, the judiciary has issued contradictory statements regarding the human right to health and the capacity of the state to provide any approved medicine to patients in the public health system.

Q: How has COFEPRIS adopted these recent changes?

A: The commission should ideally approve the drugs/devices that prove to be safe and effective in the most efficient and least bureaucratic way possible, undergoing the greatest controls allowed by law to correct any situation that may generate a health risk. In an ideal scenario, the authority would be efficient and fast on approvals, engaging in continuous communication with the industry, patient associations and other important players.

However, there have been significant delays in drug approval processes in the country as a result of several administrative changes in the operation of the commission. Just this year, COFEPRIS has undergone several personnel changes. The delays have given rise to accusations of corruption within the agency, which further delays COFEPRIS’ operations, generating a bottleneck that only harms the population.  

Q: Mexico is pursuing the approval of a Digital Health Law. As someone who collaborates with clients on this subject, what are the primary expectations from the industry?

A: The sector is very interested in this law because of its potential for the development of new technologies or the provision of services with them. The problem is that if these emerging technologies are not regulated, they can generate health risks by integrating into the system without knowing what standards they have to meet. There is a risk that when the authority starts regulating this sector, it will force companies to take their products off the market.

Q: How is Mexico supporting medical devices companies that seek proper recognition in Mexico’s General Health Law?

A: Other jurisdictions are developing advanced regulations at the same pace as innovation is introduced to the market. Mexico’s current regulations for medical devices are similar for all of them, whether they are syringes or AI-powered devices. It is essential for the regulator to recognize the existence of new technologies, to evaluate how they are being regulated in other jurisdictions and provide certainty both to the company selling them and to the service provider.

The FDA, for example, is working hand in hand with the industry to create regulations linked to the use of technology.

Q: The current regulation bans the use of vaping devices. How is this changing the market and the availability of these products in Mexico?

A: The worst thing authorities can do is to implement a public health policy banning a product without effective enforcement and campaigns to generate awareness about the health risks that the product causes. With these vaping devices, the ban could create a gray or black market for them. It is always better to have a robust regulation with strict standards that are clearly communicated to the general public.

Sánchez Devanny is a Mexican law firm that advises national and international companies in the life sciences, energy, automotive, retail, real estate and manufacturing industries.