As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender binding for all those companies interested to sell medical supplies in Mexico (medical devices included). This is for the period 2021-2024. In this article, we would like to explain some of the reasons behind this bid and opportunities you may find interesting.

During this year, the Mexican Government expressed the necessity to acquire low prices medical supplies with the support of international entities. This was legally approved in the official diary the last August 11. Such amendment, basically allows the Mexican Government to acquire any product without following the rules that used to be the legal basis for every public bid performed in Mexico.

A few days after such legal amendment, the Government worked with the UNOPS to publish the procurement of medicines and medical aid supplies (medical devices) in Mexico. These are a few key facts to consider:

• Published: 25-Aug-2020
• Deadline: 15-Sep-2020 23:59 (GMT -5.00) Central Time (US & Canada), Mexico City
• 900 type of medical devices required

In addition, it was also reported that:

• Participants do not necessarily require to present sanitary registrations approved in Mexico by COFEPRIS
• It is expected that for 2021 the value of this bid would be approximately $6 billion USD

It is worth mentioning that this is the first time the Mexican Government makes such acquisition process. And this is important to the country, considering that the public sector covers 70-80% of the total medical services.

Even though a COFEPRIS sanitary registration is not a requirement to participate, we found in the official UNOPS platform that once you submit your application, they asked you if a COFEPRIS sanitary registration has been granted. This does not necessarily implicates that you need such registration.

From UNOPS webpage (taken on August 9^th 2020)

In conclusion, there is still uncertainty if this process will effectively promotes a real benefit on prices. Nevertheless, we consider that if you are a medical device manufacturer with local sanitary approvals in your country, this could be a great chance to get into the Mexican market.

In case you are interested to know more about this bid, please send us an email to contact@veraqueconsulting.com

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COFEPRIS has initiated an ambitious project to digitalize the regulatory processes in a similar way to other regulatory agencies. The aim of this transition to paperless systems is to speed up the response times, reduce bureaucracy, eliminate corruption, and dismiss discretionary practices.

The first stage in this strategy was concluded in 2019, which mainly consisted on performing a full diagnosis of the current process.

The second stage has been implemented on September 1, 2020. Specifically, COFEPRIS released a new electronic system to schedule the submission of requests and procedures in the Integral Service Center (CIS). It is worth mentioning that in order to use this new system, an electronic signature, known as e.firma, is needed. Specifically, the e.firma is a confidential file used to retrieve financial and taxes information from the company. In addition, this electronic signature is only granted to legal entities located in Mexico.

The above changes will bring benefits for the COFEPRIS and users of their services. Even when COFEPRIS is still accepting priority requests, the CIS have been opened for all users since September 1, 2020 with strict hygienic measures to avoid the propagation of COVID-19.

The third stage of this project consist in the process mapping, analysis and design of optimal procedures and simplified pathways for its digitalization.

The intention of COFEPRIS is to optimize requests through the standardization and reduction of processes. They are also looking to digitalize the whole regulatory procedures. As an example of this, all type of Import Permits are requested digitally in VUCEM.

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Up to August 19, 2020 according to the Health Law, COFEPRIS was a separated administrative commission but part of the Ministry of Health, with technical, administrative and operative autonomy.

However, some changes were performed in the Mexican laws that changed this scheme. In this article we summarize those amendments and its possible consequences.

In August 19, 2020 an official agreement was published. In this agreement the internal structure of the Ministry of Health is changed. These changes include the modification of COFEPRIS from being hierarchically dependent from the Ministry of Health to a lower level. Specifically, as a Direction that depends on the Sub secretary of Prevention and Health Promotion. As a reference, the head of this entity is Hugo López Gatell, public servant that have been in charge of handling the COVID-19 pandemic in Mexico.

In addition of this amendment, it is expected that the Mexican Congress will modify the Health law to legitimize these changes and make the laws coherent. Up to date Lawmakers have not declared regarding this issue.

The above-mentioned changes means that COFEPRIS will lose its autonomy from the Government, unlike most regulatory agencies from other countries. The Federal Commissioner who was the head of COFEPRIS will disappear, now all decisions will be taken directly by Hugo López Gatell.

Specialized analysts have noticed that this modification will negatively impact the health care industry. They expect an increase in bureaucratic procedures and decreased quality, efficacy and professionalism in the function of the COFEPRIS.

According to experts, these changes represent a drawback to the times before the creation of the COFEPRIS in 2001, when the regulatory procedures were deficient. It is important to mention that these observations do not represent the opinion of Veraque regarding this topic. However, we noticed consistency in this judgment.

Companies and professionals in the sector must monitor the changes mentioned above and those that may arise in the coming months.

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