Covid-19 and life sciences in Mexico
Ingrid Paulina Ortiz Muñoz
Olivares, Mexico City
There is no doubt that Covid-19 has impacted almost every known aspect of life. Life sciences are no exception and have also been heavily impacted. Due to the ongoing health crisis, governments have (among other efforts) implemented measures expecting to curtail high rates of infection; tried to adapt the regulatory landscape to respond to the new virus; and continued to attend other illnesses.
In Mexico, the Health Counsel is, in accordance with the Constitution, the highest health authority. In addition, our legal system allows other authorities to act in relation to health issues at the State and Municipal levels. However, this paper is focused on Federal decisions and measures.
On 24 March 2020, the Mexican President announced that, officially, Mexico had entered into Phase 2 (local transmission) of the outbreak of Covid-19. New measures to contain the spread of Covid-19 and ‘flatten the curve’ of infection were to be implemented, including:
- protecting the elderly and vulnerable;
- suspending national education system classes, from 23 March to 19 April 2020;
- temporarily suspending events and meetings of 100 people or more;
- temporarily suspending work activities that involve the mobilisation of people from all sectors of society; and
- strengthening basic sanitary prevention measures.
Prior to such official communications, many of those preventive measures were being adopted gradually by a significant proportion of the private sector. Fewer public entities did so. The jurisdictional authorities (Federal Courts) were the first public entities to suspend activities, keeping just a few guards in case of emergency. On 23 March 2020, the Mexican Patent and Trademark Office (IMPI) issued a decree suspending and interrupting terms from 24 March.
On 26 March 2020, the Ministry of Health issued a decree suspending the legal terms in all administrative actions and procedures before the Ministry of Health, including the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), the authority on sanitary matters in our country. This is still in force at the time of writing.
The Ministry of Health specified that all its dependencies will provide everything necessary, so that in all the procedures that are essential and/or urgent for dealing with the contingency, the necessary personnel are kept in work, ensuring continuity of operations of essential functions related to the control of the Covid-19 virus pandemic.
In terms of the supplies and health products required to manage the crisis, on 27 March, the Mexican President published a Decree in the Federal Gazette that empowered the Ministry of Health through the following measures:
- the use of all medical resources in the public and private sectors, available in the regions and the surrounding areas;
- the acquisition of all types of goods and services, at national or international level, such as medical equipment, diagnostic agents, surgical and healing materials and hygiene products, as well as any other type of good or service, without any public tender procedure, for the quantities or concepts that are necessary to face the contingency;
- the import and authorisation of imports of the above-mentioned goods and services, with minimal or no administrative procedure requirements, for the required quantities or concepts;
- taking the corresponding measures in order to avoid price speculation and stockpiling of the essential products mentioned above; and
- any other measure that is considered necessary by the Ministry of Health.
All entities and offices of the Federal Public Administration must work jointly and provide all the required support to the Ministry of Health, in order to implement the corresponding measures to mitigate and control the pandemic virus.
However, the acquisition of the goods and services mentioned in the measures implemented were still to be subject to approval by the corresponding authority.
Health authorities also noted that in order to carry out diagnostic tests, it was necessary to comply with the national and international standards that the Epidemiological Diagnostic and Reference Institute (‘InDRE’) enforces, as well as with the General Health Law and the ‘Official Mexican Standard NOM-017-SSA2-2012 for epidemiological surveillance’, among others. The InDRE has the power to determine the technical competence of public and private laboratories, which is important for validating tests and results.
In regard to other products and services, at the end of March, COFEPRIS (as the authority responsible for applying and enforcing the regulatory framework in relation to pharmaceuticals biotech products, chemicals, medical devices, cosmetics as well as some regulation of food and beverages) announced on its website that it would partially continue working; that it would continue to receive petitions and proceedings; and that its Comprehensive Services Center (CIS) would also remain open to receive and attend to those procedures (not necessarily related to Covid-19) required to continue supplying medical products and responding to the health needs of the population .
At that point, it appeared that the sanitary authority would continue providing ‘normal’ services as far as possible. At the same time, they were still trying to find an adequate means of operating. By then, COFEPRIS was already prioritising sanitary authorisations related to medicine, medical devices and importation of supplies, among others, all strictly related to the Covid-19 pandemic.
On 12 April 2020, COFEPRIS published on its website the 'List of procedures that are considered as priority during the health emergency derived from COVID-19’. This was broader and included procedures that are not directly related to Covid-19, aiming to provide solutions to the industries that still required attention from COFEPRIS.
This list continued to be updated. The latest update was published on 24 April 2020, a few days after Phase 3 of the pandemic was declared in Mexico. The remit of this update was narrower than the previous version. This list classified the procedures by code, including the name of the procedure, its modality and the specific department that will be in charge.
This list has prioritised the pharmaceutical industry, leaving behind others, such as cosmetics and the regulation of some food and beverages that may require attention from COFEPRIS.
In addition to these limitations, due to entry into Phase 3 and in order to strengthen social distancing measures, COFEPRIS announced that such entity would only be receiving submissions via courier.
The combination of the list of priorities and system of submission via courier has been successful for submissions related to procedures which do not necessary involve technical complexities. However, other procedures (which involve higher levels of complexity) have, in some cases, faced struggles and unnecessary delays, due to this improvised system. The authority and the private sector are continually trying to work through those kinds of situation, in order to improve the system and handle the crisis without impacting important health matters not related to Covid-19.
Although enormous efforts have been made to manage and control every aspect of the health crisis, it has been necessary to implement an official document that can be used for reference where needed. After several weeks of discussion and controversy, on 30 April, the Mexican General Health Council approved the ‘Triage Guide for the Allocation of Critical Medical Resources’ (the 'Guide').
The Guide aims to outline how decisions should be taken if the current health emergency generates a demand for critical medical resources which it is not possible to satisfy. Examples of critical medical resources mentioned in the guide, which may generate high demand, are organs for transplantation, critical care beds and mechanical ventilators. A prioritisation scale is proposed, which gives critical care priority to certain patients over others, depending on a number of factors.
The guide also makes suggestions as to how to organise the triage system and which personnel should make the decisions. It is important to note that the triage system is to be applied to all patients who require critical care, not just those with Covid-19. The aim in a public health emergency is to save as many lives as possible and also to save the most lives-to-complete.
Upon its approval, due to the controversy aroused, the Supreme Court made it clear that the Guide is not definitive and may be amended if required. The Guide is also not mandatory, but if hospitals intend not to adopt it they must be able to explain their own protocols for the allocation of resources, if they become stretched.
The Guide allows actions within hospitals to be governed by objective criteria that will discourage influence and corruption and provides legal certainty to all those involved.
The hope is that, due to its early implementation of social distancing measures, Mexico will not experience a shortage of critical medical resources and, therefore, such difficult decisions will not need to be made.
It is clear that, Covid-19 has impacted life sciences in many ways. Health products are in high demand during these times, involving several changes in the system as known. The regulatory scenery has changed significantly: new guidelines and measures have been implemented in order to manage and control the health crisis. Those modifications have transformed the normal ways to obtain health supplies; approve them; and review and prosecute the corresponding submissions that are necessary for life sciences industries to continue operate, both despite the Covid-19 pandemic and in order to mitigate the virus. Hopefully, the impact will not be anymore significant, as we keep working on improving the existing measures and creating new ones, while the sciences provide more responses in relation to the pandemic.