Fernando Becerril Orta
Senior Partner
Becerril, Coca & Becerril
/
Expert Contributor

How COVID-19 is Impacting Laws Related to Health

By Fernando Becerril | Fri, 01/15/2021 - 13:06

The health contingency resulting from the propagation of SARS-CoV-2 took us by surprise in early 2020 in Mexico and since then, it has forced us to carry out, and in many cases without any prior preparation, a radical change in our lives. Since the beginning of the outbreak, the world also has changed significantly. First, with the onset of the coronavirus in China, and later, with its accelerated spread in Southeast Asia, reaching Europe, and finally its arrival on the American continent, the way in which we behaved socially, professionally, personally and within our family had to be redesigned. In the same way, companies, institutions and states have had to display all their skills to continue, as well as possible, to function properly.

The first months in Mexico were critical. Most people decided to indubitably adopt the recommended standards of health and hygiene and isolation measures, through which economic, social and political activity was reduced significantly. In the first weeks, everything stopped and only the essential industries remained active. As expected, and given the conditions of the then incipient pandemic, these essential industries were within the healthcare, emergency systems, supply chains of basic needs, and those economic activities that were critical to keeping cities functioning and to guaranteeing access to necessary health services for the population. However, as time has passed, the reactivation of the economy has proven to be critical. Therefore, the entire machinery of the state has begun to move. At this time, and despite the fact that the health contingency is still fundamentally active, practically all activities in these essential sectors have resumed to their “normal” level, albeit under strict health standards. Only those industries that have been able to maintain remote work have continued as “normal” as much as possible.

The forecast for this health contingency is not at all flattering. Everything seems to suggest that the duration in which we will continue in a health contingency, and consequently in confinement (even partially), will extend at least until the beginning of the second half of 2021. The speed with which the long-awaited vaccines against the coronavirus disease can be approved and distributed, will determine how quickly we can resume our activities in a way that, to some extent, is comparable to our old normality.

There are many legal and regulatory issues in the health sector that have been impacted by the very long period of time passed in contingency. Industries also have had to adapt and change. In the last year, several laws have been approved by the Mexican Congress and the regulations for their implementation are, in many cases, pending. At this time, there are also many pending issues that need to be clarified from a regulatory point of view.

In the first instance, we can talk about an initiative that in recent years has stolen the spotlight in Mexico. This is related to the regulation of cannabis for medical use in our country. While it is true that there has been legislation in this regard since 2017, it is also true that there are many issues still to be clarified about whether or not its use, which has been strictly allowed for medical use only, can be extended to all uses.

Additionally, the coronavirus health emergency has complicated procedures. While the rules for the use of cannabis were proposed on July 27 after an almost three-year wait, the date of entry into force was pushed back by the courts until Dec. 15, 2020, and then pushed back again until 2021. The issue is by itself complex in a society like ours, but given the legislative and regulatory advances, it is very likely that this year, Mexico will become the country with the largest population to have federal regulation on cannabis. Still, there are many additional tasks that must be considered in order not to affect other sectors in this industry, such as the production of construction materials, cosmetics products and others that obtain products from industrial hemp which, given the legislated conditions, may become subject to over-regulation even though they are products that do not contain psychoactive cannabis.

In another case, but also from a health point of view, there is the issue related to the so-called NOM 051 on the labeling of products with high caloric and sugar content, among others. While it is true that at the present time a large number of products are already commercially available with the labeling standard that came into force on Oct. 1, it is also true that an extension was given until Nov. 30 so that companies could identify their products properly. This norm has sparked great controversy about its effectiveness and to date, there are already amparo appeals launched by some producers to avoid adhering to the norm’s rules regarding the labeling of food and non-alcoholic beverages. At this moment, it is difficult to know what the future holds for this standard. It is possible that there could be some modification to eventually adapt to a much more flexible and appropriate standard for all parties involved.

A third relevant issue, and one that is very controversial, is that of public tenders for medicament acquisitions. In 2019, the Ministry of Finance and Public Credit established a system for consolidated purchases for medicines. However, the truth is that, of these consolidated purchases, about 40 percent of the tenders in the last few months were declared void. To date, there remain a large number of questions about the way in which the federal government has been managing the issue of bids and direct awards. From the perspective of many of the participants in this type of activity, it seems that there is no clarity and that, although the system for consolidated purchases exists, it has not been properly implemented and, therefore, it has not only affected the issue of tenders per se, but worryingly, the accessibility of the health system to necessary drugs, medical supplies and adequate equipment at the national level. This issue is and will continue to be the subject of great discussion in the coming months, especially due to the impact that a bad implementation or an incorrect decision can have on the entire national health system, and much more during a health emergency.

Last but not least regarding the health sector, there is the issue related to generic drugs. On July 1, the new Federal Law for the Protection of Industrial Property was approved. It entered into force on Nov. 5. This new law incorporates an exception equivalent to the so-called Bolar provision, in which the use, importation and commercialization of products for experimental purposes is allowed. It is also intended to make it easier for generic drug producers to develop their own products for sale as of the day after the expiration of the related patents that cover innovative products. This clearly is in line with the social vision of this 4T (Fourth Transformation) government and will allow, according to the expectation of the government itself, people to have access to low-cost pharmaceutical products in a shorter time.

Again, the important factor will be how it is implemented and regulated to avoid abuse from either of the parties involved. Additionally, the so-called Linkage system is well-defined within the law. This system establishes that there must be adequate coordination between IMPI and COFEPRIS to comply with the Linkage regulations. However, and as is known, COFEPRIS is experiencing internal problems and it is foreseeable that this Linkage system will face some setbacks and complications regarding its correct implementation.

After this brief tour on the relevant health issues in Mexico, we can see that there are some initiatives that, even though the legislation has been consolidated, are still facing many dark clouds that foretell storms in their implementation. Much work remains to be done by the health-related industries so that in the coming months all the necessary steps are taken to ensure that all these initiatives are correctly put into effect, and that all those systems that guarantee access to health systems, better hospital conditions, adequate medications and, in general, to better health conditions of the population are respected.

Mexico needs much more than a collection of inert legislative modifications. Our country urgently needs the political will to improve the health situation of the population, including the participation and close collaboration of all industries related to the health sector. Only with this real and effective collaboration can we ensure that Mexico aspires to have a health system worthy of its population.

The health contingency resulting from the propagation of SARS-CoV-2 took us by surprise in early 2020 in Mexico and since then, it has forced us to carry out, and in many cases without any prior preparation, a radical change in our lives.

Since the beginning of the outbreak, the world also has changed significantly. First, with the onset of the coronavirus in China, and later, with its accelerated spread in Southeast Asia, reaching Europe, and finally its arrival on the American continent, the way in which we behaved socially, professionally, personally and within our family had to be redesigned. In the same way, companies, institutions and states have had to display all their skills to continue, as well as possible, to function properly.

The first months in Mexico were critical. Most people decided to indubitably adopt the recommended standards of health and hygiene and isolation measures, through which economic, social and political activity was reduced significantly. In the first weeks, everything stopped and only the essential industries remained active. As expected, and given the conditions of the then incipient pandemic, these essential industries were within the healthcare, emergency systems, supply chains of basic needs, and those economic activities that were critical to keeping cities functioning and to guaranteeing access to necessary health services for the population. However, as time has passed, the reactivation of the economy has proven to be critical. Therefore, the entire machinery of the state has begun to move. At this time, and despite the fact that the health contingency is still fundamentally active, practically all activities in these essential sectors have resumed to their “normal” level, albeit under strict health standards. Only those industries that have been able to maintain remote work have continued as “normal” as much as possible.

The forecast for this health contingency is not at all flattering. Everything seems to suggest that the duration in which we will continue in a health contingency, and consequently in confinement (even partially), will extend at least until the beginning of the second half of 2021. The speed with which the long-awaited vaccines against the coronavirus disease can be approved and distributed, will determine how quickly we can resume our activities in a way that, to some extent, is comparable to our old normality.

There are many legal and regulatory issues in the health sector that have been impacted by the very long period of time passed in contingency. Industries also have had to adapt and change. In the last year, several laws have been approved by the Mexican Congress and the regulations for their implementation are, in many cases, pending. At this time, there are also many pending issues that need to be clarified from a regulatory point of view.

In the first instance, we can talk about an initiative that in recent years has stolen the spotlight in Mexico. This is related to the regulation of cannabis for medical use in our country. While it is true that there has been legislation in this regard since 2017, it is also true that there are many issues still to be clarified about whether or not its use, which has been strictly allowed for medical use only, can be extended to all uses.

Additionally, the coronavirus health emergency has complicated procedures. While the rules for the use of cannabis were proposed on July 27 after an almost three-year wait, the date of entry into force was pushed back by the courts until Dec. 15, 2020, and then pushed back again until 2021. The issue is by itself complex in a society like ours, but given the legislative and regulatory advances, it is very likely that this year, Mexico will become the country with the largest population to have federal regulation on cannabis. Still, there are many additional tasks that must be considered in order not to affect other sectors in this industry, such as the production of construction materials, cosmetics products and others that obtain products from industrial hemp which, given the legislated conditions, may become subject to over-regulation even though they are products that do not contain psychoactive cannabis.

In another case, but also from a health point of view, there is the issue related to the so-called NOM 051 on the labeling of products with high caloric and sugar content, among others. While it is true that at the present time a large number of products are already commercially available with the labeling standard that came into force on Oct. 1, it is also true that an extension was given until Nov. 30 so that companies could identify their products properly. This norm has sparked great controversy about its effectiveness and to date, there are already amparo appeals launched by some producers to avoid adhering to the norm’s rules regarding the labeling of food and non-alcoholic beverages. At this moment, it is difficult to know what the future holds for this standard. It is possible that there could be some modification to eventually adapt to a much more flexible and appropriate standard for all parties involved.

A third relevant issue, and one that is very controversial, is that of public tenders for medicament acquisitions. In 2019, the Ministry of Finance and Public Credit established a system for consolidated purchases for medicines. However, the truth is that, of these consolidated purchases, about 40 percent of the tenders in the last few months were declared void. To date, there remain a large number of questions about the way in which the federal government has been managing the issue of bids and direct awards. From the perspective of many of the participants in this type of activity, it seems that there is no clarity and that, although the system for consolidated purchases exists, it has not been properly implemented and, therefore, it has not only affected the issue of tenders per se, but worryingly, the accessibility of the health system to necessary drugs, medical supplies and adequate equipment at the national level. This issue is and will continue to be the subject of great discussion in the coming months, especially due to the impact that a bad implementation or an incorrect decision can have on the entire national health system, and much more during a health emergency.

Last but not least regarding the health sector, there is the issue related to generic drugs. On July 1, the new Federal Law for the Protection of Industrial Property was approved. It entered into force on Nov. 5. This new law incorporates an exception equivalent to the so-called Bolar provision, in which the use, importation and commercialization of products for experimental purposes is allowed. It is also intended to make it easier for generic drug producers to develop their own products for sale as of the day after the expiration of the related patents that cover innovative products. This clearly is in line with the social vision of this 4T (Fourth Transformation) government and will allow, according to the expectation of the government itself, people to have access to low-cost pharmaceutical products in a shorter time.

Again, the important factor will be how it is implemented and regulated to avoid abuse from either of the parties involved. Additionally, the so-called Linkage system is well-defined within the law. This system establishes that there must be adequate coordination between IMPI and COFEPRIS to comply with the Linkage regulations. However, and as is known, COFEPRIS is experiencing internal problems and it is foreseeable that this Linkage system will face some setbacks and complications regarding its correct implementation.

After this brief tour on the relevant health issues in Mexico, we can see that there are some initiatives that, even though the legislation has been consolidated, are still facing many dark clouds that foretell storms in their implementation. Much work remains to be done by the health-related industries so that in the coming months all the necessary steps are taken to ensure that all these initiatives are correctly put into effect, and that all those systems that guarantee access to health systems, better hospital conditions, adequate medications and, in general, to better health conditions of the population are respected.

Mexico needs much more than a collection of inert legislative modifications. Our country urgently needs the political will to improve the health situation of the population, including the participation and close collaboration of all industries related to the health sector. Only with this real and effective collaboration can we ensure that Mexico aspires to have a health system worthy of its population.