Life Sciences 2024 Comparisons

The legal framework regulating pharmaceuticals and medical devices is largely federal in Mexico, and includes the following laws and regulations:

• the General Health Law (GHL);
• the Health Supplies Secondary Regulations (Reglamento de Insumos para la Salud, or RIS);
• the Health Services Secondary Regulations;
• the Health Advertisement Secondary Regulations;
• the Clinical Research Secondary Regulations (CRSR); and
• several official Mexican standards on specific technical aspects (eg, good manufacturing practices, labelling and stability).

In Mexico, the legal and administrative nature of the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS) is that of an autonomous agency, under the administrative structure of the Ministry of Health (MoH). The GHL created COFEPRIS and gave it administrative, technical and operational autonomy. However, that autonomy was placed under pressure after a ministerial decree was issued in 2020, changing its ascription from the Minister directly to a Vice-Minister.

Decisions of the regulatory bodies that apply and enforce pharmaceutical and medical device regulations may be challenged through the following optional appeal proceedings:

• an initial administrative review, decided by the same authority that issued the original administrative decision;
• an annulment trial, decided by the Federal Administrative Tribunal; and
• an amparo trial, decided by a judicial body, a judge or a court (depending on the nature of the decision being challenged).

The formal requirements for challenging a decision vary depending on the nature of the decision being challenged, but generally the appeal lawsuit will include:

• identification of the affected party;
• identification of the challenged decision;
• identification of the authority that issued the decision;
• a description of the facts; and
• the available evidence.

However, the most important element for successfully litigating regulatory decisions is to have an interdisciplinary team of lawyers and pharmaceutical chemists, so that the science and the law can be properly understood and argued in each case.

Strangely, there is still a general impression within companies that there has been no significant litigation relating to decisions taken by health regulators. However, this is not an accurate perception, as litigation has always existed in this area ‒ particularly in relation to sanctions. There is now a lot of litigation in relation to the system of authorisations and the interpretation of technical regulations. As the regulatory system has evolved into a more complete set of legal rules, and as regulatory work is now being undertaken not only by pharmaceutical chemists but also by lawyers, companies have better understood their rights and have felt increasingly confident in challenging regulatory decisions that affect their interests.

For a whole decade following the creation of COFEPRIS in 2000, regulatory work was highly technical and was mainly handled by pharmaceutical chemists, both in companies and in regulatory agencies. The health law and regulation did not evolve as quickly as the science and the market. The government’s regulatory decisions were frequently taken based not on existing legal rules but exclusively upon technical criteria, which led to a highly discretionary system. Although decisions were always legally vulnerable, the concern of companies was that legally challenging a decision on one product would affect other decisions pending over other products. At the same time, public affairs actions were rather successful in achieving results without the need to litigate.

Two COFEPRIS administrations (2010–18) then brought the legal framework up to date, bringing in lawyers to key positions and modernising the administrative system. This helped to trigger a trend for in-house lawyers and external counsel specialising in the field. At the same time, compliance controls tightened, forcing companies to evaluate, enforce and defend their rights and obligations on the one hand and to put pressure on the area of public affairs on the other.

Finally, the actions of the two most recent COFEPRIS administrations (2018–20 and 2020–23) deliberately isolated the agency from the industry by replacing experienced examiners and reducing the number of available examiners, leading to a huge backlog that disrupted commercial operations. This created strong incentives for companies to litigate all kind of pending approval applications.

All of that combined has resulted in a significant and sustained increase in litigation, year after year, for the past decade. This led to the creation of a Specialised Chamber for Regulatory Matters within the Federal Administrative Tribunal, which heard 300 cases against COFEPRIS in 2020. Now there is significant litigation against a lack of response on renewals, modifications, rejections and inspection procedures, in addition to litigating sanction decisions. In 2022, the total number of all types of litigation cases against COFEPRIS skyrocketed to 12,000.

Since 2023, the current administration has partially restarted communication with the regulated industries via the Commissioner for Health Promotion, through technical sessions and goodwill meetings. Both schemes are confidential, non-binding and not regulated by applicable regulations. Nonetheless, these represent an alternative means for the industry to understand COFEPRIS’ interpretation of regulations and requirements.

The GHL contains many relevant classifications for medicines, including reference and generic/biocomparable drugs, prescribed and non-prescribed drugs, standard and controlled drugs, and so on.

Medical devices are divided into three classes, according to the risk they represent to human health, as follows:

• Class I – those that are recognised in medical practice, whose safety and efficacy have been proved, and that generally are not introduced into the human body;
• Class II – those that are recognised in medical practice, that can vary in the way they are manufactured or in their concentration, and that are regularly introduced into the human body (remaining there for less than 30 days}; and
• Class III – new products or those recently accepted by medical practice, or those that are introduced into the human body and remain there for more than 30 days.

The regulation of clinical trials includes the following key instruments:

• the GHL;
• the CRSR;
• Technical Standard NOM-012-2012-SSA3;
• the Guidelines for Good Clinical Practice published by COFEPRIS; and
• the Decree for the Operation of Ethics Committees, co-ordinated by the National Bioethics Commission.

In general, clinical trials (Phases I–IV) must be:

• preceded and supported by pre-clinical data;
• conducted in accordance with scientific and ethical principles;
• performed with the informed consent of the participating human subjects;
• executed under a research protocol;
• overseen by a principal investigator; and
• performed in licensed health institutions.

In addition, they must obtain the relevant approvals from a health institution, an ethics committee and COFEPRIS.

Historically, the operation of ethics committees was largely self-regulated and based on international best practice. There was also a lack of co-ordination between COFEPRIS and the National Bioethics Commission (ConBioetica). However, the Decree for the Operation of Ethics Committees (2012) provides a clearer legal framework for ethics committees, establishing their structure, their objectives, the role of their members and the requirement to be registered with ConBioetica and COFEPRIS. Unfortunately, ConBioetica has accumulated enormous regulatory delays, forcing serious consideration of litigating the lack of response.

Notably, the Guidelines for Good Clinical Practice (2012) make clear reference to international best practice, including standards developed by the International Conference on Harmonisation. These good clinical practices will be the basis to move towards a certification system, for which COFEPRIS has already started to conduct inspections of research sites.

The operation of contract research organisations (CROs) is not fully regulated, with references only found in the guidelines, but there are ongoing initiatives to address this.

Other regulatory measures have been introduced to promote Mexico as a place for conducting clinical research, including the following.

• An important amendment to the RIS – Article 170 of the RIS originally required a certificate of free sale of the country of origin to be submitted as part of an application for obtaining a marketing authorisation (MA) of a drug produced abroad, which therefore made it impossible to have Mexico as the first country of registration. In 2012, however, this was changed to make it possible to submit a clinical trial report instead, provided that the Mexican population was included in the trial.
• The creation of third authorised parties for clinical research – COFEPRIS has authorised several public hospitals with extensive experience in clinical research to conduct a pre-evaluation of research protocols. If their report is positive, approval times at COFEPRIS are reduced significantly.

The same rules regulate medical devices and pharmaceuticals.

The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical or a medical device is comprised of three basic steps, which are sequential and cannot be applied for in parallel, as follows:

• favourable opinion of the research protocol by the ethics committee of the health institution where the trial is to be conducted, which – according to the Decree for the Operation of Ethics Committees – must take place within 30 business days of filing;
• authorisation of the research protocol by the director of the health institution where the trial is to be conducted, which must take place under its relevant internal rules; and
• approval of the research protocol from COFEPRIS, which – according to the Federal Law on Administrative Proceedings ‒ must take place within three months of filing.

After their protocols have been authorised by COFEPRIS, most trials are currently recorded in the National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos, or RNEC). The information contained in the RNEC is collected by COFEPRIS in collaboration with those responsible for conducting the clinical trial (ie, sponsor, CRO or healthcare institution). The RNEC publishes an electronic database that includes only general information about the clinical trials. Although limited, this shows significant progress, as until very recently almost no local information was made publicly available. Confidential information is not included in the RNEC, nor is the health information of patients, which will be regarded as sensitive personal information under data protection laws and will be protected accordingly.

On the other hand, there is no binding provision to disclose or publish the results of clinical trials, but the CETIFARMA (the Council of Ethics and Transparency of the Pharmaceutical Industry)’s Code of Ethics does contain a specific obligation for sponsors to disseminate the positive and negative results of trials, particularly the adverse events.

There are no specific restrictions regarding online clinical trial platforms. However, it would be important for the platform to comply with the regulations regarding the recruitment of and interaction with patients enrolled in a clinical trial if those functionalities are included in the platform. Additionally, this platform could involve other regulatory implications, such as the advertising of health inputs, services and privacy protection, so it is important for its content to be reviewed on a case-by-case basis.

The data resulting from the clinical trial would be considered personal if the patients enrolled in the clinical study are identified. If the results of the clinical trial are presented without providing information or images that could lead to the identification of the patients, those results would not be considered personal data.

It is permitted to transfer the data resulting from the clinical trial to a third party or an affiliate, as long as the privacy notice reveals that a transfer will occur and identifies a justifiable purpose for that transfer. When sensitive personal data is involved, the data controller must obtain express written consent for processing, through a signature, an electronic signature or any authentication mechanism established for that purpose.

The creation of databases that contain sensitive personal data must be justified and must follow legitimate and concrete purposes that correspond to the activities and explicit objectives of the data controller. These kinds of databases are not subject to authorisation before operations commence.

The GHL provides a general definition for pharmaceuticals. In this respect, any product that falls into such definition should be considered a pharmaceutical. According to the GHL, a medicine is any substance or mixture of substances of natural or synthetic origin that has any therapeutic, preventative or rehabilitative properties, which is presented in any pharmaceutical form and is identified as such for its pharmacological activity and physical, chemical and biological characteristics.

On the other hand, the new definition of medical device contained in Section 3.41 of Standard NOM-241-SSA1-2021 (NOM-241) is broader: “Medical device, instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product, to be used, alone or in combination, directly or indirectly in human beings; with any of the following purposes of use:

(i) diagnosis, prevention, surveillance or monitoring, and/or aid in the treatment of diseases;

(ii) diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the healing of an injury;

(iii) substitution, modification or support of the anatomy or of a physiological process;

(iv) life support;

(v) control of conception;

(vi) disinfection of medical devices;

(vii) disinfectant substances;

(viii) provision of information through an in vitro examination of samples taken from the human body, for diagnostic purposes;

(ix) devices incorporating tissues of animal and/or human origin, and/or

(x) devices used in in vitro fertilisation and assisted reproductive technologies,

as well as those whose main purpose of use is not through pharmacological, immunological or metabolic mechanisms; however, they can be assisted by these means to achieve their function. Medical devices include supplies for health in the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, supplies for dental use, surgical and healing materials, and hygienic products.”

Initially, any product that falls into this definition should be considered a medical device.

It is also important to remember the List of Products That Due to Their Nature, Characteristics and Uses Are Not Considered Medical Devices. Products included on this list will be excluded from the regulation of medical devices.

There are other categories that are recognised in practice (eg, combination products), but these are not formally regulated through mandatory instruments.

In general, there is only one type of MA for pharmaceuticals for human health and for medical devices, which is granted by COFEPRIS. The same requirements of quality, safety and efficacy apply, regardless of whether the product is allopathic, homeopathic, herbal or a vitamin pharmaceutical.

However, there is a significant difference between the extent and scope of safety and efficacy data that would be required for an innovator product and that which would be required for a subsequent product, and the specific requirement for releasing biologic products after importation. Biotech drugs are also subject to a pre-submission regulatory meeting with the COFEPRIS’ New Molecules Committee.

Please note also that a new class of approvals was introduced during the COVID-19 pandemic (albeit without a legal basis for doing so): emergency authorisations. These would have to expire once the health emergency is declared to be over.

The period of validity of any MA for pharmaceuticals and medical devices is five years. After this period, MAs may be renewed every five years. In contrast, a Recognition Letter for Orphan Drugs (the equivalent of an MA) lasts for two years only.

Also, any authorisation may be revoked by COFEPRIS at any time – for instance, when a new risk to human health is found, if an infringer repeatedly disregards safety measures, or if false information is submitted. During the pandemic, MAs were cancelled for companies that failed to submit renewal application on time.

A recent change to the RIS means that the second and subsequent renewals of MAs ‒ both for medicines and for medical devices – will only be subject to a notification, not to an authorisation.

In general, the procedure for obtaining an MA for pharmaceuticals includes filing the MA application form at COFEPRIS, along with evidence of the following:

• the payment of governmental fees;
• a manufacturing licence or equivalent;
• notice of appointment of a qualified sanitary officer;
• draft labels;
• the information to prescribe;
• certificates of good manufacturing practices for the finished product, its active ingredients and its additives;
• the draft distinctive name;
• the quantitative and qualitative formula;
• quality information; and
• pre-clinical studies, including pharmacodynamics, pharmacokinetic and toxicology studies.

For products manufactured abroad, it is also necessary to file a representation letter granted to the holder.

The application to obtain an MA for medical devices must be submitted with the following:

• the payment of governmental fees;
• the technical and scientific information that proves the security and efficacy standards;
• draft labels;
• instructions;
• a general description of the manufacturing process;
• a description of the structure, materials, parts and functions;
• certificates of good manufacturing practices for the finished product;
• laboratory tests; and
• bibliographic references, if such are required.

For products manufactured abroad, it is also necessary to file the following:

• a free sale certificate;
• a representation letter issued by the manufacturer of the product;
• a certification of analysis;
• sanitary notification of the distribution warehouse; and
• notification of the sanitary official of the distribution warehouse.

Approval times are as follows:

• for pharmaceuticals that include active and therapeutic indications already registered in Mexico, the decision must be granted within 180 days;
• for pharmaceuticals whose active ingredients are not registered in Mexico but are registered and sold freely in their country of origin, a decision shall be taken within 240 days;
• for new molecules, after a prior technical meeting between applicants and the New Molecules Committee of COFEPRIS, the decision shall be taken within 180 days;
• for homeopathic, herbal and vitamin pharmaceuticals, decisions shall be taken within 45 days; and
• for biotechnological drugs, applications must be resolved within 180 days.

These approval times can be extended if COFEPRIS requires additional information.

For Class I medical devices, the decision must be granted within 30 days; for Class II, the decision shall be taken within 35 days; and for Class III, the decision shall be taken within 60 days.

As with pharmaceuticals, these approval times can be extended if COFEPRIS requires additional information.

There is no mandatory requirement to conduct clinical trials in a paediatric population nor to obtain a waiver from this requirement in relation to individual pharmaceuticals; this is completely optional and subject to stricter requirements.

The variation of MAs can be classified as administrative or technical. Technical modifications are those relating to changes in the formulation, indication or manufacturing process. Administrative modifications include variations such as changes to the corporate name or address of the holder, or changes to the information to prescribe. An assignment of an MA is regarded as an administrative modification. Each application to modify an MA must contain the technical and legal documentation supporting the relevant change.

There are a limited number of cases where an unauthorised product can be imported into the country and be supplied to patients, including low-prevalence diseases, donations (eg, in natural disasters), personal use, experimental products for clinical research, and medical use.

In addition, if the relevant product is included in the List of Products That Due to Their Nature, Characteristics and Uses Are Not Considered Medical Devices, it would not be considered as a medical device and consequently would not require an MA.

The MoH published two decrees, on 28 January 2020 and 22 June 2021, creating the option to import medicines and medical devices that do not have an MA in Mexico and to place them on the public market, provided they have an MA from certain recognised jurisdictions. For that, a number of steps must first be taken, including obtaining a prior declaration of necessity issued by multiple authorities. These decrees have also become a source of litigation.

Holders of MAs must comply with good manufacturing practices and stability, pharmacovigilance or technovigilance and labelling standards and regulations; they must also comply with the advertising regulations that apply to pharmaceuticals or medical devices. Product recall obligations have also became relevant of late.

In general, pharmaceuticals and medical devices are subject to post-approval vigilance. These obligations are developed in technical standards, which generally specify the rights and obligations for holders of MAs, distributors, research sites, health institutions, physicians and patients to monitor adverse events or incidents, and to investigate and report them. It is also necessary to have a pharmacovigilance or technovigilance unit, someone responsible for pharmacovigilance and someone responsible for technovigilance, and a pharmacovigilance or technovigilance manual.

However, Phase IV data is only required for more complex products (eg, complex biologics or biotech drugs), as decided by the New Molecules Committee.

COFEPRIS has periodically published lists of applications and lists of granted or rejected MAs. However, these lists are not updated regularly, and frequently contain limited information that excludes confidential information. Full access to individual files is only granted to the applicant.

Although third parties have long been able to file public information requests in relation to any file held by COFEPRIS under the mechanisms overseen by the National Institute for Access to Public Information and Data Protection (INAI), COFEPRIS historically resisted providing access to most of the files of MAs, which it regarded as being confidential in their entirety. Nevertheless, through several INAI decisions, an increasing number of data elements can now be accessed. Fortunately, COFEPRIS has now begun to populate a public database on its website that displays key data contained in the MAs for pharmaceuticals.

Confidential information is protected by several special laws, including those related to privacy, IP and administrative procedures, and labour and criminal law.

Relevant legislation includes the GHL, the Federal Consumer Protection Law, and the Federal Criminal Code. These legislative bills provide jurisdiction to multiple government agencies to undertake enforcement actions upon the notice of existence of falsified or illegal goods that could affect healthcare. The action that can be triggered will depend on the facts of the case and the illicit goods involved, as it could be within the legal authority of any of the above-mentioned laws.

In essence, the bills provide a legal framework to file and start complaints, through a potential infringement of the Consumer Protection Law or the GHL. These investigations will be based on a human health risk or a consumer protection liability, rather than IP infringement. Please note that other actions – such as a damages claim for unlawful conduct that affects a company or damages its prestige and reputation – could be explored in a subsequent stage, provided that an infringement is found to have existed and depending on the direct liability of the offender.

The actions available under these bills are not in the title-holder’s control; instead, they are under the control of the relevant agency, such as COFEPRIS, the Federal Attorney General Office, the Federal Consumer Protection Agency or the federal police. In this regard, the title-holder/manufacturer is entitled to present a complaint for the relevant agency to start an investigation, which could be a joint investigation with law enforcement agencies, depending on the facts of the case. The agency will be in control of the investigation, while the title-holder/manufacturer can assist with the investigation and provide relevant information that will help build the case, although they will not be in control of the investigation and its outcome.

As a result, depending on the investigation’s outcome, there can be injunctive relief such as seizure of illicit goods, or temporary closure of the factory or retail store. These options will be taken by the administrative agencies or the law enforcement agencies ex officio, as the title-holder is not part of the case. For these situations, it is important for the title-holder to follow the official investigation closely to ensure that the administrative agencies or law enforcement agencies liaise in due course.

A combination of provisions found in international free trade agreements, the Mexican Industrial Property Law and Customs Law provide for the possibility of filing border measures against counterfeited pharmaceuticals and medical devices – provided a recognised IP right is at risk, which includes trade marks, patents and industrial designs. The system is operated through detection technology and databases that are built or fed by title-holders, who will be alerted to suspected goods.

A pharmaceutical manufacturing plant is subject to a licence, and a medical device manufacturing plant is subject to submitting a notice of operation. COFEPRIS is the authority responsible for granting the manufacturing licence and receiving the notice of operation.

To obtain the manufacturing licence, a certificate of Good Manufacturing Practices (GMP) must be obtained. For that, a COFEPRIS inspection visit to the manufacturing plant must first be requested, to review whether the plant complies with Technical Standard NOM-059-SSA1-2015 on GMP for pharmaceuticals. If COFEPRIS determines in the inspection visit that the facility is in compliance, it will grant a certificate, which must be included in the manufacturing licence application. Once the application is submitted, COFEPRIS will take no more than 60 business days to grant the manufacturing licence. The activities typically approved by the manufacturing licence are the manufacture and warehousing of pharmaceuticals in the same facility. The operation licence does not have an expiry date.

The notice of operation for a medical device manufacturing plant needs only to be submitted to COFEPRIS, and becomes valid the moment it is filed. The notice of operation requires the appointment of a sanitary officer, who shall be in charge of the facility. The typical activities covered by the notice of operation are the manufacture and warehousing of medical devices in the same facility. The notice of operation does not have an expiry date. With the recent issuance of the new NOM-241 on GMP for medical devices, a GMP certificate must be obtained. This new version of NOM-241 has been a source of controversy, as it also applies to manufacturing sites dedicated exclusively to exporting, which are covered by the IMMEX (Manufacturing Industry, Maquiladora, and Export Service) programme.

As a general rule, establishments involved in the wholesale of pharmaceuticals and/or medical devices are only required to submit a notice of operation to COFEPRIS. The notice of operation enters into effect at the moment of filing and does not have an expiry date.

The exception to the general rule is warehouses dedicated to the wholesale of controlled pharmaceuticals (eg, psychotropic and narcotics) and/or biological products for human use, which are subject to a licence.

Pharmaceuticals are divided into the following six sections in relation to their prescription status:

• Section I – prescription pharmaceuticals that can only be acquired by a special prescription or permit issued by the regulatory authority (eg, controlled substances);
• Section II – prescription pharmaceuticals that require a prescription to be collected and retained in the pharmacy as well as being registered in the pharmacy control books;
• Section III – pharmaceuticals that can only be purchased with a prescription that may not be supplied more than three times and that must be recorded in the control book and retained in the pharmacy after the third supply;
• Section IV – pharmaceuticals that require a prescription, but which can be supplied as many times as directed by the physician (eg, antibiotics);
• Section V – non-prescription pharmaceuticals, authorised for sale only in pharmacies; and
• Section VI – pharmaceuticals that do not require a prescription and can be supplied in any establishments other than pharmacies (eg, OTC products).

A vast body of law, including secondary regulations, technical standards and administrative decrees, controls the area of foreign trade and customs law. These are not necessarily co-ordinated with the health regulation, creating frequent issues for companies in the pharma and medical devices sectors.

By way of example, product classifications can differ to the extent that a product may be classified from a customs perspective as a cosmetic for importing purposes and as a medical device from a regulatory perspective for commercialisation purposes. This in turn can have a tax impact on the applicable rate of Value Added Tax.

Depending on the moment and the type of regulation to which the goods are subject, the following authorities could be involved:

• the Tax Administration Service;
• the National Customs Agency of Mexico;
• the MoH, through COFEPRIS;
• the Ministry of Economy, mainly through the General Direction of Standards and the Federal Consumer’s Protection Agency (PROFECO); and
• the Attorney General’s Office.

Depending on the type of good, enforcement may also be in the remit of the Ministry of Agriculture, Livestock and Natural Resources, the Ministry of Defence, the Federal Commission of Telecommunications, etc.

Imports must be carried out by an individual or legal entity that is registered in the Importers’ Registry, which is administered by the Tax Administration Service.

Depending on their tariff classifications, certain goods – including certain chemical products, radioactive goods, chemical precursors and essential chemical products – may be subject to registration in the Specific Sectors of the Importers’ Registry. This registration is subject to additional requirements, which depend on the sector in which the importer is to be registered.

Imports of all pharmaceuticals and some medical devices are subject to the obligation of securing specific import permits.

While such imports are normally administered by the MoH through COFEPRIS, depending on the type of product they may also be subject to other types of import or export permits, including those imposed by the Ministry of Economy, the Ministry of Agriculture, Livestock and Natural Resources, the Ministry of Defence, and the Federal Commission of Telecommunications.

Among others, the following exceptions to the obligation to secure an import or export permit may apply, but only for non-commercialisation purposes:

• importing for personal use;
• importing for donations;
• importing for experimental use; or
• importing for low-prevalence diseases.

In Mexico, non-tariff regulations and restrictions – such as import permits and licences – are imposed based on the tariff classification (Harmonised Tariff Schedule (HTS) code) and the description of the goods to be imported or exported.

Pursuant to the Mexican Constitution, the executive power may regulate or restrict the importation or exportation of products, provided that Congress grants it such authority. The use of that authority needs to be approved by Congress at the end of each year.

Under the Foreign Trade Law, Congress grants this authority to the executive power, with the condition that – in order for a non-tariff regulation or restriction to be imposed ‒ the corresponding decree or administrative regulation must be published in the Federal Official Gazette and the goods subject to such regulation or restriction must be listed by tariff classification and description.

Mexico has entered into 14 free trade agreements with more than 50 different countries.

Mexico is an active party to the Pacific Alliance (along with Chile, Colombia and Peru). The Pacific Alliance and its framework agreement have specific provisions on regulatory co-operation and product-specific annexes, covering cosmetics, medical devices, dietary supplements and cleaning products. This has started a very promising regulatory harmonisation/convergence process in the region.

Mexico is also party to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (the revised Trans-Pacific Partnership Agreement), which contains promising provisions on the regulatory co-operation side, as well as product-specific annexes.

The United States–Mexico–Canada Agreement (USMCA) entered into force in July 2020 and contains several regulatory annexes for pharmaceuticals, medical devices, chemical substances, cosmetic products and food products.

In Mexico, the private and public markets for medical products have separate rules depending on whether the products are patented. However, this mainly applies to pharmaceuticals and has changed during the new federal administration.

The very general legislative bases of the dual system are contained in two laws: the GHL (Article 31) and the Federal Economic Competition Law (Article 9). However, the rest of the rules are largely contained in separate regulatory instruments of lower hierarchy, including the Addendum to the Agreement for Drug Pricing Co-ordination signed in 2004 between the Ministry of Economy and the National Chamber of the Pharmaceutical Industry, and the technical standard for the labelling of drugs (NOM-072-SSA1-2012).

Private Market

Patented drugs for the private market are subject to a hybrid system that is largely self-regulated and voluntary. Under this system, companies compile their own information about their prices in other jurisdictions and submit that to the authority, which monitors the accuracy of the data.

The manufacturer is required to stamp the price on the label of the product at the end of the manufacturing process. PROFECO verifies that the prices at the point of sale (ie, at pharmacies) do not exceed that price.

Generic drugs, off-patent products and medical devices in general are not part of this pricing regulation, being subject to direct price competition in the market. Newly launched products are initially exempted, as explained here.

Public Market

Until very recently, patented pharmaceuticals for the public market were subject to a different process of annual negotiation. For ten years, such negotiations were held with the Co-ordinating Commission for Negotiating the Price of Medicines and other Health Inputs (Comisión Coordinadora para la Negociación de Precios de Medicamentos y otros Insumos para la Salud, or CCPNM), which was created in 2008 and gathered all major public institutions buying drugs in Mexico, as well as the Ministries of Public Administration, Finance, Economy and Health. However, the new federal administration that took office on 1 December 2018 introduced two major changes.

First, it eliminated the CCPNM, transferring the whole pricing process to the public procurement system. That change eliminated the prior distinction between pricing and acquisition, which are now defined in the same process for patented medicines.

The estimated price for generic and off-patent products was initially defined by those public institutions co-ordinating the public procurement exercise, based on their market research. However, the price would also be influenced by the discounts offered by the participating bidders and would ultimately be determined in the acquisition award and contract.

The administration then changed the rules again, by means of issuing a new version of the Secondary Regulations for the National Compendium, which creates a National Formulary from which public health institutions must – in principle – acquire the medical products they need. The new version incorporated new provisions under which a company must provide a maximum price as part of process to add products; if the addition is approved, that maximum price will become the basis for any public acquisition mechanism.

Newly launched pharmaceuticals for the private market are initially exempted from the maximum retail price (MRP) system ‒ given that, in principle, they would not have a comparator. The manufacturer can initially set the price, subject to a re-evaluation three months after the product launch. The review is conducted to verify whether the product exists in the international market. If this is confirmed, an MRP will be estimated. If this occurs, the price of newly launched products will be influenced by prices for the same product in other countries, but not based on a health technology assessment. The price regulations for medicines do not apply to medical devices.

The Mexican system operates not through a model of reimbursement, but through a model of public procurement of drugs and medical devices.

There is a comprehensive legal regime for public procurement in Mexico, overseen by the Ministry of Public Administration in co-ordination with the purchasing entity. However, this may change during the new federal administration. In general, public procurement operates through three mechanisms:

• public bidding, with a national or international scope;
• invitation to at least three persons; and
• direct awards.

Whereas public bidding is the general rule, purchasing by invitation or direct award is allowed under certain circumstances, which are listed in the Federal Law for Procurement, Leases and Services of the Public Sector. One of the exemptions refers to cases where there are no substitute products, there is only one possible supplier or the required product is patent protected.

Accessing the public market for pharmaceuticals does not begin directly with public procurement. Other key regulatory steps must first be met, given that public procurement works through product codes granted by other health authorities, in relation to a Basic Formulary and several Institutional Formularies. The process for incorporating a product to the Basic Formulary and then to Institutional Formularies takes two to four years. The decision is based largely on economic evaluation. A product can only become part of a public procurement exercise once it has been allocated a code, which ‒ in the case of medicines ‒ is assigned per active ingredient.

On 8 November 2022, the General Health Council (GHC) published a Decree that created a new Commission for the National Compendium for Medical Products, replacing the Inter-Ministerial Commission for the Basic Formulary. A new set of International Regulations for the National Compendium was then issued on 22 November 2022, bringing several changes to the system – including one that has been a source of controversy and litigation, relating to the introduction of a new requirement. The new rules now state that an application to add a product must first obtain and submit a sponsoring letter from one of the public payors, representing an access barrier.

In 2022, after the results achieved through the collaboration agreement signed by the National Health Institute for Wellness (Instituto de Salud para el Bienestar, or INSABI) and the United Nations Office for Project Services (UNOPS), it was decided that the mechanism would no longer be used as the main route to acquire medical products. Instead, a new decentralised body was created (Instituto de Seguridad Social para el Bienestar, or IMSS-Bienestar), which – together with INSABI – is expected to co-ordinate public acquisitions of medical products.

A lot of uncertainty continues to exist and many stakeholders expect the public procurement system to go back to normal once this federal administration finishes its term in 2024.

Previously, the methodology was quite clear and included cost-benefit analyses. Now it is not clear. It is also not currently clear whether the new administration will be open to exploring value-based proposals.

The regulatory framework links the rules of prescription and dispensing with those of substitution at the point of sale. There are two scenarios for the private and public markets.

• For the private market, the first rule is that prescribing by the active ingredient or generic name is mandatory, and that the use of the distinctive name or trade mark of the product is optional for the health professional. The second and perhaps most important rule is that if the prescription contains only the generic name, pharmacists are allowed to substitute the product. Conversely, if the product was prescribed by its distinctive name, then substitution at the point of sale is forbidden.
• For the public market, although the basic rule structure is the same, there is no reference to the option of prescribing by trade mark – meaning that substitution is always allowed. At the same time, it has also become a long-held practice in the public sector to prescribe using the product code allocated in the Basic Formulary or National Compendium, which is based on the active ingredient as well. There are provisions allowing prescriptions to be made under different conditions, but the respective institution would need to authorise such decisions, which is not common.

Until December 2021, there were no specific regulations for medical apps. However, this changed with the new version of NOM-241 and there are now specific provisions for software with health-related functionalities, including a definition of software as a medical device (SaMD). NOM-241 entered into force on 20 June 2023.

In addition, a new version of the Supplement on Medical Devices was published. The Supplement on Medical Devices is the more detailed legal instrument for the regulation of digital health applications, including medical apps. These new rules a cover classification of risk level, quality system, and clinical evaluation of both SaMD and medical apps. SaMD as a concept was introduced by the International Medical Device Regulators Forum.

There are no special rules for telemedicine as yet; a technical regulation was drafted at one point but it was withdrawn. That failed attempt did not fully address the physician-to-patient private market interaction,covering only a clinic-to-clinic scenario, mainly to address an urban-to-rural public institution vision.

The absence of special new rules for telemedicine means that the existing rules and requirements for the provision of health services and the exercise of medicine are applicable, including the existence of a physical consulting room from which the health service is supposedly provided, and the need to be licensed in Mexico in order to practise medicine. Several draft initiatives on digital health have been submitted to the Federal Congress, all of which proposed a prior approval system for telemedicine platforms.

The same legal instruments that are applicable to printed regulated advertising material apply to online content. However, additional guidance documents have been produced by the regulator, including provisions that refer to digital advertising, advertising on social networks, and permits for online portals.

There is still a contradiction between two key regulatory instruments. Whereas the Secondary Regulation for Medical Services was amended in 2018 to allow the prescription of medicines by electronic means, the Secondary Regulations for Medical Products still refers to a handwritten signature. The problem is that the first instrument applies to physicians and the second one applies to pharmacies. The contradiction has made pharmacies hesitate, as they are primarily bound by the unchanged instrument. However, in 2020, the Supplement for Establishments of the Mexican Pharmacopeia was amended to allow for an e-signature. The problem was that it imposed an additional authentication measure that was not previously required and it excluded certain groups of products from its scope. Several draft initiatives have been submitted to the Federal Congress that would align this at the law level. One of these draft initiatives was approved by the lower chamber on 27 March 2023.

The online sale of medicines and medical devices is closely linked to the issue of whether the retail of a product category is restricted to a particular point of sale.

In that context, there would essentially be three groups of medicines:

• those that require a prescription and can only be sold in pharmacies;
• those that do not require a prescription but have to be sold in pharmacies; and
• those that do not require a prescription and can be sold elsewhere.

In contrast, there would be two groups for medical devices:

• those that are restricted to specialised shops (ie, orthopaedic devices); and
• those that can be sold elsewhere, including pharmacies.

From there, it is important to note that there is not yet any regulation addressing the online sale of medicines; the existing rules applicable to physical pharmacies would apply. Thus, the regulatory set-up to support the online sale of products would have to take into account the existence of a retail control for the relevant medical product and the existing rules for certain specialised retail shops.

There are multiple legal instruments to consider, including Technical Standard NOM-004-SSA3-2012 on health records and NOM-024-SSA3-2012 on the electronic health record. However, there are still gaps in the regulation, including more flexible mechanisms to account for the electronic signature of such records.

Patents are regulated by the new Federal Law for the Protection of Industrial Property (FLPIP), which entered into force on 5 November 2020, and are granted by the Mexican Institute of Industrial Property (Instituto Mexicano de la Propiedad Industrial, or IMPI).

In Mexico, the issues most frequently encountered by companies when trying to apply for patents include the intention of some examiners to limit the scope of protection of the subject matter as exemplified in the specification of the invention. Understanding the law and the science behind the invention is required to overcome this, which calls for in-house technical expertise.

One of the critical issues with regard to pharmaceutical patents is the need to obtain patent protection for second and subsequent medical uses. Despite the fact that second uses have been accepted in Mexico, there had been no legal bases for their protection. The new FLPIP provides legal certainty for such protection and expressly states that new uses of known compounds shall be patented as long as they comply with the other requirements established in the law.

Any activity conducted in relation to the protected second use without proper consent will constitute an infringement.

Under the new FLPIP, it is now possible to adjust the validity of patents through supplementary certificates for patent applications filed as of 5 November 2020. These supplementary certificates must be requested by the patent applicant to compensate for unreasonable delays from the IMPI, provided that the granting of the patent took more than five years from the date of its presentation in Mexico. The term of validity of the supplementary certificates may not exceed five years, and the validity will be one day for every two days of unreasonable delay attributable to the IMPI.

Unreasonable delays will be counted from the date on which the IMPI notifies the patent owner of the official action informing that the formal examination has been concluded. The periods attributable to actions or omissions of the applicant (such as delays in answering requests or extending the deadlines to respond to them) will not be taken into account when accounting for the unreasonable delay, nor will periods that are not attributable to the IMPI (such as the procedure being suspended owing to litigation or by acts of force majeure).

Supplementary certificates that were granted in violation of the law could be objected to by third parties.

The following activities constitute patent administrative infringements:

• giving the appearance that a product is patented when it is not – if the patent has lapsed or been declared invalid, the infringement will begin one year after the date of the lapse or, where applicable, the date on which a declaration of invalidity became effective;
• manufacturing or producing products that are protected by a patent without the consent of the owner of the patent, without the appropriate licence;
• offering for sale or distributing products that are protected by patent knowing that they were manufactured or produced without the consent of the patent owner or without the appropriate licence;
• using patented processes without the consent of the patent owner or without the appropriate licence; and
• offering for sale or distributing products that are the result of the use of patented processes, knowing that these have been used without the consent of the patent owner.

It is worth noting that, in Mexico, only actual infringement is actionable; the threat of infringement is not considered by the FLPIP.

The Bolar Exemption was initially incorporated into the health regime. The RIS grant this protection to an application of a generic drug that is submitted during the last three years of a patent over an active ingredient, and to an application of a biosimilar drug that is submitted during the last eight years of a patent over the active ingredient.

The new FLPIP included a new provision that the right conferred by a patent will not produce any effect against a third party that uses, manufactures, offers for sale or imports a product with a valid patent exclusively to generate tests, information and experimental production necessary to obtain an MA for drugs for human health.

This is different to the Research Exemption found in the former industrial property regulation and maintained in the new FLPIP, which stipulates that a patent shall not have effect against any third party who – in the private or academic field, and not for commercial purposes ‒ engages in scientific or technological research for purely experimental, testing or teaching reasons.

Under the Mexican IP regime, compulsory and emergency licences are available.

Compulsory Licences

With regard to compulsory licences, the FLPIP provides that – three years after the date of the grant of the patent or four years from the filing of the application (whichever happens first) – any person may apply for the grant of a compulsory licence to use the invention when it has not been used, unless there are justified reasons for the invention not having been used. The importation of the patented product is considered to be use.

However, prior to granting the first compulsory licence, the IMPI shall give the patent owner the opportunity to exploit the patent within a period of one year, counted from the date the compulsory licence request was notified. If the patent is not exploited after that year, there will be a hearing, and the IMPI will decide whether to grant the compulsory licence. If it decides to do so, the IMPI shall specify its duration, terms and scope, as well as the royalties payable to the patent holder.

Emergency Licences

As regards emergency licences, the FLPIP provides that – for emergency reasons or national security and for as long as the relevant situation continues (including serious diseases designated as such by the GHC) ‒ the IMPI shall publish a declaration in the Federal Official Gazette, whereby certain patents can be exploited by means of granting a public use licence. This is for cases where the production, supply or distribution of the patented product would be prevented, hindered or made more expensive for the public if such a declaration is not made.

In the case of an emergency caused by serious diseases that may harm national security, the GHC will make a declaration of priority treatment. Once the declaration is published in the federal Official Gazette, pharmaceutical companies may request from the IMPI the right to exploit the corresponding patent. The IMPI would then have 90 days to decide whether to grant the emergency licence, after hearing the parties and evaluating the circumstances.

The MoH shall establish the conditions applicable to the production, quality, duration and scope of the emergency licences, and the qualification of the technical capacity of the applicant, as well as a reasonable amount for the royalties to be paid to the patent owner.

The following points are worth noting in relation to important procedural considerations:

• any patentee or licensee can submit a suit against a third party for infringement (unless it is expressly forbidden from doing so in its licence agreement);
• an important available remedy is the option to obtain provisional injunctions; and
• another essential available remedy is to claim damages before a civil court or before the IMPI under the new FLPIP, but this can only be initiated after the administrative infringement has been declared by the IMPI.

The patent infringement procedure is essentially composed of two stages. First, an infringement declaration is obtained through an administrative proceeding before the IMPI. Then, damages must be obtained directly with the IMPI or before a civil court.

An invalidity defence is available in the Mexican IP regime if the patent being enforced was:

• granted in violation of the provisions on requirements and conditions for the grant of patents;
• granted in violation of the provisions of the law in force at the time the patent was granted;
• abandoned as an application during its prosecution; or
• granted by error or to someone who was not entitled to it.

In practice, invalidity is invoked by the defendant when answering the infringement complaint.

In Mexico, there are no pre-launch declaratory actions, requirements to notify a patent holder, or requirements to clear the way.

Patent linkage was introduced in Mexico in 2003 through a parallel amendment of the RIS and the Secondary Regulation of the Industrial Property Law (SRIPL).

The amendment to the RIS introduced a patent linkage that excludes process patents and explicitly includes only product patents over the active ingredient. However, through litigation, protection has been extended to patents over formulation, doses and use.

The amendment to the SRIPL created a Special Edition of the Intellectual Property Gazette, issued by the IMPI, in which all relevant and valid patents for active ingredients are listed.

The trigger for protection is the inclusion of a relevant patent in the Special Gazette. The extended protection mentioned was achieved through litigation aimed at the inclusion of patents over formulation, dosing and use in the Special Gazette.

At the same time, the amendment to the RIS mandates all applicants for an MA of a drug to submit full information on the status of patent protection relating to its product. Applicants must demonstrate that they are the owner or the licensee of the relevant patent, if any. For this, applicants must produce and sign a sworn oath that they do not infringe patent rights. Then, when receiving an application for a drug approval, COFEPRIS is obliged to make an internal consultation to the IMPI in relation to the patents that may be directly relevant to that product.

However, the provisions are not very clear, and the ambiguities have created a system that has led to much litigation and to a situation where the burden of proof is essentially carried by users. Patent holders have to litigate inclusions and, if successful, they have to inform COFEPRIS of the results in order to have an impact on the drug approval system.

At the end of 2020, the IMPI implemented electronic tools to make it easier to consult information on patents, with the aim of improving transparency. Through these tools, it is possible to consult:

• the list of patents that will expire in the next ten years;
• a search tool for patents associated with allopathic drugs; and
• the IMPI’s responses to COFEPRIS on patent linkage issues.

Assuming that a patent infringement action has already been initiated, there are a couple of additional measures that can be taken to obtain extra protection against the counterfeit of protected pharmaceuticals and/or medical devices. One of these measures is the seizure of the infringing goods, both in actual commerce and in customs. Alternatively, the confiscation of packaging, stationery, advertisements and similar objects that might be used to infringe the protected rights is also possible, as well as the seizure of instruments used for the manufacture and commercialisation of those infringing products, according to the Mexican IP Law.

Criminal procedures can be triggered against the following:

• the reoccurrence of a patent infringement;
• the intentional falsification of a protected trade mark;
• the production, storage, transportation, importation, distribution or commercialisation of goods that bear a counterfeited trade mark; or
• the intentional supply of raw materials used for the manufacture of the previously mentioned goods.

Once the trade mark registration has been obtained from the IMPI, no direct restrictions can be actioned against the use of those rights, unless a prior annulment declaration has been issued by the proper authority. However, limitations on the use of a trade mark can be caused by infringement actions against unfair competition practices or trade dress violations. In addition, parallel importation restrictions could affect the use of brands, but only when the owner of the trade mark abroad is not the same as the one in Mexico or when both parties do not belong to the same corporate structure. Given that prior use rights are recognised under the Mexican IP Law, restrictions on the exclusive use of a protected trade mark could be updated as well, as prior users are not regarded as infringers.

Antitrust, consumer welfare and sanitary restrictions could also affect the use of trade marks, although they do not jeopardise the validity of the IP registration. By way of example, the name of a pharmaceutical product could first be protected by a registered trade mark, but eventually not be allowed by COFEPRIS to be used as the distinctive name for the approved medicine, owing to the different approval criteria (eg, the health law regime forbids names that contain the same three letters in a word or generally any reference to organs and diseases on the respective product’s name).

Under the new FLPIP, trade dress (plurality of operative elements, image elements (including size, colour, design, packaging) or any other elements that distinguish products or services) can be protected in Mexico as a trade mark. In addition, trade dress had been protected in the former law and continues to be protected by the FLPIP through infringement actions against any individual who uses signs, operative elements and image combinations that are employed to identify goods or services that are confusingly similar to previously registered ones ‒ given that such usage deceives consumers, making them believe a commercial relation exists between the owner of the rights and the unauthorised user.

Protection for the design of pharmaceuticals and medical devices, as well as their packaging, can be achieved through the registration of a trade mark (design, 3D or trade dress), copyrights, unfair competition and/or an industrial design (ornamentation arrangements in 2D and 3D).

According to the Mexican IP Law, data exclusivity for pharmaceuticals (only) is protected under the terms of the international treaties to which Mexico is a party (eg, the USMCA). The protection is granted for at least five years from the date of the approval, but the regulator – as a matter of policy – has only recognised such protection for new chemical entities, excluding orphan drugs, biologics and biotech drugs. However, the protection for these can be obtained through litigation.

Although the first USMCA text adopted in 2018 contained stronger provisions on data exclusivity, the final amended protocol of 2019 eliminated them, leaving the protection essentially as it was before.

The federal government did not generally seek to facilitate the import and commercialisation of any medicine or medical device required in the private sector to combat COVID-19, focusing only on public acquisitions of medicines and medical devices. On 27 March 2020, the government issued a decree in which it exempted medicines and medical devices acquired by the federal government from public tenders and import permits.

Instead of facilitating existing procedures, it created new authorisations and emergency approvals, which did not exist before and still lack any legal bases.

COFEPRIS did not issue any measure to facilitate the continuation of clinical trials. Instead, it issued a communication on 21 April 2020 whereby it reiterated that any change to the approved conditions described in a research protocol would require the approval of an ethics committee and COFEPRIS.

Although emergency authorisations do not exist in the regulatory framework in Mexico, the federal government issued many of these during the pandemic, including for:

• diagnostic tests performed at labs;
• ventilators;
• sanitisation services;
• vaccines; and
• medicines.

The scope of these authorisations is largely unknown, as there is no transparency or publicly known database in this regard.

Apparently, certain restrictions have been incorporated in some of these emergency authorisations – for example, in the authorisation of the medicine Remdesivir, the indication for which was apparently limited to “use in specialised hospitals”. However, as this form of authorisation does not exist in the legal framework, any restriction could be challenged.

COFEPRIS published an informal announcement on its website on 8 July 2020, in which it indicated that GMP certificates could be extended for six months under certain conditions. The extension would apply if the product had not been subject to:

• complaints in Mexico;
• sanitary alerts issued abroad; or
• safety measures in Mexico (eg, suspension of activities).

On 27 March 2020, a presidential decree was issued in relation to any medicine or medical device related to COVID-19, allowing for:

• its public acquisition without public tenders; and
• its importing without any administrative requirement.

No specific regulation was issued to facilitate telemedicine, although some local governments created limited programmes for remotely monitoring the conditions of patients. However, no new instrument was issued to clarify any of the pending issues, such as the existence of contradictory secondary regulations in relation to e-prescriptions.

The federal government did not announce any intention to issue compulsory licences for products related to COVID-19. However, during a formal visit to Mexico in February 2021, the President of Argentina announced Argentina’s intention to request G20 countries to declare COVID-19 vaccines as “global goods”, which the Mexican President endorsed. Nevertheless, no further legal step was taken in this regard.

If the federal government decides to pursue that avenue, it would have to comply with \Article 153 of the FLPIP, which establishes the conditions for issuing a compulsory licence in the event of emergencies when not doing so would impede, hinder or make more expensive the availability of medicines.

The aforementioned provision creates a procedure where the GHC first issues a declaration of serious disease for priority attention. Interested companies can then apply for licences to the IMPI, which will make a decision in no later than 90 days, after receiving the opinion of the GHC. The MoH will then define the manufacturing and quality requirements for the product, as well as the scope, timeframe and royalties for the compulsory licence, which shall be non-exclusive and non-transferable.

The federal government has declared that, since March 2020, COVID-19 constituted a serious disease for priority attention. However, this was a verbatim replication of the similar declaration made regarding the 2009 AH1N1 pandemic, rather than an announcement of its intention to issue compulsory licences.

On May 2023, the federal government declared the end of the emergency health measures to prevent and control COVID-19, formally putting an end to the pandemic.

No special provisions were introduced over product liability of COVID-19 vaccines.        

In contrast to health services, where there was indeed an official programme to convert public hospitals into COVID-19 care facilities, there was no equivalent intention in relation to the manufacturing of pharmaceuticals or medical devices.

There have been profound changes to the system for public procurement of medicines and medical devices since the new federal administration took office in 2018, including changes to large centralised purchases, which for many years had been managed by the Mexican Institute of Social Security. The administration first transferred the responsibility to the Ministry of Finance; when that failed, it signed a collaboration agreement and transferred it to the United Nations Office for Project Services (UNOPS), which so far has also failed. However, those changes pre-dated the pandemic.