Life Sciences 2021

Last Updated March 22, 2021

Mexico

Law and Practice

Authors



Baker McKenzie provides a healthcare and life sciences industry group which is active on matters throughout the whole life cycle of products, from research and development to manufacturing and commercialisation. It provides industry-focused and integrated advice in the fields of regulatory, data privacy, intellectual property, transactional and M&A, foreign trade, antitrust, compliance, tax and litigation. It acts for the leading players of the industry, including local and multinational companies, with key sectors including medicines, medical devices, health services, dietary supplements, cosmetics, food and beverages, cleaning products, seeds, biocides, fertilisers, biofuels, alcohol and tobacco. Lawyers are also actively involved in the legal and trade associations that have a life sciences focus or working groups.

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 (HSR);
  • the Health Services Secondary Regulations (HSSR);
  • the Health Advertisement Secondary Regulations (HASR);
  • the Clinical Research Secondary Regulations (CRSR); and
  • several Official Mexican Standards (OMS) on specific technical aspects (eg, good manufacturing practices or stability).

In Mexico, the legal and administrative nature of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is that of an autonomous agency, under the administrative structure of the Ministry of Health. The General Health Law created and provided the COFEPRIS with administrative, technical and operational autonomies. 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. For a federal administration that took office in 2018 with a promise to eliminate the COFEPRIS as an independent body and absorb it into the Ministry of Health, this Ministerial Decree has been regarded as a legal step towards it becoming fully part of the centralised administration.

Decisions from 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 shall 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 requirement for litigating regulatory decisions is to have an interdisciplinary team of lawyers and pharmaceutical chemists, so that both the science and the law can be properly understood and argued in each case.

There is a general impression that there has been no significant litigation relating to decisions taken by health regulators, but this is not an entirely accurate perception, as litigation has always existed in this area. However, it is true that, as the regulatory framework has evolved into a more complete set of legal rules and as regulatory work is now being undertaken not only by technical professionals such as pharmaceutical chemists, but also by lawyers, companies have felt increasingly confident to challenge regulatory decisions that affect their interests.

It is important to understand the historical context behind those perceptions. On the one hand, given its highly technical content, regulatory work was mainly undertaken by pharmaceutical chemists, both in companies and in regulatory agencies. On the other hand, the law in this area did not evolve as quickly as did the science and the market. Regulatory decisions frequently had to be made, not on the basis of existing legal rules, but exclusively upon technical criteria, which led to a highly discretionary system. Although decisions were vulnerable, the concern was that challenging a decision over one product would affect other pending administrative decisions over other products.

Fortunately, the situation has changed in recent years. New administrations have aimed at keeping the legal framework up to date and have brought in more lawyers, in an effort to achieve a Rule of Law in health law and regulation. This means that litigation matters have been increasing, which is reflected in the specialisation of courts. In fact, the Federal Administrative Tribunal has a Specialised Chamber to appeal decisions made by the COFEPRIS.

A clear trend has now emerged, this year. The new federal administration that took office in December 2018 decided that corruption was the main problem in Mexico. With that in mind, they decided to replace the first and second levels of all public agencies, including the COFEPRIS, and to forbid direct contact with the users.

This resulted in a regulator both inexperienced and unwilling to meet with the industry to understand and discuss the challenges of the sector. This combination quickly led to a sharp increase in litigation of regulatory decisions. In 2021 a new federal commissioner at the COFEPRIS was appointed and there is a great deal of expectation that things may improve.

The administrative review, annulment action and amparo trial would also be the applicable appeal proceedings to challenge the decisions of federal regulatory bodies that involve other products, such as foods, beverages and dietary supplements.

There are two basic categories of pharmaceuticals: prescribed and non-prescribed drugs. In addition, controlled substances require a special prescription.

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

  • Class I – those which are recognised in medical practice, of which the safety and efficacy has been proved, and that generally are not introduced into the human body;
  • Class II – those which are recognised in medical practice, that can vary in the way they are manufactured or in their concentration, and that regularly are introduced into the human body, remaining there for fewer 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 General Health Law;
  • the Clinical Research Secondary Regulations;
  • Technical Standard NOM-012-2012-SSA3;
  • the Guidelines for Good Clinical Practice published by the COFEPRIS; and
  • the Decree for the Operation of Ethics Committees, co-ordinated by the National Bioethics Commission.

In general, clinical trials (Phases I-IV) shall 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 of the Health Institution, the Ethics Committee and the 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 the COFEPRIS and the National Bioethics Commission (ConBioetica). However, the Decree for the Operation of Ethics Committees (2012) provides a clearer legal framework, establishing their structure, their objectives, the role of their members and the requirement to be registered before both ConBioetica and the COFEPRIS.

Notably, the Guidelines for Good Clinical Practice (2012) (GCPs) make a clear reference to international best practice, including standards developed by the International Conference on Harmonisation (ICH). It is important to note that these GCPs will be the basis to move towards a certification system, for which the 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.

In addition, other regulatory measures have been introduced to promote Mexico as a place for conducting clinical research, including the following:

  • an important amendment to the Health Supplies Secondary Regulations (RIS) – Article 170 of 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 of a drug produced abroad, which therefore made it impossible to have Mexico as the first country of registration; however, in 2012, this was changed to make it possible to submit a Clinical Trial Report instead, provided that the Mexican population was included in the trial; and
  • the creation of Third Authorised Parties for Clinical Research – the COFEPRIS has now authorised several public hospitals with extensive experience on clinical research to conduct a pre-evaluation of Research Protocols. If their report is positive, approval times at the COFEPRIS will be reduced significantly.

The same rules regulate both medical devices and pharmaceuticals.

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

  • the 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 from 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 the COFEPRIS, which, according to the Federal Law on Administrative Proceedings, must take place within three months of filing.

Currently, after their protocols have been authorised by the COFEPRIS, most trials are recorded in the National Registry of Clinical Trials (RNEC). The information contained in the RNEC is collected by the COFEPRIS in collaboration with those responsible for conducting the clinical trial (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 there was almost no local information 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.

However, there is no binding provision to disclose or publish the results of clinical trials, but the Code of Ethics of the Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) does contain a specific obligation for Sponsors to disseminate the positive and negative results of the 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 recruiting 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 that its content is reviewed on a case-by-case basis.

The resulting data from the clinical trial would be considered as personal if the patients enrolled in the clinical study were 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 as personal data.

It is permitted to transfer the resulting data of the clinical trial to a third party or to 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 from the person concerned express written consent for processing, through their 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 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 starting operations.

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

However, the definition contained in different legal instruments for medical device is as follows: "the substance, material, apparatus, or instrument (including software), used on its own or in combination, for the diagnosis, monitoring or prevention of diseases; or as auxiliaries for the treatment of diseases and disabilities; as well as for the replacing, correction, restoring or modification of the anatomy or physiological processes of humans". Initially, any product that falls into that definition should be considered as a medical device.

It is also important to remember the "List of Products that for its Nature, Characteristics and Uses are not Considered Health Inputs". If the relevant product is found in this List, it 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 marketing authorisation for pharmaceuticals for human health and for medical devices, which is granted by the COFEPRIS. The same requirements of quality, safety and efficacy apply, regardless of whether the product is allopathic, homeopathic, herbal or a vitamin pharmaceutical. However, a significant difference would exist between the extent and scope of safety and efficacy data that would be required for an innovator product than 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 New Molecules Committee of the COFEPRIS.

The period of validity of any marketing authorisation for pharmaceuticals and medical devices is five years. After this period, marketing authorisations may be renewed every five years. At any time, marketing authorisations may be revoked by the COFEPRIS, for instance when a new risk to human health is found, if an infringer repeatedly disregards safety measures or if false information is submitted.

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

  • payment of governmental fees;
  • a manufacturing licence or equivalent;
  • a notice of appointment of a qualified sanitary officer;
  • draft labels;
  • 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
  • preclinical studies, including pharmacodynamics, pharmacokinetic and toxicology studies.

In addition, for products manufactured abroad, it is necessary to file a representation letter granted to the holder.

The application to obtain a marketing authorisation for medical devices must be submitted with the following:

  • payment of governmental fees;
  • 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, in case they are required.

In addition, for products manufactured abroad, it is necessary to file 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 a term of 180 days;
  • for pharmaceuticals of which the active ingredients are not registered in Mexico but are registered and sold freely in their country of origin, a decision shall be taken within a maximum of 240 days;
  • for new molecules, after a prior technical meeting between applicants and the New Molecules Committee of the COFEPRIS, the decision shall be taken within a maximum term of 180 days;
  • for homeopathic, herbal and vitamin pharmaceuticals, decisions shall be taken within a term of 45 days; and
  • for biotechnological drugs, applications shall be resolved within a period of 180 days.

These approval times can be extended if the COFEPRIS requires additional information, and can also be reduced significantly if applicants include a prior favourable opinion issued by a Third Authorised Party.

For class I medical devices, the decision must be granted within a term of 30 days; for class II, the decision shall be taken within 35 days; for class III, the decision shall be taken within a maximum term of 60 days. As with pharmaceuticals, these approval times can be extended if the COFEPRIS requires additional information, and can also be reduced significantly if applicants include a prior favourable opinion issued by a Third Authorised Party.

There is no mandatory requirement to conduct clinical trials in a paediatric population or to obtain a waiver from this requirement in relation to individual pharmaceuticals. This is completely optional and subject to stricter requirements.

The variation of marketing authorisations is classified under administrative or technical modifications. 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 marketing authorisation is regarded as an administrative modification. Each application to modify a marketing authorisation shall 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.

Additionally, if the relevant product is included in the List of Products that for its Nature, Characteristics and Uses are not Considered Health Inputs, it would not be considered as a pharmaceutical or medical device and consequently would not require a marketing authorisation.

In January 2020, the Ministry of Health issued a Decree that (i) extends the equivalency registration route, which expedites the approval of products already registered in certain other jurisdictions, to include larger groups of countries, and (ii) allows the government to take a decision to import medicines without a marketing authorisation if they conclude that existing and approved products have problems of quality, safety and efficacy or GMP issues and there is a need to guarantee supply for the public sector. This has been highly controversial, as the measure includes four different groups of countries, with one including China and India.

Furthermore, in November 2020, the Ministry of Health issued another Decree, which creates a new ultra-fast registration pathway, built upon the extended equivalency route previously mentioned. For products previously approved in any of 50+ countries included in the January 2020 Ministerial Decree, it provides: (i) an approval deadline of five working days, and (ii) if the regulator fails to take a decision in that deadline, it will be considered approved, which is known as "approval by afirmativa ficta". The COFEPRIS has since announced this will only apply to products to be acquired by the government, but the Decree does not necessarily states that clearly. Thus, this will likely be a source of contention and litigation.

This ultra-fast registration pathway, on the one hand, has been highly criticised, as a form of renouncing a constitutional duty to protect the human health of people. On the other hand, this could represent a first example of "regulatory reliance", which has supporters in international organisations.

Holders of marketing authorisations must comply with good manufacturing practices, stability, pharmacovigilance or technovigilance and labelling standards and regulations; they must also comply with advertising regulations applicable to pharmaceuticals or medical devices.

In general, both pharmaceuticals and medical devices are subject to post-approval vigilance. These obligations are developed in Technical Standards, which generally specify rights and obligations for holders of marketing authorisations, distributors, research sites, health institutions, physicians and patients to monitor adverse events or incidents, investigate them, and report them. It is also required 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), which is decided by the New Molecules Committee.

The COFEPRIS has periodically published lists of applications, and of granted or rejected marketing authorisations. 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 the COFEPRIS, under the mechanisms overseen by the National Institute for Access to Public Information and Data Protection (INAI), the COFEPRIS had historically resisted providing access to most of the files of marketing authorisations, 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, however, the COFEPRIS has now begun to populate a public database on its website that displays key data contained in the marketing authorisations for pharmaceuticals.

Confidential information is protected by several special laws, including privacy intellectual property, administrative procedures, labour and criminal law.

Relevant legislation includes a combination of the Health Law, the Federal Consumer Protection Law and the Federal Criminal Code. These legislative bills provide jurisdiction to other 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 specific 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 either the Consumer Protection Law or the Health Law. These investigations shall be based on a hazard against health or a consumer protection liability, rather than intellectual property infringement. It should be noted 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.

As a general note, it is important to note that 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 the COFEPRIS, the Federal Attorney General Office (PGR), 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 of the foregoing, depending on the investigation’s outcome, there can be injunctive relief such as the 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 that the title-holder follows the official investigation closely to ensure that the Administrative Agencies or the Law Enforcement Agencies will liaise in due course.

A combination of provisions found in international free trade agreements, the Mexican Industrial Property Law and Customs Law provide 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. The COFEPRIS is the authority responsible for granting the manufacturing licence and receiving the notice of operation.

To obtain the manufacturing licence, a COFEPRIS inspection visit to the manufacturing plant must first be requested, to review whether it complies with the Technical Standard NOM-059-SSA1-2015 of good manufacturing practices of pharmaceuticals. If, in the inspection visit, the COFEPRIS determines that the facility is in compliance, it would grant a certificate, which shall be included in the manufacturing licence application. Once the application is submitted, the COFEPRIS shall not take more than 60 business days to grant the manufacturing licence. The activities 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 the 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 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.

As a general rule, the establishments involved in the wholesale of pharmaceuticals and medical devices are only required to submit a notice of operation before the COFEPRIS. As previously mentioned, the notice of operation enters into effect at the moment of filing. The notice of operation 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 biological products for human use, which are subject to a licence. 

As mentioned above, pharmaceuticals are divided into the following six classes in relation to their prescription status:

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

There is a vast body of law, secondary regulations, technical standards and administrative decrees controlling the area of foreign trace 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.

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

  • the Tax Administration Service (Servicio de Administración Tributaria), mainly through the General Customs Administration (Administración General de Aduanas);
  • the Ministry of Health (Secretaría de Salud), through the Federal Commission for the Prevention of Sanitary Risks (COFEPRIS);
  • the Ministry of Economy (Secretaría de Economía), mainly through the General Direction of Standards (Dirección General de Normas) and the Federal Consumer's Protection Agency (Procuraduría Federal del Consumidor or PROFECO);
  • the Attorney General's Office (Procuraduría General de la República); and
  • 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 most pharmaceuticals and some medical devices are subject to the obligation of securing specific import permits.

While they are normally administered by the Ministry of Health through the COFEPRIS, depending on the type of products, 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, the Federal Commission of Telecommunications, etc.

Among others, the following exceptions to the obligation of being registered in the Importers' Registry or securing an import or export permit may apply: 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, licences, etc, are imposed based on the tariff classification (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. By the end of each year, the use of that authority needs to be approved by Congress.

In terms of 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 (Diario Oficial de la Federación), and the goods subject to that regulation or restriction must be listed both by tariff classification and by description.

Mexico is currently 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 in the cosmetic and pharmaceutical industries, and have a specific agreement for inter-institutional co-operation among the sanitary authorities of the four member states in the latter. This has started a very promising regulatory harmonisation/convergence process in the region.

In addition, Mexico is a Party to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (the revised Trans-Pacific Partnership Agreement), which also contains promising provisions on the regulatory co-operation side.

Also, the United States–Mexico–Canada Agreement (USMCA), which entered into force in July 2020, 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 or not 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 (CANIFARMA), the Presidential Decree that created the Co-ordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), and the Internal Rules of Operation of the CCPNM and the technical standard for 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. The PROFECO (Agency for Consumer Protection) 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 below.

Public Market

Patented pharmaceuticals for the public market are subject to a different process of annual negotiation. For ten years, such negotiations were held with an entity created in 2008 called the Co-ordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), which gathered all major public institutions buying drugs in Mexico, as well as the Ministries of Public Administration, Finance, Economy, and Health. The new federal administration that took office on 1 December 2018 eliminated the CCPNM, gave wide faculties to control public acquisitions, including medicines, to the Ministry of Finances, particularly the Office of Administration. Under the new system, prices are directly negotiated directly with the Office of Administration.

That change eliminated the prior distinction between pricing and acquisition and is now defined in the same process for patented medicines.

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

As stated previously, 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, a Retail Price System (RPS) and 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. As previously mentioned, the price regulations for medicines do not apply to medical devices.

The Mexican system does not operate 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 that is 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, it operates through three different mechanisms: public bidding, with either 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 the case where there are no substitute products, there is only one possible supplier or the required product is patent-protected.

It is worth noting that accessing the public market for pharmaceuticals does not begin directly with public procurement. There are other key regulatory steps to be met before that, given that public procurement works through Product Codes granted by other health authorities.

Until 2019, the General Health Council (GHC) administered the Basic Formulary of pharmaceutical products and medical devices, and other individual entities, such as the IMSS and the ISSSTE, managed separate Institutional Formularies. The process for incorporating a product to the Basic Formulary and then to Institutional Formularies took two to four years. The decision was largely based on economic evaluation. Only after a Code had been allocated to a given product, which in the case of medicines was assigned per active ingredient, could that product be part of a public procurement exercise.

In 2019, the new federal administration eliminated the Basic and Institutional Formularies and created the Single Compendium, which is prepared by a group of experts under the supervision of the GHC. The criteria for addition are not yet clear and not reflected in any legal instrument, but the new federal administration refers to a "triple optimisation", which will take into account the situation of patients (medical), the prevalence of the disease (public health), and the available budget (economic).

In July 2020, a Collaboration Agreement was signed between the National Health Institute for Wellness (INSABI) and the United Nations Office for Project Services (UNOPS). This agreement provides for an international acquisition of medicines and other medical products, through a procedure that is managed by the UNOPS, with the assistance of the INSABI, under the UNOPS' own procurement standards.

In August 2020, the Mexican Government published in the Official Gazette a brief but important amendment to the Procurement Law, through which it added a fifth paragraph to Article 1. This provision establishes a rule of exception for the application of the Procurement Law for the acquisition of goods or health services contracted by agencies and entities with international inter-governmental organisations, when the acquisition of such goods and the contracting of services are carried out through previously established collaboration mechanisms, provided that it is proven that the guiding principles for public procurement referred to in the Mexican Constitution are applied.

The recent adoption of all those legal instruments have created a scenario of great concern regarding the public procurement of medicine and medical products in Mexico.

Previously, the methodology was quite clear and included cost-benefit analyses. Now, it is not clear. Likewise, it is 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 different 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, the 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.

In contrast, for the public market, although the basic rule structure is the same, there is no reference to the option of prescribing by trade mark, which means 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, which is also based on the active ingredient. There are provisions allowing prescriptions to be made under different conditions, but the respective institution would need to authorise such decisions, which are not commonly used.

No specific regulation has yet been issued establishing clear criteria to determine when the regulations of medical devices should apply to online platforms or apps that have health-related functionalities. However, in order to determine the regulatory status of the platform or app, it is relevant to assess whether the product:

  • is used in the context of a disease;
  • is used to monitor vital processes; or
  • has a medical purpose (prevention, treatment of diagnosis of a disease).

In order to obtain official confirmation of the regulatory status of the online platform or app, depending on the particular situation, it may be recommended to prepare carefully and obtain a ruling confirmation.

At the same time, it is worth noting that there is a draft technical standard for GMP of medical devices currently under discussion, which incorporates the notion of "Software as a Medical Device" (SaMD), as introduced at the International Medical Device Regulators Forum (IMDRF).

There are no special rules for telemedicine as yet; a technical regulation was drafted at some 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 institutions 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.

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

Until very recently, electronic prescription was in general only explicitly provided for a small category of medicines: controlled substances. This was introduced to promote the availability of medicines used for palliative care. Only decentralised public institutions, which have greater flexibility to introduce their own rules, have been exploring e-prescription systems for the wider population.

However, the Secondary Regulation for Medical Services was amended in 2018 to allow the prescription of medicines by electronic means. Moreover, the Secondary Regulation for Medical Products also refers to prescriptions and its requirements but it was not amended, creating a contradiction that has not yet been resolved.

This contradiction has resulted in a limited implementation of the first amendment.

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 for physical pharmacies would apply.

Thus, the regulatory set-up to support an 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), and are granted by the Mexican Institute of Industrial Property (IMPI). The new FLPIP entered into force on 5 November 2020.

In Mexico, the issues most frequently encountered by companies when trying to apply for patents include the intention of some examiners to try to limit the scope of protection of the subject-matter as exemplified in the specification of the invention. Understanding both the law and the science behind the invention is required to overcome this. This requires having 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 were no legal bases for its protection. The new FLPIP provides legal certainty for its 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, adjusting the validity of patents through supplementary certificates is now possible 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 with the official action informing them that the formal examination has been concluded. To account for the unreasonable delay, the periods attributable to actions or omissions of the applicant will not be taken into account, such as delays in answering requests or extending the deadlines to respond to them; or periods not attributable to the IMPI, such as the procedure being suspended due 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 protected by a patent without the consent of the owner of the patent, without the appropriate licence;
  • offering for sale or distributing products 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 incorporated initially in the health regime. The Health Supplies Secondary Regulations (HSR) 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.

Additionally, the new FLPIP included a new provision stating 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 a marketing authorisation of drugs for human health.

This is different from 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.

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 not having used the invention. The importation of the patented product is considered as 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.

With regard to 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 General Health Council, the IMPI shall publish in the Federal Official Gazette a declaration whereby certain patents can be exploited by means of granting a public-use licence. This is for cases where, if such a declaration is not made, the production, supply or distribution of the patented product would be prevented, hindered or made more expensive for the public.

In the case of an emergency caused by serious diseases that may harm national security, the General Health Council shall 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 or not to grant the emergency licence, after hearing the parties and evaluating the circumstances.

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

In relation to important procedural considerations, the following points are worth noting:

  • any patentee or licensee (unless expressly forbidden in its licence agreement) can submit a suit against a third party for infringement;
  • an important available remedy is the possibility 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, obtaining an infringement declaration through an administrative proceeding before the IMPI, and then obtaining damages 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 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 both 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 includes explicitly 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, where 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 a marketing authorisation of a drug to submit full information on the status of patent protection relating to its product. Applicants must demonstrate that they are either 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, the 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. The ambiguities have created a system that has led to numerous litigations 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 the COFEPRIS of the results, in order to have an impact on the drug-approval system.

At the end of 2020 and with the aim of improving transparency, the IMPI implemented electronic tools to make it easier to consult information on patents. 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 the 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 in order 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, as well as the seizure of instruments used for the manufacture and commercialisation of those infringing products, is also possible, 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. Additionally, 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. Since 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 affect the use of trade marks, too, although they do not jeopardise the validity of the IP registration. For instance, the name of a pharmaceutical product could first be protected by a registered trade mark, but eventually not be allowed by the COFEPRIS to be used as the distinctive name for the approved medicine, due 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).

Trade dress can be indirectly protected 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 the existence of a commercial relationship between the owner of the rights and the unauthorised user. No "trade dress trade mark" is available in Mexico.

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 or 3D) 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 it 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, in general, did not seek to facilitate the import and commercialisation of any medicine or medical device required in the private sector for COVID-19.

The Federal Government focused only on public acquisitions of medicines and medical devices. It issued a Decree on 27 March 2020, where it exempted medicines and medical devices acquired by the federal government from public tenders and import permits.

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

At the same time, the COFEPRIS shut down for some time, due to a general suspension of activities. During that time, a list of priority procedures was created, which only included COVID-19-related products.

The COFEPRIS did not issue any measure to facilitate the continuation of clinical trials. Instead, it issued a Communication on 21 April 2020, where it reiterated that any change to the approved conditions described in a research protocol would require an approval of both the Ethics Committee and the 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. Apparently, certain restrictions have been incorporated to some of these emergency authorisations, for example, to the authorisation of the medicine Remdesivir, the indication of which was apparently limited to "use in specialised hospitals". However, since this form of authorisation does not exist in the legal framework, any restriction could be challenged.

There was an informal announcement from the COFEPRIS, published on their website on 8 July 2020, where it indicated that GMP Certificates could be extended for six months under certain conditions. The extension would apply if the product (i) had not been subject to complaints in Mexico, (ii) had not been subject to sanitary alerts issued abroad, or (iii) had not been subject to safety measures (eg, suspension of activities) in Mexico.

On 27 March 2020, a Presidential Decree was issued in relation to any medicine or medical device related to COVID-19, allowing for: (i) its public acquisition without public tenders, (ii) its importation without any administrative requirement.

No specific regulation was issued to facilitate telemedicine. Some local governments created certain limited programmes for monitoring the condition of patients remotely. 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 had not announced any intention to issue compulsory licences for COVID-19-related products. However, in February 2021, during a formal visit to Mexico, the President of Argentina announced their intention to request the countries of the G-20 to declare the COVID-19 vaccines as "global goods", which the Mexican President endorsed. Nevertheless, no further legal step was advanced in this regard.

If the Federal Government were to decide to pursue that avenue, it would have to comply with the FLPIP. This law establishes in Article 153 the conditions for issuing a compulsory licence in the case of emergencies, when not to do so would impede, hinder or make more expensive the availability of medicines.

The aforementioned provision creates a procedure where the General Health Council (GHC) first issues a declaration of serious disease of priority attention. Then, interested companies can apply for licences to the IMPI, who will take a decision in no later than 90 days, after receiving the opinion of the GHC. The Ministry of Health 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. 

It should be noted that the Federal Government had declared, in March 2020, that COVID-19 constituted a serious disease of priority attention. However, this was a verbatim replication of the similar declaration made with the 2009 pandemic over AH1N1, rather than an announcement over their intention to issue compulsory licences.

No special provisions were introduced over the 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 of public procurement of medicines and medical devices since the new federal administration took office in 2018. This includes changes to the large centralised purchase process, which for many years had been managed by the Mexican Institute of Social Security (IMSSS). The administration first transferred the responsibility to the Ministry of Finance, but when that failed they then 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.

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Sánchez DeVanny Eseverri, S.C. is a leading Mexican law firm that provides full-service legal advice both to Mexican and international clients. With distinct practice areas that regularly collaborate with one another, the firm provides comprehensive counsel to help clients make better decisions for their businesses as a whole, especially in the life sciences, energy, automotive, retail, real estate, and manufacturing industries. The firm provides more than just attorney-client services, building enduring client relationships that go beyond individual service contracts by making every effort to understand clients’ businesses and expectations, aiming to serve as an ally, and to provide complete, accessible and personalised advice. Everyone in the firm takes pride in serving their clients with a combined approach of experience and creativity, enabling the team to take a broader view. With offices in Mexico City, Monterrey, and Querétaro, as well as several strategic alliances worldwide, the firm is well positioned to represent and respond quickly and efficiently to clients across the entire Mexican Republic and abroad, shortening the distance between the firm and its clients.

Purchase of Drugs and Devices to Be Made outside the Scope of the Law of Acquisitions, Leases and Services of the Public Sector

A reform to the Law of Acquisitions, Leases and Services of the Public Sector was published in the Official Gazette on 11 August 2020, which excludes from the scope of the law acquisitions of health-related goods or services, as long as two conditions are met:

  • acquisitions outside the scope of the law must be made through international organisms, with pre-established agreements; and
  • acquisitions must be made in line with the principles of the Mexican Constitution.

This reform follows an agreement signed between the Mexican Government and the United Nations Office for Project Services (UNOPS) to co-ordinate purchase of drugs from international suppliers.

The reform has faced legal challenges, as it greatly affects pharmaceutical companies established in Mexico; under previous legislation, any company offering health-related products/services to the Mexican government had to prove regulatory approvals under Mexican standards. This new model allows companies with no presence/approval in Mexico to offer these goods and services for sale and to have expedited approval proceedings if they are awarded in the tender.

Another relevant issue will be accountability deriving from health risks; companies with no presence in Mexico are much less likely to face responsibilities, due to the difficulties in monitoring and executing sanctions.

Innovation-based companies may also be impacted by the reform; the Acquisitions law has specific provisions forbidding acquisition of goods in violation of patents or other intellectual property rights and under the new model, the UNOPS will not have responsibility over patent protection in Mexico. Purchases could be challenged if the goods or services are deemed to be infringing a patent.

This model also eliminates the benefits that innovator companies receive from linkage under Mexican regulations; foreign companies competing on price to sell to the Mexican government are likely to face a lower intellectual property (IP) standard in their own jurisdictions upon securing marketing authorisations and expedited approvals associated to the UNOPS acquisitions are not subject to a full linkage review by the Mexican Institute of Industrial Property (IMPI).

Several business chambers, including the National Chamber of the Pharmaceutical Industry, have publicly expressed their concern with this reform to the law.

To date, the UNOPS has already made some purchases of innovative products. The large acquisitions of generic products and medical devices is still ongoing. Several rounds of inquiries and meetings with industry representatives have taken place. 

Elimination of Distributors in Acquisitions of Drugs and Devices at the Federal Level

The current federal government has changed a longstanding practice which allowed distributors to offer drugs and devices in public tender proceedings as long as they showed a letter of support from the company holding the drug marketing authorisation. 

As per instructions from the office of the president, and with the intention to cut intermediation costs, all federal drug acquisition proceedings have included, as a requisite, that the participating company be the holder of the relevant authorisation.

A gap within this new model was logistics, as pharmaceutical companies did not have the capacity/expertise to deliver at all the sites that distributors could reach. The Federal Government initially intended to substitute these services using the army, but eventually settled on separately acquiring logistics services.

Modifications to the General Health Law (GHL) and the Law of National Health Institutions (LNHI)

Several modifications to the GHL and the LNHI came into force on 1 January 2020. 

The modifications follow two main policy purposes: to ensure the constitutionally ordered free universal healthcare, regardless of social security status, and to eliminate the former People’s Insurance (Seguro Popular), substituting for it the Institute of Health for Well-being (Instituto de Salud para el Bienestar or INSABI).

Below are some of the main aspects of the bill.

  • The INSABI will act as a public health services provider instead of an insurer. Under the former structure, the People’s Insurance provided health insurance for access to several different federal and local health institutions; people who were not covered by Social Security would have access to this insurance, which would gradually increase the number of illnesses covered. With this change, the INSABI will cease acting as an insurer, and will absorb administrative responsibilities over healthcare provision.
  • The former National Formulary of Health Supplies (Cuadro Básico) is substituted by a National Compendium. All National Health Institutions will have to adhere to this Compendium. The main impact that this change will have is to speed up the ongoing process of concentration and centralisation of drug/device access mechanisms. With the former National Formulary, institutions such as the Institute for Social Security and Services for State Workers (ISSSTE) and the Mexican Social Security Institute (IMSS) had the possibility to create their own specific sub-formularies for supply purchases.
  • The innovator and follow-on biologic drug (Biocomparables) products will be subject to the same code in the National Compendium. This provision will have the effect of creating price-based competition between innovator biologic products and any relevant biosimilars, regardless of technical differences.
  • Packaging of drug products will have to be different for drugs intended for sale in the public and private markets. This is a return to a policy position that had been abandoned a few years ago; it will likely increase costs associated to products in Mexico, due to the need to produce differentiated packages.

Mexican Ministry of Health Issues a Fast-Track Approval Process for Products Approved in other Jurisdictions, and Rules Regarding the Import of Drug Products without the Need for a Mexican Marketing Authorisation

The Mexican Regulatory Agency (COFEPRIS by its initials in Spanish) had previously followed a policy of increasing approval/quality standards, in order to obtain reciprocal recognition. This has changed under the current administration, with a new focus on opening the possibility to bring in drug products from different markets as fast as possible, in order to lower prices.

In line with this policy change, several official communications have been issued. The most relevant ones include that Mexico now recognises approval processes from several jurisdictions and World Health Organization (WHO) bodies, and establishes a fast-track proceeding for local approval.

The recognised jurisdictions/WHO bodies are:

  • Swissmedic;
  • the European Medicines Agency (EMA);
  • the United States Food and Drug Administration (US FDA);
  • Health Canada;
  • the Australian Administration of Therapeutic Products;
  • the WHO reference regulatory agencies; and
  • products that have undergone WHO pre-qualifications.

The fast-track approval process consists of specific interchangeability requirements for generics and biosimilars (including Good Manufacturing Practices), and an additional need for a favourable opinion from the New Molecules Committee to approve new products. 

Approvals must take place within five days. Through a communication issued on 11 November 2020, the Minister of Health ordered the COFEPRIS to issue approvals for drugs and devices that have been previously approved in certain recognised countries within five days. If a submission is incomplete, the length of time to require additional documentation is three days.

Proceedings are subject to tacit affirmative response, meaning that silence/delays from the COFEPRIS will imply automatic approval of the marketing authorisation.

It is important to point out that the COFEPRIS has historically been reluctant to recognise tacit affirmative responses (even when established in the regulations). Legal challenges to these decisions by the agency have generally been successful.

The patent-marketing authorisation linkage review is limited. Under previous regulations/practices, approval of a generic/biosimilar product involved the Mexican Patent office; when an application was filed for one of these products, the applicant was required to provide a statement/technical information which confirmed that no Mexican patent associated with the drug product (compound, formulation or second medical uses) was being infringed.

This information would then be sent by the COFEPRIS to the Mexican Patent office for verification, and the approval would not be issued until a favourable opinion was obtained.

According to one of the relevant communications, if the product seeking approval has a Mexican Patent in force covering the active ingredient/compound, a licence must be recorded before the Mexican Patent Office before product approval. This limits linkage review in two main aspects: 

  • only active ingredient/compound patents will be taken into account (no reference to patents covering other aspects of a drug product, such as formulations);
  • the requirement for analysis/clearance from the Mexican Patent office is eliminated.

Import of products is allowed without need for previous approval (or patent review). In a clear reaction to a broadly documented 2019 shortage of oncology-related drug products, the January 28th communication establishes that the Ministry of Health, in co-ordination with other public institutions providing healthcare services in Mexico, can import products without marketing authorisation.

There are no standards to determine when these imports can take place; the only limitation is that an import of this nature can only take place once, as otherwise a marketing authorisation process is required for further imports.

Mexico Issues a New Federal Law of Industrial Property Protection to Comply with the United States–Mexico–Canada Agreement (USMCA) Requirements

This Law includes relevant provisions on pharmaceutical products, including an obligation to establish new rules for linkage review.

The new law substitutes the former Industrial Property Law, and clarifies several pending issues on practices on patents, trade marks and litigation proceedings.

The most relevant changes for pharmaceutical companies are as follows.

Patents

  • A paragraph is included in Article 45 section I, indicating that new uses of existing substances are patentable (which includes second pharmaceutical indications). Use claims were already recognised by the Mexican Institute of Industrial Property (IMPI), but the provision generated controversy in Congress during discussion of the new law, and two different bills have been introduced for discussion by the legislator.
  • Experimental production intended to secure a pharmaceutical product approval upon patent expiry is not considered patent infringement (Bolar-type exemption; it existed in the previous law, but was limited to a three-year period).
  • Patent term adjustments (to be addressed in the following section).
  • A specific reference is included to allow applicants to claim multiple priorities.
  • Double patenting is expressly forbidden.
  • Disclosure of an invention by a third party does not prevent a patent application from being filed, if the filing takes place within 12 months after that disclosure.
  • Recognition of matter based on biological materials and genes as an invention requires isolation through technical means.

Litigation

  • The IMPI is granted capacity to mediate between the parties in conciliation proceedings (when both parties agree to these proceedings).
  • In addition to issuing fines in infringement proceedings, the IMPI is granted tax-authority status, and will be able to collect those fines.
  • One of the main problems with litigation proceedings in Mexico is timeframes before collection of damages. Under the previous law, a party suffering an infringement of an exclusive right had to obtain a favourable decision from the IMPI and go through two or three stages of appeal before initiating a separate civil trial to collect damages. The new Federal Law establishes two alternatives, as follows:
    1. to initiate infringement proceedings before the IMPI; once an infringement decision is issued (and an administrative fine is imposed), the IP owner can request the IMPI to determine an amount of damages. That monetary determination will then be submitted before a civil judge for execution; or
    2. to initiate infringement proceedings directly before a civil judge, seeking a decision combining infringement and damages. A counterclaim challenging the validity of the underlying right can then be submitted by the defendant before the IMPI, which would suspend a civil trial.

This dual system does not address the actual problem, since any litigation proceedings will still include several different stages before both the IMPI and the civil courts before coming to final decisions:

  • regarding the lifting of injunctions, the 40% extra amount for bonds provided in the former IP Law has been deleted;
  • fines related to infringement of IP rights have been raised, the highest fine being over MXN20 million.

Supreme Court Precedent Allowing for Extensions of Patents under the Previous Industrial Property Law, Based on a Pharmaceutical Patent Trial

According to Article 23 of the Mexican Industrial Property Law, which was in force until 5 November 2020, all patents in Mexico were granted with a life term of 20 years from the date of filing (whether Patent Co-operation Treaty (PCT) or domestic filings). This article was coincident with the text of the North America Free Trade Agreement (NAFTA), which established in section 12 of Article 1709 the following:

"Article 1709.  Patents

12. Each Party shall provide a term of protection for patents of at least 20 years from the date of filing or 17 years from the date of grant. A Party may extend the term of patent protection, in appropriate cases, to compensate for delays caused by regulatory approval processes."

In December 2018, Bayer Healthcare LLC filed a brief before the Mexican Institute of Industrial Property (IMPI), requesting the extension of term of patent No 238942, covering the pharmaceutical compound SORAFENIB (used as an active ingredient in oncology drug NEXAVAR ®), from 12 January 2020 to 26 July 2023, arguing, among other points, that a proper interpretation of the North American Free Trade Agreement (NAFTA) should allow for the broader benefit between the two alternatives.

This petition was denied by IMPI; in a first stage of appeal, a District Court confirmed the refusal, by considering in part that there was no administrative delay in the process of grant to support the broader term between the two alternatives provided by the NAFTA. The appeal to this decision was remanded to the Supreme Court.

Even though the denial of a term extension by the District Court was coincident with all precedents up to date, in a decision approved on 14 October 2020, the Supreme Court considered that the overall patent prosecution process of six years from the PCT filing date unduly affected the patent owner, limiting the possibility to secure this broader benefit, and is ordering the Mexican Patent Office to extend the term to 17 years from the date of grant (which adds up to 23 years from the date of filing).

The effects of this decision can be very broad, as the same reasons can apply to many patents in force in Mexico, regardless of technical area, and based on it, patent holders could request for similar extensions from the IMPI and proceed to litigate if those requests are refused. 

Patent Term Adjustment (PTA) under the USMCA and the New Federal Law of Intellectual Property Protection

The Federal Law of Intellectual Property Protection, which came into force on 5 November 2020, in line with the United States, Mexico and Canada Agreement (USMCA), contemplates the possibility of requesting a Patent Term Adjustment to compensate for delays in prosecution attributable to the Mexican Patent and Trademark Office.

These extensions are granted through supplementary protection certificates and are allowed for all types of patents.

With this roadmap laid out, there are the following scenarios.

Scenario 1

In patents granted before 1 July 2020, holders can now attempt to apply for an adjustment/extension to switch the life term of the relevant patent to 17 years from the day of grant (as opposed to 20 years from filing).  These petitions will be filed before the IMPI, and they will likely quote the decision from the Supreme Court. 

Where it is considered that the IMPI will likely refuse these petitions, applicants can challenge those refusals with reasonably high chances of success. 

It should be noted that the fact that the New Federal IP Law has entered into force (which establishes the PTA) could be used as an argument for the courts to re-study the recent Supreme Court criteria, by stating that compensation of life term should adjust to the New Law as opposed to a blanket 17 years from grant.

Scenario 2

In patents granted as of 1 July 2020, patent holders may apply for a PTA of up to five years from the expiry date, in the case that the patent grant takes more than five years from the application date and delays are attributable to the IMPI (the PCT filing date or filing date of a domestic patent application).

An additional life term will be one day of compensation for every two days of unreasonable delays in grant, for a maximum of five years.

Reasonable delays (which would not allow for adjustment of the term) include:

  • the period between the date of filing and the date of a favourable decision on the initial documentary analysis (compliance with filing requirements, not including novelty or inventive step), which means that the PTA can only refer to delays after an analysis on the merits has started;
  • time periods attributable to actions or omissions by the applicant which delay the patent analysis, and additional terms used in responding to requirements from the IMPI;
  • periods not attributable to the IMPI, such as litigation proceedings delaying the patent grant;
  • force majeure.

Protection granted afforded the PTA is the same as that during the normal patent term.

Sánchez DeVanny Eseverri, S.C.

Paseo de las Palmas 525
Piso 6
Col. Lomas de Chapultepec
Ciudad de México 11000
México

+50 298 500

+50 298 571

jlserrano@sanchezdevanny.com www.sanchezdevanny.com
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Law and Practice

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Baker McKenzie provides a healthcare and life sciences industry group which is active on matters throughout the whole life cycle of products, from research and development to manufacturing and commercialisation. It provides industry-focused and integrated advice in the fields of regulatory, data privacy, intellectual property, transactional and M&A, foreign trade, antitrust, compliance, tax and litigation. It acts for the leading players of the industry, including local and multinational companies, with key sectors including medicines, medical devices, health services, dietary supplements, cosmetics, food and beverages, cleaning products, seeds, biocides, fertilisers, biofuels, alcohol and tobacco. Lawyers are also actively involved in the legal and trade associations that have a life sciences focus or working groups.

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Sánchez DeVanny Eseverri, S.C. is a leading Mexican law firm that provides full-service legal advice both to Mexican and international clients. With distinct practice areas that regularly collaborate with one another, the firm provides comprehensive counsel to help clients make better decisions for their businesses as a whole, especially in the life sciences, energy, automotive, retail, real estate, and manufacturing industries. The firm provides more than just attorney-client services, building enduring client relationships that go beyond individual service contracts by making every effort to understand clients’ businesses and expectations, aiming to serve as an ally, and to provide complete, accessible and personalised advice. Everyone in the firm takes pride in serving their clients with a combined approach of experience and creativity, enabling the team to take a broader view. With offices in Mexico City, Monterrey, and Querétaro, as well as several strategic alliances worldwide, the firm is well positioned to represent and respond quickly and efficiently to clients across the entire Mexican Republic and abroad, shortening the distance between the firm and its clients.

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