I INTRODUCTION

Mexico has had a strong legal tradition of health law. In 1891, it was the first country in the Americas to adopt a codified body of health norms. This changed, however, and for a very long time (from 1960 to 2011), health and life sciences law became largely an area dominated by other health professionals (e.g., physicians and pharmaceutical chemists). This explains why in 2018, it is often stated that life sciences is a new practice area for lawyers in Mexico.

Since the early incorporation of health-related provisions in the Constitution (1908), public health has been framed largely as a federal issue, with central agencies controlling the main aspects of the resulting regulatory system.

After the Constitution, which currently recognises the protection of health as a human right, the main regulatory instrument is the General Health Law (GHL), which creates a federal regulatory agency within the remit of the Ministry of Health, namely the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS). This is the main regulatory agency for the life sciences industry.

After the GHL, there are a number of secondary instruments controlling certain products, activities and services more specifically. These include:

  1. General Products Secondary Regulations (GPSR);
  2. Chemicals Secondary Regulations (CSR);
  3. Medical Products Secondary Regulations (MPSR);
  4. Health Services Secondary Regulations (HSSR);
  5. Health Advertisement Secondary Regulations (HASR);
  6. Clinical Research Secondary Regulations (CRSR);
  7. several Official Mexican Standards (NOMs) on specific technical aspects (e.g., manufacturing best practices); and
  8. the Mexican Pharmacopeia, which has different supplements for different products or activities (e.g., Supplement for Warehousing; Supplement for Medical Devices).

Other authorities have a key role in both the public and private markets for medical products, including the General Health Council (HGC). The HGC is an autonomous body which is in charge of several key functions, including: (1) defining the interchangeability tests for generics, which is required for obtaining a marketing approval from COFEPRIS; and (2) managing the system to add products to the Basic Formulary, which is a prerequisite for selling medical products to the government.

II THE REGULATORY REGIME

The Medical Products Secondary Regulations (MPSR) include four kinds of ‘medical products’: medicines, medical devices, herbal remedies and specialised nutritional products.

The regulatory framework is much more extensive for medicines than for medical devices or any other medical product. This has led the regulator to use the most complete set of provisions on medicines as an interpretative tool to fill in any gaps that may exist in relation to other medical products.

i Classification

The regulatory regime offers different definitions for the many categories of regulated products. These definitions distinguish products based generally on four elements: ingredients, intended use, primary function and product claims.

Regulated products can be divided into four large groups:

  • a Medical products:

• medicines;

• medical devices;

• herbal remedies; and

• specialised nutritional products.

  • b Consumer goods:

• food and drinks;

• dietary supplements;

• cosmetics; and

• cleaning products.

  • c Targeted goods:

• alcohol; and

• tobacco.

  • d Chemicals:

• pesticides;

• fertilisers; and

• toxic substances.

Whereas all products prior to the North American Free Trade Agreement (NAFTA) required a prior evaluation and approval under the 1984 General Health Law, the modernising effect of the 1991–1994 NAFTA negotiations led to a profound review of the regulatory framework. This review introduced a post-commercialisation regulatory model for many product categories. As a result, only medical products, pesticides and fertilisers require a prior marketing authorisation.

Increasingly, the initial classification of a product, prior to its launch on the market, has become a crucial factor in the commercial plans of companies. This is because each product category offers regulatory advantages and disadvantages (e.g., whereas dietary supplements may not require a prior marketing authorisation, they are heavily restricted in terms of labelling and advertising), and these regulatory considerations must be weighed against other commercial objectives. Also, the single regulatory analysis is being increasingly combined with other analyses, for instance a combined customs law analysis or a combined tax analysis. A tax analysis is important because the product categories may be subject to different taxes or tax rates (e.g., dietary supplements are subject to a VAT rate of 16 per cent, whereas plain food products and medicines are subject to a VAT rate of zero per cent).

Mexico has made important efforts to simplify and regulate products that were previously considered medical devices and were therefore subject to a marketing authorisation. On the one hand, the regulator identified a list of nearly 100 products that were declared to entail a low risk and would benefit from a faster regulatory approval. On the other hand, the regulators identified more than 2,200 products that were declared not to constitute medical devices any more and were therefore significantly deregulated.

If there is any doubt regarding the regulatory or tax classification of a product, a ‘ruling request’ can be filed and obtained from the relevant authority. The request would contain information about the four elements mentioned above (ingredients, use, function and claims), as described in key documents to be submitted, including the formula, the product monograph and a draft of the local label. Based on this data, the regulator would make a decision about the authority status and classification of the relevant product.

ii Non-clinical studies

Official Mexican Standard NOM-0622 regulates the use of animals in laboratories. This legal instrument is implemented by the Ministry of Agriculture. It requires animal facilities (1) to be registered; (2) to have an appointed veterinary surgeon; (3) to acquire only animals that are certified; and (4) to comply with a series of obligations regarding the transport, feeding, handling and euthanasia of animals.

iii Clinical trials

In general, clinical data is required for demonstrating the safety and efficacy of products. Regulatory requirements for clinical trials are very similar for medicines and medical devices. Some of the most relevant features include that:

  1. clinical trials shall be preceded and supported by pre-clinical data;
  2. research shall be conducted in accordance with scientific and ethical principles;
  3. research is subject to the informed consent of the participating human subjects;
  4. trials shall be executed under a research protocol, overseen by a principal investigator, and performed in research sites that are licensed health institutions;
  5. research protocols are subject to prior approvals from both an ethics committee and the regulator; and
  6. adverse events shall be monitored and notified.

In 2012, Guidelines for Good Clinical Practice (GGCPs) were issued, which make a clear reference to international best practice, including standards developed by the International Conference of Harmonization (ICH). The GGCPs will be the basis for moving towards a certification system, for which COFEPRIS has already started to carry out inspections of the research sites.

By contrast, the operation of contract research organisations (CROs) is not yet fully regulated, with references found only in the GGCPs. Current practice includes registering CROs in the database of COFEPRIS, which facilitates regular filing of different regulatory applications (e.g., obtaining import permits for experimental drugs).

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

  1. eliminating the requirement to submit a ‘certificate of free sale’ of the country of origin, when registering a medicine in Mexico for the first time;
  2. creating ‘third authorised parties for clinical research’, which are hospitals with extensive experience of clinical research and are authorised to conduct a pre-evaluation of research protocols. If a report is positive, approval times at COFEPRIS are reduced significantly; and
  3. creating a National Registry of Clinical Trials (RNEC), which is fed with data submitted by the regulator, the sponsor and the research sites.

There is no binding provision requiring the disclosure of results of clinical trials. However, the code of ethics of the pharmaceutical industry does contain a specific obligation for sponsors to disseminate the positive and negative results of trials, particularly regarding adverse events.

iv Named-patient and compassionate use procedures

Whereas the general rule is that the importing of medicines and medical devices is subject to obtaining prior marketing authorisation and import permits, there are certain exemptions that have traditionally been used for introducing and supplying products that are not yet approved in Mexico. These include the import exemptions of (1) personal use, (2) medical use, and (3) diseases of low prevalence. These exemptions, however, were not designed for commercial purposes.

v Pre-market clearance

As mentioned before, the commercialisation of medicines and medical devices requires a prior marketing authorisation. The general registration process for these product categories is very similar, as is the structure of the three basic approval routes.

For both medicines and medical devices, the regulatory pathways include:

  1. a ‘conventional’ registration route, in which the applicant prepares and submits the dossier directly to the regulator;
  2. an ‘equivalencies’ registration route, in which the applicant submits to the regulator the prior approval from another recognised jurisdiction, as part of the local dossier; and
  3. a ‘third authorised party’ registration route, in which the applicant first files the dossier with a private entity, who conducts a pre-review, issues a pre-report and, if complete, files the whole dossier with the regulator.

At the same time, there are important differences between the approval routes for medicines and medical devices, given the nature of each product, its local regulation, and the regulation in other countries.

First, there is a distinction in the marketing of medicines between the originator and subsequent products, which does not exist locally in relation to medical devices.

The pathway for originators involves a pre-submission regulatory meeting with a New Molecules Committee. This meeting is crucial because the primary goal is to decide whether or not to require local clinical trials.

Oddly, however, the separate pathway for subsequent entry products does not exist with all types of medicines. It only exists clearly in relation to drugs of chemical and biotechnological origin. It does not exist in relation to biologicals or orphan drugs.

Second, the eligibility rules for becoming a marketing authorisation holder vary between medicines and medical devices. The eligibility for medicines is linked to a manufacturing plant, whereas the eligibility for medical devices is linked to the warehousing facility. At the same time, although a manufacturing plant for medicines can be located abroad, for medical devices the warehouse must be located in Mexico. In other words, having a foreign market authorisation holder is allowed for medicines but not for medical devices. Now, if a foreign holder exists, a local entity must be appointed as local legal representative, to respond before the regulator for all regulatory enquiries and liabilities.

In relation to the new fast-track route created for both medicines and medical devices that already have marketing authorisation from other countries, the list of recognised jurisdictions changes.

Whereas for medicines the fast-track route includes prior authorisations from the European Union, Switzerland, the United Stated, Canada and Australia, for medical devices the list only includes Japan, Canada and the United States. The reason for this is that the latter three jurisdictions had traditionally required a full marketing authorisation for medical devices and their regulatory frameworks could therefore be deemed to be equivalent.

vi Regulatory incentives

There are no patent term extensions in Mexico. It is construed that, since patents are already exemptions to the constitutional prohibition of monopolies, a patent extension could violate the Constitution. This could change, however, as a result of trade negotiations. Mexico is currently negotiating revisions to all its major existing agreements, including NAFTA, the agreement with the European Union, and the Trans-Pacific Partnership (now rebranded as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), which contain provisions in this regard.

In turn, there is a linkage system between marketing authorisation for medicines and certain pharmaceutical patents. The list of pharmaceutical patents that can block the regulatory approval of a subsequent entry product, unless proof of consent from the patent holder is provided, includes (1) patents for the active ingredient, (2) patents for the formulation, (3) patents for particular uses, and (4) patents for dosage. These are all ‘product’ patents, as ‘process’ patents are excluded. When the applicant for the regulatory approval does not produce proof of consent or otherwise demonstrate that no relevant patent is being infringed, the regulator will conduct an inter-agency consultation with the Mexican Patent Office.3 This office will produce a report of ‘technical correspondence’ between the technical characteristics described in the patent claims and the regulatory data contained in the dossier, as summarised and shared by the regulator. If technical correspondence is confirmed, and no proof of consent was provided, the regulator will reject the regulatory application.

In relation to other regulatory incentives, while there is no ‘market exclusivity’ in Mexico, there is ‘data exclusivity’ for certain pharmaceutical products. This form of protection is available for new molecular entities, in relation to clinical data on safety and efficacy. It lasts for a period of five years from the relevant regulatory approval. This protection has been made available through litigation aimed at enforcing obligations found in NAFTA, and against the official position of the Ministry of Health. This means that, if the current trade negotiations mentioned above, for some reason fail to conclude or to include a similar obligation, data exclusivity may soon not be available in Mexico.

There are no further incentives in relation to rare diseases, tropical diseases or paediatric use.

vii Post-approval controls

A marketing authorisation requires there to be a qualified person or ‘sanitary responsible’ as a permanent regulator at the relevant premises (i.e., at the manufacturing plant or warehouse). It also requires there to be a pharmacovigilance or technovigilance officer, who can often be the same qualified person.

Whereas all medical products will require a final local release, conducted by an in-house or outsourced laboratory, certain pharmaceutical products require a special procedure. Biologics, biotech and controlled medicines require a supervised release by the regulator.

Although pharmacovigilance (for medicines) or technovigilance (for medical devices) tend to be perceived as a post-approval matter, many of the requirements actually need to be implemented before the marketing authorisation is applied for (e.g., having notified the pharmacovigilance officer or having obtained the approval of the pharmacovigilance unit). After the approval, there is a continuing obligation to identify, investigate and, if applicable, report on adverse events or incidents, and submit periodic reports. Also, certain medicines may require post-approval Phase IV pharmacovigilance studies to be carried out, which would be indicated in the marketing authorisation.

In relation to variations or modifications to a marketing authorisation, these can either constitute ‘administrative’ or ‘technical’ variations. For instance, a change of manufacturing site would constitute a major technical variation, taking up to 18 months to be approved, whereas a change of corporate name or a transfer of marketing authorisation would constitute an administrative variation, taking four to six months.

Marketing authorisations remain valid for five years and can be renewed indefinitely, provided that the same conditions for approval remain. In addition, at any time, marketing authorisations may be revoked by COFEPRIS in the following circumstances:

  1. it is found that the authorised products represent a risk or potential harm to human health;
  2. if the activities performed exceed the limits of the relevant authorisation;
  3. in the event of a material breach of any health or sanitary law or regulations;
  4. if the holder repeatedly disregards orders issued by COFEPRIS;
  5. if the product no longer meets any of the specifications or requirements as established by the health and sanitary laws and regulations;
  6. if the applicant is found to have submitted false information or documents;
  7. if the product loses its attributes, characteristics or therapeutic properties;
  8. if the holder does not comply with any of the terms, conditions and requirements established under the marketing authorisation;
  9. if the holder so requests it.
viii Manufacturing controls

Whereas a manufacturing plant for medicines is required to have a sanitary licence, a manufacturing plant for medical devices needs only to file a ‘notice of operation’. In both cases, COFEPRIS is the responsible authority for evaluating and either granting or rejecting the licence application, or for receiving the notification. And in both cases, it is a requirement to have a qualified person or sanitary officer in charge of the facility.

A key part of the application process for a sanitary licence is to receive and pass an inspection visit by the regulator, who will verify whether the plant complies with the good manufacturing practices (GMPs) set out in NOM-059 for medicines4 and in NOM-241 for medical devices.5 If the plant complies and the GMP certificate is issued, then the application for a manufacturing licence can continue. The scope of a licence would typically include both manufacturing and warehousing.

Both the GMP certificate and the sanitary licence can be modified to reflect a change of either the holder or the corporate name. This is relevant for different forms of transferring ownership.

ix Advertising and promotion

Whereas ‘advertising’ of medical products refers mainly to advertising material and is regulated through mandatory provisions, ‘promotion’ refers mainly to promotional activities, which is an area regulated more extensively by two industry codes of ethics.

A similar structure is followed to define the ‘advertising bases’ of both medicines and medical devices. The similarity exists in relation to the mechanism that is used: when a marketing authorisation is issued, there is a decision made by the regulator as to whether the product can be advertised to the wider public, or only to healthcare professionals.

The difference exists in the form in which the distinction operates for medicines and medical devices. For medicines this is linked to whether the product will require a prescription or not: prescribed medicines can only be advertised to healthcare professionals, whereas over-the-counter products can be advertised to the wider public. Regarding medical devices, the decision is simpler, as the regulator will indicate directly in the marketing authorisation whether the product can be advertised to the wider public or only to healthcare professionals.

Once the aforementioned distinction is made, different procedures apply: (1) advertising to the wider public is subject to obtaining a prior advertising permit, and (2) advertising to healthcare professionals is subject only to an advertising notification.

Some of the most relevant requirements are that:

  1. a information must be verifiable, should not mislead about the nature, quality or properties of the product and should not promote self-medication;
  2. b information must be consistent with the specifications and indications contained in the marketing authorisation;
  3. c the Information to Prescribe (IPP) cannot be used for advertising to the general public, since it is for the exclusive use of physicians; and
  4. d the material must not make reference to any national or international authority.
x Distributors and wholesalers

As a general rule, the operation of facilities involved in the distribution or wholesale of medicines and medical devices is subject only to filing a notice of operation with COFEPRIS. The notification must be submitted within 30 days of initiating operations, has an immediate effect once submitted and does not expire. Thereafter, an updated notice needs to be filed only when the conditions of operation change.

The exception to the general rule refers to warehousing of biological products for human use, or controlled medicines (e.g., psychotropics and narcotics). In these cases, a sanitary licence is required.

The wholesale and retail of medicines and medical devices are subject to different regulations. It is clear that a wholesaler of medicines cannot commercialise products directly to final consumers, because that role is reserved for retailers (i.e., pharmacies), there is a less clear distinction in relation to medical devices.

xi Classification of products

As mentioned above, the basic distinction is whether a medicine requires a prescription or not, which will have an impact on (1) how flexibly the product can be sold, and (2) how the product can be advertised.

From that general distinction, further classifications exist. There are six classes of medicines in all:

• Class I: Prescription pharmaceuticals that can only be acquired with a special prescription or permit issued by the regulator (e.g., controlled substance).

• Class II: Prescription pharmaceuticals that require for their purchase a prescription to be collected and retained in the pharmacy, and should 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, which must be sealed, recorded in the control book and retained in the pharmacy after the third supply.

• Class IV: Prescription pharmaceuticals that can be supplied as many times as directed by the physician (e.g., antibiotics).

• Class V: Non-prescription pharmaceuticals, but authorised for sale only in pharmacies.

• Class VI: Pharmaceuticals that do not require a prescription to be purchased and can be supplied in any establishments other than pharmacies (e.g., over-the-counter products).

xii Imports and exports

From a customs law perspective, only local entities can act as an ‘importer of record’ for medical products, and these must be recorded in the National Importers Registry.

From a regulatory perspective, the main importer must be indicated in the marketing authorisation, which means that any subsequent change will require an administrative variation.

From a combined perspective of regulation and customs law, medical products only require an import permit if the individual product is included in an ‘official list of merchandises’, which is jointly issued by the Ministries of Trade and Health. The products are listed according to their tariff code. In general, exports do not require additional permits.

xiii Controlled substances

The whole regulatory system is stricter around narcotics and psychotropics:

  1. acquisition for use in manufacturing processes requires a special permit;
  2. final release requires a supervised visit by the regulator;
  3. both import and export require a special permit;
  4. distribution requires a sanitary licence, as opposed to just filing a notice of operation;
  5. prescription requires a prior and special permit from the regulator, which is now available electronically;
  6. retail requires registering any transaction or handling in auditable books.
xiv Enforcement

Enforcement of the regulatory framework occurs through an administrative procedure that has two stages: (1) an inspecting stage, in which the regulator gathers factual information about potential infringements and orders safety measures to correct the violations and manage the risks involved; and (2) a sanctioning stage, in which the regulator evaluates the evidence and decides a suitable sanction.

Typically, an inspection action would result from (1) a public complaint filed by a consumer or competitor, (2) a scheduled programme (e.g., the inspection of a clinic), or (3) a random inspection act, which is less common.

III PRICING AND REIMBURSEMENT

Pricing in Mexico

In relation to pricing, although the price control rules could apply in principle in relation to both medicines and medical devices, the system has developed only in relation to medicines.

There are different pricing rules, deriving from both mandatory6 and voluntary mechanisms,7 which distinguish (1 between the private and public markets, and (2) between patented and unpatented medicines.

Pricing – 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 sale prices in other jurisdictions and submit that to the authority, which monitors the accuracy of the data and approves a ‘maximum sale price’.

The manufacturer is required to stamp that maximum sale price on the label of the product during the manufacturing process. The Agency for Consumer Protection (PROFECO) verifies that the prices at the point of sale (i.e., at pharmacies) do not exceed that price.

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

Pricing – public market

Patented medicines and medical devices for the public market are subject to a different process of annual negotiation with the Coordinating Commission for Negotiating the Price of Medicines (CCNPM), which coordinates all major public institutions buying medicines in Mexico, as well as the Ministries of Public Administration, Finance, Economy and Health.

Based largely on economic data, the price negotiated through this process becomes mandatory for each and all of the public procurements of drugs undertaken by the federal government. However, state institutions can also adhere to the scheme.

The CCNPM allows the primary public health institutions to negotiate together as a single entity with individual medicine manufacturers for a single procurement price applicable nationwide for one year to all public institutions, including those not engaged in the negotiation process.

The estimated price for generic and off-patent products is initially defined by those public institutions coordinating 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 fixed by the best bid.

Reimbursement in Mexico

The Mexican system does not operate per se through a model of reimbursement, but through a model of public procurement of medicines and medical devices.

There is a comprehensive legal regime for public procurement that is overseen by the Ministry of Public Administration in coordination with the purchasing entity. In general, it operates through three mechanisms: (1) public bidding, with either a national or international scope; (2) invitation to at least three persons; and (3) 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 (e.g., if there are no substitute products, if there is only one possible supplier or if the required product is patent protected).

Accessing the public market, for both medicines and medical devices, does not begin directly with public procurement. There are other key regulatory steps to be met first, given that public procurement works through product codes, which are granted by other health authorities.

The General Health Council (GHC) administers the basic formulary of pharmaceutical products and medical devices, but there are also other institutional formularies administered by individual entities, such as the Mexican Social Security Institute and the Institute for Social Security and Services for State Workers. The process for incorporating a product in the basic formulary and then in the institutional formularies can take two to four years. The decision here is largely based on economic evaluation. Only after a ‘code number’ has been allocated to a given product can that product be part of a public procurement exercise.

IV ADMINISTRATIVE AND JUDICIAL REMEDIES

Any decision or action taken by the regulatory authorities can be challenged through different legal procedures, including (1) an administrative appeal, filed with the same authority that issued the original administrative decision; (2) a nullity trial, filed at the Tribunal of Federal Administrative Law; and (3) an amparo trial, filed either at a federal district court (indirect amparo) or at a federal collegiate court (direct amparo).

There is a general impression that there is no significant litigation in Mexico in relation to regulatory decisions. However, this is not accurate. In fact, a Special Chamber for Regulatory Matters has recently been created at the Tribunal of Federal Administrative Law, in addition to the Special Chamber for Intellectual Property Matters. Both ‘special chambers’ are generally used to litigate matters relating to medicines and medical devices. Magistrates of these special chambers are becoming increasingly familiar with highly technical cases, which makes it important to integrate interdisciplinary teams of both lawyers and chemist pharmaceuticals.

V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS

The rules that control the interactions between companies and healthcare professionals, including gifts, hospitalities and hired services, are mostly found in industry codes.

These include the Code of Good Promotional Practices, issued by the Council for Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA), which is an internal body within the National Chamber of the Pharmaceutical Industry (CANIFARMA). This applies to both medicines and medical devices.

There is also the Code of Interaction with Healthcare Professionals, issued by the Mexican Association of Innovative Industries of Medical Devices (AMID).

In general, the codes defend the principles of:

  1. transparency;
  2. free and fair competition;
  3. regulatory compliance;
  4. accuracy of information;
  5. confidentiality of information; and
  6. responsible prescription.

VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS

There is no special legal regime on liability for medicines and medical devices, except for damages caused to a person as a result of a clinical trial.

The General Health Law and the Clinical Research Secondary Regulations establish that medical institutions will be responsible for providing medical assistance to a person suffering a medical condition as a result of clinical research. Additionally, the person will receive compensation for damages.

Under NOM-012 for clinical trials8 and the GGCPs, medical institutions and sponsors, when determining a budget for clinical research, should include a specific provision for payment of medical assistance and damages to persons suffering a medical condition as a result of clinical trials.

With regard to compensation and damages, secondary legislation regulates the contractual responsibility and non-contractual liability that applies for medicines and medical devices: the first prevails in instances that arise from a contract; and the second arises from the facts or conduct not derived from the contract that results in damage to a certain person.

Following legal reforms in 2011, Mexican legislation has established a new series of procedural rules to be followed in the case of class actions related to product liability, which can apply to both medicines and medical devices.

VII TRANSACTIONAL AND COMPETITION ISSUES

i Competition law

There are currently no specific ‘pay for delay’ cases. However, in different investigations and studies, the antitrust authority has been requesting company information about intellectual property practices, with a clear aim to identify whether this is taking place in Mexico.

In general, there has been an increased intervention on the life sciences market. This is evidenced by several actions and cases concluded or initiated recently, which include:

  1. confirmation by the Supreme Court of Justice of a resolution in which it recognised that economic analyses are a valid form of indirect evidence to identify anticompetitive conducts;
  2. the launching of a large market investigation in relation to the marketing of expired patent medicines;
  3. the issuance for the first time of both structural remedies and behavioural remedies to approve a concentration in the healthcare industry;
  4. the launching of several cartel investigations in both the public and private markets, including the manufacture, distribution and commercialisation of drugs, as well as the public acquisition of blood bank and diagnostics services; and
  5. the initiation for the first time in Mexico of criminal proceedings against diverse individuals allegedly engaged in cartel conduct in public tenders.
ii Transactional issues

Although it is generally true that asset deals have a stronger regulatory impact than share deals (given the need to transfer all regulatory approvals in asset deals, which translates in longer timeframes for a transaction), care must be given also to subsequent corporate name changes in share deals. Essentially, both a transfer and a change of corporate name require the same administrative variation to all marketing authorisations.

At the same time, share deals offer important advantages for existing contracts with the government. Since public procurement contracts cannot be assigned, a share deal would avoid commercial disruptions in that public market.

Finally, proper attention should be given to distinguishing clearly the objectives of a commercial distribution agreements and licensing agreements. A distributor does not need to be given a licence for the intellectual property rights of the product, particularly patents, unless some form of development would take place locally (e.g, if local clinical trials will be required).

VIII CURRENT DEVELOPMENTS

Much attention is being given to current international negotiations or reviews of free trade agreements, including the North American Free Trade Agreement (NAFTA), the Free Trade Agreement between the European Union and Mexico (FTA-EU-MX), the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), and the continuing work on the Pacific Alliance. The attention stems not only from the typical intellectual property-related provisions, but also from new provisions around the notion of ‘regulatory convergence’. This trend began with the Pacific Alliance, a Latin American FTA that has attracted a large number of observers and associated states.

At the same time, a lot of interest has been aroused around the new framework for the commercialisation of cannabinoid products. A number of cases have reached the Supreme Court of Justice recently, involving both the recreational and medicinal use of cannabis. As a result, there has been (1) an amendment to the General Health Law, recognising certain therapeutic properties to tetrahydrocannabinol (THC), and (2) the development of draft new rules for the research, import and commercialisation of THC products, including in medicines, dietary supplements, cosmetics and cleaning products.

Finally, there has been a growing interest regarding the rules of substitution of medicines. Different amendment proposals are being discussed, but there are widespread misunderstandings around the notions of ‘therapeutic change’ (changing from one molecule to another) and ‘therapeutic substitution’ (changing between two versions of the same molecule). Some proposals are directed at substitution at the point of sale, while others focus on substitution at the point of care. These discussions require proper follow-up.

1 Christian Lopez-Silva, Fernando Robles-Pesqueira and Alejandro Perez-Serrano are partners and Jaime Gary-Lopez is an associate at Baker McKenzie.

2 Official Mexican Standard NOM-062-ZOO-1999 on the technical specifications for the production, care and use of laboratory animals.

3 The Mexican Institute for Industrial Property (IMPI).

4 Official Mexican Standard NOM-059-SSA1-2015 on good manufacturing practices for pharmaceuticals.

5 Official Mexican Standard NOM-241-SSA1-2012 on good manufacturing practices for medical devices.

6 This includes the General Health Law (Article 31), the Federal Economic Competition Law (Article 9), the presidential decree that created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCNPM), as well as the Internal Rules of Operation of the CCNPM and the technical standard for the labelling of drugs: NOM-072-SSA1-2012.

7 This includes the Addendum to the Agreement for Drug Pricing Coordination signed between the Ministry of Economy and the National Chamber of the Pharmaceutical Industry (CANIFARMA).

8 Official Mexican Standard NOM-012-SSA3-2012 on clinical trials.