The Mexican Federal Constitution (the Constitution) establishes health as a fundamental right2 and provides a basis for the government to enact specific provisions related thereto. Specifically, Article 73 of the Constitution grants the Mexican Congress authority to issue laws regarding health matters. Under this authority, the Mexican government has enacted detailed bodies of laws and regulations concerning medicines, medical devices, pharmaceutical products, and related goods and activities. The main body of law in this area is the Mexican General Health Law (the Health Law), which establishes health matters as a subject of public policy and public interest.3
The Health Law provides that certain products, including, inter alia, pharmaceuticals, drugs, food and beverages, raw materials, additives and medical devices, are health-related goods subject to sanitary control.4 Likewise, the Health Law provides that certain processes related to such products are subject to sanitary control. The Law establishes that the term ‘process’5 shall include all activities related to manufacturing, packaging, handling, transportation, distribution, warehousing and supply of the above-listed products. The Health Law specifies that the following authorities6 are in charge of medicines and related products: the President of Mexico, the General Health Board, and the Ministry of Health7 and state governments (on state jurisdictional matters). The Ministry of Health has the broadest jurisdiction regarding these goods and activities.8 Moreover, the Health Law details the specific areas of competence for the different authorities in health matters,9 including the particular roles of the executive branch, the Health Board10 and each of the Mexican states.11
In addition to Congress’s authority to enact health-related laws, the Constitution12 also provides the executive branch with the authority to issue regulations that clarify or specify the content of existing laws, without extending beyond or contravening the law interpreted.13 The most relevant Mexican regulations concerning health matters are the General Health Law, Regulations for Health-Related Goods (Goods Regulations), the Regulations of the General Health Law in Health Research Matters (Research Regulations) and the Regulations of the General Health Law in Publicity Matters (Publicity Regulations).
Products and services imported, marketed or rendered in Mexico are also subject to Mexican Official Standards (NOMs). These NOMs are administrative guidelines that establish technical specifications, processes, premises, systems, activities, services, production methods and operation in Mexican territory.14 Although it is debatable whether these are legally binding, they do establish requirements for products, services and activities in Mexico that are applicable in practice. Before NOMs are issued, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) prepares and issues draft guidelines that permit interested parties to participate in their creation or amendment.15
One additional source of authority on health law are provisions issued by the authorities as internal guidelines, decrees or accords, which may or may not be published in the Federal Official Gazette16 and are applicable to diverse products and services. Finally, although the Mexican legal system is not common law based, several precedents regarding the nature of health provisions have been established by the Mexican courts. Many of those precedents focus on the establishment of health as a constitutional and human right.
II THE REGULATORY REGIME
Pharmaceuticals and medical devices are regulated at the federal level. In addition, the following goods and services are subject to sanitary control:
- a processes;
- b research;
- c food and beverages;
- d human tissue;
- e psychotropic substances and narcotics;
- f toiletries and cosmetics;
- g toxic and dangerous substances;
- h biotechnology products; and
- i publicity.
The Health Law establishes general licence, procedure, and penalty requirements applicable to these goods and activities. The regulations, NOMs and internal guidelines, then establish additional requirements applicable to each type of product and service.
The Health Law and corresponding regulations provide specific definitions of medicines, medical devices and other products and services.
The Health Law defines medicines17 as substances that have therapeutic, preventive or rehabilitative effects in a pharmaceutical presentation identifiable from pharmacological, physical, chemical and biological characteristics and classified based on:
- a preparation:18
- • specific instructions of a health professional;19 or
- • according to the Mexican pharmacopoeia;20
- b nature:21
- • allopathic;22
- • homeopathic;23 or
- • herbal remedies;24
- c marketing:25
- • prescription – requiring a medical prescription or permit from authorities;
- • controlled prescription – the prescription must be preserved by the seller and the sale must be registered;
- • prescription up to three times – supply of a single prescription up to three times with supply recorded;
- • the free sale of the medicine with prescription – requiring a prescription but not subject to other controls;
- • over the counter – freely acquired in registered premises; or
- • over the counter in premises other than registered pharmacies; or
- d other criteria:
- • vitamin medicines26 – products including vitamins and minerals for the treatment of specific ailments;
- • biotechnological medicines27 – substances produced by molecular technology that have pharmacological effects; or
- • orphan medicines28 – designed for the prevention, diagnosis or treatment of uncommon illnesses and ailments.29
In addition to medicines, other goods that are subject to similar regulation include toxins, anti-toxins, vaccines, serums, parenteral preparations, blood-related products, biological material, microbial and fungal preparations, hormones and enzymes.
The Health Law identifies six types of medical devices:
- a medical equipment;31
- b prostheses and functional aids;32
- c diagnostic agents;33
- d dental products;34
- e surgical material;35 and
- f hygienic products.36
These products are classified based on their risks, safety and efficiency, and are divided into:37
- a Class I: well-known in medical practice and not body-invasive;
- b Class II: known in medical practice or body-invasive for periods of less than 30 days; and
- c Class III: new or recently accepted in medical practice or remaining in the body for periods of more than 30 days.
Certain NOMs include additional information or requirements pertaining to medical devices that are not set out in the Health Law or regulations.38 Generally, medical device requirements are less restrictive than those for pharmaceuticals and the most restrictive requirements cover psychotropics and narcotics, subject to additional controls.
ii Non-clinical studies
Under Mexican law there is no specific restriction regarding the use of non-clinical studies. Instead, the party performing the non-clinical study is solely responsible for assuring good laboratory practices and that the studies do not represent a possible risk to human health.
iii Clinical trials
In contrast with non-clinical trials, clinical trials are subject to extensive regulation. Specifically, the Health Law, the Research Regulations and NOM-012-SSA3-2012 regulate clinical trials,39 and establish requirements regarding research and procedures.
Clinical trials may involve research regarding:
- a new prophylactic, diagnostic, therapeutic and rehabilitative resources;40
- b biosafety risk41 research;
- c DNA; and
- d radiation.
Clinical trials are classified by considering the risk42 they pose to the test subjects, including the following categories:
All research involving human beings requires authorisation before it may commence. Some exemptions to the general requirements exist (based on the specific research). To obtain such an authorisation, the performing parties must provide the relevant authorities with information regarding the scope, objectives and purpose of the research, the main investigator, the approval of the institution’s committees and the informed consent of the subjects.46
Clinical research must be carried out at registered health institutions under the direction of a principal investigator, a health professional member of such an institution. The institution must guarantee possible damages arising therefrom, any medical treatment required and indemnification for harmful consequences.47
In the case of sponsorship or other forms of remuneration, measures must be established to prevent conflicts of interest regarding the protection of the test subjects, preservation of the results’ accuracy and the assignment of resources.
Certain legal concepts associated with clinical trials, such as clinical research treatment agreements and clinical research organisation sponsorship and activities, are not regulated by Mexican law. In practice, however, the relevant authorities have issued internal criteria on these matters that may require compliance to obtain necessary authorisations.
On 2 April 2014, several amendments to the Research Regulations were published in the Official Gazette. These amendments included a considerable number of provisions and restrictions related to clinical trials in Mexico. Since these provisions are complex and there are not enough qualified officials within the health authorities to apply them, it is possible for private authorised entities to verify and qualify certain types of clinical research. Specifically, if a private authorised entity issues a favourable report or qualification, then a ‘fast-track’ authorisation is available from the health authorities.
iv Named-patient and compassionate use procedures
No specific procedures exist for using a product before it has received marketing authorisation. An exception exists in the case of clinical trials that may save a patient’s life or health, or eliminate pain, providing the patient has supplied written consent.48 Based on the April 2014 Research Regulation amendments, however, it is now more complicated to obtain such an exception unless obtained through private authorised entities.
v Pre-market clearance
Regulated products49 must be registered with COFEPRIS for marketing. Registration is granted based on available information regarding the product and generally includes:
- a technical and scientific data;50
- b stability;51
- c therapeutic efficacy and safety;52
- d product use and prescription;
- e proposed labelling;53
- f free-sale certificates from the manufacturing country;
- g certificate from the manufacturing premises;54
- h representation letter;55 and
- i government fees.
After filing these documents, if authorities consider that requirements are met and product safety is ensured, they will issue registration and the products may be manufactured, imported and marketed in Mexico. As an alternative to the general registration process, it is possible to have this information pre-reviewed by a private authorised entity that will be in charge of documentary review, and a ‘fast-track’ registration granted. These entities, however, are not governmental agencies or bodies. Fast-track registration may also be available for products that already hold a marketing authorisation in certain jurisdictions.
Previously, only Mexico-resident laboratories could obtain marketing authorisations for medicines. Currently, it is also possible for foreign laboratories engaged in the manufacturing of pharmaceutical products to obtain marketing authorisations. For medical devices, it is not necessary to have manufacturing premises in Mexico or abroad to obtain the marketing authorisation. Instead, it is only necessary to be registered as a marketing company of these types of goods and to provide the required documents and information as well as evidence of due compliance with good manufacturing practices included in NOMs.
vi Regulatory incentives
No law, regulation or any other type of provision establishes regulatory incentives for medicines or medical devices. Some specific incentives at federal or state levels may be available in general for individuals or legal entities engaged in investigation or research activities. These are, however, independent of the regulatory regime applicable to these goods and will have no specific effects on the general provisions governing such activities.
vii Post-approval controls
The holders of registries, marketing authorisation or authorisations of any kind are required to maintain the general conditions upon which such a registration or authorisation was granted during the term that it is in force; any changes thereto may be considered a grounds for cancellation. As a result, any change in the factual background upon which a marketing authorisation was issued must be duly presented for approval before the competent authorities. Failure to do so may give rise to the cancellation of such registration or authorisation.
Health authorities may carry out review and control of products marketed in Mexico at any time they consider appropriate. Likewise, the health authorities may verify due compliance with the applicable laws, regulations, NOMs and other administrative guidelines at any time through the corresponding procedures. In the specific case of pharmaceutical monitoring, in addition to the general procedures set out in the Health Law, those of NOM-220-SSA1-201256 must be satisfied. Any review or procedure must meet the applicable requirements established by specific provisions, and constitutional guarantees and provisions of the Federal Law on Administrative Proceedings.
viii Manufacturing controls
Medicine and device manufacturing is subject to sanitary control and includes requirements regarding premises where related ‘processes’ are carried out. Specifically, laboratories may be authorised to process products subject to this requirement through the issuance of a sanitary licence. The Health Law57 establishes different types of premises that may be authorised to operate in Mexico, including factories or laboratories for medicines, homeopathic, herbal remedies or biological products for human use.
Premises where pharmaceutical products are manufactured must meet the following general requirements:
- a evidence ‘good sanitary practices’;58
- b have quality control laboratories;
- c provide an individual registered with the health authorities as the point of contact for any possible health-related issues in connection with premises where regulated activities take place;59
- d provide information regarding the owner of the laboratory;
- e provide the products to be manufactured;
- f provide information on distribution and sales; and
- g in the case of psychotropic substances and narcotics, provide additional information regarding specific controls.
Compliance with the above requirements is verified through inspections following filing of an application or through an alternative verification process called an ‘operation requirements compliance certification’.60 Once approved, the Ministry of Health will issue the corresponding sanitary licence.
Additionally, these premises must meet specific operational and manufacturing requirements set out in certain NOMs depending on the kind of products manufactured.
The basic manufacturing process controls must include specific technical requirements identified in the Health Law, Regulations and NOMs:61
- a materials handling procedures;
- b controls on the product lot62 and production phases;
- c testing;
- d control systems for raw materials and finished-product inventories;
- e standard operational procedures for materials and finished products;
- f production controls (manufacturing processes, parameters and controls);
- g standardised operational procedures;
- h manufacturing processes validation (analytical laboratory controls);
- i compliance with applicable NOMs for all manufacturing-process equipment;
- j preservation of samples and documents for at least five years;
- k preparation of products must be in accordance with the Mexican pharmacopoeia; and
- l labels (including information on the manufacturer, date, registration, strength, dosage, expiration, storing, etc.).
ix Advertising and promotion
The Publicity Regulations define the term ‘publicity’ as any activity that includes all creation, planning, playing and broadcasting processes of advertisements in communication media with the purpose of promoting the sale or consumption of products or services.
The Health Law differentiates between publicity intended for health professionals and for the public.63
Publicity intended for health professionals64
Information regarding the characteristics and use of medicines and medical devices and medical65 or scientific information66 used for publicity or promotional purposes is restricted to specialised media and must be based on the prescribed information and incorporate the products’ marketing authorisations.67
Publicity intended for the public
Publicity intended for the public requires a specific permit and is only applicable to medicines that may be acquired without a prescription and herbal remedies.68 Information that promotes the sale, use or consumption of products or services is considered publicity. Promotional materials regarding pharmaceutical products and medical devices in Mexico are not subject to authorisation, as long as they do not include information other than the names of the products and the entity manufacturing or distributing them or both. Likewise, activities carried out with health professionals are generally not subject to restriction, because it is possible to organise or sponsor conferences, sessions, courses, etc., regarding products, and to provide sample products, gifts, hospitality and entertainment.69
x Distributors and wholesalers
Distribution and wholesale of pharmaceutical products and devices are ‘processes’ subject to sanitary control by the Mexican health authorities and subject to restrictions and conditions depending on the specific type of sanitary licence.
The Health Law and applicable regulations establish different premises subject to sanitary control and specific requirements for each. Generally, premises for the wholesale and distribution of pharmaceutical products and medical devices are subject to compliance with specific requirements for warehousing, transportation and control.
xi Classification of products
The Health Law and corresponding regulations set the rules and conditions for classifying pharmaceutical products and medical devices. This classification determines the conditions for marketing goods and specific permits and authorisations for related processes. The specific criteria for product classification may be determined by the health authorities.
xii Imports and exports
The Health Law identifies importation and exportation of goods as a ‘process’ subject to sanitary control and general requirements. Specific requirements apply based on the product and its tariff classification.
For products imported into Mexico, the general requirements include registration of the importer of record with the General Importer’s Registry,70 the appointment of a customs broker or in-house broker, and registration with the Specific Sectors Importer’s Registry clearance through specific customs houses.
Goods importation triggers general import duties at the rate for tariff classification, number and value of goods.71 Most products exportation is exempt from export duties. Likewise, importation of goods triggers value added tax. For finished pharmaceutical products this is zero per cent or exempted. Medical devices are subject to the 16 per cent general rate under the Value Added Tax Law.
Non-tariff requirements are also applicable. For medicines and pharmaceuticals, these are generally subject to the issuance of an import or export permit by COFEPRIS. Medical devices are generally only subject to presentation to the customs authorities of the corresponding marketing authorisation.
xiii Controlled substances
Controlled substances include all psychotropic72 and narcotic73 substances. The list of such goods is included in specific chapters of the Health Law, which establishes the general requirements applicable to these goods and their classification based on their use and effects.
Under the Health Law,74 psychotropic substances are divided into those:
- a with minimum therapeutic value by virtue of their possible unlawful use and that constitute a particularly serious public health problem;
- b with therapeutic value but that constitute a serious public health problem;
- c with therapeutic value but that constitute a public health problem;
- d with considerable therapeutic value that constitute a minor public health problem; and
- e with no therapeutic value and that are generally used for industrial purposes.
Additional substances were added to this list during 2015 and several others are currently under analysis for their inclusion. Processes involving these substances are subject to specific controls. Likewise, goods considered as raw materials for manufacturing illegal drugs are subject to specific controls, set forth in the Federal Law for the Control of Chemical Raw Materials, Essential Chemical Products and Machinery for Tablet and Pill Manufacturing and its regulations. This Law provides specific regulations regarding production, sale, acquisition, importation, exportation, transportation, warehousing and distribution of certain chemical products, and apparatus for the manufacture of tablets and pills, specific permits and control and reporting requirements.
Throughout 2015 several jurisprudential criteria were issued as regards substances that are considered illegal narcotics that must be considered as a medical alternative if enough evidence regarding their possible therapeutic effects exists.
The Mexican health authorities may verify at any time the due compliance with applicable provisions of process involving these goods. COFEPRIS is generally in charge of these verification procedures, which must meet requirements in the Health Law and the Federal Law on Administrative Proceedings.75 These procedures must always be served in writing and the scope and purpose of the verification must be established clearly. Once such a procedure notice is served, the authorities may initiate the review and verification of documents, premises and processes.
The verification procedures in health-related matters must meet the general guidelines and requirements for these types of matters included in the Constitution, Health Law and Federal Law on Administrative Proceedings.
All reviews and actions carried out by health authorities in these processes must be included in minutes and finalised with a written resolution in which the findings or potential infractions committed are set out. The determination of the commission of an infraction must always set out the factual background and legal basis upon which it is considered as such, and may be challenged through the applicable legal remedies.
III PRICING AND REIMBURSEMENT
The Health Law includes specific restrictions regarding the maximum prices for medicines offered for sale to the public at large, and it is necessary to set out these maximum prices within the labelling itself. Most medicine sales to governmental health providers are subject to specific bidding procedures under the Law on Acquisitions, Leases and Services of the Public Federal Administration. This Law establishes the general obligation to acquire goods only through public bidding procedures in which the specific conditions for a sale are established (some existing isolated cases do, however, provide exceptions to this provision). Similarly, the Mexican social security system relies on the direct rendering of health-related services by the competent governmental agencies; no reimbursement procedures exist for goods directly acquired by the population covered by the public healthcare system.
IV ADMINISTRATIVE AND JUDICIAL REMEDIES
Administrative infringements may be determined independently of possible criminal offences arising from acts or omissions set forth by the corresponding legal provisions. The applicable legal remedy depends mainly on the type of fine or penalty applied to a legal entity or individual, as well as the reasons for such a determination. In general, the penalties for failure to comply with obligations set out by the corresponding legal provisions consist of:
- a fines;
- b seizure;
- c immobilisation of goods;
- d foreclosure of premises; and
- e destruction of goods.
Various legal remedies exist for challenging decisions or determinations regarding possible infringements of health-related provisions, including the following.
Pursuant to the Health Law,76 acts by the health authorities may be challenged through an administrative appeal, which provides a term for filing of 15 business days following service of the corresponding resolution and must include:
- a the power of attorney of the legal representative;
- b the resolution to be challenged;
- c facts and legal arguments; and
- d evidence.
The administrative appeal may confirm the resolution, cancel the resolution, amend the resolution in specific terms, or order issuance of a new resolution. The resolution of the administrative appeal may be further challenged through the administrative litigation procedure before the Federal Tax and Administrative Justice Court.
Administrative litigation procedure
As an alternative to the administrative appeal, resolutions may be challenged through an administrative litigation procedure (nullity petition) before the Federal Tax and Administrative Justice Court, based on the Federal Law on Litigious Administrative Procedures.
This nullity petition must be filed before the Federal Tax and Administrative Justice Court during the 15 or 3077 business days immediately following the date on which it is formally served and attached with:
- a power of attorney of the legal representative;
- b resolution to be challenged;
- c facts and legal arguments; and
- d evidence.
The nullity petition may confirm the resolution, declare it null and void, declare partial nullity or specific nullity for a specific purpose.
Unfavourable or partially favourable resolutions to a nullity petition may be challenged through a direct amparo78 before the federal courts of appeal. In specific cases, the resolution issued by an administrative authority may also be directly challenged through filing an amparo when the resolution implies the direct violation of constitutional principles.
V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS
Mexican law does not provide any specific rules regarding financial relationships between pharmaceutical and medical device companies with prescribers and payers, except in some very limited cases involving public health service officials. In the case of acquisitions by government agencies, the Federal Law on Public Servants is applicable in connection with the prohibition on providing any kind of gift79 to an individual who holds public office when the gift is directly related to his or her activities.
On the basis of the foregoing provision, it is not possible to provide prescribers or payers with any kind of financial benefit, gift or hospitality if they act as public servants. In the case of private practitioners these restrictions are not applicable. This restriction creates a considerable number of practical issues because many health professionals may hold governmental positions and maintain private practice.
VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS
Under Mexican law there is no specific procedure or system for the compensation of possible injuries or damages arising from use of medicines or medical devices. Individuals who are affected or damaged by a medicine or medical device may file a lawsuit (ordinary civil procedure) to request the compensation of damages. Under Mexican law, only direct damages may be requested, if a direct relationship between the product and the damage can be duly evidenced.
VII TRANSACTIONAL AND COMPETITION ISSUES
i Competition law
The Law of Economic Competition (the Antitrust Law) does not include specific provisions regarding medical devices and pharmaceutical products in Mexico. These product types are subject to the general provisions of the Competition Law. Because of the nature of the pharmaceutical and medical devices business in Mexico, however, these industries tend to be severely scrutinised by the competition authorities, especially in the case of sale to governmental agencies.
ii Transactional issues
Under Mexican law, no specific provisions or regulations pertain to transactional issues regarding legal entities engaged in the pharmaceutical or medical devices business. In practice, however, various issues may be encountered in the event of mergers, acquisitions, spin-offs and sales of assets in connection with these products. Thus, the transfer of marketing authorisations, licences and authorisations (manufacturing premises, warehousing, research, psychotropic substances authorisations, etc.) by virtue of the aforementioned transactions may take considerable time to be finalised. Likewise, any change to the manufacturing processes or the grounds on which a marketing authorisation was issued must be duly reported to the health authorities and, in some cases, may be considered a ‘change’ or amendment to the conditions upon which the authorisation was granted.
The foregoing may result in delays in transactions involving these types of products and may represent a challenge for legal entities carrying out these transactions to avoid the total or partial impossibility of carrying out the importation, manufacturing or marketing of pharmaceutical products or medical devices post-transaction.
VIII CURRENT DEVELOPMENTS
Mexico has had considerable developments in the life sciences legal framework during the past couple years.
Developments in life sciences, as is the case for most scientific and technological developments, are faster and more dynamic than the legal framework regulating them. It is thus necessary to update the applicable law in the most possible efficient manner, and it is a priority for the Mexican government to establish new provisions governing life sciences issues.
Likewise, the health authorities have had a greater regulatory control and effective enforcement thanks to technological developments not previously available to the authorities. These technologies are part of the ‘National Digital Strategy’ implemented by the executive branch since 2014, which aims to have more agile procedures through the use of technology and remote access. For instance, COFEPRIS has developed various online projects that will permit up to one-third of the different procedures followed before them to be electronically filed. Owing to the nature of the information that some of these procedures require, special attention has been provided to the data privacy and security of these systems by the competent authorities.
One of the most relevant issues for 2017 is the possible implementation of new provisions regulating telemedicine. The Health Law allows health service providers to use ‘practical clinical guides and electronic media’ as support in accordance to NOMs. Regarding telemedicine, there is a draft NOM that would regulate health services rendered through electronic media, develop topics such as the importance of data protection and confidentiality, professional liability of health service providers, and the scope of the term ‘telehealth’ that describes the information exchanged between health service providers. However, the draft NOM does not contemplate specific requirements for online medical advice at premises that have no present health professionals (home, offices, etc.) or international services. The main purpose of these provisions is to support complete health coverage for Mexico and particularly healthcare services to isolated communities.
Among the most relevant developments during 2016, and a possible trend for 2017, is a greater emphasis on the monitoring of good manufacturing practices and requirements for pharmaceutical products and medical devices. This has particular relevance considering that, during 2016, some significant cases of non-compliance with these kind of provisions by well-known companies were publicly disclosed.
New anti-corruption laws will enter into force during 2017 and the business structures implemented by most companies engaged in governmental sales will require substantive review, and the implementation of new guidelines. This will be of particular relevance to the life sciences industry.
Among the recent developments regarding pharmaceutical products is the approval in 2016 of the medical use of cannabinoids arising from ‘compassionate use’ of pharmaceutical products. Likewise, amendments to the health-related provisions are expected to enter into force during 2017, allowing the possibility of using several restricted plants for investigation and medical purposes.
Obesity and related maladies (including diabetes and cardiac ailments), are still major health problems and continue to be considered health priorities.
Products that have a high caloric content and food and beverages in general, together with dietary supplements, have been subject to taxes and duties upon their importation and marketing as well as greater control upon labelling and advertisement.
Following several international trends, food and beverage safety and logistics chain controls have been considered priorities by the federal government. Owing to the close business relationship with the US and Europe, Mexico’s regulatory regime for these products may have drastic changes in order to accommodate recent changes by its main business partners. Special attention must be paid to the new provisions in food and beverage related matters in force in the US.
As in prior years, obesity and malnutrition have also been a priority for the health authorities. In southern states, chronic malnutrition affects around a 7.25 per cent of children between five and 14 years and in indigenous and rural regions, there is up to 14.5 per cent of child malnourishment. This contrasts with Mexico’s worldwide ranking as first for child obesity, meaning that around 4.1 million children in Mexico are considered obese.
One of the most urgent health threats according with the Pan American Health Organization are infectious diseases such as dengue and Zika, which are still present in Mexico because of its geography, vast regions for mosquito reproduction, lack of health services and absence of preventive actions.
During 2016, 19,510 cases of dengue followed by 19 deaths were confirmed, and in the case of Zika, there is particular concern about the risks for pregnant women because of the possible microcephaly in babies. A total of 3,669 pregnant women formally registered as having Zika during 2016.
There were 722 cases of chikungunya reported during 2016 according to the Pan American Health Organization.
The Organisation of Economic Co-operation and Development (OECD) has considered that there is significant inequality and a lack of access to the health system in Mexico, which, together with inadequate preventive actions, has led to the lowest life expectancy of all OECD countries. According to data from the Ministry of Health, in 2013, 55,992 people died from type 2 diabetes and during the same period, 148,681 died from cardiovascular diseases. The above statistics are consistent with the concerns regarding obesity, lack of medical access and inequality, among others. The Mexican government aims to improve the health of citizens through changes in the regulation of the life sciences industry.
1 José Alberto Campos-Vargas is a partner at Sánchez Devanny.
2 Article 4 of the Constitution.
3 Article 1 of the Health Law.
4 Article 194 of the Health Law establishes as sanitary control any acts and activities regarding education, verification and punishments applied by the health authorities and industry based upon applicable legal provisions and Mexican Official Standards.
5 Article 197 of the Health Law.
6 Article 4 of the Health Law.
7 The Ministry of Health acts for these purposes through COFEPRIS.
8 COFEPRIS’s specific competence is set out in Article 17 bis of the Health Law.
9 Article 13 of the Health Law.
10 Articles 15 to 17 of the Health Law.
11 The governments of each of the Mexican states have competence on health matters and may aid and collaborate with federal authorities through specific actions arising from collaboration agreements. Those collaboration agreements set out the scope and extent of the federal competence matters that may be reviewed through collaboration with local authorities.
12 Article 89, Section I of the Constitution.
13 In practice, regulations tend to go far beyond the scope of law and include new concepts or set out additional requirements as well as those contemplated by the original law.
14 Article 3, Section xi of the Federal Law on Metrology and Normalisation.
15 These procedures are contemplated by the Federal Law on Metrology and Normalisation.
16 In practice, these guidelines may differ from the procedures included in laws, regulations or NOMs, and thus require constant review.
17 Article 221 of the Health Law.
18 Article 224 of the Health Law.
19 Magistral preparations or prescriptions.
20 ‘Pharmaceutical’ prescriptions.
21 Article 224 of the Health Law.
22 Substances or mixtures with specific therapeutic, preventive or rehabilitation effects in pharmaceutical preparation and identifiable as such by pharmacological activity, biological, chemical or physical characteristics registered in the Mexican pharmacopoeia.
23 Substances or mixtures having specific therapeutic, preventive or rehabilitative effects and manufactured based on Mexican or foreign homeopathic pharmacopoeia.
24 Products manufactured from plants, parts or derivatives thereof having scientifically confirmed therapeutic efficiency.
25 Article 226 of the Health Law.
26 Article 61 of the Goods Regulations.
27 Article 81 of the Goods Regulations.
28 Article 224 bis of the Health Law.
29 Uncommon ailments or illnesses are those existing in five out of every 10,000 individuals.
30 Article 262 of the Health Law classifies these products under different categories.
31 Apparatuses, accessories and instruments for medical or surgical use, exploration, diagnosis, treatment, rehabilitation and biomedical investigation.
32 Devices bound to substitute for or aid a bodily function, organ or tissue.
33 Antigens, antibodies, calibrators, verification agents, reactive products, reactive equipment, culture and contrast media, and other auxiliary products for clinical use.
34 Products bound for dental health examination.
35 Antiseptic devices, devices, germ killers and similar products used in surgical practice.
36 Those applied on body cavities or skin for pharmacological or preventive action.
37 Article 83 of the Goods Regulations.
38 Among these are NOM-137-SSA1-2008 Medical Devices Labelling and NOM-064-SSA1-1993 Sanitary specifications for reactive diagnosis equipment.
39 NOM-012-SSA3-2012, Criterion for Human Health Research.
40 These include pharmacology, prostheses, transplants, prevention, diagnosis, treatment and rehabilitation methods.
41 This includes those related to pathogens, micro-organisms or biological materials.
42 For clinical research purposes, risk is understood as the probability of the subject of the trial suffering damage as an immediate or delayed consequence of the corresponding trial.
43 Questionnaires, interviews, files review, etc.
44 Hearing tests, electrocardiograms, stool samples, secretions collection, blood extraction, etc.
45 Defined by the regulations as that with the possibility of having unfavourable effects on the test subjects.
46 Some exceptions are applicable in cases of minimum risk.
47 Some internal guidelines regarding possible liability of the sponsor have been internally issued by COFEPRIS.
48 May be granted by legal representative or next of kin.
49 Pharmaceuticals and medical devices.
50 This includes methods for quality and quantitative control of the raw materials, components, additives, products manipulation, preservation and warehousing conditions, toxicity tests, certificate of analysis of raw materials and finished products, including physicochemical and microbiological specifications.
51 NOM-073-SSA-2015 Medicines stability. Stability-related documents must provide information about the manner in which the chemical, physical, microbiological and biological characteristics of a medicine vary over time and effects of environmental factors such as light, humidity and temperature; and establish proper warehousing conditions and expiry time in the market.
52 If no information, regarding these products is available in the Mexican pharmacopoeia or related provisions, foreign scientific and technical data may be considered.
53 This includes a description of main and secondary packaging and label design, with caution statements, instructions for use, prescription information, etc., in accordance with NOM-072-SSA1-2012 Medicines labelling.
54 Issued by the country of manufacturing or evidence of compliance with corresponding NOMs.
55 If the requesting party in Mexico is not an affiliate or subsidiary of the foreign medicine manufacturer, a representation letter issued by the manufacturer will be required.
56 Pharmaceutical vigilance operation.
57 Article 257.
58 Good sanitary practices requirements are included in several NOMs, including NOM-241-SSA1-2012 Good manufacturing practices for premises engaged in medical devices manufacturing, NOM-164-SSA1-2015 Pharmaceutical products good manufacturing practices, NOM-059-SSA1-2015 Good manufacturing practices for pharmaceutical and chemical industries engaged in medicines manufacturing, etc.
59 This individual must have technical skills or knowledge regarding medical sciences, pharmaceutical, biologic or related subjects, be registered with COFEPRIS and have a professional identity card showing that he or she holds a degree as pharmacist, industrial pharmacist, biological and clinical pharmacist, industrial chemist or any other degree closely related to the pharmaceutical area.
60 This certification may only be issued by individuals or legal entities duly authorised for such a purpose by the Ministry of Health.
61 These requirements are included in diverse NOMs, among which are NOM-241-SSA1-2012, NOM-164-SSA1-2015, NOM-059-SSA1-2015.
62 Product lot is a certain amount of product manufactured during a specific period and under a specific control regarding raw materials, additives, operating procedures, etc. The product lot permits the tracking and control of a determined product.
63 Article 310 of the Health Law.
64 Article 40 of the Publicity Regulations.
65 Medical information is considered as that bound for health professionals through any medium regarding illness, prevention, treatment or rehabilitation.
66 Scientific information is deemed as that bound for health professionals regarding active ingredients pharmacology and the therapeutic use of products.
67 Article 42 of the Publicity Regulations.
68 Article 79 of the Publicity Regulations.
69 Specific restrictions in this connection are, however, included in the industry codes of ethics.
70 Although from a strictly legal perspective no restriction exists for foreign individuals or legal entities to import goods, in practice this may only be carried out by individuals or legal entities duly registered with the Federal Taxpayer’s Registry, since this is a requirement to obtain the corresponding importation authorisation.
71 This is in addition to the price-paid brokerage fees, transportation costs, costs prior to importation, insurance costs, storing handling loading unloading, etc.
72 Psychotropic substances are specifically regulated by Articles 244 to 256 of the Health Law.
73 Narcotics are specifically regulated by Articles 234 to 243 of the Health Law.
74 Article 245 of the Health Law.
75 NOM-220-SSA1-2012 Installation and operation of pharmaceutical vigilance.
76 Article 438 of the Health Law.
77 This period will depend on the amount of the fines or nature of the infraction and punishment.
78 Constitutional remedy.
79 The yearly maximum amount of gifts or hospitality to governmental officials is restricted to approximately $50.