Decree on Amendments to Trademark Law Published in Official Diary

– LATEST NEWS –

Decree on Amendments to Trademark Law Published in Official Diary

 

As a follow-up to our Newsletter No. 5 regarding recent amendments to Mexico’s industrial property law concerning trademarks, we wish to further inform you of the following developments.

At the time of the previous newsletter, publication of the corresponding Decree announcing the amendments in the Mexican Official Diary was pending; the Decree was published on May 18, 2018 and will be in force as of August 10, 2018, pursuant to the first article of the transitional provisions.

The Mexican Institute of Industrial Property (IMPI) will need to publish a set of regulations well in advance of August 10 so that there is a clear understanding as to the scope of the amendments and new provisions. We will notify you as soon as these regulations are available.

As highlighted in our previous newsletter, the changes introduced to the Trademark Chapter of the Industrial Property Law are as follows:

  1. Trademark protection through registration is provided for trade dress, certification marks, and holograms, as well as for non-visible signs, such as smell marks and sound marks;
  2. Secondary meaning is now recognized as an exception to descriptiveness;
  3. Consent and coexistence agreements will be allowed to overcome senior rights;
  4. Bad faith is incorporated as a ground for both opposition and invalidation;
  5. Traditional class headings will no longer be possible.  It will be necessary to specify product and service descriptions according to the Nice Classification.
  6. Oppositions will become binding for IMPI; this means that the Office will have a vested interest in issuing decisions that are duly grounded in and based on the merits of each opposition filed.
  7. A declaration of use must be filed under oath within three months after the third anniversary of the date of the trademark being granted registration. Failure to file a declaration of use will cause the registration to lapse

This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.

For further information on the content of this newsletter, please contact
Sergio L. Olivares, Jr. sergio.olivares@olivares.mx;
Antonio Belaunzarán antonio.belaunzaran@olivares.mx; Alonso Camargoalonso.camargo@olivares.mx; Abraham Diaz abraham.diaz@olivares.mx

 or call at +52(55) 5322 3000

Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

No. 7  | MAY 2018

www.olivares.com.mx

– LATEST NEWS –

Comprehensive and Progressive Agreement forTrans-Pacific Partnership (CPTPP)

 

On May 23, 2018, a Decree was published in the Mexican Official Diary announcing that the Mexican Senate has officially approved the CPTPP.

Eleven countries have signed the free trade agreement formerly known as the Trans-Pacific Partnership (TPP), which has been renamed the “Comprehensive and Progressive Agreement for Trans-Pacific Partnership” (CPTPP). Mexico signed the agreement on March 8, 2018.

The other signing members are: Australia, Brunei, Canada, Chile, Japan, Malaysia, New Zealand, Peru, Singapore and Vietnam.

The Treaty will enter into force 60 days after the date on which at least 6 or at least 50 percent of the number of signatories to the Treaty, whichever is less, have notified the Depositary in writing that the applicable legal requirements have been met.

For any signatory to the CPTPP for which the Treaty has not entered into force as previously mentioned, it shall enter into force 60 days after the date on which that signatory has notified the Depositary in writing that the applicable legal requirements have been met.

We expect the CPTPP to enter into force within the last trimester of 2018 in Mexico.

For background on key differences between the original TPP and the CPTPP, please refer to our Newsletter No. 4, dated March 2018:
http://www.olivares.mx/impact-of-the-comprehensive-and-progressive-agreement-for-trans-pacific-partnership-on-life-sciences-in-mexico/

In total, 22 provisions on rules are suspended. One of the most significant revisions was in the intellectual property (IP) chapter. Under the revised IP chapter, the length of patent protection for innovative medicines and copyright periods for written materials has been shortened, and technology and information protections have been narrowed.

The suspended provisions have removed the additional requirements (pursued by the United States) in technological protection measures (TPMs), rights management information, encrypted satellite and cable signals, and safe harbors for internet service providers (ISPs).

Although the agreement will not be as positive as expected with respect to elevating IP standards in Mexico, it remains a welcome development for international trade and for certain aspects of IP protection and regulatory matters.

This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.

For further information on the content of this newsletter, please contact
Sergio L. Olivares, Jr. sergio.olivares@olivares.mx;
Alejandro Luna F. alejandro.luna@olivares.mx; Gustavo Alcocer gustavo.alcocer@olivares.mx; Daniel Sánchez daniel.sanchez@olivares.mx;  Armando Arenas armando.arenas@olivares.mx

 or call at +52(55) 5322 3000

Mexico as a member of the Madrid International Trademark System

MADRID SYSTEM IN MEXICO

 

Sergio L. Olivares, Jr., OLIVARES, Mexico City, Mexico

There is no doubt that the Madrid system should be beneficial for trademark owners when protecting their trademarks in several countries, particularly in terms of cost effectiveness.  However, with regard to Mexico, three years of experience with the Madrid system have revealed certain practical and legal issues, which are important to consider prior to making a decision as to whether to apply for a trademark in Mexico via the Madrid system or directly with the Mexican Trademark Office (“TMO”).

 

Multi-Class Trademark Filings

A first issue to consider is the fact that the Mexican Industrial Property Law (IPL) does not allow for multi-class trademark applications.  Consequently, an International Registration designating Mexico covering more than one class will automatically be split into separate Mexican applications (one per class).  Each of these separate Mexican applications are subject to individual examination on both formalities and absolute/relative grounds for refusal, and the costs for responding an eventual provisional refusal in each class are also independent.

It is true that renewals and changes in ownership for multiple classes via Madrid filing are easier, as long as a single petition will renew registrations or make of record a change in ownership against several national registrations derived from Madrid, However, until the local registrations are finally granted by the TMO, costs for prosecuting the national applications derived from an international registration may substantially increase.

 

Goods and Services Descriptions

A second important issue to consider is that although Mexico is part of the Nice Agreement, and thus the TMO applies the Nice Classification system derived from such agreement, the TMO will likely request amendments to products and services descriptions in International Registrations designating Mexico, despite the fact that such descriptions have been already accepted by WIPO without any objection.

The above is due to an extremely formalistic and rigid provision in the Regulations to the IPL, as well as the narrow criteria adopted by the TMO during the formalities examination, consisting of the fact that if certain specific products or services do not exactly appear listed in the latest edition of the Nice Classification of products and services, the examiners will issue provisional refusals, requesting that the applicants clarify of the nature of the products or services and the language of their description in order to exactly match the alphabetical list of products and services provided in such classification.

For instance, if an application is filed through the Madrid System designating Mexico for a trademark covering “vegetable juices” in International Class 32, the Mexican Trademark Office is very likely issue a provisional refusal requesting applicant to clarify the nature of the “vegetable juices” sought to be covered in order to assess their correct classification, or otherwise suggesting to reword such products as “vegetable juices (beverages)” in order to keep the products in Class 32.

However, an application filed directly with the TMO by an experienced local counsel would surely avoid a similar objection, not because the examiner’s criteria is different, but because of the knowledge of local practice of an experienced local counsel would make him suggest the client to reword the description of services to avoid such and odd requirements..  As a result, there is typically a delay in the prosecution of an application derived from a Mexican designation of an international registration, and also increased costs associated with the engagement of local counsel to file an Office Action response to the TMO.

Likewise, in those cases when a provisional refusal issues requesting that the applicant clarify the nature of goods/services to be covered arises from a clear mistake of the translation of such goods/services made by WIPO, the Mexican Trademark Office refuses to amend such mistake, thus forcing the applicant of the international registration to request the pertinent correction from WIPO. Nevertheless, the applicant is required to respond to the provisional refusal arguing WIPO’s mistake in order to avoid the abandonment of the application (Mexican designation), which of course represents a further delay and an additional increase in costs.

 

Appointment of Local Agents

A third and arguably the most important issue to take into consideration is that although a large number of Mexican local applications derived from International Registrations designating Mexico have been successfully granted without any provisional refusals, and the Mexican trademark registrations granted under these circumstances are currently in full force and effect, it is nevertheless highly advisable for the registrants to appoint local agents for service in those registrations.

The reason for this is that, under the current legal frame, if a Mexican registration obtained through the Madrid system is ever challenged by a third party, and no local agent has been recorded for service with respect to such registration, the service of such claim would be effected through “Letters Rogatory”, with all inconvenience this may bring in terms of time and cost. [See. Article 550 of the Federal Code of Civil Procedures]

Particularly, it is clear that the service of a claim through Letters Rogatory involves an extremely formalistic international legal procedure, which may take several months or even years to be effectively concluded.  Therefore, in some cases the delay in the service of a claim may preclude defendant from pursuing a counter claim, in those cases where the statutory term for asserting a counterclaim under certain grounds is quite short.

In practice, there have been a few cases where, in absence of an appointment of local agent for service in a Mexican Trademark Registration, claims filed by third parties have been served through a publication in the Official Gazette and a national newspaper.  [See. Article 154 of The Mexican Industrial Property Law] This kind of service procedure results extremely risky, because the publications in both the Official Gazette and a national newspaper are usually hard to detect.  Consequently, an invalidation or cancellation claim served by these means which is not detected by the defendant would produce their legal effects, and the registrations under this scenario would be declared cancelled without an opportunity for their owners to defend the actions.  It is important to keep in mind that WIPO is only obliged to advise the affected party of the final decision declaring cancellation/invalidation of a registered mark, but not the existence of the claim and not the deadline to file its response.  [See. Rule 19 of the Common Regulation of the Madrid Agreement and Protocol]

On the other hand, owners of Mexican Trademark Registrations filed directly with the TMO have local counsel already appointed in the case of an invalidation or non-use cancellation filing.

 

Additional Legal Issues

Some additional legal issues have been discussed in Mexico in connection with the Madrid System, particularly as far as it concerns to its Constitutionality, based on certain clear violations to the so called “National Treatment” principle.  [See Article 133 of the Mexican Constitution in relation to all the provisions established in its Chapter I, as well as in relation to all International Treaties signed by Mexico (TRIPS, NAFTA, WTO, etc.)]

Indeed, the so called “National Treatment” principle establishes that all Laws and Treaties applied in Mexico should grant foreigners (individuals or companies) the same treatment and benefits granted to nationals and vice versa.  However, in practice there are certain situations where the users of the Mexican National trademark system are imposed with higher burdens that those imposed to the users of the Madrid System, and there are also certain benefits for the users of the National Trademark System with respect to those granted for the users of the Madrid System.  Three examples of the above situations are described hereunder:

  1. Under the National Trademark System, the IPL currently in force requires the applicant to indicate in the application papers a date of first use of the mark in Mexico, when such prior use exists, or the indication that the trademark has not been used, and this requirement is not imposed to the users of the Madrid System. [ Article 113 Section III of the Mexican Industrial Property Law]

It is important to mention that use is not a requirement for obtaining registration in Mexico, but when such use has commenced prior to the filing of the application, such information becomes relevant.

The above because in case that any interested party attempts to cancel a registration where a date of first use was declared based on an alleged prior use, such party needs to demonstrate prior use not only in respect to the filing date of the application to be challenged, but also in respect to the date of first use declared in the corresponding application papers.  [See. Article 151 Section II of the Mexican Industrial Property Law] This possibility is not granted to the users of the Madrid System, since there is no requirement for them to declare a first of use date when designating Mexico in an International Registration.

 

  1. For renewal purposes, the IPL currently in force requires the registrants under the National Trademark System to declare under oath that the trademark to be renewed has been used in Mexico within the last three years preceding the renewal application date, and this is the only requirement stated in our law for renewal purposes. [ Article 134 Section II of the Mexican Industrial Property Law] This requirement is not imposed to the users of the Madrid System for the renewal of the registrations derived from their Mexican designations.
  2. When applying for recordation of any change of ownership (assignments, mergers, changes of names, etc.) under the National Trademark System, the Mexican IPL still imposes the applicants with the obligation to submit either original signed assignment documents or certified and legalized copies of assignments, mergers or change of name documents, while the users of the Madrid Systems are not required to provide any documentation when applying for recordation of such changes. [ Articles 9 and 10 of the Regulations to the Mexican Industrial Property Law]

No constitutional claims have been filed before the Mexican Courts so far in connection with any of the above situations, but it would be interesting to see the potential consequences of an eventual constitutional claim in the future.

In conclusion, up to date it is difficult to tell which way (whether applying via WIPO or Mexican national system) may be more beneficial for the trademark owners, since the accession of Mexico to Madrid is still quite recent, and practitioners are still learning about the functionality and efficiency of the system in Mexico.  However, the above issues should be taken into account when making the relevant decision.

 

Use of the Madrid System by foreign users vs. Mexican users

 

An interesting situation to consider is the poor use of the Madrid System by Mexican companies and individuals in comparison with the use of such system by foreign users.

 

According to the ROMARIN database, since Mexico’s adoption of the Madrid Protocol in February 2013 up to May 5, 2018, the statistics of use of the Madrid system by Mexican users vs. foreign users is as follows:

 

International Registrations with

Mexico as a base country                                                            374

 

Mexican designations in International

Registrations based on foreign

Registrations                                                                                    50,636

 

 

The above statistics clearly reflect that the Madrid System has been definitively beneficial for foreign trademark owners when protecting their marks in Mexico, but regrettably so far not for Mexican trademark owners when protecting their trademarks abroad, as very few big Mexican companies are the only ones who have used such system to protect their marks in foreign countries.

 

Apparently, there are two factors which may have caused this situation, namely:

 

  1. It is a reality that most medium to small size Mexican companies or businesses do not consider IP protection as a priority investment, but as an expense which they try to drag as much as possible. In most cases, small size Mexican companies or businesses start protecting their marks in Mexico and other countries after they have started commercializing their goods or services, and in most cases once they find obstacles;

 

  1. The fact that only Cuba and Colombia have joined Madrid in Latin America has precluded Mexican individuals and companies from using such system in this world’s region, which is naturally one of most interesting regions for Mexican manufacturers, merchants and service providers.

 

Hopefully, the above situation will start changing as long as more Latin-American countries start joining Madrid, though, at this point in time no Latin American countries have openly showed interest in joining Madrid.  Brazil and Canada have expressed their intention to join the international system, but in none of this cases will occur at least before 2020.

 

Product regulation and liability in Mexico

BY  Alejandro Luna F. , Alejandro Torres

Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions.

Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

On March 8 2018 Mexico signed the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), formerly known as the Trans-Pacific Partnership (TPP). While the CPTPP incorporates most of the TPP provisions, others are suspended, including provisions relating to life sciences:

  • Regulatory data protection – Mexico will continue to grant five years of regulatory data protection for chemicals. Certain legal strategies will be required to achieve protection for new indications of orphan drugs and biologics.
  • Patent linkage – the existing linkage system will remain in place.
  • Patent term adjustments – the patent term under domestic law will remain in place (ie, the non-extendable life term of a patent is 20 years from the international filing date).

Considering the hierarchy of international treaties in the Mexican legal system, CPTPP will be an important part of the legal framework for Mexico life sciences companies. To be effective in Mexico, international agreements must be ratified by the Senate – the CPTPP’s ratification is expected this year.

In December 2017 the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) issued new guidelines regarding the advertising of prescription-only medicinal products. According to these guidelines, prescription-only medicinal products can now be advertised on mass media platforms, provided that these advertisements:

  • are transmitted within:
    • specialised programmes, informative capsules or advertising breaks, which should target professionals, technicians and health discipline auxiliaries; or
    • another type of programming or means of communication;
  • contain a strong message outlining the consequences of self-prescription and microbial resistance with an approximate duration of 10% to 20% of the entire advertising message;
  • promote knowledge of innovative or generic medicines;
  • include a preventive legend (eg, ‘exclusive information for health professionals’ or ‘avoid self-medication’); and
  • are made five days before the product’s dissemination via any means of communication to allow for COFEPRIS approval.

On March 13 2018 amendments to the Industrial Property Law regarding the extension of design validity from 15 to 25 years were approved. This may have repercussions for medical devices. Regarding industrial property, the extension will likely increase the number of inventions and stimulate the search for novel designs. Further, as inventors race to develop designs that are distinctive, the market will grow increasingly competitive. However, the resulting rise in validity claims also increases the likelihood of infringement and litigation.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The main regulatory framework concerning medicinal products is set out in:

  • the General Health Law;
  • the Health Supplies Regulation;
  • the Official Mexican Standards; and
  • the Mexican Pharmacopoeia.

Are any legislative changes proposed or expected in the near future?

No amendments to the IP or health laws are expected in the near future, unless other treaties also under negotiation (eg, the North American Free Trade Agreement and the Free Trade Agreement between Mexico and the European Union) include similar patent term compensations schemes.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The authority responsible for enforcing the regulatory framework in relation to medicines is the Federal Commission for Protection Against Sanitary Risk, which is part of the Ministry of Health.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Other legal regimes applicable to the trade of medicinal products include:

  • competition;
  • antitrust;
  • transparency;
  • data protection regarding clinical trials and other activities involving patents or clinical data;
  • consumer protection; and
  • industrial property.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No medicinal products are exempt from regulation.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

Companies manufacturing medicines and medical products in Mexico must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS) through a manufacturing licence or authorisation.

What is the fee for obtaining authorisation?

Government fees for analysing a manufacturing approval application are around $3,000.

What is the validity period for authorisation?

Drug manufacturers must renew their licence every five years, subject to the relevant test, including the presentation of a certificate of good manufacturing practice.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Good manufacturing practices are well adhered to in Mexico.

COFEPRIS can make onsite visits at any time to inspect premises and verify compliance, and can initiate ex officio legal proceedings to penalise non-compliance. Ultimately, these legal proceedings can result in the revocation of marketing authorisation.

Good manufacturing practices, stability, labelling standards and all other applicable provisions must be complied with. A programme to recall and destroy products that do not meet quality standards must be in place.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

COFEPRIS is entitled to implement measures on behalf of public health, such as:

  • the seizure of products; and
  • ordering partial or total suspension of activities, services or advertisements.

Under certain conditions, COFEPRIS has statutory authority to revoke any manufacturing approval and impose penalties, ranging from a fine of up to 16,000 times the minimum wage (approximately $3,523) to closure of the establishment.

The imposition of administrative penalties does not exclude civil and criminal liability.

Distribution

How are the distribution and storage of medicinal products regulated?

The Official Mexican Standard (NOM) for the good manufacturing practice of medicinal products (NOM-059-SSA1-2015) requires a programme to recall products that do not meet quality standards in an appropriate and efficient manner. This programme must include:

  • activities planned for recalling products in a rapid and effective manner;
  • storage; and
  • a list of authorities to be notified according to the product distribution.

Marketing authorisation holders must report any product recall decision to COFEPRIS, providing details of the products and the causes leading to the recall.

Import and export

How are the import and export of medicinal products regulated?

A marketing authorisation granted by COFEPRIS is required when importing medicinal products.

Foreign marketing authorisations are not valid in Mexico. However, COFEPRIS has set a special procedure for drugs requiring first-time approval in Mexico, but that have been approved by equivalent regulatory authorities abroad. In this procedure, the approval requirements of the foreign agencies are recognised as equivalent to those in Mexico.

Are parallel imports permitted in your jurisdiction?

Any import of drugs, health products or raw materials for drugs must be approved by COFEPRIS. Marketing authorisations are required. The import of a minimum quantity of products without a marketing authorisation can be approved in certain circumstances (eg, clinical trials and orphan drugs).

Regarding IP rights, parallel imports are allowed in Mexico in relation to trademarks where:

  • the product was legally introduced in the country of origin; and
  • the trademark is owned by the same company or a related company in Mexico.

The IP Law does not specifically address patents in this context, as it does for trademarks. However, it is likely that the principle of exhaustion of rights also applies to patents.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

Price control in the private sector is based on a self-regulated maximum retail price (MRP) scheme covering patented products, which is overseen by the Ministry of Economy. The participation of pharmaceutical companies is voluntary. Under the price control, each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established penalties for MRP violations.

In 2008 the government created the Committee for the Negotiation of Drug Prices to:

  • support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies; and
  • evaluate cost benefits of new medicines and therapies in view of prices and other comparable products in the market.

Are there any restrictions on the online sale and purchase of medicinal products?

Unless they are over-the-counter products, medicines must be made available only in authorised drug stores and can be sold to patients only with a physician’s prescription. Dispensers must keep original prescriptions regarding antibiotics.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

The following rules govern named patient supply of pre-launch medicinal products:

  • the Code of Good Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA);
  • the CANIFARMA Code of Ethics;
  • the Health Law Regulations; and
  • the NOM-072- SSA1-2012 for medicinal products labelling.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Any research on human beings must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS). Research can include testing new medicinal products and new uses, as well as dosages and administration routes for already approved medicinal products. Essentially, the main requirements for an application for authorisation from COFEPRIS include:

  • approval by an independent ethics committee registered with the Ministry of Health;
  • approval by the medical institution or institutions where the clinical trials will be conducted;
  • COFEPRIS approval for institutions to conduct clinical trials;
  • clinical trial protocol (including a schedule and the approximate amount of medicinal products to be imported);
  • written informed consent templates;
  • pre-clinical and clinical data that justifies conducting the research;
  • a description of available resources to conduct the research and to address emergencies (including a statement of sponsorship); and
  • a written letter by the qualified investigator acknowledging his or her responsibilities, and data from the qualified investigator and his or her staff.

Medical assistance and financial indemnification for damage caused by the clinical trial must be provided to research participants.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Good clinical practice in Mexico is well regulated. However, although the regulation is robust, there is scope for improvement. Currently, efforts are in place to reach international standards.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The Health Law Regulations for Health Research and the Official Mexican Standard (NOM) for health research in human beings provide the guidelines and standards for the clinical trial protocol, including rules concerning documentation, compilation, confidentiality and reports.

Essentially, according to the NOM for health research in human beings, any clinical trial must be conducted following ethical guidelines regarding the dignity, rights and welfare of human beings.

Clinical trials can specify certain steps or goals to be achieved. The principal researcher must compile a final technical report for the clinical trial. When clinical trials last longer than one year, annual technical reports for the health authorities must be compiled. Accordingly, NOMs apply to:

  • medicinal products labelling (NOM-072- SSA1-2012);
  • pharmacovigilance (NOM-220-SSA1-2012);
  • interchangeability and bio-comparability tests (NOM-177-SSA1-2013);
  • biological products (NOM-257-SSA1-2014);
  • good manufacturing practices for medicinal products (NOM-059-SSA1-2015); and
  • active ingredients (NOM-164-SSA1-2015).

What are the informed consent obligations with respect to clinical trial subjects?

Investigators must collect informed consent from research participants in a formal written document signed by two witnesses. A participant must grant consent on a voluntary basis, with sufficient access to information regarding potential risks and benefits. Participants maintain the right to give up the research at any time. Investigators must ensure post-care for patients until it is clear that no damage has occurred as a result of the research.

Insurance

What are the insurance requirements for clinical trials?

According to NOM-012-SSA3-2012, regarding clinical trials in human beings, the clinical trial budget should include compensation to which the subject of investigation will be legally entitled in case of damages directly related to the clinical trial. Where appropriate, this financial fund may be covered under study insurance.

Data protection

What data protection issues should be considered when conducting clinical trials?

The primary legislation is the Personal Data Protection Law. This legal framework requires the person or entity in charge of compliance to observe consent, quality, purpose, loyalty, proportionality, responsibility, security and confidentiality requirements. It relates to the pharmaceutical legal framework (eg, health research, clinical trials and pharmacovigilance).

The NOM for health research in human beings requires protection of access, rectification, cancellation and opposition rights of research participants by deferring to the Personal Data Protection Law. Investigators and committees of the institution where the research is conducted must protect participants’ personal data in the research and publishing stages. Investigators must collect informed, valid consent from research participants.

The NOM for pharmacovigilance also recognises the protection of personal data of research participants and healthcare professionals submitting reports by deferring to the Personal Data Protection Law.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

Manufacturers must obtain marketing authorisation from the Federal Commission for Protection Against Sanitary Risk (COFEPRIS) to sell any medicinal product. Requirements and timeframes vary among new molecules, biologics and follow-on products. An Official Mexican Standard (NOM) compiling the requirements for granting marketing authorisations for medicinal products (NOM-257-SSA1-2013) is in place. In addition, there is a NOM for the specifications of stability tests (NOM-073-SSA1-2015), which was published in 2016. This NOM specifically addresses the test for stability to be carried out on drugs in Mexico (World Health Organisation classification: Climate Zone II, subtropical with possible high humidity). Article 166 of the Health Law Regulations sets out the following approval timeframes:

  • 180 calendar days for medicines including an active pharmaceutical ingredient or therapeutic indication already approved in Mexico;
  • 240 calendar days for medicines approved abroad but not in Mexico; and
  • 180 calendar days for new drugs (a meeting with the New Molecules Committee is required).

The approval timeframe for biologics and bio-comparables is 180 calendar days (Articles 177 and 177bis 4 of the Health Law Regulations).

These timeframes may vary in practice, but can be reduced if the application has been pre-examined by a third health institution approved by COFEPRIS.

What criteria are considered in granting marketing authorisation?

New molecules

Essentially, applicants for marketing authorisations must prove the safety and efficacy of their products through:

  • standard clinical trials;
  • adherence to General Health Law regulations; and
  • adherence to NOMs regarding good manufacturing of medicines and active ingredients.

Applicants must also seek approval of their products as new molecules from the COFEPRIS New Molecules Committee. According to Article 2(15) of the Health Law Regulations, a new molecule is:

  • an active ingredient or drug not approved worldwide (new molecular entity);
  • an active ingredient or drug without approval in Mexico but already available in other countries, but with limited clinical experience or disputed information;
  • a drug which is a non-marketed combination of two or more active ingredients; and
  • an active ingredient or drug already available in the market, but to be marketed for a new therapeutic indication.

Research and development companies can benefit from a special procedure for drugs which have been previously approved by a regulatory authority abroad but require first-time approval in Mexico.

Generics

Applicants for marketing authorisations must prove that their products are bioequivalent to the innovator product. They must provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a list of reference medicinal products.

Recently, the NOM setting the test to prove that a generic drug is interchangeable with a reference drug was updated (NOM-177-SSA1-2013). Legally, COFEPRIS should not grant marketing authorisation for generics breaching exclusivity rights.

There is a linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI), which aims to prevent the granting of marketing authorisation in violation of patent rights. According to the IP Regulations, every six months the IMPI must publish patents covering allopathic medicines in the Linkage Gazette. The initial IMPI position was that only patents relating to a compound were relevant to linkage review (excluding formulation and use patents). On July 31 2012, for the first time, the IMPI included formulation patents in the Linkage Gazette, in accordance with a 2010 Supreme Court ruling (2a/J7/2010, Federal Judicial Gazette, XXXI, page 135).

Use patents and purpose limited product patents are included in the Linkage Gazette by court orders, since the IMPI considers that they should not be included in the linkage system.

Under the linkage regulations, at the filing of the application the applicant must prove that it is the owner or licensee of the patent of the product’s active ingredient (recorded with the IMPI), or state under oath that the application does not violate the list of products published in the Linkage Gazette and observes patent law.

Biologics

Recent amendments to the legal framework to regulate the approval of biologics are being tested. Applicants must prove the quality, safety and efficacy of products under the General Health Law, its regulations and applicable NOMs, particularly those for good manufacturing practices for medicinal products (NOM-059-SSA1-2015) and active ingredients (NOM-164-SSA1-2015).

According to NOM-257-SS1-2014, all biological drugs authorised before the legal reform and that are still on the market must enter a regularisation process to comply with the new biologics standard. NOM 257 emphasises that key points to ensure the safety, efficacy and quality of biologics are regulated by other Official Standard Rules (eg, regarding clinical trials and pharmacovigilance). NOM 257 empowers the Assessment Sub-committee on Biotech Products (SEPB) to:

  • assess technical and scientific data in connection with clinical trials, approval or renewal of innovator biologics or follow-on biologics (biocomparables); and
  • issue opinions to characterise biologics as innovators, reference products or biocomparables.

NOM 257 provides transitional provisions for the renewal of those marketing authorisations of biologics granted before the amendments to the Health Law Regulations for Biologics issued in 2011 came into force. These provisions establish that:

  • COFEPRIS will assess whether biologics refer to innovators or biocomparables;
  • renewal applications for innovators will not require SEPB assessment; and
  • renewal applications for biocomparables will require prior SEPB assessment to identify the product of reference in order for applicants to submit the corresponding tests.

These provisions apply only to renewal applications submitted before December 31 2015. However, COFEPRIS missed an opportunity to address the uncertainty in respect of regulatory data protection for biologics, as NOM 257 does not provide for guidelines in this regard.

Biocomparables (follow-ons)

Applicants must submit clinical tests, and when appropriate in vitro tests, to prove the safety, efficacy and quality of the product comparable or similar to the reference biologic.

The pre-clinical and clinical test used by an applicant for a biocomparable must use the corresponding reference biologic to perform comparative and physic-chemical studies. The applicant must submit to:

  • in vitro studies;
  • a comparative pharmacokinetic test, if determined by the Ministry of Health, to show pharmacokinetic comparability on key parameters between both the follow-on and reference biologic;
  • pharmacodynamics test reports; and
  • a comparative efficacy and safety clinical test to show similarity between the follow-on and reference biologic.

Although industry participants have welcomed amendments to approve biologics, specific rules to approve follow-ons have caused debate. There is currently no indication of a data protection period for biologics. The recognition of data package exclusivity rights for biologics can be achieved only through litigation. Accordingly, there are concerns regarding the accurate application by COFEPRIS for linkage provisions.

Orphan drugs

Orphan drugs were recently introduced into the General Health Law and the Mexican Pharmacopeia. In practice, they are approved by a particular procedure, following rules for new molecules when applicable and appropriate. Specific rules are still pending. The draft NOM compiling requirements for marketing authorisation includes orphan drugs.

What is the fee for obtaining marketing authorisation?

Government fees for analysing marketing authorisation applications are as follows:

  • new molecules and biologics: $8,600; and
  • generics and biocomparables: $4,800.

What is the validity period for marketing authorisation?

Marketing authorisations must be renewed every five years. Applicants must prove compliance with good manufacturing practices, safety and efficacy standards, pharmacovigilance, labelling standards and all other applicable provisions.

What are the consequences of failure to obtain marketing authorisation?

Manufacturers that do not obtain a marketing authorisation from COFEPRIS cannot sell the applied-for medicinal product.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has a permanent pharmacovigilance programme based on information regarding possible adverse effects of drugs issued by:

  • doctors and physicians, on a voluntary basis;
  • the pharmaceutical companies that manufactures the products; and
  • conductors of clinical trials.

Under the Health Law Regulations and Official Mexican Standards (NOMs), COFEPRIS’s monitoring is focused, among other things, on:

  • ensuring compliance with good manufacturing practices and standard operating procedures;
  • ensuring that activities do not exceed the limits set by the authorisation and do not differ from those activities which are authorised; and
  • ensuring the performance of validation analysis of the manufacturing processes and systems involved.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

The primary legislation is the Personal Data Protection Law. This legal framework requires that the person or entity in charge of compliance observe consent, quality, purpose, loyalty, proportionality, responsibility, security and confidentiality requirements. It relates to the pharmaceutical legal framework, such as in the case of health research, clinical trials and pharmacovigilance.

The NOM for health research in human beings requires the protection of access, rectification, cancellation and opposition rights of research participants by deferring to the Personal Data Protection Law. Investigators and committees of the institution where the research is conducted must protect the personal data of participants in the research stages and publishing stages. Investigators must collect informed, valid consent from research participants.

The NOM for pharmacovigilance also recognises the protection of personal data of research participants and healthcare professionals submitting reports by deferring to the Personal Data Protection Law.

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) covering patented products and overseen by the Ministry of Economy. The participation of pharmaceutical companies is voluntary. Under the price control, each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. In 2008 the government created the Committee for the Negotiation of Drug Prices (CNDP) to:

  • support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies; and
  • evaluate cost benefits of new medicines and therapies in view of prices and other comparable products in the market.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

The Mexican healthcare system comprises public and private insurers, out-of-pocket payments and informal arrangements. The major public segments of the Mexican healthcare system are Social Security (IMSS), Social Security for State Workers (ISSSTE) and Seguro Popular. The Seguro Popular was created for people with lower incomes. The federal government pays 70% of the annual family premium, while states provide 20% and participants provide 10%.

Public insurers dispense medicinal products prescribed by their healthcare professionals. Products are prescribed from a basic medicinal products list, which public insurers base on the National Formulary issued by the Ministry of Health. Public insurers acquire those listed products mostly by public tender processes. The IMSS is the largest public sector buyer of drugs.

For direct purchasing of patented products, the CNDP analyses the effectiveness of the drugs and relevant therapeutic alternatives and the feasibility and implications of an eventual substitution with equivalent medicines. The CNDP also conducts an economic evaluation of the cost-effectiveness of patented medicines compared with potential substitutes.

For the ISSSTE, a prescribed medicinal product can be dispensed in a private drug store registered with a public insurer, provided that this is not available within ISSSTE facilities and under certain conditions. The ISSSTE reimburses the cost of that product according to previous agreements.

In the private sector, most payments are made on an out-of-pocket basis. Private insurers are improving the level of pharmaceutical coverage as the private market in medicines has grown considerably.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The primary legislation on advertising of medicinal products is the General Health Law’s regulations regarding advertising (RLGSMP) and opinions issued by the Advertising Council. The IP Law and the Federal Consumer Protection Law also have provisions on advertising.

The Federal Commission for Protection Against Sanitary Risk (COFEPRIS – health legal framework) and the Federal Attorney’s Office of Consumers (consumer legal framework) are regulatory authorities in this field.

The National Chamber of the Pharmaceutical Industry has a code of ethics that includes provisions on advertising. Although these provisions are not mandatory, failure to comply can result in a suspension of rights as a member of the chamber or exclusion from it.

Do any special rules apply to online advertising of medicinal products?

Electronic advertising falls under the general rules for advertising in Article 2 of the RLGSMP. COFEPRIS is increasing its monitoring of online advertisements for medicinal products, which to date has been less stringent than advertising on television and radio.

Labelling

What are the packaging and labelling requirements for medicinal products?

Packaging and labelling of medicinal products are regulated by the:

  • General Health Law;
  • Health Law Regulations; and
  • NOM 072-SSA1-2012 relating to the labelling of medicinal products.

COFEPRIS is responsible for enforcing the provisions concerning the packaging and labelling of medicinal products.

The labelling of medicinal products should include the following:

  • the distinctive brand name;
  • the generic name;
  • the pharmaceutical form;
  • the drug concentration;
  • the formulation;
  • the formula description;
  • the dose;
  • the mode of administration;
  • the conservation and storage information;
  • the precaution and warning legends, including risks in case of pregnancy;
  • the marketing authorisation number;
  • the batch number;
  • the expiration date;the manufacturer’s and, if applicable, distributor’s information, including address;
  • the content;
  • the maximum price to the public; and
  • in cases of drugs with a biological origin, the specifications of the live organism used for the preparation of the medicinal product and the name of the disease for which it is indicated, according to the revised international nomenclature.

How is the promotion of off-label use regulated?

Whereas there is no specific provision in the Health Law Regulations concerning advertisements for off-label use, advertisement activities addressed to health professionals do not require a permit from COFEPRIS; a notice of such an advertisement is sufficient. However, off-label advertisements should be avoided.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

Government officers must not request, accept or receive any gifts or donations from persons with whom they have direct links through commercial or industrial activities, including activities that they regulate or supervise (Article 8 of the Federal Law of Responsibilities for Government Officers).

Doctors working for the Social Security (IMSS) and Social Security for State Workers (ISSSTE) are considered to be government officers and are therefore not allowed to receive gifts or donations from pharmaceutical companies when on duty and working in the name of IMSS or ISSSTE facilities.

The General Health Law and its regulations do not address doctors in private practice, although they specify that private doctors must act according to professional ethics.

Companies must not provide doctors with goods or incentives of any kind to use, prescribe, purchase or recommend a medicinal product or to influence the result of a clinical trial (Article 4.9.1 of the Code of Good Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA)). The corresponding penalties range from a warning to a fine.

Similarly, CANIFARMA’s Code of Ethics indicates, in general terms, that companies should act responsibly in relation to sponsorships and donations.

Mexico does not currently have any anti-bribery laws to limit these practices, and there is no domestic legislation to regulate these cases beyond Mexico’s jurisdiction. However, Mexico has ratified certain international treaties which do regulate, and in some cases prohibit, these practices.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Limitation periods

Depending on the conduct and cause of action, limitation periods are:

  • two to 10 years for civil actions; and
  • one to nine years for certain criminal actions.

Class actions

The federal procedural laws have been amended to allow class actions before the federal courts. The Federal Agency for Protection of Consumers, the Attorney General’s Office, non-profit associations and a common representative of a group of at least 30 members can now pursue class actions. These amendments are subject to testing in the courts and apparently there are no precedents of class actions for product liability.

In addition, there is an action available whereby any individual with or without proper legal standing can file a complaint before Federal Commission for Protection Against Sanitary Risk (COFEPRIS), arguing and proving that the certain health risks are associated with a product on the market. However, the claimant’s procedural rights are limited and these actions are intended to eliminate a health risk, not to obtain compensation.

Which parties can be held liable for a defective medicinal product?

All those involved in selling and distributing medicinal products can be held liable in civil actions for harm derived from a defective medicinal product. In this regard, the Official Mexican Standard (NOM) for good manufacturing practices of medicinal products (NOM-059-SSA1-2015) states that the marketing authorisation holder is responsible for the quality of the approved product. Accordingly, the NOM states that when manufacturing through third parties, the marketing authorisation holder must supervise the manufacture of the product and establish in agreements the liabilities and duties of each party involved.

Physicians are also subject to liability for malpractice. In this case, patients can opt between filing a civil action or requiring medical arbitration from the National Commission of Medical Arbitration. The latter is a quick alternative where a non-judicial solution is proposed.

Remedies

What remedies are available to successful claimants?

Preliminary injunctions can be ordered to stop the commercialisation and distribution of a product. Monetary compensation is the most common remedy, but equitable remedies are also available.

Punitive damages are not subject to regulation and there are no public precedents to make estimations in this regard.

Exclusion and limitation

On what grounds can liability be excluded?

There are no cases where liability can be excluded.

What preventive steps can be taken to limit liability?

COFEPRIS has a permanent pharmacovigilance programme based on information regarding possible adverse effects of the drugs provided by:

  • doctors and physicians on a voluntary basis;
  • conductors of clinical trials (periodical reports must be submitted according to the relevant phase); and
  • pharmaceutical companies (periodical safety reports must be submitted once every six or 12 months, according to the year after the granting of the marketing authorisation).

For clinical trials and approved health products, severe harmful effects must be reported within 15 days of identification of the effects.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The following measures are in place to enforce the laws governing medicinal products:

  • orders to stop the activity;
  • fines;
  • closure of the facilities where the activities take place; and
  • onsite visits at any time to inspect premises.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Mexico has no specific anti-bribery law to limit these practices and there is no domestic legislation to regulate such cases beyond Mexico’s jurisdiction. However, Mexico has legislation to prevent such practices and has ratified certain international treaties that regulate, and in some cases prohibit, these practices.

New Relevant Amendments to the Mexican Industry Law Regarding Trademarks

No. 5  | MARCH 2018

www.olivares.com.mx

– LATEST NEWS –

New Relevant Amendments to the Mexican Industrial Property Law Regarding Trademarks

On March 22, 2018, the Mexican Senate approved a Decree whereby some articles of the Mexican Industrial Property Law (IPL) were amended and new provisions dealing with trademarks were introduced. 

The Decree is yet to be published in the Mexican Official Diary so that becomes in full force. We expect the publication to be effected soon. 

The main highlights can be summarized as follows:

·     It is incorporated for the very first time in Mexico, trademark protection for non-visible signs, such as smell marks and sound marks, as well as for certain animated marks such as holograms and for the so-called “trade-dress” in a broader manner.

·     Acquired distinctiveness (secondary meaning) will be recognized as an exception to the absolute grounds for refusal.

·     Consent and coexistence agreements will be allowed to overcome senior rights, except when dealing with identical trademarks for identical goods or services.

·     Bad faith, in a broad sense, is incorporated as a ground for opposition, and also as a ground for invalidation.

·     Protection for Certification marks is recognized.

·     Class headings will no longer be possible.  It will be necessary to be specific in products and services descriptions according to the Nice Classification.

·     Oppositions will become binding for the Trademark Office, which therefore will have to issue decisions duly grounded and justified based on the merits of each opposition filed.

·     In order to clear-up the Mexican Register from non-used marks, it has been established a use declaration under oath , which must  be filed within the next three months after the third anniversary of the date of grant of the trademark registration. If no use is declared by such date, the registrations will automatically lapse.

·     It will no longer be possible to renew a trademark registration in certain class based on the use of the same registered trademark in other class. 

We will follow-up on this subject immediately after these amendments are published in the Mexican Official Diary.

This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.

For further information on the content of this newsletter, please contact

Sergio L. Olivares, Jr. sergio.olivares@olivares.mx; Antonio Belaunzarán antonio.belaunzaran@olivares.mx; Alonso Camargo alonso.camargo@olivares.mx

or call at +52(55) 5322 3000

New Law Governing Fintech Companies

No. 1  | MARCH 2018

www.olivares.com.mx

 

– LATEST NEWS –

New Law Governing Fintech Companies

Last week President Enrique Peña Nieto enacted the Decree whereby the Financial Technology Law (Ley Para Regular Las Instituciones de Tecnología Financiera the “Fintech Law”) was issued. The Decree was published in the Official Gazette of the Federation on March 9, 2018, and entered into force the day following the publication.

The term “Fintech” qualifies the manner in which financial services are provided.  Implementation of technology in the provision of financial services has been evolving as rapidly as we can see e-commerce transactions and in Mexico was lacking a proper legal framework.  These services are carried out more quickly and economically, unlike traditional financial services. Services provided by Fintechs range from payments and remittances, crowdfunding and crowdsourcing, to virtual asset management (cryptocurrencies).

The Fintech Law introduces governing principles for consumer protection, financial stability preservation, competition and promotion, as well as money laundering prevention, within the scope of digital platforms or web applications offering and providing financial products and services.

As a result of the new Fintech Law existing non-financial entities or newly incorporated entities that have as a corporate purpose to provide fintech services, shall apply for authorization to provide these services and may only conduct activities expressly authorized by the regulator. Such authorization will be directly issued by the National Banking and Securities Commission (CNBV for its initials in Spanish).

The authorization requests shall include, among other conditions, the following:

  • Business plan and policies for risks and IT infrastructure;
  • Client and proprietary account separation policies;
  • Privacy policies for use of personal data, management and risk disclosure;
  • Security measures that will apply to information management;
  • Processes and criteria for client Identification;
  • Anti-Fraud and anti-money laundering prevention policies;
  • Adherence Agreement templates for the general public to be filed before the National Commission for the Protection and Defense of the Users of Financial Services (CONDUSEF for its initials in Spanish); and
  • Information related to the interface, digital platform, URL, web page or electronic, digital or social media used, through which financial services will be provided.

Furthermore, the CNBV will also be the authority in charge to determine, through general resolutions and provisions, which Fintechs will required to have a Board of Directors, a Managing Director and with an Audit Committee, depending on the type of the company to be created or currently existing as a Fintech, based on the current General Corporations Law and the Securities Market Law.

While we anticipate that the regulations will increase for Fintechs in Mexico, with the new Fintech Law currently in effect, our preliminary recommendations include adopting a corporate vehicle with limited liability, preferably an which is stock corporation (S.A. for its initials in Spanish) or an investment promotion stock corporation (SAPI for its initials in Spanish), depending on the size and activity, as these vehicles provide greater transparency and corporate governance principles which adapt better to the processes, business models, asset types and portfolios, as well as other elements relevant to the business models of Fintechs wordlwide.

Notwithstanding the foregoing, it is important to consider the legal vehicle and regulations applicable to consumer protection, personal data protection and privacy, and financial operations.

Finally, it is necessary to mention the Law will result in several amendments to different laws, i.e. the Law on Credit Institutions, the Securities Market Law, the Law of Transparency and Financial Services Order, the Law of Protection and Defense of the Users of Financial Services, and the Federal Law for the Prevention and Identification of Transactions with Funds from Illegal Sources, thus placing Mexico as one of the few leading countries in the world with regard to Fintechs.

This newsletter is intended only as a general discussion of the addressed issues, and should not be regarded as legal advice.

For further information on the content of this newsletter, please contact

Gustavo Alcocer gustavo.alcocer@olivares.mx; Abraham Díaz abraham.diaz@olivares.mx or José Miguel Lecumberri jose.lecumberri@olivares.mx

or call at +52(55) 5322 3000

Life Sciences: product regulation and liability in Mexico

by Alejandro LunaAlejandro TorresIngrid Ortíz and Laura Medina

Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

It is expected that the North American Free Trade Agreement will be soon reviewed, renegotiated or terminated. However, there is a degree of uncertainty about the issue.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The main regulatory framework in relation to medicinal products is set out in the following federal laws:

  • the General Health Law;
  • the Health Supplies Regulation;
  • the Official Mexican Standards; and
  • the Mexican Pharmacopoeia.

Are any legislative changes proposed or expected in the near future?

The Trans-Pacific Partnership (TPP) is a trade agreement among 12 Pacific Rim countries. It was signed on February 4 2016 in Auckland, New Zealand, after seven years of negotiations. It has not yet entered into force in Mexico.

There is a multiparty scheme in place for the TPP to enter into force. However, considering that the United States has recently withdrawn from the ratification process, there is a degree of uncertainty about the issue.

In this regard, it is possible that Mexico will execute bilateral agreements with some of the 12 Pacific Rim countries. It is expected that the eventual bilateral free trade agreements will have a TPP standard.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The authority responsible for enforcing the regulatory framework in relation to medicines is the Federal Commission for Protection Against Sanitary Risk, which is part of the Ministry of Health.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Other legal regimes applicable to the trade of medicinal products include:

  • competition;
  • antitrust;
  • transparency;
  • data protection regarding clinical trials and other activities involving patents or clinical data;
  • consumer protection; and
  • industrial property.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No medicinal products are exempt from regulation.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

Companies manufacturing medicines and medical products in Mexico must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS) through a manufacturing licence or authorisation.

What is the fee for obtaining authorisation?

Government fees for analysing a manufacturing approval application are around $3,000.

What is the validity period for authorisation?

Drug manufacturers must renew their licence every five years, subject to the relevant test, including the presentation of a certificate of good manufacturing practice.

How robust are the standard good manufacturing practices followed in your jurisdiction?

Good manufacturing practices are well adhered to in Mexico.

COFEPRIS can make onsite visits at any time to inspect premises and verify compliance, and can initiate ex officio legal proceedings to penalise non-compliance. Ultimately, these legal proceedings can result in the revocation of marketing authorisation.

Good manufacturing practices, stability, labelling standards and all other applicable provisions must be complied with. A programme to recall and destroy products that do not meet quality standards must be in place.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

COFEPRIS is entitled to implement measures on behalf of public health, such as:

  • the seizure of products; and
  • ordering partial or total suspension of activities, services or advertisements.

Under certain conditions, COFEPRIS has statutory authority to revoke any manufacturing approval and impose penalties, ranging from a fine of up to 16,000 times the minimum wage (approximately $3,523) to closure of the establishment.

The imposition of administrative penalties does not exclude civil and criminal liability.

Distribution

How are the distribution and storage of medicinal products regulated?

The Official Mexican Standard (NOM) for the good manufacturing practice of medicinal products (NOM-059-SSA1-2015) requires a programme to recall products that do not meet quality standards in an appropriate and efficient manner. This programme must include:

  • activities planned for recalling products in a rapid and effective manner;
  • storage; and
  • a list of authorities to be notified according to the product distribution.

Marketing authorisation holders must report any product recall decision to COFEPRIS, providing details of the products and the causes leading to the recall.

Import and export

How are the import and export of medicinal products regulated?

A marketing authorisation granted by COFEPRIS is required when importing medicinal products.

Foreign marketing authorisations are not valid in Mexico. However, COFEPRIS has set a special procedure for drugs requiring first-time approval in Mexico, but that have been approved by equivalent regulatory authorities abroad. In this procedure, the approval requirements of the foreign agencies are recognised as equivalent to those in Mexico.

Are parallel imports permitted in your jurisdiction?

Any import of drugs, health products or raw materials for drugs must be approved by COFEPRIS. Marketing authorisations are required. The import of a minimum quantity of products without a marketing authorisation can be approved in certain circumstances (eg, clinical trials and orphan drugs).

Regarding IP rights, parallel imports are allowed in Mexico in relation to trademarks where:

  • the product was legally introduced in the country of origin; and
  • the trademark is owned by the same company or a related company in Mexico.

The IP Law does not specifically address patents in this context, as it does for trademarks. However, it is likely that the principle of exhaustion of rights also applies to patents.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

Price control in the private sector is based on a self-regulated maximum retail price (MRP) scheme covering patented products, which is overseen by the Ministry of Economy. The participation of pharmaceutical companies is voluntary. Under the price control, each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established penalties for MRP violations.

In 2008 the government created the Committee for the Negotiation of Drug Prices to:

  • support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies; and
  • evaluate cost benefits of new medicines and therapies in view of prices and other comparable products in the market.

Are there any restrictions on the online sale and purchase of medicinal products?

Unless they are over-the-counter products, medicines must be made available only in authorised drug stores and can be sold to patients only with a physician’s prescription. Dispensers must keep original prescriptions regarding antibiotics.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

The following rules govern named patient supply of pre-launch medicinal products:

  • the Code of Good Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA);
  • the CANIFARMA Code of Ethics;
  • the Health Law Regulations; and
  • the NOM-072- SSA1-2012 for medicinal products labelling.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Any research on human beings must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS). Research can include testing new medicinal products and new uses, as well as dosages and administration routes for already approved medicinal products. Essentially, the main requirements for an application for authorisation from COFEPRIS include:

  • approval by an independent ethics committee registered with the Ministry of Health;
  • approval by the medical institution or institutions where the clinical trials will be conducted;
  • COFEPRIS approval for institutions to conduct clinical trials;
  • clinical trial protocol (including a schedule and the approximate amount of medicinal products to be imported);
  • written informed consent templates;
  • pre-clinical and clinical data that justifies conducting the research;
  • a description of available resources to conduct the research and to address emergencies (including a statement of sponsorship); and
  • a written letter by the qualified investigator acknowledging his or her responsibilities, and data from the qualified investigator and his or her staff.

Medical assistance and financial indemnification for damage caused by the clinical trial must be provided to research participants.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Good clinical practice in Mexico is well regulated. However, although the regulation is robust, there is scope for improvement. Currently, efforts are in place to reach international standards.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The Health Law Regulations for Health Research and the Official Mexican Standard (NOM) for health research in human beings provide the guidelines and standards for the clinical trial protocol, including rules concerning documentation, compilation, confidentiality and reports.

Essentially, according to the NOM for health research in human beings, any clinical trial must be conducted following ethical guidelines regarding the dignity, rights and welfare of human beings.

Clinical trials can specify certain steps or goals to be achieved. The principal researcher must compile a final technical report for the clinical trial. When clinical trials last longer than one year, annual technical reports for the health authorities must be compiled. Accordingly, NOMs apply to:

  • medicinal products labelling (NOM-072- SSA1-2012);
  • pharmacovigilance (NOM-220-SSA1-2012);
  • interchangeability and bio-comparability tests (NOM-177-SSA1-2013);
  • biological products (NOM-257-SSA1-2014);
  • good manufacturing practices for medicinal products (NOM-059-SSA1-2015); and
  • active ingredients (NOM-164-SSA1-2015).

What are the informed consent obligations with respect to clinical trial subjects?

Investigators must collect informed consent from research participants in a formal written document signed by two witnesses. A participant must grant consent on a voluntary basis, with sufficient access to information regarding potential risks and benefits. Participants maintain the right to give up the research at any time. Investigators must ensure post-care for patients until it is clear that no damage has occurred as a result of the research.

Insurance

What are the insurance requirements for clinical trials?

According to NOM-012-SSA3-2012, regarding clinical trials in human beings, the clinical trial budget should include compensation to which the subject of investigation will be legally entitled in case of damages directly related to the clinical trial. Where appropriate, this financial fund may be covered under study insurance.

Data protection

What data protection issues should be considered when conducting clinical trials?

The primary legislation is the Personal Data Protection Law. This legal framework requires the person or entity in charge of compliance to observe consent, quality, purpose, loyalty, proportionality, responsibility, security and confidentiality requirements. It relates to the pharmaceutical legal framework (eg, health research, clinical trials and pharmacovigilance).

The NOM for health research in human beings requires protection of access, rectification, cancellation and opposition rights of research participants by deferring to the Personal Data Protection Law. Investigators and committees of the institution where the research is conducted must protect participants’ personal data in the research and publishing stages. Investigators must collect informed, valid consent from research participants.

The NOM for pharmacovigilance also recognises the protection of personal data of research participants and healthcare professionals submitting reports by deferring to the Personal Data Protection Law.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

Manufacturers must obtain marketing authorisation from the Federal Commission for Protection Against Sanitary Risk (COFEPRIS) to sell any medicinal product. Requirements and timeframes vary among new molecules, biologics and follow-on products. An Official Mexican Standard (NOM) compiling the requirements for granting marketing authorisations for medicinal products (NOM-257-SSA1-2013) is in place. In addition, there is a NOM for the specifications of stability tests (NOM-073-SSA1-2015), which was published in 2016. This NOM specifically addresses the test for stability to be carried out on drugs in Mexico (World Health Organisation classification: Climate Zone II, subtropical with possible high humidity). Article 166 of the Health Law Regulations sets out the following approval timeframes:

  • 180 calendar days for medicines including an active pharmaceutical ingredient or therapeutic indication already approved in Mexico;
  • 240 calendar days for medicines approved abroad but not in Mexico; and
  • 180 calendar days for new drugs (a meeting with the New Molecules Committee is required).

The approval timeframe for biologics and bio-comparables is 180 calendar days (Articles 177 and 177bis 4 of the Health Law Regulations).

These timeframes may vary in practice, but can be reduced if the application has been pre-examined by a third health institution approved by COFEPRIS.

What criteria are considered in granting marketing authorisation?

New molecules

Essentially, applicants for marketing authorisations must prove the safety and efficacy of their products through:

  • standard clinical trials;
  • adherence to General Health Law regulations; and
  • adherence to NOMs regarding good manufacturing of medicines and active ingredients.

Applicants must also seek approval of their products as new molecules from the COFEPRIS New Molecules Committee. According to Article 2(15) of the Health Law Regulations, a new molecule is:

  • an active ingredient or drug not approved worldwide (new molecular entity);
  • an active ingredient or drug without approval in Mexico but already available in other countries, but with limited clinical experience or disputed information;
  • a drug which is a non-marketed combination of two or more active ingredients; and
  • an active ingredient or drug already available in the market, but to be marketed for a new therapeutic indication.

Research and development companies can benefit from a special procedure for drugs which have been previously approved by a regulatory authority abroad but require first-time approval in Mexico.

Generics Applicants for marketing authorisations must prove that their products are bioequivalent to the innovator product. They must provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a list of reference medicinal products.

Recently, the NOM setting the test to prove that a generic drug is interchangeable with a reference drug was updated (NOM-177-SSA1-2013). Legally, COFEPRIS should not grant marketing authorisation for generics breaching exclusivity rights.

There is a linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI), which aims to prevent the granting of marketing authorisation in violation of patent rights. According to the IP Regulations, every six months the IMPI must publish patents covering allopathic medicines in the Linkage Gazette. The initial IMPI position was that only patents relating to a compound were relevant to linkage review (excluding formulation and use patents). On July 31 2012, for the first time, the IMPI included formulation patents in the Linkage Gazette, in accordance with a 2010 Supreme Court ruling (2a/J7/2010, Federal Judicial Gazette, XXXI, page 135).

Use patents and purpose limited product patents are included in the Linkage Gazette by court orders, since the IMPI considers that they should not be included in the linkage system.

Under the linkage regulations, at the filing of the application the applicant must prove that it is the owner or licensee of the patent of the product’s active ingredient (recorded with the IMPI), or state under oath that the application does not violate the list of products published in the Linkage Gazette and observes patent law.

Biologics Recent amendments to the legal framework to regulate the approval of biologics are being tested. Applicants must prove the quality, safety and efficacy of products under the General Health Law, its regulations and applicable NOMs, particularly those for good manufacturing practices for medicinal products (NOM-059-SSA1-2015) and active ingredients (NOM-164-SSA1-2015).

According to NOM-257-SS1-2014, all biological drugs authorised before the legal reform and that are still on the market must enter a regularisation process to comply with the new biologics standard. NOM 257 emphasises that key points to ensure the safety, efficacy and quality of biologics are regulated by other Official Standard Rules (eg, regarding clinical trials and pharmacovigilance). NOM 257 empowers the Assessment Sub-committee on Biotech Products (SEPB) to:

  • assess technical and scientific data in connection with clinical trials, approval or renewal of innovator biologics or follow-on biologics (biocomparables); and
  • issue opinions to characterise biologics as innovators, reference products or biocomparables.

NOM 257 provides transitional provisions for the renewal of those marketing authorisations of biologics granted before the amendments to the Health Law Regulations for Biologics issued in 2011 came into force. These provisions establish that:

  • COFEPRIS will assess whether biologics refer to innovators or biocomparables;
  • renewal applications for innovators will not require SEPB assessment; and
  • renewal applications for biocomparables will require prior SEPB assessment to identify the product of reference in order for applicants to submit the corresponding tests.

These provisions apply only to renewal applications submitted before December 31 2015. However, COFEPRIS missed an opportunity to address the uncertainty in respect of regulatory data protection for biologics, as NOM 257 does not provide for guidelines in this regard.

Biocomparables (follow-ons)  Applicants must submit clinical tests, and when appropriate in vitro tests, to prove the safety, efficacy and quality of the product comparable or similar to the reference biologic.

The pre-clinical and clinical test used by an applicant for a biocomparable must use the corresponding reference biologic to perform comparative and physic-chemical studies. The applicant must submit to:

  • in vitro studies;
  • a comparative pharmacokinetic test, if determined by the Ministry of Health, to show pharmacokinetic comparability on key parameters between both the follow-on and reference biologic;
  • pharmacodynamics test reports; and
  • a comparative efficacy and safety clinical test to show similarity between the follow-on and reference biologic.

Although industry participants have welcomed amendments to approve biologics, specific rules to approve follow-ons have caused debate. There is currently no indication of a data protection period for biologics. The recognition of data package exclusivity rights for biologics can be achieved only through litigation. Accordingly, there are concerns regarding the accurate application by COFEPRIS for linkage provisions.

Orphan drugs Orphan drugs were recently introduced into the General Health Law and the Mexican Pharmacopeia. In practice, they are approved by a particular procedure, following rules for new molecules when applicable and appropriate. Specific rules are still pending. The draft NOM compiling requirements for marketing authorisation includes orphan drugs.

What is the fee for obtaining marketing authorisation?

Government fees for analysing marketing authorisation applications are as follows:

  • new molecules and biologics – $8,600; and
  • generics and biocomparables – $4,800.

What is the validity period for marketing authorisation?

Marketing authorisations must be renewed every five years. Applicants must prove compliance with good manufacturing practices, safety and efficacy standards, pharmacovigilance, labelling standards and all other applicable provisions.

What are the consequences of failure to obtain marketing authorisation?

Manufacturers that do not obtain a marketing authorisation from COFEPRIS cannot sell the applied-for medicinal product.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has a permanent pharmacovigilance programme based on information regarding possible adverse effects of drugs issued by:

  • doctors and physicians, on a voluntary basis;
  • the pharmaceutical companies that manufactures the products; and
  • conductors of clinical trials.

Under the Health Law Regulations and Official Mexican Standards (NOMs), COFEPRIS’s monitoring is focused, among other things, on:

  • ensuring compliance with good manufacturing practices and standard operating procedures;
  • ensuring that activities do not exceed the limits set by the authorisation and do not differ from those activities which are authorised; and
  • ensuring the performance of validation analysis of the manufacturing processes and systems involved.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

The primary legislation is the Personal Data Protection Law. This legal framework requires that the person or entity in charge of compliance observe consent, quality, purpose, loyalty, proportionality, responsibility, security and confidentiality requirements. It relates to the pharmaceutical legal framework, such as in the case of health research, clinical trials and pharmacovigilance.

The NOM for health research in human beings requires the protection of access, rectification, cancellation and opposition rights of research participants by deferring to the Personal Data Protection Law. Investigators and committees of the institution where the research is conducted must protect the personal data of participants in the research stages and publishing stages. Investigators must collect informed, valid consent from research participants.

The NOM for pharmacovigilance also recognises the protection of personal data of research participants and healthcare professionals submitting reports by deferring to the Personal Data Protection Law.

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) covering patented products and overseen by the Ministry of Economy. The participation of pharmaceutical companies is voluntary. Under the price control, each product’s MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. In 2008 the government created the Committee for the Negotiation of Drug Prices (CNDP) to:

  • support public acquisitions through a process of transparent negotiation between public insurers and pharmaceutical companies; and
  • evaluate cost benefits of new medicines and therapies in view of prices and other comparable products in the market.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

The Mexican healthcare system comprises public and private insurers, out-of-pocket payments and informal arrangements. The major public segments of the Mexican healthcare system are Social Security (IMSS), Social Security for State Workers (ISSSTE) and Seguro Popular. The Seguro Popular was created for people with lower incomes. The federal government pays 70% of the annual family premium, while states provide 20% and participants provide 10%.

Public insurers dispense medicinal products prescribed by their healthcare professionals. Products are prescribed from a basic medicinal products list, which public insurers base on the National Formulary issued by the Ministry of Health. Public insurers acquire those listed products mostly by public tender processes. The IMSS is the largest public sector buyer of drugs.

For direct purchasing of patented products, the CNDP analyses the effectiveness of the drugs and relevant therapeutic alternatives and the feasibility and implications of an eventual substitution with equivalent medicines. The CNDP also conducts an economic evaluation of the cost-effectiveness of patented medicines compared with potential substitutes.

For the ISSSTE, a prescribed medicinal product can be dispensed in a private drug store registered with a public insurer, provided that this is not available within ISSSTE facilities and under certain conditions. The ISSSTE reimburses the cost of that product according to previous agreements.

In the private sector, most payments are made on an out-of-pocket basis. Private insurers are improving the level of pharmaceutical coverage as the private market in medicines has grown considerably.

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The primary legislation on advertising of medicinal products is the General Health Law’s regulations regarding advertising (RLGSMP) and opinions issued by the Advertising Council. The IP Law and the Federal Consumer Protection Law also have provisions on advertising.

The Federal Commission for Protection Against Sanitary Risk (COFEPRIS – health legal framework) and the Federal Attorney’s Office of Consumers (consumer legal framework) are regulatory authorities in this field.

The National Chamber of the Pharmaceutical Industry has a code of ethics that includes provisions on advertising. Although these provisions are not mandatory, failure to comply can result in a suspension of rights as a member of the chamber or exclusion from it.

Do any special rules apply to online advertising of medicinal products?

Electronic advertising falls under the general rules for advertising in Article 2 of the RLGSMP. COFEPRIS is increasing its monitoring of online advertisements for medicinal products, which to date has been less stringent than advertising on television and radio.

Labelling

What are the packaging and labelling requirements for medicinal products?

Packaging and labelling of medicinal products are regulated by the:

  • General Health Law;
  • Health Law Regulations; and
  • NOM 072-SSA1-2012 relating to the labelling of medicinal products.

COFEPRIS is responsible for enforcing the provisions concerning the packaging and labelling of medicinal products.

The labelling of medicinal products should include the following:

  • the distinctive brand name;
  • the generic name;
  • the pharmaceutical form;
  • the drug concentration;
  • the formulation;
  • the formula description;
  • the dose;
  • the mode of administration;
  • the conservation and storage information;
  • the precaution and warning legends, including risks in case of pregnancy;
  • the marketing authorisation number;
  • the batch number;
  • the expiration date;
  • the manufacturer’s and, if applicable, distributor’s information, including address;
  • the content;
  • the maximum price to the public; and
  • in cases of drugs with a biological origin, the specifications of the live organism used for the preparation of the medicinal product and the name of the disease for which it is indicated, according to the revised international nomenclature.

How is the promotion of off-label use regulated?

Whereas there is no specific provision in the Health Law Regulations concerning advertisements for off-label use, advertisement activities addressed to health professionals do not require a permit from COFEPRIS; a notice of such an advertisement is sufficient. However, off-label advertisements should be avoided.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

Government officers must not request, accept or receive any gifts or donations from persons with whom they have direct links through commercial or industrial activities, including activities that they regulate or supervise (Article 8 of the Federal Law of Responsibilities for Government Officers).

Doctors working for the Social Security (IMSS) and Social Security for State Workers (ISSSTE) are considered to be government officers and are therefore not allowed to receive gifts or donations from pharmaceutical companies when on duty and working in the name of IMSS or ISSSTE facilities.

The General Health Law and its regulations do not address doctors in private practice, although they specify that private doctors must act according to professional ethics.

Companies must not provide doctors with goods or incentives of any kind to use, prescribe, purchase or recommend a medicinal product or to influence the result of a clinical trial (Article 4.9.1 of the Code of Good Practices of Advertising of the National Chamber of the Pharmaceutical Industry (CANIFARMA)). The corresponding penalties range from a warning to a fine.

Similarly, CANIFARMA’s Code of Ethics indicates, in general terms, that companies should act responsibly in relation to sponsorships and donations.

Mexico does not currently have any anti-bribery laws to limit these practices, and there is no domestic legislation to regulate these cases beyond Mexico’s jurisdiction. However, Mexico has ratified certain international treaties which do regulate, and in some cases prohibit, these practices.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

Limitation periods

Depending on the conduct and cause of action, limitation periods are:

  • two to 10 years for civil actions; and
  • one to nine years for certain criminal actions.

Class actions The federal procedural laws have been amended to allow class actions before the federal courts. The Federal Agency for Protection of Consumers, the Attorney General’s Office, non-profit associations and a common representative of a group of at least 30 members can now pursue class actions. These amendments are subject to testing in the courts and apparently there are no precedents of class actions for product liability.

In addition, there is an action available whereby any individual with or without proper legal standing can file a complaint before Federal Commission for Protection Against Sanitary Risk (COFEPRIS), arguing and proving that the certain health risks are associated with a product on the market. However, the claimant’s procedural rights are limited and these actions are intended to eliminate a health risk, not to obtain compensation.

Which parties can be held liable for a defective medicinal product?

All those involved in selling and distributing medicinal products can be held liable in civil actions for harm derived from a defective medicinal product. In this regard, the Official Mexican Standard (NOM) for good manufacturing practices of medicinal products (NOM-059-SSA1-2015) states that the marketing authorisation holder is responsible for the quality of the approved product. Accordingly, the NOM states that when manufacturing through third parties, the marketing authorisation holder must supervise the manufacture of the product and establish in agreements the liabilities and duties of each party involved.

Physicians are also subject to liability for malpractice. In this case, patients can opt between filing a civil action or requiring medical arbitration from the National Commission of Medical Arbitration. The latter is a quick alternative where a non-judicial solution is proposed.

Remedies

What remedies are available to successful claimants?

Preliminary injunctions can be ordered to stop the commercialisation and distribution of a product. Monetary compensation is the most common remedy, but equitable remedies are also available.

Punitive damages are not subject to regulation and there are no public precedents to make estimations in this regard.

Exclusion and limitation

On what grounds can liability be excluded?

There are no cases where liability can be excluded.

What preventive steps can be taken to limit liability?

COFEPRIS has a permanent pharmacovigilance programme based on information regarding possible adverse effects of the drugs provided by:

  • doctors and physicians on a voluntary basis;
  • conductors of clinical trials (periodical reports must be submitted according to the relevant phase); and
  • pharmaceutical companies (periodical safety reports must be submitted once every six or 12 months, according to the year after the granting of the marketing authorisation).

For clinical trials and approved health products, severe harmful effects must be reported within 15 days of identification of the effects.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The following measures are in place to enforce the laws governing medicinal products:

  • orders to stop the activity;
  • fines;
  • closure of the facilities where the activities take place; and
  • onsite visits at any time to inspect premises.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

Mexico has no specific anti-bribery law to limit these practices and there is no domestic legislation to regulate such cases beyond Mexico’s jurisdiction. However, Mexico has legislation to prevent such practices and has ratified certain international treaties that regulate, and in some cases prohibit, these practices.