The Federal Commission for Protection Against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS). COFEPRIS is certified as a level 4 national regulatory authority that is competent and efficient in the performance of the health regulation functions recommended by the Pan American Health Organization (PAHO) and World Health Organization (WHO) to guarantee the safety, efficacy, and quality of medicines. It is responsible for making drugs and medical devices regulation more efficient, encouraging the use of regulatory decisions from other jurisdictions, and formulating and implementing strategies to strengthen its regulatory system.

In July 2020, the government signed a procurement agreement with the United Nations Office for Project Services (UNOPS). Under this agreement, UNOPS directly purchases medications on behalf of Mexican health institutions, according to UNOPS' procurement policies and procedures. Although the government's intention was for UNOPS to be exclusively responsible for the acquisition of medicines, at the end of 2021 it was announced that two independent consolidated acquisitions would be carried out, one by the Institute of Health for Wellbeing (Instituto de Salud para el Bienestar) (INSABI) and another by UNOPS. In December 2021, both INSABI and UNOPS independently announced tenders for medicines to be acquired by the government.

On 30 May 2023, the Decree reforming, adding, and repealing various provisions of the General Health Law, to regulate the Health System for Welfare, came into effect. The regulatory and administrative provisions necessary for the application of this Decree are pending issue. It disestablishes the Institute of Health for Welfare (Instituto de Salud para el Bienestar) (INSABI), providing that the functions of INSABI will become part of the Mexican Institute of Social Security for Welfare (Instituto Mexicano del Seguro Social-Bienestar) (IMSS-Bienestar). In collaboration with the Ministry of Health, IMSS-Bienestar will be the decentralised entity in charge of providing free health services, medicines, and other supplies to people without social security in Mexico. IMSS-Bienestar will participate in the consolidated contracting procedures for the acquisition and distribution of medicines and other health-related supplies, under the terms provided in the Public Sector Acquisitions, Leasing and Services Law and other applicable provisions.

On 1 July 2020, as a result of the entry into force of the United States-Mexico-Canada Agreement (USMCA), the new Federal Law for Protection of Industrial Property (new IP Law) was enacted. The new IP Law represents an important legislative change, as it aims to align domestic law with the standards set by the trade and cooperation agreements signed by Mexico in recent years. It came into force on 5 November 2020 and amendments to the health laws to reflect this are expected in the near future.

The Mexican financial market offers many alternatives for life sciences funding through:

All types of private funding are available, including venture capital, private equity, incubators, and crowdfunding. Government funds and financing are also available with financial aid, tax incentives, and sponsorship programmes for small and medium-sized companies involved in certain industries and sectors.

The most common sources of life sciences financing in Mexico are:

The Ministry of Health (Secretaría de Salud) governs the health care system in Mexico. The Mexican health care system comprises public and private institutions, insurers, and independent professionals.

The public sector comprises:

The public health sector often faces financial problems and implements measures to limit costs by, for example, pressing for price reductions in consolidated public tenders (involving the most important health institutions) and encouraging competition.

Individuals and private insurers fund the private sector. Private health insurance generally covers professional, executive, and higher levels of the private sector. According to official figures, up to 50% of annual health spending in Mexico comes from out-of-pocket expenses related to private doctors, insurance, and drug acquisitions.

On 30 May 2023, the Decree reforming, adding, and repealing various provisions of the General Health Law, to regulate the Health System for Welfare, came into effect. It disestablishes INSABI, providing that the functions of INSABI will become part of IMSS-Bienestar (see Question 1).

In the public sector, social security and public institutions provide medicines directly to the public at no cost.

Social security institutions, for example, the IMSS and ISSSTE, are responsible for delivering medicines to their beneficiaries. After a medical appointment, the treating doctor delivers a prescription with a validity period that varies depending on the type of condition. To obtain medication free of charge, the patient must present a valid prescription to the pharmacy of the institution itself or any pharmacy designated by the institution.

Public health institutions for people who do not have social security, aim to deliver free medical care and medicines, although patients may be required to contribute personally under certain conditions.

Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) covering patented products, which is overseen by the Ministry of Economy (Secretaría de Economía). Pharmaceutical companies' participation is voluntary. Under the price control scheme, 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 sanctions for violations of the MRP.

During public tenders, the convening authority conducts market research and submits requests for quotations to private companies and UNOPS (in connection with the international referencing of drug prices).

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

For direct purchasing of patented products, the Committee for the Negotiation of Drug Prices (CNDP) analyses:

The CNDP also conducts an economic evaluation of the cost-effectiveness of patented medicines compared with those potential substitutes.

For persons covered by the ISSSTE, a prescribed medicinal product can be dispensed in a private drug store registered with the public insurer, provided that it 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 currently improving the level of pharmaceutical coverage as the private market in medicines has grown considerably.

In the public sector, the ISSSTE is the only social security institution that expressly regulates reimbursement of health services. Although reimbursement for medications is not expressly mentioned, depending on the case and circumstances, pharmaceutical products are considered included within the health services for which reimbursement can be requested.

A Request for Reimbursement for Extra-Institutional Medical Expenses is submitted using the format available for these purposes, meeting the requirements in the ISSSTE Regulation of Medical Complaints and Reimbursement Requests. The request must be submitted within two years from the date the events occurred. The ISSSTE usually responds within about 115 business days from the filing of the request.

Private health services vary depending on whether or not the patient has private health insurance, the chosen hospital unit, the insurer, and the coverage of the chosen policy.

Medicines must be made available through authorised pharmacies and can only be sold to patients with a physician's prescription, except for specific over-the-counter products that can be marketed in various types of establishments.

Pharmacies must obtain a sanitary authorisation from COFEPRIS. This certifies that the pharmacy complies with the current sanitary requirements for the commercialisation and dispensing of medicines and health supplies, to preserve the safety, quality, and efficacy of products until they reach patients.

Wholesale distribution is not independently regulated in Mexico. Therefore, any company dedicated to the commercialisation and wholesale distribution of medicines must comply with the main legislation for pharmaceuticals and procurement of medicines:

The Ministry of Economy and the Ministry of Health supervise the distribution and commercialisation of pharmaceuticals, and set the maximum prices for the sale of medicines and supplies to the public (General Health Law). In addition, the Ministry of Finance and Public Credit (Secretaría de Hacienda y Crédito Público) determines prices for goods produced by the public sector.

COFEPRIS is responsible for the control and surveillance of all aspects related to sanitary regulation, including the distribution and commercialisation of pharmaceuticals. COFEPRIS can make on-site inspection visits of the manufacturing, distribution, or storage facilities, to:

COFEPRIS can initiate legal proceedings to sanction non-compliance. COFEPRIS can implement measures such as:

The imposition of administrative sanctions does not exclude civil and criminal liability. Repeated infringement is also considered a criminal offence.

Sanctioned parties can appeal COFEPRIS decisions, through the administrative or judicial channels.

As a rule, all medicines must have a marketing authorisation to be manufactured and commercialised in Mexico (General Health Law and Health Supplies Regulation).

In certain circumstances (for example, in relation to clinical trials and orphan drugs), import of a small quantity of products without a marketing authorisation can be approved. COFEPRIS can also grant permission for the import of finished products that do not have a marketing authorisation in the following cases:

In January 2020, the Ministry of Health published an official administrative decree, establishing an expedited procedure for applications for marketing authorisation and import of medicines into Mexico (Equivalence Decree). The Equivalence Decree confirms that both:

On 22 June 2021, the Ministry of Health published a Decree amending the Equivalence Decree. The Decree includes the following amendments:

Patent holders can enforce border measures and the remedies provided by the Federal Law for the Protection of Industrial Property (Ley Federal de Protección a la Propiedad Industrial) (IP Law). If a generic application is approved while the corresponding patent is still in force, the patent holder or licensee can bring a court action against marketing approval and a patent infringement action to stop the manufacture and sale of the generic products.

In relation to trade marks, parallel imports are allowed if the product was legally introduced in the country of origin. The packaging and labelling of pharmaceuticals are governed by the General Health Law and the General Health Law Regulations, and require approval by COFEPRIS. Altering or modifying the authorised packaging or labelling of approved pharmaceutical products may be considered a criminal offence. The IP Law does not specifically address patents in this context. However, it is likely that the principle of exhaustion of rights also applies to patents.

The primary legislation for the advertising of medicinal products is the General Health Law and its Advertising Regulations (Reglamento de la LGS en materia de Publicidad) (RLGSMP). These are supplemented by guidelines published by COFEPRIS, which controls the advertising of medicinal products, and industry codes of practice.

The Council of Ethics and Transparency of the Pharmaceutical Industry (Consejo de Ética y Transparencia de la Industria Farmacéutica) (CETIFARMA) has issued the following self-regulatory codes:

Affiliate members of the National Chamber of the Pharmaceutical Industry (Camara Nacional De La Industria Farmacéutica) (CANIFARMA) must comply with these codes. CETIFARMA supervises members' and adherents' compliance.

There are also opinions issued by the Advertising Council, which includes representatives from the Ministry of Health, the academic and scientific communities, the business sector, the media, and consumer groups.

Additionally, other general legislation may be relevant for the advertising of medicinal products, particularly, the Federal Law for the Protection of Consumers (Ley Federal de Protección al Consumido) and the IP Law.

Advertising is defined as an activity consisting of any process of creation, planning, execution, and circulation of adverts in media channels, to promote the sales or consumption of products and services. An advert is a message directed at the public or a section of the public, to inform them about the existence or characteristics of a product, service, or activity, for its commercialisation and sale or to influence action. (Article 2, General Health Law Regulations.)

In terms of the GPP Code, promotion means any activity undertaken, organised, or sponsored by a pharmaceutical company or under its authority (that is, by subsidiaries, foundations, associations, institutes, and agencies), that supports the prescription, dispensing, sale, and acquisition or administration of its medicines, complying with applicable rules, regulations, and standards.

The Code of Ethics and Transparency of the Pharmaceutical Industry requires CANIFARMA members to act in accordance with sound trading practices and in strict compliance with the prevailing legislation. Members must establish the proper measures and monitoring procedures to verify that their associated members comply with the applicable regulations.

Advertisements of medicinal products must be approved by COFEPRIS. An application for approval must include all details of the proposed advertisement. Companies can obtain a preliminary opinion on their advertisement from an authorised expert. This opinion can be filed with the approval application to speed up the process.

Only non-prescription medicines can be advertised to the general public, subject to approval by COFEPRIS (Article 310, General Health Law).

Any visual or audio advertisement must bear the words "Consult your physician" (Article 43, General Health Law Regulations). Advertisements must mention applicable precautions and contraindications (Article 43, RLGSMP).

The GPP Code requires that members' promotional activities directed towards consumers must be undertaken with the aim of generating a new culture for the rational and appropriate consumption of medicines, encouraging the guidance of health care professionals authorised to prescribe.

Advertisements directed at health care professionals only need to be notified to COFEPRIS.

Advertisements directed at health care professionals can only be published in specialised media, and must be based on the approved prescription information of the corresponding medicinal product (Article 42, General Health Law Regulations).

Various provisions on comparative advertising apply to pharmaceutical advertising:

There are no specific provisions relating to references to a competitor's product that has not been approved in Mexico (and that does not have a well-known trade mark in Mexico). Therefore, it is advisable to submit the advertisement before COFEPRIS for an opinion or an authorisation.

Information about an unlicensed product should not be provided to a private institution, as it is likely to be perceived as advertising of an unauthorised medicine.

Similarly, prescribing information for unlicensed products cannot be provided to health care professionals, as the authorisation to provide prescribing information is granted under the general marketing authorisation for the corresponding product.

Where the results of clinical trials are published in specialised or widely distributed magazines, pharmaceutical companies must request the authors to disclose any conflicts of interest (GPP Code).

Off-label information must be strictly limited to a scientific audience, avoiding the promotion, directly, indirectly, or through a third party, of any unauthorised directions of use.

The General Health Law Regulations apply to any advertising activity, including advertising through electronic means and other forms of technological media. COFEPRIS monitors advertising on the internet.

COFEPRIS issued guidelines for digital advertising that apply to any product subject to monitoring or approval by COFEPRIS. These guidelines clarify that digital advertising campaigns must be approved by COFEPRIS before being used on any digital media.

It is recommended that companies adopt the proper measures to ensure the promotion of prescription medicines through electronic means is only accessible to health care professionals.

COFEPRIS has not yet regulated mobile medical applications.

CANIFARMA member pharmaceutical companies must also comply with the following:

In response to non-compliance with the rules of advertising pharmaceuticals, the Ministry of Health, through COFEPRIS, can impose any or all of the following penalties:

COFEPRIS' decisions and orders can be appealed before COFEPRIS or the federal courts.

COFEPRIS constantly monitors advertising activities and is strict in imposing penalties. COFEPRIS has imposed large fines against specific over-the-counter medication manufacturers for using misleading advertising related to their products, inciting the public to self-medicate.

The General Health Law and the General Health Law Regulations both contemplate the possibility of a "people's action," which is a complaint filed before COFEPRIS regarding a breach of the law.

There is a co-ordinated effort between COFEPRIS and pharmaceutical companies to encourage self-regulation. In addition, CETIFARMA can supervise and impose monetary sanctions on its members in breach of its various codes.

Only non-prescription medicines can be advertised to the general public (Article 310, General Health Law).

The objective of the advertisements must be to inform the public about the products' characteristics, therapeutic properties, and form of use. The GPP Code requires that members' promotional activities directed towards consumers must be undertaken with the aim of generating a new culture with regard to the rational and appropriate consumption of medicines, encouraging the guidance of health care professionals authorised to prescribe.

Any visual or audio advertisement must bear the following message: "Consult your physician." Advertisements should mention applicable precautions, and whether the use of the medicine represents any danger in the event of an existing pathology.

The following rules apply:

The GPP Code establishes guidelines for sampling. It prohibits members from offering or supplying samples with the aim of seeking or rewarding prescription practices. It also prohibits any trade of samples.

Those providing samples must have full and up-to-date control over their samples, including in relation to their manufacture, storage, delivery to regional co-ordinators or others, and provision to medical representatives and physicians.

Collaboration between the pharmaceutical industry and patient organisations must be subject to a written agreement including, at least:

(GPP Code.)

Pharmaceutical organisations must follow their applicable guidelines, codes of ethics and conduct, transparent practices, and the deontological instruments approved by CETIFARMA and CANIFARMA. They must also provide criteria and procedures for the approval and implementation of these kinds of collaborations.

Health care professionals are defined as personnel who work in health institutions (for example, doctors, dentists, biologists, bacteriologists, nurses, social workers, chemists, psychologists, sanitary engineers, nutritionists, dieticians, and pathologists), who have a professional title or certificate of specialisation that has been legally issued and registered by the competent educational authorities.

Advertisements directed at health care professionals can only be published in specialised media, and they must be based on the approved prescription information relating to the corresponding medicinal product (Article 42, HLR). When promotional material refers to published studies, these must be faithfully reproduced or clear, easily accessible references must be given (GPP Code).

Medical and scientific departments must ensure that the information provided to health care professionals is accurate, balanced, fair and objective, and sufficiently complete to enable the recipients to form their own opinion of the medicine's therapeutic value (GPP Code). The departments have scientific and moral responsibility for the content of the information provided by them, or by others under an outsourcing agreement.

Health care professionals in government institutions must not request, accept, or receive any gifts or donations from persons whose commercial or industrial activities are directly linked to, or regulated or supervised by, government officers (Article 47, Federal Law on Responsibilities for Government Officers). This also applies to doctors working for the IMSS or ISSSTE.

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

Providing free samples of products does not require approval, provided that the samples meet the requirements of the approved medicinal product. These samples must be contained in a package with a smaller number of units than the approved product (Article 49, General Health Law Regulations).

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, Code of Good Practices of Advertising of CANIFARMA). The corresponding sanctions range from a warning to a fine.

CETIFARMA-affiliated companies must act responsibly in relation to sponsorships and donations. For example:

(GPP Code.)

Similarly, the Code of Ethics and Transparency of the Pharmaceutical Industry 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 that regulate, and in some cases prohibit, these practices.

The General Health Law Regulations do not require pharmaceutical companies to disclose details of transfers of value to health care professionals, health care organisations, or patient organisations.

However, the GPP Code and the GPI Code allow CETIFARMA to require CANIFARMA members to record any valuable support given to health care professionals, institutions, or patient organisations. Members must provide information concerning donations granted, on a yearly basis, to be made available to the public to promote transparency.

The interactions of the pharmaceutical industry with health care professionals (including in relation to supporting studies, invitations to conferences, and other promotional activities), can generate conflicts of interest. In these cases, CETIFARMA should be consulted, to avoid uncertainty.

In the case of non-compliance with the rules on marketing to health care professionals, COFEPRIS can warn companies with approved products to modify advertisements. If not modified, or the modification is considered to not comply with the legal provisions, the Ministry of Health, through COFEPRIS, can impose either or both of the following penalties:

CETIFARMA can impose monetary sanctions on CANIFARMA members who are in breach of the GPP Code or the GPI Code.

Patent applications are regulated by the IP Law and its regulations.

Patentable inventions must meet all of the following requirements:

Products and processes can be the subject of patent protection under the IP Law. The Mexican Patent and Trademark Office (Instituto Mexicano de la Propiedad Industrial) (IMPI) grants patents protecting compounds, formulations, uses, and manufacturing processes for medicines.

New uses of pharmaceutical or biotechnological compounds or compositions are only patentable if they are not obvious to a person skilled in the art. Purpose-limited product and Swiss-type claims are accepted in practice to claim new uses.

The following subject matter is not patentable in Mexico:

The following are not considered inventions in Mexico:

Regulations of the new IP Law are pending (see above, Types of Patent Available).

Applications must be filed with the IMPI. Details on the application procedure and government fees are available in Spanish on the IMPI's website.

Generally, it takes three to six years to obtain a patent in Mexico, depending on the field of technology.

Application. A patent application contains a statement that must include all of the following:

If the application is filed in English, a Spanish translation must be filed within two months from the filing date.

For applications under the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention), a certified copy of the priority right document must be filed within three months from the filing date.

Formal examination and clarifications. The IMPI conducts a formal examination of the documents and can order clarifications or further details, or that an omission be remedied. The IMPI usually issues an official communication to request any outstanding documents four to six months after filing. The applicant has two months (plus two additional months on payment of extra fees) to comply with a request. If the applicant fails to comply, the application is deemed abandoned.

After all the formal documents have been filed, the IMPI issues an official communication that covers any priority claimed, when applicable. An abstract of the application is published in the Official Gazette 18 months after filing of the priority claim, or if no priority is claimed, 18 months from the filing date.

Examination on the merits of the invention starts automatically after the corresponding fees are paid on filing of the application.

Within the two months following the publication of the patent application, third parties can file information related to the patentability of the invention with the IMPI. This does not suspend the application process and the IMPI has discretion whether to consider the information filed. A third party is not considered a party to the patent prosecution and does not have access to the patent file or immediate legal standing to challenge a granted patent.

Grant. An official decision on the application is issued about three to six years after the filing date, either requesting amendments to the claims (for example, clarification regarding novelty), or granting the protection sought and requesting payment of the final IMPI fees, together with payment of the first five annual fees.

After a patent is granted, anyone can inform the IMPI of causes of invalidity, including third parties. The IMPI can consider this information to initiate cancellation proceedings.

Patent Prosecution Highway (PPH). The IMPI has implemented PPH pilot programmes to recognise examinations by the:

These programmes are an attempt to accelerate pending applications.

Parallel patent grant (PPG). On 7 December 2020, the USPTO and IMPI announced the launch of a PPG initiative. This allows for patents to be granted in Mexico based on published US patents. The aim is to expedite the examination of Mexican applications for which there is a corresponding US patent, and therefore reduce application processing times.

While an applicant must request to benefit from the PPH before the issuance of a first office action, the IMPI will directly invite applicants to participate in the PPG. If the applicant agrees, they must pledge to claim the same matter that is covered by the corresponding US patent. However, the Director of the IMPI has stated that applicants will still be able to request participation in the PPG programme. The specific procedures for requesting and inviting participation in the programme are yet to be determined.

The term of a Mexican patent is 20 years from the filing date of the patent application in Mexico. For Patent Cooperation Treaty 1970 (PCT) applications, the effective filing date is the date of filing of the international patent application.

The new IP Law allows patent owners to request an extension of their patent term to compensate for delays during prosecution. This only applies to patents that are filed and granted after 5 November 2020.

Under the new system, a complementary certificate can be granted when both:

The validity of a complementary certificate cannot exceed five years. The IMPI determines the period that corresponds to an unreasonable delay (based on one day for every two days of unreasonable delay). A complementary certificate takes effect the day after the expiration of the original 20-year patent term and confers the same rights as the patent from which it derives.

Under case law, it may be possible to extend the term of patents due to unjustified delays during patent prosecution under the old IP law. However, this only applies to the parties to the case and does not bind the IMPI. Therefore, it is expected that the IMPI will not extend the term of patents for unjustified delays without a court order. The decision is not binding on Mexican courts, but is highly persuasive.

The USMCA provides for the extension of patent protection in cases of unreasonable curtailment of the effective patent term, due to the time taken to obtain marketing approval. However, this mechanism has not been implemented into national law.

The IP Law grants patentees the right to the exclusive exploitation of the patented invention and to exclude others from making, using, offering for sale, or importing the protected invention.

In a patent infringement action, the claimant must prove either of the following:

The IP Law does not recognise a contributory infringement doctrine.

In November 2016, the First Circuit Court issued a non-binding isolated opinion that peripheral interpretation, based on identity or equivalence, constitutes a method for establishing infringement.

Defences to a patent infringement action include:

Patent Cooperation Treaty 1970 (PCT).

WIPO Madrid Agreement Concerning the International Registration of Marks 1891.

Paris Convention for the Protection of Industrial Property 1883.

The IP Law and its Regulation regulate trade marks in Mexico.

A trade mark is any sign that both:

As long as they meet the above requirements, trade mark protection is also available for:

(IP Law.)

Applications must be submitted to the IMPI.

Details on the application procedure and government fees are available in Spanish on the IMPI's website.

Application. A trade mark application must include the following information:

Formal examination. A formal examination is undertaken, which checks compliance with the formal legal requirements (for example, the official application form must be duly completed and the government fees paid). If any formal information or documents are missing, or if the products or services are not correctly classified, the IMPI will give the applicant two months to remedy the defect(s). (This period can be automatically extended for a further two months.)

Second examination. A second examination of the registrability of the mark (without evidence of use) is undertaken, to establish whether it complies with the legal conditions for registration. The examiner considers both relative grounds for refusal (prior rights) and absolute grounds for refusal (inherent registrability of the mark). If there are any objections to registrability, the IMPI gives the applicant two months to remedy the defect(s). (This period can be automatically extended for a further two months.)

It generally takes four to seven months for the IMPI to conduct both examinations.

Publication and opposition. Filed applications are published for opposition in the Industrial Property Gazette within ten working days of receipt of the application. If an opposition is filed, the applicant must file a response within four months of service of the opposition. If no response is filed, the registration application is considered abandoned. The party that filed the opposition cannot later file an invalidity action against the registered trade mark on the same grounds and based on the same evidence.

The deadline to file final arguments in opposition proceedings is five days from notification by the IMPI. If the application filing date changes during the prosecution of a trade mark application for any reason, the application is published again for opposition purposes.

Registration and cost. If there are no requests for further information, and no oppositions or objections to registration, the average cost for obtaining a Mexican non-priority trade mark registration is about USD800.

The main legislation is:

The Federal Economic Competition Commission (Comisión Federal de Competencia Económica) (COFECE) enforces the competition legal framework in Mexico. This is an administrative agency with technical and operational autonomy. It is related to the Ministry of Economy (but is not supervised by it).

The COFECE has statutory authority to review practices by pharmaceutical companies. In 2010, the COFECE imposed a fine on six pharmaceutical companies for anti-competitive practices in public tender proceedings organised by the IMSS. The COFECE is currently conducting an investigation into alleged irregularities in the market for the production, distribution, and marketing of medicines.

The Ministry of Public Function (SFP), which has the power to impose fines on companies for acts of corruption or bad practices, has prohibited certain drug distributors from participating in public contract tenders for allegedly monopolising purchases from Mexico's social security institutes.

An action can be brought before the COFECE against activities falling outside the scope of a patent, for example:

Actions can also be brought before the COFECE for other forms of abuse of patent rights, for example, clearly unfounded attempts to enforce a patent.

After three years from the date of grant of the patent or four years from the filing date, whichever is later, any person can request the grant of a compulsory licence from the IMPI when a patent has not been used in Mexico, except where there are justified reasons for non-use.

A compulsory licence will not be granted when either:

A party applying for a compulsory licence must have the technical and economic capacity to efficiently work the patented invention.

Before the grant of the first compulsory licence, the IMPI gives the patentee the opportunity to begin working the patent within one year from the date notification. If the patentee does not work the patent within that time frame, the IMPI will decide on the grant of a compulsory licence following a hearing with the parties. If the IMPI decides to grant a compulsory licence, it sets out its duration, conditions, field of application, and amount of royalties to be paid to the patent holder. The royalties are determined by the IMPI after a hearing with the parties. Royalties must be fair and reasonable.

There have not been any compulsory licences granted in recent years.

There are no restrictions on licensing or transferring patents to foreign parties. There are no restrictions on intellectual property transfers for inventions funded, or partially funded, by public investment.

There is no requirement for a patent or trade mark licence and payment of royalties under it to a foreign licensor to be approved by a government or regulatory body.

Recording a patent or a trade mark licence is not mandatory and the agreement is enforceable between the parties regardless of recordal. However, to be enforceable against third parties, and to ensure the title holder can use the trade mark or patent, the licence must be recorded with the IMPI (IP Law).

COFEPRIS's monitoring is focused, among other things, on:

(General Health Law Regulations and NOMs.)

In cases of potential non-compliance, COFEPRIS has statutory authority to:

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

In co-ordination with COFEPRIS, the Federal District Attorney's office (FGR) can:

The Federal Agency for the Protection of Consumers (Procuraduría Federal de Protección al Consumidor) (PROFECO) can start proceedings for violations of NOMs.

COFECE can conduct investigations on many aspects related to the manufacturing and commercialisation of medicines, and carry out inspection visits on requests of individuals or on its own initiative. After conclusion of the investigation stage, COFECE determines whether to close the case or to start administrative proceedings. In both cases, COFECE can impose preliminary injunctions. The affected party can claim damages before a court. Follow-on private litigation against manufacturers is possible, but not common. Additionally, COFECE can file criminal complaints.

Generally, liability arises from federal or local civil codes. Liability can also arise from violations of statutory provisions. The NOM for good manufacturing practices of medicinal products (NOM-059-SSA1-2015) also contains provisions regarding liability. The Federal Consumer Protection Law allows class actions.

Liability claims are mainly regulated by statutes rather than court precedents. Therefore, there is no clear substantive test. The standards to determine damages are high. According to precedents from the federal courts, the causal nexus between actions/omissions and damage must be fully proved.

All persons involved in selling or distributing medicinal products can be liable in civil actions for harm derived from defective medicinal products. The marketing authorisation holder is responsible for the quality of the approved product (NOM-059-SSA1-2015). In addition, when manufacturing through third parties, the marketing authorisation holder must supervise the manufacturing of the product and establish in agreements the liabilities and duties of each party involved (NOM-059-SSA1-2015).

Available defences to product liability claims include:

Liability for defective medicinal products cannot be excluded.

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

The federal procedural laws were recently amended to allow class actions before the federal courts. PROFECO, 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 there does not appear to be any precedent for class actions for product liability.

In addition, through a "popular action," any individual with or without legal standing can file a complaint with COFEPRIS on the ground that a product on the market poses certain health risks. However, the claimant's procedural rights are limited, and these actions are intended to remove a health risk, not to obtain compensation.

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 legal precedents for this.