The Pharma Legal Handbook: Mexico
Join industry executives in staying informed on pharma regulations in Mexico:
Regulation, Pricing, Clinical and Preclinical Trials, Marketing, Manufacturing, Trademarks, Patents, and more!
Get your pharmaceutical legal and regulatory questions answered in The Pharma Legal Handbook – a must-have guide for any company operating in the country or looking to enter the market.
Prepared in association with OLIVARES, a leading Mexican law firm.
If legal handbook content is updated, you will receive an updated PDF free for up to one year after purchase.
July 2018
1. Health & Patent Rights During the COVID-19 Pandemic
There is no doubt that COVID-19 has impacted almost every aspect of our lives. Due to the ongoing health crisis, among other efforts, governments have implemented measures expecting to break high rates of infection while trying to adapt the regulatory landscape to respond to the new virus and continuing to attend other illnesses. Moreover, the vaccination process has increased discussions over human rights, from right to health to patent rights.
An equitable and global distribution of the vaccine will be a challenging task for humanity. It requires the cooperation of governments, the pharmaceutical industry, distributors, health institutions, and healthcare professionals, as well as conscious and responsible behavior from the general population.
In Mexico, with more than 120 million individuals, it will be tough to ensure a fair, equitable and timely distribution for all Mexicans who need to be vaccinated. Nevertheless, it is important to point out that being able to get vaccinated in a timely manner is a right… a human right to health. Public and private health services should not be understood as a benefit or concession provided by the current government, or from any other, nor from a political party.
Human rights are inherent to all people, without any distinction of nationality, place of residence, sex, national or ethnic origin, color, religion, language, or any other condition. Furthermore, human rights are interrelated, interdependent and indivisible. For instance, one cannot respect one another, not randomly either, because some of these rights afect the enjoyment of the others.
The right to life is, perhaps, the original fundamental right. Without this right, we would not have access to any other, since they depend on the guarantee and conservation of the right to life. In this context, and considering the indivisibility of fundamental rights, the right to health protection is much more than the absence of disease or having access to medical care; it is a fundamental right that touches all aspects of life. That is why it is so important to understand health in the broadest and most progressive manner possible.
Therefore, it is understandable that all efforts are made to ensure the protection of the human rights to life and health, even if means looking at the possibility of suspending other rights.
So far, we are facing a worldwide shortage of vaccines, which has led to debates on the measures which need to be taken. Consequently, some jurisdictions, such as the US, India and South Africa have proposed lifting or suspending intellectual property (IP) rights for COVID-19 vaccines.
Indeed, such proposals are a good start to overcoming the pandemic, however, the patent system is not the problem, and the solution is not the waiver of the patents. Yet, it is impossible to deny that, during the COVID 19 pandemic, more than ever, the world has witnessed the relevance of pharmaceutical innovation.
The innovative pharmaceutical industry has risen to the situation and, as a result, there are now various COVID-19 vaccine options available. Additionally, this industry continues to work on the research and development (R&D) of new treatments and devices aimed at treating and/or curing this disease which has turned the world upside down. This R&D involves great efforts and resources, finding a fair balance and support in a healthy patent system.
We would all agree that the human right to heath is probably at the top of our list, as explained above. However, it is necessary to broaden the scope of the situation, since focusing only on the patent system will not promptly solve the situation.
A suitable and instant solution is required. Hence, it is necessary to include other measures, such as scaling up production, support from wealthier nations to those with lower income levels in order to receive enough dosages, licensing agreements, etc. Moreover, access to raw materials, transfer of know-how and technology, as well as infrastructure to create the vaccines needs to be addressed.
The issue arises from a scarcity of goods and services, among other reasons, but not from the exclusive rights that ae involved, especially since new products, devices, and vaccines are being developed by this innovative industry, which finds a great balance and stimulation from the patent system.
In brief, COVID-19 has impacted the life sciences in many aspects. Health products have become essential during these times, involving several changes in the system as known. The regulatory scenery has changed significantly, as new guidelines and measures had to be implemented to address the health crisis.
Those modifications have and may continue to transform the normal ways to obtain sanitary authorizations, exclusive rights, and the paths of access, among others, as the world is facing one of the most challenging tasks in history.
Thus, while ensuring proper access to the human right to health and patent rights, it is necessary to establish measures to expedite access along with a system that nurtures a balance between stakeholders, innovators, and governments.
Also from this Legal Handbook
2. Biosimilars & Biologics: Mexico
Key facts about biosimilars and biologics in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. Are biosimilar medicines considered the same as generic medicines in your country?
No, biosimilars are not considered the same as generic medicines. Biosimilars are regulated by specific provisions within the sanitary legislation.
The Mexican General Health Law defines a “biologic product” as any substance that: has been manufactured by molecular biotechnology; has therapeutic, preventive or rehabilitative effects; is provided in a dosage form; and is identified as such by its pharmacological activity and physical, chemical and biological properties.
Article 222 Bis of the Health Law names follow-on biotechnology products (biosimilars) as “biocomparables”, since they must be comparable to reference products with regard to safety, efficacy and quality.
For instance, applicants for marketing authorizations of generics only have to prove basically that their products are interchangeable to the innovator product. They have to provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a list of reference medicinal products.
On the other hand, the essential dossier submission requirements for biocomparables follow the same line as those requirements for innovative biotech products, except for the requirements to prove safety, efficacy and quality, since applicants must submit clinical tests and, when appropriate, in-vitro tests, to prove safety, efficacy and quality of this product biocomparable (biosimilar) to those of the reference biologic.
2. Are all biologic medicines, including biosimilar medicines, patentable in your country?
Biologic medicines are patentable in Mexico. Concerning biosimilar medicines may be protected under IP rights if the specific product, somehow fulfils, among others, the patentability requirements.
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
The primary legislation for the authorization of biosimilar, is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Mexican Standards (NOMS) published by COFEPRIS.
Biologics are treated differently to non-biologic drugs for the purposes of gaining regulatory approval. The biologics-specific path is mainly provided in the Mexican official standard Rule, NOM-257-SSA1-2014 “Regarding biologic medicines”.
In addition, the Mexican official standard Rule NOM-177-SSA1-2013 regarding “Interchangeability and biocomparability tests” mainly establishes the guidelines for generating clinical protocols, quality management system, pharmacovigilance, biocomparability and establishes the reference products.
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
In general terms, the standard dossier submission requirements for marketing authorization applications for drugs usually comprise legal and administrative information, summaries, chemical, pharmaceutical and biological information, nonclinical reports and clinical study reports.
The additional dossier requirements for biotech products include, for example, a description of the manufacturing process, the provision of information concerning the starting and biological origin materials, and a description of the manufacturing facilities and equipment.
Innovative biotech products may be used as the reference product for the approval of non-innovative products. The Health Law calls these products ‘biocomparables’, since they must be comparable to reference products regarding to safety, quality and efficacy. The Health Law Regulations provide that a biocomparable may be a reference product for another one, where an innovative product has not been approved in Mexico yet.
Applicants must submit clinical tests and, when appropriate, in-vitro tests, to prove safety, efficacy and quality of this product comparable (similar) to those of 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. For this, the applicant must have to submit essentially:
- In vitro studies
- A report of comparative test of pharmacokinetics, if determined by the Ministry of Health, to show pharmacokinetic comparability on key parameters between both the follow-on and the reference biologic;
- Pharmacodynamics test reports; and
- Comparative efficacy and safety clinical tests to show similarity between both the follow-on and the reference biologic.
5. What are the requirements for the choice of the reference comparator product?
According to the Health Law Regulations reference medicinal products, are those indicated by the Ministry of Health as such, that has the registry of said agency, that is commercially available and is selected according to the criteria established in the Standards;
In 2018 the Federal Commission for Protection against Sanitary Risks (COFEPRIS) issued the guidelines that establish the requirements for the recognition and selection of a reference medicine, which establish that the medicine that have its marketing authorization and that was presented through New Molecules Committee, may be recognized as a reference medicine by COFEPRIS, in case of having a patent in force, it can be designated as a reference medicine, only three years before of the expiration of the same and comply with the following:
- Have a current marketing authorization issued by the Federal Commi-ssion for Protection against Sanitary Risks (COFEPRIS).
- Have the information of the clinical trials that support the safety and efficacy of the product or with the official communication of the resolution issued by the New Molecules Committee.
- Submit a letter under oath stating that the drug and its different concentrations are currently marketed, which must be signed by the Legal Representative.
- Provide the information to prescribe authorized in non-editable electronic format
- Comply with the provisions of the current Official Mexican Standard NOM-2020-SSA1-2016 “Installation and operation of pharmacovigilance.”
https://www.gob.mx/cms/uploads/attachment/file/295040/Lineamientos_MedRef_31ene2018.pdf
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
Under the guidelines that establish the requirements for the recognition and selection of a reference medicine, it is possible to have the comparator product be sourced from one of the following regulatory jurisdictions, if the product of reference (comparator) is not included within the corresponding list or may be included but is not commercially available in Mexico.
- The European Medicines Agency;
- The US Drug and Food Administration;
- Health Canada;
- The Swiss Agency for Therapeutic Products (Swissmedic); and
- The Therapeutic Goods Administration in Australia.
- The National Agency of Sanitary Vigilance (ANVISA) in Brazil.
- The Pharmaceutical and Food Safety Bureau.
7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?
Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation 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 sanctions for violations of the MRP.
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.
Public acquisitions are supported by the Committee for the Negotiation of Drug Prices (CNDP).
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.
On August 11, 2020, the Mexican Congress published the Decree amending Article 1 of the Public Sector Procurement, Leasing and Services Law, through which the Mexican Government is now empowered to acquire medicines through intergovernmental organizations, such as UNOPS, without having to observe the procedures set forth in the applicable Law and Regulation on public procurement.
According to UNOPS’ guidelines, the process is made up of different stages grouped within three phases identified as:
- Pre-Bidding Process (market research, requirements definition and identification of potential suppliers).
- Bidding Process (publication of the bases and call for bids and/or invitations for negotiation, bid management, evaluation and award).
- Post-Bidding Process (contract management and logistics). The distribution to the final destination will be in charge of INSABI.
Therefore, during these proceedings UNOPS is entitled to negotiate the prices of the supplies.
8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?
The primary legislation for the reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Mexican Standards (NOMS) published by COFEPRIS.
In private sector, there is no reimbursement in Mexico. 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.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
In general terms it should not have any impact as the Institution would prescribe the product that has been appointed in previous agreements. Yet, those agreements may only appoint the biosimilar as the product to be reimbursed.
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
- General Health Law (Ley General de Salud).
- General Health Law Regulations for Healthcare Products (Reglamento de Insumos para la Salud).
- Official Mexicans Standards (NOMs).
No, the requirements are the same for both drugs.
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
The regulations do not prevent automatic switching /substitution. Thus, pharmacists may choose to dispense any product with the same non-proprietary name (INN). Physicians may not prohibit substitution, but in the private sector, patients may prohibit substitution.
In the private sector or out-of-pocket acquisitions, patients can prevent substitution by requesting that the pharmacist not make the substitution. If the pharmacist insists on making the substitution, the patient may choose not to purchase the medicine and may search for the prescribed product in a different pharmacy.
However, under a public insurer, patients cannot prevent substitution, and a pharmacist may dispense any product with the same non-proprietary name (INN).
There was a proposal published in 2013 to amend the Health Law to prevent automatic substitution/switching from innovative biological products to biocomparables, and vice versa. However, the proposal was not further discussed in the Mexican Senate, and has since lapsed.
12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
Post-authorisation requirements are the following:
- Comply with the Official Mexican Standards such as:
-
- Pharmacovigilance, NOM-220-SSA1-2016 (NOM-220).
- Good manufacturing practices for medicinal products (NOM-059-SSA1-2015).
- Good manufacturing practices for Active ingredients (NOM-164-SSA1-2015).
- Interchangeability and biocomparability tests (NOM-177-SSA1-2013).
- Medicinal products labelling (NOM- 072- SSA1-2012).
- • Drug manufacturers must renew their marketing authorization every five years, subject to the relevant tests, including submission of a certificate of good manufacturing practices in force.
13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?
The requirements for the labelling of medicines are established in the Official Mexican Standard NOM-072-SSA1-2012, Labelling of medicines and herbal remedies.
Between the requirements of biologics and biosimilars there are the following differences or exceptions:
- In labeling of secondary packaging the distinctive denomination is optional in the case of generic or biocomparable drugs.
- The labeling must bear the acronyms M.B. in the case of innovative biotech drugs, and M.B.B. in the case of biocomparable biotech drugs.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
On August 19, 2020, the regulatory agency in Mexico (COFEPRIS), announced new operating rules for the approval of generic drugs in Mexico, based on the following guidelines:
- COFEPRIS will have a special procedures window for the generic pharmaceutical industry.
- These applications for approvals could be filed, the day after the granting of the patent related to the innovative medicine.
- The respective applications would be decided at any time, prior to the expiration of the patent, if the registration or approval is given, COFEPRIS will provide a provisional official communication, which would be exchanged for the definitive sanitary registration or approval, the day after the expiration or the validity of the patent.
COFEPRIS indicates that they are complying with the elimination of the temporality of 3 years (for chemically synthesized drugs) and 8 years (for biotechnological) to research and develop generics or biocomparables, according to the reforms to the so-called Bolar Exception in the new Federal Law for the Protection of Industrial Property (New IP Law) which entered in force on November 2020.
The communication also mentions that the rules for granting sanitary registrations of generic drugs, “second-use patents, which refer to the therapeutic indication, are no longer allowed,” which seems to mean that the patents of new uses will not be considered as part of the linkage system.
These rules announced by COFEPRIS, still without legal basis, since it is only a statement on its official website.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
Proposal of decree to amend article 222 Bis of the General Health Law:
Public health institutions should establish an effective differentiation mechanism to ensure adequate pharmacovigilance and continuity of medical treatment, thus preventing an automatic substitution of biotechnology / biocompatible drugs, without due medical prescription.
Proposal of decree to amend article 26 of the Health Supplies Regulation. “The General Health Law orders that the packaging of medicines directed to the public sector and those directed to the private sector must be differentiated, therefore the Regulation of Health Supplies is harmonized with such provision.”
Click the following links to read more legal articles from Mexico:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
3. Localization: Mexico
Key facts about Localization in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
Largely, there are no specific rules or regulations requiring and/or encouraging localization in Mexico. Thus, there is no legal framework defining localization rules and policies in Mexico.
Although the legal framework may involve a slight advantage if part of a specific process is carried out in Mexico or may be appointed as a requirement.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
No.
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
Despite the lack of a specific legal framework defining localization rules and setting policies in Mexico There are some provisions, which may fall under localization policies in relation to marketing authorization process
Concerning drugs containing new molecular entities which are not authorized in other countries and are intended to be registered in Mexico, it is possible to file the report of clinical studies with the participation of the Mexican population demonstrating the safety, quality and efficacy of the product. This can be submitted instead of a Free Sale Certificate or its equivalent in other countries.
Even though such provision does not necessarily mentions that the study should be conducted in Mexico, it was amended in 2014 in order to stimulate the participation of foreign companies in Mexico.
Moreover, for the authorization of biologics it is required to conduct clinical trials in Mexico.
If the eventual MAH is a foreign company with no establishment in Mexico, the MAH must submit a license/certificate/document issued by the local corresponding Sanitary authority that proves that it has an authorized manufacturing facility in that country.
It is not necessary to have a subsidiary, however it is necessary to have a legal representative in Mexico.
The local representative must have a warehouse authorized by COFEPRIS (or a contract with an existing warehouse, in order to be able to be considered as legal representative of the MAH holder within the eventual authorization.
In general, the warehouse should mainly be an authorized site and have a registered Sanitary Responsible (a person in charge of supervising and managing the activities at the facilities).
Is not mandatory that the legal representative is a subsidiary or an affiliate of the Marketing Authorization Holder (MAH).
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No.
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No.
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
No.
In fact, on July 31, 2020, the “Specific Agreement between the Institute of Health for the Welfare of the United Mexican States (INSABI) and UNOPS” was signed for the execution of the Implementation Project called “Acquisition of medicines and medical supplies” for the period 2021-2024, which allows open international competitive bidding modality (national and international market companies) for the consolidated purchase of medicines under the procurement policies and procedures of UNOPS.
The Mexican Government transfers to UNOPS all the resources and UNOPS oversees implementing, tendering and contracting said activities, as well as managing the respective contracts with third parties.
Also, on January 28, 2020 a Decree was published in the Federal Official Gazette by the Ministry of Health which states the sanitary requirements equivalence and allows the importation of drugs without marketing authorization into México.
If the product has met all the requirements and procedures of the foreign regulatory agency, i.e., if they were granted a MA, this is considered equivalent to having complied with all the requirements of the Mexican legislation. In addition, products which have previously been approved by the EMA, FDA, Health Canada, the Swiss Agency for Therapeutic Products (Swissmedic) or the TGA in Australia can benefit from an expedited MA approval process with time frames up to 60 working days.
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?
N/A
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
No.
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
There are no specific discussions about the possibility of implementing localization policies.
On the other hand, some amendments have been proposed that may fall under the shadow of localization polices, such as “plant requirement”. The Mexican legislation used to state a “plant requirement”. Thus, it was required to have a manufacturing or conditioning plant in our country, in order to obtain a marketing authorization (even if the product was manufactured abroad and imported). This caused different pharmaceutical companies to sign hosting agreements with national companies to be able to sell their products, these national companies were, then, the holders of the marketing authorizations.
The plant requirement was eliminated in 2008. According to the current regulation, the holder of a marketing authorization still needs to have a manufacturing plant, but that plant may be located abroad.
Recently, a proposal to amend the Health Law Regulations was published. This project has proposed to include the “plant requirement” again.
In this regard, the Mexican Association of Pharmaceutical Research Industries (AMIIF), has conducted lobbying efforts in order to prevent the approval of such reform.
Moreover, there is a legal precedent issued by an International Court, ordering Mexico to eliminate said requirement. The International Court considered that Mexico violated the international treaty concluded with Central America, by demanding the “plant requirement”, since the principle of “national treatment” was violated, in relation to El Salvador.
Thus, we believe that the chances of such an initiative being approved are few, however, we continue to follow up.
Click the following links to read more legal articles from Mexico:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
4. Orphan Drugs & Rare Diseases: Mexico
Important legal info for orphan drugs and rare diseases in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. What is the definition of Rare Diseases in your country?
In accordance with the General health law, rare diseases are those that have a prevalence of not more than 5 people for every 10,000 inhabitants.
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
Yes, in Mexico there is a designation of Orphan Drugs contemplated in the General Health Law and these drugs are intended for prevention, diagnosis or treatment of rare diseases.
3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
The regulatory framework for the authorization of an Orphan Drug are:
- General Health Law (Ley General de Salud).
- General Health Law Regulations for Healthcare Products (Reglamento de Insumos para la Salud).
- Official Mexicans Standards (NOMs).
- Mexican Pharmacopoeia;
Foreign marketing authorizations are not valid in Mexico.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
Orphan drugs were introduced into the General Health Law and the Mexican Pharmacopeia some years ago. However, they follow the main principles and general rules as other drugs.
5. Is there an expedited pathway for Orphan Drugs?
Orphan drugs were introduced into the General Health Law and the Mexican Pharmacopeia some years ago. In practice, they are approved by a particular procedure, following some of the rules for new molecules when applicable and appropriate, yet it is not necessary to go through the New Molecules Committee as a requirement to submit an approval application. Despite that this procedure has worked reasonably well, specific rules would be welcomed.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
Foreign marketing authorizations are not valid in Mexico. However, COFEPRIS has set a special procedure for drugs to be approved for the first time in Mexico, already approved by equivalent regulatory authorities abroad. In this procedure, the requirements for approval of these agencies are recognized as equivalent to those in Mexico. According to the equivalence agreement, marketing authorizations which have been approved by the following agencies:
- The European Medicines Agency;
- The US Drug and Food Administration;
- Health Canada;
- The Swiss Agency for Therapeutic Products (Swissmedic); and
- The Therapeutic Goods Administration in Australia.
Yet, concerning Orphan Drugs, there are no express provisions to consider as reference these foreign approvals, thus in these cases it would be under the authority’s discretion, to consider them in the evaluation process.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?
The primary legislation for the reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL), its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
In private sector, there is no reimbursement in Mexico. 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.
8. How are the prices of Orphan Drugs regulated?
Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation 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 sanctions for violations of the MRP.
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.
Public acquisitions are supported by the Committee for the Negotiation of Drug Prices (CNDP).
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.
The political party currently governing in Mexico (MORENA) is promoting an amendment to the scheme of self-regulated maximum retail price (MRP), which consist, in general terms, that the Ministry of Economy in collaboration with the Ministry of Health shall guarantee, through a transparent process and taking into consideration differentiated policies, the access to medications and inputs to people in situations of poverty. In addition, the price control would be regulated and annually reviewed by these Authorities.
On August 11, 2020, the Mexican Congress published the Decree amending Article 1 of the Public Sector Procurement, Leasing and Services Law, through which the Mexican Government is now empowered to acquire medicines through intergovernmental organizations, such as UNOPS, without having to observe the procedures set forth in the applicable Law and Regulation on public procurement.
According to UNOPS’ guidelines, the process is made up of different stages grouped within three phases identified as:
- Pre-Bidding Process (market research, requirements definition and identification of potential suppliers).
- Bidding Process (publication of the bases and call for bids and/or invitations for negotiation, bid management, evaluation and award).
- Post-Bidding Process (contract management and logistics). The distribution to the final destination will be in charge of INSABI.
Therefore, during these proceedings UNOPS is entitled to negotiate the prices of the supplies.
9. In case of reference price based on a basket of countries, what countries are included?
As mention in answer 8, 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.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
In 2014, the Mexican Supreme Court of Justice ruled that the refusal to supply orphan drugs is not unconstitutional if they have not been approved, prior examination and analysis, by the inter-institutional commission of the so-called National formulary, which is the document containing all medicines, medical supplies, instruments used by the public health institutions in Mexico.
The Second Chamber of the Supreme Court issued a partial favorable decision in this case. First, such decision recognized the right to health is a constitutional right of primary importance. Yet secondary laws shape the access to health services. Therefore, the denial of providing basic health services, such as medical care for conditions that require “orphan” drugs for their treatment, directly affect the fundamental right to protection of health.
On the other hand, the Chamber considered it was necessary to follow the procedure to include the product in the National Formulary, as this is a mechanism through which the State guarantees that the drugs necessary to treat the diseases of the population are safe, efficient and effective.
Thus, the Supreme Court recognizes that the health institution that should be providing these to the patients can and should request the evaluation and analysis of the drug to be included in such list, in order to be able to provide the orphan drug.
In conclusion, the Supreme Court mainly stated that the applicable procedures should be observed in order to be able to supply the drug. Yet, the Second Chamber may have omitted to consider that it would take a while, which would eventually put in danger the health of the patients.
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?
No, there are no proposals to reform or significantly change the regulation. Nevertheless, specific rules would be welcomed.
Click the following links to read more legal articles from Mexico:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
5. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Mexico
Cannabinoid drugs, medicinal cannabis and opioid drugs in Mexico – a comprehensive legal overview. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines for which the active ingredient is THC.
On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives was published in the Federal Official Gazette.
The new Cannabis Regulation is intended to regulate, promote, and monitor the use of cannabis and its derivatives for medicinal use. The regulation includes provisions regarding primary production, research, manufacturing of pharmacological derivatives and medicines, distribution, advertising, prescription, and commercialization. This regulation come into force on January 13, 2020.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
So far, the authority responsible for applying and enforcing the regulatory framework in relation to Cannabinoid Drugs is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health. On the other hand, it is worth mentioning that the proposal of this new law refers to the creation of the “Mexican Institute for Regulation and Cannabis Control”. This proposal may impact the role of COFEPRIS, as the main regulatory authority. Additionally this Institute will be in charge of the creation of specific regulation and guidelines concerning the permitted activities with cannabis.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
The General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives recently published established the authorization of Cannabinoid Drugs only for investigation, production and medicinal use. The primary legislation for the authorization, pricing, and reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL), its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation 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 sanctions for violations of the MRP. In private sector, there is no reimbursement in Mexico.
Public acquisitions are supported by the Committee for the Negotiation of Drug Prices (CNDP).
4. Which are the cannabinoid drugs that have received market approval to date?
The official Website of COFEPRIS does not show any registration concerning cannabinoid drugs which have an approval on force. However, there have been authorizations granted concerning cannabinoid drugs.
5. Who can prescribe Cannabinoid Drugs?
Healthcare professionals who have registered before COFEPRIS and have been granted with the specialized prescription forms concerning narcotic substances.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
So far, there is no list of doctors authorized to prescribe Cannabinoid Drugs.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
There is no express regulation in this regard.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
N/A
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
So far, there is no list of retailers/distributors authorized to sell Cannabinoid Drugs.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Phar-macological Derivatives was published in the Federal Official Gazette.
On the other hand, it is worth mentioning that the proposal of this new law refers to the creation of the “Mexican Institute for Regulation and Cannabis Control”. This proposal may impact the role of COFEPRIS, as the main regulatory authority. Additionally this Institute will be in charge of the creation of specific regulation and guidelines concerning the permitted activities with cannabis.
11. When are they likely to come into force?
The proposal is still under discussion by the Mexican Congress. An the cannabis path has taken quite a while, therefore we expect one year more for these document to be approved and enters into force.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
The use of cannabis has been authorized for medicinal use, including investigational activities and granting marketing authorizations for medicines which active ingredient is THC. On January 12, 2020, the General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives was published in the Federal Official Gazette.
The new Cannabis Regulation is intended to regulate, promote, and monitor the use of cannabis and its derivatives for medicinal use. The regulation includes provisions regarding primary production, research, manufacturing of pharmacological derivatives and medicines, distribution, advertising, prescription, and commercialization. This regulation come into force on January 13, 2020. However, there is still missing the issuance of specific and specialized regulation.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
So far, the authority responsible for applying and enforcing the regulatory framework in relation to Cannabinoid Drugs is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives recently published, established the authorization of Cannabinoid Drugs only for investigation, production and medicinal use. So far, there is no specific regulatory framework for pricing, and reimbursement of Medicinal Cannabis. The primary legislation for the authorization, pricing, and reimbursement of these kind of drugs, is the General Health Law (Ley General de Salud) (HL), its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
According to the new General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharma-cological Derivatives the production and import of Medicinal Cannabis is regulated by the National Service for Agro-Food Safety and Quality (SENASICA) and the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health. And by the Ministry of Economy.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The new General Health Law Regulation on Sanitary Control for the Produc-tion, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives establishes that the authorization to sow cannabis for the research and manufacturing purposes, must be processed before SENASICA attaching the research protocol, or the marketing authorization of the drug that is intended to be produced.
COFEPRIS may authorize public and private establishments that are destined to the manufacturing process, or that import, export or use Raw Material, Pharmacological Derivatives or Cannabis Medicines, which MUST have control books authorized by COFEPRIS, in which the manufacture of batches of Raw Material, Pharmacological Derivatives or Cannabis Medicines destined to obtain sanitary registration for commercialization of research must be registered.
A permit for commercialization issued by COFEPRIS is required to apply for a sanitary importation permit.
On the other hand, the said General Health Law Regulation on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives establishes that for the import and export of Raw Material, Pharmacological Derivatives and Cannabis Medicines, is required to have a prior sanitary permit for Import or Export, granted by the Ministry of Agriculture and Rural Development (SADER) or COFEPRIS, within the scope of their attributions. However, there is still lack of harmonization of the current sanitary legislation and the International Trade legislation. In the international Trade legislation field, despite of existing tariff schedules allowing importation for certain forms of cannabis, there are some other tariff schedules concerning cannabis are still forbidden; and keep obstaculizing the importation of certain types of products.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
The primary legislation for the marketing and distribution of Medicinal Cannabis is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
18. How can patients obtain Medicinal Cannabis?
Patients would be entitled to obtain Medicinal Cannabis as long as they have a valid and codified prescription
19. Who can prescribe Medicinal Cannabis?
Healthcare professionals who have registered before COFEPRIS and have been granted with the specialized prescription forms concerning narcotic substances.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There is a database of authorized healthcare professionals. However, so far there is no list of doctors authorized to prescribe Medicinal Cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.
The healthcare professionals interested in obtaining the bar code for special prescription recipes for Cannabis Medications must file an application before COFEPRIS for this purpose.
22. Where is Medicinal Cannabis available?
Up today, there is no official information on medicinal cannabis available.
COFEPRIS may authorized drugstores, apothecaries or pharmacies to supply the public with Cannabis Medications.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
So far, there is no list of retailers authorized to sell Medicinal Cannabis.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
N/A
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Yes.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
So far, the authority responsible for applying and enforcing the regulatory framework in relation to Opioid is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law (Ley General de Salud) (HL) and its Regulations. These law and regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies’ participation 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 sanctions for violations of the MRP. In private sector, there is no reimbursement in Mexico.
28. Which are the Opioid drugs that have received market approval to date?
Morphine.
29. Who can prescribe Opioid Drugs?
The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There is a database of authorized healthcare professionals. However, so far there is no list of doctors authorized to prescribe Medicinal Cannabis.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The healthcare professionals must be registered before COFEPRIS have been granted with the specialized prescription forms concerning narcotic substances.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
N/A.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is no list of retailers/distributors authorized to sell Opioid Drugs.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No.
35. When are they likely to come into force?
Not applicable.
Click the following links to read more legal articles from Mexico:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs