By Moeller IP.
Patent Linkage in Mexico
The Mexican linkage system refers to the cooperation between the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for Protection against Health Risks (COFEPRIS) to avoid the granting of marketing authorizations for allopathic drugs which may infringe any in-force patent.
This linkage system was issued on September 19, 2003. It is established in articles 167 bis of the Health Supplies Regulations and article 47 bis of the Industrial Property Regulations which state the system procedure.
Authorization for an allopathic drug
Allopathic drugs are defined in article 224 of the Mexican Health Law as natural or synthetic substances having therapeutic, preventive or rehabilitative effects, which may be identified by their pharmacological activity, physical, chemical or biological characteristics and are presented in a pharmaceutical form.
Whenever a marketing authorization application for an allopathic drug is submitted to COFEPRIS, the applicant is required to either submit the documents which demonstrate that owns the patent or patents related to the active pharmaceutical ingredient (API), possess the corresponding license, both registered at the IMPI, or, according to the Mexican Linkage Gazette, declare under oath that it complies with the provisions applicable in patent matters.
In the case of the latter, COFEPRIS will request IMPI to confirm this statement. COFEPRIS will file a form detailing the following information about the marketing authorization application and deliver it to IMPI:
- Applicant of the marketing authorization
- Name of the API, salts as APIs or International Nonproprietary Name
- Chemical name according to the International Union of Pure and Applied Chemistry
- Structural formula of the API
- Pharmaceutical formulation, API and excipients
- Dosage form
- Therapeutic indications
- Drug presentations
- Drug characteristics
- Any additional information submitted by the applicant
The above information is considered confidential, thus only COFEPRIS and IMPI are aware of its contents.
Based on the information received, IMPI will have ten business days to confirm whether an in-force patent may be infringed. If no patent is found to be infringed, the marketing authorization application will comply with this administrative requirement and follow its normal procedure. Otherwise, IMPI will notify COFEPRIS which in turn will notify the applicant of the possible infringement. COFEPRIS will request the applicant to submit the corresponding license and if the applicant fails to do so the marketing authorization will be denied.
Mexican Linkage Gazzete
Regarding the Mexican Linkage Gazette, this document is published semi-annually by IMPI and its purpose lies in keeping a record of the in-force Mexican patents associated with specific APIs.
Patents listed in the Mexican Linkage Gazette include those of composition of matter, formulations, medical uses or combination thereof. These are listed automatically by the IMPI whenever a patent is granted. Alternatively, patent owners may also request the Mexican PTO to include a certain patent in the Gazette. Lastly, patents related to processes or methods of producing the drugs are expressly excluded from being published in the Mexican Linkage Gazette.
Mexican Patent Linkage System is limited to cases related to IMPI and COFEPRIS involving potential patent litigation between patent owners and applicants submitting new marketing authorizations. It was designed to avoid unnecessary litigation from these private parties, thus Its current design does not allow the direct participation of the patent owners or applicants of new marketing authorizations.
Patent owners may participate indirectly through ensuring its most relevant patents are listed in the Mexican Linkage Gazette. On the other hand, applicants of new marketing authorizations may submit additional information to argue its product does not infringe the patents listed in the Mexican Linkage Gazette.
Given the limited participation from the parties in the current Patent Linkage System so far, patent owners have resorted to filing patent infringement procedures to prohibit the production and commercialization of the infringing products while applicants of new marketing authorizations have resorted to nullity actions over patents. Both procedures are handled by the IMPI and its ruling may be appealed before the Federal Court of Administrative Justice, which, in turn, may be appealed before the Collegiate Courts.
Overall, in our opinion, the Mexican Linkage System remains imperfect as it could benefit from increasing the transparency of the procedure to both parties, patent owners and applicants of new marketing authorizations.
Source: www.gob.mx/impiRead More
Agreement between Mexico and EPO
Memorandum of Understanding (MoU) – Reinforced Partnership
The EPO has signed a Memorandum of Understanding (MoU) on Reinforced Partnership with the Mexican Institute of Industrial Property (IMPI), further strengthening the longstanding co-operation between Europe and Mexico in the area of patents. The MoU was signed on 4 November 2019 in Mexico City by EPO President António Campinos and IMPI Director General Juan Lozano.
“Mexico is a very important partner for us, and our offices have already worked together to support innovation for 25 years” said EPO President Campinos. “Through our joint projects on the Cooperative Patent Classification, the EPO’s online patent search tool EPOQUE Net, comprehensive data exchange and judicial training we have brought our patenting procedures and work more closely in line. We are now entering a new phase in our co-operation, extending it to more strategic areas, with a view to making our patent systems as efficient, user-friendly and relevant as possible for innovators in both regions.”
The IMPI Director General Juan Lozano underlined the importance of the strategic alliance with the EPO to enhance the use of Mexican resources dedicated to the examination of national patents, as well as to accelerate applications previously examined by EPO, issuing “more patents, faster, as well as reducing the backlog”.
He said that the MoU will promote the exchange of information and good practices, and the Institute will be able to benefit from training, certification, tools and technical support provided by the EPO in a framework of collaboration.
Through the Reinforced Partnership, the EPO and IMPI will join forces to develop a number of activities aimed at increasing efficiency, timeliness and quality of the patent grant process with a view to promoting investment and technology transfer between Europe and Mexico. The EPO will support IMPI in strengthening search and examination in fast-growing and emerging technology fields such as the Internet of Things (IoT) and Industry 4.0. At the same time, IMPI will make effective use of EPO work products, tools and standards to ensure a high quality, timely and efficient examination of both national first and second filings.
According to figures from the World Bank and the European Commission, Mexico is the 11th largest economy in the world (EUR 2.2 trillion) with a strong focus on manufacturing and a population of almost 130 million. The country has strong macroeconomic institutions, and is open to trade and private investment. The EU is Mexico’s second-biggest export market after the United States.
Source: www.epo.orgRead More
Through the Madrid Protocol any national from a signatory country can file a trademark application through the World IP Office designating one or various other signatory countries, obtaining the registration of their mark in several countries with just one application. This saves time and money for the applicant.
In Latin America, Brazil, Colombia, Cuba and Mexico are signatories of the Madrid Protocol. Brazil will start implementing the Protocol in October 2019, and it will be possible to designate this country through WIPO.
However, this poses some risks. Most times, the application is filed designating several countries without the recommended prior registrability and availability search reports, increasing the risks of provisional refusals from the national trademark offices.
When an applicant designates a country, a formal study of the mark is conducted, and sent to each of the national trademark offices designated, who also study the application. The national examination studies the intrinsic registrability of a mark, as well as the prior marks, in search for any absolute or relative grounds for rejection.
In case any are found, a provisional refusal is issued and served to the applicant through WIPO, and given a term to reply to it, including whichever argumentation, agreements and limitations the applicant may deem sufficient to overcome the objection.
Unfortunately, due to a recent amendment to WIPO regulations, any limitation or clarification to the applications must be made through WIPO, and not directly before the national Offices. As a result, the reply to the objection would require a higher expense, both in time and money.
In light of an amendment to the Mexican Trademarks Law, which came into effect last August 2018, coexistence agreements are now binding for the Examiners, as long as the trademarks are not identical. If the owners of the marks consider that there is no risk of confusion in case of coexistence, the IP Office is compelled to admit said coexistence.
Despite the fact that registering trademarks through the Madrid Protocol is indeed a simpler procedure, the implications and possible consequences of this must be taken in consideration, and the necessary preventive measures (availability searches, possible negative connotations of words or designs, negotiations, agreements, limitations in scopes of protection) should be undertaken.
Lastly, it must be mentioned that, despite the simpler application procedure, Madrid Protocol designations tend to be longer procedures, as there is an international and a national stage, whereas national applications just have the latter.
All in all, designations of international registrations through Madrid Protocol are really useful, and they do simplify the registration procedure for applicants that want to protect their brands worldwide, but the national consequences must be taken in consideration. The professional advice of an IP expert in the region is always recommended in order to avoid conflict and dilations.
Source: www.inpi.gov.br/Read More
Protection of personal data is an issue that has gained relevance in the last year in all parts of the world. An example of this phenomenon is the implementation of the General Regulation of Personal Data (GDPR) in the European Union in 2018 or the new laws, modifications to the current ones or judicial decisions on the matter, that Latin American countries began to implement to be in accordance with the community regulations.
In this respect, in a recent judicial ruling, the Supreme Court of Justice of the Nation of Mexico (SCJN) analyzed the pertinent period to keep personal data within the Law for the Protection of Personal Data in Possession of Obligated Subjects of the State of Guerrero and determined the invalidity of a portion of the regulations since it established generic terms for the preservation of personal data.
In this sense, the Court understood that this generic term was in violation of the right to the protection of these data, since the treatment of them requires individualization in each specific case, so to decide what deadlines to apply should be attended to the applicable provisions in the matter in question.
As a result of the aforementioned resolution, the Supreme Court ordered the Institute of Transparency, Access to Information and Protection of Personal Data of the state of Guerrero to issue, within 90 days, the guidelines to which the general law of the corresponding subject refers. Finally, it is important to note that this decision was applied to other states such as Jalisco, Michoacán and Sinaloa, in which the Institute of Transparency, Public Information and Protection of Personal Data was notified to adapt its regulations to this criterion, since it was improperly extended the term to one year, in the local law.
Source: www.elpuntocritico.comRead More
by Marta García
On November 30, 2018, a new trade agreement called the United States-Mexico-Canada Agreement (USMCA) was signed by United States President Donald Trump, Mexican former President Enrique Peña Nieto, and Canadian Prime Minister Justin Trudeau, during the 2018 G20 Summit in Buenos Aires.
The agreement, which must still be ratified by each party, is also unofficially known as “NAFTA 2.0”, since it is intended to replace the North American Free Trade Agreement (NAFTA) currently in force.
The text of the USMCA, which was published on the Office of the United States Trade Representative website shortly after the formal agreement was announced on October 1, 2018, includes an extensive chapter on Intellectual Property covering standards concerning trademarks, geographical indications, patents and undisclosed tests, industrial designs, copyright and related rights, trade secrets, as well as a section regarding IPR enforcement.
Below is an analysis of some key provisions of the USMCA´s patents and data protection chapter, and their implication for the Mexican IP system after the agreement comes into force.
Non-confidentiality of patent files
Article 20.43 of the USMCA establishes that for published patent applications and granted patents, each party shall make available to the public: search and examination results, non-confidential communications from applicants, and patent and non-patent related literature citations submitted by applicants and relevant third parties.
Nonetheless, Mexico already complies with the above provision, since the new IP Law in force since August 2018 establishes that all patent files must be available for public inspection as soon as they are published. Before the enactment of the new IP law, all patent prosecution files were kept confidential until grant.
Currently, voluntary claim amendments can be filed at any time during patent prosecution, as long as they do not broaden the scope of the application as filed. However, granted patents may only be amended by the patent owner in the following circumstances: a) to correct obvious or form errors, and b) to limit the scope of the claims. Therefore, at the moment no claim amendments, other than those aimed at limiting the claims, are possible when the Mexican PTO (IMPI) finds patentable an invention as originally claimed and a notice of allowance is directly issued.
Article 20.42 of the USMCA establishes that each party shall provide a patent applicant with at least one opportunity to make amendments, corrections, and observations in connection with its application. Hence, the USMCA’s implementation will require that Mexico changes its provisions on claim amendments of granted patents.
Article 20.36 of the USMCA on patentable subject matter establishes that patents must be available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.
Although in practice Mexico already allows novel uses of known compounds, currently there are no legal provisions that specifically regulate these inventions, which will be likely to change as a result of the USMCA.
Patent term adjustment
The patent term extension provisions of the USMCA provide for an adjustment to a patent term due to: (i) unreasonable delays owing to the patent granting authority, and (ii) unreasonable curtailment of the patent term as a result of the regulatory or marketing approval process for pharmaceutical products.
Mexican law does not currently provide for patent term adjustment neither for unreasonable delays in the issuance of a patent by the IMPI nor for unreasonable delays during the marketing approval for pharma products by the regulatory authority (COFEPRIS). Therefore, amendments to the IP and Health laws will be required in order to implement the USMCA provisions regarding patent term adjustments.
At this time there is no indication of which duration the patent term extensions will have. However, regarding patent term adjustment for delays in the granting of a patent, it should be noted that currently the maximum processing time from patent filing to grant in Mexico is on average 5 years. Therefore, very few requests for patent term extension for delays in the granting of a patent are expected to be filed in Mexico.
Current data protection regime
Mexican law is silent with regard to data exclusivity. However, in 2012 COFEPRIS published an internal decree that provided a 5 year-term of data protection for new chemical entities only. Accordingly, Mexico is currently granting five-year protection periods for new chemicals. However, the legal value of the decree is uncertain.
Additionally, the internal guidelines do not apply to biological medicinal products and new indications.
Under the USMCA, Mexico has agreed to extend the term for data protection of new agricultural chemical products, new pharmaceutical products, new indications and biologics as follows:
Data protection exclusivity for new agricultural chemical products under the USMCA
The USMCA prohibits generic manufacturers from referencing undisclosed test or other data concerning safety and efficacy of “new agricultural chemical products” for at least ten years from the date marketing approval was first granted.
A “new agricultural chemical product” is defined in the text of the USMCA as one that “contains a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.”
Data protection exclusivity for biologics under the USMCA
The USMCA establishes that parties should not permit generic manufacturers referencing undisclosed test or other data concerning safety and efficacy of new pharmaceutical products that contain a “biologic” for at least ten years from the date marketing approval was first granted.
A biologic is defined in the text of the USMCA as a product that, at minimum, is “produced using biotechnology processes and that is, or, alternatively, contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, for use in human beings for the prevention, treatment, or cure of a disease or condition.”
Data protection exclusivity for new and previously approved pharmaceutical products under the USMCA – Non-biologics
The USMCA prohibits generic manufacturers from referencing undisclosed test or other data concerning safety and efficacy of “new pharmaceutical products” for at least five years from the date marketing approval was first granted.
A “new pharmaceutical product” is defined in the text of the USMCA as “a pharmaceutical product that does not contain a chemical entity that has been previously approved in that Party.”
The USMCA also establishes at least three years of data protection for new clinical information submitted for a previously approved pharmaceutical product covering a new indication, formulation, or method of administration.
The USMCA has not yet come into force, and it will still have to be ratified by each party. From the date of entry into force of the USMCA, Mexico will have four and a half years to implement its obligations with respect to the patent term adjustment for unreasonable curtailment and five years to implement its obligations with respect to data protection.
Source: https://ustr.govRead More
We live in a dynamic reality, and in no area is that more evident than in commercial law, which constantly adapts to the new practices and requirements of an ever-changing world market.
With the backdrop of the globalized marketplace in mind, the Mexican Government has recently approved a series of amendments to the IP Law, which will be effective as of August 10, 2018. There are several amendments in relation to trademarks that will change how we are used to working in this country: The very definition of what a trademark is has changed, and although the essence is still the same, it can now be constituted by any sign perceived by the senses that may identify or define a product or service. The text now allows for the registration of holographic signs, sounds and smells, which were previously barred from registration. Trade dress and certification mark registrations are also included in the new text.
A new requirement has been included, as a declaration of effective use will have to be filed during the third year of registration. If this is not done, the registration will expire. No extension is possible. This also applies for renewals: In order to renew a registration the use in at least one of the protected products in that registration will have to be declared.
It is important to highlight that only the registrations granted after the effective date of these amendments will be held to the obligation of filing a Declaration of Use.
Date of first use is required in the application. Failing or neglecting to do so will be considered as a declaration of no prior use. This cannot be amended.
Perhaps one of the most relevant amendments is the fact that Consent Letters or Co-Existence Agreements will now be binding for the Examiners in cases of likelihood of confusion, even if the resemblance between the marks is very high. Although a bold move, we have yet to see how it is enacted.
Finally, a completely new relevance has been given to the concept of “bad faith,” allowing for objections and oppositions to applications based on the bad faith of the applicant. The amendments also include a revision of the grounds for cancellation of a mark based on bad faith, when there has been a commercial relation between the parties.
These are only some of the amendments included in the new legislation, which is not yet effective, and a Regulation for this new Law is still pending. Therefore, how it will be enacted and applied is yet to be seen. However, it is useful to have this in sight, in order to prepare clients for the new scenario.
Source: http://dof.gob.mx/Read More
The Mexican Senate approved on Thursday, April 26, 2018, an amendment to the Federal Law of Copyright that would possibly affect the right to freedom of expression on the Internet. There was no prior discussion in commissions and without respecting the legislative process by 63 votes in favor, 11 against and 23 abstentions.
The aforementioned amendment adds “Article 213 Bis” to the Federal Copyright Law and attaches a paragraph to “Article 215” of the same law. These modifications would allow judges to dictate measures to “suspend public representation, communication and/or execution” and for “the precautionary assurance of the instruments used in public representation, communication or execution” in order to prevent violations of the rights of author.
Regarding these modifications, Luis Fernando García, Director of the Network in Defense of Digital Rights (R3D), reported that the figure of “precautionary measures” is introduced to the head of the courts when there is only suspicion or risk of a violation of copyrights. This would imply that any court will have the power to order that a public communication, for example a video on the Internet, be censored or that servers, routers or other instruments used in its dissemination be inspected without having been previously proven in a trial that such communication violates copyright.
However, it should be noted that the amendment also determines that before making a judicial request, the copyright holder must give notice to the infringers of his/her rights.
Undoubtedly, these modifications put the confrontation of two rights of equal importance in the discussion focus. On one hand, the right of every author to defend his/her moral interests as patrimonial to be affected by a third party, and, on the other hand, the right to freedom of expression, in this case on the Internet, which allows the free flow of information without borders. Due to the advancement of technology, both rights are in a constant tension and a fair solution for both parties has yet to be developed.
On March 13, 2018, the Mexican government and the Mexican Patent and Trademark Office (IMPI) made amendments to the Mexican Industrial Property Law. These changes affect specifically the publication of utility model and industrial design applications, the definition of independent creation and significative degree concepts, the extension term of industrial designs and the shortened time period for third party pre-issuance patent submissions.
These amendments will go into effect beginning April 13, 2018 and a detailed description is below.
Publishing of Utility Model and Industrial Design applications
Under the current law only patent applications are published in the Official Gazette. Once formal requirements are duly fulfilled (Articles 30 BIS and 37 BIS) Utility model applications and design applications will also be published in the Official Gazette as soon as possible. Granted utility models, industrial designs and patents will continue to be published as before.
Definition of Independent creation and significative degree concepts
Article 31 of the current Law defines as registrable designs that are new and susceptible to industrial applicability. On the hand, the same article defines as new the designs that are created independently the known designs or combinations of known features of designs, and which differ significantly therefrom. The amendment introduced a new Article 32 BIS defining independent creation and significative degree.
Independent creation is considered when no other identical industrial design has been made public before the filing date of the design application, or before the recognized priority date.
Significative degree is defined as the general impression produced by the industrial design to a person skilled in the art and that differs from the general impression produced by another industrial design, which has been made public before the filing date of the design application, or before the recognized priority date.
Restriction of Industrial design scope of protection
Article 33 was amended to specify that the drawings must be sufficiently clear for the comprehension of the design and its publication. The second section of this article was amended to require the identity of the product for which the design will be used, and deleting the previous requirement for the genre of the product. Considering the scope of the protection is defined both by the description and the drawings this amendment would appear to be aimed to restrict the scope of protection.
Extension of Term of Industrial Designs
The protection term for an industrial design (Article 36) is established for 5 years. It is renewable every 5 years up to 25 years, calculated from the filing date.
Both industrial design registrations and the renewal thereof will be published in the Gazette.
Renewal of Industrial Designs
According to Article 36 BIS, the industrial design renewal shall be requested by the owner within 6 months prior to the expiration of its term. However, the Mexican Institute will accept those requests filed within the grace period (6 months) contemplated by Article 80, section II of this Law.
Period Shortening of Third party pre-issuance patent submissions
The term for the third party pre-issuance patent submissions has been reduced from 6 to 2 months, in accordance to Article 52 BIS.
Official files open for to public after publication of the application
Once the corresponding application is published in the Official Gazette, the official files for pending utility model, industrial design and patent applications will be open for public inspection. Under the current law the files were considered confidential until the resulting patent was published in the Official Gazette (Article 186).
Industrial design registrations granted before the effective date of the amendment will maintain the original term of 15 years and will be subject to the payment of annuities (paid every 5 years), however, the same may be renewed by two five-year successive periods up to a total term of 25 years from the filing date. The first renewal must be requested within 6 months prior to the expiration of the original 15 year term.
Applicants may opt to prosecute pending design applications under the provisions of the amended Law. To this effect, applicant must file a request with the Mexican Institute within 30 working days from the effective date of the amendment (deadline: May 25, 2018).
By Moeller IP Advisors
A recent report by the WIPO placed Mexico among the first 15 countries for the number of patents granted per year.
According to the last data available, in 2016, the Mexican Intellectual Property Office (IMPI) received 17413 applications and granted 8652 patents.
The average pendency time for a first office action is only 3 months, while a final decision is provided, on average, in 36 months.
The pendency time depends on the quality of the application which should be complete, clear and concise; and on the complexity of the claim, which may require longer evaluations.
In order to further increase the speed of the process, the IMPI has signed several Patent Prosecution Highway programs with foreign patent offices. Notably, since 2011, PPH has been signed with the USA, Japan, Spain, Korea, Singapore, China, Canada, Portugal, the European Patent Office, Austria and with the other members of the Pacific Alliance – Colombia, Chile and Peru.
Through a PPH, when an applicant receives a final ruling from a first patent office saying that at least one claim is allowed, the applicant may request a fast-track examination of the corresponding claims to the second patent office.
This can eliminate any unnecessary overlapping, avoiding that the same claim is analyzed twice.
So far the most successful PPH seems to be the one signed with the US – as the pilot program which started in 2011 has been renewed in 2013. In 2016, 20% of applications before the IMPI were filed from non-residents, of which 36% were US applicants. The PPH signed with the EPO, the Japanese Patent Office and the Canadian Patent Office also proved to be particularly popular.
In order to benefit from a PPH, the applicant should make sure that the claims requested in the application, substantially correspond to the claims that had been granted by the office of first filing, that is, they are of the same or similar scope as the claims indicated as patentable/allowable in the office of first filing. It is not possible to benefit from the PPH if the second office has already started the substantial examination of the claim. The applicant should also provide a copy of all the official actions relevant to the patentability issued by the office of first filing.
Finally, the applicant should submit a claims correspondence table, which indicates how the claims in the second application sufficiently correspond to the claims determined to be patentable by the office of first filing. Design applications and utility models are excluded from the PPH.
PPH proved to be particularly useful for industries which are highly innovative and for which it is critical to obtain patent coverage in a short time frame, like mechatronics, biotech and pharmaceuticals.
Some matters, however, may not be deemed as worthy of protection by both offices. For instance, while the US Patent Office would grant patents to treatments, surgical or diagnostic methods, IMPI would not, as, under Mexican Industrial Property Law, those are not considered as inventions.Read More
By Moeller IP Advisors
Gene therapy is a pioneering medical technique which consists in introducing genes or other genetic materials into a patient’s cells for therapeutic purposes. Genes are inserted to correct or replace abnormal or mutated genes into the patient’s body. Gene therapy has been developed to cure hereditary genetic conditions but late discoveries seem to give partial evidence that this technique could also have a promising role in treating acquired conditions like cancer.
However, since gene therapy is an extremely innovative technique, in its early stages, the legal framework has to effectively keep up with it, especially in developing countries like Mexico.
Patentability Issues in Mexico for Gene Therapy Treatments
It is clear that protecting the creation of gene therapy techniques can become pivotal for allowing the development of these treatments. Is gene therapy currently protected under Mexican Intellectual Property Laws?
Most of the time, gene therapy involves a surgical procedure for inserting the genetic materials into the patient’s body. This is particularly critical: indeed, it is well-known that Mexican Industrial Property law, in line with many other IP laws in South America, does not allow the patentability of medical methods.
Article 19 of the section 7 of the Ley de propiedad industrial establishes that “surgical, therapeutic and diagnostic treatment methods for the treatment of the human body and those related to animals” are not to be considered inventions.
This is particularly important. While gene therapies do not only involve innovative procedures, but also tangible components like modified cells or other materials, it is undeniable that the surgical method assumes a central role. Until the patentability is denied to the method, the whole therapy cannot be effectively protected by IP law in Mexico.
Legal Issues related to Health Safety of Gene Therapy Techniques in Mexico
Another criticality arises when the necessary health safety assessment comes into play. Indeed, although gene therapies can be considered as extremely promising techniques, they are still in most cases carried out under experimental conditions. To date, gene therapy has failed to prove its effectiveness in the totality of examined cases and its safety for use is also under scrutiny.
Moreover, the legal criteria for evaluating the safety and effectiveness of this new technique are still not properly defined in Mexico. Indeed, the Mexican General Health Law establishes that healthcare providers must be licensed and authorised by Cofepris, the Federal Commission for the Prevention of Health Risks, before they start experimental medical procedures.
But specific safety guidelines that the Cofepris can follow for granting approval to gene therapies currently do not exist.
The most immediate consequences of such an unclear legal framework is that, on the one hand, pharmaceutical and research companies are not encouraged to settle and invest in Mexico; on the other hand, the unclarity in the legal regime has created a panorama of clinics and providers that perform experimental treatments with little or no evaluation of the health risks by the competent authorities. Given its proximity to the US, Mexico could benefit from a flux of investments, companies, and, last but not least, patients – motivated by the relatively lower costs of the infrastructure and the personnel. However, the normative gap needs to be filled as soon as possible.Read More