By Moeller IP Advisors
In the last years, Mexico has been facing a rise in health issues connected to poor diet and drinking habits. According to the National Health and Nutrition Survey 2006, hypertension increased of 25% in the previous six years, while data from the OECD shows that in 2015 a whopping 30% of the adult population was obese. According to a research by the WHO, diabetes was the leading cause of death in Mexico in 2016: the population that died to diabetes has tripled since 1990, and by 2050, it is predicted that half of Mexicans will suffer from the disease. Finally, the WHO also shows that alcohol consumption appears to have been on the rise in the last 40 years – leading to an increase in alcoholism and related diseases.
The Ministry of Health has been trying to reduce the impact of nutrition-related chronic diseases by enacting a complex legal framework to ensure that consumers receive transparent information in connection with the sale of food and beverages.
The regulatory efforts have been especially focused on regulating the information contained in advertising and products labels.
The Standard Rule for Food and Non-Alcoholic Beverages
In 2014, the Federal Commission for Protection against Health Risks (COFEPRIS) amended the Mexican Official Standard Rule NOM-051-SCF/SSA1-2010 for Food and Non-Alcoholic Beverages (NOM-051). NOM 051 dictated the labeling requirements for food, non-alcoholic beverages and other pre-packed products that are imported, manufactured and sold in Mexico. In an effort to improve the quality of the information displayed to consumers, the amendments established stricter requirements for the producers, detailing how additional information, like nutrition facts, should be displayed on labels.
However, the new rules proved to be extremely complex and difficult to implement for companies, due to an unclear and ambiguous wording of the Standards. COFEPRIS and the Federal Bureau for Consumer Protection (PROFECO), in charge of verifying compliance with the new regulation, soon realized that for many companies, a total conformity with the standards was extremely difficult to achieve. In 2016, COFEPRIS assessed that more than 75% of the companies had failed to fully comply with the NOM-051.
The New Copy Advice System
With regard to alcoholic beverages labelling and advertising, in 2011 COFEPRIS had already implemented successfully the so-called Copy Advice System.
In May 2016 the system has been extended to food and soft drinks. Under the Copy Advice System, COFEPRIS will provide assistance to companies, helping them understand and implement the legal requirements of the NOM-51. Moreover, with regard to advertising, COFEPRIS will provide a pre-analysis on the advertisements drafts – before companies apply for the required formal authorization.
Although the advice provided by COFEPRIS is nonbinding, the experience with the Copy Advice System for alcoholic beverages has proved to be particularly successful to improve compliance and ultimately avoid fines. In the last 6 years, COFEPRIS and the companies involved have worked together to develop uniform, practical guidelines on the implementation of alcoholic drinks labelling and advertising regulations. This is definitely to be taken as a promising indicator for the success of the Copy Advice System on food and non-alcoholic beverages requirements, reducing the sanctions, the costs for the companies and speeding up the procedures. In particular, COFEPRIS estimates that the Copy Advice system will reduce the response time for obtaining an advertising authorization from 40 to 5 working days.Read More
by Moeller IP Advisors
In the prestigious Bloomberg’s 2017 Innovation Index published last year, Mexico failed to rank among the first 50 top countries. Brazil and Argentina ranked respectively 46th and 49th.
The index is developed on the basis of benchmarks that include spending on research and development, manufacturing, the presence of hi-tech companies and of course, the number of patents filed in the country within the year. From a legal point of view, this last aspect is particularly worth analyzing.
Patents filed in Mexico and the role of Patent Prosecution Highways
In the period 2011-2015, 79019 patent applications were filed, according to data released by the IMPI, the Mexican Intellectual Property Institute. Only around 8% of all the patent applications came from Mexican applicants, a number that is particularly striking if compared with China, where 85% of the applications in the country are filed by Chinese applicants.
In practice, in Mexico, there was one patent application per 100,000 inhabitants per year, while in China there was an average of 50 applications per 100,000 inhabitants per year.
Patent applications in Mexico come especially from public educational and research centres like the UNAM – the National Autonomous University of Mexico, the CINVESTAV – the Center for Research and Advanced Studies of the National Polytechnic Institute and the UAEH – the Autonomous University of the State of Hidalgo. These entities are usually interested in licensing their patents to foreign companies.
There are, however, examples of successful Mexican private companies, like the pharma company Laboratorios Senosiain or Laboratorios Silanes, that have developed a treatment for venomous snake bites, entering the U.S. market this year.
As said, the vast majority of patent applications in Mexico come from foreign applicants, especially Norway, Turkey, Canada and United States residents. This is certainly an indicator of the interest of foreign companies in the Mexican market, triggered by the lower cost of labour, the good infrastructure and the interest toward pharmaceuticals and biotechnology, two areas that have seen several legal developments in the latest years.
WIPO World Intellectual Property report 2017 showed that IMPI is still one of the slowest offices to issue a final decision on a patent application, with an average of 3 years. For this reason, Mexico has heavily relied on Patent Prosecution Highway procedures to speed up the analysis and filing of patent applications that have been previously filed in another country.
As of 2017, Mexico had 11 Patent Prosecution Highways with foreign entities, namely the US, Japan, Spain, South Korea, Singapore, China, Canada, Portugal, Austria, the European Patent Office and the Pacific Alliance.
Since 2011 (the year in which the first agreement with the USPTO was signed) by 2016, the Mexican patent office has received 1188 PPH applications, of which 785 have already been granted.
Patents filed by Mexican companies abroad
However, the country suffers from a low innovation potential that mirrors in the number of patents filed by Mexican residents abroad. In 2015, patents received by Mexican companies in front of the USPTO were only 172. As a comparison, South Korean residents filed 17924 patents the same year and Chinese residents 8116.
To trigger innovation, the Mexican President Enrique Pena Nieto has declared he intends to increase the government’s funding of science to 1 percent of GDP by the end of his term in 2018.Read More
By Moeller IP Advisors
Cannabis is the preferred designation of the plant Cannabis sativa and Cannabis indica. The plant has a relatively long history of medical use, as it was already included in the US Pharmacopeia in 1850 for its sedative and anticonvulsant effects. In 1932 cannabis was removed from the British Pharmacopeia and in 1941 from the US Pharmacopeia as it was replaced by pure chemical compounds that could be prescribed at known and reliable doses. More recently the effects of the cannabis have been debated for treating symptoms of debilitating chronic diseases and chronic pain and its use for medical purposes has come back under the spotlight. As of today, several countries, among which Austria, Belgium, Canada, Chile, Colombia, the Czech Republic, Finland, Israel, Netherlands, Spain and 29 States of the US legally allowed the medical use of cannabis. Mexico has legalised medical cannabis in June 2017.
The Legal Panorama in Mexico
At the end of 2015, the Mexican Supreme Court had already debated on the use of cannabis for therapeutic purposes. An NGO had filed a request to the Cofepris, the Mexican Commission for Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios). The request aimed at receiving an authorization to plant, cultivate, prepare, possess and transport cannabis for personal use, but Cofepris had denied the authorization. The Supreme Court established that there was a minor health risk associated with cannabis and ordered Cofepris to issue the corresponding authorization but only for non-commercial use. Similarly, at the end of 2015, a District Court ordered Cofepris to approve the import and personal use of a drug containing cannabis to a patient who suffered epileptic seizures.
More recently, in February 2016, Cofepris authorized imports of a drug produced by the Californian company Medical Marijuana Inc. for the specific use in two patients, in both cases young epilepsy sufferers.
Following a heated debate, the Mexican Senate and Lower House of Congress approved a bill legalizing the use of cannabis for medical purposes. As a consequence of that, on June 19, 2017, the President of Mexico issued a decree that amended some provisions of the General Health Law and legalised the therapeutical use of cannabis. At article 235-bis the Decree stated that “The Ministry of Health shall design and implement public policies regulating the medicinal use of pharmacological derivatives of cannabis sativa, indica and cannabis or marijuana, including tetrahydrocannabinol, its isomers and stereochemical variants, as well as how to regulate the research and national production of them.”
The Ministry of Health will have 180 days to implement the decree and harmonise regulations on the topic.
Opportunities for a growing sector
According to many sources, the decree opens the door to external investments as many companies in the medical cannabis business may consider the opportunity to expand to Mexico.
Stuart Titus, Medical Marijuana’s chief executive, said Mexico represents a “$1 billion to $2 billion opportunity” in terms of revenues in the next 10 years.
On April 28, 2016, the Joint Ordinary General Assembly for Medical Devices took place in Mexico D.F. organized by the Mexican Pharmaceutical Industry Chamber (CANIFARMA). At this meeting, the medical device market was strengthened between the countries of the Pacific Alliance (Colombia, Chile, Peru and Mexico). It should be emphasized that this regional bloc represents the ninth largest economy in the world.
Representatives of the medical device industry created closer ties between the nations to enhance opportunities in this sector and ensure access to the best health technologies for patients. The main objective is to develop a regulatory framework in order to operate as a single market, to facilitate trade exchange and to increase the leadership position in the production of medical devices by means of the Pacific Alliance.
Medical devices, also called health products, can range from a latex glove (healing material), whitening toothpaste (dental input), ultrasound equipment (medical equipment) to implants (functional support). They are used to prevent, diagnose or substitute the function of any part of the body. In Mexico, these devices have to comply with a sanitary registration in order to be manufactured, distributed, sold or used, as it is the case for several countries around the world. This registration is the authorization granted by the Mexican Federal Government once the applicant has demonstrated through documented evidence that the product is safe, effective and of quality. Since 2005, these registrations are valid for five years and may be renewed in compliance with the provisions established by the Mexican Ministry of Health.
The sanitary recordal can be revoked and revised according to the General Health Law established in the Regulation of Health Products in which legal, administrative and technical information is included, in accordance with the procedure that is to be performed (new sanitary registration, modifications and/or renewal).
The medical device industry has become an engine of the Mexican economy and Mexico is the largest exporter of medical technologies in Latin America.
The Mexican Health Authority (COFEPRIS) has recently signed joint declarations with Germany and Denmark to promote and strengthen the cooperation and exchange of good practices regarding health risks.
Regarding the agreement with the Danish Health Authority (DMA), the Federal Commissioner of COFEPRIS, Julio Sánchez y Tépoz, stated that “the agreement will allow the exchange of information in the field of healthcare products, including drugs, raw materials for pharmaceutical use, biological products and medical devices.”
COFEPRIS and the German Health Authority (BfArM) agreed about the exchange of information regarding the drugs and medical devices regulations, including policies, guidelines, practices, laboratory analysis, marketing authorizations and drug surveillance.
Source: http://www.cofepris.gob.mxRead More
The head of the Federal Commission for Protection against Health Risks (“Comisionado Federal para la Protección contra Riesgos Sanitarios”), Julio Sanchez y Tépoz, met with a delegation of Korean government representatives to help strengthen the communication and cooperation between both countries and improve the quality, technology, and effectiveness of healthcare consumables.
“The relationship between South Korea and Mexico, regarding regulation of health has strengthened significantly in recent years, and thus have improved our regulatory systems to successfully meet the growing need for quality and efficacy concerning drugs and medical devices,” stated Sanchez y Tépoz.
The three priority areas for improvement are: effective access, quality service and prevention. In order to achieve the objectives in this field, a comprehensive strategy based on five basic principles and fifteen actions contained in the COFEPRIS program 5/15 is being implemented.
Source: www.cofepris.gov.mxRead More
In February 2016, Mexico updated its regulations 059 and 164 regarding the Good Manufacturing Practices (GMP) of drugs and active pharmaceutical products with the goal of joining the Pharmaceutical Inspection Cooperation Scheme (PICS).
The GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The PICS is an international instrument between countries and pharmaceutical inspection authorities to support the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.
The Mexican Health Authority (COFEPRIS) plans to join PICS later in 2016, after amendment of its GMP regulations and the evaluation of its quality management system by experts from Spain, Italy, U.S.A. and Germany.
The inclusion of Mexico to the PICS program will strengthen its international cooperation mechanisms regarding inspections, promote the exchange of information and implement the best international practices for the manufacture of pharmaceutical products.
The Argentinian National Administration of Drugs, Foods and Medical Devices (ANMAT) is the only Latin American health authority that is currently part of PICS.
During the first Medical Devices Congress “Eyesforpharma Latin America 2015,” the Federal Commissioner of the Mexican Health Authority (COFEPRIS) Mikel Arriola announced that in 2016 Mexico will seek the World Health Organization (WHO) certification for medical devices. COFEPRIS has already this certification for drugs and vaccines.
The main objective of the WHO certification is to facilitate international trade in medical devices between member states, ensuring safety and performance.
Arriola also presented figures regarding the seizure of illegal medical devices in Mexico during the last three years: 2.3 million items were seized in 32 operations across eight Mexican states.
Source: http://www.cofepris.gob.mxRead More
A list of 2,242 deregulated low-health risk medical devices and products that are no longer considered to be health consumables has been generated since September 2, 2015. These devices will no longer require the submission of a health registration or import permit to Mexican customs.
The two-step deregulation process started in 2012 with a first deregulation of 1,669 medical devices and consumables, followed by further 573 deregulations at the beginning of this year. The process is part of the regulatory improvement and administrative modernization policy implemented by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS).
Deregulated products comprise diagnosis agents, hygienic products, first aid products, dental consumables, acupuncture patches and lenses, among others.
Click here to access the list of 2,242 deregulated products and consumables.Read More
The Federal Commissioner of the Mexican Health Authority (COFEPRIS) Mikel Arriola has recently announced that Mexico has become the most competitive Latin American country regarding the approval times for clinic research protocols for new drugs, which have been reduced from three to one month.
This time reduction has been possible due to the collaboration of COFEPRIS with universities, national health institutes and clinical research centers that are authorized as third parties to carry out the assessments.
In August 2015, COFEPRIS signed a collaboration agreement with the Autonomous University of Nuevo León (UANL), which is the first public state university to be authorized for the evaluation of clinic research protocols. UNAL has joined 13 other authorized third parties collaborating with COFEPRIS.
Arriola stated that speeding protocols is expected to increase pharmaceutical industry investment in Mexico.
Source: http://www.cofepris.gob.mxRead More