Julio Sánchez
Federal Commission for the Protection Against Sanitary Risks
View from the Top

Technical Authority Based on Scientific Analysis

Wed, 09/07/2016 - 09:34

Q: How has the current administration contributed and followed up with existing policies, while creating complementary regulations to increase efficiency?

A: Mikel Arriola’s contributions to Mexico’s health policies have tremendously boosted the industry. When he first took on the role of Commissioner in 2011, he focused on reducing the registration backlog of the pharmaceutical industry. Having served as his Chief of Staff, I took on the primary duty to improve the efficiency of certification procurement. For example, the pharmaceutical industry accounts for 4.5 percent of Mexico’s GDP. Each pharmaceutical registration for market authorization is worth around MX$1 million (US$53,000). In 2011, we had a backlog of close to 30,000 applications.

The impact of deficient procedures on the part of the country’s sanitary authority can be enormous on the economy. COFEPRIS’ administrative tasks and legal structure were not properly organized. As such, Arriola developed a strategy to minimize certification backlogs and modernize the institution’s regulations. We classified COFEPRIS’ shortcomings and assigned them to different teams based on their specific nature. Although backlogs were a major issue, modernizing our regulations was equally important. We aimed to align and standardize our sanitary practices to those established in first world countries with prominent sanitary authorities. Thereafter, we streamlined our communication with international organizations, such as the Pan American Health Organization (PAHO) and the World Health Organization (WHO). We wanted to gather information regarding best international practices, bringing certainty and predictability to our processes, while also establishing an efficient and rapid authorization protocol. Through risk-based analysis, COFEPRIS could ensure quality product releases with ample efficiency, quality and safety components.

COFEPRIS has obtained international recognition. We have secured the status of National Regulatory Authority Regional Reference Level IV through PAHO’s drugs and vaccines recognition plan, the maximum level of specialization possible in the Americas. Secondly, COFEPRIS passed the global exam on sanitary evaluation for vaccine development and manufacturing. By securing these two achievements, COFEPRIS proved that a quality management system was put in place, showing an assessment standardization from civil servants in Mexico. There should never be different decisions made on equal applications, which is precisely what our quality management systems prevent.

Q: How will stringent regulations influence the pharmaceutical market and new product development?

A: The Mexican pharmaceutical industry and COFEPRIS want to offer the best possible solutions to the population. Our pharmaceutical policy is strengthened by our presence as a technical authority whose work is based on scientific analysis. Our professionals have science-based backgrounds that allow them to analyze product conditions. We create reliable, rapid, flexible and accessible plans for sanitary authorizations to certify products promptly and create incentives for new product developments. COFEPRIS must also remove entry barriers to the Mexican market and we have harmonized our protocols to international practices. These points have established Mexico’s pharmaceutical policies, including the deregulation of certain products.

There are instances when products were developed by new technologies, giving way to new treatments with a high technological background. In their natural development process, medical devices are changing and minimizing risk levels. Considering the medical device arena is filled with new technologies, COFEPRIS must be aware of their origin and assess the risk alignment of a specific product.

For example in 2012, we found that 1,800 products were no longer considered medical devices abroad but Mexico still evaluated them as sanitary liabilities. Afterward, we started deregulating them. The results saw 2,300 deregulated products starting in 2013, reducing COFEPRIS’ regulatory workload by 16.2 percent. It also freed up over MX$5 billion (US$266 million) in public resources. The most influential change was incentivizing foreign companies to come to Mexico and commercialize their products.

Q: How has COFEPRIS decreased approval times more than Japan, the US and Canada?

A: COFEPRIS’ pharmaceutical policy of broadening its market access was implemented after in-depth planning and strategizing. One of these strategies recognized previous registrations in foreign sanitary institutions, such as the Food and Drug Administration (FDA), Canada’s Health Products and Food Branch and Japan’s Pharmaceuticals and Medical Devices Evaluation Agency. As a result, COFEPRIS issues the correspondent registration of medical devices after only 30 working days. While we are seeing more medical devices in-house, we still monitor them extensively. For instance, in 2015, we disposed of two tons of irregular medical devices that did not follow COFEPRIS’ lines.

We have created the same equivalence scheme with Europe, Canada, Australia and the US for innovative drugs. New molecule certifications are reduced by 60 to 360 days, improving Mexico’s attractiveness for foreign laboratories. In 2011, we developed a plan to analyze all pharmaceutical patents that were soon to expire and those with a bioequivalent application. COFEPRIS aimed to recognize which similar drugs could be used in Mexico’s healthcare system, lowering costs and budget allocation in the public sector. The value penetration of the generic market in Mexico shifted consequently, so that in 2011, 52 percent of the market was attributed to generics. In 2016, that number grew to 82 percent. We have moved from 36 generic substances to 491 options derived from the former.

Q: How do you plan to increase restrictions and regulations of miracle products and nutritional supplements?

A: We have to maintain the strictest standards in reviewing and analyzing all the products in our market so that we can ensure the patient is given access to quality products. In the last few years, so-called miracle products have caused problems because advertising regulations for these products failed to account for the fact the media was also partly responsible for advertising campaigns. Advertising of all other products was subject to regulation and we had the ability to impose sanctions for non-compliance. Essentially, there was no requirement by miracle product suppliers to demonstrate to the media that the product was legitimate. From 2012 onward, there was a significant change in terms of the way the advertising was regulated. The advertising media is now obliged to seek a permit. We were also able to impose sanctions that were 400 times more powerful than we had before. We then began to see this advertising reduced in the space of six months.

In terms of medical devices, we imposed sanctions in 2012, and by 2015, we had eliminated two tons of medical devices that were inappropriate for sale. In 2016, 300 million cigarettes and 5 million liters of alcohol were removed from sale due to quality issues. COFEPRIS has an important economic impact because we regulate 40 cents out of each peso that is spent on medicines, beverages, food and cosmetics. If we regulate well, we can generate incentives for the industry to be more efficient and we can create a more competitive market with more options.

The sanitary authorization agencies around the world must comply with three important mandates. The first is to provide authorization for products that we review in terms of quality, safety and manufacturing practices and this is done through market authorization analysis. Secondly, we must monitor the quality of the products that are already in the market through market intelligence. Thirdly, we must communicate with the public through sanitary promotion. The primary feature in the smooth running of any sanitary regulation authority is cooperation and we want to establish a center of excellence based on the idea that technical knowledge is created inside the laboratory. We want to create a channel wherein all expertise is shared. For this reason, COFEPRIS is creating a national laboratory of sanitary sciences. We will form a number of strategic alliances, one of which will be with UNAM's Faculty of Sciences and the other will be with CONACYT. This will allow us to stay up to date and share information with institutions around the world.