Rafael Gual
Director General
View from the Top

Simplified Registration Boosts Mexico Pharma Market

Wed, 09/06/2017 - 16:58

Q: How has the pharmaceutical industry evolved in the past two years?
A: I think it has evolved well and regulation has continued to advance. The structure of registration has been simplified so that time targets set out in the law are met for any process involving the sanitary authorities. This is an important advance that has allowed the pharmaceutical industry to be more competitive in Mexico and in international markets. Being recognized as a regulatory agency has allowed COFEPRIS to be much more agile in registering products in Central and South America.

In terms of R&D, we have authorized a series of third parties to be much faster in clinical authorizations, which will allow Mexico to become a center of clinical research. In economic terms, the market has maintained 3-4 percent yearly growth over the past decade, a rate that will probably not increase as the market is mature and grows in line with the population. The export market has grown in double digits and will continue to do so thanks to COFEPRIS, which has been recognized as a national regulatory reference agency in Central and South America. Companies have this advantage in addition to GMPs. Thanks to economies of scale, the Mexican economy is more competitive and can export to these other regions.

Q: How has the new pharmacovigilance NOM affected companies and how easy or di cult is it for companies to adapt to it?
A: The new norm offers patients security and provides faster product registration. If a drug does not have any reports of major adverse effects caused by the pharmacovigilance NOM, then registration can be renewed quickly. The NOM also commits other parties such as doctors and patients to reporting adverse effects. It is no longer the sole responsibility of the industry. It will cost the industry more but we think we will reach an agreement with the authorities on what is necessary and what is desirable.

Q: How is CANIFARMA helping the industry homogenize its regulation with the FDA and EMA?
A: They are already homogenized. There is not much difference between the regulation that exists in Mexico and

those countries. Existing regulations and laws in Mexico are not insufficient; all that is lacking is evidence that they are being followed. Having them written is one thing, ensuring compliance is another. The recognition from the WHO and PAHO of Mexico in terms of vaccines provides certainty that the role is being fulfilled. COFEPRIS has to report evidence of verifications and certainty of reports. Tracking may be different in the US and Europe, but we are still missing an agreement with the FDA and the EMA on a bi-dimensional code that can be applied worldwide.

Q: What advantages does Mexico present for clinical research, other than its large population?
A: In Mexico, most R&D is carried out in private centers. The main issue is researchers being paid to carry out the studies. There is a promising environment in IMSS to incentivize clinical research in Mexico, sponsored by the industry as there were issues with IP. This has been changed. Previously, if IMSS found a second use then the IP belonged to the agency. But an agreement has been reached so that the IP does indeed belong to the industry sponsoring the research. The advantage is that there are 50 million patients in IMSS with varying stages of disease because in Mexico there is no culture of prevention, which means diseases are available for study at advanced stages that may be hard to find in other countries.

Q: What other steps are being taken to boost clinical research in Mexico?
A: IMSS, COFEPRIS and CANIFARMA are on the verge of signing a contract to facilitate the path to clinical research. During our CANIFARMA Awards 2016 we announced that a research fair would be held during which companies will be able to have direct contact with the companies that won the awards in 2016 and 2015, to allow the research to be taken to market. Julio Sánchez, Commissioner of COFEPRIS, has announced he will support this with a certificate and the research will be followed by COFEPRIS from the beginning. This will contribute to further improving the relationship with the industry. Brazil and Argentina are Mexico’s biggest competitors in clinical research in the region. The fact that we have a large number of patients to register in a clinical trial aids our competitiveness worldwide. Mexico can increase patient numbers greatly if we make the most of IMSS. Brazil and Argentina are more agile.

Q: What are the biggest challenges in the human pharma industry?
A: We need to become an important center for clinical research because its potential is underused and we have to consolidate COFEPRIS’ recognition to open new markets for the industry. There is great quality in the products manufactured in Mexico and they are competitive. In addition, we need to continue consolidating regulations. I would add access, which is one of the main issues in the country, including new technologies which, despite having a greater cost, can bring increased benefits to the population. We need to facilitate this access in IMSS, ISSSTE, CSG and the National Formulary and I personally believe that opening clinical research in IMSS will facilitate the inclusion of new technologies, because having done the trials will shed light on the benefits they can provide in comparison to current medicine.

Q: What are the biggest challenges in the veterinary pharmaceutical industry?
A: They are extremely different. First, because there is no animal social-security system and there is no worry of incorporating new technologies. Challenges are more related to competitivity and access to international markets, as the market has been conservative in worrying only about the Mexican market. There are many multinationals here that are growing. The main issue is the topic of pure salts in food mixes. If a farmer administers pure salts instead of the correct medication it will cause problems. There are also issues with antibiotic resistance due to residue in food. There is no pure clenbuterol medicine for example, only medicine that contains traces of it. Sadly, we do not have the muscle in Mexico to create a regulation around this.

Q: What role do you play in investigations such as that of COFECE?
A: We give COFECE the information it requests but we do not have a proactive role. We clarify the panorama of the pharma industry. There are topics such as prices that are forbidden for discussion during any of the chamber’s meetings. In every act it says that it is forbidden to exchange commercial information. This legally binds the chamber and its members to avoid these issues, so we provide requested information. We are asked for example why all expired patented products do not have generic alternatives. It may not be commercially viable, it may be a di cult product to create or the ingredient source may be unique, and this is a worldwide condition. If the patented product is interesting enough for a generic to exist, it will.