Cristina Viruega Aranda
Director General
View from the Top

Breaking Barriers With a Unique Authorized Third Party Model

Sat, 09/05/2015 - 13:08

Q: How do you describe TAPVS history?

A: First of all, we have to make a distinction between two different entities. On the one hand we have the sanitary health state regulators and, on the other hand, authorized third parties (ATP’s) as auxiliaries to the authority since the 1990’s health law reform. The Congress created this figure as a tool of the Ministry of Health to increase its coverage by providing not only a Favorable Technical Opinion (FTO’s) of marketing authorization licenses, but also a recognition of bioequivalence. Initially, the third party figure rose ten years ago with bioequivalence studies, since in order to have a marketing authorization license for generic drugs, this was the main requirement. However, there are many other fields in which ATP ́s are applicable, such as the tequila industry.

In 2011, the Mexican authorities introduced the figure of Authorized Third Parties in order to accelerate the authorization process of medicines and medical device applications. It is important to mention that COFEPRIS has a wide coverage that ranges from cosmetic products to complex drugs molecules. No single institution could do this job alone — nor is there a budget in the world that could possibly cover it. The Health Authority has used this tool to make their work more efficient.

When the opportunity came our way, we visualized TAPVS. During my time as head of the legal department at COFEPRIS from 2000 to 2006, I established a strong background in regulatory law, as well as a long working period in the pharmaceutical industry. We synthesized both of these aspects of my career to create a company that could provide services to the pharmaceutical industry by being an extension of the health authority.

Q: How do you measure your progress as an institution?

A: We started TAPVS with 14 employees and have today become a company of more than 82. We expect to have 100 employees by the end of 2015. About 80% of our team is composed of technical professionals representing the heart of TAPVS. We try to merge youth with experience, creating a unique combination of professional reviewers, which has had a high-end result in front of COFEPRIS and our clients. At present, COFEPRIS statistics demonstrate that we head the list of ATP’s with 30% of the total market share, from which more than 60% is focused on medicines (our core business), positioning TAPVS as the market leader. We also offer our customers the evaluation of medical devices as well as facility inspection to complement our services, making TAPVS a one-stop shop option. To date, we have evaluated about 2,500 application dossiers as an extension of coverage of the Health Authority in order to reduce the release time of the marketing authorizations.

For the pharmaceutical industry we represent a better time to market, providing an 85% time reduction. We give our clients the possibility of commercializing their products and at the same time help ensure that the Mexican population has much freer access to medicines. Access leads to competition, which in turn leads to lower prices. The benefits are passed on to the people. One particular thing we are proud of is that we have regulated new molecules to treat 70% of chronic diseases. This way, our work directly addresses the leading causes of death in Mexico including diabetes, cardiovascular, respiratory, among others, and directly influences the health of the country.

Q: What sorts of challenges do you face in your day-to- day activities?

A: Our work means breaking barriers. We come to the pharmaceutical industry with a fresh pair of eyes and we are committed to the safety and quality of products, which means we have to be highly aligned with current regulations. That is, if the product does not meet the standards set by the health authority COFEPRIS, we are jointly responsible for any effect on the health of the population. This means that our review has to be very thorough. We have a shared responsibility with the laboratory, helping to ensure that the product is perfect. The government does not absorb the cost of authorized third parties; it is the third party itself who does. Likewise, the decision to go through this path depends only on the industry. Therefore it is not an imposition on the health authority, but an alternative.

Q: How does the work of TAPVS measure against similar institutions in other countries?

A: Since we are not simply an advisory body, but a regulatory one, our work is governed by executive legislation from a national level. Some of our multinational clients have begun to ask us to export our model abroad. They have noticed that some countries have extremely slow regulatory agencies, or else have complicated barriers to entry that block access to that country’s market. As an authorized third party regulatory agency, we are located outside the scope of government and commercial interests. This is what establishes our impartiality. If you look at the list of companies that have chosen us to work with them, they are mostly multinational companies with high standards of compliance, so there is no favoritism.

Q: Do you have any overseas expansion plans?

A: The scheme of authorized third parties as regulatory verification units exists nowhere else in the world. The concept of a third party in other countries is just as a certifying body. Other nations have a version of this process, but it is not the same as it is in Mexico. We are, in essence, a private sector extension of the government. Some people and foreign governments have shown interest in our model so as to translate it into one for their own countries. We have to explain to them what the scheme of an authorized third party is, along with its benefits, to make it cross borders. This of course is always based on the best practices that guide us in the Mexican legislature.

Q: What is your short-term development plan?

A: Firstly, we want to obtain biotechnology certifications. Until we have these documents in our hands, we will not consider this year to have been successful. We are also seeking approval to regulate other categories of medicines, including vitamin supplements. This will help reach the overall number of products entering the market. Another wider goal is to keep up our standards, continuing to build the pharmaceutical industry’s trust in us. We have most recently expanded into technology, an area in which we had been pushing to enter for quite some time, as well as vaccinations. Controlled drugs are already under our mandate, so we are currently reviewing regulations on drug categories 4, 5, and 6, along with vitamins. Given our pioneer status in the field of regulation and our strongly established position in the Mexican market, we believe we have the know-how to export the model to other countries. We have had productive discussions with Colombian regulators, so concretizing that relationship is the next step. Regulatory bodies in Peru, Bolivia, and Venezuela have made inquiries about our model and how it can be transferred to their own markets. Finally, regulatory bodies in Argentina have presented us with their authorities’ structures, so this indicates the beginning of a sharing relationship there