Third Parties Can Alleviate Pressure on GovernmentMon, 04/15/2019 - 13:42
Q: As an authorized third party, what is your relationship with government regulators?
A: We interact with many government regulators, although the particular body depends on the sector. In health, COFEPRIS acts both as a regulator and as an inspection unit and we have operated according to its rules for many years. In some areas, they remain the only authorized body for certifications. We hope the government will soon open up these areas to authorized third parties.
Q: How could new government policies help NYCE broaden its service scope?
A: Due to the restrictions the government places on third parties, it is hard for companies like us to grow beyond their niche. Luckily, we are part of a bigger group with different business lines. It is my understanding that this government wants to make its spending more efficient. This could be an opportunity for the private sector to take on more duties that have been traditionally assigned to the government. We have the team, the facilities and the experience to expand in various areas. COFEPRIS has opened up several areas to smaller new players, although not all private parties. This has limited competition, which I consider a wrong approach.
Private parties can do more professional and elaborate work. We can broaden our portfolio to new factories, plants and laboratories in all kinds of industries. We could even audit our own competitors in the industry. Moreover, many pharmacy networks are in the process of expanding but only COFEPRIS is authorized to inspect these companies.
Q: How do you handle the potential conflict of interest that arises from having other commercial operations?
A: It is important to maintain full impartiality in our work. For this reason, we will never produce any products in areas where we also conduct inspections. In this business, upholding a reputation of integrity is very important. There have instances in the past been where we have encountered bad practices during our inspections, such as falsification of certifications or cheating during tests. The Mexican Accreditation Entity has a specific area that monitors and addresses these practices.
Q: How are your operations distributed across the country?
A: We have established branch offices in Mexico City, Tijuana, Ciudad Juarez, Monterrey and Guadalajara in line with our clients’ demands. We are now looking at the southeast. In Cancun, we already have a small presence that caters to the tourist industry. We inspect hotels, restaurants and other service establishments. If we were to start inspecting and certifying pharmacies, we would need to shape our infrastructure beyond just offices. In that way, we could cover the whole country.
Q: What effect do quality control and vigilance have on the pharmaceutical industry?
A: COFEPRIS has made a good effort to open up the market and attract more players. It has stimulated more production of medicines and greater product diversity, which has increased medicine access for the entire population.
Pharmaceutical is a strong sector. It continues to innovate, introducing new technologies, equipment and plants, which means it also requires continuous inspection and recertification. Maintaining high-quality controls helps the whole industry advance, allowing it to capitalize on the potential to export to international markets.
Q: What are your growth expectations for authorized third parties in the next 18 months?
A: There are already several players in our line of work; I am not sure if there is space for more. Most authorized third parties cover around 1-2 percent of the market. We are on the larger side, with approximately 3 percent of the market. This year, our goal is to grow 20 percent in size and increase our penetration by 2 percent. We have seen favorable signs in 1Q19 toward reaching this goal and we are certain that even though we will not become the biggest player, we will further strengthen our position.