Jaime Castro
Director General
BPF Part of QbD Group
View from the Top

Regulatory Paralysis Hinders Technology Adoption

Mon, 04/22/2019 - 13:40

Q: What trends does BPF, Part of QbD Group, perceive in the health sector and what regulatory concerns could arise from these trends?
A: We are witnessing technology trends such as AI, virtual reality, nanotechnology and additive technology, as well as Advanced Therapy Medicinal Products (ATMP). CONACYT has an area in Guadalajara in charge of developing these new therapies and so far, it has delivered good results. Effective ATMP research could pave the way for the implementation of other technologies in the country related to biotechnology and genetics therapy, among others.
QbD Group is leading the charge in the research of these new technologies, especially in ATMPs. We have developed a partnership with Antleron, a company that specializes in the development of gene therapy and microprocesses for these therapies. Our partnership focuses on Cell by Design (CbD), a cloud-based software platform that facilitates scalable, cost effective and sustainable ATMP process development and disruptive capsules that work as micro factories that produce genetically-manipulated cells. Being a genetics-based therapy, patients have a cell-generating capsule specifically designed for them. By using CbD, it is possible to build a design space of the process and product and to apply cheaper parametric releases compatible with Industry 4.0 standards, including remote monitoring and control and efficient data capturing and storage. This way of working facilitates process automation and allows for the implementation of machine learning methods and predictive modelling. We are exploring the possibility of introducing these new technologies to Mexico, either through a partnership with a local player or directly as new players.
Q: What should be the balance in terms of regulation for startups and for established companies?
A: The country lacks a long-term vision that makes technology the cornerstone for industry growth in pharma, and in healthcare in general. There are very few technology-based health startups in Mexico and unfortunately, the government and regulations have always treated them as if they were larger and consolidated companies, which does not work. We need to evaluate the risks of the technology used by startups and it might even be necessary to put more controls at a technical level to ensure the quality of the products these startups are producing. However, putting up regulatory barriers only discourages the development of new technologies.
Regulatory changes must be accompanied by a long-term country vision. Technology is always one step ahead of current processes and regulations, so new rules must encourage technology development. CONACYT’s budget cuts make no sense because of that very reason.
Q: How has the industry reacted to changes in regulations and what can the government do to boost certainty among investors?
A: The way in which many government policies have been conducted has hindered the needed certainty for the creation of new businesses, employment and investment. We have seen cases such as pharmaceutical vetoes, which have not been cleared, while public declarations in newspapers without any evidence have generated losses for companies and has led to an uncertain environment.
At the same time, COFEPRIS is semi-paralyzed and its authorities have gone back and forth with some changes that have not convinced everyone in the industry. During past administrations, COFEPRIS had managed to create an image and strength that transcended the local market, garnering praise internationally. This helped to position Mexico as a reference point in healthcare, particularly in Latin America. However, these latest changes have put Mexico’s leadership position at risk, especially since there is no clear public policy of where we are going as a country. Having said that, I hope things will take a turn for the better in the coming months.