Xavier Ordoñez
Partner in Strategy and Operations Consulting
Horacio Peña
Horacio Peña
Senior Manager in Strategy and Operations Consulting
View from the Top

New Rules: A Challenge for Both Private, Public

Wed, 09/06/2017 - 09:19

Q: What can Deloitte offer healthcare companies?

A: We offer help with regulatory compliance, like GMPs for medical devices and materials, and we manage regulations such as NOM-059 concerning drugs. We deal with topics related to follow-ups for the use of drugs and medical device types 1, 2 and 3. Medical supplies must meet the quality regulations of each company.

Even though we manage this process, sometimes compliance is not achieved because it is not just about meeting the authorities’ requirements but also regulations. Mexicans must have control of the drugs from their production to their consumption. This control must be present both in distribution and along the supply chain. There are many biotechnological products in development, so the cold chain is important and requires great care. In September 2016, NOM022 was published on pharmacovigilance. The law regulates products commercialized in the country and the demands for compliance are very different from the former law. This represents a new challenge for the public and private health sectors because active pharmacovigilance and tracking systems are required, with metrics presented as proof of use.

Q: How can you help clients adopt this new regulation?

A: We can help them by checking their pharmacovigilance programs and verifying how they work. We also advise on communication with physicians because they are the first ones to be notified about these kinds of issue when patients tell them a drug made them ill. Unfortunately, patients in Mexico do not notify the authorities about these issues, even though it is the only way to know what is being done right to make it better and what is done wrong to improve on it.

Q: How can companies deal with public sector budget cuts?

A: Considering there are growth opportunities in both the private and the public sector, for many companies the latter has been the main driver and with budget constraints there are many questions about how to continue growing. There are companies looking for and succeeding in finding growth opportunities. Some are highly specialized and target their investment to specific segments. There are also those that target large medical audiences so their portfolio and investments are consistent with their market intentions. Most of these are national companies. Companies with top growth levels have only one of these profiles. The companies we see struggling are trying to do both simultaneously. During times of constraint the real challenge is to have a clear strategy without trying to accomplish everything, because that creates inconsistency.

In Mexico, the public sector’s budget is large. It is concentrated in IMSS and the different public institutions that require medicine and it is distributed through tenders for which providers must comply with bioequivalence, quality, good manufacturing practices, exportation costs and other requirements related to transparency, ethics and legal topics. We expect an increasingly better supply of medicine, devices and also services.

Q: How is innovation integrated into the Mexican healthcare system and how open is the system to innovation?

A: Mexico needs to innovate more. We are in a different Mexico. Before, we had family doctors, now we have social security, Seguro Popular and medical consultancies in pharmacies, so we must strengthen health services through innovation and by guiding doctors, so they can approach the population with quality drugs. Instead of filling the market with generic products, we should provide more innovative products.

At first glance, it could be said that Mexico does not innovate as much as other countries, but we have seen interesting cases of health-related innovations by Mexican entrepreneurs. With regard to innovation brought by transnational companies, perhaps more than openness to innovation the issue is our speed in adopting it. Remember, over 10 years ago our country was a preferred territory for medical releases.