Edgar Romero
View from the Top

Promoting the Medical Devices Sector

Wed, 09/06/2017 - 18:07

Q: AMID was created to eliminate “regulatory challenges” in the industry. What are the biggest problems?

A: AMID was indeed created for regulatory reasons to bring products to Mexico. COFEPRIS was the main focus of our e orts for around eight years. Our agenda is now broader and our main focus is access: how to collaborate with authorities to gain advances for patients and be a more productive country based on investment in health. We also have an ethics and compliance committee because we must ensure these practices are the best they could possibly be in Mexico while trying to establish the same rules as in Europe and the US. We are also working against the black market. We want products to be controlled and traced from the point they leave the manufacturing site to the point they are implanted in a patient. Finally, we are working on being known as a reference in healthcare in the same way as the pharma industry.

Q: How have medical device trends evolved since 2015?

A: Products now have a shorter innovation cycle than 15- 20 years ago. There is an increasing number of players with new technological processes, including Big Data. Consequently, the government faces the challenge of how to evaluate them and ensure that the most innovative medical devices reach patients. Now, from releasing a product to releasing its next generation, there are only two or three years and the evaluation system for new products is not used to working with such short time frames. Medical devices account for 70-80 percent of sanitary registrations in Mexico. How to evaluate them and the cost/benefit over time is a new challenge for any government, including Germany and the US. The main challenge is bringing these devices to the country.

Q: What is the impact of the black market, which is usually associated with pharmaceuticals, on medical devices companies?

A: The impact of the black market may not be as large in medical devices as in pharma but there are medical devices that cross borders illegally without the proper temperature controls and distribution procedures. Appropriate techno-vigilance needs to be implemented. It is not that devices are copied like in other industries; for example, many are bought abroad and brought across the border without the correct quality protocol and temperature control, or a hospital may throw away devices and they are fished out from the trash.We have an agreement with COFEPRIS: if we find out about the sale of illegal products, they act immediately to remove them from the market.

Q: How are AMID members impacted by COFEPRIS’ deregulation of medical devices?

A: We have always had good channels of communication with COFEPRIS, but in 2016 and 2017 AMID planned a full schedule with them. They are working on the third package of deregulated medical devices. The first came through in 2011 and the second in 2014. This deregulation is simply recognizing that certain products used in medical practice are not medical devices and as such should not be regulated by COFEPRIS. There are some companies that are part of AMID that commercialize these products, but they are merely components of medical devices per se. This causes a problem as the number of devices in the market is multiplied by the number of side products that are produced. COFEPRIS was saturated by regulating these products they never needed to. These deregulation  packages are a list we share with the authorities of these accessories that can be deregulated. We are responsible for 80 percent of COFEPRIS’ sanitary registers and as innovation cycles decrease, their workload increases. Deregulating these items is good because COFEPRIS can use its time to check true technological innovations instead of regulating these other products. This will increase investment in innovation because less time needs to be spent on other things.

Q: What regulatory points are you lobbying for to improve access?

A: The toughest part of gaining access is going through the CSG. We are asking them to make their processes simpler and to implement the most adequate rules possible for medical devices as the current rules were designed for pharma. If we followed pharma’s rules, we would have to innovate at the same rhythm as that industry, which is much slower. We have been working with the CSG since 2016 and we have just begun our first e orts with the IMSS on a process level. They have the ability to define whether or not a product will reach a patient through public hospitals. We are looking at how we can help make this process faster.

Of the three stages of approval (COFEPRIS, CSG and the institution), CSG is always the hardest for us. The process can take up to four years, while an ideal process takes two to three years. We want to implement this time frame for everyone, regardless of their product, and we want to make the approval process predictable so that everyone follows the same steps. This is an additional challenge. If the innovation cycle shortens but approval still takes the same amount of time, it becomes unprofitable to create new products; by the time a product is approved a second generation is already available, so we have to try and gain general approval. In summary, innovation is designed before the corresponding regulation. At this moment, the challenge is how to evaluate innovation faster. We are behind when compared to similar countries such as Colombia, Chile, Brazil and Argentina.

Q: How are global economic conditions impacting imports and exports of medical devices?

A: Since the Mexican peso depreciated against the dollar, it has been an industrywide worry but companies plan on a long-term basis. The peso appreciated against the dollar in the first three months of 2017, strengthening from MX$22 to the dollar to MX$19. There has been an impact on profitability but we need to think long-term and see this trend through. No company has shown genuine concern or considered leaving the country.

AMID associates are projecting growth above 9 percent in sales during 2017 and expectations for 2018 remain in a good health. In addition, AMID is ensuring its presence in free-trade negotiations such as NAFTA. We are being present as an industry to ensure the continuation of adequate conditions. We generate US$8 billion in medical devices exports but we export 92 percent of that to the US. The medical-devices sector is considered an emerging economic area for Mexico, along with IT and pharmaceuticals.

Q: What will be AMID’s main focus for 2017?

A: During the second half of my presidency, we will focus on finishing our work with the CSG to improve patient access to medical devices for better diagnostics, treatment, prognosis and the patient’s quality of life. AMID will also continue promoting ethics and compliance in the healthcare industry. We grew from 23 to 30 companies last year thanks to a broader agenda and we now run several agenda items in parallel, which enables us to get more done.