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Clinical Trials Can Benefit Patients, Mexico’s Economy

Luis Hernández - ACROM
President

STORY INLINE POST

Wed, 09/05/2018 - 14:02

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Q: What is ACROM’s role within the healthcare ecosystem?

A: Our goal is for pharmaceutical companies to see us as reliable partners. The pharmaceutical industry has put its trust in companies affiliated with ACROM, so our goal is to meet its expectations. ACROM was created to strengthen clinical research in Mexico and to comply with international standards to make the country attractive to foreign companies. Mexico's image as an unpredictable country would hinder investment and trials. The association promotes regulatory changes to ensure that regulators comply with established deadlines. ACROM works closely with its clients, centers, institutes and hospitals to attract patients for trials.

Q: What can clinical trials represent for Mexico in terms of investment attraction?

A: Mexico receives only 6 percent of the total investment in clinical research across the globe. Considering the size of the population, the country could attract up to 40 percent of the total. COFEPRIS and the government want to canalize this investment to the public sector but the challenge is that these payments are forbidden by law. Thus, the first step is to change the rules. The sector is unwilling to invest if there is not enough transparency.

Q: What do CROs need to do to bring more clinical trials into the country?

A: Many CROs are international companies and we, as their Mexican representatives, keep pushing their head offices to bring more trials to Mexico. Even though tests performed in the country are trustworthy, the objection we hear is that timelines in the region are unpredictable. For instance, the earthquake of September 2017 greatly damaged COFEPRIS’ main offices, paralyzing the council for three months.

Q: What are the main objectives behind ACROM’s recent partnership with CETIFARMA?

A: All CROs in Mexico should produce quality, transparent information. For that reason, we allied with AMIIF and signed a collaboration agreement in 2018 with CETIFARMA. This agreement also will facilitate the close monitoring of ethics compliance in clinical trials. This is a self-regulation principle taken by CROs that will help to improve Mexico’s transparency regarding clinical trials.

The agreement between ACROM and CETIFARMA has been fully supported by the industry and by COFEPRIS. It sets an important precedent for self-regulation. The main goal for 2018 is for all companies that belong to ACROM to guarantee transparent operations.

Q: Mexico’s strong potential for clinical trials is an objective but not a reality. How can this be changed?

A: Just having good intentions is not enough. We are working with AMIIF to bring pharmaceuticals and CROs together and ProMéxico is promoting the sector internationally. Operations have improved thanks in part to oversight of clinical trials by the National Commission of Bioethics (CONBIOETICA). Several years ago, Mexico had a boom in clinical trials, but at that time the country lacked the infrastructure and the appropriate regulations to carry them out, which left a negative image. Before incorporating more clinical trials in the country, all health institutions must have the infrastructure to carry them out efficiently.

Q: What must be done to make public health institutions more receptive to clinical trials?

A: Public health institutions need to fully understand the need for these trials, the benefits they bring to patients and how they differ from other research lines. Doctors at public institutions continuously perform basic research with excellent results but performing industry-sponsored research is taboo. It is necessary to change this mindset within public institutions. Clinical trials provide access to innovative medicines to people who would otherwise have to wait for their approval and then pay high prices to acquire these medications.

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