Sonia Pérez
Executive Director
UDIBI
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View from the Top

Challenges, Opportunities Emerging in Biotech

Wed, 09/06/2017 - 11:33

Q: What challenges in implementing the pharmacovigilance NOM in biotech is UDIBI helping overcome?

A: The law in Mexico is not designed to provide security for biotechnological drugs because it does not consider relevant aspects related to their nature. The regulations demand reports of adverse events but they do not control the postmarketing phase to prevent them from occurring. In biotech, it is necessary to know what happens when the drug reaches the open population because patients might present therapeutic failure or develop antibodies against the drug, which is not reversible. Once the organism has produced antidrug antibodies, the patient cannot take the drug or another related drug because the antibodies would neutralize its effect. There should be active vigilance in testing patients taking biotech drugs, which would help pharmaceutical companies gauge when to intervene or when to stop administrating the drug. This is a totally different concept to pharmacovigilance. Therefore, we must make recommendations to COFEPRIS and other health institutions about the pharmacovigilance of proteins because it is conceptually different.

Q: What more can regulators and companies do?

A: Regulatory institutions and manufacturing companies should take greater responsibility. In other countries, regulatory agencies also monitor the market. They do not solely rely on the information provided by manufacturers. They have fixed verification measures, which is lacking in Mexico because there is not enough infrastructure to handle the demand. Mexico also needs a more consolidated pharmacovigilance culture. From the beginning of a drug’s life onward we should be checking the patient’s reaction to the drug.

Q: How can Mexico overcome its biotech development limitations?

A: Our regulatory system is rigid, pyramidal and based on the political constitution, the general health law, the ISOs, NOMs and pharma regulation. To modify something, we have to work from basic issues. Unfortunately, in Mexico science moves faster than law. Everything has to go through a legal process in which the different chambers have to approve it and by the time this happens, science has already moved on. A few years ago, the concept of biotechnology did not even exist in the law. It took us two years to establish NOM-177, which is already obsolete. Trying to change it will take us two more years and by then it will be outdated. We have a real issue with this regulatory path because we cannot produce guidelines easily. There is a group of researchers like me who are trying to speed up the process for updating guidelines. Usually, we follow what is already published by international agencies such as the FDA and EMA, but sooner or later our normativity must change because we operate differently from other countries. The WHO is also asking for it and COFEPRIS is becoming a more concrete regulatory agency with a strong group of experts but we lack the dynamism to improve it. Without clear guidance, we will have to check every case individually. If we do not have an established metric for evaluation, the process becomes complex.

Q: What are your expectations for the future of biotech in Mexico?

A: If we become more competitive, Mexico could be a reference for evaluation of biosimilars worldwide due to its geographic location and because many countries are looking to access other markets. Furthermore, laboratories like UDIBI could continue supporting the authorities since they do not have the infrastructure required to evaluate new molecules. The knowledge we gather when we perform a detailed evaluation might be useful in developing innovative molecules. Mexico has great potential, but our innovation system is not articulated. In other countries, the academy and the industry have been working hand in hand for years, while in Mexico the science and technology law was implemented just last year. This will advance technology but laboratories like ours that already know the path of elemental testing must provide an opening to innovative Mexican drugs. We will also start attending technology summits in the US because we are now working with US companies that have reached out to us due to our high-quality service at lower costs.