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Mexico 2013 | HEALTH & EDUCATION | INTERVIEW

TBY talks to Sandra Sánchez, General Director of Amgen Mexico, on developing biotech, Mexico's institutional progress, and patent regulations.

Sandra Sánchez

How is Mexico's role as a gateway for the biotech industry been developing?

Mexico is very well positioned to be a gateway, especially in the pharmaceutical arena, for three reasons. First of all is market value; we are the second largest market in Latin America. Mexico is the number one manufacturer of pharmaceuticals in Latin America and a huge exporter. Mexico is also a great center for R&D investments, especially in terms of development. Second is innovation; Mexico is a part of the growth of biotech. The pharmaceuticals industry is growing by 3% annually and biotech is growing by around 25%. The reason for this explosive growth is the heavy investment in R&D, coupled with the discovery of the human genome, which are leading investigations toward very targeted therapies. If we know the underlying causes and pathways of diseases by understanding how the genome may trigger them, we can target them better. The previous ways of treating diseases won't disappear, but they will be complemented by biotech. The third reason that Mexico is leading the way is through regulations. We have one of the best regulatory systems in the region, which has just been implemented in the last 18 months.

How is certification helping to develop the industry?

Mexico has been very active in making sure that we leverage our Pan American Health Organization (PAHO) certification with other PAHO countries to establish recognition or equivalence agreements. Today, Mexico has equivalence agreements with five agencies: the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the Swiss, Canadian, and Australian agencies. This means that pharmaceutical companies that want to introduce a new medication in Mexico will benefit from an expedited review if any of our partner agencies have approved the drug already. Instead of waiting 21 months for the product to be on the market, it will take just 90 days. This is a hugely positive development, supporting innovation, technology, and access.

How much of a barrier to growth do access issues remain?

Access means ensuring that the product is available to the majority of the population. In Mexico, this involves a three-step process, and the first part is regulatory. COFEPRIS evaluates whether a drug is safe and effective before proceeding to step two. Then, the product needs to get into the National Basic Formulary. The third step is getting into the public health institutions' Basic Formulary. I believe that Mexico has sped up this process over the past two years, especially in the regulatory step. There are opportunities for improvement in steps two and three of the process and the reasons are at least two-fold. One is that there is a lot of cost containment in institutions. Their vision on innovation is cost, and we need to shift the mindset away from the cost of the product to the cost of the disease in the long run. For example, the cost of a patient in the hospital, who has cancer and is in the ICU with doctors, nurses, and physicians, is much higher than treating the patient with an innovative treatment. Another reason access is limited is the duplication associated with the processes. In the National Basic Formulary, if a product is approved, it is listed. This does not mean that institutions will start purchasing the product; before this, the same listing process has to be repeated in every institution, which is a duplication of efforts and a delay in access. We need to look at examples worldwide, such as in the EU or the US, where once a product is listed in the National Basic Formulary, you have access to public health institutions. This does not mean that the institutions are going to buy the product, as this depends on their budgets, but the product is listed in their Basic Formulary. The Mexican system can be improved. Considering our ranking in the OECD in terms of innovation reaching the patient, Mexico's position is very low. It simply takes too long. The timeline for everything happening during step two and three could take three or four years if the company is lucky.