Market Access Brazil

Mar 25, 2014 - Mar 26, 2014, Sao Paulo

Develop valuable partnerships and understanding to gain access to the market

A Mexican Perspective on New Market Access Models

Julio Querol, Market Access Associate Director at UCB México talks about new market access models in Mexico and offers his thoughts on the best ways to implement them in the current environment.



Mexico, the second largest pharma market in Latin America after Brazil, is one of the 10 biggest drug producers in the world and holds plenty of potential for businesses looking to move into this area. Rafael Gual director general of Mexico’s pharmaceutical trade association CANIFARMA, recently shared his thoughts with us about how foreign companies can achieve better market penetration in Mexico. This provided many valuable insights for the industry, but what are the current obstacles to accessing this market and how can pharma companies break through thesein one of Latin America’s largest and most dynamic emerging markets? Querol offers some useful insights on this.

Barriers to market access

Querol considers that the first obstacle is obtaining Sanitary Registry, which authorizes the commercialization of any product in the Mexican territory. In recent years COFEPRIS (Committee for Protection against Health Risks) has implemented new processes in an effort to reduce approval times and lags in renewals. “However, there are still delays due to the continuous changing of staff who are responsible for these processes, and there’s lack of clear transparency in the process”. He notes that whilst there are plenty of good ideas about the ways to improve the situation, implementation is poor, meaning the progress in approval times not has been significantly increased.

The second challenge is related to access to the public sector. A government agency called the General Health Council (CSG) evaluates drugs and medical devices. The basic criteria of this evaluation is to establish whether the relationship between costs and benefits of the new product are superior to the alternatives available in the National Basic Formulary. “In recent years the CSG has made efforts to improve the evaluation process. We have had significant advances but there are still things that can be enhanced to ensure assessments are more objective,” says Querol. He adds that one of the important issues is to improve the definition of the criteria and assessment tools as well as providing clear feedback of the reasons on which the CSG based a rejection. In addition, he considers that there is not enough information to increase the transparency surrounding breakdown of costs associated with the evaluated alternatives, or on quality of life benchmarks to allow the use of cost-utility assessments.

The fact that pharma companies do not have good opportunities to conduct local studies, especially Outcomes Research studies, which provide improved support for economic evaluations is another concern. “The effect of these shortcomings often results in slow evaluation processes and a lack of transparency, because it is not so clear what the authority needs to know to enable them to make a decision.”

The final consideration revolves around the evaluations conducted by major public institutions once the product has been approved by the CSG. Querol notes that these institutions cover more than 60 percent of the Mexican population, but for highly specialized products can be above 90 percent, meaning they are a key part of the market. “These institutions are mainly interested in generating savings in the care process if they accept the inclusion of a new product or, at least a minimum budgetary impact”.

Each institution has its own evaluation process and very specific criteria, including requirements for evidence covering efficiency, safety and effectiveness that can take many years to prepare. “A fundamental deficiency shared by all institutions is that our law does not allow the use of trade agreements based on pay for performance or risk-sharing agreements, unless there are very exceptional circumstances.”

Keys to success

In such a dynamic market, it is no longer enough to have a product that is clearly superior to the alternatives available in terms of efficacy and safety explains Querol. He sees that it is increasingly unlikely for these kinds of products to be developed or, when they do exist, he predicts it is those with a strong body of demonstrable evidence to prove superiority that will succeed. This essentially opens up the market place for highly innovative companies that have a track record for well-documented research. “I have no doubt that the best recipe is a good proposal value, supported by solid scientific evidence, which reflects good knowledge of unmet needs for the physicians, patients and payers, including answers for these needs matched with a fair price.”

It can be difficult for a pharma business to work out which new market access model will be better than another for their product. Querol has observed that sometimes the same model from the same company can be successful for one product in one market; and not work at all for another product, even in the same market. “I see even less chance of success in the attempt to copy models from other companies that are very similar in regards to products and markets. The successful model is the one that gives results and this can change from product to product and customer to customer.” The best model, he believes, is the one that provides an understanding of what the client needs.

Querol believes that for companies to be successful in Mexico, "access" should be looked at from the customer's perspective, especially that of the patient. “The access functions do not end with the inclusion of a product in a drug formulary.  To ‘gain access’ means we have been successful in removing all barriers that prevent a patient to always get the product in a timely manner. I think something pharmaceutical companies have to learn and practice is that successful strategies are based on listening to our customers, understanding their needs, interests and preferences and having the ability to act on them, with actions guided by ethics and respect for the rules and policies that govern us.”



Market Access Brazil

Mar 25, 2014 - Mar 26, 2014, Sao Paulo

Develop valuable partnerships and understanding to gain access to the market