Reforms aim to facilitate commercialisation of new drugs in Mexico

 

Stakeholders are seeking to expand the research and development (R&D) potential of the pharmaceutical market. Currently, clinical studies get around 10% of the overall investment portfolio in pharmaceutical companies in Mexico. According to the Mexican Association of Medicine Manufacturers, increasing investment will require the domestic R&D community as a whole to develop better processes and continuity in commercialising ideas. R&D in Mexico is worth around $155bn, but the sector is targeting $500bn within the next few years. Early growth signals are encouraging: in 2013-17 R&D in clinical investigation rose by 25%.

A Willing Partner

The most important advance in clinical trials in the drug development industry in recent years has been the signing of collaboration agreements with Mexican health institutions after a five-year hiatus. In 2012 the Mexican Institute of Social Security (Instituto Mexicano de Seguridad Social, IMSS) and the Institute of Social Security and Services for Government Employees (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, ISSSTE) stopped clinical trials in order to maintain control of all intellectual property (IP) based on trials conducted in their system. In January 2017 IMSS and ISSSTE reversed their IP clauses and allowed pharmaceutical companies to retake control of their royalties. This has enabled collaboration between private players and IMSS and ISSSTE for clinical studies to resume.

According to Gabriela Dávila Loaiza, regional director of clinical research of north Latin America at Pfizer, expanding this collaboration is essential for Mexico to be a competitive location for medical trials. “We either accomplish this change within the public sector to become a more competitive country or lose out on the opportunity,” she told OBG. The industry looks for a 50:50 split between trials in public and private institutions, she added, whereas in Mexico 70% of clinical studies are handled in the private sector and 30% in the public sector. Though prospect of a change in the federal administration after the July elections contributed to a challenging outlook for 2018, stakeholders are hoping that the incoming administration of Andrés Manuel López Obrador will maintain the agreements the pharmaceutical industry finalised with the public health sector over the past two years.

Regulation

To further cement the progress being seen, clinical research is part of the general health law put forth in 2017. If passed, this would bring important changes to regulations, and the regulators. Currently, there are three committees to approve medicines in development: ethics, research and security. Each is controlled by a different governing body, which can cause delays and confusion during the drug approval process. The law would combine the three committees to streamline the process, as well as help define the role of principal researcher and clinical site standards. Additionally, the law aims to clarify the role of the agency that pre-approves drugs before they are placed before the Federal Commission for the Protection from Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, Cofepris) for authorisation.

The legislation has been passed by the Senate in March 2018, and as of July 2018 was under review in the Chamber of Representatives. Industry stakeholders hope that the law will be fully implemented by the end of the year. A number of players are also pushing for the ethics committees of Cofepris to consistently meet the 30-day time frame for approvals, as this is currently often missed. “Players in clinical investigation agree that the protocols need to start up faster. Other countries are moving regulatory pieces to take market share that could be Mexico’s,” Dávila told OBG.

Investments Views

While the reform process is ongoing, some steps have already been taken. One such change is that whereas clinical trials were not previously required in Mexico, now the Commission of New Molecules at Cofepris determines which new medicines need clinical trials before launch. This enables pharmaceutical companies to enter into the market more quickly and run trials early in development. Regulatory players hope this will mean that investment in clinical trials, which has been relatively scarce in the past, will go up. “Investment is still small and should rise,” Francisco Acosta, director-general of regulatory consultant Inteligencia Sanitaria, told OBG. “The private sector should drive this investment as it is in their interest. To invest more, pharmaceutical firms need a more agile process in regard to regulatory protocols and approvals. In this sense, Cofepris has said it is working on making a more expeditious process for clinical trials.”

First-Wave Releases

Mexico has been pushing to be in the first wave of new medicine releases since 2012 when Cofepris amended Article 170 of the Health Product Regulations. Until then, manufacturers of new molecules seeking registration had to present proof of registration in their country of origin per an article by pharmaceutical industry publication Clinical Leader. The amendment replaced this requirement by allowing companies to present clinical data with Mexican patents for molecules that had not already been launched elsewhere. Pharmaceutical companies chose Mexico to launch a total of six drugs between 2012 and 2017: Sanofi/Zealand Pharma’s Lixisenatide for diabetes was the pioneer, and Sanofi’s dengue vaccine, Dengvaxia, was the most recent to take advantage of this change. Locally, there are two possible centres where new drug development could take place, Guadalajara and Cuernavaca, which both have significant biotech investment. Two domestic firms, Probiomed and Pisa Farmacéutica Mexicana, have R&D operations, though neither has brought a fully produced new drug to market.

Even with a big push industry players do not see Mexico overcoming the obstacles necessary to become a regular first-tier launch country. One key factor for this is the relatively small size of the market for pharmaceuticals. Mexico is still usually in the second wave of new drug releases – after Japan, the US and Europe – due to the size of the market. Advancement into the first wave in biosimilars in the near future is thus unlikely.

Getting to Market

Another challenge facing the sector is to match researcher with private firms. “There are researchers in many different institutions, but no one to invest in them. In part this is because the researchers do not know how to sell themselves or their discoveries, or register their intellectual property,” Dávila told OBG. Better links between academia and businesses would help to facilitate the movement of ideas to market. The National Autonomous University of Mexico – one of the biggest research centres in the country – does not have a specific policy governing the use of intellectual property, according to the World Intellectual Property Organisation. This makes using discoveries from their researchers a legally tangled issue.

“There are a lot of public funds that end up in no one’s hands. We need better communication between the biggest institutions in Mexico and the research community in Mexico,” Dávila told OBG. “We need to create the process and cut down the bureaucracy.”

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