RISING TO THE CHALLENGE
Communication is the name of the game
Life has not been easy for Mikel Arriola since he stepped in as head of COFEPRIS in March 2011. The organization regulates
10% of the Mexican GDP and 12% of the country's international trade, and the regulatory authority's agenda is, and has been,
fit to bursting since Arriola's entrance. But aside from the immense responsibility and the current administrative blockages
in the system, there was a different kind of challenge that presented itself first of all. For Arriola it was a completely
new area, which represented a tough barrier in terms of communicating with the industry.
Mikel Arriola, Federal Commissioner, COFEPRIS
"The most important challenge I faced when entering COFEPRIS was the human challenge. There was a myth that this agency had
to be administered by doctors or by people related to the medical or pharmaceutical business, and I came from the Ministry
of Finance, so conceptually, that was the biggest challenge," he recalls.
It also seemed that there was a strong sense of good cop-bad cop where historically the authorities seemed to systematically
challenge the opinion of the industry. This required Arriola to apply a complete communication 'reset'. Regular meetings with
CANIFARMA and other industry associations, together with an 'open door' policy for meeting directly with pharmaceutical companies
helped the relationship enormously.
As Rafael Gual of CANIFARMA points out "The way they have been communicating and working with the [industry] has been tremendously
Strengthening Guidelines for Biosimilars
Indeed, the new COFEPRIS leadership team appeared, by almost complete industry consensus, to bring about one of the most positive
changes the industry has seen.
Both leading up to and while Arriola and his team have been heading up the organization, there have been three main items
on the COFEPRIS agenda. Firstly, the essential 'clean up' of the market. Secondly, the continuous improvement of regulatory
framework and reduction of barriers to enter the market. Finally, the agency has been working hard to get recognition from
PAHO as a regulatory body.
Getting rid of bad eggs
In terms of 'cleaning up' the market, in February 2005 COFEPRIS amended Article 376 of the country's General Health Law that
mandated the renewal of every drug registration in the market. All generic pharmaceutical products were expected to have proven
bioequivalence and therapeutic efficacy by February 2010. It was a much anticipated move for the industry, opening up the
way for innovative and generics companies alike. It also ensured there were only two types of medicine available: generic
The reform was crucial, but it was also the main cause of the administrative backlog when the government enforced the reform
in February 2010. Normally, COFEPRIS would receive 400 renewals or registration applications per month, but in February 2010
they received more than 4000. In the last twelve months, COFEPRIS met the backlog challenge and issued an impressive 9000
renewed drug registrations, representing, Arriola said, about 1.2 billion USD.
To help them through this backlog, last year COFEPRIS published three separate calls for individuals or entities interested
in working alongside them. The idea was to assist COFEPRIS with the control and assessment of pharmaceutical products under
the new registration scheme. Cristina Viruega, co-founder of TAPVS, one of the new authorized third parties, explains one
of the many benefits of the system.
"We can communicate more closely with the industry. It is just like having an official from COFEPRIS working with you in the
company, helping to integrate and create the correct dossiers in anticipation of your product registration applications,"
This new registration setup was an important milestone in the organization's history, and more so because it helped to phase
out the so called similares from the market. Similares were legally questionable medicines without proof of bioequivalence, and incredibly popular amongst lower income population
groups. Similares caused regulatory and safety concerns for the government and some say that due to adverse side effects, they had fired up suspicion in the general public about generic medicine as a whole. The elimination of similares, together with the increase in public healthcare using predominantly generic medicines, have essentially made generics more
accessible to the Mexican public; both financially and psychologically.
Hector Valle, general manager for IMS Health in North Latin America, says that as a company they run 10,000 interviews on
a monthly basis with customers leaving the point of pharmaceutical sale. This is to understand what is happening to the end
As a testimony to the increasing levels of public understanding on generics, Valle explains "80% of the people we interviewed
said they understand generics, but when we ask more questions to qualify their understanding, it is actually 50%. Around 41%
said that if there was a generic version of products they buy normally, they would buy the generic. That's a huge change,
and part of it has to do with the government putting a lot of information out, and also giving quick registrations for generic
drugs to speed up access."
Héctor Valle, General Manager North Latin America, IMS Health
This flurry of activity to make generics more understandable and better trusted also generated a need for companies to provide
bioequivalence and clinical analysis services, approved by the authorities.
There were some drugs on the market that had never been submitted for clinical analysis at all. "This created an explosion
of necessity that had never existed in Mexico before. There were a few clinics around, but none integrating all the services
that were required." remarks Hector Avila, general manager of CECyC Pharma, an authorized third party bioequivalence clinical
trials center. "I decided to create a Mexican company that could cater for all those needs in one place. Our main areas are
clinical research and analysis, and the whole regulatory section—because new regulations are tough to understand, and we wanted
to offer this regulatory service as part of our value chain."