RISING TO THE CHALLENGE

Communication is the name of the game

Mikel Arriola, Federal Commissioner, COFEPRIS

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.

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 and innovative.

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," she says.

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 consumer.

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."