The coming of age of generics
SOURCE: ABC FARMA MAGAZINE
TEXT: CELSO ARNALDO
A 1999 law, enacted when José Serra was Minister of Health, changed the Brazilian pharmaceutical landscape forever. By encouraging the production of unbranded drugs with maximum therapeutic safety that were at least 35% cheaper, the law ushered in a new era, exponentially increasing access to medicines in Brazil. To celebrate these 18 years, ABCFARMA Magazine interviewed the president of PróGenéricos – an association that brings together 14 laboratories responsible for producing 90% of the generics sold in the country. About to complete five years in office, Telma Salles says that there is still a long way to go before generics find their rightful place in the market.
You will have been at the helm of PróGenéricos for five years this June. How would you assess your tenure?
We have 14 members representing 92% of the generic drug market and nearly 40% of the total drug market in the country. And we intensified Pró's agenda because I devoted more time to the regulatory framework, which underwent significant changes during this period—such as the traceability law, the introduction of bioequivalence for all drugs, the reorganization of post-registration, and policy changes that undoubtedly affect the sector. There was a time when generic drug manufacturers only needed to develop their portfolios. Now there are many other concerns.
In these last two years of ongoing crisis, have generic drugs also been affected?
We slowed down the pace of growth in our economy during this period. But that doesn't mean we stopped growing. Even though we didn't maintain the same pace, we continued to drive growth in the sector.
What type of medication is driving the growth of generics today?
The leading causes of death in Brazil and worldwide are chronic degenerative diseases such as hypertension, high cholesterol, and diabetes. Medications for the ongoing treatment of these conditions are therefore at the forefront of generics—they are the best sellers and the most widely available.
And what about PróGenéricos' relationship with Anvisa?
It's good. President Jarbas Barbosa has brought more momentum to the agency's agenda, which, for us, has been very receptive, with no breaks in dialogue. But the regulatory agenda is very extensive, with more than 150 items. The Serra Law (1311), which establishes a maximum period of one year for the registration of new drugs, has brought a new concern to the agency. And, for us, a better expectation, although we understand that Anvisa needs to structure itself—there is no point in forcing you to get to China in one day if you cannot fly there. Anvisa needs more people and more training for its employees to respond more efficiently to the analysis deadlines we need.
What is the deadline today?
On average, for generics, 1,286 days. And we are talking about products with dossiers of molecules that are already known and registered. Each drug dossier has more than two thousand pages.
What does that mean in practice?
It takes four years for a new generic drug to enter the market. However, the agency prioritizes the first generic drug for a substance within 90 days.
Why would a pharmaceutical company decide to launch a generic drug that already exists on the market?
Because competitiveness is everything. Brazil has 200 million inhabitants, with a potential 100 million consumers of medicines, roughly speaking.
And is there still great market potential for new generics, based on substances that currently only have reference brands?
Yes. There are still many patented products to be won. We are working with the Ministry of Health, in the patent group, precisely targeting those drugs that are the subject of PDP (Productive Development Partnership) and technology transfer. The most prevalent chronic diseases I mentioned already have good generic coverage. However, for more expensive diseases, there are still many reference drugs to be won.
Any other bottlenecks in patent granting?
There was a major impasse in the circuit between the INPI (National Institute of Industrial Property) and Anvisa. A patent application for a drug is submitted to the INPI, which sends it to ANVISA for technical analysis, then returns it to the INPI for approval or rejection. There was a major impasse in this circuit—the INPI often did not recognize ANVISA's ability to analyze the product's patentability criteria and shelved it. There are more than 6,000 products stuck in this impasse. Now, a decree that has just been signed, after a struggle by PróGenéricos, may bring the solution. Together with the Ministry of Industry, Foreign Trade, and Services and the Ministry of Health, a new form of approval for the granting of these patents has been found, which will reduce the queue.
The average increase in drug prices this year is around 3.4%. Was that enough for generics?
Insufficient, because raw materials are dollarized and costs in Brazil have not fallen with the crisis. On the contrary, they have risen. This adjustment does not cover the increase in costs.
You have 18 years of experience with generics and five years managing PróGenéricos. What is the main message behind the continuous growth of this category of medicines over all these years?
When people still question whether generics are of good quality, costing much less than the reference drug, you take atenolol—which, since 1999, has grown 1006%; losartan, from 2002 to now, has grown almost 20,000 percent. It used to sell 600,000 boxes; now, 20 million. What does this mean? Expanded access. More people are being treated with these products. And adherence means effectiveness. It is unreasonable to imagine that someone would take a medication continuously if it had no effect—and to imagine that the generic market would grow at such a rate without therapeutic effectiveness.
X-ray of generics in Brazil
Created by Law 9,787 of 1999
First products launched on the market: February 2000
Over these 18 years, they have provided savings of R$ 87 billion for consumers.
Growth in antidiabetic drugs: 953.26%. Growth in antilipemic drugs: 1872.90%.
Statins market: 1,988,149 units sold in 1999/63,593,240 in 2017 (estimate)
The 5 most commonly prescribed generic drugs in Brazil: Losartan, Hydrochlorothiazide, Atenolol, Metformin, Amoxicillin
See original article: http://progenericos.org.br/Revista%20ABCFARMA-309%20entrevista%20TS%2018%20anos%20Gen%C3%A9ricos.pdf