When we interviewed you four years ago, you gave us a picture of the industry. How has that picture changed since then?
We can start with the regulatory picture. In the past four years, Brazil went through a transition from an old system to a new system consistent with international organizations around the world, although from my point of view, we are still updating and adapting the regulation. For example, in the case of similares, the transition is not yet complete, though in of innovators and herbal medicines, since 2003/2004 the harmonization process is finished from an international point of view. We are now updating in the areas of materials and packaging. All the cartons and labelling are in review. The knowledge regarding process, fabrication, formulation, and so on is quite finished, as are the requirements in bioequivalence and bioavailability. New technologies, like biologicals, biosimilars, and biogenerics, are still in an understanding phase in the process of harmonization – though it’s important to note that these topics around the world are not finished either.
Besides this, there have been changes due to [CONCIA], which is the council regulating the use of animals in experiments, and tries to avoid the use of animals and humans in laboratories, with the goal of becoming more economic and ethical. There are many NGOs fighting against animal testing, but at a certain point you can’t avoid it. If you are a surgeon, you can use silicone replicas of organs to practice. But I would prefer to have a surgeon who has first practiced on animals! It’s not easy to replace a pure laboratory in this case, and it’s the same in bioavailability and bioequivalence, despite big evolutions in both science and technology.
And in education as well. I heard about how you got started in the industry many years ago when the exams for pharmacy and chemistry were on the same day!
Things have changed – but this is a real story! My vocation was for chemistry, not pharmacy. When I finished it was necessary to choose in order to work. In that time, I preferred pharmacy because one could work nights. Also, chemistry in Brazil has had a poor evolution. University faculties were growing only in petrochemistry, but in pharmacy there was robust growth.
There’s an important trend in the growth of generics, with 53% annual growth expected to make that segment represent 20% of the market. How do you view the importance of this trend?
We know that people need medicines, and are unhappy with health deviation. We all want to live as long as possible without health deviation. Generics are one way to offer medicines that are no longer protected by patents and can be produced in good quality conditions to offer access to people who need the medicine. There are special programs from the government to provide access, but generics are just one part of the equation. We need more and more new medicines. There are a lot of problems still unsolved, such as Alzheimer’s, Parkinson’s, cancer, and many kinds of viruses. Generics are used for already-solved problems, and are important to help, but we are not happy with the problems still yet to be solved.
What role do you see Brazil playing in solving those problems, in contributing to a cure for Alzheimer’s, Parkinson’s, or cancer?
Brazil is trying to research new ingredients thanks to its rich biodiversity in plants and other microorganisms. To find new medicines is not easy. First comes understanding the reason behind a deviation in the body, for example, tuberculosis, which remains a big problem around the world and is a bacteria very resistant to antibiotics. It’s not easy to fight against immunological diseases. We are not evolved, biologically, to win this war.
Then comes the second step: making a correlation between what’s in the ground and how to fight the sickness.
And then eventually hopefully clinical trials? Global expenditures are $44 billion, Brazil attracts $142 million. How can we bridge the gap?
It’s a question of investment. Until recently, Brazil was not seen favourably in terms of investment. Due to the political evolution of our country, it was not possible to structure the educational system to have people specialized enough to perform experiments and research. Nowadays, Brazil has come a long way, where there are now synergies to be gained from cooperation with other countries and centres and we can promote a big evolution in our vocation in this instance to perform research. Sindusfarma is part of the Conselho Nacional de Saúde, where they have made a special commission to OK research spending. This system is new, and we are growing in geometric, not arithmetic proportion. We have a good young population and lots of expertise in different areas. The potential for research is big. We need to grow more and more in all medicines we need to offer to the population, and this includes herbal, homeopathics, specific OTCs, generics, innovators, and new technological preparations from old products proven as safe and effective. There are many rationalizations to insert in the new medicines already in commerce and production.
Where does the government enter the picture?
15 years ago during the Fernando Henrique Cardoso administration, the government decided to privatize all the state companies, and as a result they do not directly produce. However, Brazil runs one of the most effective programs against contagious diseases with vaccines and good technology, and has two or three laboratories promoting research and with the technology to produce. More and more we must grow in this area, because obviously, preventing disease means more health.
But the government has no strategic plan. When you return to the past, say 20 years, there was big inflation and big social problems. These have been solved, but now we need to reorganize the government and decide how they will act with the important sectors, and how they will promote and develop social organizations.
Lula’s took the direction of assisting the people in the most need; now it’s time to take the next step.
SINDUSFARMA, having been founded in 1933, is one of the oldest associations in Brazil and has witnessed the social reorganization of the Brazilian state. These social programs have ensured the workers are supported in many activities by the government.
What is your final message to Pharmaceutical Executive readers about SINDUSFARMA?
Our entity represents its members without any division or discrimination between national or international origin. The most important thing is that the Brazilian population needs medicines of a high quality, safety, and efficacy. This is the main principle from the WHO. We need to offer services for the people, to represent them, to produce more and more products and increase productivity to reduce prices. That is the old system from the industrial era! More goods, lower prices, conform to regulation and specification.
And we want to have people well-trained, to a high level of productivity. It’s not enough to produce with a good quality if the people don’t have access.
There are many rationalizations to have the products free or heavily subsidized, and for social programs to cover costs. There are many resources in the government to make medicines available. I’m not happy when I see people with many diseases and no access to medicine. Around the world it’s the same. The big challenge for leaders is how to get medicines to the people who suffer.
I saw one proverb in a French review, many years ago: “Rien n’est bon pour l’homme qui souffre” (Nothing is good for the man who suffers). Therefore, while there are still many people who suffer, what we are doing is not enough.