Technological innovation in national pharmaceutical industry

Revista Facto Abifina/SP | 07/18/2017
Fonte: DANTE ALARIO JUNIOR
DANTE ALARIO JUNIOR | CSO - CHIEF SCIENTIFIC OFFICER AT BIOLAB FARMACÊUTICA 

Year after year harping on the same topic, it means, on the need and importance of pharmaceutical industry, especially national industry, to have their own innovative developments, I am extremely happy to say that for many companies it has already become real. It is true that some companies are ahead (even designing new molecules) and others are in previous stages, but all of them are innovating.

I also said several times that generic drugs were very important as a new business opportunity to industry, also to government, which uses them to increase population access to the drugs.

I know that, when I say the words in the paragraph below, people will look at me askance, as if I was suspicious and opposite to national interest. As a counter-argument, I tell my personal and professional life story. Feel free to make me questions. The true is that generic drugs were and are made to justify some positive aspects already mentioned; they did not enable a more expressive technological leap other than learning how to make bioequivalence. As we have already learned this, generic drugs have nothing further to add to industry with regard to knowledge. As a consequence, there is only one pathway to follow, i.e., technological innovation, where we do not take only one leap, because it is a process that starts but never ends. In other words, there is always knowledge and results to be added and the industry that starts this process is unlikely to interrupt it, except for compelling reasons.

However, innovation pathways in Brazil are still hard, badly planned and not continued. We live at every hiccup, scaring those who work in the field. I’ve said this before, but it is worth mentioning, because in universities some fields do not accept this positioning yet: you have to start with more simple innovations, and as more complex knowledge is added, you raise the level of these incremental innovations. There will come to a point where pharmaceutical industry, due to all acquired knowledge, will be able to opt for jumping higher, for radical innovation, by creating new molecules. And continuing and specializing in incremental innovation will always be a good option.

And for radical innovation, all areas of the university clap hands. There are no voices raised against it. Nevertheless, you have to understand that in order to alphabetize a child you do not give them an article written by Ruy Barbosa and ask them to read it. In my time, I learned to read adding to a consonant, for example, the letter “d”, the many vowels and we had: d + a = da, d + e = de, and so forth. Alphabetization was a gradually process, which resulted, years later, in reading and understanding the most complex texts. It is not different for innovation, in other words, it starts with more simple incremental, reaches the most sophisticated ones and achieves the radical ones, which is the last stage of innovation.

Most national pharmaceutical industries are in this first stage of incremental learning. Therefore, there is a long way to go, a multitude of knowledge to be aggregated and a lot to invest. In this path to be followed, the industry faces several difficulties which unfortunately are not recognized by governmental field and thus remain without the required solutions. We mention some:

Starting with ministerial area, there is no conjoined action between the several ministries for innovation. But the theme is much discussed. According to my dear friend Nelson Brasil, of ABIFINA, we need less studies and diagnosis and more “doing”. Execution is the word used by those who want to do something and not just to diagnose. According to other friend of mine, Sergio Sacurai, One who knows does something and one who doesn’t speaks.

There aren’t non-repayable financing programs, except for when values are addressed to universities, but this is a situation where industry loses control of the project and we are not interested in it. There isn’t a long-term project in order to enable innovation in Brazil and more and more companies start to use it. These are governmental and not state programs.

However, the view of politicians only lasts until next election, a very short deadline for a project that, as I’ve already said, only has a beginning and not an end, due to its importance and essentiality for the country and industries.

The universities prepare their students for scientific research and not for applied research. When we look for our collaborators there, we have to prepare them (some years more) for new functions. It means resumes of colleges should be suitable to new needs of production segments. This is not just about technical suitability, but also administration, market, legislation and entrepreneurship, if any scholar wants to fly solo. And why not? Purchase processes of equipment, intermediates, patterns and reagents on a small-scale (workbench and pilot) are desperately slow. When there is no stock of the product in Brazil (most of them), from order issuance to arrival at the manufacturing plant elapses 90 to 150 days. For those who conduct the research, this deadline is unacceptable.

When pre-clinical assays are required, many of them are not conducted here. Well, we go abroad. Then, there is another unpleasant surprise: when assays are conducted abroad, there is an increment of almost 40% in service provision value, corresponding to taxes and fees of something that Brazil does not offer yet for those who need it. Only recently two sites (Santa Catarina, of Professor João Batista Calixto, and Ceará, of professors Odorico de Moraes and Elisabeth de Moraes) have started providing services similar to those that research in industry needs. I hope they succeed as deserved due to the brutal fight they had in order to reach the position they have today. But it is not enough. 

Regarding I and II clinical phases, we are taking the first steps on our own, because what is conduct here is designed abroad - we are only “an arm” in the research. It is a learning experience. In clinical phase III, Brazil has a good competency.

Now it is time for Anvisa to act, which is the governmental body where drugs are registered. We only ask for more agility, flexibility - without compromising quality - and maturity on decisions. Our old plea is for Anvisa to have an area only to analyze and guide the industries which have products with incremental and also radical innovation. This is because, for the first time, we have innovative products developed in Brazil, when in the past everything used to arrive from abroad by international companies.

Now we are going to quickly approach a taboo of pharmaceutical industry: drug price. The Câmara de Regulação do Mercado de Medicamentos (CMED) works with old rules, which do not consider the hypothesis for Brazil to develop its own innovative products, whether incremental or radical. These are old rules and they need to be updated. We do not have space to discuss all CMED rules, but if it remains as it is, it will discourage innovation practice in Brazil.

Without approaching more details about Anvisa, I understand the agency has been trying and being able, at least in some areas, to reach this desired international quality level. The problem is that Anvisa establishes rules in Brazil, all at once, rules which were discussed for years abroad, took years to be gradually implemented and a few more years to be completely setup. The Brazilian agency forgets it has a capacity to write new rules quicker than we, from industry, have to execute them. So we are always outdated. It is not helpful at all to establish in Brazil all rules in force abroad, because industrial ambience from here is far below those from abroad.

Other points could be approached herein, but they have already been duly identified by the many diagnosis conducted to date. The question that remains is: facing so many difficulties in Brazil, is it worth to make innovation here? My answer is yes, because this is the only way that leads industries to reach an international status and walk on their own. Our patented innovations will lead us to internationalize our companies, and not commodities (generic drugs). This should be both industry’s and governments’ goal.

I also remember that reluctance of our leaders to provide better work conditions to companies, which make innovation in Brazil, is widely compensated by the voracity the foreign governments approach and stimulate us, in order to take us outside Brazil. We do not use only cost x benefit ratio to decide, but it is highly important to these decisive moments. And this ratio is highly unfavorable to Brazil. It has to be quickly changed so that a migration, with no return, outside Brazil is not started. 

I finish repeating that there is so much more to talk about innovation. However, everything or almost everything has been already said in studies and diagnosis conducted by diverse ministries and governmental bodies. What we need is a government to embrace the cause, to stop discussing about innovation and to start taking actions which will bring as a consequence the establishment of a long-lasting innovation program in Brazil. It has long been known that accomplishments are not only made with economic and warlike power, but mainly with technological power. If accomplishing is not our vocation, I am also sure that being overwhelmed, absorbed and uncultured are not what we strive for.
 
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