Technological innovation in the national pharmaceutical industry

After years and years of banging on about the need and importance for the pharmaceutical industry, especially the national one, to have its own innovative developments, I am extremely pleased to say that for several companies this is already a reality. It's true that some are already well advanced (including designing new molecules) and others are at an earlier stage, but all are making innovations.

I've also said many times that generic drugs have been very important as a new business opportunity for the industry, and also for the government, which uses them to increase access to medicines for the population.

I know that when I say what follows in the paragraph below, people will look at me sideways, as if I were suspicious and contrary to national interests. As a counter-argument, I use the story of my professional and personal life. Feel free to ask. The truth is that, while generics have served and continue to serve to justify some of the positive aspects already mentioned, they have not enabled any more significant technological leap forward, other than the fact that we have learned how to make bioequivalence. As this learning has already taken place, generics have nothing more to add to the industry in terms of knowledge. As a result, there is only one path left to follow, that of technological innovation, in which there is not just one leap, because it is a process that only begins, but has no end. In other words, the aggregation of knowledge and results is such that the industry that begins this process is unlikely to interrupt it, except for compelling reasons.

However, the paths of innovation in Brazil are still arduous, poorly planned and lacking in continuity. We live from hiccup to hiccup, with many scares assailing the work of those who work in the field. I've said it before, but it bears repeating, because there are still areas in universities that don't accept this position: you have to start with simpler innovations and, as you add more complex knowledge, raise the level of these incremental innovations. There will come a point when the pharmaceutical industry, because of all the knowledge it has acquired, will be able to take the bigger leap, which is radical innovation, by creating new molecules. And it will always be a good option to remain and specialize in incremental innovation.

As for radical innovation, all areas of universities applaud it. There are no dissenting voices. However, you have to understand that in order to teach a child to read, you don't give them an article written by Ruy Barbosa and ask them to read it. At least in my day, I learned to read by adding various vowels to a consonant, for example the letter "d", and it looked like this: d + a = da, d + e = de, and so on. Literacy was gradual, culminating years later in reading and understanding the most complex texts. It's no different with innovation, i.e. you start with the simplest incremental changes, work your way up to the more sophisticated ones and then reach the radical ones, which is the last stage of innovation.

Most national pharmaceutical companies are at this first stage of incremental learning. There is therefore a long way to go, a plethora of knowledge to add and a lot to invest. On this long road, the industry is faced with countless difficulties which, unfortunately, are not recognized by the government and thus remain without the necessary solutions. Here are a few:

Starting with the ministerial area, there is no joint action between the various ministries on innovation. But there is a lot of talk about it. According to my dear friend Nelson Brasil, from ABIFINA, we need fewer studies and diagnoses and more "doing". Execution is the word of those who want to do and not just diagnose. According to another friend, Sergio Sacurai, those who know do and those who don't talk.

There are no non-repayable funding programs, except when the money goes to universities, but this is a situation where industry loses control of the project and that doesn't interest us. There is no long-term project to make innovation viable in Brazil and for more and more companies to start practicing it. These are government programs, not state programs. But the politicians' vision only reaches until the next election, a very short time for a project that, as I said, only has a beginning and no end, due to its importance and essentiality for the country and its industries.

Universities prepare their students for scientific research, not applied research. When we go there to find our employees, we have to prepare them (a few more years) for their new roles. In other words, university curricula must be adapted to the new needs of the productive segments. I'm not just talking about technical adequacy, but also about administration, the market, legislation and entrepreneurship, in case any academics want to go solo. And why not? The process of buying equipment, intermediates, standards and reagents on a small scale (bench and pilot) is so slow it's hopeless. When the product doesn't have stock in Brazil (most of them do), it takes between 90 and 150 days for the order to be issued and for it to arrive at the factory. For anyone doing research, this timeframe is unacceptable.

When there is a need for pre-clinical trials, many of them are still not carried out here. Fine, go abroad. Then comes another unpleasant surprise: when it's done abroad, there's an increase of almost 40% in the value of the service, corresponding to fees and taxes for something that Brazil still doesn't offer to those who need it. Only recently have two centers (Santa Catarina, run by Professor João Batista Calixto, and Ceará, run by Professors Odorico de Moraes and Elisabeth de Moraes) started providing services that are closer to what industry research needs. May they have the success they deserve for the brutal struggle they undertook to get to where they are today. But it's not enough.

As for clinical phases I and II, we're taking the first steps on our own, because what they do here is designed outside - we're just "an arm" in the research. It's more of an apprenticeship. As for clinical phase III, Brazil has good expertise.

This is now followed by action by Anvisa, which is the government body where the drug is registered. What we are asking for is more agility, flexibility - without compromising quality - and maturity in decision-making. Our long-standing demand is for the agency to have an area just for analyzing and guiding industries that have products with incremental and radical innovation. This is because, for the first time, we have innovative products developed in Brazil, whereas before everything came from abroad via international companies.

Let's now briefly touch on a taboo subject in the pharmaceutical industry: drug prices. The Medicines Market Regulation Chamber (CMED) works with old rules that do not allow Brazil to develop its own innovative products, whether incremental or radical. These rules are outdated and need to be updated. There isn't enough space here to discuss all of CMED's rules, but I will say that, if they remain as they are, they will strongly discourage innovation in Brazil.

Without going into more detail about Anvisa, I understand that it has been making an effort and succeeding, at least in some areas, in achieving the level of international quality that it so desperately wants. The problem is that all at once, it puts rules in place in Brazil that took years to discuss abroad, another year to gradually implement and even longer to fully comply with. The agency forgets that it has the capacity to write new rules much more quickly than we in the industry have the capacity to implement them. As a result, we are always out of date. It doesn't help to establish all the rules in force abroad in Brazil, because the industrial environment here is far behind that abroad.

Other points could be addressed here, but they have already been duly identified by the various diagnoses carried out to date. The question that remains is: in the face of so many difficulties in Brazil, does it pay to innovate here? I answer yes, because this is the only way that will lead industries to achieve international status and walk on their own two feet. It's our patent-protected innovations that will lead to the internationalization of our companies, not commodities (generics). This should be the goal of both industry and governments.

I would also point out that the unwillingness of our governments to provide better working conditions for companies that innovate in Brazil is largely offset by the voracity with which foreign governments approach us and encourage us to move outside Brazil. It's not just the cost-benefit ratio that we use to decide, but it has a high specific weight in these decisive moments. And this ratio is highly unfavorable to Brazil. It needs to be changed quickly so that we don't start a migration out of the country with no turning back.

I'll end by repeating that much more could be said about innovation. However, almost everything has already been said in studies and diagnoses carried out by various ministries and government bodies. What we need is a government that takes up the cause, stops talking about innovation and starts implementing actions that will result in the establishment of a lasting innovation program in Brazil. It has long been known that conquests are not only made with economic and military power, but mainly with technological power. If conquering is not our vocation, I am also sure that being subjugated, absorbed and acculturated is not what we want.

FACTO MAGAZINE ABIFINA/SP | 18/07/2017