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13/06/2022
Conversations: Nelson Mussolini, Sindusfarma, Brazil

Veículo: Executive Forecast

O portal norte-americano “Executive Forecast” publicou uma entrevista com o presidente executivo do Sindusfarma, Nelson Mussolini, sobre o desempenho da indústria farmacêutica e o panorama do mercado de medicamentos no Brasil.

Leia íntegra da entrevista:

2020 was a year of diagnosis and prevention and 2021 was a year of vaccines. What do you expect the year 2022 will be?
Nelson Mussolini - I believe it will be a year of health reconstruction. Since the beginning of the pandemic, many health issues have been left aside, they have not been taken care of the way they should. We have to be very careful with the “post-pandemic pandemic”, which can occur due to the lack of attention that has been given to some diseases, especially in the area of Oncology, where treatments were abandoned because people were afraid to go to hospitals.

As people stayed at home during the pandemic, there were not many respiratory problems. However, at the beginning of 2022, people began to leave home and contracted influenza, which arrived violently because people lost the immunity they acquired when they were out on the streets. For me, 2022 is the year of the reconstruction of the health area in a very global way, especially here in Brazil.

What were the lessons learned within the supply chain, leadership, sector structure, and the strategic importance for the country?
Nelson Mussolini - The whole world has realized that there is a need for supply centres with better distribution around the world. This is not an economic issue, it's just a strategic health issue. The continents need to be prepared and that was the biggest lesson we learned. First of all, we didn't believe we'd have another pandemic. We had the “avian flu”, and nothing happened, therefore nobody thought that we would face a pandemic again. One of the good lessons that have remained is that we need to prepare for another pandemic, we do not know when, but we will certainly have another one.

The second lesson is that the global supply chains cannot be restricted to a single continent. This will be a very serious problem that we’ll have to face and is a high investment because these products are made in tons to be sold in milligrams, so the cost of production is very high. That's where the need for state intervention comes in because it will be impossible for only private initiatives to take care of it. If we do not have the local conditions to create a production chain, this production will hardly be established.

In the past, we had a local production chain. When I started in the pharmaceutical industry, Brazil was the largest producer and precursor of benzathine penicillin. We had three major local producers, but in the 1980s the countries decided to abandon their fine chemistry industry and transfer all of this to Asia, China, and India. That wasn't right. Today, we need a state policy, not a government one. We need a policy where states think about what they want for the future of their residents' health, they must wonder if they want to remain dependent and that's where financial power comes in. Brazil suffered from this issue because, during the pandemic, respirators were bought but they did not arrive here in Brazil because the countries with better financial conditions preferred to pay a fine in order to keep the products for themselves.

We were not prepared, and we must be ready in the future, but this will only be possible with state policies, not government or isolated policies of ministers, and we're going to need them in the different countries, at least in the Americas. We will have to have this well established and against production poles to meet the local market which is large and has the capacity to absorb this, but there is a need for better-established policies.

What was the impact of inflation on medicines?
Nelson Mussolini - In Brazil we have control of the prices of medicines, and this is a problem because we had high inflation of inputs, and we could not pass on this price, and this generated the lack of some products. We have important products in our country that are no longer being manufactured and sold because the cost of production is much higher than the final price of the product. So, we have policies that in my view are wrong policies because at first glance it is wonderful, but the scenario changes when the products start to lack in the market. This is a serious problem. There is a need for state policies, otherwise, we cannot face pharmaceutical inflation like the one that happened in the world and continues to happen. With the war in Ukraine, the routes had to be changed so as not to pass through the conflict area. All this has generated a higher cost, which is extremely negative for the development of the health of our countries.

What are Sindusfarma's priorities for the future?
Nelson Mussolini - We urgently need to abandon some things and prioritize others. During the pandemic, the Brazilian Health Surveillance Agency, ANVISA, had great agility. It was an example even for other countries. ANVISA quickly focused on what was most important, which was not to miss the product within the country. Thus, production routes were changed and made more flexible without abandoning the safety and effectiveness of the products. That was of the utmost importance.

However, we are still stuck with other issues. For example, the registrations of new products that were unrelated to the pandemic have been delayed even until today in Brazil. We now need to review all this without throwing away everything else we learned.

Another good lesson is that we can approve surveys faster in Brazil. We don't need to take a year to approve clinical research in our country. We did clinical research without harming the research subject and without violating any ethical norms, and we were able to do this quickly. This is a lesson that we cannot abandon. We shouldn’t stop being agile just because the pandemic is almost completely over.

Clinical research saves and improves the lives of individuals, especially in a country like Brazil, which has excellent research centres of the highest quality. However, there is an ideological problem within clinical research.

Another point that Sindusfarma already cared about and that has become even more concerning now, is the issue of intellectual property. There is a need for an uncompromising defence of this matter. The pandemic showed us that. The governments bought the vaccine from those whom they knew would deliver it, but they didn't fund anything. The British government bought a vaccine, and the U.S. government bought another because they knew that these scientists had the competence to develop them.

For complex problems, there are no simplistic solutions, that's a fact. So, we don't need compulsory licensing of vaccines. Who will develop new products for the next pandemic if the right to intellectual property is not preserved during this current one? We need flexibility. We must keep looking at the least developed countries to help them and create a fund, but without hurting intellectual property, because if not, neither rich nor poor will have the development of products.

We have to be very careful about this. I debated this a lot here in Brazil by showing how technology transfer is much more effective and much safer than simply “breaking” a patent. Patent breaking is the last path that a nation can use to solve a problem. Technology transfer and negotiation are the most effective ways. Instead of breaking patents, the World Health Organization can allocate a portion of the production of rich or developed countries to poor or underdeveloped countries. It may even be an expropriation of this production to better distribute throughout the country, but without abandoning the right to recognition of intellectual property.

So, the priorities would be chemical research and intellectual property?
Nelson Mussolini - Also, the development of local production of at least part of the ingredients. Many of these ingredients no longer have intellectual property, such as penicillin, dipyrone, and paracetamol. Governments could help with their public laboratories, as is the case in Brazil, which has several of these facilities. These laboratories could develop the products that are necessary for the maintenance of the Brazilian hospital park. Products that do not require technology transfer, but that we need to relearn to do because, unfortunately, we want to switch to biological ones, and we leave many chemical inputs aside. Now, everyone wants to know about the biologicals, but we have many inputs that would be extremely useful and that no one else produces. Thus, there could be a government incentive for these products that have no patent and where there is no need for large investments for technology transfer.

What is personal definition of “access”?
Nelson Mussolini - Access is expanding within your ability to do so and bring people into health. Brazil has a phenomenal access program, larger than any other country in the world, which is the Brazilian Unified Health System, which expands access. However, we know that resources are finite, and the needs of the population are endless. We are seeing the rise of gene therapy and advanced therapies that have cost thousands of dollars for each person and countries must find a way to afford and deliver those treatments to their citizens. At the same time, we have great disparities in Brazil. People have access to gene therapy, but on the outskirts of big cities, people don't have basic sanitation. Thousands of people were saved with the vaccine, but how many lives would we save if our countries, the countries of Latin America in particular, had effective basic sanitation?

It would be much cheaper for the state to finance an effective sanitary structure that generates much better health for people than to finance the research and development (R&D) and the fabrication of a biological product, for example. The risk of the drug and vaccine development process must be taken by the pharmaceutical industry. We need to take a look at that. Thus, access to state-of-the-art health has to be very well studied from the point of view of how private health can expand this through insurance and through an effective distribution of responsibilities.

If I say that my product will have the ABC efficacy and it only has the A efficacy, the B efficacy, or the C efficacy, I have to contribute to the state in accessing that product. This is the division of responsibilities. So, we can reduce the health costs for the states by sharing duties, and that expands access. Another point regarding access is the basic health programs for those diseases that are acquired, such as obesity and heart problems. We would have to have education within primary schools so that people learn that having a better diet and practising physical exercises prevents them from becoming a cost to the government.

Another issue of access that governments need to understand is that health is not a cost, health is an investment. A person who works generates taxes, which generates wealth. This person buys a car, or a house and so it is moving the economy. A sick person inside a hospital only generates expenses. Governments need to look at access to health as an investment, even if they have a purely financial vision because a healthy population can work and pay their taxes. Also, sick people don't pay taxes and those who don't pay taxes don't generate wealth.

What do you think will be the importance of health tech in the health of Brazil?
Nelson Mussolini - I have no doubt that it will have great importance. We have a continental country where telemedicine will be essential to the proper functioning of things. Now I use telemedicine. I changed my health plan and in my new health plan, before any visit to a specialist, I do an interview with my family doctor, something that already happens in Canada and in other countries. It was more difficult here in Brazil because we had a very big barrier due to the lack of personal contact. We don't like this story of not being able to shake hands, not being able to look at each other eye to eye.

I managed to solve some health problems I had during the pandemic with the consultation screen. Then, I wonder: “All right, I'm here in the capital of the state of São Paulo, which is the most developed state in the country, has a hospital and pharmacy on every corner, so it's easy to treat me”. But I keep imagining the most distant centres, whether in Brazil, South Africa, or other countries in Latin America and Africa. If we have effective telemedicine, we will solve a lot of problems.

A few days ago, I attended from inside a hospital here in São Paulo a surgery that was done by a doctor who was in Boston, in the United States. With telemedicine and all the technical support of the people who were here, the doctor performed surgery in Boston by using a robot here in Brazil. This is going to be sensational for the development of people's health.

I visited the staff of the Oswaldo Cruz hospital and from their technology, they showed that a surgery that used to take 12 hours can be performed in 4 hours, due to the technical and technological part that was developed. They can map a person's body and everything that will happen during surgery, with all the problems that can arise. Assertiveness at the time of intubation of a person with Covid was at a 95% rate thanks to the studies. They knew the characteristics of the person, for example: "Oh, Nelson is obese, he's bald, he's of Italian descent, then he will be intubated between such and such a moment”.

Technology will be key to expanding access, because if I used to spend 12 hours on surgery and, thanks to the technology, I now spend four hours, that will able me to do three more surgeries instead of one. So, this access is going to be critical. Telemedicine will help people a lot because they won't have to move, even in the big centers, where you need to go from one end of town to the other to see the doctor and it can take you two or three hours to get there. Already with telemedicine, you can have a video conference that will at least direct you to the right place and to the right specialist. So, no doubt the technology will be key.

For this to happen, the states will have to prepare. The corporatism of some medical classes must be broken. I've heard advice from doctors positioning themselves against this technology because personal contact creates great power over the patient, and the contact with the machine decreases this power because of ‘Doctor Google’. If the doctor says that the person has a disease, the first thing the person will do is go into Google and research what are the possible treatments for that disease. This forces doctors to specialize more because today a day the patient arrives at the doctor’s office with certain information, and in some countries of the world, this information is very bad.

Bearing in mind that this year Brazil will have presidential elections, what advice do you have for a new administration on health policy, industrial policy, or any other point you want to address?

We're even preparing a document to deliver to the candidates for the Presidency of the Republic. We hired a big consultancy and relied on a few things. The first is that politics should look at health as an investment and not as an expense. The government and the next ruler need to see it this way so they don't have problems. Secondly, health taxation is a crime. In our country, taxation is extremely high. 33% of what you spend to treat yourself becomes a tax. So, for every US$ 100.00 spent, US$ 33.00 are taxed. This money doesn't go back to health. If the rich paid for the poor to have better health, perfect, only this money goes to the government's cash, goes to the IRS and the IRS does not redistribute at this level, does not send the 33% to health. So that's a very serious problem. The government should look at health the same way that other countries in the world have. Health cannot be taxed because you cannot tax an investment. If you tax investment, you avoid growth.

In addition, the government should support the simple access systems that have been proven effective in the country. Brazil has a national immunization program that is an example for the world. We were able to immunize the 5,700 cities that we have in our country because in every city we had a refrigerator to store vaccines.

At the end of the year, my wife was vaccinated in Milan. It was necessary to make an appointment to take the vaccine, and it was only in one place. She spent almost a whole day there waiting to be vaccinated. Of course, she had wonderful care, but between us, here in Brazil, if I leave here now, I can go to the health centre, extend my arm, and be vaccinated.

So, we need to keep these simple programs that we have here in Brazil, which are the National Immunization Program and the AIDS program. We need to study how to use the AIDS program and transform it into a program for Oncology, for example. It would be extremely important to have funds already earmarked for Oncology. We can save people's lives and, once again, invest in them so that they can be healthy and yield much more in the eyes of the state, as individuals who pay taxes, and in health as recipients of investment.

10 years from now, if you look at this moment in your professional career, how would you like to remember it?
Nelson Mussolini - As a moment of transformation, but first as a moment of gratitude. I think we have to thank all the health professionals. In my public statements, I make a point of thanking the doctors, the nurses, the ambulance drivers who carried people up and down, to all those who helped in some way to save lives. I think we need to be grateful for that.

But we also need to value who delivered the "war material" so that these people could work. No soldier goes to war without ordnance (vaccines in this case) and ordnance is out of the industry. I am very proud of this, and I am sure that 10 years from now I will be able to tell my grandchildren that I participated in a special moment in human history, which meant saving lives and bringing people to a better world.

I'm sure this pandemic will turn the world into a better one. People will be more concerned about their health; they will be more worried about how not to let people die inside their homes because that was very sad, people died inside their homes from lack of care. So, I do believe that the world will prepare for the next pandemic. This was an excellent but hard lesson because it brought many deaths. But, without a doubt, it also brought extremely important visions in agility, care for people, and technology. The world has come a long way in the last two years, we have achieved things that would have taken more than 10 years to achieve.

Is there something else that you want to comment on or add?
Nelson Mussolini - Pricing issues in Brazil are becoming very important. We have an initial product pricing law, which began in 2003. It's been 20 years; the world has changed, not only because of the pandemic but because of the new products that came in. For example, we didn't have generic drugs or generic competition in our country. Today, generics already represent 30-40% of the market in terms of value. 40% in units, 30% in values. It's a relevant market.

However, the current drug pricing regulation in Brazil causes a much bigger and more serious problem from the point of view of public health and people’s quality of life. The rigid and outdated pricing model often inhibits the launch of innovative products or forces the withdrawal of traditional and often essential products by imposing values that hinder their production and commercialization. Some very old products, due to this competitive restriction, are disappearing from the Brazilian market and this is generating a shortage in the market and, consequently, will generate a shortage in our continent because Brazil is the producer of some products that are exported. So, there is an effective need to take care of Latin America in terms of medicines. We need to have an effective review and modernization of pricing legislation in Brazil. This point is extremely relevant for us. 

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