A proposal that creates rules for clinical research with human beings, approved by the Chamber of Deputies last week, divides opinions.
At the same time as it can represent an advance for clinical research and assist in the development of new medicines for rare diseases, there is concern about data and people’s physical integrity.
Bill 7,082/17, by former senator Ana Amélia (RS), defines the main rights of voluntary research participants, as well as the duties of researchers, sponsors and entities involved.
Among these points is the creation of a committee composed of a multidisciplinary team, with members from medical, scientific and non-scientific areas, and also a representative of the research participants.
The board will be responsible for filtering and analyzing the proposals. The decision will be sent to the Unified Health System (SUS) and, if there is strategic interest, as defined by the Ministry of Health, the research will have priority in ethical analysis and will have special analysis procedures, provided for in a regulation to be drawn up.
Regarding voluntary and unpaid participation in research involving human beings, interested parties will be required to present a free and informed consent form signed by the participant or their legal representative.
The volunteer may withdraw at any time, at no cost or loss to him or her. In addition, he or she will be entitled to reimbursement for transportation or food expenses for the volunteer and companions, if any.
For the rapporteur of the proposal in the Chamber, deputy Pedro Westphalen (PP-RS), it is a regulatory framework for clinical research on humans. He told CNN that the project will simplify studies and transform Brazil into a reference in clinical research in the world.
“It will unlock the research industry in Brazil. Universities and hospitals will also benefit,” said Westphalen.
“We managed to approve it in the Chamber, where it was very difficult due to the plurality of ideas, the number of deputies. But we talked to everyone and resolved points of disagreement. I hope that, in the Senate, approval will be faster. Certainly patients with cancer and other rare diseases are very satisfied”, added the parliamentarian.
According to estimates by the FarmaBrasil group, with regulation, Brazil will be able to attract R$3 billion in direct investments in clinical studies annually and generate R$5 billion in economic activity per year.
“The regulations establish a safe legal system, guarantee ethics and protection in favor of the patient and expand the population’s access to new life-saving medicines and therapies. It is an excellent opportunity for our country to expand the horizons of its research and Science and boost local pharmaceutical innovation. We consider the approved legislation a true legal framework for clinical research in Brazil”, celebrated the group’s president, Reginaldo Arcuri.
The proposal is also defended by patient groups. For Juliana Yamin, president of the National Institute of Dwarfism, the approval of the PL is progress.
“Technology in medicine has been advancing rapidly. Developed countries host studies of new technologies and Brazil is outside this context. I think that the change in legislation, obviously based on technical and ethical analysis, will be beneficial to stimulate progress in research in our country and give patients the opportunity to participate in studies that bring advances in treatments”, he said.
Data protection and “guinea pigs”
The project, however, also faces resistance. During the vote in the Chamber, deputies allied with the government advised against the proposal.
One of the sensitive points is the maximum period of five days for Anvisa to inspect and release international products aimed at research.
Representative Ana Pimentel (PT-MG) also stated that there is a risk of turning people into guinea pigs.
The parliamentarian stated that recently there was a “scandal” involving medication, also used for the sterilization of women, in which the participants in the process did not receive support after the experiments.
According to her, the PL “is a step backwards in supervision” in relation to people who put themselves “altruistically” in research.
“This is a very important point, because it is a serious setback for this bill. If it is approved, we will be removing the main instrument that we built in recent years and which was a response to the violence committed in research on the bodies of human beings, especially women”, he lamented.
Another issue raised by parliamentarians is the period in which participants will only be able to receive experimental medicines.
According to the proposal, volunteers will be able to receive the products up to five years after completing the research.
“People’s lives cannot be turned into merchandise. They want to free the pharmaceutical industries, so that the responsibility for treating patients with new medicines is limited to five years. Another bill for the SUS: with the end of the five years of supply of the medicine by the industry, the person will take legal action so that the SUS continues the supply”, the leader of the PT in the Chamber, deputy Zeca Dirceu (PR), told CNN.
“In other words, instead of being a loss, for the industry it will turn into a certain profit. It is an irresponsible position to limit this obligation to 5 years, even in the case of rare diseases, whose treatments are expensive and their acquisition is prohibitive and whose new medicines are even more prohibitive, even more expensive”, he argued.
The parliamentarian points out that this point should remain as it is today. Resolution of the National Health Council (CNS) determines that participants in this type of test have free and indefinite access to the products even after the end of the research.
There is also concern about the data of patients undergoing these studies.
The lawyer specializing in regulation Marcus Pessanha, partner at Schuch Advogados, points out that clinical research carried out with human beings involves the analysis of data and information relating to biological materials, in most cases
“Thus, as they have an inevitable flow of information from everyone involved — be they doctors, researchers, financiers, laboratories, hospitals —, in addition to the already traditional issues of bioethics, it is necessary to respect the Personal Data Protection Law (LGPD) ”, said Pessanha.
“Thus, not only must the rules of consent in the processing of personal data be observed, but also the guidelines that prevent undue access or possible leaks of information must be observed, without forgetting the adoption of compliance in appropriate cases”, added the lawyer .
A proposal that creates rules for clinical research with human beings, approved by the Chamber of Deputies last week, divides opinions.
At the same time as it can represent an advance for clinical research and assist in the development of new medicines for rare diseases, there is concern about data and people’s physical integrity.
Bill 7,082/17, by former senator Ana Amélia (RS), defines the main rights of voluntary research participants, as well as the duties of researchers, sponsors and entities involved.
Among these points is the creation of a committee composed of a multidisciplinary team, with members from medical, scientific and non-scientific areas, and also a representative of the research participants.
The board will be responsible for filtering and analyzing the proposals. The decision will be sent to the Unified Health System (SUS) and, if there is strategic interest, as defined by the Ministry of Health, the research will have priority in ethical analysis and will have special analysis procedures, provided for in a regulation to be drawn up.
Regarding voluntary and unpaid participation in research involving human beings, interested parties will be required to present a free and informed consent form signed by the participant or their legal representative.
The volunteer may withdraw at any time, at no cost or loss to him or her. In addition, he or she will be entitled to reimbursement for transportation or food expenses for the volunteer and companions, if any.
For the rapporteur of the proposal in the Chamber, deputy Pedro Westphalen (PP-RS), it is a regulatory framework for clinical research on humans. He told CNN that the project will simplify studies and transform Brazil into a reference in clinical research in the world.
“It will unlock the research industry in Brazil. Universities and hospitals will also benefit,” said Westphalen.
“We managed to approve it in the Chamber, where it was very difficult due to the plurality of ideas, the number of deputies. But we talked to everyone and resolved points of disagreement. I hope that, in the Senate, approval will be faster. Certainly patients with cancer and other rare diseases are very satisfied”, added the parliamentarian.
According to estimates by the FarmaBrasil group, with regulation, Brazil will be able to attract R$3 billion in direct investments in clinical studies annually and generate R$5 billion in economic activity per year.
“The regulations establish a safe legal system, guarantee ethics and protection in favor of the patient and expand the population’s access to new life-saving medicines and therapies. It is an excellent opportunity for our country to expand the horizons of its research and Science and boost local pharmaceutical innovation. We consider the approved legislation a true legal framework for clinical research in Brazil”, celebrated the group’s president, Reginaldo Arcuri.
The proposal is also defended by patient groups. For Juliana Yamin, president of the National Institute of Dwarfism, the approval of the PL is progress.
“Technology in medicine has been advancing rapidly. Developed countries host studies of new technologies and Brazil is outside this context. I think that the change in legislation, obviously based on technical and ethical analysis, will be beneficial to stimulate progress in research in our country and give patients the opportunity to participate in studies that bring advances in treatments”, he said.
Data protection and “guinea pigs”
The project, however, also faces resistance. During the vote in the Chamber, deputies allied with the government advised against the proposal.
One of the sensitive points is the maximum period of five days for Anvisa to inspect and release international products aimed at research.
Representative Ana Pimentel (PT-MG) also stated that there is a risk of turning people into guinea pigs.
The parliamentarian stated that recently there was a “scandal” involving medication, also used for the sterilization of women, in which the participants in the process did not receive support after the experiments.
According to her, the PL “is a step backwards in supervision” in relation to people who put themselves “altruistically” in research.
“This is a very important point, because it is a serious setback for this bill. If it is approved, we will be removing the main instrument that we built in recent years and which was a response to the violence committed in research on the bodies of human beings, especially women”, he lamented.
Another issue raised by parliamentarians is the period in which participants will only be able to receive experimental medicines.
According to the proposal, volunteers will be able to receive the products up to five years after completing the research.
“People’s lives cannot be turned into merchandise. They want to free the pharmaceutical industries, so that the responsibility for treating patients with new medicines is limited to five years. Another bill for the SUS: with the end of the five years of supply of the medicine by the industry, the person will take legal action so that the SUS continues the supply”, the leader of the PT in the Chamber, deputy Zeca Dirceu (PR), told CNN.
“In other words, instead of being a loss, for the industry it will turn into a certain profit. It is an irresponsible position to limit this obligation to 5 years, even in the case of rare diseases, whose treatments are expensive and their acquisition is prohibitive and whose new medicines are even more prohibitive, even more expensive”, he argued.
The parliamentarian points out that this point should remain as it is today. Resolution of the National Health Council (CNS) determines that participants in this type of test have free and indefinite access to the products even after the end of the research.
There is also concern about the data of patients undergoing these studies.
The lawyer specializing in regulation Marcus Pessanha, partner at Schuch Advogados, points out that clinical research carried out with human beings involves the analysis of data and information relating to biological materials, in most cases
“Thus, as they have an inevitable flow of information from everyone involved — be they doctors, researchers, financiers, laboratories, hospitals —, in addition to the already traditional issues of bioethics, it is necessary to respect the Personal Data Protection Law (LGPD) ”, said Pessanha.
“Thus, not only must the rules of consent in the processing of personal data be observed, but also the guidelines that prevent undue access or possible leaks of information must be observed, without forgetting the adoption of compliance in appropriate cases”, added the lawyer .
