🚁 Flying cars

Happy Friday! Today, we talk about regulators’ moves to set up regulations for vertiports — structures for eVTOLs (also known as “flying cars”). Looser rules for human drug trials. And a new entrant in the São Paulo mayoral race.

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eVTOL regulatory sandbox is close

Anac, Brazil’s civil aviation agency, is expected to publish next week its call for proposals around the construction of vertiports, which are designed for the vertical take-off and landing of aircraft such as eVTOLs (electric vertical take-off and landing).

 Why it matters. This is the first specific notice focused on vertiport infrastructure. Anac says the process will allow the agency and companies in the sector to work together to develop standards to guarantee innovation.

Rules of engagement. To admit interested parties, Anac will consider the maturity of the proposals in terms of risk management, potential for regulatory advancement, responsiveness, and collaborative attitude — as well as the level of technological maturity.

Challenges. The main challenge for creating vertiports has been how to make recharging eVTOLs possible. “It takes time for you to create an infrastructure that can take all the power to charge eVTOLs,” said Maria Paula Macedo, manager of Anac’s airport infrastructure department.

• According to her, even the possibility of changing batteries is complex. “There is the question of where batteries will be stored. We’re talking about a large amount [of batteries], in addition to their need for cooling.”

• In a recent trade industry event, Luiz Renato Mauad of Eve Air Mobility — a startup spun off Embraer-X years ago — added that the powering challenge is the biggest hurdle for transforming current helipads into vertiports.

Hopes. Eve hopes to have the first full-size prototype of its aircraft ready by the end of this year and flying by the end of 2026. 

Plans. The company projects its aircraft will operate routes of between 25 to 30 kilometers, which would cater to the main spots of most important urban patches. Each vehicle would have 100-kilometer autonomy and fit four passengers, not including the pilot.

• Eve believes that São Paulo could have up to 35 vertiports by 2040, with roughly 450 aircraft serving 8 million passengers.

Human trials

President Luiz Inácio Lula da Silva enacted a law establishing new rules for carrying out human clinical trials, but vetoed two provisions of the bill approved by Congress in April.

 Why it matters. Pharmaceutical companies say the new regulations will encourage innovation. Multiple scientific organizations, however, warn that these rules reduce scientific rigor and human dignity. If it were up to them, Lula would have vetoed many more of the bill’s provisions.

What was scrapped. Lula vetoed a section that shortened to five years the period in which companies, after carrying out research, were obliged to continue providing experimental medicines to participants. Currently, this obligation is valid for an indefinite period of time, “regardless of [the drug’s] commercial availability in the private sector.”

• The determination that prosecution offices should be notified about the participation of indigenous people in research was also done away with. The Indigenous Peoples Ministry considered the provision a violation of the principle of equality between citizens.

What stood still. The president preserved the section establishing that it will be up to the head of state to define which body within the Health Ministry will oversee the research ethical assessments, despite calls for a veto from the Brazilian Public Health Association and dozens of other entities. 

• For scientists, this responsibility should remain with the National Research Ethics Committee, linked to the National Health Council.

• The council brings together representatives of users of the health system, workers, and industry. Researchers say this configuration has allowed the committee to protect patients “from abuses carried out in the name of science.”

What they are saying. “With an appropriate regulatory environment, it is safe to say that Brazil will be able to attract more investments to the area and possibly jump at least ten positions in the ranking of leading research countries,” said Senator Dr. Hiran, the bill’s rapporteur.

Other provisions. The text defines 56 legal and scientific terms, including the concept of biobanks, which store biological material for research without commercial purposes.

• It also establishes deadlines for the National Health Surveillance Agency (Anvisa) to evaluate requests for human trials, and automatic approval in case the regulator exceeds this period.

Political conflicts. The new law, with Lula’s vetoes, will come into force within three months. Until then, Lula’s vetoes can be overturned by Congress — something which has happened quite frequently in recent months.

A right-wing spoiler?

Self-help guru Pablo Marçal — a sort of Brazilian answer to Tony Robbins — a week ago announced his candidacy for mayor of São Paulo. He surprised many by hitting 7 percent of voting intentions in a recent Datafolha poll — in a statistical tie for third place with other candidates. According to Atlas Intel, Mr. Marçal polls at roughly 10 percent.

 Why it matters. While Mr. Marçal remains miles below frontrunners Guilherme Boulos (a leftist congressman) and incumbent Ricardo Nunes, he could be a spoiler for Mr. Nunes — who is catering to the conservative electorate. 

Know the candidate. Mr. Marçal is a life coach and motivational speaker who became infamous for endangering roughly a dozen followers in an ill-fated attempt to reach the top of a hill amid poor weather conditions. Also, one of his students died after suffering a heart attack after taking part in a “surprise marathon” organized by Mr. Marçal..

• He has also been a notorious spreader of disinformation. Recently, Mr. Marçal helped relay a rumor that the Rio Grande do Sul government was stopping trucks with aid to people affected by the state’s recent floods for bureaucratic reasons, and forcing them to go back. 

• Moreover, in 2010, he was convicted for having joined, at the age of 18, a ring that embezzled money from banks. The statute of limitations, however, made it possible for him to avoid serving his sentence behind bars.

Campaign accounts. Mr. Marçal considered running for president and then for Congress in 2022 but ended up being investigated by the Federal Police on suspicion of using the campaign to launder money. He says he is being politically persecuted. 

On his side. Other candidates with appeal to the right-wing may drop out. That is notably the case of television presenter José Luiz Datena, who made a name for himself by presenting true crime shows. At almost every new electoral cycle, Mr. Datena throws his name in the hat — only to drop out when push comes to shove. 

Against him. Mr. Marçal is running for the tiny PRTB party, which has no representation in the House. Therefore, TV stations are not necessarily obliged to invite him to televised debates, which could reduce his exposure. That would be a major hurdle for him — at least in theory, although Mr. Marçal commands a large social media following of more than 10 million people.

Quick catch-up

Enel’s board approved the nomination of Guilherme Lencastre, the current chairman of the board, to be the company’s new head of São Paulo operations. Enel, a power distributor, has attracted much scrutiny due to recent outages in the country’s biggest city.

Brazil’s public debt reached rose to 76 percent of GDP and reached a nominal high of BRL 1.04 trillion. Part of the reason for the rise is the fact that Brazil has endured sky-high interest rates for years — the benchmark rate currently sits at 10.5 percent.

São Paulo’s top court rejected a motion by left-wing parties to block the privatization of Sabesp, a major sanitation company.

President Lula’s approval rating in the city of São Paulo continues to fall. Lula had 45 percent approval last year — which has dropped to 38 percent in March and 35 percent now.

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