Saturday, January 22

People with rare diseases will be affected by the ‘Build Back Better’ plan

Rare disease investigations receive a tax credit that could be suspended.


Although the Build Back Better (BBB – Rebuild Better) agenda has been celebrated for its economic benefits on a number of fronts, including health insurance and reducing the cost of certain medications, there is a proposal that seeks savings, but it would affect millions of people, including Latinos, with rare diseases.

There are more than 7,000 rare diseases, such as muscular dystrophy, multiple sclerosis, anemia, and autoimmune conditions, But there are not treatments for all of them, so a law passed in 1993 helped to continue research so that these patients had a better quality of life.

The so-called Orphan Drug Tax Credit (ODTC) allows drug companies to raise funds to create new drugs for rare diseases and testing some existing drugs against other diseases, but that will no longer be the case with the BBB law that the House and Senate are currently discussing.

This request is about the importance of not reducing funds ”, warned Dr. Elena Ríos, President and CEO of the National Hispanic Medical Association (NHMA) and member of the RDDC Steering Committee. “It allows companies to research new drugs for rare diseases … and to investigate current medications, which could be used for different diseases ”.

Since the Orphan Drug Law was passed in 1993, Dr. Ríos points out that the number of medications for rare diseases went from 30 to 600.

“The BBB agenda – they are looking for money for new programs, very important, but we fear that Congress will withdraw the funds,” he said.

During the pandemic of COVID-19, patients with any of the thousands of rare diseases faced greater challenges in their treatment. A recent study on immune disorders of the central nervous system, such as multiple sclerosis, pointed out, for example, that Latino and African American communities were particularly affected.

“(They are diseases that) carry a high risk of disability and disproportionately affect blacks and Latinos,” says the report from the Keck School of Medicine at the University of Southern California.

He adds that a disease associated with a rare inflammatory disorder of the central nervous system represents up to 42% of patients, a high number of them are Latino, it added.

“Considering the disadvantages these populations face is critical to achieving health equity,” the report states.

What Congress Proposes

Subpart E of the $ 1.75 billion bill passed in the House of Representatives refers to “other business tax provisions,” where it is clear the limitation of funds for testing to orphan drugs of first use or indication.

This provision limits the credit for qualified clinical trial expenses to expenses related to the first use or indication of an orphan drug.“, indicated. “The provision establishes that the costs of clinical trials of any drug that has received a marketing approval for any use or indication (whether for use in rare diseases or conditions or non-rare diseases or conditions) do not qualify for the credit.”

It is specified that said modifications made apply to taxable years beginning after December 31, 2021.

“We are going to have a decrease in funds for these diseases, such as muscular dystrophy, multiple sclerosis, anemia … which have shown improvements, so many people can now live longer in our communities, in our families, in Latino communities,” he warned Dr. Ríos.

An ‘inconceivable’ action

For this reason, the expert joined the call of the National Organization for Rare Disorders (NORD), which also recognizes the provisions in the BBB law for medical aid in general, but described the proposed changes in Subpart E.

It is inconceivable that Congress is targeting this fundamental incentive which, for decades, has successfully fueled the development of new cures and hope for the rare disease community, ”NORD said in a statement.

Dr. Ríos said that senators should suspend their intention to withdraw the funds, noting that the incentives are maintained for current drugs, not for new ones that could be effective.

“Those studies have to be in Latinos, African Americans, each person is very different,” he warned. “There are people who are already walking thanks to these drugs … many Latino families do not always know what disease it is, because they are rare.”

The expert said that senators must understand the importance of maintaining this incentive, especially after seeing results in patients.

“It is important to have access to medicines, so you don’t have to go to the hospital, you can be treated at home,” he said. “The issue of rare diseases is that there are families everywhere … This is a problem that all senators must understand, that they cannot change the law just to save some money.”

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