ANNAPOLIS, Md., April 15, 2011 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) applauds Congress and President Obama for preserving patient access to safe and effective plasma protein therapies by repealing the 1099 tax-reporting provision.
PPTA strongly supported passage of the new law, the ''Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act of 2011,'' because without the repeal of this requirement, the number of human plasma donations could have been drastically reduced. Proteins fractionated from human plasma are the active agents in a variety of lifesaving, medicinal therapies, including blood clotting factors and immune globulin. President Obama's signature was a critical development for the rare disease community.
"The repeal of this tax-reporting provision is a victory for patients who depend on access to plasma protein therapies and for which there are no substitutes or generic equivalents," said Julie Birkofer, senior vice president, North America, PPTA. "Plasma donors are essential to the creation of these therapies, and we are grateful to them."
Plasma is a biological material that cannot be manufactured. Vital to collection of high-quality plasma is the repeat or "qualified" donor. In order to be "qualified," the donor must give plasma twice within a six month period and test negatively on both occasions for known pathogens. Only then can either donation be used to produce a therapy. This voluntary industry standard, which is the cornerstone of the International Quality Plasma Program (IQPP), is crucial to the production of safe therapies.
Because of the length of time it takes to donate plasma, on average one-and-a-half hours; strict eligibility requirements; the rigorous donor screening process; and volume of plasma required to produce therapies, plasma donation is compensated. The tax-reporting provision could have interrupted the regular flow of repeat plasma donors and discouraged healthy, committed donors from giving plasma.
Plasma protein therapies, which include plasma-derived therapies and recombinant blood clotting factors (a biotechnology product), are used every day to treat people with bleeding disorders such as hemophilia, which causes painful internal bleeding and debilitating joint damage; primary immunodeficiency diseases, which render the body defenseless from even the most common infections, often leading to pneumonia and other serious illnesses; and alpha-1 antitrypsin deficiency, also known as genetic chronic obstructive pulmonary disease (COPD). Additionally, a plasma protein therapy is used in critical care settings, when treating severe trauma, burns and during major surgery.
Under the Patient Protection and Affordable Care Act signed into law last March, starting in 2012, businesses would have been required to file an IRS Form 1099 for each vendor from whom they purchase more than $600 in goods and services over the course of the year. Compensation provided to plasma donors for the time and effort associated with donating would have qualified for the onerous reporting requirement under the provision.
The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.
SOURCE Plasma Protein Therapeutics Association (PPTA)