The Plasma Protein Therapeutics Association (PPTA) expresses serious concern about the ongoing hostilities in Ukraine and the devastating impact on the lives of people in the region. As an association representing plasma collectors and manufacturers dedicated to saving and improving human lives, our primary focus remains on ensuring that patients have access to the essential plasma-derived treatments they rely on. Our member companies are making every effort to secure access for patients in the affected region during the conflict and in its aftermath.

Dear PPTA Members and Patient Stakeholders,

We are writing to you today to inform you that Amy Efantis, PPTA’s president & CEO, recently informed the Global Board of Directors of her decision to leave the association. Her last day was Tuesday, February 15. We appreciate Amy’s contributions to PPTA in her time leading the association and wish her well in her future pursuits.

The Plasma Protein Therapeutics Association (PPTA) disagrees with the 15 February 2022 ruling from the Romanian Competition Council (RCC) finding that PPTA directed manufacturers to withhold immunoglobulin (Ig) therapies from the Romanian market to force repeal of the so-called “clawback” tax. This conclusion is not supported by the RCC’s own investigation, which produced no evidence that company withdrawals from the Romanian market were the result of anything other than independent business decisions.

The Plasma Protein Therapeutics Association (PPTA) is aware of emerging reports regarding patients not having reliable access to lifesaving plasma-derived therapies used to treat a variety of serious, rare, and chronic conditions caused by missing or deficient proteins in their blood. While there could be many reasons for these access challenges, the fact remains that for most of these conditions, plasma is the only starting material for effective therapies.

An article published by ProPublica on June 24 (“The U.S. Is Closing a Loophole That Lured Mexicans Over the Border to Donate Blood Plasma for Cash”) is the latest sensationalized reporting from ProPublica and ARD German TV reporters who continue to misrepresent and malign U.S. policies regarding plasma donation as well as the scores of committed individuals who cross the U.S.-Mexico border to donate their plasma. Tens of thousands of people safely donate their plasma every day in the U.S., with every donation directly contributing to helping nearly 125,000 Americans with serious and often life-threatening conditions live healthy and normal lives, as well as countless others facing trauma and emergency medical needs every day.

The journal publication, “Immunoglobulin Replacement Therapy is critical and cost-effective in increasing life expectancy and quality of life in patients suffering from Common Variable Immunodeficiency Disorders (CVID): A health-economic assessment,” is authored by Professor Philippe van Wilder with the Université libre de Bruxelles and Professor Esther de Vries of Tilburg University and offers a health economic model to estimate the value of treatment with IG therapy for CVID patients.

The International Plasma and Fractionation Association  and the Plasma Protein Therapeutics Association are pleased with the recent publication by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) "CHMP Position statement on quality and safety assessment for the Plasma Master File (PMF) certification with regard to donor deferral criteria for sexual risk behaviour," as such a position was highly needed, especially regarding men-having-sex-with-men (MSM). It clarifies that the application of these nationally defined deferral periods will from now on also be considered when assessing appropriateness of locally collected plasma to be included in a PMF.

In a recent communication, the U.S. Food and Drug Administration (FDA) limits the collection and use of COVID-19 convalescent plasma authorized under Emergency Use Authorization for the treatment of hospitalized patients with COVID-19.¹ It is important to note, however, that this development does not mean that the need for plasma donations has diminished.  Both normal source plasma donations, from healthy individuals, and convalescent plasma donations, from individuals who have recovered from COVID-19, are still needed to fight COVID-19 and the many non-COVID-19 conditions (e.g., immune deficiencies and blood clotting disorders) for which plasma protein therapies are ordinarily used.

A recent publication¹  explores possible reasons for the increased use of immunoglobulins (IG) and suggests growing clinical need can be met by restricting patient access to IG while denying the need to collect more plasma in Europe. With a global mission rooted in promoting the availability of, and access to, plasma-derived therapies for all patients who need them, the Plasma Protein Therapeutics Association (PPTA) disagrees with these suggestions and remains dedicated to its long-standing commitment to supporting patients and to expanding plasma collection, particularly in Europe.

The Plasma Protein Therapeutics Association (PPTA) and its member companies wish success to President Biden, Vice President Harris, and the dedicated public servants of their Administration as we join them to improve the health of all Americans.