Press Releases

Lifting of long-time ban on use of UK plasma for manufacturing of immunoglobulins will help patients

February 25, 2021 (Annapolis, MD) - The Plasma Protein Therapeutics Association (PPTA) welcomes the decision of the UK government to lift a two decades old ban on the use of UK-donated plasma for the manufacture of immunoglobulins, following a scientific review conducted by the Medicines and Healthcare Products Regulatory Agency. The ban was imposed in 1998 to mitigate the spread of variant Creutzfeldt Jakob Disease (vCJD), but experts have now concluded that the use of UK-sourced plasma to manufacture immunoglobulins is safe and can recommence, supported by a set of robust safety measures.

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Treatments for rare diseases at risk, due to the decline of plasma donations

Representatives of patient advocacy groups, expert physicians, thought leaders, and representatives from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research came together on December 9 at a roundtable sponsored by the Plasma Protein Therapeutics Association (PPTA) to discuss the impacts on people with rare diseases if not enough plasma is available to manufacture lifesaving plasma-derived therapies. These therapies are often the only treatments available for people with primary immune deficiencies, bleeding disorders, Alpha-1 Antitrypsin deficiency, hereditary angioedema, and certain neurological conditions.

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Inception Impact Assessment Underlines the Need for Timely Action to Decrease the Reliance on Third Countries for Plasma

The Plasma Protein Therapeutics Association (PPTA) welcomes the European Commission’s publication of the Inception Impact Assessment (IIA) as a necessary step in the ongoing evaluation of the EU legislation on blood, tissues, and cells (BTC). Rightfully, the assessment underlines the need for timely action to decrease Europe’s reliance on third countries for plasma. We appeal to authorities to urgently take the necessary steps to collect more plasma through plasmapheresis in Europe As highlighted by the European Commission, plasmapheresis is a more efficient collection method compared to the collection of recovered plasma.1

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EU Health Commissioner Says Plasma Donation is “More Important Than Ever”

The Plasma Protein Therapeutics Association (PPTA) welcomes EU Health Commissioner Kyriakides’ recognition of the importance of plasma donation in her observance yesterday of World Blood Donor Day. By noting plasma’s role in the manufacture of plasma-derived medicinal therapies (PDMPs) for people with a range of life-challenging diseases, as well as its potential role in treating people with COVID-19, Commissioner Kyriakides rightly notes that “donating plasma is therefore now more important than ever.”

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New Edition of EDQM Blood Guide Risks Decreasing European Plasma Collection

28 May 2020 (Brussels) - The Plasma Protein Therapeutics Association (PPTA) is concerned about the recommendations contained in 20th version of Blood Guide of The European Directorate for the Quality of Medicines (EDQM) which aims to harmonise standards and recommendations on blood collection, preparation, and the use of blood and blood components. This Guide, if applied, will have a negative impact on the availability of plasma to develop Plasma-Derived Medicinal Products (PDMPs) for European patients as it fails to distinguish between requirements for transfusable blood components and plasma for manufacturing, especially concerning donor deferrals.

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PPTA Applauds Administration for Focus on Plasma Donation

April 24 — (Annapolis, MD) — The Plasma Protein Therapeutics Association (PPTA) applauds the Administration for comments made during the April 23 White House Coronavirus Task Force briefing in which Americans were encouraged to contact their local plasma donation center to learn how they can help. There are currently more than 800 plasma donation centers across the United States, many of which are now collecting plasma from recovered COVID-19 patients, as well as source plasma relied upon by thousands of people living with serious, rare, and often life-threatening conditions. Donation centers can be found by visiting www.donatingplasma.org.

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Plasma-Derived Therapies Provide Significant Health Value Gain

New report analyses clinical, economic, and societal perspectives for patient access

12 March 2020—(Brussels, Belgium)—The Plasma Protein Therapeutics Association (PPTA) recognizes Vintura, a leading consultancy specializing in healthcare and life sciences, for publishing “Key Economic and Value Considerations for Plasma-Derived Medicinal Products in Europe.” The report provides a critical investigation into the clinical, economic, and societal dimensions of PDMPs, with a focus on improving patient access to these lifesaving medicines.

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PPTA encourages EDQM to take a patient-centric approach in the implementation of its Plasma Supply Management Recommendations

The European Commission and the European Directorate for the Quality of Medicines (EDQM) recently published recommendations on plasma supply management in Europe. The recommendations were drafted by a working group of transfusion specialists representing national blood services (also called the TS093 working group). PPTA thanks the EDQM and the European Commission for addressing this important issue but is concerned that the recommendations do not go far enough towards ensuring the collection of sufficient plasma to meet the growing clinical need for plasma-derived medicinal products (PDMPs). 

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