The pharmaceutical industry represented by AESGP¹, EFPIA², EUCOPE³, EuropaBio⁴, Medicines for Europe and PPTA⁵ – henceforth referred to as ‘the pharmaceutical industry’ – generally welcomes the European Commission (EC)’s Proposal for a Regulation on HTA⁶. We understand the scope of the joint clinical assessments foreseen in the proposal is limited to medicinal products subject to the centralised marketing authorisation, and exempting generic, biosimilar and non-prescription medicines⁷. 

The article, “How Blood-Plasma Companies Target the Poorest Americans,” by H. Luke Shaefer and Analidis Ochoa, published in The Atlantic on March 15, was unfair to plasma donors as well as to individuals living with rare, genetic, and chronic diseases who rely on access to plasma protein therapies. Plasma donors are due our gratitude and respect, not sweeping negative characterizations.

Yesterday, a Congressional committee took an unprecedented step that limits access to innovative life-saving medications relied upon by thousands of patients living with rare diseases. The repeal of the Orphan Drug Tax Credit would have devastating effects for those facing chronic and genetic diseases, as it has proven to be essential to the development of hundreds of medicines, including plasma protein therapies.

Introduction
A recent publication in the Emerging Infectious Diseases journal (published online on June 12, 2017) describes two individuals with bleeding disorders who were diagnosed with sporadic Creutzfeldt-Jakob disease (sCJD) (1). The authors of this scientific report have not established a causal link between the treatment with clotting factors and the development of sporadic CJD and concluded that “the occurrence of these cases may simply reflect a chance event in the context of systematic surveillance for CJD in large populations”.

The Plasma Protein Therapeutics Association (PPTA) is proud to support Rare Disease Day, an annual international event that seeks to raise awareness about rare diseases and the patients and families that are affected by a rare disease.

PPTA has viewed the documentary "Das Geschäft mit dem Blut" / "Le business du sang" that will air on Feb. 21, 2017 in Germany, France, and Belgium on ARTE TV. PPTA strongly objects to the content of the documentary because it is not factual and contains numerous inaccuracies and misinformation.

Updated Oct. 3, 2016

Recent scientific and public press reports have heightened awareness of the emergence of Zika virus (ZIKV) in the Americas^1,2 and the causal relationship between prenatal ZIKV infection and microcephaly and other severe fetal brain defects^3,4.

April 22, 2016—The Plasma Protein Therapeutics Association (PPTA) stands together with the global primary immunodeficiency community to promote World PI Week, a global campaign aimed to raise awareness and improve diagnosis and treatment of PI.

April 17, 2015–The Plasma Protein Therapeutics Association (PPTA) recognizes World Hemophilia Day, an annual international event sponsored by the World Federation for Hemophilia (WFH) that seeks to raise awareness of people living with inherited bleeding disorders.

The Food and Drug Administration (FDA) released its final guidance (Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry) for industry on reducing the risk of HIV transmission through blood and blood products today.