Global and domestic policy changes boost plasma supply

The need for plasma is at an all-time high, with 6,500 units needed daily in the U.S. alone. Plasma donation saves millions of lives each year. Manufacturers use this clear, yellowish part of blood to create therapies that treat chronic, rare diseases like blood clotting disorders and immune system conditions. Meeting this growing demand requires science-based policies that expand access to donation while maintaining safety standards. Regulations at both the state and federal levels allow donation centers to operate efficiently and safely.

Global policy changes boost plasma supply

Governments worldwide are updating regulations based on medical evidence, which is expanding access to plasma donation and increasing the global plasma supply. These new policies represent significant progress.

United Kingdom rescinds mad cow-era donation ban

The United Kingdom (U.K.) lifted a 20-year ban in 2021 that now allows its citizens to donate plasma for domestic use. Officials originally implemented the ban as a preventative measure against transmitting variant Creutzfeldt-Jakob disease (vCJD, also known as mad cow disease), but cases have remained low since 2004. This drop in cases, combined with new processes that reduce plasma infectivity, makes the risk of transmitting vCJD through blood products extremely small. The U.K. has opened donation sites in Birmingham, Reading, and Twickenham since lifting the ban.

Canada allows for donor compensation

Canadian Blood Services (CBS), a nonprofit funded by provincial governments, reached a deal in September 2022 with the Spanish pharmaceutical company Grifols, allowing donors to be compensated for their time. CBS banned paid donations in 2014 after tainted blood products from HIV and hepatitis C-positive donors resulted in thousands of deaths in the 1980s.

Today, measures such as extensive testing and virus removal steps during manufacturing ensure plasma products are safe even if someone with an infectious disease unknowingly donates. As a result, not a single case of disease transmission through tainted blood has occurred since the 1980s outbreak. Grifols now has plasma donation centers in Calgary, Edmonton, Halifax, Hamilton, Manitoba, and Winnipeg.

Australia modernizes approach to infectious disease risk

Based on medical evidence, Australia is leading the way in replacing a previous policy of deferring entire groups of people based on sexual risk factors. The new approach evaluates risk with individual assessments for every donor, which allows men who have sex with men (MSM) to donate for the first time and could impact upwards of 57,000 people. Australia is the first country to allow men on pre-exposure prophylaxis (PrEP), a medication taken to prevent getting HIV, to donate.

To prevent HIV transmission, measures are still in place regarding an individual's sexual conduct. Healthcare providers test each donor for HIV, hepatitis B, and hepatitis C, and also test the plasma post-donation for antibodies that the body produces in response to a virus.

These new measures will not only remove unnecessary restrictions that apply to only certain groups, reducing discrimination and stigma, but will also allow many individuals who were turned away in the past to donate.

Ensuring donor safety

The health of plasma donors is just as important as the patients who need plasma-derived therapies. Research shows that plasma donation may result in a brief reduction of immunoglobulin (IgG) before levels return to baseline within 48 hours. Studies have tracked both physical and mental components before and after donation and found little to no meaningful changes, regardless of donation frequency. The most commonly reported symptoms after donation include cold, fatigue, cough, and sore throat. This research is key to sustaining participation in plasma donation programs and combatting misinformation about plasma donation.

Challenges in global plasma production

Despite these positive developments, significant challenges remain. Of the 171 countries that report on plasma-derived medicinal products (PDMP), 115 do not collect plasma donations at all. The World Health Organization (WHO) states, "providing safe and adequate blood should be an integral part of every country's national healthcare policy and infrastructure." Of the countries that do collect plasma donations, the median amount collected per 1,000 citizens is only about 5 liters per year. In context, a patient with primary immunodeficiency (PI) requires 82-142L of plasma per year, so one person living with PI can be treated for approximately every 24,000 citizens.

The European Union (EU) Commission, Council, and Parliament are currently discussing legislation introduced in 2022 on substances of human origin (SoHO). On September 12, 2023, the EU moved forward with language stating donors can only be compensated for quantifiable losses or expenses incurred during donation. It's unclear whether the paid donations system already in place in a handful of EU countries will be able to continue, and restrictive compensation language could increase EU dependence on imported plasma.

Harmonizing state regulations in the United States

While international policy changes expand access globally, on the domestic front, regulations also play a critical role in plasma supply. Some states have enacted regulations that exceed Food and Drug Administration (FDA) standards. These extra burdens reduce the incentive for companies to build new centers and create unnecessary obstacles for donors.

One example is state regulations requiring higher credentials for staff than the FDA mandates. Connecticut as of 2026 has only one plasma donation center due to a requirement that center directors needed to have specialized blood banking training—expertise that is extremely rare and that plasma centers don't use. Pennsylvania required lab directors to have a Ph.D. plus 10–15 years of experience and to be on site during all open hours, making recruitment difficult. Recently, both Pennsylvania and Connecticut passed legislation to better align with federal requirements. Vermont and New Hampshire still need updated regulations and have zero plasma donation centers as of 2026.

With the demand for plasma and plasma-derived products growing each year, a consistent supply of source plasma is critical. State regulations play an important part in maintaining safe plasma donation; however, they can also be unnecessarily burdensome, leading to fewer donation centers, operational inefficiencies, and decreased plasma donation. Above all, plasma donation regulations must prioritize the safety of donors and the patients whose lives depend on them—which the federal standard does.

Patient advocacy groups including the Immune Deficiency Foundation, the GBS/CIDP Foundation, and the National Bleeding Disorders Foundation work to educate legislators and state agencies on the role of plasma donation in creating the lifesaving therapies rare disease communities rely upon. As countries worldwide update their policies and states align their regulations with federal standards, more patients will be able to access the plasma-derived therapies they need to live healthier lives.