Donor compensation could improve Europe’s access to plasma therapies
Plasma, a liquid component that makes up about half of the content of human blood, forms the basis of many therapies for rare and complex diseases. Demand for these life-saving treatments is growing – but in Europe, where 38% of plasma is imported from the United States, raw material supplies are tight.
A new report from Copenhagen Economics (CE), commissioned by pharmaceutical giant Takeda, explored the value of plasma-derived therapies to patients and the economy at large, amid concerns about the long-term supply of the drug. Europe in plasma for the treatment of diseases.
Important patient need
The EC estimates that around 30 million Europeans are affected by rare diseases, and more than a million patients in Europe live with the 12 best known, such as hemophilia and primary immunodeficiency disease. Although there are alternative treatments for some diseases, the EC report points out that there are several conditions for which plasma-derived drugs are the only treatment available.
“Even when there are other ways of treating patients, plasma adds to the physician’s toolbox and provides very important treatment for a number of patients who otherwise would depend on treatment under. -optimal. “
Donation and supply of plasma
Europe’s supply of blood plasma is heavily dependent on imports; plasma imported by the five largest importing countries (Germany, Austria, Spain, Sweden and Belgium) accounted for 2.5% of total imports of medicines and pharmaceuticals into the EU in 2017.
There is a risk that the supply will not keep pace with the growing demand for plasma-derived therapies in Europe, according to the report, and the scarcity of human plasma donations is a key factor in the industry’s inability. to increase the production of treatments. .
Only four countries in Europe – Germany, the Czech Republic, Austria and Hungary – allow monetary compensation of donors and the collection of plasma by private entities, while reimbursement and non-financial purchase policies vary across the continent.
In the report, CE describes the “commodification” of plasma-derived therapies, where different treatments are “treated as homogeneous and undifferentiated products and therefore bought and priced as such”. It offers the different immunoglobin therapies as an example; reimbursement policies may vary depending on the type of immunoglobulin therapy, and in some countries only one specific type is reimbursed. As a result, some patients will receive suboptimal treatments for their specific medical needs, although better options are available.
According to the report, a reassessment of donation programs across Europe is needed to help secure the continent’s plasma supply. The authors claim that while reimbursement for expenses associated with plasma donation is “ethically acceptable, compatible with the principle of VUD and in line with European law”, such reimbursements are currently not available in all EU states.
“A paradigm shift in the remuneration of plasma donors in Europe that includes a small monetary or non-monetary compensation will be ethically acceptable, significantly increase donations and make the European supply of plasma-derived therapies more resilient to shocks in the supply chain. ‘supply,’ the report says.
While it says there is a strong case for a review of plasma donation programs, the report stresses that compensation should not incentivize donations from people who otherwise would not have done so.
Haanperä also points out that CE does not make specific policy recommendations in the report, but rather provides an evidence base on which policies to secure Europe’s plasma supply can be developed and implemented.
“What we are emphasizing is that this principle of voluntary and unpaid giving can be respected with different donation programs,” he says. “These solutions have worked and they may be compatible with the directive and ethically acceptable. There is an important distinction between compensating donors for the costs they incur and inducing donors who otherwise would not give.
A spokesperson for Takeda, the pharmaceutical company that commissioned the report, said: “Global demand for plasma and these life-saving therapies continues to outstrip supply, in large part due to a lack of infrastructure for plasma collection and fractionation and very restrictive regulatory and legislative frameworks in place.
“Some of these policies and regulations have not kept pace with current scientific knowledge. We hope that increased awareness will help spark the conversation about the urgent need to update science-backed laws and regulations that govern the collection of human plasma for the production of these essential medicines. ”