Message from the president of the Association

In recent years, Romanian patients have suffered repeatedly because they did not have access to essential treatments made of human plasma.

Repeated immunoglobulin crises have mainly affected patients with immunodeficiency, for whom normal human immunoglobulin was the only therapeutic alternative that protects them from severe infections that can have severe forms, with serious consequences and even death.

Not only Romania is affected by these immunoglobulin crises, but also other European countries, precisely because Europe depends on the plasma collected from American donors.

Practically, currently, manufacturers of plasma-derived medicinal products are no longer in competition with each other, because the demand for immunoglobulin, in particular, is over 15% higher than the production.

Thus, instead of a competition between manufacturers, in the market for plasma derivatives the competition is manifested only between customers, respectively between various European countries, which are trying to provide the necessary medicines for their own patients, offering higher and higher prices.

This severely affects competition in the European immunoglobulin market, which is a deficient product due to the lack of raw materials.

Only the four European countries (Austria, the Czech Republic, Germany and Hungary), which allow the collection in private centers, but also the compensation of plasma donors, manage to ensure the consumption of medicines made of plasma from their own donors. The four countries mentioned also manage to ensure a fully competitive environment, in which producers are in direct competition in both the plasma collection and capitalization on the finished products.

The rest of the European countries, such as France, Italy or Spain, depend on the plasma collected in the USA and equally on the plasma collected in private centers in Austria, the Czech Republic, Germany or Hungary. Moreover, in order to cover the shortages of finished products, all these countries have had to accept higher and higher prices, especially for normal immunoglobulin.

Producers adapt to this situation, in which they become the beneficiaries of a production crisis, by raising prices.

However, the European Commission is delaying the modernization of legislation on the collection, testing, processing and storage of human plasma for fractionation, although there is already sufficient evidence to demonstrate the success of the model already implemented by the four European countries, where the public and private sectors coexist in the field of plasma for fractionation.

Under these conditions, most countries are slow to implement best practice models that have proven to be effective and sustainable. In this way they contribute to the aggravation of the deficiency of human plasma and derived medicines, especially immunoglobulin.

Romania has no time to wait anymore! We can no longer be inactive witnesses to new immunoglobulin crises that bring many Romanian patients into serious condition.

The “Donam Plasma” Association, in accordance with the current legislation in Romania, will start the construction, authorization and operation of the first 10 plasmapheresis centers in Romania.

We will mobilize the best performing transfusion centers in Romania, together with great private companies with experience in collecting, testing and processing of human plasma for fractionation, so as to collect human plasma from Romanian donors, for the manufacture of essential medicines for Romanian patients.
Together with the associations of Romanian patients and doctors, we will promote human plasma donation, both in public and private centers, continuing to militate for the modernization of Romanian and European legislation.

In no more than two years, we want to open the first 10 plasmapheresis centers in Romania, with a total capacity of 200,000 liters of plasma annually.

This is just the beginning, because we hope that next year, the latest, European legislation will be amended to encourage all countries to allow plasma collection in public and private centers, respectively donor compensation, as in Austria, the Czech Republic, Germany and Hungary.

We invite all those interested in contributing to the smooth running of our project to actively participate in both the selection procedures and the public consultation sessions. More information can be found on the page www.donamplasma.ro More information can be found on the page www.donamplasma.ro/en

Florin Hozoc,

President of “Donam Plasma” Association

Bucharest, December 23rd, 2021