Main actors

The main actors that can play a role in collecting plasma for the manufacture of derived medicines are:

a) Transfusion centers

According to the legislation in force, in Romania, only the transfusion centers or the transfusion units at the hospital level can harvest blood or blood components.

The hospital transfusion units function as external sections of the county transfusion centers. In exactly the same way, plasmapheresis centers can be set up and function as external sections of a public transfusion centers. Plasma thus collected is the property of the transfusion center. Plasma for fractionation can be transferred to a manufacturer in exchange for the finished products, which are then sold to hospitals.

The amounts thus collected through the sale of finished products will cover the costs of collection, testing, processing, storage that are in charge of the “Donate Plasma” Association, respectively the costs with donors (voucher, transport settlement, one day off) and any other indirect costs which are in charge of the transfusion center. Margin from the sale of finished products is used exclusively for campaigns to promote plasma donation and the donation of blood and other blood components.

b) Local authorities (County Councils, City Halls, County Hospitals, Medical Universities)

Perhaps the most important thing is alongside the plasmapheresis and transfusion centers to be the local authorities in order to mobilize the community. That is why, one of the most important criterion in selecting the 10 transfusion centers where we will implement our project, is the one related to the involvement of local authorities.

Whether we are talking about the County Council, the City Hall, the County Hospital or even the local University of Medicine, the transfusion center needs to prove that it enjoys the support of at least one of these institutions that represents the community and plays the role of local sponsor, meaning that it provides non-financial/non-material support.

The role of these local sponsors is to mobilize the population and, in general, local resources, but especially to ensure the dialogue and support of the central authorities.

The local sponsor will be the one who has the duty to ensure that the partnership between the “Donam Plasma” Association and the transfusion center is also supported by the central authorities, respectively by all local actors.

c) Private companies (manufacturers of plasma-derived medicines, independent plasma collection companies for fractionation, manufacturers of blood and blood components collection, testing or processing equipment).

Perhaps the most serious threat to the success of this project is the lack of experience of the Romanian actors involved in this initiative. That is why, a very important role is played by private international companies, which have a great deal of experience in collecting plasma for fractionation.

That is why, this project is open to all private companies interested in participating, both through investments in the infrastructure of these 10 centers, through the contribution of know-how, or even only through the development of strictly commercial relations (finished products offered in exchange for the collected plasma).

In this way, private companies will compete for access to the plasma collected in the 10 plasmapheresis centers, offering in return the finished products needed.

The braver companies will be able to offer more, namely the financial participation in the construction and operation of some of the 10 plasmapheresis centers, thus ensuring their long-term access to the collected plasma and the amortization of investments in a relatively short time.

d) Medical professional associations (hematology, transfusion, immunology, neurology, etc.)

An extremely important role is played by specialist doctors, both those in the specialties directly involved in the collection, testing, processing of plasma, and doctors who use plasma-derived medicines in the treatment of patients.

Thus, the most important role is played by associations of hematologists, especially those specialized in transfusion, which will help us select, train and evaluate the staff in the plasmapheresis centers. They will also help us to write and regularly review the working procedures in the plasma collection centers.

Also, the medical associations in the clinical fields that use plasma derivatives in the treatment of patients, will have an important role in the activities of informing donors about the importance of their gesture, respectively about the role of plasma derivatives in the treatment of thousands of Romanian patients.

e) Patient Rights Associations (ARPID – Romanian Association of Patients with Primary Immunodeficiency, APAA – Association of Patients with Autoimmune Disorder etc.)

Perhaps the most important role is played by patient rights associations, especially those of patients with conditions that require treatment with human plasma-derived medicines.

Especially in the circumstances in which Romania has already gone through several severe immunoglobulin crises, the “Donam Plasma” Association aims to involve patient associations in all decision-making processes regarding each stage of development of plasmapheresis centers.

Thus, the patient associations will be constantly consulted and will actively participate in all decisions regarding the selection of transfusion centers, respectively the private partners with whom the plasmapheresis centers will be developed.

Also, the patient associations will be consulted and actively involved in the development of donation promotion campaigns, precisely because the final beneficiaries of the products made from the collected plasma will be the Romanian patients.

f) The Ministry of Health will be permanently consulted and will be actively involved in each phase of the project. Also, the National Institute of Transfusion Hematology will be constantly informed and consulted, in each phase of the project.