The report is available in English with a Dutch summary - KCE

8 Plasma KCE Reports 120
In the light of these criteria, only products that comply with these two criteria should
be considered as “medicinal products”. However, one must remain cautious on that
point, and keep this legal issue under scrutiny.
Apart from purely regulatory subjects, the EU level also plays a strategic role in the
promotion of voluntary unpaid donation, in order to identify avenues worth exploring
to improve EU countries’ self-sufficiency, within the ethical and regulatory framework
described above. This EU will play an important role over the next years.
EU policy and ongoing projects on promotion of voluntary unpaid donation
SURVEY OF THE EU COMMISSION (DG SANCO) ON PROMOTION OF UNPAID
DONATION
One of the key issues for political decision-makers, but also for practical organization of
blood and plasma donation is the lucrative or unpaid nature of donation. This takes us
back to ethical notions, and to a philosophical and political debate.
Some countries like the United States clearly opted for remuneration of donation,
whereas others - like Canada and EU countries - opted for non remuneration of
donation. The EU level formally recorded that donation is unpaid. Within this ethical
framework, the EU level organized an in-depth enquiry to learn more on existing
practices on unpaid donation across Member States.
A Europe-wide survey has been launched by the EU-Commission (DG Sanco) 5 a few
years ago on that subject, and a summary report has been issued on 17 th May 2006.
Across Member States, practices can vary on two points: Interpretation of the principle
of “unpaid donation” and Promotion of donation itself.
Interpretation of the principle of “unpaid donation”: from a political and ethical point of
view, the principle of “unpaid donation” is the cornerstone of the donation systems, all
over the EU. However, this principle does not exclude “financial compensation” for
donors in some countries (or in specific institutions within these countries, depending
on their own political options). The amount of this financial compensation is kept below
a specific threshold set out by legislation, and the nature of expenses covered (and not
covered) by this compensation (travel expenses, car park, etc..) is generally set out very
precisely by the country’s legislation.
Germany is a traditional example on that point: as explained further in the report, many
German institutions involved in donation - especially private institutions involved in
plasma donation- apply financial compensation as an incentive for donors. The amount
of this compensation can reach € 25 for each donation (maximum amount set out by
the German legislation).
As a result of this compensation mechanism and depending on the frequency of
donation, regular donors are apt to receive a yearly amount of money, that is far from
being nominal (around 1000 €).
Promotion of donation itself: a very wide range of media and institutions have been
used or mobilised to support donation:
• Information campaigns resorting to traditional media (leaflets, posters,
press) or modern media, especially internet.
• Special events on donation: World blood donor day or other events
focusing on donation.
• Specific Student and secondary schools’ pupils awareness: in many
Member States, raising awareness of this age group is of paramount for
further recruitment of donors.
FURTHER DEVELOPMENTS ON THAT SUBJECT ON THE EU LEVEL: SHARING BEST
PRACTICES BETWEEN MEMBER STATES
In the light of these findings, the EU Commission decided to carry out a new study on
best practices for promotion of voluntary unpaid, in order to share best practices
between Member States. The findings of this new study should be available in early
2010.