51998AP0112

A4-0112/98

Proposal for a Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (COM(97)0605 - C4-0027/98 - 97/0315(CNS))

The proposal was approved with the following amendments:

(Amendment 1)

Recital 9

>Original text>

9. Whereas donations should be voluntary and unpaid;

>Text following EP vote>

9.

Whereas, in accordance with Directive 89/381/EEC, donations should be voluntary and unpaid; whereas the term 'voluntary non-remunerated donation' is defined in Council of Europe Recommendation R (95)14;

(Amendment 2)

Recital 12

>Original text>

12. Whereas all blood and plasma used for therapeutic purposes, whether for transfusion or for further manufacture into industrially-prepared medicinal products, should be obtained from individuals whose health status is such as to ensure that transmission of disease does not take place, and that each and very blood donation should be tested in accordance with the rules which provide assurances that all necessary measures have been taken to safeguard the health of Community citizens who are the recipients of blood and blood products;

>Text following EP vote>

12.

Whereas all blood and plasma used for therapeutic purposes, whether for transfusion or for further manufacture into industrially-prepared medicinal products, should be obtained from individuals whose health status is such as to minimize the risk of diseases transmissible by blood being transmitted, and whereas each and very blood donation should be tested in accordance with the rules which provide assurances that all necessary measures have been taken to safeguard the health of Community citizens who are the recipients of blood and blood products;

(Amendment 3)

Recital 19

>Original text>

19. Whereas measures at Community level should take into account existing guidelines, recommendations and standards in the area of blood at both national and international levels;

>Text following EP vote>

19.

Whereas measures at Community level should take into account existing guidelines, recommendations and standards in the area of blood at both national and international levels, and in particular Recommendation R (95)15 and Agreement No 26 of the Council of Europe;

(Amendment 4)

Recital 25a (new)

>Original text>

>Text following EP vote>

25a. Whereas it has now been recognized that there may be a risk of blood products being contaminated with nvCJD and whereas it is necessary to take appropriate steps which include the use of imported blood between Member States;

(Amendment 5)

Section 3.2 (a)

>Original text>

a. Information on their health and medical history including any relevant social and behavioural characteristics that may assist in identifying and screening out persons whose donation could present a higher risk of transmitting infections as well as those who could have contracted a recent infection that may not yet be detectable in the screening tests;

>Text following EP vote>

a.

Information on their health and medical history including any relevant social and behavioural characteristics that may assist in identifying and screening out persons whose donation could present a risk of transmitting infections as well as those who could have contracted a recent infection that may not yet be detectable in the screening tests;

(Amendment 6)

Section 3.3 (b)

>Original text>

b. The prospective donor's agreement that if their blood or plasma donation becomes excess to the needs of their own Member State, it may be shared with another Member State of the Community that is in need;

>Text following EP vote>

b.

The prospective donor's agreement that if their blood or plasma donation, the components thereof and/or products prepared from the donated blood or plasma become excess to the needs of their own Member State, they may be shared with another Member State of the Community that is in need;

(Amendment 7)

Section 4, introduction

>Original text>

Member States, in order to facilitate future verification of repeat and regular donors, future tracing of donations, and future exchanges of information, establish a mutually compatible donor identification/registration system to:

>Text following EP vote>

The Member States responsible for collecting the blood and plasma, in order to facilitate future verification of repeat and regular donors, future tracing of donations, and future exchanges of information, agree to the establishment of a single donor identification and registration system common to all Member States so as to:

(Amendment 8)

Section 4.1 (a)

>Original text>

a. Permit every donation centre in each Member State to be uniquely identified, by communicating to all other Member States and to the Commission a list of centres and their identification comprising the country code and a suitable combination of letters and numbers at their discretion;

>Text following EP vote>

a.

Permit every donation centre in each Member State to be uniquely identified, by communicating to a central body the list of centres and their identification comprising the country code and a suitable combination of letters and numbers, in accordance with the single donor identification and registration system common to all Member States;

(Amendment 9)

Section 6.2 (ba) (new)

>Original text>

>Text following EP vote>

ba. Ensure that epidemiological data on viral markers is regularly collected, analysed and verified, use being made of uniform definitions, and that they keep themselves regularly informed of the existence of new markers;

(Amendment 10)

Section 6.2 (bb) (new)

>Original text>

>Text following EP vote>

bb. Ensure that the nature and duration of deferral criteria are based on good scientific evidence when known and that the precautionary principle prevails when that evidence is not available;

(Amendment 11)

Section 7 (a)

>Original text>

a. Ensure that measures are in place for prospective donor identification and accurate data verification;

>Text following EP vote>

a.

Ensure that measures are in place for prospective donor identification and accurate data verification, by means of a code that is unique and common to all Member States and is communicated to the central body;

(Amendment 13)

Section 9

>Original text>

9. TESTING SAMPLES OF DONATED BLOOD

>Text following EP vote>

9.

TESTING SAMPLES OF DONATED BLOOD AND PLASMA

>Original text>

Member States, in order to ensure the safety of all blood and plasma donations:

>Text following EP vote>

Member States, in order to ensure the safety of all blood and plasma donations:

>Original text>

a. Ensure that a sample of all donations whether intended for transfusion purposes or for further manufacturing into industrially prepared medicinal products is tested for diseases transmissible by blood using licensed screening tests to eliminate units that are repeat reactive;

>Text following EP vote>

a.

Ensure that a sample of all donations whether intended for transfusion purposes or for further manufacturing into industrially prepared medicinal products is tested for diseases transmissible by blood and/or plasma using licensed screening tests to eliminate units that are repeat reactive;

>Original text>

b. Ensure that all blood donations be found non-reactive for the transmissible disease markers listed in Annex 7;

>Text following EP vote>

b.

Ensure that all blood and plasma donations be found non-reactive in licensed screening tests for the transmissible disease markers listed in Annex 7;

>Original text>

c. Require re-testing of the blood samples found to be reactive in an initial screening test in accordance with the general algorithm set out in Annex 8.

>Text following EP vote>

c.

Require re-testing of the blood and plasma samples found to be reactive in an initial screening test in accordance with the general algorithm set out in Annex 8.

(Amendment 14)

Section 10 (b)

>Original text>

b. Member States take all necessary measures to encourage the voluntary and unpaid donation of blood or plasma.

>Text following EP vote>

b.

Member States implement the principle of voluntary and unpaid donation of blood or plasma.

(Amendment 15)

Section 10 (ba) (new)

>Original text>

>Text following EP vote>

ba. Member States take appropriate measures to exclude any risks related to nvCJD for donated blood and blood plasma products.

(Amendment 16)

Section 10 (bb) (new)

>Original text>

>Text following EP vote>

bb. Member States take the necessary steps to collect, analyse, publish and update epidemiological data.

(Amendment 17)

Section 10 (bc) (new)

>Original text>

>Text following EP vote>

bc. Member States bring forward binding legislation for the European Union with respect to blood products, donated blood and plasma by the end of 1998 (and no later than the end of 1999).

(Amendment 18)

ANNEX 1, last definition

>Original text>

Same meaning as in Directive 89/381/EEC.

>Text following EP vote>

Council of Europe definition: 'Donation is considered voluntary and non-remunerated if the person gives blood, plasma or cellular components of his or her own free will and receives no payment for it, either in the form of cash or in kind which could be considered a substitute for money. This would include time off work other than that reasonably needed for the donation and travel. Small tokens, refreshments and reimbursements of direct travel costs are compatible with voluntary, non-remunerated donation.'.

(Amendment 19)

ANNEX 2, third point, sixteenth sub-point

>Original text>

- has a spouse who is HIV positive

>Text following EP vote>

-

has a partner who is HIV positive

(Amendment 20)

ANNEX 2, fifth point

>Original text>

- Whether prospective donor has travelled

- outside Western Europe & North America

>Text following EP vote>

-

Whether prospective donor has travelled

- outside the European Union

If so, when?

Length of stay?

(Amendment 29)

ANNEX 2, sixth point

>Original text>

- Men who have sex with other men

>Text following EP vote>

-

Men who have unsafe sex

(Separate vote)

ANNEX 2, eighth point

>Original text>

- Sexual activity in countries other than those in Africa: (to specify country)

>Text following EP vote>

Deleted

(Amendment 23)

ANNEX 3, sixth definition

>Original text>

The packed cell volume (haematocrit) should be determined prior to donation and shall be no less than 38% for females and 40% for males. For apheresis plasma donors, the minimum shall be 38%.

>Text following EP vote>

Where the haemoglobin concentration has not been determined, the packed cell volume (haematocrit) should be determined prior to donation and shall be no less than 38% for females and 40% for males. For apheresis plasma donors, the minimum shall be 38%.

(Amendment 24/rev.)

ANNEX 3, eighth definition

>Original text>

For whole blood, the maximum number of times allowable for donations should be 6/year for men, 4/year for women and 3/year for pre-menopausal donors.

>Text following EP vote>

For whole blood, the maximum number of times allowable for donations should be

4/year for men and 3/year for women.

>Original text>

For apheresis plasma, the maximum donation frequency should be twice per week.

>Text following EP vote>

For apheresis plasma, the maximum donation frequency should be twice per week.

(Separate vote)

ANNEX 5(1), seventh point

>Original text>

- Men who have sex with other males

>Text following EP vote>

Deleted

(Amendment 25)

ANNEX 6, second definition

>Original text>

Maximum volume per donation

Donor weight Volume collected

(excluding anticoagulant)

50-67 kg 625 ml

68-79 kg 750 ml

80 kg or more 800 ml

Minimum time interval between donations 72 hours

Maximum number of donations per 7 day period 2

>Text following EP vote>

Maximum volume per donation

: 650 ml

Maximum volume per donation

per continuous 12 month period: 15 l

Minimum time interval between donations 72 hours

Maximum number of donations per 7 day period 2

Legislative resolution embodying Parliament's opinion on the proposal for a Council Recommendation on the suitability of blood and plasma donors and the screening of donated blood in the European Community (COM(97)0605 - C4-0027/98 - 97/0315(CNS))(Consultation procedure)

The European Parliament,

- having regard to the Commission proposal to the Council, COM(97)0605 - 97/0315(CNS),

- having been consulted by the Council pursuant to Article 129 of the EC Treaty (C4-0027/98),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection (A4-0112/98),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to notify Parliament should it intend to depart from the text approved by Parliament;

4. Asks to be consulted again should the Council intend to make substantial modifications to the Commission proposal;

5. Instructs its President to forward this opinion to the Council and Commission.