Exclusion from donating Blood
The "Guideline for collections of blood and blood components as well as the use of blood products (Haemotherapy Guideline, 7 August 2017)” includes regulations for Germany as to who will be allowed to donate blood. Pursuant to this guideline, persons with sexual practices that present a significantly increased risk of transmission of infectious diseases transmissible by blood, including HBV, HCV, or HIV, shall be deferred from donating blood for 12 months.
Significance of infection safety of blood products
In the late 1980s, many patients suffered from virus infections caused by blood products such as the virus known as AIDS (human immune-deficiency virus, HIV). Ever since, the safety of blood products with regard to infections has been of high importance. There will never be a 100 percent safety, but with 99.9 percent, the infection safety of transfused blood donations in Germany is very high, and the adherence to this high standard is undoubtedly important in the patients’ interest. The availability of blood transfusions depends on whether there are persons willing to donate blood to help sick people. However, in some cases, persons are excluded from donating blood. The reason for this is the primary aim to protect patients who receive blood transfusions or blood products from dangerous infections.
Patients must be in a position to rely on the fact that the safety of blood transfusion has priority over other considerations. Even shortages during the holiday season must sometimes be accepted. Overall, the supply with blood transfusions in Germany is well assured with 57 blood units (red blood concentrates) per 1,000 inhabitants (figures from 2010) – the European median value for the reported figures from 30 member states was just below 36 blood units per 1,000 in 2010.
Even in the event of a shortage, this would be a cause for increased efforts to recruit new blood donors, but by no means a reason for making allowances with regard to safety.
Exclusion of donors
The Haematology Guideline, which includes regulations as to who will be allowed to donate blood and who will not, lays down that certain groups of persons are excluded from donating blood – in the interest of a maximum possible degree of safety. In this context, the Haemotherapy Guideline describes the circumstances and conditions in great detail. Persons who are permanently excluded from donating blood include:
- with serious cardiovascular diseases,
- with serious diseases of the central nervous system,
- with clinically relevant blood coagulation disorders,
- with repeated fainting attacks or seizures,
- with other serious active or chronic diseases of the gastro-intestinal, urogenital, haematological, immunological, metabolic, renal, or respiratory system in whom the blood donation could cause a hazard to the donor or the recipient, or
- who are suffering or used to suffer from malignant neoplasia (exceptions: in situ carcinoma and basal cell carcinoma after complete removal),
- With diabetes mellitus, if treated with insulin
Persons in whom one of the following infections has been identified:
- HIV-1 or HIV-2,
- HBV, exception: recovered from an HBV infection (anti-HBc-specific reactive, negative result of a test for HBV genome by means of NAT (minimum sensitivity ≤ 12 IU/ml), and anti-HBs titre of ≥ 100 IU/l. If a donor is admitted under the above circumstances, renewed anti-HBc screening can be dispensed with. The anti-HBs titre must be determined again at intervals of 2 years. If a titre < 100 IU/I is detected, donations from this donor can no longer be used for the production of blood components.
- HTLV type 1 or type 2 (HTLV-1/-2),
- Protozoonoses: babesiosis, trypanosomiasis e.g. Chagas disease), leishmaniosis,
- Malaria, osteomyelitis, tuberculosis, and infections with salmonella typhi und paratyphi (exceptions can be made after confirmed recovery in accordance with documented assessment from a medical doctor; please refer to the Haemotherapy Guideline for information on malaria),
- Other chronic persisting bacterial infections such as brucellosis, typhus, and other rickettsioses, leprosy, relapsing fever, melioidosis, or tularaemia (exceptions can be made after confirmed recovery in accordance with documented assessment from a medical doctor),
Persons with the risk of transmitting spongiform encephalopathies (TSEs):
- After treatment with hormones collected from human pituitary glands,
- After receiving dura mater and/or corneal transplants,
- In the event of a confirmed or suspected TSE (Creutzfeldt-Jakob-Disease, variant of Creutzfeldt-Jakob-Disease or other TSEs),
- Due to a familial risk of developing TSE (known Creutzfeldt-Jakob-disease or other TSE in on or more than one genetic relatives),
- After staying in the United Kingdom and Northern Ireland for a total of more than 6 months during the period from 1980-1996,
- After an operation and/or transfusion (cellular blood products, therapeutic plasma) in the United Kingdom and Northern Ireland after 1 January 1980,
- Recipients of xenotransplants, live cells of animal origin
- Persons confirmed or suspected to consume drugs or persons with a confirmed or suspected history of abuse of medicinal products.
In accordance with the comprehensive revised version of the "Guideline on the collection of blood and blood products for the use of blood products (Haemotherapy Guideline)" issued on 7 August 2017, persons with sexual practices that present a significantly increased risk of transmission of severe infectious diseases transmissible by blood, compared with the general population, including HBV, HCV, or HIV, shall be deferred from donating blood for 12 months. The life-long exclusion of men who have sex with men (MSM) thus no longer applies.
The Paul-Ehrlich-Institut (PEI) frequently receives questions concerning the exclusion of MSM from donating blood. We answer the frequently asked questions below.
Why are MSM (men who have sex with men) deferred from donating blood for a limited period of time?
A number of hazardous viruses can be transmitted by sexual contacts and then circulate in the blood unrecognised for a long time. The most important and most well-known example is HIV, which, at first, only causes minor or hardly noticeable symptoms. If the infection remains undetected and untreated, it will – partly only a few years later – cause an immune deficiency. However, HIV will bind to certain immune cells and will continuously enter the blood stream. Thus, it is possible for individuals to feel healthy for a long period of time and fit enough to donate blood. However, the virus can be transmitted even at that stage.
For this reason, all persons whose sexual behaviour will create an increased risk of infection are deferred from donating blood. This does not only apply to men who have sex with men (MSM). The wording in the Haemotherapy Guideline is as follows:
Persons to be deferred from donating blood for a limited period include:
Persons whose sexual behaviour presents a significantly increased risk of transmission toward the general population, including HBV, HCV, or HIV, for 12 months:
- Heterosexual persons with hazardous sexual behaviour such as sexual intercourse with frequently changing partners,
- Persons offering sexual intercourse in return for payment or other services (e.g. provision of drugs) (male and female sex workers)
- Men who have sex with men (MSM),
- Transsexual persons with hazardous sexual behaviour,
It has been confirmed based on some date that sexual intercourse among men involves a particularly high risk of HIV transmission. Epidemiological data captured by the Robert Koch-Institute (RKI) show that around two thirds of the new infections with HIV occur in the group of MSM. Judging a risk of HIV depends on various factors. Epidemiological examinations revealed that the share of MSM with more than one sex partner has been higher in the last twelve months than in the group of heterosexual persons. The use of condoms as a preventive measure altogether does not significantly differ between heterosexuals and HIV-negative homosexuals. Since the portion of MSM compared with the total population is estimated to be approximately three to five percent, but comprises around two thirds of all HIV infected individuals, the risk of infection in this group is particularly high.
All blood donations in Germany are tested for evidence of HIV infections using sensitive methods. However, the results of these tests can turn out to be false negative in the early phase after an HIV infection. This so-called diagnostic window essentially is the reason why a residual risk from HIV transmissions by transfusions from freshly infected persons remains.
Thus, donor testing cannot remove an increased risk of HIV transmission by blood donations after hazardous sexual behaviour so that a deferral from donating blood is necessary in the event of hazardous behaviour. In accordance with the German Transfusion Act (Transfusionsgesetz, TFG), donors are accepted for a blood donation after the suitability for donating blood has been assessed by the medical doctor present at the blood donation centre. As explained above, not only MSM but also other persons with hazardous heterosexual are deferred from donating blood in conformity with the Haemotherapy Guideline. Questions concerning hazardous sexual behaviour are contained in the blood donation questionnaire.
Even a thorough donor consultation cannot, with 100 percent certainty, exclude the possibility that a man who considers himself as MSM has contracted a fresh infection with HIV; HBV,or HCV. Thus, it will not be possible to use the consultation to rule out safely whether the necessary “safer sex” practices were truly and effectively adhered to. Furthermore, there was a case of a donor, who was convinced that he lived in a stable and true relationship with a man, and did therefore not reveal his status of MSM, but was infected by his partner, who, in fact, had other sex partners, thus transmitting HIV by donating blood.
Besides, the perspective involved in the risk assessment is important: The risks which a man tolerates with regard to his sexual contacts, i.e. which action he takes to reduce the risks, can be fundamentally differ from the perspective seen by the blood donation centres and the authorities, who are responsible for undertaking all efforts to prevent a transmission of infections by blood transfusions to patients.
The deferral of MSM and other groups of persons from donating blood does not present an arbitrary act of unequal treatment. Both measures, which complement each other, must be used to prevent a transmission of infections through blood donations: the deferral from donating blood by persons with hazardous sexual behaviour as a result of the donor questionnaire and testing for the infection marker.
The Robert Koch-Institut publishes reports regularly containing figures on the epidemiological situation with HIV showing a significantly increased risk of MSM compared with other groups. In view of these figures, the deferral of MSM from donating blood is an important precautionary measure, which serves the protection of patients/recipients of transfusions.
Up to the coming into force of the comprehensive revised version of the Haematology Guideline of 7 August 2017, a life-long exclusion from donating blood applied for persons with a certain hazardous sexual behaviour. The "Guideline for collections of blood and blood components as well as the use of blood products" (Haemotherapy Guideline) in its comprehensive revised version stipulates a deferral from donating blood for persons with certain hazardous sexual practices for 12 months after the last hazardous contact.
What are the problems involved if donors with hazardous behaviour do not answer the questionnaire truthfully?
If donors with a hazardous sexual behaviour do not fill out the questionnaire truthfully, the required deferral from donating blood may not be recognised as necessary, and may therefore not be carried out. In Germany, there are around 100 donors annually, in whom an HIV infection is detected by the test. Out of these, around 50 percent are MSM, who, however, did not indicate this in the questionnaire.
In the past 20 years, based on the success of the obligatory testing for HIV using certified tests, only six cases of transmission of HIV through infected blood donations have been reported in Germany altogether: only four out of these before the introduction of the direct virus detection, and only two after that. Thus, even if the direct detection of the virus reduces the period of the diagnostic window, transmissions of HIV can still occur if freshly infected persons donate blood. All cases could have been avoided if the donors affected had filled out the questionnaire correctly. In all cases, the persons concerned were persons who, based on their individual hazardous sexual behaviour could have been recognised as not suitable for donating blood, if truthful information had been provided. These infections could have been avoided, and persons with underlying health impairments would not have been exposed to even more risks.
The fact that some persons knowingly give false answers to questions concerning sexual hazards, however, does not justify changing the criteria. Instead, the consequences should be persistent information on the significance of the exclusion from donating blood or the temporally limited deferral due to hazardous sexual behaviour, i.e. minimising the risk for the patients treated with blood transfusions.
Are the regulations under discussion?
The exclusion of MSM from donating blood has also been questioned critically by the media repeatedly. A change in this regulation has also been demanded by interest groups in various postings, publications, and actions on the internet. On the other hand, there have also been appeals by affected patients, including haemophilia patients, to maintain the strict exclusion.
The Haematology Guidelines are constantly reviewed against the state of science, and are, in particular, adapted to the epidemiological data and the technological development of the testing systems. A working party, to which the PEI contributed, came to the conclusion that instead of excluding MSM from donating blood permanently, this group of persons should be deferred from donating blood for one year after the last sexual contact with a man. This recommendation has been implemented in the applicable comprehensive revised version of 2017.
Another aspect is the preparation and testing of questionnaires on the donor consultation, which permit a more accurate capture of hazardous sexual behaviour. A uniform donor questionnaire has been elaborated in the past few years, which is designed to record in detail the hazardous sexual behaviour of all persons willing to donate blood, independently from a person’s sexual preferences. This questionnaire has partly been criticised sharply because of the explicit questions on sexual practices.
A European Directive provides for the exclusion of persons with very hazardous sexual behaviour from donating blood. In a court case, the European Court of Justice negotiated the accusation of discrimination of an MSM, who was excluded from donating blood. The court decision was made on 29 April 2015. It confirmed: The safety of patients treated with blood transfusions has top priority. At the same time, the court ruling made it clear that an exclusion of persons from donating blood does not represent an illegal discrimination if the exclusion is necessary to minimise the risk of a transmission of an infectious disease to the donor. The court ruling also eliminated any previous doubt as to whether EU law should allow a temporary deferral from donating blood instead of a life-long exclusion.
An expert group of the "European Directorate for the Quality of Medicines and Health Care" (EDQM, Strasbourg) discussed the question of how different regulations in different countries affected the health risk involved in HIV transmissions. This working group represented the PEI and the RKI.
The PEI is also actively co-operating with the "Blood Regulators Network" (BRN) of the World Health Organisation (WHO), a working party of seven leading authorities responsible for blood products worldwide. The experts participating in the BRN have published their considerations on the exclusion of MSM and emphasised that social aspects such as the avoidance of discrimination should be considered. Likewise, they pointed out that any changes in the criteria could be possible if scientific data, above all with regard to the epidemiological situation, permit this. The safety of the patients, however, should always have top priority. In Germany, it has been discussed for a long time to include in the guideline a temporally limited deferral from donating blood for one year after the last sexual contact of a man with a man as implemented in the comprehensive revised version of the guideline, which has also been advocated by the PEI. The ruling by the European Court of Justice of 29 April 2015 made it clear that the legal framework conditions for this exist.