0A4F4F9BD490A749D5437F821CF06DF1
Opinion No. 52: Use of Human Tissues and Cells in Reproductive Medicine (2012)
https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/opinion_52_web.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
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p.000002: beneficence and non-maleficence.
p.000002: The principle of beneficence means that we must try to maximise the quantity of “good”. Applied to the medical
p.000002: context, this means that the costs incurred must be beneficial. Performing useless tests or those for
p.000002: which results are not conclusive is a waste of scarce resources. More “good” can be generated by this
p.000002: money on the basis of more judiciously allocated means.
p.000002: The second principle is that of non-maleficence. A medical procedure that causes harm must be justified by a) a
p.000002: relative advantage compared to the application of another ethical principle;
p.000002: b) the certainty of preventing greater harm. Harm to the donor (testing, sampling) is justified by the concern for
p.000002: preventing harm (contamination) to the recipient. If it is obvious that the tests do not protect against any
p.000002: contamination or if another procedure can achieve the same result by causing less harm, then there is cause to amend
p.000002: the regulations as a consequence.
p.000002:
p.000002:
p.000002: 1. Donation between partners other than for immediate use
p.000002:
p.000002: Is it necessary to conduct blood tests repeated at each collection of gametes in couples treated, even if sperm and
p.000002: autologous oocytes of the couple in treatment are used8?
p.000002:
p.000002: According to the present regulations, virological analysis for HIV, hepatitis B and C (HBV and HCV) and syphilis is
p.000002: required (with or without PCR/NAT9) at each procedure involving oocytes
p.000002:
p.000002: Law of 19 December 2008 on procurement and use of human body material intended for human medical applications or for
p.000002: purposes of scientific research, hereafter designated as the “human body material (2008)” law.
p.000002: 6 Cited on the last page of this opinion.
p.000002: 7 Beauchamp T.L., Childress J.F., Principles of Biomedical Ethics, Oxford University Press, 6th ed., 2008 (French
p.000002: translation Les principes de l'éthique biomédicale, Paris, Les Belles Lettres, Médecine & Sciences humaines, 2008).
p.000002: 8 See Art. 4.2. of Annex IV of the Royal Decree “quality and safety standards (2009)”: “Blood samples must be
p.000002: collected upon donation” (“general conditions for determining biological markers”) and Articles
p.000002: 2.1. to 2.6.; see also Art. 4.2. of Annex III of the aforementioned directive of 8 February 2006.
p.000002: 9PCR (polymerase chain reaction) designates a modern technique for DNA analysis lending itself to
p.000002: automation and using the molecular biology of in vitro DNA amplification. Polymerase or reverse
p.000002: transcriptase is an enzyme associated with carcinogenic viruses, those of some leukaemias and that of AIDS (HIV), and
p.000002: allows this RNA virus to incorporate itself into the chromosomes of the cell it infects and that are made of DNA. PCR
p.000002: allows for example a bacterium or virus to be identified or a gene mutation to be revealed to diagnose a genetic
p.000002: disease (Dictionnaire Garnier-Delamare des termes de médecine, Paris, Maloine, 30th ed., 2009, see "gene
p.000002: amplification" and "reverse transcriptase"). The Royal Decree uses NAT (Nucleic Acid Amplification Technology),
p.000002: which designates the same technique for nucleic acid amplification, instead of PCR.
p.000002:
p.000002: FINAL VERSION
p.000003: 3
p.000003:
p.000003: or sperm in the two partners of a couple in the context of a medically assisted procreation procedure, in the case of
p.000003: other than immediate use. This high frequency is very difficult to defend and hardly feasible in practice:
p.000003:
p.000003: A/ The risk of exogenous contamination by diseases during treatment is very low. This is moreover confirmed in
p.000003: international studies10.
p.000003:
p.000003: B/ Systematic monitoring in order to protect the laboratory personnel is meaningless, given that the entire
p.000003: procedure must take place in a completely sterile environment where the personnel must always observe standard
p.000003: sterility precautions11.
p.000003:
p.000003: C/ Systematic monitoring and repeated performance of blood analyses at each donation generate a resulting
p.000003: additional cost for the community. The additional cost for INAMI12 in Belgium is approximately 4.8 million euro13.
p.000003:
p.000003: D/ Given that at present no contamination has been reported in major international studies14, the
p.000003: investment of such a significant sum of public money for such a low benefit is difficult to justify from an
p.000003: ethical point of view.
p.000003:
p.000003: E/ Physical and psychological pressure is also added to the financial factor, as the patients must
p.000003: submit to blood sampling and appear each time for a series of procedures.
p.000003:
p.000003: F/ A recent study by the Belgian Society of Reproductive Medicine (BSRM)15 has shown that various intervals between
p.000003: virological tests are assigned in the various countries of the European Union. They are as follows: Norway 12
p.000003: months, Denmark 24 months, Finland and Sweden 12 to 24 months, Poland 6 months, France less than 6 months for the
p.000003: first cycle and then every 24 months. In Germany, examinations must take place one week before oocyte collection.
p.000003: In Italy, the period is 3 months; in Greece, screening is advised before the first sperm donation and
p.000003: after three to four cycles. Finally, in Latvia, a check is required every 6 months.
p.000003: Moreover, a European bill exists to limit repetition of testing to one test every 24 months16.
p.000003:
p.000003: Recommendation
p.000003:
p.000003: In the light of these aspects and on the basis of the information collected on the international scale, it is
p.000003: proposed that virological analysis for HIV, hepatitis B and C and syphilis be performed only at the
p.000003: first procedure and conducted afterward only at 12-month intervals.
p.000003:
p.000003: 10 Wingfield M., Cottell E., Viral screening of couples undergoing partner donation in assisted
p.000003: reproduction with regard to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC: what is the evidence for
p.000003: repeated screening? E. Hum Reprod. 2010; 25(12):3058-65. Pepas L., Macmahon E., El Toukhy T., Khalaf Y. &
p.000003: Braude P., Viral screening before each cycle of assisted conception treatment is expensive and unnecessary: a
p.000003: survey of results from a UK inner city clinic , Human Fertility, 2011; 14(4):224-229.
p.000003: 11 See Annex VII of the aforementioned Royal Decree “quality and safety standards (2009)” (text attached in the
p.000003: Appendix).
p.000003: 12 The National Institute for Health and Disability Insurance.
p.000003: 13 Estimate of Prof. Devroey P. at the 21st BSRM meeting, 30 January 2009, Elewijt Center, Zemst.
p.000003: 14 Wingfield M. et al., op. cit.; Pepas L. et al., op. cit.
p.000003: 15 Belgian Society for Reproductive Medicine, chaired by Prof. A. Delvigne.
p.000003: 16 Summary Report of the Meeting of the Competent Authorities for Tissues and Cells, 23-24 June 2011, available at
p.000003: http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_mi_20110623_en.pdf “The NCAs group concluded that it was
p.000003: not needed to maintain the current testing requirements for partner donation as laid down in Annex III of Directive
p.000003: 2006/17/EC. This will require a future amendment of the Directive, through the regulatory procedure. It is the
p.000003: responsibility of the NCAs to ensure that ART tissue establishments have in place the appropriate safety and quality
p.000003: systems, which does not affect the safety and quality of reproductive cells and/or human health when donors are tested
p.000003: at up to 24 months time intervals”.
p.000003:
p.000003: FINAL VERSION
p.000004: 4
p.000004:
p.000004: This would correspond to the international consensus published in a number of scientific publications17.
p.000004:
p.000004: With this adaptation, a balance can be reached between greater safety on the one hand and costs and burdens on the
p.000004: donor/partner on the other hand. In this regard, reference can be made to an article from the American Medical
p.000004: Association: The Harms of Screening, New Attention to an Old Concern 18.
p.000004:
p.000004: In a discussion of preventive diagnostic examinations, false positive results can never be forgotten, nor
p.000004: the burden of additional examinations. In this context, it should also be noted that these useless additional
p.000004: examinations sometimes represent a high cost to the community and thus uselessly squander the scant resources essential
p.000004: to the curative sector19.
p.000004:
p.000004:
p.000004: 2. Sperm and oocyte donation, fresh or after cryopreservation, other than partner donation
p.000004:
p.000004: 2. 1. Virological analyses required for sperm donation other partner donation
p.000004:
p.000004: 2.1.1. Technical data
p.000004:
p.000004: Current regulations require virological testing20 at least for HIV, hepatitis B and C, syphilis and
p.000004: chlamydia (by PCR = NAT test or not) at each consecutive donation of sperm by the same donor21.
p.000004:
p.000004: 17 Bhargava P.M., On the critical assessment of the impact of the recent European Union Tissues and Cells Directive.
p.000004: Reprod Biomed Online, 2005; 11(2):161.
p.000004: Hartshorne G.M., Challenge of the EU ‘tissues and cells’ directive. Reprod Biomed Online 2005; 11: 404- 407.
p.000004: Mortimer D.A., Critical assessment of the impact of the European Union Tissues and Cells Directive (2004)
p.000004: on laboratory practices in assisted conception, Reprod Biomed Online, 2005; 11(2):162-176. European Society
p.000004: of Human Reproduction and Embryology (ESHRE), Statement 2009 on the European commission proposal of viral
p.000004: screening in assisted reproduction treatments (www.eshre.eu). Hughes C., Emerson G., Grundy K., Kelly P., Mocanu
p.000004: E., Is performing viral screening within 30 days of oocyte collection justified?, Hum Reprod, 2010; 25:239.
p.000004: Janssens P.M., Rules and regulations in reproductive medicine: sensible requirements that should start with evidence,
p.000004: Hum Reprod. 2010; 25(12):3055-7. 2010.
p.000004: Wingfield M. et al., op. cit.
p.000004: 18 Woolf S H., Harris R., The Harms of Screening, New Attention to an Old Concern, JAMA, 2012-Vol 307, No 6, p.565-566.
p.000004: 19 N.B. We will not consider here examinations carried out with a view to treatment of the person himself (too-advanced
p.000004: preventive examinations) nor the harm caused by useless treatments (by the examination itself and also – this is not
p.000004: rare – through additional treatments that can lead to serious injuries). For this type of issue, one can refer to
p.000004: a (more general) article published in Lancet: The perils of excessive medical care, by Shangavi D.M.,
p.000004: Lancet, 2011; 377, 1561-1562, and also the article Overdiagnosed: Making People Sick in the Pursuit of
p.000004: Health, M.D., 2011 by Welch H.G.G., Schwartz L.M., Woloshin S., which refers to the healthcare saga of Brian Mulroney,
p.000004: who was Prime Minister of Canada from 1984 to 1993. A preventive helicoidal scan of the thorax showed that he had two
p.000004: small nodules on the lung. A biopsy showed them to be completely benign. But the patient had to be hospitalised three
p.000004: months for this reason, and because of a complication due to the biopsy, developed life-threatening pancreatitis.
p.000004: 20Serology does not allow the virus itself to be detected. As for all diseases, it only allows the traces of its
p.000004: passage to be detected, that is, the antibodies that are produced by the body in response to its “attack”. The
p.000004: antibodies produced are specific for each disease; a blood test detects only the antibodies for the disease
p.000004: that it is supposed to detect (see notably
p.000004: http://www.3trois3.com/experience_pratique_du_sdrp/5-interets-des-differentes-techniques-d-analyses-
p.000004: :-serologie-pcr-s_606/; Plantier J.-C. and Simon F. (UHC Charles Nicolle Virology Laboratory, Rouen),
p.000004: “Diagnostic sérologique des infections à VIH (Serological diagnosis of HIV infections)”, Développement et Santé, no.
p.000004: 162, December 2002).
p.000004: 21Royal Decree “quality and safety standards (2009)”, Art. 9 §2: “Donors of gametes, gonads, fragments of gonads,
p.000004: foetal human body material and embryos are subject to the biological tests specified in items 1, 2 and 3 of Annex IV
p.000004: (items 3.2 to 3.4, cf. text attached to this opinion). The biological tests specified in paragraph 1 are conducted
p.000004: according to the general provisions of item 4 in Annex IV.”
p.000004:
p.000004: FINAL VERSION
p.000005: 5
p.000005:
p.000005: We note that item 4.2 of Annex IV of the Royal Decree “quality and safety standards (2009)” reads as follows: “Les
p.000005: échantillons de sang doivent être prélevés lors du don (Blood samples must be collected at donation)”, while in
p.000005: the corresponding Dutch version we read: 4.2. “Bloedmonsters worden op het tijdstip van de donation
p.000005: afgenomen (Blood samples are collected at the time of donation)”. This difference in translation gives rise to a
p.000005: divergence in interpretation.
p.000005:
p.000005: These sperm donations generally take place twice per week, with repetition of the aforementioned tests each
p.000005: time, while the sperm is frozen each time. The reliability of the result of the PCR conducted immediately after
p.000005: contamination (in acute cases) is inadequate in this respect.
p.000005:
p.000005: 2.1.2. Precautions to be observed
p.000005:
p.000005: A quarantine of a minimum of 180 days after the last sperm donation22 must be observed, as has already
p.000005: been practised for years in all the approved centres. Only at the end of this quarantine period is the previously
p.000005: described viral serology again tested for the donor23.
p.000005:
...
p.000005: of candidate sperm donors at present in our country and every complication in the procedure only exacerbates this
p.000005: shortage.
p.000005:
p.000005: The Committee thus also proposes that, for sperm donation other than partner donation, the standard
p.000005: method existing up to now be reinstituted. It involves conducting an in-depth virological and bacteriological
p.000005: test in a very short period before the first donation. The sperm samples donated are then frozen. There
p.000005: follows a quarantine period of 180 days, at the end of which a new clinical examination and serological
p.000005: test are performed in order to exclude in this way any risk. By combining these two factors, safe sperm donation
p.000005: can be maintained without additional and repeated blood tests.
p.000005:
p.000005:
p.000005:
p.000005: 22Royal Decree “quality and safety standards (2009)”, Art. 12: “Human body material is kept in quarantine until it
p.000005: can be released in application of Article 17”. And Annex IV, item 4.3: “Donations of gametes, embryos, gonads
p.000005: and fragments of gonads other than partner donations, or donations of gametes intended for the use of
p.000005: surplus embryos, are put into quarantine for a minimum of 180 days, at the end of which period the tests must be
p.000005: recommenced”.
p.000005: 23See however Article 4.3. of Annex 3 of the directive of 8 February 2006: “Sperm donations other than partner
p.000005: donations are put into quarantine for a minimum of one hundred eighty days, at the end of which period
p.000005: tests must be recommenced. If the blood sample collected at the time of donation is also tested for HIV, HBV and
p.000005: HCV using the nucleic acid amplification technique, it is not necessary to recommence the examination on
p.000005: another blood sample. Likewise, it is not necessary to recommence the examination when the processing procedure
p.000005: includes a validated inactivation step for the viruses concerned.”
p.000005:
p.000005: FINAL VERSION
p.000006: 6
p.000006:
p.000006: 2. 2. Donation of fresh oocytes
p.000006:
p.000006: As stated above, Annex III of the aforementioned directive of 8 February 2006 (Art. 4.2.) and Annex IV of the
p.000006: aforementioned Royal Decree of 28 September 2009 (Art. 4.2.) indicate, in the general conditions for determination
p.000006: of biological markers, that blood samples must be collected upon donation of oocytes. This also specifies the
p.000006: time when tests are conducted for HIV, HBV and HCV using the nucleic acid amplification technique (NAT).
p.000006:
p.000006: The result of the PCR test can generally be obtained after approximately 72 hours at the earliest.
p.000006:
p.000006: This is why the Committee puts forward the following recommendations:
p.000006:
p.000006: Recommendations
p.000006:
p.000006: A/ It would be preferable to perform this analysis within a certain time period before the donation of oocytes. This
p.000006: period can be 14 days to 3 weeks maximum. In this way, results would already be known at the time of implantation into
p.000006: the recipient. Clearly, the safety of the procedure would be increased.
p.000006:
p.000006: B/ In this regard, the Committee declares itself in favour of vitrification24, a preservation
p.000006: technique currently perfectly developed. Although this technique is still only authorised in six university centres,
p.000006: the Committee believes, on the basis of the current scientific data25, that the vitrification technique should be
p.000006: preferred henceforth to donation of fresh oocytes, for the reasons that:
p.000006:
p.000006: - there is no difference in viability or reproductive capacity between an oocyte transplanted
p.000006: after vitrification and a fresh transplanted oocyte (1),
p.000006: - on the other hand, the safety of the transfer after 6 months of vitrification is greater than in the case of
p.000006: transfer of a fresh oocyte (2).
p.000006:
p.000006:
p.000006: 2. 3. Tests necessary in the case of donation and cryopreservation of oocytes for subsequent use
p.000006:
p.000006: It is again26 required that virological tests by PCR/NAT be conducted at each donation.
p.000006:
p.000006:
...
p.000008: certain provisions applied to the Centres for medically assisted procreation.
p.000008:
p.000008: 1. Article 6, §1, of the Royal Decree “quality and safety standards (2009)”, dealing with (1) the guarantee of
p.000008: traceability of all human body material (gametes and embryos) collected, procured, processed, stored or
p.000008: distributed, goes too far in that it also involves (2) all the pertinent data on the products and materials
p.000008: coming into contact with this human body material.
p.000008:
p.000008: Requirement (1) poses no problem; (2) does, due to the fact that traceability of the products and materials
p.000008: is required retroactively, which raises a significant ethical problem.
p.000008:
p.000008: 2. In the past, traceability of all these human body materials as well as the products and materials coming into
p.000008: contact with them has not been observed in practice.
p.000008:
p.000008: 3. The consequence of this is that thousands of cryopreserved gametes and embryos can no longer serve the purposes
p.000008: initially planned, those of satisfying a future desire for pregnancy, even in the patients from whom these human body
p.000008: materials come.
p.000008:
p.000008: The Committee unanimously believes that, in this specific case, these regulations are not ethically defensible in their
p.000008: consequences. The request is therefore made to the legislator that transitional measures be taken so that these gametes
p.000008: and embryos can still be used. The current regulations impose the following biological tests30:
p.000008:
p.000008: 3.1. Concerning partner donation other than for immediate use as specified in item 1, the Royal Decree requires a
p.000008: series of biological tests for HIV, hepatitis B and C, syphilis and chlamydia to be conducted at each donation
p.000008: of gametes not intended for immediate use within a couple.
p.000008:
p.000008: These requirements are not scientifically based and moreover impose an additional useless burden on patients,
p.000008: personnel and the healthcare budget. A sounder way of proceeding from a scientific and economic point of view would
p.000008: consist of repeating a test every 12 months after a first test of the biological markers (more precisely
p.000008: described in 2.2. above).
p.000008:
p.000008: 30 With reference to Annex IV and to Section 3, Art. 9 §2 of the Royal Decree “quality and safety
p.000008: standards (2009)”. In Chapter IV, Section 2, Art. 8 §1 on donor selection, in particular in item 2°, the selection
p.000008: criteria taken into account for donors of gametes, gonads, fragments of gonads and embryos intended for assisted
p.000008: procreation are listed.
p.000008:
p.000008: FINAL VERSION
p.000009: 9
p.000009:
p.000009: 3.2. With regard to donations other than between partners after cryopreservation, whether donation of sperm
p.000009: or oocytes, it is also required several times that tests be performed at each donation.
p.000009:
p.000009: The Committee believes that it would be more reasonable – scientifically as well as ethically – to
p.000009: strictly apply the “quarantine principle”. According to this, (1) biological testing takes place before
p.000009: collection(s), (2) the cells or tissues are frozen, (3) the results of the tests are communicated after an
p.000009: additional check of the biological tests (after 180 days).
p.000009: In the present state of science, given the possibility of vitrifying oocytes and given that there is no
...
p.000011: 50 years.
p.000011: § 4. The data specified in §§2 and 3, paragraph 2, are kept in the procuring establishment immediately after
p.000011: collection.
p.000011: In the event of application of Article 8, §2, paragraph 3 of the law, the data specified in §§2 and 3 are preserved by
p.000011: the bank of human body material responsible, as specified in Article 8,
p.000011: §2, paragraph 4 of the law.
p.000011:
p.000011: Annex IV
p.000011: Selection criteria and biological tests required for donors of gametes, embryos, gonads and fragments of gonads
p.000011: intended for assisted procreation
p.000011:
p.000011: 1. Partner donations for immediate use without storage or processing.
p.000011: The donor selection criteria and laboratory tests do not apply in the case of a donation of male gametes
p.000011: between partners for immediate use.
p.000011:
p.000011: 2. Partner donations other than for immediate use, as specified in item 1.
p.000011:
p.000011:
p.000011:
p.000011: FINAL VERSION
p.000012: 12
p.000012:
p.000012: Gametes, gonads, fragments of gonads and embryos that are processed and/or stored and gametes which will result
p.000012: in embryos that will be cryopreserved must fulfil the following criteria:
p.000012: 2.1. The treating physician of the donor must verify and document, on the basis of the medical history
p.000012: of the patient and the therapeutic indications, the justifications for the donation and the safety of the
p.000012: donation for the recipient and for any child that may be born from this donation.
p.000012: 2.2. The following biological tests must be performed to evaluate the risk of cross- contamination:
p.000012: - anti-HIV-1, 2
p.000012: - HBsAg
p.000012: - anti-HBc
p.000012: - anti-HCV
p.000012: - a syphilis screening test.
p.000012: In the case of sperm processed with a view to intrauterine insemination, not intended to be preserved, and if the
p.000012: establishment can demonstrate that the risk of cross-contamination and exposure of personnel has been taken into
p.000012: account through use of validated procedures, the biological tests are not necessarily performed.
p.000012: 2.3. If the results of the tests for HIV 1 and 2, hepatitis B or C are positive or not available, or if the donor
p.000012: proves to be a source of infectious risk, a separate storage system must be provided.
p.000012: 2.4. Tests for HTLV-I antibodies must be performed in the case of donors living in areas with a high incidence of this
p.000012: infection or originally from these areas, or whose sexual partners or parents originate from these areas.
p.000012: 2.5 In some circumstances, additional tests must be performed, depending on trips made by the donor, his exposure to
p.000012: risks, and the characteristics of the human body material donated (for example, RhD, malaria, CMV, T cruzi).
p.000012: 2.6. Positive results do not necessarily rule out partner donation.
p.000012:
p.000012: 3. Donations other than partner donations.
p.000012: Aside from partner donations, use of gametes, embryos and gonads or fragments of gonads must fulfil the following
p.000012: criteria:
p.000012: 3.1. Donors must be selected as a function of their age, their state of health and their medical histories, on the
p.000012: basis of a questionnaire and an interview with a qualified healthcare professional trained to this effect.
p.000012: This evaluation must involve all the pertinent factors that can contribute to identifying and excluding persons whose
p.000012: donation could be hazardous to the health of another, notably the possibility of transmitting diseases
p.000012: (sexually transmitted infections, for example), or to their own health (for example, superovulation, sedation, risks
p.000012: related to harvesting ova, or psychological consequences related to the donation).
p.000012: 3.2. The HIV 1 and 2, HCV, and HBV tests and the syphilis test made on a serum or plasma sample from the donor in
p.000012: accordance with the provisions of Annex VI, item 1.1, must be negative for donors. In addition, chlamydia
p.000012: tests made on a urine sample using the nucleic acid amplification technique must be negative for sperm donors.
p.000012: 3.3. The HTLV-I antibody test must be performed for donors living in areas with a high incidence of this
p.000012: infection or originally from such areas, or whose sexual partners or parents originate from these areas.
p.000012: 3.4. In some circumstances, additional tests must be performed, depending on the history of the donor and the
p.000012: characteristics of the human body material donated (for example, RhD, malaria, CMV, T. cruzi).
p.000012: 3.5. For autologous donors, the provisions of Annex II, item 2.1.1 are applicable.
p.000012: 3.6. After consent to this effect has been granted:
p.000012: a) genetic screening is performed for the autosomal recessive genes prevalent in the ethnic context of the donor,
p.000012: according to international scientific knowledge;
p.000012: b) the risk of transmission of hereditary disorders known to be present in the family is evaluated.
p.000012: The recipient is fully and intelligibly informed of the associated risks and of the measures taken to
p.000012: reduce them.
p.000012:
p.000012:
p.000012:
p.000012: FINAL VERSION
p.000013: 13
p.000013:
p.000013: 4. General conditions for determining biological markers.
p.000013: 4.1. Tests must be performed in accordance with Annex VI, items 2.1 and 2.2.
p.000013: 4.2. Blood samples must be collected at donation.
p.000013: 4.3. Donations of gametes, embryos, gonads and fragments of gonads other than partner donations or
p.000013: donations of gametes intended for use for surplus embryos are put into quarantine for at least 180 days, a
p.000013: period at the end of which the tests must be recommenced. If the blood sample from the donor at the time of donation is
p.000013: also tested using the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, it is not necessary to perform
p.000013: the tests on a second blood sample or to implement the quarantine specified above. Likewise, it is not necessary to
p.000013: recommence the test when the processing procedure includes a validated inactivation step for the viruses
p.000013: concerned.
p.000013:
p.000013: Annex VII
p.000013: Various provisions on the quality and safety of activities in the establishments
p.000013:
p.000013: A. Organisation and management
p.000013: 1. A manager of human body material should be designated, equipped with the qualifications specified in the law as
p.000013: well as at least two years of practical experience in management of human body material, including quality, safety
p.000013: and traceability.
p.000013: 2. An establishment must have an organisational structure and standard operating procedures suited to the procedures
p.000013: for which approval is requested; an organisational chart must exist which clearly defines the lines of responsibility
p.000013: and the hierarchical structure.
p.000013: 3. The manager of human body material is responsible for the activities of the establishment such as donor selection,
p.000013: evaluation of clinical data on the human body material used or any interactions with clinical users.
p.000013: 4. A documented quality management system must be applied to the procedures for which approval is requested, in
p.000013: compliance with the standards set by the law and by the present decree.
p.000013: 5. It should be ensured that the risks inherent in use and handing of human body material are identified and reduced
p.000013: insofar as possible, while maintaining a level of quality and safety appropriate for the use for which the
p.000013: human body material is intended. These risks include notably those related to procedures, the environment and the state
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000003: months, Denmark 24 months, Finland and Sweden 12 to 24 months, Poland 6 months, France less than 6 months for the
p.000003: first cycle and then every 24 months. In Germany, examinations must take place one week before oocyte collection.
p.000003: In Italy, the period is 3 months; in Greece, screening is advised before the first sperm donation and
p.000003: after three to four cycles. Finally, in Latvia, a check is required every 6 months.
p.000003: Moreover, a European bill exists to limit repetition of testing to one test every 24 months16.
p.000003:
p.000003: Recommendation
p.000003:
p.000003: In the light of these aspects and on the basis of the information collected on the international scale, it is
p.000003: proposed that virological analysis for HIV, hepatitis B and C and syphilis be performed only at the
p.000003: first procedure and conducted afterward only at 12-month intervals.
p.000003:
p.000003: 10 Wingfield M., Cottell E., Viral screening of couples undergoing partner donation in assisted
p.000003: reproduction with regard to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC: what is the evidence for
p.000003: repeated screening? E. Hum Reprod. 2010; 25(12):3058-65. Pepas L., Macmahon E., El Toukhy T., Khalaf Y. &
p.000003: Braude P., Viral screening before each cycle of assisted conception treatment is expensive and unnecessary: a
p.000003: survey of results from a UK inner city clinic , Human Fertility, 2011; 14(4):224-229.
p.000003: 11 See Annex VII of the aforementioned Royal Decree “quality and safety standards (2009)” (text attached in the
p.000003: Appendix).
p.000003: 12 The National Institute for Health and Disability Insurance.
p.000003: 13 Estimate of Prof. Devroey P. at the 21st BSRM meeting, 30 January 2009, Elewijt Center, Zemst.
p.000003: 14 Wingfield M. et al., op. cit.; Pepas L. et al., op. cit.
p.000003: 15 Belgian Society for Reproductive Medicine, chaired by Prof. A. Delvigne.
p.000003: 16 Summary Report of the Meeting of the Competent Authorities for Tissues and Cells, 23-24 June 2011, available at
p.000003: http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_mi_20110623_en.pdf “The NCAs group concluded that it was
p.000003: not needed to maintain the current testing requirements for partner donation as laid down in Annex III of Directive
p.000003: 2006/17/EC. This will require a future amendment of the Directive, through the regulatory procedure. It is the
p.000003: responsibility of the NCAs to ensure that ART tissue establishments have in place the appropriate safety and quality
p.000003: systems, which does not affect the safety and quality of reproductive cells and/or human health when donors are tested
p.000003: at up to 24 months time intervals”.
p.000003:
p.000003: FINAL VERSION
p.000004: 4
p.000004:
p.000004: This would correspond to the international consensus published in a number of scientific publications17.
p.000004:
p.000004: With this adaptation, a balance can be reached between greater safety on the one hand and costs and burdens on the
p.000004: donor/partner on the other hand. In this regard, reference can be made to an article from the American Medical
p.000004: Association: The Harms of Screening, New Attention to an Old Concern 18.
p.000004:
p.000004: In a discussion of preventive diagnostic examinations, false positive results can never be forgotten, nor
p.000004: the burden of additional examinations. In this context, it should also be noted that these useless additional
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000012: (sexually transmitted infections, for example), or to their own health (for example, superovulation, sedation, risks
p.000012: related to harvesting ova, or psychological consequences related to the donation).
p.000012: 3.2. The HIV 1 and 2, HCV, and HBV tests and the syphilis test made on a serum or plasma sample from the donor in
p.000012: accordance with the provisions of Annex VI, item 1.1, must be negative for donors. In addition, chlamydia
p.000012: tests made on a urine sample using the nucleic acid amplification technique must be negative for sperm donors.
p.000012: 3.3. The HTLV-I antibody test must be performed for donors living in areas with a high incidence of this
p.000012: infection or originally from such areas, or whose sexual partners or parents originate from these areas.
p.000012: 3.4. In some circumstances, additional tests must be performed, depending on the history of the donor and the
p.000012: characteristics of the human body material donated (for example, RhD, malaria, CMV, T. cruzi).
p.000012: 3.5. For autologous donors, the provisions of Annex II, item 2.1.1 are applicable.
p.000012: 3.6. After consent to this effect has been granted:
p.000012: a) genetic screening is performed for the autosomal recessive genes prevalent in the ethnic context of the donor,
p.000012: according to international scientific knowledge;
p.000012: b) the risk of transmission of hereditary disorders known to be present in the family is evaluated.
p.000012: The recipient is fully and intelligibly informed of the associated risks and of the measures taken to
p.000012: reduce them.
p.000012:
p.000012:
p.000012:
p.000012: FINAL VERSION
p.000013: 13
p.000013:
p.000013: 4. General conditions for determining biological markers.
p.000013: 4.1. Tests must be performed in accordance with Annex VI, items 2.1 and 2.2.
p.000013: 4.2. Blood samples must be collected at donation.
p.000013: 4.3. Donations of gametes, embryos, gonads and fragments of gonads other than partner donations or
p.000013: donations of gametes intended for use for surplus embryos are put into quarantine for at least 180 days, a
p.000013: period at the end of which the tests must be recommenced. If the blood sample from the donor at the time of donation is
p.000013: also tested using the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, it is not necessary to perform
p.000013: the tests on a second blood sample or to implement the quarantine specified above. Likewise, it is not necessary to
p.000013: recommence the test when the processing procedure includes a validated inactivation step for the viruses
p.000013: concerned.
p.000013:
p.000013: Annex VII
p.000013: Various provisions on the quality and safety of activities in the establishments
p.000013:
p.000013: A. Organisation and management
p.000013: 1. A manager of human body material should be designated, equipped with the qualifications specified in the law as
p.000013: well as at least two years of practical experience in management of human body material, including quality, safety
p.000013: and traceability.
p.000013: 2. An establishment must have an organisational structure and standard operating procedures suited to the procedures
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.000015: d) or it is not technically possible to perform the required process in a class A environment, for example due to
p.000015: the necessity for having a specific piece of equipment that is not fully compatible with class A in the
p.000015: processing area.
p.000015: 5. In the situations described in item 4, letters a) to d), the environment must be specified. It should be proven,
p.000015: with supporting documents, that the chosen environment guarantees the required quality and safety, taking account
p.000015: at least of the planned use, the method of application and the immune status of the recipient. Appropriate
p.000015: clothing, personal protective equipment and hygiene facilities, as well as written instructions with regard to hygiene
p.000015: and apparel, must be provided in each section concerned within the establishment.
p.000015: 6. When the procedures for which approval is requested involve storage of human body material, the storage
p.000015: conditions necessary to preserve the required properties of the human body material, including key parameters such as
p.000015: temperature, humidity or air quality, should be specified.
p.000015: 7. Critical parameters, including temperature, humidity or air quality, must be controlled, monitored and
p.000015: recorded to prove their compliance with the required storage conditions.
p.000015: 8. The storage premises must ensure clear separation and distinction between human body material before release and in
p.000015: quarantine, human body material that has been released and human body material that has been rejected, in order
p.000015: to prevent any confusion and cross- contamination between them. In both quarantine areas and storage areas for
p.000015: released human body materials, physically separated areas or secure storage or isolation systems are to be
p.000015: provided for storing human body material fulfilling specific criteria.
p.000015: The specific criteria cited are for example the fact that human body material intended for autologous or
p.000015: deferred use is kept, or that gametes intended for partner donation are involved.
p.000015: 9. The establishment must have written directives and procedures for controlling access to the premises, cleaning and
p.000015: maintenance, removal of waste and continuity of services in the event of an emergency.
p.000015:
p.000015: E. Documentation and recording
p.000015: 1. A system characterised by clearly defined and efficient documentation, proper reporting and registers,
p.000015: and authorised standard operating procedures should be established for the procedures for which approval
p.000015: is requested. Documents must be regularly revised and compliant with the law and the present decree. The system
p.000015: must guarantee standardisation of the procedures performed and the possibility of retracing all the steps,
p.000015: that is, collection, codification, donor eligibility, procurement, processing, preservation, storage,
p.000015: transport, distribution or disposal or destruction, including aspects related to quality control and quality assurance.
p.000015: 2. For any critical activity, the materials, equipment and personnel involved must be identified and documented.
p.000015: 3. Any change in the documents must be checked, dated, approved, documented and executed without delay by
p.000015: authorised personnel in the establishments.
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000004: Reprod Biomed Online, 2005; 11(2):161.
p.000004: Hartshorne G.M., Challenge of the EU ‘tissues and cells’ directive. Reprod Biomed Online 2005; 11: 404- 407.
p.000004: Mortimer D.A., Critical assessment of the impact of the European Union Tissues and Cells Directive (2004)
p.000004: on laboratory practices in assisted conception, Reprod Biomed Online, 2005; 11(2):162-176. European Society
p.000004: of Human Reproduction and Embryology (ESHRE), Statement 2009 on the European commission proposal of viral
p.000004: screening in assisted reproduction treatments (www.eshre.eu). Hughes C., Emerson G., Grundy K., Kelly P., Mocanu
p.000004: E., Is performing viral screening within 30 days of oocyte collection justified?, Hum Reprod, 2010; 25:239.
p.000004: Janssens P.M., Rules and regulations in reproductive medicine: sensible requirements that should start with evidence,
p.000004: Hum Reprod. 2010; 25(12):3055-7. 2010.
p.000004: Wingfield M. et al., op. cit.
p.000004: 18 Woolf S H., Harris R., The Harms of Screening, New Attention to an Old Concern, JAMA, 2012-Vol 307, No 6, p.565-566.
p.000004: 19 N.B. We will not consider here examinations carried out with a view to treatment of the person himself (too-advanced
p.000004: preventive examinations) nor the harm caused by useless treatments (by the examination itself and also – this is not
p.000004: rare – through additional treatments that can lead to serious injuries). For this type of issue, one can refer to
p.000004: a (more general) article published in Lancet: The perils of excessive medical care, by Shangavi D.M.,
p.000004: Lancet, 2011; 377, 1561-1562, and also the article Overdiagnosed: Making People Sick in the Pursuit of
p.000004: Health, M.D., 2011 by Welch H.G.G., Schwartz L.M., Woloshin S., which refers to the healthcare saga of Brian Mulroney,
p.000004: who was Prime Minister of Canada from 1984 to 1993. A preventive helicoidal scan of the thorax showed that he had two
p.000004: small nodules on the lung. A biopsy showed them to be completely benign. But the patient had to be hospitalised three
p.000004: months for this reason, and because of a complication due to the biopsy, developed life-threatening pancreatitis.
p.000004: 20Serology does not allow the virus itself to be detected. As for all diseases, it only allows the traces of its
p.000004: passage to be detected, that is, the antibodies that are produced by the body in response to its “attack”. The
p.000004: antibodies produced are specific for each disease; a blood test detects only the antibodies for the disease
p.000004: that it is supposed to detect (see notably
p.000004: http://www.3trois3.com/experience_pratique_du_sdrp/5-interets-des-differentes-techniques-d-analyses-
p.000004: :-serologie-pcr-s_606/; Plantier J.-C. and Simon F. (UHC Charles Nicolle Virology Laboratory, Rouen),
p.000004: “Diagnostic sérologique des infections à VIH (Serological diagnosis of HIV infections)”, Développement et Santé, no.
p.000004: 162, December 2002).
p.000004: 21Royal Decree “quality and safety standards (2009)”, Art. 9 §2: “Donors of gametes, gonads, fragments of gonads,
p.000004: foetal human body material and embryos are subject to the biological tests specified in items 1, 2 and 3 of Annex IV
...
Health / hospitalized patients
Searching for indicator hospitalised:
(return to top)
p.000004: of Human Reproduction and Embryology (ESHRE), Statement 2009 on the European commission proposal of viral
p.000004: screening in assisted reproduction treatments (www.eshre.eu). Hughes C., Emerson G., Grundy K., Kelly P., Mocanu
p.000004: E., Is performing viral screening within 30 days of oocyte collection justified?, Hum Reprod, 2010; 25:239.
p.000004: Janssens P.M., Rules and regulations in reproductive medicine: sensible requirements that should start with evidence,
p.000004: Hum Reprod. 2010; 25(12):3055-7. 2010.
p.000004: Wingfield M. et al., op. cit.
p.000004: 18 Woolf S H., Harris R., The Harms of Screening, New Attention to an Old Concern, JAMA, 2012-Vol 307, No 6, p.565-566.
p.000004: 19 N.B. We will not consider here examinations carried out with a view to treatment of the person himself (too-advanced
p.000004: preventive examinations) nor the harm caused by useless treatments (by the examination itself and also – this is not
p.000004: rare – through additional treatments that can lead to serious injuries). For this type of issue, one can refer to
p.000004: a (more general) article published in Lancet: The perils of excessive medical care, by Shangavi D.M.,
p.000004: Lancet, 2011; 377, 1561-1562, and also the article Overdiagnosed: Making People Sick in the Pursuit of
p.000004: Health, M.D., 2011 by Welch H.G.G., Schwartz L.M., Woloshin S., which refers to the healthcare saga of Brian Mulroney,
p.000004: who was Prime Minister of Canada from 1984 to 1993. A preventive helicoidal scan of the thorax showed that he had two
p.000004: small nodules on the lung. A biopsy showed them to be completely benign. But the patient had to be hospitalised three
p.000004: months for this reason, and because of a complication due to the biopsy, developed life-threatening pancreatitis.
p.000004: 20Serology does not allow the virus itself to be detected. As for all diseases, it only allows the traces of its
p.000004: passage to be detected, that is, the antibodies that are produced by the body in response to its “attack”. The
p.000004: antibodies produced are specific for each disease; a blood test detects only the antibodies for the disease
p.000004: that it is supposed to detect (see notably
p.000004: http://www.3trois3.com/experience_pratique_du_sdrp/5-interets-des-differentes-techniques-d-analyses-
p.000004: :-serologie-pcr-s_606/; Plantier J.-C. and Simon F. (UHC Charles Nicolle Virology Laboratory, Rouen),
p.000004: “Diagnostic sérologique des infections à VIH (Serological diagnosis of HIV infections)”, Développement et Santé, no.
p.000004: 162, December 2002).
p.000004: 21Royal Decree “quality and safety standards (2009)”, Art. 9 §2: “Donors of gametes, gonads, fragments of gonads,
p.000004: foetal human body material and embryos are subject to the biological tests specified in items 1, 2 and 3 of Annex IV
p.000004: (items 3.2 to 3.4, cf. text attached to this opinion). The biological tests specified in paragraph 1 are conducted
p.000004: according to the general provisions of item 4 in Annex IV.”
p.000004:
p.000004: FINAL VERSION
p.000005: 5
p.000005:
p.000005: We note that item 4.2 of Annex IV of the Royal Decree “quality and safety standards (2009)” reads as follows: “Les
p.000005: échantillons de sang doivent être prélevés lors du don (Blood samples must be collected at donation)”, while in
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000015: at least of the planned use, the method of application and the immune status of the recipient. Appropriate
p.000015: clothing, personal protective equipment and hygiene facilities, as well as written instructions with regard to hygiene
p.000015: and apparel, must be provided in each section concerned within the establishment.
p.000015: 6. When the procedures for which approval is requested involve storage of human body material, the storage
p.000015: conditions necessary to preserve the required properties of the human body material, including key parameters such as
p.000015: temperature, humidity or air quality, should be specified.
p.000015: 7. Critical parameters, including temperature, humidity or air quality, must be controlled, monitored and
p.000015: recorded to prove their compliance with the required storage conditions.
p.000015: 8. The storage premises must ensure clear separation and distinction between human body material before release and in
p.000015: quarantine, human body material that has been released and human body material that has been rejected, in order
p.000015: to prevent any confusion and cross- contamination between them. In both quarantine areas and storage areas for
p.000015: released human body materials, physically separated areas or secure storage or isolation systems are to be
p.000015: provided for storing human body material fulfilling specific criteria.
p.000015: The specific criteria cited are for example the fact that human body material intended for autologous or
p.000015: deferred use is kept, or that gametes intended for partner donation are involved.
p.000015: 9. The establishment must have written directives and procedures for controlling access to the premises, cleaning and
p.000015: maintenance, removal of waste and continuity of services in the event of an emergency.
p.000015:
p.000015: E. Documentation and recording
p.000015: 1. A system characterised by clearly defined and efficient documentation, proper reporting and registers,
p.000015: and authorised standard operating procedures should be established for the procedures for which approval
p.000015: is requested. Documents must be regularly revised and compliant with the law and the present decree. The system
p.000015: must guarantee standardisation of the procedures performed and the possibility of retracing all the steps,
p.000015: that is, collection, codification, donor eligibility, procurement, processing, preservation, storage,
p.000015: transport, distribution or disposal or destruction, including aspects related to quality control and quality assurance.
p.000015: 2. For any critical activity, the materials, equipment and personnel involved must be identified and documented.
p.000015: 3. Any change in the documents must be checked, dated, approved, documented and executed without delay by
p.000015: authorised personnel in the establishments.
p.000015: 4. A procedure must be established for monitoring documents to provide the history of revisions and
p.000015: changes in the documents and to guarantee that only current versions of documents are used.
p.000015: 5. It must be demonstrated that the data recorded are reliable and constitute a faithful representation
p.000015: of the results.
p.000015: 6. The data recorded must be legible and indelible. They can be handwritten or recorded in another validated electronic
p.000015: system.
p.000015: 7. Without prejudice to Article 6, §3, paragraph 2 of the present decree, all the data recorded, including basic data,
p.000015: that are critical for the safety and quality of the human body material must be preserved in such a way that access to
p.000015: these data is guaranteed for at least ten years after the expiry date for clinical use or disposal.
p.000015:
p.000015:
p.000015:
p.000015: FINAL VERSION
p.000016: 16
p.000016:
p.000016: F. Evaluation of the quality
p.000016: 1. An auditing system should be established for the activities for which approval is requested. Trained and competent
p.000016: persons must perform these audits independently, at least every two years, in order to ensure that the approved
p.000016: protocols and regulatory requirements are observed. The results and corrective measures must be documented.
p.000016: 2. Any breach in observance of the requirements provided by the quality and safety standards must result in
p.000016: documented investigations, along with a decision on any corrective and preventive measures. The fate of
p.000016: non-compliant body material must be decided in accordance with the written procedures, under the supervision of the
p.000016: person responsible, and recorded. All the human body material concerned must be identified and undergo the
p.000016: necessary measures.
p.000016: 3. Corrective measures must be documented, implemented and completed efficiently and within appropriate time
p.000016: periods. The efficacy of the preventive and corrective measures should be evaluated after they are applied.
p.000016: 4. The establishment must establish procedures allowing the efficacy of the quality management
p.000016: system to be evaluated in order to guarantee systematic and ongoing improvement.
p.000016:
p.000016: ***
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
...
Social / Age
Searching for indicator age:
(return to top)
p.000012: - anti-HIV-1, 2
p.000012: - HBsAg
p.000012: - anti-HBc
p.000012: - anti-HCV
p.000012: - a syphilis screening test.
p.000012: In the case of sperm processed with a view to intrauterine insemination, not intended to be preserved, and if the
p.000012: establishment can demonstrate that the risk of cross-contamination and exposure of personnel has been taken into
p.000012: account through use of validated procedures, the biological tests are not necessarily performed.
p.000012: 2.3. If the results of the tests for HIV 1 and 2, hepatitis B or C are positive or not available, or if the donor
p.000012: proves to be a source of infectious risk, a separate storage system must be provided.
p.000012: 2.4. Tests for HTLV-I antibodies must be performed in the case of donors living in areas with a high incidence of this
p.000012: infection or originally from these areas, or whose sexual partners or parents originate from these areas.
p.000012: 2.5 In some circumstances, additional tests must be performed, depending on trips made by the donor, his exposure to
p.000012: risks, and the characteristics of the human body material donated (for example, RhD, malaria, CMV, T cruzi).
p.000012: 2.6. Positive results do not necessarily rule out partner donation.
p.000012:
p.000012: 3. Donations other than partner donations.
p.000012: Aside from partner donations, use of gametes, embryos and gonads or fragments of gonads must fulfil the following
p.000012: criteria:
p.000012: 3.1. Donors must be selected as a function of their age, their state of health and their medical histories, on the
p.000012: basis of a questionnaire and an interview with a qualified healthcare professional trained to this effect.
p.000012: This evaluation must involve all the pertinent factors that can contribute to identifying and excluding persons whose
p.000012: donation could be hazardous to the health of another, notably the possibility of transmitting diseases
p.000012: (sexually transmitted infections, for example), or to their own health (for example, superovulation, sedation, risks
p.000012: related to harvesting ova, or psychological consequences related to the donation).
p.000012: 3.2. The HIV 1 and 2, HCV, and HBV tests and the syphilis test made on a serum or plasma sample from the donor in
p.000012: accordance with the provisions of Annex VI, item 1.1, must be negative for donors. In addition, chlamydia
p.000012: tests made on a urine sample using the nucleic acid amplification technique must be negative for sperm donors.
p.000012: 3.3. The HTLV-I antibody test must be performed for donors living in areas with a high incidence of this
p.000012: infection or originally from such areas, or whose sexual partners or parents originate from these areas.
p.000012: 3.4. In some circumstances, additional tests must be performed, depending on the history of the donor and the
p.000012: characteristics of the human body material donated (for example, RhD, malaria, CMV, T. cruzi).
p.000012: 3.5. For autologous donors, the provisions of Annex II, item 2.1.1 are applicable.
p.000012: 3.6. After consent to this effect has been granted:
...
Social / Child
Searching for indicator child:
(return to top)
p.000007: human body material.”
p.000007: 28“Human body material (2008)” law. Traceability is defined there in Article 2, 23°, as “the ability to locate and
p.000007: identify the human body material at all steps of the process from procurement to distribution with a view to its use
p.000007: or destruction, including processing, testing and storage. This involves the ability to identify the donor
p.000007: and the structures or the production facility involved that receives, modifies or stores the human body material, and
p.000007: the ability to identify the recipients in hospitals that use the human body material. This also involves the
p.000007: ability to locate and identify all the pertinent data concerning the products and materials coming into
p.000007: contact with this human body material during the process.”
p.000007: 29Art. 43 of the “human body material (2008)” law (Transitional provisions and effective date): “After the effective
p.000007: date of the present law (14 July 2010, under the terms of the law of 16 June 2009, Art. 46), human body material that
p.000007: was collected before this effective date and that is not traceable cannot be used for human applications but can be
p.000007: used for purposes of scientific research.”; Art. 44: “Human body material collected before the effective date of the
p.000007: present law can be used for human application after the effective date of this law insofar as the provisions of the
p.000007: present law, with the exception of Articles 10, 12, 20 and 21, are observed.”
p.000007:
p.000007:
p.000007: FINAL VERSION
p.000008: 8
p.000008:
p.000008: destruction is an option very difficult to defend; these gametes and embryos have in effect been entrusted by the
p.000008: patients with a view to later satisfying their desire for a child.
p.000008:
p.000008: Recommendation
p.000008:
p.000008: The Committee therefore requests that the regulations be amended. Strict regulations can have a very
p.000008: positive effect in the future, but with regard to the past, only traceability of the origin of the gametes and embryos
p.000008: can be provided, not information on the use of solutions and material.
p.000008:
p.000008:
p.000008: III. Conclusions and recommendations
p.000008:
p.000008: With this opinion, the Committee wishes to draw the attention of the competent authorities to the ethical problems
p.000008: raised in implementation of the Belgian law “human body material (2008)” and its implementing decrees by
p.000008: certain provisions applied to the Centres for medically assisted procreation.
p.000008:
p.000008: 1. Article 6, §1, of the Royal Decree “quality and safety standards (2009)”, dealing with (1) the guarantee of
p.000008: traceability of all human body material (gametes and embryos) collected, procured, processed, stored or
p.000008: distributed, goes too far in that it also involves (2) all the pertinent data on the products and materials
p.000008: coming into contact with this human body material.
p.000008:
p.000008: Requirement (1) poses no problem; (2) does, due to the fact that traceability of the products and materials
p.000008: is required retroactively, which raises a significant ethical problem.
p.000008:
p.000008: 2. In the past, traceability of all these human body materials as well as the products and materials coming into
p.000008: contact with them has not been observed in practice.
p.000008:
p.000008: 3. The consequence of this is that thousands of cryopreserved gametes and embryos can no longer serve the purposes
...
p.000011: b) or distribution with a view to another possible use as specified in a);
p.000011: c) the destruction of the human body material.
p.000011: Application of the preceding paragraph cannot have the consequence that the specified data are preserved for more than
p.000011: 50 years.
p.000011: § 4. The data specified in §§2 and 3, paragraph 2, are kept in the procuring establishment immediately after
p.000011: collection.
p.000011: In the event of application of Article 8, §2, paragraph 3 of the law, the data specified in §§2 and 3 are preserved by
p.000011: the bank of human body material responsible, as specified in Article 8,
p.000011: §2, paragraph 4 of the law.
p.000011:
p.000011: Annex IV
p.000011: Selection criteria and biological tests required for donors of gametes, embryos, gonads and fragments of gonads
p.000011: intended for assisted procreation
p.000011:
p.000011: 1. Partner donations for immediate use without storage or processing.
p.000011: The donor selection criteria and laboratory tests do not apply in the case of a donation of male gametes
p.000011: between partners for immediate use.
p.000011:
p.000011: 2. Partner donations other than for immediate use, as specified in item 1.
p.000011:
p.000011:
p.000011:
p.000011: FINAL VERSION
p.000012: 12
p.000012:
p.000012: Gametes, gonads, fragments of gonads and embryos that are processed and/or stored and gametes which will result
p.000012: in embryos that will be cryopreserved must fulfil the following criteria:
p.000012: 2.1. The treating physician of the donor must verify and document, on the basis of the medical history
p.000012: of the patient and the therapeutic indications, the justifications for the donation and the safety of the
p.000012: donation for the recipient and for any child that may be born from this donation.
p.000012: 2.2. The following biological tests must be performed to evaluate the risk of cross- contamination:
p.000012: - anti-HIV-1, 2
p.000012: - HBsAg
p.000012: - anti-HBc
p.000012: - anti-HCV
p.000012: - a syphilis screening test.
p.000012: In the case of sperm processed with a view to intrauterine insemination, not intended to be preserved, and if the
p.000012: establishment can demonstrate that the risk of cross-contamination and exposure of personnel has been taken into
p.000012: account through use of validated procedures, the biological tests are not necessarily performed.
p.000012: 2.3. If the results of the tests for HIV 1 and 2, hepatitis B or C are positive or not available, or if the donor
p.000012: proves to be a source of infectious risk, a separate storage system must be provided.
p.000012: 2.4. Tests for HTLV-I antibodies must be performed in the case of donors living in areas with a high incidence of this
p.000012: infection or originally from these areas, or whose sexual partners or parents originate from these areas.
p.000012: 2.5 In some circumstances, additional tests must be performed, depending on trips made by the donor, his exposure to
p.000012: risks, and the characteristics of the human body material donated (for example, RhD, malaria, CMV, T cruzi).
p.000012: 2.6. Positive results do not necessarily rule out partner donation.
p.000012:
p.000012: 3. Donations other than partner donations.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000012: basis of a questionnaire and an interview with a qualified healthcare professional trained to this effect.
p.000012: This evaluation must involve all the pertinent factors that can contribute to identifying and excluding persons whose
p.000012: donation could be hazardous to the health of another, notably the possibility of transmitting diseases
p.000012: (sexually transmitted infections, for example), or to their own health (for example, superovulation, sedation, risks
p.000012: related to harvesting ova, or psychological consequences related to the donation).
p.000012: 3.2. The HIV 1 and 2, HCV, and HBV tests and the syphilis test made on a serum or plasma sample from the donor in
p.000012: accordance with the provisions of Annex VI, item 1.1, must be negative for donors. In addition, chlamydia
p.000012: tests made on a urine sample using the nucleic acid amplification technique must be negative for sperm donors.
p.000012: 3.3. The HTLV-I antibody test must be performed for donors living in areas with a high incidence of this
p.000012: infection or originally from such areas, or whose sexual partners or parents originate from these areas.
p.000012: 3.4. In some circumstances, additional tests must be performed, depending on the history of the donor and the
p.000012: characteristics of the human body material donated (for example, RhD, malaria, CMV, T. cruzi).
p.000012: 3.5. For autologous donors, the provisions of Annex II, item 2.1.1 are applicable.
p.000012: 3.6. After consent to this effect has been granted:
p.000012: a) genetic screening is performed for the autosomal recessive genes prevalent in the ethnic context of the donor,
p.000012: according to international scientific knowledge;
p.000012: b) the risk of transmission of hereditary disorders known to be present in the family is evaluated.
p.000012: The recipient is fully and intelligibly informed of the associated risks and of the measures taken to
p.000012: reduce them.
p.000012:
p.000012:
p.000012:
p.000012: FINAL VERSION
p.000013: 13
p.000013:
p.000013: 4. General conditions for determining biological markers.
p.000013: 4.1. Tests must be performed in accordance with Annex VI, items 2.1 and 2.2.
p.000013: 4.2. Blood samples must be collected at donation.
p.000013: 4.3. Donations of gametes, embryos, gonads and fragments of gonads other than partner donations or
p.000013: donations of gametes intended for use for surplus embryos are put into quarantine for at least 180 days, a
p.000013: period at the end of which the tests must be recommenced. If the blood sample from the donor at the time of donation is
p.000013: also tested using the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, it is not necessary to perform
p.000013: the tests on a second blood sample or to implement the quarantine specified above. Likewise, it is not necessary to
p.000013: recommence the test when the processing procedure includes a validated inactivation step for the viruses
p.000013: concerned.
p.000013:
p.000013: Annex VII
p.000013: Various provisions on the quality and safety of activities in the establishments
p.000013:
p.000013: A. Organisation and management
p.000013: 1. A manager of human body material should be designated, equipped with the qualifications specified in the law as
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000006: Sep;23(3):341-6 (an abstract of which is available on the site http://www.ncbi.nlm.nih.gov/pubmed/21767989).
p.000006: Cobo A., Meseguer M., Remohí J., Pellicer A., Use of cryo-banked oocytes in an ovum donation programme:
p.000006: a prospective, randomized, controlled, clinical trial, Hum Reprod. 2010 Sep; 25(9):2239-46. Epub 2010 Jun 30.
p.000006: Source: Instituto Valenciano de Infertilidad (IVI), University of Valencia, Valencia, Spain. (an abstract of
p.000006: which is available on the site http://www.ncbi.nlm.nih.gov/pubmed/20591872).
p.000006: See also Herrero L., Pareja S., Losada C., Cobo A., Pellicer A., Garcia-Velasco J.A., Avoiding the use of human
p.000006: chorionic gonadotropin combined with oocyte vitrification and GnRH agonist triggering versus coasting: a new
p.000006: strategy to avoid ovarian hyperstimulation syndrome, 2011 Mar 1;95(3):1137-40. Epub 2010 Nov 3.
p.000006: Mertes H., Pennings G., Social egg freezing: for better, not for worse, Reproductive BioMedicine Online (2011) 23,
p.000006: 824-829.
p.000006: 26In accordance with the general provisions of item 4 of Annex IV of the Royal Decree “quality and safety standards
p.000006: (2009)”.
p.000006:
p.000006: FINAL VERSION
p.000007: 7
p.000007:
p.000007: Recommendations
p.000007:
p.000007: A/ It would be preferable that these tests rely on the same principles as those applicable to
p.000007: heterologous sperm donation.
p.000007: Here as well, it seems desirable that a virological test performed 14 days to 3 weeks maximum before the collection
p.000007: procedure be the rule. This would offer greater safety than the provision specifying that the PCR be performed at the
p.000007: time of collection, as 72 hours generally pass before the result is known. Given the restricted time interval and the
p.000007: impossibility of always organising a quarantine, an additional possibility must obviously be provided for
p.000007: conducting the PCR if the oocytes must be used in the short term.
p.000007:
p.000007: B/ It would be preferable that the quarantine period also be observed in the case of freezing (vitrification) (as for
p.000007: sperm donation).
p.000007:
p.000007: 3. The traceability requirement27
p.000007:
p.000007: A requirement of complete traceability of gametes and embryos is justified and can certainly be satisfied. In addition
p.000007: to this condition, the new regulations have also introduced that of traceability for all solutions and equipment
p.000007: used28. This provides that each sample must be accompanied by extensive methodological traceability (in
p.000007: other words, by any useful information in connection with the products, materials and equipment used
p.000007: for processing and preservation).
p.000007:
p.000007: The Committee entirely approves of this traceability requirement, to be applied at once and in the future. This can
p.000007: only increase the safety of the procedures and the commitment of the staff involved.
p.000007:
p.000007: However, the new regulations also require that the same provisions be observed with regard to gametes and embryos
p.000007: collected in the past. Serious ethical objections are however raised.
p.000007:
p.000007: A/ First of all, it is not admissible – at least for this type of provision – to introduce retroactive regulations29.
p.000007:
p.000007: B/ Given that the centres cannot fully observe these requirements, these regulations can have the effect that
p.000007: they are obliged to destroy thousands of cryopreserved embryos and gametes. These embryos and gametes can in
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000013: 5. It should be ensured that the risks inherent in use and handing of human body material are identified and reduced
p.000013: insofar as possible, while maintaining a level of quality and safety appropriate for the use for which the
p.000013: human body material is intended. These risks include notably those related to procedures, the environment and the state
p.000013: of health of the personnel within the establishment in question.
p.000013: 6. Agreements concluded between establishments and third parties must comply with the provisions of the
p.000013: law and of the present decree. Agreements made with third parties must specify the methods of collaboration
p.000013: and the responsibilities, as well as the protocols to be followed to fulfil the required performance demands.
p.000013: 7. A standard operating procedure must exist, supervised by the manager of human body material and
p.000013: serving to confirm that the human body material satisfies the required specifications with regard to safety
p.000013: and quality, for its release and distribution.
p.000013: 8. In the event of cessation of activities, the agreements concluded and the procedures adopted in
p.000013: compliance with the law include traceability data and information on the quality and safety of the human body material.
p.000013: 9. A standard operating procedure exists guaranteeing identification of each unit of human body material at all steps
p.000013: of the procedures.
p.000013:
p.000013: B. Personnel
p.000013: 1. The personnel of the establishments must be available in sufficient number and be qualified for the
p.000013: tasks to be performed. The competence of the personnel must be evaluated at appropriate intervals specified in the
p.000013: quality system.
p.000013: 2. Clear job descriptions, documented and updated, must exist for all members of personnel. Their tasks, functions and
p.000013: responsibility must be clearly documented and well-understood.
p.000013: 3. The personnel must receive basic training and refresher training when a change in procedures or a
p.000013: development in scientific knowledge requires it, and be given appropriate opportunities for professional
p.000013: development in the area involved. The training programme ensures and provides documented proof that each
p.000013: individual:
p.000013: a) has proven his competence in performing the tasks assigned to him;
p.000013:
p.000013:
p.000013:
p.000013: FINAL VERSION
p.000014: 14
p.000014:
p.000014: b) has adequate knowledge and comprehension of the principles and/or the scientific and/or technical processes that are
p.000014: important for the tasks allotted to him;
p.000014: c) understands the organisational framework, the quality system and the health and safety rules of the
p.000014: establishment in which he works;
p.000014: d) is duly informed of the broader ethical, legal and regulatory context involved in his work.
p.000014:
p.000014: C. Equipment and materials
p.000014: 1. All equipment and materials must be designed and maintained in such a way that they are suitable for the use for
p.000014: which they are intended, and must reduce insofar as possible any risk for the recipients and the personnel.
p.000014: 2. All critical equipment and technical devices must be identified and validated, and undergo regular inspections and
p.000014: preventive maintenance in accordance with the manufacturer’s instructions. When the equipment or
p.000014: materials involve critical processing or storage parameters (for example, temperature, pressure, particle
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000002: FINAL VERSION
p.000003: 3
p.000003:
p.000003: or sperm in the two partners of a couple in the context of a medically assisted procreation procedure, in the case of
p.000003: other than immediate use. This high frequency is very difficult to defend and hardly feasible in practice:
p.000003:
p.000003: A/ The risk of exogenous contamination by diseases during treatment is very low. This is moreover confirmed in
p.000003: international studies10.
p.000003:
p.000003: B/ Systematic monitoring in order to protect the laboratory personnel is meaningless, given that the entire
p.000003: procedure must take place in a completely sterile environment where the personnel must always observe standard
p.000003: sterility precautions11.
p.000003:
p.000003: C/ Systematic monitoring and repeated performance of blood analyses at each donation generate a resulting
p.000003: additional cost for the community. The additional cost for INAMI12 in Belgium is approximately 4.8 million euro13.
p.000003:
p.000003: D/ Given that at present no contamination has been reported in major international studies14, the
p.000003: investment of such a significant sum of public money for such a low benefit is difficult to justify from an
p.000003: ethical point of view.
p.000003:
p.000003: E/ Physical and psychological pressure is also added to the financial factor, as the patients must
p.000003: submit to blood sampling and appear each time for a series of procedures.
p.000003:
p.000003: F/ A recent study by the Belgian Society of Reproductive Medicine (BSRM)15 has shown that various intervals between
p.000003: virological tests are assigned in the various countries of the European Union. They are as follows: Norway 12
p.000003: months, Denmark 24 months, Finland and Sweden 12 to 24 months, Poland 6 months, France less than 6 months for the
p.000003: first cycle and then every 24 months. In Germany, examinations must take place one week before oocyte collection.
p.000003: In Italy, the period is 3 months; in Greece, screening is advised before the first sperm donation and
p.000003: after three to four cycles. Finally, in Latvia, a check is required every 6 months.
p.000003: Moreover, a European bill exists to limit repetition of testing to one test every 24 months16.
p.000003:
p.000003: Recommendation
p.000003:
p.000003: In the light of these aspects and on the basis of the information collected on the international scale, it is
p.000003: proposed that virological analysis for HIV, hepatitis B and C and syphilis be performed only at the
p.000003: first procedure and conducted afterward only at 12-month intervals.
p.000003:
p.000003: 10 Wingfield M., Cottell E., Viral screening of couples undergoing partner donation in assisted
p.000003: reproduction with regard to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC: what is the evidence for
p.000003: repeated screening? E. Hum Reprod. 2010; 25(12):3058-65. Pepas L., Macmahon E., El Toukhy T., Khalaf Y. &
p.000003: Braude P., Viral screening before each cycle of assisted conception treatment is expensive and unnecessary: a
p.000003: survey of results from a UK inner city clinic , Human Fertility, 2011; 14(4):224-229.
p.000003: 11 See Annex VII of the aforementioned Royal Decree “quality and safety standards (2009)” (text attached in the
p.000003: Appendix).
...
p.000003: systems, which does not affect the safety and quality of reproductive cells and/or human health when donors are tested
p.000003: at up to 24 months time intervals”.
p.000003:
p.000003: FINAL VERSION
p.000004: 4
p.000004:
p.000004: This would correspond to the international consensus published in a number of scientific publications17.
p.000004:
p.000004: With this adaptation, a balance can be reached between greater safety on the one hand and costs and burdens on the
p.000004: donor/partner on the other hand. In this regard, reference can be made to an article from the American Medical
p.000004: Association: The Harms of Screening, New Attention to an Old Concern 18.
p.000004:
p.000004: In a discussion of preventive diagnostic examinations, false positive results can never be forgotten, nor
p.000004: the burden of additional examinations. In this context, it should also be noted that these useless additional
p.000004: examinations sometimes represent a high cost to the community and thus uselessly squander the scant resources essential
p.000004: to the curative sector19.
p.000004:
p.000004:
p.000004: 2. Sperm and oocyte donation, fresh or after cryopreservation, other than partner donation
p.000004:
p.000004: 2. 1. Virological analyses required for sperm donation other partner donation
p.000004:
p.000004: 2.1.1. Technical data
p.000004:
p.000004: Current regulations require virological testing20 at least for HIV, hepatitis B and C, syphilis and
p.000004: chlamydia (by PCR = NAT test or not) at each consecutive donation of sperm by the same donor21.
p.000004:
p.000004: 17 Bhargava P.M., On the critical assessment of the impact of the recent European Union Tissues and Cells Directive.
p.000004: Reprod Biomed Online, 2005; 11(2):161.
p.000004: Hartshorne G.M., Challenge of the EU ‘tissues and cells’ directive. Reprod Biomed Online 2005; 11: 404- 407.
p.000004: Mortimer D.A., Critical assessment of the impact of the European Union Tissues and Cells Directive (2004)
p.000004: on laboratory practices in assisted conception, Reprod Biomed Online, 2005; 11(2):162-176. European Society
p.000004: of Human Reproduction and Embryology (ESHRE), Statement 2009 on the European commission proposal of viral
p.000004: screening in assisted reproduction treatments (www.eshre.eu). Hughes C., Emerson G., Grundy K., Kelly P., Mocanu
p.000004: E., Is performing viral screening within 30 days of oocyte collection justified?, Hum Reprod, 2010; 25:239.
p.000004: Janssens P.M., Rules and regulations in reproductive medicine: sensible requirements that should start with evidence,
p.000004: Hum Reprod. 2010; 25(12):3055-7. 2010.
p.000004: Wingfield M. et al., op. cit.
p.000004: 18 Woolf S H., Harris R., The Harms of Screening, New Attention to an Old Concern, JAMA, 2012-Vol 307, No 6, p.565-566.
p.000004: 19 N.B. We will not consider here examinations carried out with a view to treatment of the person himself (too-advanced
p.000004: preventive examinations) nor the harm caused by useless treatments (by the examination itself and also – this is not
p.000004: rare – through additional treatments that can lead to serious injuries). For this type of issue, one can refer to
p.000004: a (more general) article published in Lancet: The perils of excessive medical care, by Shangavi D.M.,
p.000004: Lancet, 2011; 377, 1561-1562, and also the article Overdiagnosed: Making People Sick in the Pursuit of
p.000004: Health, M.D., 2011 by Welch H.G.G., Schwartz L.M., Woloshin S., which refers to the healthcare saga of Brian Mulroney,
p.000004: who was Prime Minister of Canada from 1984 to 1993. A preventive helicoidal scan of the thorax showed that he had two
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: centres
p.000002:
p.000002:
p.000002: 11) Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting
p.000002: standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and
p.000002: distribution of human tissues and cells; 2) Directive 2006/17/EC of the Commission of 8 February 2006 implementing
p.000002: directive 2004/23/EC of the European Parliament and the Council as regards certain technical requirements for the
p.000002: donation, procurement and testing of human tissues and cells; 3) Directive 2006/86/EC of the Commission of 24
p.000002: October 2006 implementing Directive 2004/23/EC of the European Parliament and the Council as regards traceability
p.000002: requirements, notification of serious adverse reactions and events, and certain technical requirements for the
p.000002: coding, processing, preservation, storage and distribution of human tissues and cells.
p.000002: 2See in particular opinion no. 11 of the Committee of 20 December 1999 on collection of organs and tissues from
p.000002: healthy living subjects with a view to transplantation, opinion of the Committee no. 42 of 16 April 2007 on umbilical
p.000002: cord blood banks and opinion of the Committee no. 50 of 9 May 2011 on certain ethical aspects of the amendments made by
p.000002: the law of 25 February 2007 to the law of 13 June 1986 on organ collection and transplantation.
p.000002: 3See opinion of the Committee no. 18 of 16 September 2002 on research on the human embryo in vitro. 4Royal Decree of
p.000002: 28 September 2009 setting quality and safety standards for donation, collection, procurement, testing,
p.000002: processing, storage and distribution of human bodily material, with which banks of human bodily material,
p.000002: intermediate structures for human bodily material and production establishments must comply, hereafter
p.000002: designated as the Royal Decree “quality and safety standards (2009)”, in particular Annex IV.
p.000002: 5Law of 6 July 2007 on medically assisted procreation and destination of excess embryos and gametes, hereafter
p.000002: designated “MAP (2007)” law.
p.000002:
p.000002: FINAL VERSION
p.000002: 2
p.000002:
p.000002: concerned. From an ethical point of view, the opinions are based on the model of the four traditional principles
p.000002: of medical ethics. Analysis of the regulations shows that in several provisions, it contradicts these
p.000002: principles.
p.000002: Thus, it is difficult to defend a position stipulating that in the event of manifest shortage of means, these
p.000002: valuable resources will be devoted to performing less useful technical examinations. The same
p.000002: reasoning also applies when the examinations to be performed prove to be detrimental to the persons examined.
p.000002:
p.000002: II. Analysis
p.000002:
p.000002: Interviews with some experts6 have revealed certain concerns, specified below, with regard to both donations between
p.000002: partners other than for immediate use and donations other than those between partners.
p.000002:
p.000002: The ethical analysis is based on the four principles of biomedical ethics7. We have considered whether the new
...
Social / parents
Searching for indicator parents:
(return to top)
p.000012: in embryos that will be cryopreserved must fulfil the following criteria:
p.000012: 2.1. The treating physician of the donor must verify and document, on the basis of the medical history
p.000012: of the patient and the therapeutic indications, the justifications for the donation and the safety of the
p.000012: donation for the recipient and for any child that may be born from this donation.
p.000012: 2.2. The following biological tests must be performed to evaluate the risk of cross- contamination:
p.000012: - anti-HIV-1, 2
p.000012: - HBsAg
p.000012: - anti-HBc
p.000012: - anti-HCV
p.000012: - a syphilis screening test.
p.000012: In the case of sperm processed with a view to intrauterine insemination, not intended to be preserved, and if the
p.000012: establishment can demonstrate that the risk of cross-contamination and exposure of personnel has been taken into
p.000012: account through use of validated procedures, the biological tests are not necessarily performed.
p.000012: 2.3. If the results of the tests for HIV 1 and 2, hepatitis B or C are positive or not available, or if the donor
p.000012: proves to be a source of infectious risk, a separate storage system must be provided.
p.000012: 2.4. Tests for HTLV-I antibodies must be performed in the case of donors living in areas with a high incidence of this
p.000012: infection or originally from these areas, or whose sexual partners or parents originate from these areas.
p.000012: 2.5 In some circumstances, additional tests must be performed, depending on trips made by the donor, his exposure to
p.000012: risks, and the characteristics of the human body material donated (for example, RhD, malaria, CMV, T cruzi).
p.000012: 2.6. Positive results do not necessarily rule out partner donation.
p.000012:
p.000012: 3. Donations other than partner donations.
p.000012: Aside from partner donations, use of gametes, embryos and gonads or fragments of gonads must fulfil the following
p.000012: criteria:
p.000012: 3.1. Donors must be selected as a function of their age, their state of health and their medical histories, on the
p.000012: basis of a questionnaire and an interview with a qualified healthcare professional trained to this effect.
p.000012: This evaluation must involve all the pertinent factors that can contribute to identifying and excluding persons whose
p.000012: donation could be hazardous to the health of another, notably the possibility of transmitting diseases
p.000012: (sexually transmitted infections, for example), or to their own health (for example, superovulation, sedation, risks
p.000012: related to harvesting ova, or psychological consequences related to the donation).
p.000012: 3.2. The HIV 1 and 2, HCV, and HBV tests and the syphilis test made on a serum or plasma sample from the donor in
p.000012: accordance with the provisions of Annex VI, item 1.1, must be negative for donors. In addition, chlamydia
p.000012: tests made on a urine sample using the nucleic acid amplification technique must be negative for sperm donors.
p.000012: 3.3. The HTLV-I antibody test must be performed for donors living in areas with a high incidence of this
p.000012: infection or originally from such areas, or whose sexual partners or parents originate from these areas.
p.000012: 3.4. In some circumstances, additional tests must be performed, depending on the history of the donor and the
p.000012: characteristics of the human body material donated (for example, RhD, malaria, CMV, T. cruzi).
p.000012: 3.5. For autologous donors, the provisions of Annex II, item 2.1.1 are applicable.
p.000012: 3.6. After consent to this effect has been granted:
p.000012: a) genetic screening is performed for the autosomal recessive genes prevalent in the ethnic context of the donor,
p.000012: according to international scientific knowledge;
p.000012: b) the risk of transmission of hereditary disorders known to be present in the family is evaluated.
p.000012: The recipient is fully and intelligibly informed of the associated risks and of the measures taken to
p.000012: reduce them.
p.000012:
p.000012:
p.000012:
p.000012: FINAL VERSION
p.000013: 13
p.000013:
p.000013: 4. General conditions for determining biological markers.
p.000013: 4.1. Tests must be performed in accordance with Annex VI, items 2.1 and 2.2.
p.000013: 4.2. Blood samples must be collected at donation.
p.000013: 4.3. Donations of gametes, embryos, gonads and fragments of gonads other than partner donations or
p.000013: donations of gametes intended for use for surplus embryos are put into quarantine for at least 180 days, a
p.000013: period at the end of which the tests must be recommenced. If the blood sample from the donor at the time of donation is
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Opinion no. 52 of 12 March 2012 on the ethical aspects of certain provisions of the European and Belgian
p.000002: regulations with regard to human tissues and cells used in the context of reproductive medicine
p.000002:
p.000002: Referral
p.000002: The question submitted to the “Ethics and regulation in reproductive medicine” commission was formulated on the
p.000002: initiative of the Bureau of the Advisory Committee on Bioethics itself on 26 February 2010.
p.000002: More precisely, it concerns the issue of whether, as an ethical consideration, the new Belgian regulations following
p.000002: transposition of certain provisions of the European directives on human tissues and cells1 include features that
p.000002: make the application of good clinical practices and principles of medical ethics more difficult with regard to
p.000002: medically assisted procreation.
p.000002:
p.000002: The Committee decided in its plenary session of 8 March 2010 to take this question into consideration
p.000002: and entrusted the 2010/4 commission with examining it. In the light of this examination, the Committee has
p.000002: then carried out its own evaluation of the regulations.
p.000002: This evaluation emphasises the Belgian situation, which has been compared successively to international consensus
p.000002: (via the experts consulted) and needs in the field (practitioners in Belgium).
p.000002:
p.000002: I. Preamble
p.000002: This opinion will not deal with issues covered by opinions previously issued by the Committee on the ethical problems
p.000002: raised by collections of human body material intended for academic research or used for commercial purposes, or by
p.000002: banks of organs, cells or tissues constituted with a view to autologous or heterologous transplantation for
p.000002: therapeutic purposes, or by banks of blood or its constituents for therapeutic purposes2. This opinion will also not
p.000002: deal with the use of gametes or embryos for purposes of scientific research3. It will concentrate on certain specific
p.000002: factors that hinder good clinical practice in centres for medically assisted reproduction (called “MAP
p.000002: Centres”).
p.000002:
p.000002: These centres are responsible for the use of gametes or reproductive tissues with a view to medically assisted
p.000002: procreation and in this capacity must apply the Belgian regulations in this regard, in particular the Royal Decree of
p.000002: 28 September 2009 concerning banks of human body material4. This is combined with the legislation on medically
p.000002: assisted procreation (MAP) and that on obtaining and using human body material5, which must also be applied in the
p.000002: centres
p.000002:
p.000002:
p.000002: 11) Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting
p.000002: standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and
p.000002: distribution of human tissues and cells; 2) Directive 2006/17/EC of the Commission of 8 February 2006 implementing
p.000002: directive 2004/23/EC of the European Parliament and the Council as regards certain technical requirements for the
p.000002: donation, procurement and testing of human tissues and cells; 3) Directive 2006/86/EC of the Commission of 24
p.000002: October 2006 implementing Directive 2004/23/EC of the European Parliament and the Council as regards traceability
p.000002: requirements, notification of serious adverse reactions and events, and certain technical requirements for the
p.000002: coding, processing, preservation, storage and distribution of human tissues and cells.
p.000002: 2See in particular opinion no. 11 of the Committee of 20 December 1999 on collection of organs and tissues from
p.000002: healthy living subjects with a view to transplantation, opinion of the Committee no. 42 of 16 April 2007 on umbilical
p.000002: cord blood banks and opinion of the Committee no. 50 of 9 May 2011 on certain ethical aspects of the amendments made by
p.000002: the law of 25 February 2007 to the law of 13 June 1986 on organ collection and transplantation.
p.000002: 3See opinion of the Committee no. 18 of 16 September 2002 on research on the human embryo in vitro. 4Royal Decree of
p.000002: 28 September 2009 setting quality and safety standards for donation, collection, procurement, testing,
p.000002: processing, storage and distribution of human bodily material, with which banks of human bodily material,
p.000002: intermediate structures for human bodily material and production establishments must comply, hereafter
p.000002: designated as the Royal Decree “quality and safety standards (2009)”, in particular Annex IV.
p.000002: 5Law of 6 July 2007 on medically assisted procreation and destination of excess embryos and gametes, hereafter
p.000002: designated “MAP (2007)” law.
p.000002:
p.000002: FINAL VERSION
p.000002: 2
p.000002:
p.000002: concerned. From an ethical point of view, the opinions are based on the model of the four traditional principles
p.000002: of medical ethics. Analysis of the regulations shows that in several provisions, it contradicts these
p.000002: principles.
p.000002: Thus, it is difficult to defend a position stipulating that in the event of manifest shortage of means, these
p.000002: valuable resources will be devoted to performing less useful technical examinations. The same
p.000002: reasoning also applies when the examinations to be performed prove to be detrimental to the persons examined.
p.000002:
p.000002: II. Analysis
p.000002:
p.000002: Interviews with some experts6 have revealed certain concerns, specified below, with regard to both donations between
p.000002: partners other than for immediate use and donations other than those between partners.
p.000002:
...
p.000002: The second principle is that of non-maleficence. A medical procedure that causes harm must be justified by a) a
p.000002: relative advantage compared to the application of another ethical principle;
p.000002: b) the certainty of preventing greater harm. Harm to the donor (testing, sampling) is justified by the concern for
p.000002: preventing harm (contamination) to the recipient. If it is obvious that the tests do not protect against any
p.000002: contamination or if another procedure can achieve the same result by causing less harm, then there is cause to amend
p.000002: the regulations as a consequence.
p.000002:
p.000002:
p.000002: 1. Donation between partners other than for immediate use
p.000002:
p.000002: Is it necessary to conduct blood tests repeated at each collection of gametes in couples treated, even if sperm and
p.000002: autologous oocytes of the couple in treatment are used8?
p.000002:
p.000002: According to the present regulations, virological analysis for HIV, hepatitis B and C (HBV and HCV) and syphilis is
p.000002: required (with or without PCR/NAT9) at each procedure involving oocytes
p.000002:
p.000002: Law of 19 December 2008 on procurement and use of human body material intended for human medical applications or for
p.000002: purposes of scientific research, hereafter designated as the “human body material (2008)” law.
p.000002: 6 Cited on the last page of this opinion.
p.000002: 7 Beauchamp T.L., Childress J.F., Principles of Biomedical Ethics, Oxford University Press, 6th ed., 2008 (French
p.000002: translation Les principes de l'éthique biomédicale, Paris, Les Belles Lettres, Médecine & Sciences humaines, 2008).
p.000002: 8 See Art. 4.2. of Annex IV of the Royal Decree “quality and safety standards (2009)”: “Blood samples must be
p.000002: collected upon donation” (“general conditions for determining biological markers”) and Articles
p.000002: 2.1. to 2.6.; see also Art. 4.2. of Annex III of the aforementioned directive of 8 February 2006.
p.000002: 9PCR (polymerase chain reaction) designates a modern technique for DNA analysis lending itself to
p.000002: automation and using the molecular biology of in vitro DNA amplification. Polymerase or reverse
p.000002: transcriptase is an enzyme associated with carcinogenic viruses, those of some leukaemias and that of AIDS (HIV), and
p.000002: allows this RNA virus to incorporate itself into the chromosomes of the cell it infects and that are made of DNA. PCR
p.000002: allows for example a bacterium or virus to be identified or a gene mutation to be revealed to diagnose a genetic
p.000002: disease (Dictionnaire Garnier-Delamare des termes de médecine, Paris, Maloine, 30th ed., 2009, see "gene
p.000002: amplification" and "reverse transcriptase"). The Royal Decree uses NAT (Nucleic Acid Amplification Technology),
p.000002: which designates the same technique for nucleic acid amplification, instead of PCR.
p.000002:
p.000002: FINAL VERSION
p.000003: 3
p.000003:
p.000003: or sperm in the two partners of a couple in the context of a medically assisted procreation procedure, in the case of
...
p.000004: Health, M.D., 2011 by Welch H.G.G., Schwartz L.M., Woloshin S., which refers to the healthcare saga of Brian Mulroney,
p.000004: who was Prime Minister of Canada from 1984 to 1993. A preventive helicoidal scan of the thorax showed that he had two
p.000004: small nodules on the lung. A biopsy showed them to be completely benign. But the patient had to be hospitalised three
p.000004: months for this reason, and because of a complication due to the biopsy, developed life-threatening pancreatitis.
p.000004: 20Serology does not allow the virus itself to be detected. As for all diseases, it only allows the traces of its
p.000004: passage to be detected, that is, the antibodies that are produced by the body in response to its “attack”. The
p.000004: antibodies produced are specific for each disease; a blood test detects only the antibodies for the disease
p.000004: that it is supposed to detect (see notably
p.000004: http://www.3trois3.com/experience_pratique_du_sdrp/5-interets-des-differentes-techniques-d-analyses-
p.000004: :-serologie-pcr-s_606/; Plantier J.-C. and Simon F. (UHC Charles Nicolle Virology Laboratory, Rouen),
p.000004: “Diagnostic sérologique des infections à VIH (Serological diagnosis of HIV infections)”, Développement et Santé, no.
p.000004: 162, December 2002).
p.000004: 21Royal Decree “quality and safety standards (2009)”, Art. 9 §2: “Donors of gametes, gonads, fragments of gonads,
p.000004: foetal human body material and embryos are subject to the biological tests specified in items 1, 2 and 3 of Annex IV
p.000004: (items 3.2 to 3.4, cf. text attached to this opinion). The biological tests specified in paragraph 1 are conducted
p.000004: according to the general provisions of item 4 in Annex IV.”
p.000004:
p.000004: FINAL VERSION
p.000005: 5
p.000005:
p.000005: We note that item 4.2 of Annex IV of the Royal Decree “quality and safety standards (2009)” reads as follows: “Les
p.000005: échantillons de sang doivent être prélevés lors du don (Blood samples must be collected at donation)”, while in
p.000005: the corresponding Dutch version we read: 4.2. “Bloedmonsters worden op het tijdstip van de donation
p.000005: afgenomen (Blood samples are collected at the time of donation)”. This difference in translation gives rise to a
p.000005: divergence in interpretation.
p.000005:
p.000005: These sperm donations generally take place twice per week, with repetition of the aforementioned tests each
p.000005: time, while the sperm is frozen each time. The reliability of the result of the PCR conducted immediately after
p.000005: contamination (in acute cases) is inadequate in this respect.
p.000005:
p.000005: 2.1.2. Precautions to be observed
p.000005:
p.000005: A quarantine of a minimum of 180 days after the last sperm donation22 must be observed, as has already
p.000005: been practised for years in all the approved centres. Only at the end of this quarantine period is the previously
p.000005: described viral serology again tested for the donor23.
p.000005:
p.000005: 2.1.3. Recommendations
p.000005:
p.000005: A/ Performance of tests repeated at each donation is rather meaningless when the standard quarantine period
p.000005: with separate collection is observed. It is much more sound to strictly observe the quarantine rule alone because, in
p.000005: this way, negative serology at the end of 180 days points to the absence of contamination.
p.000005:
...
p.000007: the ability to identify the recipients in hospitals that use the human body material. This also involves the
p.000007: ability to locate and identify all the pertinent data concerning the products and materials coming into
p.000007: contact with this human body material during the process.”
p.000007: 29Art. 43 of the “human body material (2008)” law (Transitional provisions and effective date): “After the effective
p.000007: date of the present law (14 July 2010, under the terms of the law of 16 June 2009, Art. 46), human body material that
p.000007: was collected before this effective date and that is not traceable cannot be used for human applications but can be
p.000007: used for purposes of scientific research.”; Art. 44: “Human body material collected before the effective date of the
p.000007: present law can be used for human application after the effective date of this law insofar as the provisions of the
p.000007: present law, with the exception of Articles 10, 12, 20 and 21, are observed.”
p.000007:
p.000007:
p.000007: FINAL VERSION
p.000008: 8
p.000008:
p.000008: destruction is an option very difficult to defend; these gametes and embryos have in effect been entrusted by the
p.000008: patients with a view to later satisfying their desire for a child.
p.000008:
p.000008: Recommendation
p.000008:
p.000008: The Committee therefore requests that the regulations be amended. Strict regulations can have a very
p.000008: positive effect in the future, but with regard to the past, only traceability of the origin of the gametes and embryos
p.000008: can be provided, not information on the use of solutions and material.
p.000008:
p.000008:
p.000008: III. Conclusions and recommendations
p.000008:
p.000008: With this opinion, the Committee wishes to draw the attention of the competent authorities to the ethical problems
p.000008: raised in implementation of the Belgian law “human body material (2008)” and its implementing decrees by
p.000008: certain provisions applied to the Centres for medically assisted procreation.
p.000008:
p.000008: 1. Article 6, §1, of the Royal Decree “quality and safety standards (2009)”, dealing with (1) the guarantee of
p.000008: traceability of all human body material (gametes and embryos) collected, procured, processed, stored or
p.000008: distributed, goes too far in that it also involves (2) all the pertinent data on the products and materials
p.000008: coming into contact with this human body material.
p.000008:
p.000008: Requirement (1) poses no problem; (2) does, due to the fact that traceability of the products and materials
p.000008: is required retroactively, which raises a significant ethical problem.
p.000008:
p.000008: 2. In the past, traceability of all these human body materials as well as the products and materials coming into
p.000008: contact with them has not been observed in practice.
p.000008:
p.000008: 3. The consequence of this is that thousands of cryopreserved gametes and embryos can no longer serve the purposes
p.000008: initially planned, those of satisfying a future desire for pregnancy, even in the patients from whom these human body
p.000008: materials come.
p.000008:
p.000008: The Committee unanimously believes that, in this specific case, these regulations are not ethically defensible in their
p.000008: consequences. The request is therefore made to the legislator that transitional measures be taken so that these gametes
p.000008: and embryos can still be used. The current regulations impose the following biological tests30:
p.000008:
...
p.000009: The Committee believes that it would be more reasonable – scientifically as well as ethically – to
p.000009: strictly apply the “quarantine principle”. According to this, (1) biological testing takes place before
p.000009: collection(s), (2) the cells or tissues are frozen, (3) the results of the tests are communicated after an
p.000009: additional check of the biological tests (after 180 days).
p.000009: In the present state of science, given the possibility of vitrifying oocytes and given that there is no
p.000009: difference in viability or reproductive capacity between an oocyte transplanted after vitrification and
p.000009: a fresh transplanted oocyte, and that the safety of the transfer is greater after 6 months of vitrification,
p.000009: the Committee believes that donation of fresh oocytes should no longer be practiced except in the case of lack of
p.000009: vitrified oocytes.
p.000009:
p.000009: 4. Moreover, the “bilingual” nature of the legal and regulatory texts sometimes gives rise to a lack of optimal
p.000009: consistency in the meaning of their terms. The Committee stresses the necessity of establishing rigorous correspondence
p.000009: between French and Dutch texts that deal with the same material.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: FINAL VERSION
p.000010: 10
p.000010:
p.000010: The opinion was prepared in the select commission 2010/4 consisting of:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Joint chairpersons
p.000010:
p.000010: R. Rubens
p.000010: G. Schamps
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Joint reporters
p.000010:
p.000010: R. Rubens
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Members
p.000010:
p.000010: A. Beyers
p.000010: N. Gallus
p.000010: V. Geenen
p.000010: I. Liebaers
p.000010: G. Pennings
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Member of the Bureau
p.000010: P. Devroey
p.000010:
p.000010: Member of the secretariat
p.000010:
p.000010: B. Orban
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: Experts interviewed
p.000010:
p.000010: Prof. A. Delvigne, President of the Belgian Society for Reproductive Medicine (BSRM) Prof. K. Vandewoude, Assistant
p.000010: Clinical Director, Intensive Care Department, Ghent University Hospital
p.000010: M. P. Ballegeer, Head of the Health Products Division of the Federal Agency for Medicines and Health Products (Agence
p.000010: Fédérale des Médicaments et des Produits de Santé, AFMPS)
p.000010: S. Ziebe, President of the Tissues and Cells Directive Task Force of the European Society of Human Reproduction and
p.000010: Embryology (ESHRE)
p.000010:
p.000010:
p.000010: The working documents of the select commission 2010/4 – question, personal contributions of the
p.000010: members, minutes of the meetings, documents consulted – are stored as Annexes 2010/4 at the documentation centre of
p.000010: the Committee, and can be consulted and copied there.
p.000010: ***
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000015: and apparel, must be provided in each section concerned within the establishment.
p.000015: 6. When the procedures for which approval is requested involve storage of human body material, the storage
p.000015: conditions necessary to preserve the required properties of the human body material, including key parameters such as
p.000015: temperature, humidity or air quality, should be specified.
p.000015: 7. Critical parameters, including temperature, humidity or air quality, must be controlled, monitored and
p.000015: recorded to prove their compliance with the required storage conditions.
p.000015: 8. The storage premises must ensure clear separation and distinction between human body material before release and in
p.000015: quarantine, human body material that has been released and human body material that has been rejected, in order
p.000015: to prevent any confusion and cross- contamination between them. In both quarantine areas and storage areas for
p.000015: released human body materials, physically separated areas or secure storage or isolation systems are to be
p.000015: provided for storing human body material fulfilling specific criteria.
p.000015: The specific criteria cited are for example the fact that human body material intended for autologous or
p.000015: deferred use is kept, or that gametes intended for partner donation are involved.
p.000015: 9. The establishment must have written directives and procedures for controlling access to the premises, cleaning and
p.000015: maintenance, removal of waste and continuity of services in the event of an emergency.
p.000015:
p.000015: E. Documentation and recording
p.000015: 1. A system characterised by clearly defined and efficient documentation, proper reporting and registers,
p.000015: and authorised standard operating procedures should be established for the procedures for which approval
p.000015: is requested. Documents must be regularly revised and compliant with the law and the present decree. The system
p.000015: must guarantee standardisation of the procedures performed and the possibility of retracing all the steps,
p.000015: that is, collection, codification, donor eligibility, procurement, processing, preservation, storage,
p.000015: transport, distribution or disposal or destruction, including aspects related to quality control and quality assurance.
p.000015: 2. For any critical activity, the materials, equipment and personnel involved must be identified and documented.
p.000015: 3. Any change in the documents must be checked, dated, approved, documented and executed without delay by
p.000015: authorised personnel in the establishments.
p.000015: 4. A procedure must be established for monitoring documents to provide the history of revisions and
p.000015: changes in the documents and to guarantee that only current versions of documents are used.
p.000015: 5. It must be demonstrated that the data recorded are reliable and constitute a faithful representation
p.000015: of the results.
p.000015: 6. The data recorded must be legible and indelible. They can be handwritten or recorded in another validated electronic
p.000015: system.
p.000015: 7. Without prejudice to Article 6, §3, paragraph 2 of the present decree, all the data recorded, including basic data,
...
Orphaned Trigger Words
p.000014: guarantee that critical parameters are kept within acceptable limits at all times. All equipment with a critical
p.000014: measurement function must be calibrated on the basis of a standard if one exists.
p.000014: 3. New and repaired equipment must be tested upon installation and validated before use. The results of the
p.000014: tests must be documented.
p.000014: 4. Maintenance, inspection, cleaning and disinfection and decontamination of all critical equipment must be
p.000014: performed regularly; these procedures must be recorded.
p.000014: 5. Procedures must exist for the operation of each critical piece of apparatus, detailing the steps to be followed in
p.000014: case of malfunction or breakdown.
p.000014: 6. Procedures relating to the operations for which approval is requested must describe in detail the
p.000014: characteristics of all the critical materials and reagents. Specifications must in particular be defined for
p.000014: additives (solutions, for example) and packaging materials. Critical reagents and materials must fulfil the
p.000014: documented requirements and characteristics and, if necessary, the provisions of the Royal Decree of 18 March 1999
p.000014: on medical devices and the Royal Decree of 14 November 2001 on medical devices for in vitro diagnosis.
p.000014:
p.000014: D. Facilities/premises
p.000014: 1. Establishments must have facilities appropriate for the performance of the procedures for which approval is
p.000014: requested, in compliance with the standards set by the present directive.
p.000014: 2. If, in the framework of the procedures, human body material is processed while exposed to the environment, this
p.000014: processing must take place in an environment with an established air quality and cleanliness in order to reduce
p.000014: the risk of contamination, including cross- contamination between donations, as much as possible.
p.000014: The efficacy of these measures must be validated and monitored.
p.000014: 3. Except in the case of item 4, when human body material is exposed to the environment in the course of processing
p.000014: without undergoing a subsequent microbial inactivation procedure, an air quality characterised by a particle number and
p.000014: a microbial colony count equivalent to those of class A, as defined in Annex 1 of the current European guide to good
p.000014: manufacturing practice (GMP) and Annex IV of the Royal Decree of 14 December 2006 on medications for human and
p.000014: veterinary use should be ensured; the background environment must be suitable for the processing of the human body
p.000014: material concerned, but must be at least equivalent to class D in the GMP with regard to particle numbers and microbial
p.000014: colony count.
p.000014: By derogation to the preceding paragraph, it is required that the number of microbial colony units in the background
p.000014: environment corresponds at least to class C of the GMP instead of class D in cases of cells that are exposed to the
p.000014: environment during processing, as well as for cardiac valves, blood vessels and musculoskeletal system transplants.
p.000014: The condition specified in the preceding paragraph does not apply in the case of use of a closed
p.000014: functional system or for gametes; in this case, it suffices that the number of microbial colony units corresponds to at
p.000014: least class D of the GMP.
p.000014: 4. A less strict environment than that specified in item 3 with regard to class A is acceptable insofar as:
p.000014: a) a validated microbial inactivation or final sterilisation procedure is used;
p.000014:
p.000014:
p.000014: FINAL VERSION
p.000015: 15
p.000015:
p.000015: b) or it is demonstrated that exposure to a class A environment has a harmful effect on the required properties of the
p.000015: human body material concerned;
p.000015: c) or it is demonstrated that the method and means of application of the human body material to the recipient
p.000015: involve a risk of transmission of a bacterial or mycotic infection to the recipient significantly less than
p.000015: that presented by transplantation of human body material;
p.000015: d) or it is not technically possible to perform the required process in a class A environment, for example due to
p.000015: the necessity for having a specific piece of equipment that is not fully compatible with class A in the
p.000015: processing area.
p.000015: 5. In the situations described in item 4, letters a) to d), the environment must be specified. It should be proven,
p.000015: with supporting documents, that the chosen environment guarantees the required quality and safety, taking account
p.000015: at least of the planned use, the method of application and the immune status of the recipient. Appropriate
p.000015: clothing, personal protective equipment and hygiene facilities, as well as written instructions with regard to hygiene
p.000015: and apparel, must be provided in each section concerned within the establishment.
p.000015: 6. When the procedures for which approval is requested involve storage of human body material, the storage
p.000015: conditions necessary to preserve the required properties of the human body material, including key parameters such as
p.000015: temperature, humidity or air quality, should be specified.
p.000015: 7. Critical parameters, including temperature, humidity or air quality, must be controlled, monitored and
p.000015: recorded to prove their compliance with the required storage conditions.
p.000015: 8. The storage premises must ensure clear separation and distinction between human body material before release and in
p.000015: quarantine, human body material that has been released and human body material that has been rejected, in order
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| child | Child |
| disability | Mentally Disabled |
| embryo | embryo |
| emergency | Public Emergency |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| hospitalised | hospitalized patients |
| job | Occupation |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| physically | Physically Disabled |
| restricted | Incarcerated |
| sick | Physically Ill |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
harm
protect
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input