by Alliance VITA | February 28, 2020 | Euthanasia and Suicide, News
On February 27, 2020, the Federal Constitutional Court in Germany overturned the legal ban which prohibited doctors or associations from “organizing” suicide, by declaring the 2015 law unconstitutional.
In 2015, the German parliament (“Bundestag”) voted to prohibit assisted suicide services from being conducted for remuneration, following the bill tabled by Chancellor Angela Merkel’s party, the Christian Democratic Union (“CDU”).
Passively helping patients commit suicide – such as providing deadly medication for them to take themselves, or accompanying them to specialized Swiss clinics is not illegal. However, the medical code of ethics bans assisted suicide; thus doctors who practiced assisted suicide in some regions had their medical licenses revoked. This presented a legal grey area (neither banned, nor explicitly allowed), which could have allowed professional businesses, similar to those in Switzerland, to show up in Germany. Thus, the German parliamentarians finally passed a law in 2015 to prohibit assisted suicide from being organized on a “business basis”.
Germany’s Criminal Code stipulated in article 217 that anyone who promoted assisted suicide or collaborated with someone to this end could be fined and imprisoned. Relatives and those who were not remunerated were exempt; nonetheless, the ambiguity of the terms permitted all individuals not providing “recurring” assistance to be exempt as well.
Jurisprudence was established in 2017 after the Federal Supreme Administrative Court in Leipzig, questioned the validity of this law in the “Koch vs. Germany” case in 2005, which was finally submitted to the European Court of Human Rights (ECHR).
In 2004, the Federal Institute of Drugs and Medical Devices (FIDMD) refused to grant Mrs. Koch, a quadriplegic, the lethal drugs she requested for committing suicide. She and her husband then filed an administrative appeal, which was also refused. Following his wife’s assisted suicide in Switzerland in 2005, Mr. Koch filed suit against the FIDMD, to request that their previous decision be declared unlawful. His request was judged inadmissible by the Administrative Court, the Court of Appeal and the Federal Constitutional Court.
Mr. Koch insisted that by refusing to examine the merits of his complaint, the German courts had infringed on article 8 of the European Convention on Human Rights (ECHR), which provides “a right to respect for one’s private and family life…” There was indeed talk of interfering with his rights as a husband and caregiver, and but not with those of his wife. Due to the marital link, the ECHR agreed with Mr. Koch, but also declared that it was up to the German courts to render a judgment for his complaint.
According to Pierre-Olivier Koubi-Flotte, Doctor of Law, barrister, and member of the Marseille Bar, the ECHR’s decision is “questionable” and “surprisingly lacking in consistency”. This is further accentuated by the fact that each individual State has enormous leeway in deciding whether or not their respective national laws should allow assisted suicide.
Nevertheless, both prior to and after this decision, Germany preserved its freedom to decide whether or not to allow its federal agencies to deliver lethal products to individuals who wish to commit suicide.
Finally, the Leipzig Administrative Court judge established jurisprudence by ruling that “in exceptional cases, the State cannot prevent the access to anaesthetic products which would allow the patient to kill himself in a dignified manner, without suffering”. However, by ministerial order, all subsequent assisted suicide requests were rejected by the FIDMD.
Recently, doctors, patients, and associations offering assistance to commit suicide in Germany and Switzerland, challenged a constitutional complaint.
In the end, Article 217 of the Criminal Code was declared unconstitutional, null and void, because it “effectively vitiates any possibility for the individual concerned to resort to assisted suicide“.
According to the judges, this article violates Articles 1 and 2 of the country’s Basic Law which provides that “Every person shall have the right to free development of his personality insofar as he does not violate the rights of others or offend against the constitutional order or the moral law” and that “every person shall have the right to life and physical integrity. Freedom of the person shall be inviolable. These rights may be interfered with only pursuant to a law.”
The Constitutional Court decision states that: “The general right to self-fulfillment and to the dignity of the human being includes a citizen’s right to determine their own death.” This interpretation of dignity, which legitimizes suicide, is mind-boggling. The Court specifies: “it does not follow that the legislator is completely barred from regulating suicide assistance. But any legislation on this subject must be guided by the notion of humans …capable of pursuing and exercising their freedom in self-determination.” The right to a self-determined death would not be limited to certain criteria such as “the diagnosis of an incurable illness”.
The European Institute of Bioethics appropriately points out: “Thus Germany would become the first country to organize assisted suicide on an unconditional basis (…). By the Constitutional Court’s ruling that the principle of human dignity allows a person’s self-determination to take precedent over the right to life (although both are included in the Basic Law) German legislators are left with extremely limited options since they will now be required to implement laws allowing everyone the means to commit suicide. ”
In 2015, the President of the German Medical Association, Frank Ulrich Montgomery voiced his opposition to legalizing such acts: “As doctors, we must be very clear on the fact that we come to patients’ bedsides to provide assistance and care, and not to kill.”
The German Palliative Care Foundation also deplored: “From now on, making suicide more accessible for those who are ill, and for those who are tired of life has become a routine service.”
Thomas Sitte, a palliative care physician in Fulda, declared: “The experience in all other countries has shown that supply creates demand. Our Foundation will continue to fight against the current trend, so that at some point everyone may realize that it is possible to relieve suffering without killing. “
by Alliance VITA | February 21, 2020 | Euthanasia and Suicide, News
Last October in Belgium, a bill was tabled to extend the conditions permitting euthanasia.
The State Council has voiced reserve on the bill’s three flagship measures.
- The validity of advance euthanasia directives would be extended from five years to an unlimited period. The State Council protests that such a measure “reverses the logic”, by encouraging a person’s self-determination at the expense of his life.
- A doctor who refuses to perform euthanasia would be required by law to refer his patient to another doctor who would be ready to perform this act. According to the State Council, such a requirement “infringes on a doctor’s freedom of conscience clause […] in that he is forced to facilitate the act of euthanasia”.
- Hospitals would not be allowed to conclude agreements with doctors which would prohibit euthanasia on their premises. The State Council declared that such a measure “limits the freedom of thought, conscience and religion, as well as the freedom of association for creating these health-care establishments”. Still, the State Council did not request to leave out this measure.
The European Bioethics Institute, which published a critical analysis of these measures, points out that: “a real individual right to have euthanasia performed, is thus gradually established, enforceable against any health-care community, whose right to freedom of conscience would be denied.”
On February 18, the bill was approved by the Health Committee, with discussions planned in plenary session in the upcoming weeks.
For the record, the Belgian parliament legalized euthanasia in 2002.
In 2019, Belgian caregivers, (university professors, nurses, and ethicists) published “Euthanasia, behind the scenes”, a book which clearly outlines the consequences that euthanasia has had on health-care practices. The law has already been amended several times and the number of euthanasia cases is constantly rising. Their book is currently being translated into English and Spanish.
by Alliance VITA | February 21, 2020 | Euthanasia and Suicide, News
On Thursday, February 20, 2020, Portugal’s parliament approved five bills on euthanasia at the first reading. Submitted by several socialist parties, they were adopted at the first reading and will likely be combined into a single text before the final vote.
These five texts, with variants, were tabled by the Socialists, the Left Bloc (far left), the “PAN” animal party, the “Greens” and the “Liberal Initiative” parties.
In a similar debate in May 2018, the attempt to push through euthanasia was rejected. An opinion poll published just a few days prior to the vote showed that only 7% of the Portuguese population was in favor of euthanasia while 89% of those questioned prefered palliative care and assistance in the event of serious illness.
After the October 2019 legislative elections where the abstention rate reached record highs (51.43%) the socialist party gained a stronghold, and thus put this issue back on the parliamentary agenda.
Citizen groups demonstrated outside the parliament building to voice their opposition to pushing through this measure. Indeed, it is the first legislative act by this new parliament, although none of the parties supporting these bills mentioned euthanasia in their programs during the October general election. This could have had an impact on the election results since the opposition to euthanasia is so prevalent in Portugal.
This debate appears at a time when the Portuguese health system is deteriorated and while palliative care is still underdeveloped in this country. Several organizations are opposed to this law and are pleading to have better end-of-life support and a genuine policy for the development of palliative care. The Portuguese National Council for Ethics in the Life Sciences is opposed to legalizing euthanasia. The professional orders of doctors, nurses, as well as psychologists and lawyers are also opposed. Recently, the largest private hospitals, as well as the “Misericordies” – the largest network of continuing care which provides community care for dependent persons – have declared that they will refuse the practice of euthanasia.
by Alliance VITA | February 14, 2020 | Euthanasia and Suicide, End of life, News
The recent update by the French High Authority for Health (“HAS”) on continuous deep sedation until death coupled with the announcement that Midazolam will soon be available on prescription in French pharmacies creates great confusion on the way to use this drug in a home setting for individuals at the end-of-life.
Measures Taken by the “HAS”
After the “Claeys-Leonetti” end-of-life law was voted in 2016, the French National Authority for Health (HAS) began evaluating the guidelines for pain relief, including those for the rare cases for “implementing continuous deep sedation until death (CDSUD)”. Their “care pathway guide” for CDSUD was published in 2018 to assist in the decision-making process on implementing this sedation.
This text has now been updated to specify the modalities for administering drugs, including off-label* drugs, to sedate patients at the end-of-life by “appropriate, deep, transient or continuous sedation until death”. No drug in France has an officially approved indication for use in sedative practices. Thus, by publishing “analgesia for unbearable, resistant pain and sedation in adults: drug use in palliative care until the end-of-life” the “HAS” is basically endorsing specific drugs for sedation as well as recommending their methods of use.
The Midazolam which is currently restricted for use in hospitals, is the recommended first-line drug for sedation.
On February 10, 2020 in a press release issued by the “HAS”, and based on its recommendations, it requested that the government authorize pharmacies to dispense these drugs to general practitioners who care for patients at the end-of-life in their homes.
* Marketing Authorization (MA) refers to the properties of a drug and its use. It is issued with a Summary of Product Characteristics (SmPC) and an informational leaflet for the patient.
What is Midazolam?
Midazolam, more frequently referred to as Hypnovel®, its old trade name, is the only benzodiazepine currently available on the market with an extremely short duration of action. Benzodiazepines are prescribed in psychiatry, mainly for its anti-anxiety effect, in neurology for epilepsy, in anesthesia-resuscitation for sedation, in addictology for alcohol withdrawal … Well-known drugs in this class of benzodiazepines include Lexomil®, Xanax®, Valium®, Rivotril®…However one of the drawbacks for these drugs is their duration of action, with elimination half-lives ranging from 7 to 10 days. Midazolam has the advantage of being eliminated rapidly, with a half-life of approximately 2 hours, thereby minimizing the risk of accumulating the doses. This is an important advantage for balancing drug dosage and treatment, especially in elderly patients, or those with major organ deficiencies (cardiac, respiratory, hepatic, renal…) symptoms which often occur at the end-of-life. In these situations, it is appropriate to prescribe Midazolam. It could even be recommended, whether at the end-of-life or not, to treat anxiety, or to alleviate various anxiety disorders. Thus from a pharmacological point of view, general practitioners should be able to prescribe Midazolam. Up until April 30, 2013 it was dispensed in pharmacies under the name of Versed®.
In addition to analgesic treatment, based on professional agreement, the French National Safety Agency for Medicine and Health Products (“ANSM”) recommends the off-label use of Midazolam for its effect of amnesia, when undergoing painful procedures which may provoke anxiety.
Today, this product has only received marketing authorization for anesthesia. However, the Health Ministry has announced that it intends to approve Midazolam for sedation, which will create an amalgam between this product and deep continual sedation until death.
Continuous deep sedation until death, an exceptional last resort measure
Before the law was voted, “deep and continuous sedation until death” had been previously practiced by professionals in rare cases, for circumstances of unbearable, resistant suffering which could not be relieved by any other means, and when faced with a short-term vital prognosis. Basically, sedation alters the patient’s consciousness and thus severs any further relationship. The sedative doses may be proportional to the intensity of the symptoms and reversible. Professionals prefer to use, when it is possible, painkillers which allow patients to remain conscious. On the contrary, sedating a patient whom we know will not wake up is difficult both for close relatives and caregivers. The official French National Authority for Health “HAS” text rightly points this out and recommends a specific support for the various participants concerned to ensure that these situations are not trivialized, and must remain a rare practice.
The law provided that sedation request could be initiated by the patient himself. When stopping or restricting care, including nutrition and hydration, there is a risk that this practice could veer towards euthanasia. Alliance VITA takes part in the movement “Relieve Suffering without Killing” which also brings together health professionals, and together they denounced this gray zone during debates for revising the law. Some ambiguities still persist despite the recommendations by the “HAS”.
What the Law Stipulates
France passed a law on April 22, 2005 which allowed families and doctors of terminally-ill patients to withhold life-sustaining treatment. However in 2008, following the case of Chantal Sébire, suffering from an incurable facial tumor, and who requested assisted suicide, this law was revised and the Code of Ethics was modified. Thus article 37, (§III) of this law concerning patient rights at the end-of-life states: “(…), even if the patient’s suffering cannot be assessed due to his cerebral state, the doctor may implement treatment to relieve the pain of the person, in particular analgesics and sedatives (…). He also ensures that the patient’s relatives are informed of his situation and receive the necessary support. The principle of maintaining sedation and this article of the Code of Ethics were not explicitly included in the law of April 22, 2005.
The law of February 2, 2016 allows “continuous deep sedation until death” under very specific conditions: at the patient’s request to avoid all suffering and unreasonable obstinacy. According to the law on unreasonable obstinacy, acts of prevention, investigation, treatment or care must not be performed or continued if they are unnecessary, disproportionate or have no other effect than the artificial maintenance of life”. In February, 2018, two years after this law was enacted, the “HAS” issued recommendations concerning continuous deep sedation until death. The two-year time lapse prior to the “HAS” publication testifies to how difficult it is to evaluate these cases before implementing sedation, which must remain exceptional and cannot be trivialized.
Where does the confusion come from?
1 / In her letter addressed to the French Union of Liberal Doctors, the Health Minister, Agnès Buzyn equated administering Midazolam with deep and continuous sedation. This threatens to conceal its real usefulness and to use it as an “ordinary” medicine, whereas this type of sedation must remain exceptional. Due to the Claeys-Leonetti law of 2016, if Midazolam becomes more widely available today, we risk to be confronted with even more cases of hidden euthanasia.
2 / Already last December, a general practitioner from the Seine-Maritime region was accused of having involuntarily put 5 of his elderly patients to death with Midazolam, which was labeled as a powerful sedative reserved for hospital use. The product was obtained illegally from his wife who is an anesthesiologist. This legal case is difficult to assess, as the trial is still ongoing. The doctor stated that he wanted to alleviate his patients with this anxiolytic, not kill them. He explained that: “by using this drug, the intention was neither to accelerate the patients’ death nor unnecessarily prolong their lives. Strictly speaking, it was meant to help the patients to remain at home and for their families to remain as serene as possible, since this is always a difficult period.”
Will hidden euthanasia increase when Midazolam is dispensed to general practitioners?
There should be no cause and effect relationship; unless end-of-life support is reduced and sedation until death is practised. As long as the drug is used correctly, there should be an improved quality of care. However for patients experiencing pain, augmented by severe anxiety, the appropriate use of Midazolam may decrease the number of requests to end life, which are very rare and often associated with inadequate care.
The challenge is rather that of training doctors to use this product, and relying on genuine collegiality when establishing conditions for using it for sedation. It is the context of the Claeys-Leonetti law that is unclear and leads to confusion.
by Alliance VITA | February 13, 2020 | Bioethics Law, News
The vote for the first reading of the Bioethics law was held in the French Senate on February 4, 2020, passing by 10 votes (153 votes for, 143 against). Although we appreciate the attempts made to amend the draft law, it has not fundamentally changed.
The Senators have made one contradictory vote after another. In the end, this text is still unacceptable because of the serious injustices it inflicts on future generations by yielding to individualism and scientific technology. Ethics is supposed to protect human rights, life and human dignity but never before has a text on bioethics been so far removed from ethics. Nevertheless, all these new revisions could still be reformed during the second reading at the National Assembly, which is most likely to be held in April, although the exact date has not yet been confirmed.
Authorizing “ART without a father”, but health care reimbursement denied
The controversial subject of a number of discussions, Article 1, dealing with medically assisted procreation (the so-called “ART”) with a donor for female couples or a woman on her own, without a male partner, was finally adopted after considerable modifications. Some revisions previously recommended by the special committee were reintegrated, such as the criterion of medical infertility for heterosexual couples and the subsequent reimbursement for the procedures. On the other hand, the senators denied health care reimbursement of ART with a donor for single women or lesbian couples. The words asserting that “no one has the right to a child”, justifiably specified in the preamble to this same article, lose their forcefulness, when “ART without father” is made possible.
In view of these reforms for expanding ART, the senators have argued in vain to include a conscience clause for doctors and health care personnel who do not wish to be professionally involved in these procedures, regardless of the context. In addition, the national research infertility program, which was introduced by the deputies to study the causes and prevention of infertility, was abolished by the special committee under the pretext that it is not a legislative matter. Why not address the major health issue of infertility in its entirety, instead of focusing only on artificial procreation techniques, which are physically and psychologically burdensome for both women and couples? All the more surprising knowing that less than half of the couples resorting to ART have no child.
Nonetheless, the senators discussed the clause for double gamete donation and banned this practice. They also adopted an amendment to specify that only non-profit centers could be allowed to receive, store and freeze embryos. Previously, this stipulation had been deleted by the Senatorial special committee, which would have opened the door to the procreation market.
Gamete auto-preservation rejected
Article 2 for oocyte auto-preservation for women in the absence of any pathology, for procreation at a later date, by in vitro fertilization, was rejected.
The dilemma of lifting the anonymity for gamete donations
Another key measure hotly debated by the Senate was that of lifting the anonymity for gamete donations. The initial draft, approved by the National Assembly during the first reading, stipulated that the donor had to reveal his identity if the child requested it when he is 18. The Senators have amended this article to allow the donor the prerogative of whether or not to disclose his identity upon the child’s request. As a result of this significant modification, the so-called lifting of anonymity will not have much impact. This hypocritical situation is a ticking time bomb and extremely detrimental to the child.
Two maternal filiations denied
In the original text regarding ART requested by female couples, the rules to establish parentage purported to recognize both “women” as parents. The Senators rewrote this article and the establishment of either two maternal or two paternal filiations for the same child is no longer allowed. The woman who gives birth will automatically be considered as the child’s mother, while a distinction will be made for the other woman, who must file for adoption of the child. Unmarried couples who live together or who have signed a civil solidarity agreement (“PACS”) are now allowed to adopt, with less complicated adoption procedures for the second partner.
Surrogacy – Civil Registry Transcriptions Prohibited
The issue of surrogacy, which had been discussed by the special committee, was raised again.
For children born abroad from surrogacy, the ban to transcribe the foreign birth certificates onto the French civil registry has indeed been maintained (after having been adopted by the committee). Nonetheless, the rapporteur, Muriel Jourda, filed an amendment to authorize the transcription of adoption rulings, without any reference to this unfair practice. For the record, in a recent case law, the Court of Cassation allowed the transcription in France for these birth certificates established abroad, despite the fact that surrogacy is a fraud against French law.
Articles 5, 6 and 7, relating respectively to transplants, donating hematopoietic stem cells and the consent requirement for persons under protective supervision, were all adopted.
Precautionary Principle for Bioethics Rejected
At the very beginning of the discussions, an amendment to include a precautionary approach in the law was rejected. The answer by the Keeper of the Seals, Nicole Belloubet is instructive: “the precautionary approach is both a system of assessing and implementing proportional and provisional measures in the event of serious and irreversible damage. However in bioethics I think we could endlessly question what constitutes a serious and irreversible attack; this would be difficult.” This is exactly why this bill raises voices of concern and why our opposition is justified.
“Recreational” genetic testing and preconception screening refused
The Senate also voted to delete articles 10bis and 10ter, which had been adopted by the Special Committee. Article 10bis, initiated by the senator and rapporteur Olivier Henno (“Union Centriste Group”) would have allowed “recreational” genetic testing. He had also tabled an amendment (article 10ter) to allow couples to have recourse to preconception screening “on an experimental basis“, meaning that both members of a couple could have their genetic characteristics analyzed, without any prior medical reason, to determine if they are “compatible” or whether there is a potential risk of transmitting a known genetic disease to their future children. Currently, preconception screening is very rarely practiced, only in cases where the family in question has a previous history of transmitting a genetic disease. The Health Minister, Agnès Buzyn, declared in support of deleting this article: “This would eventually pressure everyone into feeling required to have this kind of test performed […] It portrays the image of a society where DNA controls everything, where man controls his descendants, the delusion of having future generations unscathed. “
Creation of Transgenic and Chimeric Embryos Denied
Although less mentioned in the media, research on human embryos remains an important issue in this bill.
Article 17, which proposed creating chimeric and transgenic embryos, was finally rejected by the senators. Thus, combining human embryonic cells or induced pluripotent stem cells (IPS) with animal embryos is allowed. Alliance VITA has been a whistle-blower to denounce these chimeras, especially since the general population was largely uninformed, partially due to the ambiguous and changing vocabulary used by its promoters. The bill does intend to allow research on artificial gametes, but a Senatorial amendment specified that artificial gametes (created from reprogrammed human cells, called IPS) cannot be fertilized to create an embryo.
Time period extended to 21 days for cultivating embryos for research
On the other hand, all the requests for regulating or restricting research on embryonic stem cells or human embryos were rejected. The Senate has proposed extending the research period on human embryos to 21 days, which is a very advanced stage of development, in particular for the nervous system. The deputies had voted for a maximum of 14 days. The current law specifies a limit of 7 days, a major symbolic date, since under natural conditions this is when the embryo is implanted in the maternal uterus.
Refusal to Extend Pre-implantation Genetic Diagnosis (PGD)
The PGD-HLA refers to performing pre-implantation genetic diagnosis (PGD) with tissue typing for human leukocyte antigen (HLA) to screen for compatibility. Also known as “savior babies” or “savior siblings”, it had been deleted by the National Assembly then reintroduced by the special committee. It was finally confirmed by the senators, who denied the requests to outlaw this ethically controversial procedure, which has not been practiced since 2014. PGD-HLA consists in a double selection process for embryos created by IVF. First the embryo must be free from the disease affecting a family member, and secondly it must be genetically compatible, in order to graft the stem cells obtained from the newborn “savior baby’s” umbilical cord to his sick elder. In previous bioethics legislation, this procedure was approved with the stated objective of accumulating a stock of cord blood cells, to avoid this.
The Senate did however vote to delete article 19ter, introduced by the special committee, which proposed pre-implantation diagnosis to screen embryos from IVF for aneuploidies (PGD-A), meaning an abnormal number of chromosomes, and thus including trisomy. Already with PDG alone, less than 200 children are born annually with aneuploidies. The PGD-A technique would most likely bring further eugenic practices by screening embryos for non-hereditary and therefore unpredictable criteria.
Revised consciousness clause for doctors in the event of abortions for medical reasons
The Senatorial special committee deleted the specific conscience clause for healthcare personnel regarding abortion for medical reasons because it is already covered by the public health code for terminating pregnancy. Article L2212-8 states: “No midwife, nurse, medical assistant, or whomsoever, is required to contribute to terminating pregnancy for medical reasons.”). For doctors, however, the committee decided to maintain the measure in the governmental text, in alignment with the conscience clause on other abortions, which requires them to refer the patient to another practitioner. “A doctor is never required to carry out an abortion for medical reasons, but he must immediately inform the patient of his refusal and promptly refer the patient to other practitioners likely to perform this act.” The senators also voted to abolish parental authorization for minors and to delete the proposed 7-day reflection period established by the initial bill.
Deleting the one-week reflection period prior to having an abortion for medical reasons, in addition to giving up the parental consent for minors, leads to further trivializing an act which has serious human and psychological consequences, to the detriment of alternatives such as welcoming and caring for sick or disabled newborns and their families.
