Commission

((OOC: I'll just gently point out, @Sildavia, that your post not so much breaks the fourth wall as smashes through it. Also if you could indicate to me in future when you edit your post in the application thread, since I'm not going to repeatedly go back to it unprompted to check if anything's changed. I shan't respond to the post IC since the debate on this iteration of the Bill is over.))

@Neo-Enclave Added

@enclave said in Member State Applications:

Nation Name in RP (full, with short name bolded): **the United Monarchist States of the neo-enclave (also known as the united monarchist states of Amerika)

Nation Name on NationStates (short): **the neoenclave

Map plot requested: 53

Capital city: ravenrock (coastal)
Currency: dollar,
National language(s): Latin, English

Head of State (Title + Mr/Ms* + name in bold):
empress of amerika: Donalia guiea Julia caesar the first
Head of Government (Title + Mr/Ms* + name in bold):
Enclave president (ceremonial): Mr. Lius gallius
Governing party:
(Only elections are for advisors)

European Councillor (Mr/Ms + name in bold): Ms. Augusta lamora
Current participation in other regions (if any):
None

Past participation in other regions (if any):
-too many to count

My country accepts the Constitution and the Acquis Communautaire (Y/N): yes

Plot 53 is taken, I'm afraid. Please claim an empty plot.

((OOC: Yes, this is a bit late, but my computer was broken for most of the day))

I recognise Cllr Maverick's willingness to compromise on subclause II.3, and I acknowledge the importance that the medical records of the child's biological parents are available, at least to any medical professionals treating the child.

I'd suggest, however, that the amendment that Cllr Maverick is currently proposing could be construed in multiple ways. It states first that the child has a 'right' to information on the donor's identity, and only afterwards that the donor can refuse contact with the child, and restrict their access to their medical information only. For one, those are two different things – you could, in theory, refuse contact without withholding any further information. Secondly, it could be read in such a way that the child can first access the donor's identity, and only then, perhaps if the child intends to make contact, can the donor say no. That could throw up all kinds of problems, but I could easily see it being the interpretation made by some governments and some courts, not least given the order of the provisions and the fact that the word 'right' is used to describe a child's ability to access the donor's identity, but not the donor's ability to refuse contact or make any further restrictions.

I would propose, therefore, an amendment to rewrite subclause II.3 to make it focus on establishing a minimum level of access to the donor's medical records, like thus:

AMENDMENT X: SUBCLAUSE II.3

3.1 Any person who is born as a result of medically assisted reproduction using donated sperm has a right to information on the sperm donor’s identity at the age of 18. A donor register shall assist the child in this matter.
3.2 Member States shall establish a register of the identity of sperm donors so that children can exercise their rights pursuant to this section.
Medical professionals responsible for the care or treatment of a person born as a result of medically assisted reproduction shall be able to access anonymised medical information, particularly with respect to hereditary diseases and genetic conditions, about the gamete donors. Member states shall establish a registry of the identity and medical records of gamete donors in order to facilitate this access.

I would therefore like to withdraw my Amendment I.

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I'd now like to turn my attention to the comments of the Councillor from Sildavia. I am sure that Cllr dea Arabiya-Rom can appreciate that medically assisted reproduction, as with all areas of biotechnology, can lead to grave, potentially unintended consequences; and these consequences can cross borders.

What this legislation does, in my view, is create a common baseline of good practice, most of which I hope and expect most European nations would already be following. The rest of the region cannot be left carrying the can when an experiment goes badly wrong in a country that decided against meeting this baseline.

If Sildavia wishes to ignore this Bill should it become legislation, then it's welcome to do so. We won't be pursuing a case in the ECoJ. But they can expect no sympathy or solidarity from us if their decision should lead to negative consequences for them. We would expect recompense if their decision should lead to negative consequences for us. And, in order to prevent the latter from happening, we will have to consider what relevant, common-sense measures can be taken to help protect Angleter against any potential excesses in the Sildavian biotechnology sector.

Perhaps it would be more productive for Cllr dea Arabiya-Rom to explain which specific aspects of the Bill she finds to be an overreach?

@Derecta said in European Biotechnology Act - 2019:

We would like to submit a friendly amendment to the amendment to section II.20 presented by the Angleteric Councillor. We understand medically assisted reproduction is not only limited to in-vitro fertilisation, and as such the wording of this amendment should reflect so:

AMENDMENT VI: SUBCLAUSE II.20

Information on the sex of the a fetus conceived via in vitro fertilisation medically assisted reproduction before the 12th week of pregnancy resulting from prenatal diagnosis or other examination of the fetus shall only be given if the pregnant individual is a carrier of a serious sex-linked disease that is either life-threatening, severely life-limiting, or associated with severe physical or mental disability.

I accept this change to my amendment.

Cllr Hrayr Cruthin, holding a large collection of papers in his hand, stood to speak

The proper management of biotechnology and genetic modification is, in Angleter’s view, an issue with potentially massive cross-border implications, and therefore we consider it entirely reasonable that the Council should seek to legislate on this issue. For that matter, we would welcome an additional Bill at a later stage managing the use of these technologies in non-human life.

We are all sovereign nations, but our ecosystems do not stop at our borders. Angleter is wise to these risks, foreseeable and unforeseeable, and therefore we have very strict limits on gene therapy and on genetic modification in non-human life, in addition to a complete moratorium on IVF that was instituted in 1998. Naturally, we will be seeking an amendment to this Bill to clarify that it does not overturn that moratorium.

Angleter supports the general principles of this Bill, although we have a number of concerns about the text as it stands and would like to support or propose some amendments.

Firstly, we concur with Cllr Schröder’s concerns about subclause II.3. The question of whether a sperm or, for that matter, egg donor’s identity should be revealed to their children is fraught with ethical issues. While I appreciate reassurances that donors will not be left on the hook for child support or suchlike, it’s entirely plausible that a child, upon turning 18, may expect some degree of contact with their biological parents.

Most sperm and egg donors, to my understanding, do not donate with the expectation of fulfilling the duties of a parent, even to an adult child; and I also understand that many sperm donors in particular turn out to be the biological parents of a lot of children. They have, under the provisions of this Bill, no control over who the other biological parent will be, who will parent their biological children, and what the circumstances of those children’s upbringing will be – indeed, not only that, but they have no knowledge.

I know that there are powerful moral arguments on the other side, but I believe this is a debatable enough issue that each member state should be left to decide it for themselves. I would, therefore, support the wholesale removal of subclause II.3, and if Cllr Schröder will not bring forward an amendment to such an effect, then I will.

With respect to subclause II.7, I would suggest that member states should be able to lay down further provisions on sperm banks and suchlike however they want, rather than just by regulations.

In the following subclause, I believe it is important to stress that sex-selective treatment should only be employed if either parent – not just the mother – has been demonstrated in a test to be a carrier of a sex-linked hereditary disease. I think it would be wrong for unscrupulous doctors to get off on the technicality that the mother or father turned out to be a carrier after the fact. Furthermore, the term ‘serious’ warrants more specific definition.

I’m unconvinced as to the value of banning ovary transplants and the like at the European level, and the same for the discouragement of egg donation, and I’ll table an amendment to give the Council an opportunity to decide what course of action to take.

Angleter would welcome the bans on human cloning and the intentional creation of genetically identical individuals. However, we would seek clarification in subclause II.20 to stress that it only applies to IVF cases and not to naturally-conceived unborn children.

I am concerned about subclause II.23 and would suggest that it be rewritten. At present it is unclear whether the member state would need the approval of the EBAB before giving authorisation, or whether it would simply need to notify the EBAB. I would suggest that the proper order of things should be the member state granting authorisation and then notifying the EBAB, which could then have the power to review the decision.

Finally, I concur with Cllr Greene’s point about using the age of majority rather than specific ages.

In closing, I believe this will be an important addition to the corpus of EU law, provided that it is amended appropriately in the coming days. Accordingly, I’d like to table the following amendments, which I believe I’ve explained over the course of my speech.

AMENDMENT I: SUBCLAUSE II.3

3.1 Any person who is born as a result of medically assisted reproduction using donated sperm has a right to information on the sperm donor’s identity at the age of 18. A donor register shall assist the child in this matter.
3.2 Member States shall establish a register of the identity of sperm donors so that children can exercise their rights pursuant to this section.

AMENDMENT II: SUBCLAUSE II.7

Member States may by regulations lay down further provisions on the organisation of sperm banks, the use of donated sperm and the registration and reporting of information on sperm donors.

AMENDMENT III: SUBCLAUSE II.8

Treatment of sperm before fertilisation for the purpose of selecting the sex of the child is only permitted if the pregnant-to-be individual is has tested positive as a carrier of a serious sex-linked hereditary disease that is either life-threatening, severely life-limiting, or associated with severe physical or mental disability.

AMENDMENT IV: SUBCLAUSE II.9

Genetic testing of embryos before implantation into the womb, including tests designed to choose the sex of the child (preimplantation genetic diagnosis) may only be carried out in special cases of serious sex-linked hereditary diseases that are either life-threatening, severely life-limiting, or associated with severe physical or mental disability; and for which no treatment is available. If special considerations so indicate, the European Biotechnology Advisory Board mentioned in section III may emit favourable rulings for genetic testing of embryos. Such permission may be granted for serious hereditary diseases that are either life-threatening, severely life-limiting, or associated with severe physical or mental disability and for which no treatment is available. The embryos selected must not be genetically modified. Before preimplantation genetic diagnosis is carried out, the pregnant individual shall be given genetic counselling and information.

AMENDMENT V: SUBCLAUSE II.13

The donation of oocytes or parts of oocytes by one individual to another is to be discouraged. The transplantation of gamete-producing organs and tissue from one individual to another for the purpose of treating infertility is prohibited.

AMENDMENT VI: SUBCLAUSE II.20

Information on the sex of the a fetus conceived via in vitro fertilisation before the 12th week of pregnancy resulting from prenatal diagnosis or other examination of the fetus shall only be given if the pregnant individual is a carrier of a serious sex-linked disease that is either life-threatening, severely life-limiting, or associated with severe physical or mental disability.

AMENDMENT VII: SUBCLAUSE II.23

Before presymptomatic genetic testing, listed in section I.e), is to be developed, Member States shall give separate authorisations for each disease or predisposition to a disease testing that is to be subject to research and development. Before Member States decide whether authorisation is to be given, the application shall be submitted to the European Biotechnology Advisory Board. Member States must notify the European Biotechnology Advisory Board of each authorisation within 24 hours of it being given; and the European Biotechnology Advisory Board shall have 14 days from the point of notification to decide whether to overrule the authorisation subject to the submission of sufficient additional evidence.

AMENDMENT VIII: SUBCLAUSE II.30

Gene therapy may only be used to treat serious diseases that are either life-threatening, severely life-limiting, or associated with severe physical or mental disability, or to prevent the occurrence of such diseases. Gene therapy on fetuses and embryos and gene therapy that may involve genetic modification of gametes is prohibited.

AMENDMENT IX: NEW SUBCLAUSE BEFORE II.1

(). LEGALITY OF MEDICALLY ASSISTED REPRODUCTION
Member States reserve the right to impose additional regulations and restrictions on the use of medically assisted reproduction within their territory, including with respect to the overall legality of medically assisted reproduction.

@Kholetzia @Benelux-Helvetica Added

That would be something we can get behind.

Our team has carefully examined this act, listened to feedback from citizens, government officials, religious leaders, and legal counsel, with fairly inconclusive results. Some of its provisions are agreeable, but a couple conflict with Duxburian law or culture. Legal and cultural differences are hills we are willing to die on when it comes to voting, but they can be remedied.

We'd like to start by amending all references to ages of adults and children, removing specific numbers and replacing them with generic terms like "Age of Majority" or "Legal Adult" for an adult and "Legal Minor" for a child. Without flexibility in terms, the act would be imposing a universal age for both what is considered a child and an adult. As I am sure is the case in several countries, we don't use 16 or 18 for these thresholds and would not change them without serious justification. Luckily, this is a simple concern to address.

Our second concern is about II.20 and is also a cultural difference with legal implications. This clause forbids divulging information on the sex of a fetus before the 12th "week" of pregnancy. Our calendar doesn't have "weeks"...since it's a looped Julian system, it only has days and years, no weeks or months. The closest thing we have to "weeks" is the "work cycle", which varies by industry and has no legal definition or regulation as to length. We've used Hasilthecian systems for time and measurement for thousands of years and won't recognize other systems, our entire society revolves around what we already have. The easiest way to remedy this, however, would not be to convert the weeks into days, but rather just kill the whole clause. Why withhold this information in the first place? A woman of age has the right to know the sex or potential sex of her own child at any time.

The Duxburian Universalist Church, now our largest religious community, strongly objects to II.22, which restricts genetic testing to certain objectives. Since this religion worships the universe itself as God and the laws of science as the laws of God, medical experimentation is one of the ways a Universalist seeks to understand and further a relationship with God. The feedback we received indicates that the Church is willing to ban most risky and controversial practices, such as cloning and gene manipulation in fetuses, but would prefer being allowed to test for simple curiosity and knowledge fulfillment. Their concerns are highly relevant, as the vast majority of our hospitals, R&D centers, clinics, and any other healthcare enterprises imaginable are associated with the Universalist Church. It would be best just to kill the clause, but it could be reworded to have a broader scope.

Finally, the Duxburian Federal Government is concerned about the need to send so many things for authorization to the European Biotechnology Advisory Board. What could we expect in terms of turnaround time on approvals, and is this only for methodology or for every time a patient comes in for testing? Either way, the Duxburian Government is an ultra-modern institution that operates at considerable speed and has expectations in both directions for fast turnaround. The Government is worried that there is no mention of application process or machine learning assistance for analyzation of methodologies, nor any priority system for handling applications, nor specialists to handle the human side of approvals. I do understand that the act places the responsibility for details upon the European Council, but what if the Council declines to set any? There is no default process and just a skeleton crew of national representatives, which sounds like a recipe for red tape and delays, which is no longer an acceptable way to conduct business.

If these concerns are addressed, the Duxburian Union has no further objections.

Wesley Greene
Konsilir am Iunio Dairghazburiano

I'd like to request that the Speaker extend debate for at least an additional 48 hours, given the length of this Bill.