European Biotechnology Act - 2019

[Benelux-Helvetica]

"The Kingdom of the Benelux doesn't express any particular criticism nor concern regarding the European Biotechnology Act of 2019 that was proposed by Cllr. Maverick, and as such we're quite adaptive to the General Obligations that are hereby proposed and ratified." Cllr. Ayan Hirsi Ali replied, reading through a copy of the draft whilst her colleagues took their turns discussing.

[California]

@Derecta

We would simply call for a removal of Section 3.1 and 3.2 in its entirety. I am not sure if that qualifies as an amendment.

The idea that someone should decide not to donate sperm if they are concerned about privacy is laughable. It should be entirely permissible for someone to donate sperm or eggs to a fertility facility and request that their name not be taken. Otherwise we will see a sharp decline in donations.

[Derecta]

Councillor Schröder, we do believe the striking of sections of an Act does, in fact, constitute an amendment, as it modifies part of our proposal.
However, we understand that by calling for this removal, you have indeed submitted said amendment to our proposed text.

Regarding the "laughable" concept of the disclosure of donors' identities, I would say it would be done with an altruistic purpose in mind, the same purpose that motivated the donation of genetic material in the first place.

Let us also remind that it is optional for children born through medically assisted reproduction involving third-parties to know of the identities of their genetic progenitors.
At no instance have we stated or proposed through this Act that said children and donors be forced to become acquainted with one another nor have we attacked that right to consent of visitation on behalf of the donor you previously and rightfully referred to.

Nevertheless, we would like to propose our own amendment to section II.3, which is as follows:

### II.3.THE CHILD’S RIGHT TO INFORMATION ON THE SPERM GAMETES DONOR
3.1.Any person who is born as a result of medically assisted reproduction using donated sperm gametes has a right to information on the sperm gametes 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 gametes donors so that children can exercise their rights pursuant to this section.

Replace "sperm" by gametes.
Add: 3.3.Gametes donors shall be able to state their refusal to become acquainted in person with their genetic spawn, thus restricting said spawn's access solely to their medical information, regarding in particular hereditary diseases unknown of or not fully disclosed during the donation of genetic material by the donor, without prejudice to the right established in section II.3.1 to section II.3.

[Spain]

After reading the whole act, Spain will oppose to this.

I think that we should get a common agreedment between the European Union to share our advanteges in Biotherapy and advance making a common front, also thinking on the prize and the coverage of the health assurances services to not make this ways of treating diseases very expensive for the people.

Cllr. Rodríguez
Councillior for Spain

[Derecta]

If I understand so correctly, Councillor Rodríguez, are you pushing for the sharing and divulging of information, that in most cases is proprietary, amongst Member States?
When I proposed this Act, I would have never thought about this "common front" you wish for our Member States to create.
Yet again, I believe, and I would not want to seem disrespectful by saying so, that a whole array of aspects beyond the scope of this Act are being deployed in order to undermine it.

Let us remind that, whether we like it or not, the vast majority of scientific discoveries are the result of the private sector's R&D efforts.
How would these entities reap the benefits from their hard work if their exploits were to be immediately surrendered to foreign countries and their own companies in the name of this "common front"?

We in Derecta do not share this intent to submit private R&D to a pan-European public domain. We think the purpose of free-enterprise would then be lost.

Moreover, I understand your concerns in terms of cost and accessibility to treatments palliating or curing genetic diseases, even though regulating medically assisted reproduction and trying to impede malpractice during such procedures is the primary front of this Act.
We have, nevertheless, made a precision concerning genetic testing and gene therapy that could help towards the goal of treating diseases that you mention.

At no time, and by this we would like to further reassure the Sildavian delegation that our intention is only for the European Union to protect citizens from malpractice linked with the application of biotech to human medicine, have we pushed for a regulation of the market that results from such procedures. We believe it is up to each Member State to develop the infrastructure, research capabilities and free markets relating to biotech independently, and to apply the regulations they see fit to protect the right to property, the right to cheap access to these treatments or even both, in a balanced manner.

Thus, we are appaled by the opposition to this Act the Spanish delegation has expressed. If the Kingdom of Spain's purpose is for these treatments to become available to any citizen, we believe that the restriction to solely therapeutic motives of the application of biotech to human medicine will, in fact, foster this banalisation of prices.

Any other case, where designer babies were the norm or companies could commission their own Huxleyan army of effectively brain-dead slaves, would probably encourage this unregulated private sector to abandon the purpose of alleviating diseases and exploit the deep pockets of immorality and depravity.

[A Former User]

@Derecta said in European Biotechnology Act - 2019:

Right now, there are many Member States which have the capability to apply the latest biotech procedures to human embryos. Thankfully, they, we, are generally democratic regimes, respecting human rights and the UDoHR and willing to do so.

Our Member States have declared that they accept the acquis communautaire , etc., etc. But just reading the official name of our Member States, there are some whose name is “Dictatorship of...”, to begin with. There are many of them with a unique party system, or strongly restrained economic freedom, free enterprise, etc...
So, the risks you are speaking about are not just possibilities, but realities happening in our region.
We don’t believe that further declarations on matters which will depend only on the good will... or even whim on the part of Member States will help to ensure the rights of citizens, which are in practice ignored by many of our countries. Why create even more texts without practical results, fostering an empty nutshell of unobserved legal measures? Nobody is following how Member States are taking care of their issues or policies, and nobody will have the time or be able to do so.
If Sildavia signs a treaty or a request for membership, we take it seriously. We want to accomplish our duty and do what we are legally bind to do. For this reason, we refuse to sign the multiple obligations derived from this proposal, because with all the good intentions they are filled with, they will put too many and detailed limits to legitimate choices which may be taken in the future by our democratic government of each legislature. There may be alternatives, morally and democratically acceptable, to measures fixed and decided by this text. It’s a bill made by a concrete political option, for a concrete country in a concrete historical moment. It’s not valid for countries which evolve historically, experience periodical elections and change ruling parties, because everyone of them may have different solutions for the same questions, and all acceptable within our national and regional Constitutions and within our national and regional Bills of Rights.
We are sure of the good intention and goals of Derecta, a nation which we respect and have in the highest consideration, but we insist in our opinion about this proposal going too far into the field of our respective legitime sovereignties.

[California]

@Derecta

I do think that as long as legislation in Section 3 makes it explicit that these records cannot be made available for use regarding custody or child support unless the EBAB receives notarised, authentic court documents requesting the information and that both biological parents and the adult age child all agree to allow the child access to information regarding knowing who the donor was, then Germany can get on board with the legislation. It is our only qualm.

[Angleter]

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

[Duxburian Union]

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

[Derecta]

@Angleter
We second the Angleteric Councillor's request.

[Derecta]

@Sildavia said in European Biotechnology Act - 2019:

But just reading the official name of our Member States, there are some whose name is “Dictatorship of...”, to begin with. There are many of them with a unique party system, or strongly restrained economic freedom, free enterprise, etc...

OOC: I think we have to differentiate between states currently members of the Nationstates' European Union region and the NS players who have decided to become RPers by requesting a plot in our map. I don't think there are any Member States (NS gamers turned off-site RPers) that go by the dictatorial standards you mention.

[Derecta]

@Germany

We would then like to propose the following amendment to section II.3:

Add clause II.3.1 (modifying the numbering of following clauses):
Modify title of section

II.3.THE CHILD’S RIGHT TO INFORMATION ON THE SPERM GAMETES DONOR RIGHTS OF GAMETE DONORS AND CHILDREN BORN BY MEDICALLY ASSISTED REPRODUCTION

3.1. Anonymous gamete donors shall be exempt of any parental, legal or financial responsibility over their possible genetic spawn.

3.1. 3.2. Any person who is born as a result of medically assisted reproduction using donated sperm gametes has a right to information on the sperm gametes donor’s identity at the age of 18. A donor register shall assist the child in this matter.

3.2. 3.3. Member States shall establish a register of the identity of sperm gametes donors so that children can exercise their rights pursuant to this section.

3.3. 3.4. Gametes donors shall be able to state their refusal to become acquainted in person with their genetic spawn, thus restricting said spawn's access solely to their medical information, regarding in particular hereditary diseases unknown of or not fully disclosed during the donation of genetic material by the donor, without prejudice to the right established in section II.3.1. II.3.2.

[California]

That would be something we can get behind.

[Derecta]

@Duxburian-Union

Councillor Greene, I appreciate your input on this proposed Act and would like to address your worries and queries one by one.

While we understand your concerns regarding the establishment of specific age-based restrictions, we agree that each Member State does, in fact, establish the majority threshold at different, although similar, ages. We will support this amendment, if it applies solely to section II.3.

Nevertheless, concerning the 16-year thresholds stated in sections II.24., II.27. and II.31., we would argue they're established merely on the grounds of psychological development. In general, children under the age of 16 (by commonly accepted standards) are only just starting the transition towards adulthood maturity-wise, thus why we believe parent/s' or legal guardian/s' consent must be required before engaging in the practices regulated by these sections.

In addition, we simply cannot believe the Duxburian Union does not, in fact, go by international standards when engaging in communication or collaboration with foreign powers. Whilst we respect and admire the cultural roots of the traditional Duxburian time system, I am sure the conversion of times is not impossible, and when the Duxburian authorities translate this Act, may it be approved, into your autochthonous language, they will manage to do so diligently, even if it has to be done by measuring the smallest comparable unit of time in both systems.
If not, this would imply that the Duxburian Union is willfully completely isolated from most international agreements and organisations, by refusing to adhere to such standards.
Does the Duxburian Union recognise the Constitution of the European Union, in which specific term limits expressed in Gregorian months/years are determined?
If so, then we must admit that the time limits expressed in this proposed Act should also be accepted by the Duxburian Union.

Moving on, I shall explain the motives behind section II.20.

This threshold is based on the particularities of the process of sexual differentiation of human zygotes/embryos/fetuses.
During such process, which begins with the first zygotic cellular divisions and continues well beyond the 12th week of gestation and the beginning of the fetal stage (which starts during the 8th week of gestation), sexual gonads may not be fully identifiable before this 12th week period, in particular concerning male embryos/fetuses. Nevertheless, some distinct characteristics may be observable before the 12th week.

Now, our intention is not to limit or restrain abortion rights, if applicable, in Member States, but there is a relation between this aspect and this section.
After the first trimester, id est 12 weeks, abortion is generally only advised under certain circumstances, such as the existence of a risk to the pregnant individual's life or health, fetal defects or other specific situations that may be related to the circumstances of the conception or the pregnant individual's age.
It is of common scientific belief that abortions before the 12th week should be, in general, unrestrictedly performed.
The reason why we propose that the sex of the embryo/fetus be an unknown to the pregnant individual and their families, if they're involved in the pregnancy, before the 12th week of gestation, unless there is a serious risk for the embryo/fetus to develop a critical sex-linked condition, is because we would like for abortions based on sexist attitudes be, if not eradicated, reduced to the maximum possible.
We simply cannot allow for pregnant individuals to decide to terminate their pregnancies merely on the grounds of rejection towards the sex of their spawn, especially after procedures requiring such hard work as medically assisted reproduction.

Now, regarding section II.22.
If one of the main purposes of this Act, which is, in fact, to impede ill-minded actors from performing unethical genetic modifications to humans, is suppressed on the grounds that we are to ingratiate a determined Duxburian-circumscribed religious current, I believe the whole objective of this Act is fully undermined.
I simply cannot and will not accept that Humanity's common interest, which is to preserve itself and what makes it human, be subordinated to a church's dogma.
How can the Duxburian authorities guarantee that this "simple curiosity" you invoke shall not derive into scientifical atrocities attacking the very core of what makes us humans?
You request a broader scope be given to this section. I say that there is already broad enough a scope to the therapeutical objective allowed by this proposed Act.
I would not like to enter a theological discussion, but what better way to achieve communion with God than to effectively suppress the evil of disease?

Finally, we admit the wording of this Act could be improved regarding the authorisations to be given by the EBAB. Nevertheless, we understand that they would, in fact, apply to a given methodology, and not to individual therapy administered to each patient.
Regarding the speed of said applications and the infrastructure required to deliver authorisations in a swift manner, we would invite you to illuminate the rest of us red-tape-drowned Member States and propose an amendment extrapolating that Duxburian bureaucratical expertise to the EBAB, by bringing forward what your delegation thinks that a personnel/institutional structure should optimally be.

[Derecta]

@Germany

We appreciate your will to reach a middle ground, Councillor Schröder.

[Inquista]

I'm extending the debate for another 48 hours, until 20:30 GMT July 15th.

Edward Firoux
Council Speaker and Councillor for Inquista

[Derecta]

I would like to announce to my fellow Councillors that, due to the recent General Elections celebrated in my country, I shall only remain as acting Councillor for the Republic of Derecta until the passing or dismissal of this Act.

I would like to humbly request that you let us know your respective doubts, concerns and proposals about this Act as soon as possible, as to allow the Derectan authorities to appoint my successor.

Finally, I would like to thank the Council and my fellow Councillors for the kindness and sympathy with which I have been treated ever since I succeded Dame Ricchetti as Derectan Councillor on the occasion of her accession to the Office of Premier Commissioner back in 2017.

Thank you all,

HE Acting Councillor Julian Maverick

[Derecta]

We have just received a cable from the Angleteric delegation asking about the meaning of the word "foraneous" used in section II.10.
As we have realised this was a poor choice of wording, we submit the following amendment:

Replace "foraneous" by third-party

10.USE AND IMPLANTATION OF EMBRYOS
Implantation of embryos into the individuals from whom the oocytes were obtained shall be the preferred course of action. Member States may lay down further regulations relating to implantation of foraneous third-party embryos into an individual’s body after in vitro fertilisation.

[Angleter]

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.

[A Former User]

@Angleter said in European Biotechnology Act - 2019:

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.

Why admit possible “additional regulations and restrictions”, but impose the regulations and restrictions of this bill on ALL EU MEMBER STATES? Is the protection of the civil or moral rights of citizens the reason of this bill, or just a concrete moral or even non-admitted religious Weltanschauung which lays behind it?
Sildavia believes in freedom, freedom also for science and research. In our philosophical, moral and religious system limits and restrictions should only be applied to protect subjects of right, that is, individuals, and reproductive cells or unborn foetuses (while they are not yet viable) are NOT individuals according to our laws. We don’t expect other countries to share this views, and we don’t accept that other countries expect us to accept theirs.