European Biotechnology Act - 2019

[Derecta]

European Biotechnology Act - 2019

Proposed by Cllr. Julian Maverick of the Republic of Derecta

Preamble:

Understanding the principle of respect of human dignity, human rights and personal integrity as being the ethical basis of scientific discovery,

Concerned by the hypothetical discriminatory scope genetic modifications to the human gene-pool could take,

Acknowledging the benefits of the application of biotechnology in human medicine, especially concerning the alleviation and eradication of diseases,

This Act hereby establishes:

I. Definitions

For the purpose of this Act, the following definitions apply:

• a) medically assisted reproduction: insemination and in vitro fertilisation,
• b) insemination: the introduction of sperm into an individual willing to become pregnant's body by means other than sexual intercourse,
• c) in vitro fertilisation: fertilisation of oocytes (eggs) outside an individual willing to become pregnant's body.
• d) prenatal diagnosis: examination of fetal cells, a fetus or a pregnant individual to obtain information about the genetic constitution of the fetus or to detect or exclude a disease or abnormality of the fetus. Ultrasound examination forming part of the ordinary examinations pursued during pregnancy is not considered to be prenatal diagnosis pursuant to the first paragraph, and therefore does not come within the scope of this Act.
• e) genetic testing: analyses of human genetic material at both the nucleic acid and chromosome levels, analyses of genetic products and their function, and examination of organs to obtain information on human genetic constitution.
• f) postnatal genetic testing: it encompasses the genetic testing to diagnose a disease; presymptomatic genetic testing (predictive genetic testing and testing to determine whether or not a person is a carrier of hereditary disease that will only be expressed in later generations); laboratory genetic testing to determine sex (with the exception of laboratory genetic testing for identification purposes).
• g) gene therapy: transferring of genetic material to human cells for medical purposes or to influence biological functions.
• h) cloning: techniques employed to create copies of living beings that are genetically identical.
• i) provision of genetic information to persons other than the patient: authorised provision by health personnel of information about hereditary disease in the family to at-risk relatives of such patient.

II. General Obligations:

1.Information and consent

Individuals pursuing medically assisted reproduction shall be given information on the treatment and on the medical and legal consequences it may have. Before the treatment is started, the physician providing the treatment shall ensure that written consent is provided by said individuals. If the treatment is repeated, renewed consent shall be obtained.

2.Decisions on treatment

The decision to undertake treatment with a view to medically assisted reproduction shall be taken by a physician. The decision shall be based on medical and psychosocial assessment of the individuals willing to undertake such treatment. Importance shall be attached to said individual/s’ capacity to provide parental care and the best interests of the child. The physician may obtain any information necessary to make an overall assessment of the individual/s.

3.The child’s right to information on the sperm donor

3.1Any 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.

4.Sperm donors

A sperm donor shall have reached the legal age of majority. The donor must give written consent for the sperm to be used for fertilisation and for his identity to be recorded in the donor register. Consent may be withdrawn until fertilisation has taken place. A sperm donor shall not be given information on the child’s identity or their parent/s legal guardian/s.

5.Selection of sperm donors

The physician who is providing the treatment shall select a suitable sperm donor. The establishment that carries out the medically assisted reproduction procedure shall ensure that the necessary information on the procedure is registered and reported.

6.Storage and import of sperm

Only establishments that are specifically authorised to do so may store and import sperm. Establishments that store donated sperm shall ensure that information on the identity of sperm donors is registered and reported to a donor register. Sperm shall not be provided for medically assisted reproduction procedures after the death of the donor.

7.Regulation of sperm banks

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.

8.Treatment of sperm before fertilisation

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 a carrier of a serious sex-linked hereditary disease.

9.Genetic testing of embryos

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 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 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.

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 embryos into an individual’s body after in vitro fertilisation.

11.Storage of embryos

Only establishments that are authorised pursuant to section II.33 to carry out medically assisted reproduction techniques may after authorisation store embryos. Embryos may not be stored for more than five years, and shall then be destroyed.

12.Storage of unfertilised oocytes and ovarian tissue

Only establishments that are authorised pursuant to section II.33 to carry out medically assisted reproduction techniques may after authorisation store unfertilised oocytes and ovarian tissue. Unfertilised oocytes and ovarian tissue may only be stored if the conditions relating to medically assisted reproduction set out in this Act have been fulfilled or if an individual is to undergo treatment that may impair their fertility. Stored unfertilised oocytes and ovarian tissue may only be kept for as long as the interests of the individual from whom they were taken so dictate and it is considered medically justifiable. Stored unfertilised eggs and ovarian tissue shall be destroyed if said individual dies.

13.Prohibition against egg donation and transplantation of gamete-producing organs

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.

14.Authorisation of methods of treatment

Methods of treatment that come within the scope of article I, the storage and import of sperm, cf. section II.6, treatment of sperm, cf. section II.8, and the storage of embryos and unfertilised oocytes and ovarian tissue, cf. sections II.11 and II.12, shall be authorised by Member States, and may only be used or carried out by establishments that are authorised pursuant to section II.33. Before Member States decide whether authorisation is to be given, the application shall be submitted to the European Biotechnology Advisory Board.

15.Prohibition against creating human embryos by cloning

It is prohibited:
a) to create human embryos by cloning,
b) to carry out research on cell lines derived from human embryos obtained by cloning,
c) to create embryos by cloning by the technique of inserting human genetic material into an animal oocyte.

16.Prohibition against techniques designed to create genetically identical individuals

The use of techniques designed to create genetically identical individuals is prohibited.

17.Authorisation of prenatal diagnosis

Methods of examination that come within the scope of section 1.d) shall be authorised by Member States. Before Member States decide whether authorisation is to be given, the application shall be submitted to the European Biotechnology Advisory Board.

18.Consent before prenatal diagnosis

Before prenatal diagnosis is undertaken, written consent shall be obtained from the pregnant individual who is to be examined.

19.Information and genetic counselling

Before prenatal diagnosis is undertaken, individuals shall be given information on the procedure, including the fact that it is voluntary, the risk associated with carrying out the procedure, what the procedure may reveal and the consequences this may have for the child and the pregnant individual. If there are grounds to suspect a genetic disease, the pregnant individual shall also be given genetic counselling. If the procedure indicates a disease or abnormality of the fetus, the pregnant individual shall be given information and genetic counselling on the disease or abnormality in question, and on their rights and the support that is available.

20.Information on the sex of the fetus before the 12th week of pregnancy

Information on the sex of the fetus 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.

21.Prenatal paternity testing

Prenatal diagnosis with a view to determining paternity and prenatal paternity testing are prohibited. This does not apply when the pregnancy may be the result of penally prosecutable acts.

22.Use of genetic testing

Genetic testing shall only be carried out for medical purposes if it has a diagnostic or therapeutic objective.

23.Authorisation of genetic testing

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.

24.Consent

Before presymptomatic genetic testing coming within the scope of section I.e) is carried out, written consent shall be obtained from the person who is to be examined. Before genetic testing that comes within the scope of section I.e) is carried out in the case of a child under the age of 16, written consent shall be obtained from the child’s parent/s or legal guardian/s.

25.Genetic counselling

Before, during and after presymptomatic genetic testing coming within the scope of section I.e), the person tested shall be given genetic counselling. If the person being tested is a child under the age of 16, the child’s parent/s or legal guardian/s shall also be given genetic counselling.

26.Genetic screening and pharmacogenetic testing

Member States may lay down regulations relating to the authorisation of genetic screening and pharmacogenetic testing. The regulations may make exceptions from the requirements of this Act relating to written consent, genetic counselling, authorisation of establishments and reporting.

27.Presymptomatic genetic testing of children

Presymptomatic genetic testing shall not be carried out on children under the age of 16 unless the test can detect a condition for which treatment may prevent or reduce damage to a child’s health. Member States may in special cases grant exemptions from this prohibition, following consulting of the European Biotechnology Advisory Board.

28.Prohibition of the use of genetic information outside the health service

28.1. It is prohibited to request, receive, be in possession of or use information on another person obtained through presymptomatic genetic testing that comes within the scope of section I.e) or by systematic surveys of hereditary disease within a family.
28.2. It is prohibited to ask whether genetic testing or systematic surveys of hereditary disease within a family have been carried out.
28.3. The prohibitions stated in sections II.28.1 and II.28.2 do not apply to establishments that are authorised pursuant to section II.33. to carry out genetic testing that comes within the scope of section I.e) or for research purposes.
28.4. If genetic information is to be used for research purposes, consent must have been obtained from the person from whom the information was obtained.
28.5. Health personnel who need the information for diagnostic and therapeutic purposes are excepted from the prohibition stated in sections II.28.1 and II.28.2.

29.Provision of genetic information to persons other than the patient

29.1. If it has been documented that a patient suffers from or has a predisposition to a hereditary disease, the patient himself may decide whether or not to inform at-risk relatives of his condition.
29.2. If the patient himself cannot or does not wish to inform at-risk relatives of this, health personnel may request the patient’s consent to inform his relatives, if the conditions stated in section II.29.4 are fulfilled and the disease is approved by member States pursuant to section II.29.5.
29.3. If the patient cannot give his consent to the provision of information to at-risk relatives by health personnel, they may nevertheless provide such information in special cases, if the conditions stated in section II.29.4 are fulfilled and the disease is approved by member States pursuant to section II.29.5.
29.4. Before health personnel contact the relatives, they shall assess whether:

• the disease in question has serious consequences for the individual’s life or health,
• there is a reasonable probability that the person’s relatives are also genetically predisposed to the disease and may develop the disease later in life,
• there is a documented link between genetic predisposition to the disease and the development of the disease,
• the genetic tests used to determine whether a person carries a genetic predisposition to the disease are reliable, and
• there are satisfactory methods of preventing or treating the disease. If a relative is under the age of 16, only the parent/s or legal guardian/s shall be informed.

29.5. Member States will determine by regulations the diseases for which provision of genetic information to persons other than the patient is authorised.

30.Conditions for gene therapy

Gene therapy may only be used to treat serious diseases 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.

31.Authorisation of gene therapy

Methods of treatment that come within the scope of section I.g), shall be authorised by Member States. Member States may lay down regulations relating to administrative procedures. Before Member States decide whether authorisation is to be given, the application shall be submitted to the European Biotechnology Advisory Board.

32.Consent

Before gene therapy is carried out, written consent shall be obtained from the person who is to be treated. Before gene therapy involving a child under the age of 16 is started, written consent shall be obtained from the child’s parent/s or legal guardian/s.

33.Authorisation of establishments

The medical application of biotechnology that requires authorisation pursuant to sections II.14, II.17,II.23 and II.31 of this Act may only take place at establishments specifically authorised by Member States for the purpose in question. The decision to authorise an establishment shall indicate which forms of medical biotechnology procedures it is allowed to carry out or commission. Member States may lay down further conditions for authorisation in their respective legislation.

34.Duty to provide reports

Any establishment that receives authorisation pursuant to section II.33 shall submit written reports to Member States on its activities. Member States will lay down further provisions on the duty to report.

III. European Biotechnology Advisory Board

1.Appointing of members

The Council will appoint a board that on request or on its own initiative can give opinions on matters that come within the scope of this Act and other questions relating to biotechnology. The opinions of the board are public unless otherwise required by the statutory duty of confidentiality. The Council may lay down further provisions on the board’s activities.

2.Duration of tenures

The EBAB will be appointed by the Council for two-year tenures. The board’s decisions are not subject to appeal.

3.Composition of the board

The EBAB shall be composed of one appointed representative per Member State, relating to the domain of biotechnology.

IV. Further Provisions and Regulations

The Council may by regulations lay down further provisions to supplement and implement this Act.

[Derecta]

I now urge the Speaker to allocate debate and voting times for this proposed Act.

HE Cllr. Julian Maverick,

Republic of Derecta

[Inquista]

Debate begins NOW and will last until 05:15 GMT July 13, 2019.

Before I begin, I would like to implore all Councillors to read this Act in its entirety before responding or voting on this Act. There are many, many complex components here, and I personally found myself surprised - mostly pleasantly surprised - the more and more I read this Act. I can already foretell that there will certainly be Councillors opposed to certain sections of this Act, but I would also suspect that they would also find agreeable and meaningful provisions within here too. Please do not take an all-or-nothing stance here. Again, I urge all Councillors to read this Act in its entirety, and to articulate what they like and dislike in order to produce the most optimal piece of legislation.

I must admit that I am somewhat blindsided by this piece of legislation. At first, I did not think such an Act was necessary, but I increasingly found that there are components of this Act that would significantly better the lives of those within the European Union. I support this Act for multiple reasons.

For starters, I appreciate that this Act would make consent mandatory at all levels of prenatal diagnosis, genetic testing, and all other processes outlined. Consent is absolutely key, and consent should be afforded to every European.

Secondly, I support the notion that gene therapy should only be used for medical purposes, such as to treat or prevent serious diseases. The fact that this Act prohibits the genetic modification of children is something I applaud, and I believe should be entrenched in European law.

Thirdly, I also support the provisions against cloning.

Fourthly, I believe this Act brings clarity and justice to sperm donors and to children born from sperm donations. I believe that donors should have no information in regards to the child, but that the child should have the right to know of the donor's identity, should they choose to do so, once they are 18. I once again welcome the fact that consent is brought into the equation, and that donors are required to be of legal age before donating.

Lastly, I wholeheartedly welcome the fact that this Act would bring information and proper counselling to those who are seeking the services outlined within this legislation. These services are diverse and quite complex, and it is absolutely imperative that Europeans have a proper understandings of the potential consequences of their decisions. Europeans will be much better off with this information.

Edward Firoux
Council Speaker and Councillor for Inquista

[A Former User]

Without entering into the many different, important matters contained in this proposal, the Empire of Sildavia states its refusal to consider it as a matter within the EU competences.
Nation States is formed by States, as much an oxymoron it sounds. Not “individuals”, not even political parties, who join a State called “region”, where they may act as “individual citizens” or partisan political agents of a supra-individual political community. This is a mistake repeatedly uttered in many NS regional messages, telegrams and declarations.
We represent independent, sovereign nations, which join in regions to deal with matters of common interest. For example, the last bill on air traffic and control was clearly a matter which affects our transnational interests, therefore it was justified as a regional directive, law or whatever name may given to it.
But this proposal, now, is completely out of the regional competence. It is not that we disagree with its different proposals, it’s that we refuse to discuss it as a question which can be ruled by the region. These matters are, and should stay, under each nation’s sovereign power to decide.
Therefore, in the name of the Empire of Sildavia, which I represent, I state our radical disagreement with this proposal and our intention of not taking it into account.
Lord Carlos de Kronstadt-y-Setia, Permanente Representative and Councillor.

[Derecta]

Councillor de Kronstadt-y-Setia, though I understand why you think this particular piece of legislation may indeed extend our Union's powers over its components, let me explain why I believe the rules and guidelines regulating the application of biotechnology in human medicine should be established by European Law.

We are all well aware of the fact that we live in times where technology advances incomparably faster than legislation, government institutions and national cultures do so. Every day we learn of a new application to such or such element, or of a new machine that helps people in doing this or that.
This is the Era of Technology, and if we don't do anything to preserve our human identity, we shall be engulfed by the very wonders we created, and descend towards our own demise.

Now, here comes why I believe Europe should enshrine this Act in its acquis communautaire as part of its mission to serve and protect its citizens' interests.
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.
But who is to tell that in twenty, ten or even five years none of these countries will be submitted to an undemocratic rule? What power will national legislation have to stop these regimes from using biotech wrongfully?

Alas, I don't want to seem overly pessimistic, nor do I want to imply that our Member States are inevitably doomed to fall into the grip of tyranny.
I just strongly believe that the only way we can avoid the using of biotech to create designer babies, reducing humanity to the level of a car for which you pay to add complements, or even worse, super-humans engineered to subjugate the genetically inferior masses, is by assuring there will be an entity fighting against these practices.
And to me, the only institution that is capable to assure this protection, in the long run, is the European Union.

[California]

Having read through the Act, I can say that Germany is opposed to sections 3.1 and 3.2.

We do not and will not keep a list of donors like this. Germany believes it is the right to privacy of the donor that is equally important. Not every donor wants or would welcome a visit from a child born of their sperm. The right to consent of visitation on behalf of the donor is just as important.

Another issue I have with the Act in general is the overall limit of responsibility of the donor. I think we need to ensure there are clear provisions in place to make sure donors are not going to be found legally responsible to pay child support and other similar situations.

Cllr. Gerhard Schröder
Councillor for the German Empire

[Derecta]

I invite you, Councillor Schröder, to present the amendments you consider would benefit this Act.
Although, I do believe the question of parental or even financial responsibility of donors over the child/children born after usage of their genetic material is beyond the scope of this Act. This is an aspect over which I would agree with the Sildavian councillor, and say it has to be regulated at a national level.

Concerning the donor database, its purpose is more medical than sentimental. We would argue its utility is based on the right said children have to know whether they are carriers of hereditary disease or diseases, given the case they can be screened even after the donor submitted their genetic material, thus being an unknown to physicians performing medically assisted reproduction.

Moreover, it is impossible to know the potential disease screening will have in ten years time or even the number of genetic conditions we will have managed to discover and catalogue.
This is why we consider donor databases are legitimate.

If one does not wish for their possible genetic spawn to know of their identities, the solution is very simple: one must abandon the idea of submitting their genetic material to third-parties.

However, we do understand the implications this has on a sentimental level. Nevertheless, medically assisted reproduction involving third-parties is nothing new. We trust that Member States already have implemented legislation regulating the aspects of donor responsibility over their genetic spawn, which should be now restricted to this obligation to surrender their identities to the donor database by the means of this Act.

Whether said children and their genetic progenitors want to establish relations or not is solely up to them, and we believe none of the two parties would have legitimate claims over the other.

[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.