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The ART act is so vast that it just cannot be covered in one article. So, in continuation to Part 1, we will now cover the deeper and more meaningful aspects of the ART Bill in Part 2. We now know that the registration is mandatory. Without registration, one can't enter into new practise. That's clearly there and has been well explained for the mentees for Fellowship in Reproductive Medicine in India. We have to just see whether the national registry will form. Another provision which has been given, the existing regulatory mechanism, the registration mechanism under the Surrogacy Regulatory Act, which is there, it's a supplement to that Act. That mechanism would be leveraged and used, because if a new thing is not formed, there could be a possibility that the existing mechanisms can be used, though there would be change in the, what to say, that the validity of that registration is different in both Acts. So that would be there. That mechanism already exists. We have to see and wait till the rules are made.

The contours for the rules are already given in Section 42. So, we must see that it becomes easy for the people to make the rules now, based on these 28-29 points. I think this Act also mentions in terms of who qualifies as a couple and who qualifies as a patient, and also what are the age limits for the man and the woman.

Who all can avail of this treatment and who all are eligible, who cannot undergo?

Fertility is a fundamental right, to have a child is a fundamental right of every couple. But this law is in the sense, what about living in relationships, a single man, all those kinds of things? How do we comment on this?

Well, according to the Act now, and we can't do anything more beyond this, we'll have to follow this Act. And rather than to debate on this, all those women who are between the age of 21 to 50 can avail of these services, and of those who are for men between the age of 21 to 55. Now, in so far as the live-in couples, well, they have not been really recognised that they can go in for these kinds of treatments. Now, when you say it is a fundamental right to reproduce the government is not saying you can't reproduce, but you can't take the ART services. So they are not coming in the way of your fundamental right to reproduce, you reproduce normally. So, in that way, they are not actually coming in the way. So you can't blame the government for that. The only thing is to go through these assisted reproductive technology is what they're saying you can't do. So far as you apply this law, they say that you can't do.

What about single individuals, a single man, single woman, or?

Well, single man, well, they say single man, no. And a divorcee, ever married, in the sense, widow, they have said if she has been married once, and then she can go ahead. Well, there has been a differential because of the nature of the man and the woman, they have allowed the woman, but they've not allowed the man. You may say that there is a gender disparity.

An individual or a couple who comes to any registered assisted reproductive technology clinic for the management of infertility, basically. So now there is a dichotomy here, you know, on one hand, they have used the definition in the patient's definition, they have used the word individual, or a couple, basically, okay.

Now, what definition do we attribute to that whether ordinary Oxford English definition should be given to an individual or a couple and fertility management, okay, so they have covered, even if you go for a normal advice to a doctor for AI for fertility related issue, I think so that falls and you become a patient. The way we see this is that because this act covers fertility preservation, also, it gives access to a single man to fertility treatment. Now, if that man wants to have a child, it will fall under the surrogacy act.

What is this whole mechanism that has been put forward for registration of the clinics and the banks?

The central government should form the national board within three months of the commencement of this act. And then the state government would form the state boards and the union territories would be formed by the government. And the national board should lay down the rules and regulations to give power to this act.

After the national board, and the state boards are formed, a period of 60 days would be given to all the clinics and all the banks to get registered to apply for this. And after the application, a maximum period of one month will be given to the appropriate authority to either accept your application and give you registration or to reject your application and with written instructions as to why they are rejecting with a provision to give a show cause notice or maybe a chance to explain yourself as to why your registration should not be given. And then obviously, there are provisions that you can appeal to the state authorities for the registration if you're not granted registration for your clinic.

There is a clear window. And that is how I understand is the six-month period being given in section 15.3 is a three month for the formation of national board, two months for the clinics and banks to apply and another one month for the appropriate authorities that would be formed at every district level to grant your registration or to reject registration. So, then we have that six-month period for regulation of clinics and banks.

Two understandings which I understand that these windows are the maximum period, it could be shorter than this. Government can form the state boards earlier than and the essential purpose behind this window is to give existing clinics the time to adapt to the infrastructure, the manpower requirements that will eventually come out in the rule. So, it is kind of a preparatory time that is being given to clinics.

Because if the application is rejected, they will have to give a reason as to why that application is being rejected. The Act also mentions about the various registries, the national databases for both ART and surrogacy. So, the question here to Amit is that the registries may be formed six months down the line.

But what about the procedures or data records of procedures happening from 25th of January till the date that the registry is formed? Can they ask for retrospective data? Or is it only after the registry is formed?

Formation of rules is a delegated legislation, you know, and what would happen, we need to see what kind of rules they notify because normally speaking, when from the day of notification of the Act, that is 25th of January 2022 till the formation of the registry, since the Act is now in place, they may ask you that. So, there is a possibility of them asking you because they have a legitimate power to exercise from 25th of January 2022 onwards.

So according to me, it all depends on whether the government is nice to you or no. It all depends on whether they want to create a logistical crisis or no, and whether they want to be, you know, professional and say that from the day I am setting up my registry, you please start sending the patient data from tomorrow onwards, basically. And whether it will be physical or whether it will be online, that also remains to be seen.

Taking example of the fiasco, that one big IT company created for income tax portal, I'm not very sure whether the government will form the mechanism for online registration so quickly, even if it is handled by companies like Infosys or TCS. So, we do not know about this right now. But according to me, from the day the Act comes into force, they can ask you for the details, and you should be ready with that.

If you have paperwork, you must have to preserve that. And if tomorrow they ask you for the data, you will probably need someone to feed that data. So you may have to incur that additional burden or cost for employing people. So, you will have to do it. Let's hope for the government to be nice to you. So on the safer side, maintain the data.

The Act also speaks a lot about the duties and the responsibilities in terms of who has to do what, what kind of counselling needs to be provided, you need to discuss about the details of the procedure, the risks, the side effects, help them arrive at an informed decision. And at the same time, also ensure that the information is confidential, and it is not leaked to anyone other than the couple.

What would be your suggestions that these will be your duties and responsibilities?

This all begins in Chapter 4 of the Act. And Chapter 4 begins by outlining general duties, consent and record keeping for both clinics and banks. And then it steps into the duties of the clinics. It also talks about what to do when you're doing a PGT, how do you source gametes, storage and handling, restrict sale of gametes, zygotes and embryos, talks a little bit about research and then attributes all the rights which a child would have to a natural born pregnancy to an IVF pregnancy. But specifically, particularly for those who practise, I think some things which might change in your practise are, the Act says you need to provide professional counselling to commissioning women, to commissioning couple and women that might change your practise because you may need to hire a professional counsellor or you may decide to undergo professional counselling courses yourself and say that I'm the one doing the professional counselling. The age limits which previously were not there have come in. So a woman about the age of 21 and below the age of 50 and a man about the age of 21 and below the age of 55. Written informed consent and their consent forms will probably elucidated in the rules or the regulations depending.

They say that even an arrangement by a couple to give a guarantee that they will pay a donor some money that is also it says very clearly insurance means an arrangement by which a company, individual or the commissioning couple undertakes to provide a guarantee of compensation for specified loss, damage, complication or death of a site donor during the process of site retrieval. So here you may not have to wait for the product, you will have to put the burden.

So, then it also talks about the fact that you must maintain records for 10 years which is something again which is a little different. It specifies not more than three embryos, it says about mixing of gametes and mixing of sperm and I think probably the most contentious clause of the clause which has generated the maximum amount of discussion on our very learned forums like WhatsApp and Facebook are the clauses which pertain to oocyte donors who then they should judge or donate only once and I must admit very frankly over here that after more than two decades of experience I have still not learned how to make a donor produce only seven oocytes which I will retry, make sure that they are all M2 and after all that fertility

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