This article is all about decoding and understanding ART Act, the way forward which is an essential topic for the Fellowship in Reproductive Medicine in India today. The ART Act which is brought in to address the legal deficit of the fertility segment and increases awareness, keeping a tab on malpractices involved with these processes. In this blog experts will not just decode, but they will analyse how the bill will regulate and supervise assisted reproductive technology in clinics and banks, prevent the misuse of technology and promote ethical practises.
We are talking about decoding and understanding ART Act, the way forward.
The ART Act had been on the agenda for the last 15-20 years and I think people like Padma Shri Prof. Dr. Kamini A. Rao have been working on it for a long, long time. And it has finally seen the light of the day and we have the Act notified in the Gazette on 25th of January 2022. Now, the Act has been enacted with various purposes, primarily to prevent the misuse and have safe and ethical practise of ART services.
Secondly, to cover the freezing of gametes, embryos, and embryonic tissue as a part of fertility preservation and to regulate and supervise the research and developments happening in this field. So, the Act defines assisted reproductive technology as all techniques which attempt to obtain a pregnancy by handling the sperm or the oocytes outside the human body before transferring either the gamete or the embryo into the reproductive system.
What all procedures or processes or treatments are covered under the ambit of this Act?
There was an attempt perhaps to cram everything about ART and IVF into one piece of legislation. I’m sure all of you know the quotation in Mahabharata which says, “whatever is here may be found elsewhere and what is not cannot be found anywhere else.” To a certain extent the ART Act attempts to do that because it tries to cover just about every aspect of the ART Act and it does so in a tone which I must say is rather regulatory in nature. I understand that that is a poor pun, but truly speaking it is so and when I compare this to the last Act in which I was involved that was the MTP Act, I see a very large difference in the tone and the tenor of this Act vis-a-vis the MTP Act. The MTP Act, for example, is an empowering Act for women, it’s a protective Act for doctors and this Act with its tone and tenor seems to be more about regulation rather than empowerment. Having said that, we are not here to criticise the Act but rather to understand the fact that this Act has now been passed and since it’s the law of the land, we do our best to follow this Act. So, I would have to say that broadly speaking and I’m sure we are going to delve into the nuance later, the Act essentially talks about formation of certain authorities for regulation of IVF in this country with the formation. What all procedures would be covered so that at least the people know.
So, as mentioned earlier like the quotation from Bhagavad Gita, it all covers almost everything. There is a misimpression that it does not cover procedures like IUI and it covers only IVF and that is a gross misconception. It does cover IUI, it doesn’t cover follicular studies I think but it pretty much covers anything where you handle gametes.
Starting from intrauterine insemination with the husband’s sperm, with donor sperm, etc. It also talks about the duties of clinics, offences, penalties, etc. This Act because you asked me what it covers and one important part about this Act that has really not been talked about is the fact that section 42 which talks about the rules that have to be made for the Act is actually extraordinarily extensive. Normally, the rules are supposed to give life to the Act, the rules are supposed to tell us how to follow the Act in daily practise and if you look at section 42, it has 28 items where they say that these items must be covered in the rules. The document on rules is going to be much more extensive than the Act. Everything is covered under the Act starting from intrauterine insemination to the most advanced procedures like PGD, etc. So, essentially, as you rightly said, this will cover IUI, IVF, freezing of gametes, PGT. It will also cover fertility preservation, which we had not thought would be a part of this. For an individual or for a couple and it will also regulate research in this entire field. Now, one other controversy about this Act is that the section 1 mentions that it comes into force on the date on which it has been notified and this is 25th of January 2022. Section 15.1 then mentions that no person or clinic can undertake this unless that clinic or bank is registered. But section 53 gives a leeway of a period which extends up to six months if you add all the boards and everything that are being formed.
What is this extension period for?
In the sense, is it only to define who can practise ART or it also defines what all can be done, what cannot be done? So, does it mean that since you are not registered, you are allowed to practise, we can do everything?
And secondly, if you are not in existence on 25th of January, can you begin a new clinic on 26th of January?
If you look at the Act itself which specifies, which has defined the clinic, which has defined that till the time the regulatory mechanisms or the registration mechanism happens, the existing mechanism under the Surrogacy Act would be continued and the clinics which are already participating, they need to re-register under this ART Act till first time. This six-month period is given for that. That means given the time for registration.
But it has also mentioned that no person shall establish any clinic or bank for undertaking assistance or under-assisted reproductive…unless such clinics or bank is duly registered under this Act. That means this six month is a provision which has been given for the existing clinics which are already carrying out the…already existing under the Surrogacy Act. They are under the body and the mechanism which are there.
They can continue but they have to apply and re-register themselves. So that they can continue to practise and provide services. But no other person apart from the existing persons can practise as of now.
Now when you say registration, the clinics have to register with whom?
That is the question now which are already registered. Now the six months time is given for what? Register with whom? I think the six-month time has been given for the banks or the national boards to be formed. And once those are formed, we will have to apply to this board. If you see section 15.3, what it says is from the date of establishment of National Registry, your six months is starting from that time. Yes, absolutely.
So that is a thing that we need to keep in mind that till the time this National Registry or the incidental mechanism around it is set up, you have six months from that date. So, coming back to the ICMR registration which Dr. Rao very rightly pointed out, we see that ICMR registration now being a history because depending on whether ICMR will be the National Registry or not, that is a government’s decision. But whatever you have done under ICMR guidelines will not necessarily be of any help here - six months from the date of commencement of the Act. But then it also says 60 days from the registry. Six months from the enactment of the Act. But the registration will have to be done with the National Registry. So that’s why since we don’t have that registry in place, so I assume that the registry will be set up as early as possible. And if the existing registration that you all have done under ICMR, if they get approved by the government, or if they are adopted the way it is, then I don’t think so anyone will have to re-register. Whatever are the guidelines given in that, whether it is the number of cycles that the donor can undergo, or how many sites you can retrieve from the donor, and the responsibility of maintaining the documents, you know, will all now start from 25th of January 2022. And whatever is mentioned in the Act will have to be followed. And obviously, the rules are yet to be notified.
Section 42 mention all the 28 points. And it has a last point also, which says that if anything else also is required. So, does that mean that new clinics are not allowed to commence activities in this period of six months or before registration takes place? Does it mean that from 24th of whenever the Act has commenced, no new clinics can be allowed to start till they get registered? Or does it mean that new clinics can start because there is this period of six months, and within 60 days of formation of registry, these clinics have to apply? This clarity is rather important for anybody who wants to start a new clinic.
You see, this is a huge topic of discussion and cannot be covered in just one article… So, stay tuned for Part 2 of the article.
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