 Welcome to the leaflets upfront, a new series of interviews with public figures, constitutional experts and lawyers on some of the most burning issues of the day. We have with us Anand Grover, the senior lawyer obviously, director of Lawyers Collective. But most importantly, he is also somebody who understands vaccines, understands issues of public health because many people would not know that Anand Grover besides being a very senior and distinguished lawyer is also a biochemist, a trained biochemist because of which he has done some remarkable work in the past on public health. Thank you very much. Thank you. Your commendations have to be met. Yes. Anand, lot of debate, lot of discussions have gone around the issue of vaccination. Now, I would not go into the old tried debate whether this government has completely failed on the policy of vaccination that is now well established. After the Supreme Court order where the Supreme Court called the government's vaccination policy arbitrary and irrational. Now it is proven beyond doubt that this government completely failed on the question of vaccination. But now as a country and as a people, now we are confronted with questions that what is the cost of this failure? How did we get here and what should we do going forward? So first of all, I'd like to know from you that India for many years has had a very successful universal immunization program to an extent that we eradicated many diseases because of a very unique and highly successful model of vaccination people at a very large scale. So from there where we had such a sterling record of vaccinating people, where did we go wrong? How did we come here? Well, Ashish, not only is our vaccination policy has been a very great success. And as you rightly point out that there are a number of diseases which we have actually eradicated because of that program, measles, smallpox, etc. But also India abroad is known for two main industries. One is software. Prior to 2000, we were not known as a software producing country. We were still working on what is called Y2K. And I remember those days that people didn't know that Indians had such a talent. But after Y2K, we just catapulted. Similarly, the generic industry in India is actually there and one of the leading and we called the pharmacy of the developing world now the pharmacy of the world. And we are the largest producer of the vaccine which happened because in 1970 we changed the patent law because at that time the government, Mrs. Gandhi thought it fit to take advice of legal and other experts and change the law very minimally and actually got a law which helped the generic industry and we became the generic industry, Indian generic industry became the dominant partner in India from a country which was producing the medicines at the highest prices in the world. We became a country producing the lowest prices and exporters and by 1995 we were producing antiretrovirals for whole of the developing world. So I just would like to stop you there. You made a very important point where you said in the 1970s that Indira Gandhi government by a legislative intervention led to a huge spurt in the Indian medical generic industry. Now that means that the government by legislative or executive interventions can do a lot for public health. So that is an important point. I want you to just stay on that point a little more which is that what happened in the 70s which is by way of change in the patent act and what are the existing powers that this government has? Well, we had the highest prices of medicines in the world and the cause was the patent act and Mrs. Gandhi obviously didn't understand the patent act. She was not a lawyer even most lawyers don't understand it. So she naturally took advice of people who were experts. Bakshi Teg Chan then Justice Aayingar and they actually advised her that you have to make a change because patents are of two types, product and process patents and ultimately their advice was that you actually do away with product patent protection and that will actually get rid of the monopoly in product patent, the absolute monopoly. So only process will be patented and not the final product. Correct and therefore the generic industry would actually have another process and come up and that's exactly what they did. We were very good at process chemistry. We could actually make alternative processes and that's the beginning of the rise of the Indian generic industry and they never looked back because of that. And in 2005 we had to reverse gear. At that time we introduced a very important provision in our law because we agreed to the TRIPS agreement in 1995. We had to make changes in 2005 and we made a change called 3D which allowed that no new form of a medical substance of a known substance would be patentable unless it increased the efficacy of that new form significantly. And that was what this case was about. So Anand you said that India made several exceptions including the one in 2005. Now there is a hint in the Supreme Court judgment about compulsory licensing. I am on the question of pricing now which is well we failed in terms of making vaccines universally available that everybody knows and we are way behind the aim of vaccinating 85 to 90% of the population but I am now on the question of pricing. In the latest Supreme Court order dated June 3 there is just a hint of compulsory licensing with the Supreme Court said that we would like to know from the government whether or not they would like to use the powers of compulsory licensing. So can you explain to the listeners what is compulsory licensing and can the pricing of the vaccine be brought down further? Absolutely this is a very very critical issue. In fact the Supreme Court only referred to it in a short paragraph but during the course of the hearing they made a point. This is Ravindra Bhattacharya Chandrachudra asked you know this is an issue which we need to address. What is compulsory licensing? Ordinarily business persons if I am in the US I want to and my product is patented or otherwise I want somebody in India to actually distribute it. Then I would ask that person would I would license that product and the person who is licensed as the license of the product would distribute it commercially. That is a voluntary license. Both of us agree that I give the license to you. But under the TRIPS agreement we knew that because patents are monopolies they can become unaffordable the medicines and products and they may not be available to the extent that are required. So they actually allowed for what is called used without authority or compulsory licensing. That is the government has the power to say you are the patent holder. We will now license that product without your authorization, without your permission and give it to another person. So that another person can make it a generic person would make it a company. They would then distribute it at much much lower prices and make it available. That is the whole thing. Now we have used that in India in a very famous case which I argued. So often if you oscillate a kidney and liver cancer drug and that's what happened. It reduced the prices. Whenever you have generic competition and ideally five you can reduce the prices at about one tenth. That's exactly what happened in 2000 when drugs were being sold at $10,000 to $15,000 per patient per month for HIV. Indian generic industry became famous, world famous because doctors Hameed of Sipla offered at that time and then actually made it at $350 from $10,000 to $350. You can see the difference. That's what generic competition is all about. And that is a provision within the patent act which by the way the government of India is actually promoting proactively at the international level. Under the Trips Council which is the plenary body they are saying there should be a waiver of intellectual property. But in India for some reason the government has been actually very cold about it. And my view is it's an unfortunate retrogression by the government. The whole policy of India has been that to use compulsory licensing when it is really required. And today if you don't use it will never be able to use it. This is an emergency. All the conditions are present. That's why the court asked them. And they don't want to do it because they want to protect in my opinion and I think they are making a very big mistake. They want to protect private companies and that is not only evident from not using compulsory licensing. But for example we have a monopoly in India of AstraZeneca Oxford University Covishield which is a traditional technology. But in India it is licensed only to Serum Institute. Why should it be concentrated only in one company? On the other hand Bharat Biotech they have diversified it. They should diversified even more other public sector facilities should be used. So we can have increased production. So for some reason they are not doing it. And it is to actually favor private companies and that is also evident from the fact after the 3rd June order they should have 100% government procurement and they could still have private entities distributing like they did before May which they have not done. They still have 25% of the distribution to commercial entities or private entities. But they are not distributing. They are distributing only 17%. Why should they be allowed to make a huge profit when 150 rupees is the modest profit according to Mr. Punevala in the NDTV interview. You are actually selling to private entities at 600 and the person is paying 1000 to 1800 rupees which is much much more than You are referring to an interview that Mr. Punevala gave to NDTV a couple of months ago where he said that even at a price of 150 rupees CRM institute was still making profits. Modest profit. And now you are saying that that 150 has become actually 1700-1800 rupees for some people who have to pay. If they want to pay but they will not need to have them. Because we have had a very successful program of free distribution or inoculation of vaccines to everybody and just see the comparison between India which is supposed to be mixed economy, socialist welfare state to the US. It doesn't pretend to be that. It is 100% procurement by the US federal government and inoculating and distributing it free to everyone. If that country can follow that policy, what should we do? This comparison that you made between the approach of the Indian government juxtaposed with the approach of the US government. But before we dwell further on that, I would like to stay on the question of pricing which is what really perturbs many that still there is no transparency on pricing which is how much these companies, private companies they have invested what is their cost per vaccine or per dose and how much they are making. Don't you think that because the public extra curve is now paying with all the private companies of vaccination there should be some transparency in terms of what is actually the private companies are making in terms of profits? Well actually the government has licensed the private companies to profit here at a huge level. Not only here but also in the US, ordinarily a blockbuster drug which fetches $1 billion a year, they spend according to the companies $1 billion. Actually they spend not more than $50 million according to the data which is available now. But let us assume they are spending $1 billion or $50 million whatever it is. Blockbuster drugs are those drugs which are miracle drugs. They are making a lot of money. In the first year they will make a turner of $1 billion which is 7500 crores now roughly. In this case they haven't spent a penny because all development they spend it for what is called development as opposed to discovery of the drug. Discoveries in the lab that development is actually the clinical trials. The animal toxicity studies, the first phase, second phase, third phase. Then you get the approval from the government. That is called development. For that according to them they spend a lot of money. Here in Covi Shield or Covaxin or Pfizer BioNTech or Moderna they haven't spent a penny or a cent of US money. All the money has been by way of pre-purchase agreements. So they have for example Pfizer has been aided by the US government for about $2 billion. And in the first year they are going to make $15 billion. So this is the extent of profits. You in the passing made a comparison between the approach of the US government vis-à-vis the approach of the Indian government. Now Indian government obviously it's clear to everybody was completely lackadaisical. It believed that virus had been vanquished and between November and February they did very little in terms of making a vaccination available universally. I would just like you to elaborate a little further that how did the US government ensure that vaccines were available to everybody, vaccines were procured centrally and they are almost I think they will be achieving universal vaccination in a couple of weeks if not in a couple of months. So how did Indian government fail and why did Indian government did not follow the approach of the US government? Well until the Biden administration there were problems in the US also but before the Biden administration took over they were very clear about how to tackle the COVID epidemic. Not only about the appropriate behavior but also about the fact that vaccination must be speeded up. Of course Mr. Donald Trump actually did pre-purchase agreements also but this was speeded up when the Biden administration came. They are clear cut goals about pre-purchase, getting it authorized and distributing it from central procurement and remember US is a capitalist economy to the fullest extent. They didn't go for private sectors actually selling it. That is now considered morally ethically wrong even in the US and it's surprising that our government has allowed it when we have such a good record earlier of free vaccines for everybody. I think where we went wrong maybe this was a political economic decision but where we went wrong which is known to everybody but it's not known that right from the day when the first wave actually waned off the Indian government thought right at the top that we have actually conquered the virus and there was complete lackadaisical approach. So much so that appropriate behavior was given a go-by. Super spreader events were allowed but more important this is what I want to stress. In a democratic setup where there is a liberal constitution with our roles assigned not only to the major institutions of the judiciary, the press, the media, the parliament executive but also to other expert institutions like center CSIR, ICMR, Election Commission etc etc. Advice of experts here, advice of the health experts and economic experts whether to have a lockdown or not to have a lockdown. That expert advice over a period of time the way the governance was occurring it was just being ignored. So you had a breakdown of the rule of law as a result of which decisions were being made by not experts. In fact their advice was actively ignored as has been indicated by Dr. Shahid Jameel of IgnoSoC. That is the expert body looking at the genome sequencing of the virus but he has said in the New York Times article there was stubborn resistance from the government. So unlike the 70s when the government took expert advice from experts here you had a situation where expert advice was ignored and advice based on irrational things was followed whether there is a virus whether there will be a second wave. So the second wave was not anticipated at all and expert advice was ignored or not solicited. You made a very important point that rule of law is not just about the independent courts, independent statutory institutions which is Election Commission or say CBI or ED or income tax but rule of law is also about the autonomy and giving due respect and following the advice of scientific institutions which in the past other governments had done. In this case in the case of how this government has handled COVID pandemic you are saying that the rule of law in that sense where the due regard and the due heed paid to scientific institutions was not followed. Yes, in fact when a government is faced with the unknown entity the COVID epidemic politicians are not the best person to advise you. Economic experts, health experts, epidemiologists, genome sequencing people they are the best people to tell you. You don't have to follow them to the T but you have to take their advice amalgamate and follow what you think is best in the circumstances. So what you are saying that in the case of India there was no counterpart of Anthony Fauci or CDC or the whole of that. Just take the example of not CDC the actual the regulatory procedures that were followed. We have a problem in India that it's not transparent. You are talking about transparencies. All the emergency authorizations that have been given India are not known on what basis. We don't have the data as far as the FDA is concerned in the US the application made by say Pfizer was available to everybody online and the hearings by the body the regulatory body of the FDA was also done in a public Zoom hearing. So anybody knew what was going on whereas here the subject expert committee gives you a two line thing X made an application, X firm made an application. We don't think it is right rejected or they're okay. And here we know that as far as Covaxin is concerned of Bharat biotech up to a particular time we were hearing rumors. We don't know how far they are correct that it is going to be rejected and the next day we heard otherwise. You know this latest Supreme Court order dated June 3 on every count which is a basis of pricing impact of differential pricing. The digital divide the order indicts the government and on all these counts the government had practically no answers. Do you find as a lawyer this as a very worrying trend that the government which has which doesn't have answers to basic questions that why did you go for a certain approach in pricing which is differential pricing. Why did you what was the basis of your pricing and why did you not even consider that there exists a huge digital divide in this country. How can now people of this country have faith in this government's ability to now one vaccinate and tackle with this pandemic. I think there are different facets to each question. I think still we can vaccinate provided we don't have a problem of a third wave. You know you can vaccinate after one year also but do we consider the price we have to pay like we paid in the second wave. There will be forgotten the number of people who have died which is actually attributable to the misgovernance will be forgotten. So we will perhaps even forget the third wave if it comes to early so we can vaccinate in 10 months or one year. So that we cannot vaccinate but there was urgency required which was not but I think the major problem is that the government doesn't feel it fit to answer these questions. That is the worrying part for me as a lawyer that the Supreme Court raised this question its first order again it raised it in the second order. Unfortunately I feel that the court saw the government responding or ought to have responded. The government has not responded. What he has done and what they have done is to actually come up with another policy where the main problem. Okay there were two problems in the earlier policy competing of states with the private sector that has been done. But the private sector is still near present, omnipresent which is where profiteering is going on. Why should anybody pay for it? And that answer has not been given. It's like we have decided this and we are going to continue. So they don't see anything wrong with that. One such area obviously is the digital divide that not everybody has access to smartphones and can register. That government has now tried to address by saying that anybody can walk in no pre registration is required. Recently there was an article in the Indian Express written by Yanashoka University professor where they have come with a moving map identifying the gender discrepancies which is the gap where women are lagging behind. Especially in rural areas. So there is a north-south divide, there is a poor rich divide, there is a digital analog divide and then there is a gender divide. How do you think we can address these divides? Well I think we have to be conscious of it and it's very important to get everybody involved in decision making. The good decision making procedure or process in liberal democracies is to actually consult all stakeholders or persons who are affected. There should be bodies like that but you can't have a top heavy bureaucratic body deciding this. It doesn't work. That's why in HIV when we had policy making people who were affected, HIV positive people, transgender, sex workers were on the decision making bodies. They still are. Where do you find that in COVID? The decision making is we don't know who is making the decisions to be honest. But do you think still that there is some hope that we would be able to prevent the third wave or at least deal with the third wave more effectively than we did the second wave? A person who is trying to go through a forest when she doesn't know the path, you have to do your best and what do you do when you don't know? You seek information from everywhere. You don't assume that you have the knowledge. That is the essence of trying to fight the unknown. We are fighting the unknown. We have to do our best today. We cannot be lackadisical. That is the essence. One cannot fault the government if they do the best today and still fail. But the problem with the second wave was they didn't do their best. They didn't follow the advice and I am worried that right now they are all interested in showing that they are doing the job. I hope it is done. There are good signs because there has been worry and there's been pressure from the below because people have died. People have paid a price in terms of their lives. I would like to end this interview with the final question which involves constitutional concerns. The slogan of leaflet is constitution first. You have highlighted several important points which is a violation of rule of law. You have also pointed out how the policy was arbitrary, irrational, the scientific advice, the expert advice was not followed. We were basically shooting in the dark and there was a very callous approach where we believed that we had vanquished the virus and we allowed super spreader events and we threw caution to the winds. I would like to now ask you do you believe that there was also kind of at least with regard to addressing the pandemic, a constitutional breakdown which is right to health was violated, right to life was violated, right to equality was violated. Policies were framed in a completely arbitrary irrational manner because of which we have lost tens of thousands of lives. I think the constitution was thrown to the winds and decisions were not based on the rule of law which is the constitutional imperative but on irrational basis on certain ideological precepts, certain thinking which is irrational that we have conquered the virus when in fact not only in the Spanish flu we had the largest number affected 18 million people died on account of the Spanish flu in India which is the largest number. There was a second wave raging through Europe and the US. Anybody with any kind of modicum of scientific knowledge would have said it is going to come but that was just not anticipated. That is a huge failure primarily because there was a constitutional failure and people as you rightly say have paid that the decisions of the government by losing their lives. I just hope that we go back to the constitution and our policies which have worked which is universal immunization through government government and states which has worked well. You can see the results in one week you didn't have vaccines for one month and now all the vaccines are rolling out. How is it happened? We pointed out that failure not noticed by the government. So I think if you put constitution first we can definitely achieve a lot. I would like to end this interview on an optimistic note that I believe I hope that collectively which means people of this country and also the institutions especially the institutions whose job is to ensure that the government functions as per their constitutional mandate they do more to hold people in power accountable and responsible towards the welfare of the people of this country. Thank you so much. This was the first edition of upfront series that we have just started in leaflet and we will be back soon with another interview on another issue of public importance. Thank you.