 Hello and welcome to People's Dispatch. Health is being widely recognized as a human right and one of the most important components is access to affordable medicines. But it is not only the national policies which determine whether citizens of a country will be able to have that access or not but increasingly a lot is being debated and negotiated at international levels and that is something which impacts lives of people at a very day to day level. Today we are going to talk about one of the important parts of this entire discussion at the international level which is the free trade agreements. Free trade agreements are the agreements which are being discussed between two countries or multiple countries which decide how the trade between those nations will be carried out and they are generally being discussed on various issues be it agriculture, be it digital economy etc. All these discussions impact health as well and especially access to medicines. So today we will be discussing the free trade agreement that is being discussed between India and the United Kingdom. It has created a lot of buzz. We also had recently a civil society statement that came out and the letter was sent to the British and Indian trade and commerce ministers asking them not to negotiate certain terms within that and to discuss this and throw more light and details on issues related to this. We are joined by Mr. Roshan John. Roshan is a lawyer and he specializes in intellectual property. Welcome Roshan. So what we see constantly in the FTAs is and this has been going on for many years and true for India UK FTA as well that the intellectual property is something that is being negotiated about a lot and this is impacting and or this has the potential to impact India's laws regarding intellectual property say copyright issues or patents or data exclusivity. So what is being discussed at the moment and the text that got leaked because these are otherwise very closed door negotiations that happen but this which has been leaked what does it show what how will it impact India and Indian law in terms of access to medicines and in the context of intellectual property. Thank you very much Jyotsana for having me today and as you rightly pointed out that the laws that affect people in the country are not just determined by domestic laws but also by international agreements that happen between several countries or a group of countries. Currently India is negotiating a free trade agreement or with the United Kingdom and also start starting negotiations with other countries also with very ambitious timelines. However there are many concerns that these free trade agreements have for developing countries including India especially in the areas of access to medicines that you have rightly pointed out. The UK India FTA that is being negotiated shares similar concerns as it could have a drastic impact on drug prices medicine prices and it could impact the timely entry of generic medicines in India and other developing countries. So civil society globally has been advocating against this and has asked the countries to not negotiate intellectual property chapters which could be one of the barriers to entry of these medicines. India's laws has several public health safeguards which ensures that generic medicines enter the market or enter the supply chain in time. Now this includes section 3D the pre-grant oppositions as I mentioned India does not have a patent term extension system which would increase the monopoly period beyond 20 years or it doesn't have a data exclusivity system because international law doesn't mandate that. All of this that is being sought by developed countries like as we have seen in the UK's case also the league chapter says that they need more and more protection over and above that is mandated by international law. That's why these trade agreements they put forward this proposal so that they can go beyond internationally mandated rules. Apart from the UK's proposal not only questions the substantial provisions that means they not only seeks to introduce substantial provisions like patent term extension and data exclusivity but which would directly have an impact on the when can the generic medicines enter the market. But the UK India FDA the UK puts forward proposals which also directly impacts the directly impact impacts the procedural safeguards that India has. Now both the substantial safeguards as well as the procedural safeguards which incorporated in the law is necessary to create a balance between intellectual property protection and public interest. India has a procedural safeguard through pre-grant opposition system which this mechanism is what allows any person at any time before the grant of a particular patent to say big pharma to challenge that patent at the patent office. Now how do they challenge it the the law provides any person to give information to the patent office to fill the information asymmetry in the patent office so that they can use that information from a third party to decide whether a patent should be granted or not. Now this is important because the patent is granted against the entire society as a whole so it is only fair that everyone in the society at any point of the time can challenge the patent or give information that the patent why the patent should not be granted. Now the this important safeguard is an important safeguard against the grant of unmerited patents. Now what will happen if these unmerited patents are granted so this again that would ensure that a particular company or a particular corporation will only have a monopoly period on that particular on a particular drug. So for 20 years if an unmerited patent is being granted for 20 years it will only after 20 years it can any other generic company can enter the market and produce the drug thereby for 20 years we'll see very high prices for these drugs. Now the second most important safeguard that I think is being challenged by the UK is India has a law against evergreening right so the UK the UK India FDA the UK seeks to remove this anti-evergreening provisions from the law so as you mentioned that you pointed out section 3D now what does section 3D say. Section 3D basically says that any new form any new modification or minor changes that you make make to an existing drug you cannot seek a separate patent for that. Now why does these law India have this law India has this law exactly because to stop pharmaceutical companies evergreening strategy because they don't file they don't believe in that the one but one product should have one patent they file multiple patents on a particular on one product to prolong the monopoly period to in order to check that India in 2005 when it amended its patent law introduced these safeguards like section 3D section 3E which prevents this evergreening tactics to give a very good example which on the eve of TB day there was one drug pedaculin which is one of the newer treatment for treatment against drug-resistant tuberculosis. Now Johnson and Johnson pharmaceutical corporation has had a primary patent on the drug for 20 years which is expiring in July 2023 that is this year and which would ideally mean that any any generic companies would be able to make that drug for a much cheaper price come July 2023. However J&J kind of filed a secondary patent application to to extend their monopoly period beyond 2023 July by four more years they you they filed a secondary patent or they filed an evergreening patent patent to extend the monopoly period by four years. Now because of India's safeguards as I mentioned the pre-ground opposition system and section 3D as you can see the patent was rejected by the patent office on the eve of TB day which is which would ensure that the extended period of four years the J&J won't be getting that extended period of four more years and a generic manufacturing can enter enter India and other countries where there is no patent monopolies. So which actually means that a pedaculin would actually be needed by around 150,000 patients a year who are who can are drug-resistant. So every year it would have meant so many people so that four year extension would also have actually meant at least something like six like people being affected by it. So so this is this was big and actually I think we should thank the access to medicine movement and people like you and maybe other TB survivors who pulled it through really well and we are saying that this is what is going to be impacted if India agrees to the conditions that are being put forth by UK. Yeah so so that's what when the UK now seeks to remove these particular provisions from India's patent law now which would mean that people like you and me or people people people TB activists or TB advocates who challenge this patent who and other patient group organized patient organizations with challenging patent would not be able to challenge this patent. Now what RICO's they are giving they are saying that you can challenge the patent after it is granted but the point is we have seen in several cases that once the patent has been granted it becomes extremely difficult to challenge them and revoke those particular patents. So that is why these safeguards are important to ensure that it is the unmerited monopolies or unmerited patents are stopped at the right at the beginning. So we are talking about India UK FDA but it is true that India is actually in the process of negotiating many other FTEs be it with Australia or Canada or European Union. We also have had experience a long long-term experience with RSIP which was the Regional Comprehensive Economic Partnership of which India is out now but we saw the negotiations that went on in all of these one thing emerges again and again which is what we just talked about. Where there is this constant demand from India to lower its public health safeguards with regard to intellectual property. Can you throw some more light on that aspect as well? What is happening in other FTAs and the larger picture? That's correct. So India has been now negotiating free trade agreements with several developed countries. So as you mentioned that India has been in negotiations with two years back at RCEP but it came out of RCEP but if you see that when the negotiations happened India severely pushed back on these intellectual property monopolies. Even in RCEP there were several developed countries like Japan who have been pushing for these intellectual property, higher standards of intellectual property protections to increase the monopoly period of medical products and other things. But we have also seen that this is not an isolated case. India is also in the process of negotiating a free trade agreement with the European Union. Now some of you maybe or you might remember that in 2013 European Commission or the European Union had clearly said that we won't be seeking any TRIPS plus provisions in the free trade agreements but then that negotiations stalled for a couple of years and now they are renegotiating it. Now the proposals that have been put forward by the European Union it shows that they are back to square one and asking for the same demands which I mentioned patent term extension which would on and data exclusivity which would increase the monopoly period of protection from four to five years beyond the internationally required 20 years. So the the I think India's position negotiating position should quite be quite clear because in all its international position is quite clear that it says no to anything which is beyond beyond the mandate of international rules. So I think that they should maintain that particular position internationally and refuse to accept and reject all those demands that have been put forward by whether UK or EU which is clearly beyond the mandate of international rules. But while talking about international trade it is also a fact that there is a World Trade Organization and the very idea was that the policy the rules frame there should be governing the trade across. How are FTAs or other form of bilateral agreements bypassing it? Is that correct or how do you look at it? That's quite an interesting question because the World Trade Organization's negotiations when when I can talk in the context of intellectual property then the intellectual property negotiations happened in the World Trade Organization. The demand from developing countries or developed countries was to have a certain standard of protection across the country across the world. So that was their demand they wanted more than that what existed. For example as I mentioned that there has been a demand for patent term extension in order to recuperate the time lost during the patent application process and everything. But this was the same reason why the 20-year monopoly was fixed at the first place. So if because countries like India gave a seven-year term protection for seven-year process patent protection for pharmaceutical cooperation they didn't have to do a product they didn't have to give patents on pharmaceutical products up until this trips negotiations happened and when countries had to change their laws. So from seven years it moved on to 20 years. So that was the main reasons when this was the main reason the reasoning behind that the developed countries gave then was the same that they are giving. They needed more money. Yeah they needed more monopolies or more extended period of protection. So now when these negotiations that are happening right now is they are happening in the at least in the context of IP it is they want more than what's been already negotiated with all these countries. So they want more than that. So the countries have to change their laws. So now one of the major problems is that even if suppose India agrees to UK's demand right just hypothetically if we if we see that if India it not only just impacts UK right it it's not that if I if if okay if you if you say to UK that okay we'll agree to your demands for patent term extension and data exclusivity it it does not stop there. You have to grant this similar protection for all all countries. So it's not gonna gonna just benefit say pharmaceutical cooperation from UK but it will also benefit all other pharmaceutical cooperation at the cost of at the cost of India's public health safeguards. So yeah so as I as I mentioned earlier that in India India's negotiating position has been quite clear since beginning that it says no no two trips plus provisions or anything that it is that is beyond international trade rules and it should it should be the it should be the case now also that nothing has changed since then yeah. So you mean even if one of these so many FTAs one of the developed countries is able to push India to change its laws it is actually going to help the entire developed world. So that is where we are so and that's why each FTA that India negotiates becomes important because it will change our laws not vis-a-vis one country but all the countries. So we need to keep a track we need to keep pushing back against all types of intellectual property protection and actually talk about more and more of public health safeguards. Thank you. Thank you Roshan for being with us and it was really enlightening to know about such technical topics. Thank you. Thank you so much.