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For three decades, countries around the world have agreed not to use a controversial legal tool under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). However, in a recent World Trade Organization meeting, WTO members failed to reach consensus on extending the moratorium, allowing it to expire for the first time since 1995. With the expiry of this moratorium, what are the potential consequences for Malaysia and similar countries? On this episode of #ConsiderThis Melisa Idris speaks with Dr Neil Sircar, Senior Lecturer & Programme Director of Social and Structural Determinants of Health Equity at Monash University Malaysia.
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00:10Hi, welcome back to Consider This. I'm Melissa Idris. Let's continue our discussion about the
00:15expiry of the moratorium on non-violation complaints under the TRIPS Agreement and
00:21its potential impact on Malaysia. Joining me now is Dr. Neil Sirka, who is a Senior Lecturer
00:27and the Programme Director of Social and Structural Determinants of Health Equity at Monash University,
00:34Malaysia. Neil, thank you so much for joining us on the show. Let's start with what's happened here
00:40with the latest developments on the TRIPS Agreement. Based on your work on global health law and
00:46regulations, how do you view the latest developments? What's at stake here? Why should the public care
00:52about what's happened at this obscure WTO meeting in Cameroon? Thank you, Melissa, for having me
00:59and for bringing this issue to your audience members. I think it's really important that
01:04we try and explain to the best that we can some of these really opaque processes, particularly
01:10when it affects access to medicines and people's ability to get the care that they need when they
01:17need it. The developments with the ministerial conference of the WTO that just concluded largely
01:26are that this long-standing moratorium on the bringing of certain kinds of complaints and disputes
01:33to the WTO to here has expired, as you said. And so this throws us into this place of uncertainty
01:43where we don't really know what's going to happen next, and that's kind of scary. In terms of what
01:50international law allows, Malaysia and countries like Malaysia don't have to fret for the ability
01:59for them to continue to use their legal rights, particularly when it comes to utilizing the
02:04flexibilities that are available to them to bring in medicines, to make generic versions of medicines,
02:11medicines to address health emergencies, something that Malaysia has done twice in its history. And I
02:17think that's something that Malaysians can all feel very proud of. So what we have to look forward to
02:23is what's going to happen in this environment where we don't have the moratorium on bringing what are
02:31called non-violation complaints, where a country like Malaysia could enact a measure, any kind of measure
02:38really, that might be in the interests of public health, that might advance public health, but could impact
02:43or impair the benefits or expectations that some other entity of another country, even a corporation
02:52based in another country might have had with their business or their interactions or engagements with
02:57Malaysia. And so that's kind of where we're at right now, sort of figuring out what do we do now
03:01with this?
03:02Right. So talk to me about what the consequences are for Malaysia. I mean, do you see governments
03:10becoming more hesitant or more afraid because of this environment of uncertainty with the lapse of the
03:17moratorium? Do they put themselves at risk of trade disputes or even trade sanctions, I'm thinking?
03:24That's two great questions. So I'll try and unpack them in order. I think that we have to see what
03:30happens
03:30in Geneva. The ministerial conference is one of the highest governance bodies in the WTO. But since
03:36what they did is largely does not continue the moratorium, it now goes back to the governance,
03:44the secretariat in Geneva, to decide what do we do now with this. And that is going to be setting
03:52the
03:52rules going forward. When they have those discussions, I think we need to be paying attention very closely to
04:00what is being said, what values, what even the tone is of the conversation, because that's going to
04:06really, in my opinion, speak to how countries going forward like Malaysia and similar countries
04:13should feel about the use of those rights. Really, what we're talking about, Melissa, is what's the policy
04:19space that we're operating within? Because the legality of what Malaysia can do to advance its health
04:26priorities isn't really on the table. It's what are the consequences for them using their prerogatives,
04:36their rights under international law, or the expectations on Malaysia as a sovereign country
04:42to advance its public health. So to your first question, I think that we might see some countries
04:49that are less willing to utilize the abilities that they have, the rights that they have,
04:56purely on the grounds of what happens if I do use these. And we've seen that before. It's called a
05:03chilling effect. I'm sure that's something that, as a term that you've heard quite a bit, that your
05:07audience has heard quite a bit. And that's kind of what we're going to be looking out for. Is there
05:11this chilling effect because using these rights under TRIPS, the trade agreement on intellectual
05:19property, if the use of those flexibilities like Malaysia has used before, or if advancing some
05:25other national public health priority triggers some sort of a complaint from some other country. And
05:31that act in and of itself might be something that, politically speaking, the Malaysian government might
05:39not want to engage in. And to the second question about the legality, I'm not super concerned
05:48immediately about a flood of lawsuits or disputes, more accurately, stemming from this
05:58non-decision to extend the moratorium. I think what is most likely the concern, sort of dovetailing
06:07with what I just said, is are we going to gum up the works? Are we going to, in three
06:12years, five years,
06:13however long it takes for the WTO, probably not that long, but however long it takes for them to
06:17decide what the new rules are going to be, does that lead to that chilling effect? Does it compress the
06:24policy space that governments like Malaysia feel they can operate within? Because if they were to enact
06:32a measure, and then that were to trigger a dispute, and then it has to go through the dispute process
06:37and
06:37the bodies with the WTO or nationally, even if ultimately Malaysia wins, as they almost certainly
06:43would in many cases, since Malaysia has absolute authority to promote its public health, that whole
06:50process takes time, it takes money, it takes political capital. Is that something that a
06:56government like Malaysia or a similar government is willing to expend? We've seen some countries
07:02be willing to do that. Australia is a great example when it came to plain packaging for tobacco and
07:07cigarette packets, but we have also seen other countries, or we suspect we've seen other countries
07:12that have been not willing to undertake the process of going up against powerful foreign interests or
07:18corporate interests. Okay. You mentioned a bit earlier, so I think in your previous answer,
07:23you touched on how Malaysia has used compulsory licensing twice previously. I'm just wondering,
07:30Neil, what lessons we can learn from those experiences, and also in managing past health crises,
07:38like even during the COVID-19 pandemic. What did we learn, or what lessons can we take from those crises,
07:45in terms of managing IPs and access to medicines? I'm going to start with the second question,
07:52because I think it's a really great framing device for why we're even here in the first place.
07:57And that's the real broad lesson from the various global health crises we've experienced over the past
08:0430, 40 years, but most acutely over the past five, is that countries like Malaysia, all countries,
08:11countries like Malaysia, need to have both the legal flexibility to respond to health crises,
08:17and the confidence, the political confidence, in order to act on that. To put it another way, just
08:22because governments can do something, doesn't mean they always will. And that speaks to things that are
08:28outside of the strict legal definitions, but speaking again to what we were just saying, how comfortable
08:34is a government, or how willing are they to be engaging in a policy space where there might be some
08:39pushback from other interests within or outside of the country. And so thinking about the examples we
08:46could see where Malaysia was one of the first countries to utilize the flexibilities to respond
08:51to the HIV crisis in 2003, which was phenomenal because at that time, and still to this day,
08:59but at that time, access to real life-saving medicines for HIV was prohibited just by virtue of
09:06the cost that many of these medicines were being retailed at. And the cost being the barrier to
09:13whether or not someone lives or dies, in many cases, is an unsettling policy question. And that's exactly
09:19what it is, because it's not whether or not the person, you know, is going to respond well or not
09:26to the medicine itself. It's whether or not access to that medicine is something that can be enabled so that
09:30they can get the treatment that they need to continue to live.
09:33And Malaysia answered that question by implementing a licensing scheme to create a generic antiretroviral
09:41product that would bring down the cost rather significantly to everyone who had to pay for it
09:46in Malaysia. And we saw that again in 2017 with a hepatitis C drug. And that brought the cost of
09:53that
09:53particular drug, which at that time was retailing something around 300,000 ringgit for a treatment,
09:59which is prohibited for almost everybody anywhere in the world, to something closer to about 500 to
10:041200 ringgit, which is much more doable for a lot of families, a lot of individuals in Malaysia. And
10:11I would think a lot of people would say that was a good thing, that Malaysia has been a real
10:16leader in
10:17the use of these flexibilities. And to then the point you were raising, when Malaysia did that in 2017,
10:25it triggered some pushback. It triggered some pushback from the manufacturer of the drug,
10:31in that there were some potential, I think that the term might be like blacklisting,
10:38for Malaysia to be excluded from certain programs, internal programs to the drug maker to
10:46almost act like a punishment. And that like, you're not going to be included in our preferential pricing
10:52scheme if you're going to utilize your legal rights to access our patented product and provide it to
11:00to your citizens at a much more accessible cost to them, but perhaps less of an investment return for
11:06us. And at the same time, some of the governments that are more friendly towards pharmaceutical makers,
11:14like the United States government, and particularly the United States Trade Representative's office,
11:20took some measures to put some political pressure on Malaysia as a consequence of the use of
11:29using the the TRIPS flexibilities use of the government use license in 2017. And we've seen the USTR do
11:35that with other countries. I will say, just sort of like to make it not all dour and dismal. We
11:41have seen
11:43countries, Colombia is an example of one where the mere threat of the use of some of these mechanisms
11:49to try and bring down the price of drugs has been enough for the manufacturer to enter into some sort
11:55of
11:56agreement with them so that the country doesn't utilize the legal rights available to them to bring down
12:02the cost otherwise. So it's all negotiation. It's all complex diplomacy. And that's sort of the lesson
12:11that I think we really can extract from these crises. It's a long conversation.
12:17So you mentioned the discussions now move to Geneva. So Neil, you said watch the tone
12:24and to identify what's going to happen with this policy space. So what signals are you watching
12:30just to indicate whether or not things are moving in the direction, the more favorable direction,
12:35or the uncertainty is going to grow? What will you be watching in the next few months, Neil?
12:40I think we're going to be really looking for a couple of things. We're going to be looking to see
12:45fundamentally like this, what does the WTO do? You know, at the end of the day, what does the WTO
12:50decide
12:50they're going to do now that they kind of have to, you know, a certain way of framing this moratorium
12:57is
12:57that it was set to expire years ago. And the ministerial conference continued to extend the
13:04moratorium partly because the consensus that the WTO is based on was just easier to reach for,
13:10let's continue this because we don't want to have to deal with the process of developing a mechanism for
13:16non-violation complaints. And now they have to develop that. And so what are they going to develop?
13:23What are the influences or what are the values that we then see coming out of those conversations?
13:30That'd be another thing that I'm going to be looking for that I think other people in this space are
13:33going to be looking for. What gets prioritized in this conversation? Are we going to be prioritizing?
13:39It's not all black and white. It's very much like, you know, a little bit of column A,
13:44a little bit of column B, but are we going to be seeing a priority for investment value being
13:51something that takes precedent over access to medicines and health benefits? Or are we going to
13:57see that prioritizing access to essential medicines, life-saving medicines is the priority that becomes
14:06the dominant tone setter for these future conversations?
14:11Neil, thank you so much for being on the show with me. Dr. Neil Sirka there from Monash University,
14:16Malaysia, wrapping up this episode of Consider This. I'm Melissa Idris signing off for the evening.
14:21Thank you so much for watching and good night.
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