Arun K Thiruvengadam, a brilliant constitutional law scholar who teaches at the National University of Singapore (NUS) comments on an interesting article in “law and other things” (where I co-blog as well). I reproduce his post below
“The purpose of this post is to make a somewhat obvious and trite point, which, however, seems to be worth reiterating in current times. Kaushik Basu has a recent column in the HT which articulates this very well:
“Democracy runs on participation, and we Indians are good at that — argumentative, demanding and, should the need be and, at times, even if the need should not be, disruptive. But surely there can also be something called over-participation. In many policy matters there is a fine balance between articulating preferences and taking decisions in hand. Take for instance the Indo-US nuclear agreement 123. This is a matter of great complexity and one has to commandeer a lot of information before one digs in one’s heels. It is clearly not a matter that should be decided by popular support.
This is a problem that economists have to contend with more often than other professionals, such as engineers. No one would suggest designing a plane by taking into account majority preferences. But when it comes to designing an industrial policy or setting a target exchange rate or adopting a currency convertibility system, everybody feels that he or she has an opinion that ought to count.
Drawing a line where mass participation should end and expertise take over is not an easy matter. To have everybody participate is to risk a policy hodge-podge. To leave it all to the expert is to risk policies being hijacked by small interest groups that the expert may, openly or covertly, be a part of. I do not know what the right solution is, but feel that we human beings would contribute to saner decision-making if we entertained a little bit of scepticism — an awareness of how little we know. We would have fewer fundamentalists if we could be modest enough to admit that the world is full of unknowns and wonders, and realistic enough to know that there is no book of the ultimate secrets of life.
… … … Of course, we have to express opinions (and I will in this column) and take decisions, but those opinions and decisions would be much better and more dependable, if underlying them was an awareness of the ultimate uncertainty of nature.”
Clearly, this is a problem that lawyers, especially constitutional lawyers, also have to deal with. Basu’s exhortation seems very relevant to the constituency of this blog as well.”
Basu’s article couldn’t have been more timely, when we think of the Glivec patent case, section 3(d), “efficacy”, pharmaceutical patents, balancing innovation with public health and the like. How much of public participation do we want in the process of spelling out the contours of section 3(d)?–given that this debate has sparked up more emotional rhetoric and spin than most others….
15 thoughts on “Public Participation in IP Policy Making”
I am a complete novice when compared to all the people writing the blog, making comments and participating in the discussion. But I was wondering, while reading the above post, how it applies to the 3(d) issue. Like it says
“To have everybody participate is to risk a policy hodge-podge. To leave it all to the expert is to risk policies being hijacked by small interest groups that the expert may, openly or covertly, be a part of. I do not know what the right solution is, but feel that we human beings would contribute to saner decision-making if we entertained a little bit of scepticism — an awareness of how little we know. We would have fewer fundamentalists if we could be modest enough to admit that the world is full of unknowns and wonders, and realistic enough to know that there is no book of the ultimate secrets of life.”
Wouldn’t an attempt to define “efficacy” in strict words be a futile effort? Even if it was defined to mean that a new crystalline form is not “efficacy”..and assume.. that a heat stable or water soluble form is considered under the definition as efficacious. Even if an attempt was made, would it not be an abstract definition, not restricting itself to therapeutic efficacy, or economically more profitable or other forms of efficacy? In which case 3(d) should be fine the way it is. Or what if we tried, just for sake of discussion, to see what could or could not be efficacy?(but may be that would be at the risk of subjecting the discussion to excessive public participation!)..Or should this be one of those things left to be determined by way of legal battles and precedence.
Why would defining efficacy be futile? Does it include only therapeutic efficacy? Or does it envisage clinical efficacy, and other advantages? These are things that can be defined.
I’m not sure if you got Basu’s message right–but he’s asking as to precisely how much public participation would be optimal in these circumstances. He of course ducks answering it–but I’d be hard pressed to come up with an answer myself. Maybe one of the other readers may have a smart answer to this. I think we can begin by exploring a model where an expert group drafts guidelines to elaborate on the ambit of “efficacy” and throws it open for public comments. Contrast this with having members of the public decide what the initial guideline itself should look like –this would tilt more to the side of “excessive public participation”—and it’s likely that we may not have an initial draft to start with for years to come.
Shruti Bhutani writes:
I think that policy making is very different from airplane building. One decision sets a precedent which courts follow and one policy affects a huge population at large, so when u are making policy in a democratic set up you cannot have a directorship like approach to the same. I believe that the problem that we face in India is not lack of policy making but lack of GOOD policy making. Therefore I do not agree with the view that is expressed in the article.
As far as public participation in IP policy making goes, you cannot really compare it with other scientific disciplines. For this reason, economics and law represent the humanities stream. An understanding of the public choice theory may probably provide some solution. But I am not sure since I am neither a political scientist nor an economist. But as a lawyer, I can undoubtedly say that “Law is codified common sense”, which, I believe, the people of India and “sensible” public health groups do possess! Historically, IP has never remained a pure economic or a legal issue. Law is just used as an instrument to foster some other “justifiable” objectives.
Next, the 3(d) issue cannot be left for mere legal and verbal gymnastics. We know it well that there is a blurring line where public participation should end and coherent policy expertise should follow. But dubbing the 3(d) issue as instance of excessive democratization would be wrong in every sense. Is there a final definition for words like “significance” and “efficacy” in legal dictionaries? It’s like the issue of “reasonability” which still haunts the legal world. Well, I really do not intend to say that people unconnected to the issue must have a say. But when we have people who understand the dynamics of the issue, why do we really fret about it all again? May be the pious “public health” objective is just another way to further some other economic objective. One never knows!
Looking from the other side, do you think that this has come as a pure legal issue for Novartis? Is it an issue of “innovation”, or rather, a strategic business issue of not allowing competition through Generics? If that be the case, why do we always whine over all this from one angle? I just got to hear Prof. Bhagwati yesterday. Interestingly, he now believes that public health issue has possibly come into the pure trade framework (especially, at the WTO) as it was then possible for some to bring IPRs into WTO framework! I am sure Prof. Bhagwati would now oppose an US-FTA (hypothetical) if it mandated that 3(d) must be withdrawn. He calls them (the FTA’s) as “protectionist measures” and “termites in the free trade system”. My point is that you can’t really be sure as to where you want to stop within the continuum of under protection and over protection. It’s a difficult choice indeed!
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I think you confuse two issues. The first issue is “What ought to be various balancing factors when one considers the scope and ambit of a section brought in to rein evergreening (such as section 3(d)).” I don’t think any of us here make the point that this should remain a pure legal issue. Indeed, pharma patents involve a delicate balancing of innovation incentives and public health concerns.
The second issue is as to what ought to be the level of public participation in determining the scope and ambit of the above provision. It seems to me that you are making the argument that the mere fact that IP is not about law alone would mean that we don’t even try and ask ourselves as to what level of public participation is optimal. Conversely, if it was just about law alone, we would be okay with limiting public participation!!
Please see my response to Taapsi, in which I try to highlight one of the ways in which you might go about engaging public opinion whilst at the same time, ensuring that over-democratization does not stall the process.
Yes, “public health” is very much a part of TRIPS (Art 7,8) and the Doha Declaration as well.
Thanks Shamnad. I get your point. Even I am trying hard to digest this issue of “optimal participation”. I did say that IP should be read in different contexts but this does not call for any contrary inference. The level of public participation really depends on how important the issue is and for whom.
What you have suggested in your earlier comment as a solution does make sense to me. But do you really want to look at the process or the effect of public participation? By this I mean that there is bright possibility of reaching the same conclusions, either ways, if the issue is so important for both the parties. But I would agree with you since I understand the complexities involved in people suggesting the guidelines and experts vailidating it. This has never happened.
I thought defining it would be futile coz the concept of efficacy might keep evolving. Science is at such pace that every next invention in an area is a simplification of the previous product..faster..better..cooler! but does this, or not, always necessarily mean efficacy? even if its defined it will still be a mootable issue in a lot of cases. I dont know..may be its an escapist attitude to not look for a definition. Patent is meant to protect what is important to the society (in addition to the weird patents). I think even a lot of terminology in TRIPS hasnt been defined. Basu’s msg was wrt public participation and uncertainity in situations. But what about science and uncertainity. Would defining efficacy ensure that everything outside the definition is not “patent worthy”?
Couldn’t agree more with you. Particularly re: “the level of public participation really depends on how important the issue is and for whom.”
i’m not sure if you’ve read the madras high court decision and followed the debate (some aspects of this have been touched on in the blog). the madras hc decision defines efficacy as therapeutic and therein lies the problem. not too surprising given this section was lifted from an EU drug regulatory directive. but should it be held hostage to this history and defined this way?
anyway, basu’s post is not about the precise contours of a defintion. its about what level of participation is optimal, once we decide to define something (or even throw up the question of whether we need to define something at all).
yea, u’re free to disagree. My understanding of the “how important the issue is and for whom” has the same degree of ambiguity or clarity inasmuch as your concerns on “optimal public participation”. I hope you will not have any different opinion on this for sure. Well.. no hard feelings!
I think you misunderstood my response. I said that I “couldn’t agree more with you.” In other words, that I wholeheartedly agree with you….
You see… I know no good English. hahahaha… This happens when one has preconceived notions, as I did, but not any more. We just look through our own glasses and everything appears quite contrary, even when they convey a clear literal meaning. Sorry for that. I trying hard to come out of this bias. Thanks for everything.
Shruti Bhutani writes:
The first paragraph of the article states the problems of mass participation in policy making and that is what I did not agree with.
The latter part of the article focuses on the importance of finding the equilibrium between mass participation and dictatorial approach in policy making. I completely understand that there has to be a middle way in framing the policy. This article however, just voices the oft repeated concerns about the “right” path without venturing into suggestions or even an hypothetical scenario of what might seem to be a right approach.
You’e right Shruti,
As I responded to Taapsi, Basu avoids making any concrete suggestions in this regard…. Perhaps, like Basu exhorts us to do, we ought to be “skeptical” about his piece too….