The following are the outputs of the real-time captioning taken during the virtual Fifteenth Annual Meeting of the Internet Governance Forum (IGF), from 2 to 17 November 2020. Although it is largely accurate, in some cases it may be incomplete or inaccurate due to inaudible passages or transcription errors. It is posted as an aid to understanding the proceedings at the event, but should not be treated as an authoritative record.
***
>> RON ANDRUFF: In our view, purchasing safe medicines over the internet is a complex problem by virtue of the distributed virtue is self. Using the Internet to purchase biomedicine should be no more difficult than buying a book online provided certain standards and norms are in place to ensure that highly regulated industries can function as safely within the confines of the Internet as it has for the last 100 years in the real world.
And while this transnational nature of the Internet creates the most significant complexity or part of the complexity as detailed in Dr. Ahmad's IGF Berlin paper, which he will be sharing with you in this session, from whom you will be hearing shortly, it's not the violation of federal or state laws that threaten public health, rather the actions of the rogue pharmacy operators who sell dangerous medications or fake medications over the Internet.
What we are striving for is what's been called the regulatory sweet spot that avoids both the pitfalls of over and under regulation of Internet pharmacy while mitigating the rogue actors. Most importantly, however, this is a rights‑based discourse and it's keeping people front and center. We are discussing a human rights issue at the core of all of this discussion, and that requires all of our minds to resolve is technically. So this ongoing discussion around access to medicine is also rooted in this Sustainable Development Goals particularly 3.8 which speaks to access to safe, effective, quality and affordable medicines. The Brussels Principles upon which the foundation of the discourse affirms access to affordable medical products is a fundamental right to health.
One that is moving in the right direction is the recently piloted trusted notifier program that allows for rapid takedowns in limiting the actions of dangerous, rogue, online markets. With a clear lack of rules, this patchwork around Internet access to medicines has significantly impeded the ability to generate consumer trust, trust being the theme that this workshop falls under, while at same time making the sense for credentialing of safe Internet marketplaces.
So to that extent, a broad range of stakeholders now agree that a white list model can be perhaps a more appropriate way to go forward to balance access and safety as opposed to the failed black list approaches that have been used to date.
So as you hear, much has been accomplished, but the challenges remain and that's why we are here. Today we will have three blocks of conversation over the coming 85 minutes or so where these and other issues will be delved into more deeply by originally five highly qualified individuals, however, we have lost two, unfortunately for this session. Both Dr. Jill Kohler and Patrick Kane are not able to join us due to unforeseen circumstances. So we wish them both well in this moment. So block 1, panelists will address two parts of the access to medicines question. It's impact on the technical infrastructure of the Internet and the impact around that technical infrastructure.
Block 2 will be a discussion debate amongst the panelists and you the audience, so we can flesh out the issues that are on our minds and see if we can come to some conclusions. And block 3 in many ways for me, having been behind a lot of this work over the years is really York University's Data Institute for Global Health Research, Dynamic Coalition on Access to Medicines Using the Internet is inviting participation.
Ladies and gentlemen, the goal we are seeking is nothing short of renewing the patient pharmacy bond of trust each and every time a patient's prescription and prescription medicines arrive at their door. Through these efforts Internet pharmacies will soon engender the same deep level of trust as that of the brick and mortar pharmacies today.
So before we get started, a little bit of housekeeping, for all of you who have been participating for some time, and we are very well aware, I'm sure, that the chat is for chat, and we encourage you to bring your thoughts and comments to the chat and engage with each other. Questions, please go to the Q and A box for questions, and we will then be reviewing all of the questions in our, and addressing them in our block number 2.
And then closed captioning for those who would like it is also available at the bottom of the screen so please feel free to use that if you would like.
So now I would like to turn to panelists, most of whom, for those of you that attend the RightsCon session earlier this year you will remember. At RightsCon we noted this would be a two‑part discussion, and with this IGF 2020 workshop, this is the second part. So here we are.
In order to try to give us a sense of what is right and what is wrong, I thought we might start with a poll question. Last year, this will be for the facilitators, poll question 1, if you would like to bring that up. Last year at IGF Berlin, one of our speakers, Gabriel Levitt was one of the initiators of the Brussels Principles opened his intervention with three questions that I would like to ask again this year to set the stage for our conversation.
He asked, how many of you believe that a person in one country who has a valid prescription but cannot afford their medicine should have the right to travel to another country that has much lower prices, buy it, and bring it back home?
Answer yes or no. Let's say a person is too sick to travel. In principle, how many of you believe they should be able to order it online from a safe Internet pharmacy and have it mailed to them from that same pharmacy that they had previously traveled to? Is that reasonable, yes or no?
Let's say a person suffering from HIV who is traveling back from India to home country with a three‑month supply of life‑saving antiviral medicine, would that be, would it be in violation of their human rights if a Government officer stopped and took their medicines at the border because these otherwise lawfully manufactured life‑saving drugs was not technically a registered medicine in their home country? Would that seizure be a violation of their human rights? Answer yes or no.
These questions are important to ask ourselves, because I think often this the broad discussion in the complexities how to resolve something, we forget how important the human nature aspect of it. So I wanted to bring these up on the table to give us food for thought, put it in the back of our minds as we progress through this conversation with our expert panelists. So with that in mind, let's move on. Each of the speaker's bios are detailed in the IGF website, we won't spend a lot of time going through them now. I will ask each speaker to introduce themselves and their professional affiliation and give them the floor. I think that let's start with to gain insight from each panelist as to their respective remarks to with that, may I turn to you, Bertrand de La Chapelle in Paris to get us started?
>> BERTRAND DE LA CHAPELLE: Thank you, Ron, you asked us, I'm Bertrand de La Chapelle, the Executive Director of the Internet jurisdiction policy network Secretariat, and you asked us to basically start with a sort of provocative statement or comment, and so like I did in a previous panel, there is an interesting other thing when we talk about this topic which is if you look at the history of the fight against abuses in the music industry, it was important to fight abuses, piracy, so called piracy, but it was all the more important to try to develop appropriate frameworks for legal offerings.
And the whole debate has considerably shifted now that there are legal offerings on music. Of course, medicines and music are not exactly the same, but I thought that as a provocative start it was interesting to highlight this. Ron, do you want us to stay at the introductory statement for do you want me to continue directly.
>> RON ANDRUFF: The most famous statement in 2020, you are muted. We will circumstance around. Now, let's go to Cairo, and let's hear from Zena Hani. Zina, you have the floor. I do not see her. Perhaps she has fallen off and we will come back. While we are waiting to see what happens there, I will turn to Dr. Aria Ahmad in Toronto.
>> ARIA AHMAD: Good morning, good afternoon, and good evening, everybody. My name is Aria Ahmad. I am a global health study fellow at Global Health Research Institute at York University. I am also on the board for Disclosure of Prescription Justice Institute, a U.S. based NGO, and have recently worked with the World Health Organization on issues of medicine equality, and that's been basically my professional work over the last 15, 20 years. There are three major points I will be making in my presentation later today. The first relates to the title of this panel, is that COVID‑19 as with many other issues that have been covered at IGF this year, has rapidly accelerated the urgency of needing to address these issues. It's revealed fault lines and offered opportunities around this issue specifically as well.
Number two, the existing regulatory landscape is incongruent and opaque, ultimately undermines public health. That is something I will be arguing and requires in a sense a more robust response. And number three, I will be sharing some of my experiences both from my academic work but also with the WHO on proposing a path forward that focused on an appropriate Forum and values driving the norms and standards development around this issue.
>> MODERATOR: We have dropped Zina.
>> Zina is reconnecting right now.
>> MODERATOR: Thank you. So as you see, there is some very interesting ideas that we can shape the activities that we are undertaking here. Bertrand, if I were to turn back to you, Internet jurisdiction policy network has been working on the transnational aspects of the Internet for several years ago and I congratulate you on that work. I also see Zina is back, so I will come back to you shortly, Zin. A. So Internet pharmacy has made up these highly regulated goods. There are trade issues and health concerns and perhaps even more important the human rights dimension. What are the policy questions that these four different dimensions have that, you know, how do we find that right balance looking at it from, through your eyes?
>> BERTRAND DE LA CHAPELLE: Internet jurisdiction as a group is dedicated to issues related to domain names. We not addressed directly the questions of medicines online for reasons I have mentioned, but there are things that come out of the work of these groups that are useful here. I would like to do something in part. One is a general context. The second one is as I mentioned in the provocative statement, the fight the abuses part, and the third one is some thoughts on the legal offerings part. What I'm saying here is engaging only part of the work that has been done. In terms of the context, you said it, Ron, these are highly regulated goods.
They are what is called controlled substances to there is a patchwork of legislations around the world that apply to medicines with an enormous amount of regulation and legitimately so. There are regulations regarding when prescribe the medicines, doctors, who can distribute those medicines in pharmacies, who can manufacture those medicines, and an enormous amount of recommendations regarding accreditation and acceptance in different countries of different types of medicines according to various rules ever intellectual property licensing, et cetera, and I'm not even putting in the basket at the moment the question of generics.
So R so there is enormous apparatus around this and this is fundamentally based on territorial jurisdictions. This is one of the reasons why like in other topics we are corn fronting with attention between the cross‑border nature of the Internet which is an amazing enabler and the international legal architecture that is fundamentally or territorially based system.
So as you mentioned also I want to highlight in this element of context that the issue of accessible medicines online is a part of this classic triangle that we have seen in all jurisdictional aspects. It's the interplay between the dimensions of security, human rights and economy. It is a security issue because there is a legitimate concern about what the WHO has called falsified medicines which is a different issue from the question of licensing and the question of intellectual property and distribution.
We are talking about things that are literally harmful to people including by drug cartels that are actually creating fake medicines in many respects. It is a general security issue because it touches upon the health of population that can be extremely damages both on the one side of creating bad medicines or on the other hand not having access to good medicines in situations such as the pandemic we have today.
But it is also a human rights issue, of course, but of the whole question of the condition of legal access to medicines, but also whether some products are illegal in one country and legal in another one, and there are many issues around that. And finally, it's an economic dimension because there is the question of the distribution of intellectual property, there is the question of the activities of pharmaceutical companies, the market prices depending on the Developed Countries and not Developed Countries, because part of the business model is allegedly that the high price in Developed Countries is also compensating for somewhat lower price to provide market in less developed economies. So it is a trade issue as well. One of the goals is how to reconcile the three dimensions.
Let me get down to the second element, which is fighting abuses online is obviously a major challenge. We can use a lot of expressions, it can be rogue pharmacies, it can be people that are giving falsified medical pharmaceutical components or it can be companies have a right to sell in their home country, but not necessarily the right to sell in another country, and there are various legislations regarding the general sector of pharmacy code online.
In that context, one of the documents that we decided to address and that we could maybe not speaking for Verisign in that regard, but speaking from the perspective, one of the fundamental questions is when we are confronted with an abuse on the Internet, when is it appropriate to act at the level of the Domain Name System, like taking down the Domain Name or blocking access to a particular domain because of the activity.
I see in the audience some people including Allen Woods who is there and Elizabeth was the director of the Internet domain project.
What I want to say here is the focus when we talk about abuses on the Internet, and at the level of the DNS there is a starting point which is wherever you take down a domain, it has a global effect by definition. And it is a really blunt instrument. It is something, it is a yes or no, it's a switch. It's not something that is graduated where you can make it accessible in certain countries and not in others. So for all types of abuses will is a need to meet a threshold that justifies acting at this level.
The second issue is that there is a strong difference between what has been labeled as technical adduce and content‑related abuse. Technical abuse, things like phishing, malware, botnet where it is widely understood that it is appropriate to act at the DNS level when a threshold is met, but all of the actors are willing to act in that regard.
On content related aspects it's much more complex. It's much more complex and obviously online medicines are in that category because the thresholds need to be really particularly high. And I want to share with the group and with the audience one of the outcomes of the work that we did last year, particularly in helping defining the thresholds that are appropriate, and I take this from the so‑called operational approaches that have been published in April 2019 that says that for things that are related to content, acting at the level of the DNS is appropriate only if a certain threshold is met that takes into account, one, the degree of global normative consistency regarding the illegality of something.
And I think in here it would be potentially possible to consider that falsified medicines are a different problem that access to legal and proper medicine.
The second is the proportion of the a site that is actively dedicated to something that is illegal. If it is only a portion of it, taking an action at the level of the Domain Name is disproportionate.
Third, the intent or the bad faith of the actors who are doing this, and, fourth, the lack of available alternative measures to remediate this problem. And I don't put in this basket the fundamental question of the geographic scope and reach of the domain that is in question. If you have a site that is entirely in a particular language clearly directed at one country, there is a completely different question of whether it is simply accessible in another country where it might be illegal, but there is a distinction whether it has been targeting that country or not.
So I want to close this on the question of abuses. Because working at the level of the DNS is a particularly important debate, and but Verisign tried to make the distinction between what in the domain name is the distinction between second level and Top Level Domains. There is a big distinction between the Top Level Domains that are generic, a dot com or dot net, or any other that Verisign is managing ,and level domains such as dot pharmacy that are dedicated to the sector.
The final point I want to make, so there is a burden also, a question of what is the responsibility of the DNS operators to screen all of the domains that they have under their responsibility to detect whether there is something wrong?
This is what has led to the notion of trusted notifiers, and actors who act to notify the NS operators when there is a site that is meeting the threshold. One of the challenges is what is the authority of those notifiers, and what is the national legal basis upon which they are building their notices?
Is it the law of one country, mostly the U.S. in particular, or is it a more general assessment of what is illegal? And I remember having had a brief discussion with some of those notifiers who basically were saying, you know, it is so difficult to address the question of substandard and falsified medicines because indeed it is a very difficult thing. You need to test what is being sold.
Because of that, they tend to focus on things that are more about licensing. So it is interesting to see that because of the technical difficulty of addressing substandard and falsified medicines, the focus is entirely or almost entirely on things that are related purely to licensing and intellectual property, which is an important issue, but not the only one.
So that wraps basically the second part on fighting illegal things at the level of the DNS.
The third part is more perspective, and this is not something we have directly discussed in Internet and jurisdictions, so I'm out on a limb in my special capacity here, but I want to contribute a few things. One, clearly there is a discussion about the notion of white list. The discussion of white list raises a fundamental question which is who creates the white list, and who basically accredits or will accredit the pharmacies that would be allowed to function online.
The second thing is just like this dot pharma, there is the idea of the creation of a dedicated extension for pharmacies online that would be the ones accredited to be able to register a second domain in dot pharma. There are two challenges; one, this is something that was discussed when, for those of you who are familiar with the discussions in ICANN, when there was a discussion of dot XXX for pornographic sites or adult sites as it's called.
There was a huge debate as to whether adult sites should be going to dot XXX and there were concerns that it would be a sort of quarreling of those sites and it would lead to a certain type of censorship. So the question of dedicated sites or extensions, Top Level Domains is an avenue that is interesting, but the question of whether it should be the exclusive avenue or not is an important one. The second question is when you look at a Top Level Domain, here again, you get the question of where is this Top Level Domain based and would it be the laws of one particular country that would apply globally for the registration in this Top Level Domain, or would it be a more diverse architecture and would this Top Level Domain be the only one?
But if you want to go farther and finish with this, it is an entire architecture of accreditation that has to be taken into account. Because everything here, as I said in the beginning, is being governed by very strict rules at the national level, just like doctors have to get diploma and be registered in an order at the national level that can take sanctions if the doctor is not doing things properly.
Even if we put procedural rules internationally across borders, for instance, to say, anybody must have a prescription to be able to buy something from a legitimate pharmacy. Who has issued this prescription? Is there a general scheme of accreditation? Is there a sort of adequacy mechanism that says any country that has validated particular doctor establishes the right for this doctor to issue prescriptions for people who are outside of the country? That's a very big challenge.
The pharmacies likewise are, of course, accredited at the national level. How much extra territoriality is this accreditation going to be granted? Likewise, there are enormous trade issues and intellectual property rights regarding the pricing of medicines. This is clearly a human rights violation I was talking about.
So in a nutshell it is at the same time an enormously important issue to address and an extremely complex one that I believe, and that's really personal at the moment, absolutely requires to get the different stakeholders around the table because this cannot be solved just by a trade arrangement because it is related also, it is a security dimension. The companies have to be engaged by civil society actors as well, because fundamentally what is at stake is what is the global regime internationally for accessing pharmaceuticals online.
That's a very big discussion that I do not see at the moment taking place with all of the actors around the table, and I think I understand that this is one of the things that you are trying to trigger, but I wanted to paint the picture. So a very complex issue with at least three mentions. Addressing the abuses cannot be limited to striking down in a whack‑a‑mole system one domain after the other. The real question is what is the legal positive framework that will help with this decision. Thank you.
>> RON ANDRUFF: Thank you for framing that so well, these are broad parameters we have to nail this down. It's about getting all of the stakeholders around the table and we will addressing that in block 3. I want to come back to you with one question and unfortunately Patrick Kane was going to report to us on the status of the pilot program, but you are quite familiar with that and I think the trusted notifier program is certainly the one that is leading the charge in terms of the simplest solution for us to be cable to resolve some of these technical issues but do you think it's possible to have the trusted notifier program go through the ICANN policy machine and come out the other end with a board approval of that and that might be the leverage of for us to find our way through the complex issues you have just illustrated.
>> BERTRAND DE LA CHAPELLE: My work within ICANN at the moment has been less intense than it has been in the past. So I would not have a sufficiently authorized comment on where it is inside ICANN.
The only thing I can share is this is one of the things we have worked on for technical abuse this year. Whenever we talk about trusted notifiers, it is take wording that is loaded with a lot of assumptions, and it has to be addressed in terms of what do you have to do to be a trusted notifier? Who gives you the credential of being a trusted notifier?
Is it just the fact that DNS operators recognize you as a trusted notifier, potentially make an agreement with you, or is there a third party? It can be ICANN or others, that says this is going to be a trusted notifier. Once you have solved this issue, there is a second one, which is on what basis, what legal basis and bases, particularly, does the trusted notifier or trusted notifiers make their decisions and notify.
Third, what are the due diligence steps that the notifier is taking to make sure that they do not just send anything that looks suspicious, but that has been vetted as being actually dangerous, or negative or illegal. Because otherwise the burden is on operators who do not have the technical capacity to verify whether this is indeed an abusive content site or not.
And the third element is there is a question of what is the relationship between the trusted notifiers and the different operators? Do they have an authority, in other terms is what they are recommended going to be enforceable in a certain way? And is there a problem of compliance if you do not abide or is it a notice that is being sent and there is an evaluation by the operator on this notice to be whether it should be followed or not.
So the notion of a trusted notifier is a very important one and interestingly enough I close with this, what we are discussing here about content and action at the DNS is very similar and mirrors a lot of the discussions that are happening on larger platforms, the Facebook, the Google, et cetera, YouTube of this world when we are talking about notifiers for illegal content, which can be terrorism, hate speech, copyright and anything else. So the problem of notifiers is at the heart of the question of distribution of responsibilities between the different actors, Governments, private operators and other notifiers when trying to identify, evaluate, and act upon a situation of abuse. It's a broader problem than what has been discussed in ICANN, but others, and maybe there are people in the audience that I see that would be in a position to answer your questions more precisely.
>> RON ANDRUFF: Thank you Bertrand for that response and I welcome anyone that would like to add something into the Q and A or in our next block. I will turn to Aria Ahmad right now. There is a need to unpack the opaqueness around the issue and the legislative incongruities that Bertrand brought up, they need clarity.
We can't focus solely on tech. We need to focus equally on human rights. So the regulatory sweet spot we have been talking about to avoid the pitfalls of over and under regulation, can you expand about that? What are the issues around the falsified medicines? What role can these intermediaries and regulators and patients play in this movie? So will you take the floor, Aria Ahmad.
>> ARIA AHMAD: These are comments that I will expand or issues that I will be expanding on in my section as well, but particularly in a sense the way Bertrand, I think, very astutely is trying to draw on parallel issues that are complex, that are multisectoral or multidiscipline and require a multi‑stakeholder approach. There are areas outside of initially the paradigm of Internet Governance that are now being impacted by the digital marketplace, and as you alluded to, Ron, the issue of medicine quality and falsified and substandard medicines is one of them.
And particularly because there is a significant risk to both underregulating around this issue and overregulating around this issue, because they are controlled goods without adequate protections, without a prioritizing public health and leaving the market in a sense open you create public health risks, of course, not just people being able to access products without a prescription, but also potentially substandard and falsified products that can present public health risks.
But at the same time being restrictive or overly restrictive in enabling in a sense a digital marketplace that shifts that transformation is happening in so many domains in people's lives. That can ultimately undermine access and affordability as well. So finding in a sense that regulatory sweet spot, recognizing the risks of in a sense leaving the market wide open or being too restrictive and in a sense jurisdictionally bound when the digital marketplace in a sense transcends national boundaries, creates all of these sort of blind spots that can ultimately not just lead to first order risks, but subsequent risks to both populations and access to medicines.
>> RON ANDRUFF: The World Health Organization has indicated interest in developing rules around Internet pharmacies to ensure this drug quality and security in the delivery chain. Can you shed light on that and other regulatory bodies that would be of assistance and have interest in resolving it.
>>
>> ARIA AHMAD: Absolutely. So the World Health Organization is one example of a body because part of what, I think, Bertrand is alluding to is when we talk about Internet Governance both mechanisms and regulatory approaches to addressing these issues, it requires a number of important factors. It requires a sense of legitimacy, what are the bodies that have the legitimacy to address the issue?
Is it a single state? Is it a third party actor that has delegated authority? Or is it a multisectoral, is that feasible or is it too cumbersome, for example, because that's also a consideration that you cannot establish an overly complicated system that no one is going to use. So the legitimacy is an important question, and the capacity and the ability to moderate that particular market is also important and around legitimacy, for example, an entity like the World Health Organization, or like regulators, not just sort of Internet Governance regulators, but also drug medicines regulators, so national medicine regulators have this vast network not just within national boundaries, but across countries that attempt to harmonize rules, norms, practices around various drug regulatory issues, they both have the mandate and the legitimacy, but also around very particular core capacities and functions, the ability to monitor those markets, the challenge right now with the WHO is that capacity is an issue, not just with funding, but also the understanding some of the technical challenges.
So that's why an entity like the WHO, for example, could take an active role because it fundamentally is a public health issue, but it ultimately requires multiple different epistemic it communities like Internet Governance, like trade, like IPR, like the enforcement angle being able to work in a multidisciplinary, and multi‑stakeholder Forum where other non‑state actors are participating as well and so the WHO preCOVID was attempting in eye sense to become more active around this issue, particularly through its work on medicine quality through member state mechanism on substandard and falsified medicines, not only did COVID sort of derail that, but ultimately it required more political will and more relevant stakeholders in a sense being able to participate and part of the call for in that third segment of this panel around the DCs is in a sense to sort of create that forum where we can have that discussion with not just the WHO, but many other both state and intergovernmental bodies as well.
>> MODERATOR: Thank you. I would like to have you, if you wouldn't mind, Mark has put into the chat the paper you introduced at the IGF in 2019 in Berlin. Would you give us the high points of the discussion paper and let us know where that is at in terms of what I will call a focal point document for this activity.
>> ARIA AHMAD: Absolutely. And I will keep it brief particularly because I do see some names from last year that are here as well, which is wonderful to see that there is a continuation of stakeholders across different groups that are recognizing that this is an issue that is as Bertrand just said an opportunity to address an issue at the heart of Internet, and social issues, but also one where we can draw on different experiences to develop a clarity and clear guardrails.
With the discussion paper for last year's IGF, the point really was to in a sense lay out the land of what the issues are, both from a very foundational Internet Governance perspective from a are we really talking about in establishing rules and establishing regulations, and leaning on INJ's very sort of important first edition of the global status report of in a sense understanding what the jurisdictional and regulatory issues are around these issues, and then identifying in a sense the different stakeholders, the different scales at the sub state, state and intergovernmental level, and in a sense making the case and making an argument for why you would need to get that sweet spot, that regulatory sweet spot right, and the risks of under and over regulation.
And part of the, in a sense, where some of those participants who perhaps are a little more engaged in this conversation were sort of left on a cliff hanger of so what, what next? And in a sense part of the objective of that discussion paper was to be just that, a discussion paper that invites an exploration of what some of the issues are, but also in a sense to make a case for why the so what needs to be a wider discussion among particular stakeholders and actors that perhaps at present are not at the table and ought to be at the table.
And in a sense making a call that that process ought to be founded on a set of norms and values, foundationally, and then have a permanent in a sense Forum for the thorny issues can be taken up, where the jurisdictional and regulatory challenges can be explored and where we can't be naive around these issues of expecting very sort of a simple guidelines to be established, but that you really need to work in a sense in that sort of policy domain on harmonizing rules and standards and norms in how you can promote a safe and inclusive and public health oriented marketplace for medicines online.
And so that was in a sense the objective with that paper is to be inviting and to make a case for a transparent and inclusive process to be able to have these discussions, and in my talk I will talk and lean on my experiences with the WHO's Member State mechanism on what that looks like.
>> MODERATOR: Why don't you take a moment to do that now. And then I will move to Zi. In a and block 2 or the Q and A. Thank you.
>> ARIA AHMAD: So perhaps just a 60 second background on what the mechanism was. In 2014 the WHO issue of medicine quality was one of those highly contentious issues. We realize the public health risk of medicines, but also we lacked international mechanism to address this issue, so you had a number of different approaches that were looking at the issue from very particular disciplinary perspectives. There was an enforcement that Interpol and Office of Drug Control was undertaking.
There was a private sector pharma, big pharma approach to the issue which was based on intellectual property protection across jurisdictions which is a legitimate trade concern, and there were various smaller sort of public health approaches that ultimately suffered from similar to this issue the jurisdictionality of it, because medicines are both a controlled good, but they travel, the global supply chain is now increasingly globalized and enmeshed.
So in 2014 the WHO established what was called a member state mechanism of substandard and falsified medicines. The idea was that you would have a permanent Forum within a Governing Body of the WHO where states can address and take up the issue and states in a sense having both the legitimacy and the mandate to address public health concerns within national borders.
And you would do so, you enter that Forum based on an agreed set of values, that it is fundamentally, there are multiple issues around the issue of substandard falsified but it's a public health issue and if you are to develop norms and standards, it ought to come from that foundational understanding of what the values are.
Now, some of the instruments and mechanisms that were developed in the last five or six years is more than had been done in the last 30, 40 years, establishing a global surveillance monitoring system for countries to be able to report cases. So that's the identifying bad actors, but also proactive mechanisms for what they called the prevention, detection and response to substandard falsified medicines. So harmonizing regulatory practices, dealing with issues of medicines in transit, links between access and quality.
From that experience of having worked within the member state mechanism for about four years and particularly establishing at the time the very first global study on the scale and scope of the issue, you can't really address an issue unless you understand how big of an issue it is, where is it occurring, where are the public health and socioeconomic impacts? It was not until 2017 that we had the first global scope of what the issue is.
There were three lessons that might be valuable here. The first is that while this has very core Internet Governance challenges that need to be taken up, I would argue that this issue ultimately is a technical and regulatory issue that cannot be solved without appropriate stakeholders that include national medicines regulatory authorities.
Again, they have the legitimacy. They have the mandate and they have the technical capacity to address particularly jurisdictional regulatory discrepancies. It's important that Patrick Kane isn't here, but he would have talked about different kinds of Internet Governance approaches to dealing with these issues. When you are talking about, for example, smaller digital communities, you can, like, certain Top Level Domains, you can have an audit system where you are able to screen beforehand who is entitled to let's say a Top Level Domain and who isn't.
When you are talking about a larger more difficult diffuse network like dot come. You could have edit systems where you can identify, for example, bad actors. Now, similarly around medicine regulation, because it's a public health issue, you have similar mechanisms, you have market authorization, for example, which dictates who is able to sell a particular product and import a particular product into a country so that's an audit system, but you have edit systems, you have what is called most market surveillance. When drugs are inside the market, how do you take bad drugs that Dr. Adverse drug events? That's why drug regulators are deeply important in this conversation.
Number two, is you need to be able to start with a set of norms that you begin in a sense recognizing that there are public health issues here. Recognizing that there are, of course, trade and IPR and other issues, but you need to be able to establish these norms in a transparent way so that you avoid the opaqueness and you avoid the discretionary nature of how rules are developed and particularly as it stands around conflict of interest, the issue of the member state mechanism fundamentally or initially was really about abandoning the definition of the problem or how you frame the problem.
This is something else that Bertrand talks about is how are you framing the particular problem. Is it one of rogue actors, or is it one of how do you facilitate in a sense safe access to controlled substances in a digital marketplace. And likewise, counterfeit was an IPR issue that was abandoned for substandard falsified and the process of deliberating that took a number of years, but it got all of the countries together, because everyone called it now the same thing.
That wasn't the case five years ago when different countries had different legal and regulatory ways of framing the problem. Now, likewise, in this, on the issue of online pharmacies, access to medicines over the Internet, as you alluded to, Ron, there was a multi‑stakeholder process over a couple of years through both RightsCon and engagement with ICANN and IGF of developing the Brussels Principles on the online sale of medicines. You can find those on Brussels Principles.org which uses in a sense UN‑based language recognizing certain core fundamental rights and affirming seven principles that would be very difficult to challenge in a sense because they are so embedded in existing intergovernmental documents and language around the right to health, around access to medicines and acknowledges in a sense different sectoral interests, but acknowledges that that ought to be a foundation on which discussions emerge.
And lastly, and I will stop here, this gets at the DC question, you need in a sense an institutional commitment. You need a Forum and a process for deliberating that is inclusive, that includes all of the relevant stakeholders that is transparent as we said that avoids the opaqueness and discretionary Nate fur and ensures you that don't have rules made in one place affecting populations elsewhere or markets elsewhere.
And that process, that Forum is in a sense the only way that you can avoid imposing rules, but actually discussing the thorny issues where you might have different not just disciplines and sectors with a perspective, but different countries framing the issues differently.
Now, there are other mechanisms that we can talk about in the Q and A including the EU common logo approach. That is within a very particular jurisdiction that looks at the issue of online pharmacies across the European economic area. You have, as I mentioned within the WHO member state mechanism, you actually had an opportunity in the by annual work plan to deal with issues of online pharmacies and Internet that was disrupted and that required a little more political will. And I would argue in addition to the IGF, the international Conference on drug regulatory agencies, ICDRA which was previously the international Council of March monetization. And that's what they did is harmonizing rules around access and regulation of these controlled substances.
Those are regulative structures that could participate on this issue. It's technical regulatory issues that requires the appropriate stakeholders. You have to start with a set of norms that have to start the conversation, and you need to have a forum that is inclusive, transparent, and multisectoral to deal with the thorny issues, some of which that Bertrand alluded to, for example, with the trusted notifiers system but there are others like Top Level Domain like dot pharmacy, et cetera, that we can talk about.
>> MODERATOR: Thank you for removing opaqueness and adding more clarity. Truly, what you have said in particular of that summary is the perfect segue to our friend, Zina in Cairo. How does what Aria Ahmad and Bertrand de La Chapelle Sharon look to you from a regional perspective? The mid-eastern, North Africa is one cohesive geographical part of the world, yet the clusters are very different one from the other, and so very much like the problem that we see here in North America where drugs in the United States are more expensive than Canada, what have you observed in the MENA region in this context? Is the same drug in Egypt cheaper in Lebanon? Are these challenges on the ground, things that Bertrand and Aria have mentioned? How does it look from your perspective?
>> ZINA HANY: This raises an urgency to have such a platform to support the accessibility and local availability of safe medications, which is no longer perceived as a luxury especially in the developing world like the MENA region where personally I come from having access to safe, affordable medicine is a fundamental right to all, especially in such crisis times.
To, so, as a matter of fact, implementing such a platform in the region would hinder a lot of problems such as drug shortages and inaccessibility of drugs to a great extent, however, on the other hand, it cannot be denied that to intervene such a platform would pose a lot of challenges in the region like the MENA region, which is the struggling bureaucracy, outdated systems and, of course, limited resources.
So before digging deep into the expected challenges and hurdles in this region that it would face in order to intervene with such a platform, let me emphasize quickly on the characteristics of the healthcare nature of this region. So as you said, John, despite that the MENA region, there is one cohesive geographical part of the world, yet each cluster of countries is very diverse from each other, when it comes to policies and decisions regulating the healthcare system as well. Also the economic status of each country is different and the health expenditure is different.
So the system in Egypt would be very different than that of Jordan and Lebanon. And both are unlike to the region Morocco, Tunisia, Algeria, and correspondingly all of very similar from the Gulf region, which includes higher socioeconomic countries such as Saudi Arabia, UAE, Kuwait, Qatar, Bahrain and Oman.
So countries are very different from each other. So currently hurdles to adopt an E‑pharmacy would differ not only across the cluster in the region, but it would differ on a country level within a single cluster. So as Bertrand touched base on some of the challenged that were there worldwide, having said that, let me also take you through the challenges that are aligned somehow with what has been touched on that I can foresee that would hurdle implementing such a platform in the region.
The first thing is the reimbursement system, for example, which is actually very fragmented across the countries where populated countries such as Egypt and Morocco have in-depth health insurance coverage and a significant part of pharmaceutical expenditure is paid out of pocket. So that's a good thing in a way, that would allow the freedom of the end user to purchase their medication from where they want, however, elsewhere as in UAE, Kuwait, Bahrain, Qatar, Saudi Arabia, the pharmaceutical spending is covered and is free of charge for the citizens.
So it wouldn't be good for the insurance companies to adopt such a system in their practice. The second challenge would be the manufacturer a global pricing strategy that would be threatened upon having an E‑pharmacy platform. Usually manufacturers sell the same drug in one country with a price that is totally different from another.
For example, a drug that would cost $20 in Egypt might be sold in Algeria for $26. So having a transparent competitive system that is clear to the end users as well as to the Governments to cross check prices would not be very welcomed by gate keeper whether the pharma companies or even the local distributors in the countries, as this would impose additional downward price pleasure and less profit margins as such.
So this would also create a problem within the pharma company itself and the Governments who would want to barter equivalent low prices as other markets.
Another challenge would be the registration issues, usually it's prohibited to sell a drug that is not locally registered so having a wide range of drugs not registered within a specific country would not be allowed by Governments and health Ministers to be sold. Besides labels and authorizations are another parallel challenge. For example, a drug can be registered for four indications in the U.S., but only for one indication in Morocco.
So the drug would not be neither prescribed for an off label indication nor covered by the coverage. The other would be the pharma companies themselves that do not launch, or late launch or withdraw a particular drug from the market, mostly expensive and innovative drugs in a given area as they see the price they will see from that specific market is excessively low, which result in access barriers and availability concerns in specific country.
In Algeria, for instance, companies are concerned about the spillover effect if they concede a price below the lowest in Europe. For example, in Greece. So, again, this platform, making medicines accessible would threaten the pharma global pricing strategies. Usually this is the case with the so called large reference countries in the region such as Egypt and Saudi Arabia.
In other words, low income countries such as Egypt could lead pharma countries to delay launches in country because of fear of low prices. So besides that as well unfortunately it happens that when a country or the flexibility of a country's pricing system whether to accommodate external factors such as exchange rate, fluctuation or consider inflation can actually affect drug's availability within a country. As it would alter manufacturer's decision to remain in the market.
Egypt was one of the country that suffered from that back in 2016 where there were shortages in medicines for serious conditions such as cancer due to distributers avoiding to lose and save medications under lower price regimens.
Unfortunately that's the current situation in Lebanon for a lot of drugs, for example. Also Governments across the mentioned countries support significantly the domestic over the foreign manufacturing entities, mainly they support through pricing like in Egypt and Saudi Arabia, or through reimbursement systems and policies such as Bahrain and Kuwait and Morocco, for example.
Or even deliver supports with taxation such as in Saudi Arabia and Bahrain. All of these efforts are to actually maximize the local production of medicines. In Algeria also there is an importation ban on foreign company imports into the country when there is three or more generics are available.
So having a platform of drugs would be counter acting to the countries and country strategies to maximize local production. Also there is a movement towards mandating generic prescription that is currently in place in countries like Jordan, and like Qatar and the UAE. Governments would challenge such a platform that would make more unregistered foreign manufactures available for end users especially if they might be more price appealing and with the international standards.
So last but not least as well is the E‑payment systems and the E‑prescribing systems in these countries. Well, actually the E‑payment system is not fully developed in countries such as Algeria, such as Tunisia, Morocco and Jordan, especially when it comes to paying in foreign currency. The region, the Visa and Master Cards are not owned by everybody. They are Kenned on sustainable occupation and certain margin salaries, so on, so forth. Also the E‑prescribing systems, the countries in the MENA region or so far away from that, so it would be such a big challenge on its own to change the whole prescribing practice in these countries.
Basically in a nutshell, gate keepers should work together through a comprehensive integrated strategy to allow such a platform to brought effectively and efficiently. They need to move in the direction of public health, and there is a need to control bureaucracy measures and have a facilitated process to engage diversity groups together whether governmental bodies, pharmaceutical companies, insurance entities and also distributors, for example, to catalyze efforts to enforce this integrated framework, and those stakeholders should be engaged in a dialogue and have an organized expert advice on the mechanisms for better utilization of resources efficiently as tools to expand and leverage on the E‑pharmacies and other developed regions.
And also efforts to raise gate keeper's awareness should be tackled on how such models in other western countries is sufficient to support accessibility and availability and affordability of safe, quality medications thus providing a transfer of knowledge and experience for global norms and standards as a no ball effect. So that's if from my side.
>> RON ANDRUFF: Only that?
>> A lot of challenges.
>> RON ANDRUFF: That's why we are having this conversation. It's really the perspectives that are being brought are so broad and varied, and I really am grateful that we are moving in this direction towards the Dynamic Coalition which we will get to in the next section, thank you very much, Zina for that really clear and somewhat disheartening report, particularly the fact that threatening pharma's global pricing structure. Those kinds of things are huge road blocks because we know the power that pharma has.
We have been moving through this pretty rapidly with great interventions, but let's take a few minutes. I have seen a few questions in the chat. Mark, can I turn to you for ten minutes to manage the questions and answers and if everyone could be really concise with the questions and answers, we will try to get all of them in and take the last five minutes to move to block three. Thank you.
>> MARK DATYSGELD: Thank you very much, Ron. So far, I think that the question came from Tim, he says I would be interested to know from Aria what are the Brussels Principles and possible ways for establishing norms has been socialized with any regulators or the WHO with whom he works? So I guess a bit of a question about how do we work with the Brussels Principles framework in the context of institutions, and what we can do about that?
And following right up, we have a question from Jennifer Chung which asks how is the status right now in relation to counterfeit medicines and generics across the world? And since those are both institutional questions, I think that we can definitely start looking at them from Aria's perspective who is our expert and then have the other panelists comment on that.
>> ARIA AHMAD: Thank you, Mark, and thank you. Tim and Jennifer, for those questions. In order to get to as many questions as possible, I will try to keep it relatively brief. On the question of the objective or the goal, on whether the Brussels Principles have been socialized with regulators of the WHO, yes, to some extent.
So part of our initial objective with this panel was to have a number of, I mentioned the national medicines regulators say a key stakeholder is to have not just any, but one of the top people in the space participate and indicated some interest. He is the head of the Indian Drug Regulatory Agency who is now the rotating Chair of the member state mechanism on substandard and falsified medicines and also this year when India was to host the international Conference of Drug Regulatory Agencies, he was the co-head of that process who has expressed an interest in the Brussels Principles recognizes that a shared set of norms is foundational to having this conversation. And as you can imagine, India is oftentimes a very important and strategically important actor in a lot of tensions around issues of access to medicines.
For those who are from the access to medicine space, issues around patents and intellectual property rights and generics, India played a significant role and in though small parts because they are considered largely sort of informally as the pharmacy of the world where so much of the raw ingredients and the finished products that make it to low and middle income countries are produced in India not only because of the economy of scale, but because of the capacity to produce them at such high quality at such low prices.
And so India is critically important in this conversation, but also because values, what are we ultimately trying to do is a key foundation. So they have been involved in, as I said the WHO had an activity to tackle this issue as well, and we are hopeful to reengage that particular process.
To Jennifer's question on counterfeits and generics, I wouldn't dare post my dissertations, but that's a lot of what my work, academic work background is in addressing these questions of definitional frameworks. Is a counterfeit, which is a term that was in the access to medicine space is one that has sort of fallen out of favor for a distinction between substandards where you have something that's out of specification, and falsified where there was a deliberate intent to deceive. That's sort of a distinction that at least doesn't obscure the fact that some actors may have different interests in approaching the issue and gets at the public health issue and problem with both of those.
And the question of generics, which should never be sort of brought into these questions, if there are specification issues, that is one thing, but generics with the way all countries understand them is that they are safe, they are quality and they are efficacious. So they are within a very regulated spectrum of quality and those should not be in a sense confused with this particular issue. And I will stop there.
>> RON ANDRUFF: Excellent. Thank you, Aria. So I don't see any other questions at this moment, Mark, so maybe I will turn to Bertrand.
>> BERTRAND DE LA CHAPELLE: Thank you very much. Just a few bullet points, the first thing is in all of those policy issues, it is extremely important that all actors look at unintended consequences. There may be a decision that is taken for health issues that has actually an impact on trade or vice versa, and one of the challenges is to make sure that whenever there is a measure, all of the different things are taken into account.
The GDPR privacy protection in Europe has led to the fact that now I as a French citizen cannot access a certain number of news sites in the U.S. who do not care about the European market and do not want to be bothered by the GDPR. So it's extremely important to have this in mind.
The second thing is whenever we talk about involving the stakeholders, I think we tend to implicitly forget that international organisations are stakeholders themselves. The Secretariats of international organisations are and should be considered, that's what we do in the Internet jurisdiction, are full‑fledged actors because they have a transversal perspective. But in most cases they have a siloed perspective because it can be discussed in WIPO in a certain angle and it can be discussed in the WHO with a certain different angle. And then when the trade comes in with the ACD or WTE, it's a different angle, but each of them is providing crosscutting angle and we should always keep in mind that processes need to be considered as stakeholders just like individual companies or individual Governments, et cetera.
The next element is I didn't mention it in my comments at the beginning, but how do you authenticate a prescription online? Anybody can forge a document. I even had people who told me in the Domain Name industry that they received fake court decisions, people were just taking the header of a court decision and making a completely fabricated document.
So if we require prescriptions online, how do you authenticate that it came from an actual doctor? And finally I think, and maybe it's a segue about what you are going to say about the Dynamic Coalition, when the question was asked about whether Brussels Principles circulated to the WHO and beyond, if you look at the people who are receiving stuff, they are very familiar with advocacy and lobbying. So there is one society group that is pushing the particular position, or lobbying group of interests that is pushing a particular interest of position.
Who international processes are not familiar with and need to be educated in a certain way and welcome this kind of input is multi‑stakeholder input. And when you are providing something that is the result of a work of different actors, there is a part of educational path, something that we are continuously doing, this should be given a different level of interest and credit because it is the product of adroit effort by Government, civil society, companies, et cetera, than when it is purely lobbying or purely civil society advocacy.
And I think people don't know exactly what, in which box to put those kinds of contributions and I think it will be important if the Dynamic Coalition develops to look at the balance of participants and to label the outcome of this group as something that is different from an advocacy position, et cetera. And I was just thinking of that hearing the notion of the Brussels Principles. The moment you label something as principles, it has a tone of advocacy. Whereas a part of what we are trying to do, what you are trying to do is bring the different perspectives and frame the problem in a way that all of the different actors can afterward use as a basis for their discussion. And I think it's an important distinction that we do not make enough, and I wanted to share as it came to mind as we were speaking.
>> RON ANDRUFF: Thank you very much for that. In fact, there has been two responses from two bodies that actually are in the business of confirming trusted Internet pharmacies in terms of the verification of the prescriptions and I think it's important that it should be noted that the validation of prescriptions and verification of physician licensure are parts of the process at the Canadian international pharmacy association Tim notes and he says that there are ways to ensure documents are not being effaced but it requires diligence and then Gabriel Leavitt notes that pharmacy in the U.K. can easily check the authenticity of a U.S. prescription by checking directly with the prescriber in the U.S. It's good that you brought it to the table so we can understand that element. So thank you to you, Bertrand, and also to Gabriel and Tim.
>> BERTRAND DE LA CHAPELLE: Just one question, and I very much appreciate this. There is always a distinction between it can be done, and it is done. So the difference between having something that would allow, for instance, a QR code on every single prescription that could be checked afterward for accreditation, that is an authentication mechanism. The fact that you can call the person and say is that really a prescription from you, yes, but you will not do it all of the time.
The pharmacy in India, online pharmacy in India is not going to call the doctor every time. So I would be very interested that this dimension of authentication is taken into account in discussion, but thanks for the contribution.
>> MODERATOR: The same to you. Thank you for that. So here we are, ladies and gentlemen, we have been having this really robust conversation now, I see we have six minutes or so left in the session, so what I would like to do now actually is move to our second poll question. And then we will come back to our block three and talk more about the DC. So the second poll question if the facilitator from IGF can bring it up, we would like to know the answer to this question from our participants, it's a question we have asked before. We are actually looking to see if there is data movements here. The question is are standards and norms for safe Internet pharmacies best accomplished at the intergovernmental level or rather at the Internet Governance level?
So, Mark, if we can nudge our IGF facilitator to post that while we are moving onto this next session, that would be helpful.
Are standards and norms for safe Internet pharmacies best accomplishes at the intergovernmental level or rather at the Internet Governance level? That is the question. I am not seeing the poll come up, but let's see if it does. In the meantime, Mark, can I ask he to move to block three and can you introduce the Dynamic Coalition we have been discussing during the call.
>> MARK DATYSGELD: Perfect. Thank you very much, Ron. I would like to acknowledge the incredible contributions made during this panel. I feel humbled to be part of this effort. So many interesting ideas being floated around, and thank you so much for the panelists. Every time we meet, it look you like we bring up interesting and complex questions that we need to keep exploring, and for sure this is a topic that we still have a lot to move forward, and that's exactly why we have been considering building this Dynamic Coalition on access to medicines using the Internet.
Now, we need to understand what is the broader community's vision, what are their potential contributions, and especially what is the right motto? How do we advance these important questions that we keep stumbling upon? They are diverse, they are difficult, and they are important. So that's a conversation we want to have, how do we bring the multi‑stakeholder perspective? How do we get these different points of view, and we actually manage to create some sort of action around it that furthers our goals of just making sure that people are getting quality medicines at a price they can afford and that doesn't threaten their, you know, their wellbeing.
So what we want to do is to create a group and it's still not 100% I wouldn't say it's specifically 100%. We can make a Study Group, we can make anything that makes sense for the community. It can be under the DC label, but, you know, it's a DC because we are gathering at the IGF, but we could be a research group, we could work under different Forums.
One thing I know for sure is we want to produce evidence‑based material and gather that evidence‑based material just as some sort of reference or repository that is lacking. So what is the format we want to pursue? How do we want to take this forward? Those are great questions, and we have the honour of having York University supporting us through Aria, and that is a great institutional home for us as well for us to do this kind of reup is, this kind of work.
To it is a question that we are posing to the community, how should we go about this? What can be accomplished and how should we go about it? So I will invite anyone who has interest in this DC, who has interest in this research or who knows of a person who would be interested in it, please I'm posting some emails at the chat, one is more generically for the York University central health. One is directed to Aria, the other is directed to me. You can copy all of them or send piecemeal, however, you want, what we want is to hear from anybody potentially interested what are your views on how to move this forward.
And speaking to what Bertrand was saying, speaking to what Aria raised and particularly to what Zina raised, that was very clear from, coming from her, that we have different regions with different hurdles, but that look fundamentally the same. At the end of the day, we have shared problems, and if we focus on the shared problems, I'm sure we can advance this a lot.
So Jennifer, thank you very much, Jennifer is one of the MAG members that is with us, and thank you for your support, Jennifer. We are hoping that we can advance this conversation to the MAG as well. So I will finish my intervention by saying please reach out to us. We are open to hearing your ideas and finding the best model for this, and we will do our best to assemble an inclusive coalition or research group or whatever the community feels is good for us to be able to accomplish what we want, which is safe medicines that people can afford. Thank you very much.
>> MODERATOR: Thanks very much, Mark, and indeed we are excited about this moving into this Dynamic Coalition. And basically rather than talking about this once a year, talk about it all year, and by this time next year have really important and exciting results as a result of the multi‑stakeholder model that Bertrand and others have pointed out.
It is only through the multi‑stakeholder model that these things are going to be dealt with because we get everybody around the table. So we are looking forward to that. I want to thank everyone for participating today. The poll results we will post once we get them back, and so as this brings our workshop 116, pandemics and 2020 assessment, how that looks, I want to thank all of the panelists and the participants for this conversation. It's been very fruitful, and with that, I wish you all the very best, and stay safe, wear a mask. And good luck. Thank you again for your participation today.
Bye for now.