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IGF 2019 – Day 3 – Saal Europa – WS #92 Public Health Online: Shadow Regulation-Access to Medicines

The following are the outputs of the real-time captioning taken during the Fourteenth Annual Meeting of the Internet Governance Forum (IGF) in Berlin, Germany, from 25 to 29 November 2019. 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. 

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>> MODERATOR: Good morning, everyone.  We will start the next session now.  Good morning, everyone.  Good morning, good morning, good morning.  I would like the people at the end of the hall to please allow us to start the session.

Good morning.  Good morning, everyone standing at the end of the room chatting.  Thank you very much.  We need to start our session.  Thank you.

Good morning, welcome to this workshop, Public Health Online, Shadow Regulation Access to Medicines.

My name is Ron Andruff.  I'm serving as the moderator of this session.  Esteemed panelists joining me today are Ms. Oki Olufuye, Gabrielle Levitt, and Dr. Aria Ahmad.

Oki Olufuye is a pharmacist healthcare manager with 20 years of community practice in pharmacy in Nigeria.  Dr. Olufuye, you served as secretary, Committee Of Ethic, and Pharmacy of Nigeria and Abuja branch and responsible for the reporting on the national medicines list.  The years of practice in community pharmacy and health program support the knowledge and experience in drug dispensing, inventory control, national drug control, advertising unit and federal lab.  The quantification issues in Nigeria runs deep.

Gabrielle Levitt is President and cofounder of Pharmacy Checker.  Mr. Levitt is responsible for research, managing the online pharmacy verification and listing program.  And a public advocate for affordable drugs in America, Internet freedom and U.N.  He's testified before Congress on issues reeled to affordable medicine and Internet freedom.  Gabrielle is also President of the united association Brooklyn chapter.  In the pharmacy checker role he was among the original drafters of the sale of medicines over the Internet.

Dr. Aria Ahmad is a global health research fellow at York University.  Since 2014, he's served as a consultant to the World Health Organization addressing issues of medicine safety and vigilance.  Aria Ahmad is a past Duke policy fellow and spent the past 15 years working on pharmaceutical policy issues at the intersection of Academia, Civil Society and international organizations as well as the public sector including testifying before the Canadian senate on Canada's access to medicine's regime.  Aria Ahmad received inform SC in pharmaceutical studies from the University of Toronto and Ph.D. in global health governance from the school of international affairs in Waterloo Canada.

This past Monday at the day 0 session, Aria Ahmad presented the seminal discussion panel entitled digital governance of public health toward a tilting framework of pharmacies.  Hard copies of the discussion paper are here on the corner if anyone would like to pick it up.  Otherwise, retrieve an electronic copy of this I haves the QR code noted on the top of the document.

Ten years ago at Sharm el Sheik, it was brought to the Internet Governance Forum.  Little progress is made to address a harmonized set of norms, rules, laws to allow for safe international dispensing until now.  Now we are undertaking a multistakeholder approach to resolving this growing, public, moral health hazard.  Dr. Aria Ahmad brings a unique discussion to speak to the decade including United Nations and World Health Organization.

The discussion paper's initial scoping review examines, studies stakeholders and existing regulations of Internet pharmacies, using North America as an example, it also touches on European Union regulation and legislation.

Clearly, these are serious issues.  As much in Asia and the Global South as you will hear soon from our expert pharmacist Oki Olufuye.

Is important to know Dr. Aria Ahmad's document is grounded in human rights and global public health perspective.

Equally important, the discussion paper is a thoroughly independent exercise that represents a living document at the nexus of Internet governance and public health.  It represents a primer on the topic intended to stimulate discussion and debate.

According to the U.N. Declarations of Human Rights, access to medicine is a fundamental human right to health. From this U.N. statement, the Brussels principle state we affirm the following principles relating to the sale of medical products ordered for personal use over the Internet.  Access to affordable medical products is a fundamental component of the right to health.

Just months after the Brussels principles were created at Wright's con Brussels, 2017, the U.N. Human Rights Council tabled a resolution for the right of everyone to the enjoyment of the highest attainable standards of physical and mental health, including access to essential medicines.

In fact, this discussion is rooted in the Sustainable Development goals, particularly 3.8, which speaks to access to safe, effective, quality and affordable medicines.

So what are we discussing today?  Public health online, shadow regulation, access to medicines.  Indeed, shadow regulation as noted in the title of this workshop, is a loaded term that connotes different meanings to different people.  The electronic frontier foundation describe shadow regulations as voluntary agreements between companies sometimes described as codes, principles, standards or guidelines to regulate your use of the Internet, often without your knowledge.

EFF goes on to say, shadow regulation has become increasingly popular after the monumental failure of restrictive Internet laws such as ACTA, S.O.P.A., PIPA.  This is because shadow regulation can involve restrictions that are as effective as any law, but without the need for approval by a court or parliament, end quote.

Online access to medicines is the driver of this discussion today.  Online pharmacies defined as websites that market and sell prescription medications over the Internet that is delivered by mail‑order began operating in the mid to late 1990s.

In North America, by way of example, the issue of purchasing medicines outside of one's own country gained public attention through media coverage of bus trips which brought seniors to Canada to buy medicines and were sometimes sponsored by U.S. politicians in support of reforming drug importation laws.  Some Canadian pharmacies began partnering with pharmacies in New Zealand, UK, India, Turkey and those in free trade zones.

High drug prices are one of the main reasons that Americans go online to buy medication.  The Center for Disease Control estimated that there are markets due to high domestic drug prices.

Millions are dependent on Internet pharmacies as you will soon hear.  They safely imported medicines ordered online, pursuant to a valid prescription for their own use.  As detailed in Dr. Aria Ahmad's discussion paper, it is not the violation of federal or state laws that threaten health, it is the rogue operators that sell fake or otherwise dangerous medicines.

Most importantly, this discussion is about real people in real circumstances.  It is a people issue with lots of complexity.  It is about actors in position of authority who make the rules that we, the people must all live with.  The discussion paper in the engagement we hope will follow is in search of a common understanding of safe, personal importation from a global public health perspective that moves beyond technical restrictions under the guise of protecting consumer safety from rogue websites.

Online pharmacies in the business of selling genuine medications, dispensed by licensed pharmacy and pharmacist that require a patient's prescription should not be considered rogue pharmacies.

So this morning, we'll be looking at three overarching questions, can the multistakeholder approach, that led to the Brussels principles serve as a model to inform development and standards and best practices to ensure safe access to medicine over the Internet?

Two, what is the most appropriate transnational forum for inclusively and transparently addressing the Internet governance and public health issues associated with Internet pharmacies?

Three, Internet pharmacies have emerged as key stakeholders advancing technical and policy approaches to balance public health and consumer choice.  What are the opportunities and challenges associated with intermediary efforts to regulate Internet pharmacies, including the dot‑pharmacy detail D and trusted notifier systems?

We agree with the united nations Secretary‑General Guterres who noted in remarks in the opening ceremony here, convention is outpacing policy changes.  The governance gap must be addressed, end quote.  German chancellor Merkel put a sharper point stating lawmakers need to quickly quote identify which analog rules we want to transfer to the digital world.  She continued, technology has to serve the people.  And there will be new possibilities when every voice is heard.

The hope shared by our panelists is that every voice can indeed be heard so one day soon, we, the people, will have the same trust in safe Internet pharmacies as they do in brick and mortar pharmacies.  People all over the world who need access to safe, low‑cost medicines need new norms, new rules that address our 21st Century needs.

Now, I'd like to give the floor to Dr. Aria Ahmad to give us a brief introduction to the high points of his discussion paper.

>> ARIA AHMAD:  Thank you for that introduction and setting the stage for the discussion.  I would like two housekeeping notes.  First, Ron mentioned the housekeeping paper.  There is a range of views on the state and nonstate, existing regulatory strategies and considerations for future opportunities.  As such, it is a working draft meant to serve as a primer to stimulate discussion.  Since the pre‑event on Monday and conversations throughout the week, it has already undergone changes.  If you have grabbed a copy, I urge you to pick up a fresh copy today that you can get around the room or by using the QR code on the first page.  But also to provide feedback in refining and developing this manuscript and this body of work.

Which leads me to the second point.  Since intellectual freedom is important for Academics, I have to declare I don't have financial or professional conflicts of interest.  The broader research project, drafting of this discussion paper and me being here are funded by my Academic institution, York University.  On that note, let me explain why I am here today.

For those who can't see what this picture is, that is an aerial photo.  That dark shadow is a Chinese customs agent walking on boxes of medicine that were seized or thought to be substandard.  This is a focus on correct safety and vigilance issues by working across Civil Society, Governments, Academia, as well as multilateral fora like the World Health Organization.

To contribute to the first scale and scope with the problem.  With the work with WHO set up with the global surveillance and monitoring for substandard medical products.  You can see in the documents in the picture, the issue is rich with multiple competing interests.  Including public health considerations, socioeconomic impact.  A global in nature and when you talk about surveillance monitoring, requires global cooperation particularly within a multistakeholder forum, like the WHO.

Now, balancing these competing interests is a regulatory challenge, yes, it comes down to the quintessential challenge of trust.  How can I be sure what I am taking is safe, efficacious, and quality.  It might be how trust is meted in the analog world and physical pharmacies.

Healthcare providers, usually physicians, pharmacists, medical products have life‑saving implications of course.  That trust is mediated by things like actual products that include brands and trademarks and with the actual dispenser and the professional certification as well.  That occur within a physical environment where you can actually have face‑to‑face engagement.  In many parts of the world access remains an issue.  That is true for the one in three people that don't have regular access to life‑saving medicines, which amounts to two billion people.  The amount of people that don't fill their prescriptions because of cost‑related reasons and millions of deaths prevented by improving access to affordable medicines.

Enter the great disruptor, the Internet.  The access to the Internet is an issue in million low‑income countries, billions are going online and using it for a variety of different reasons and purposes including e‑commerce.  Reasons it would be used to access medicines include cost‑related issues but others like convenience, privacy, speed, et cetera.  On the cost issue, which is the predominant reason why people use Internet pharmacies, we're talking about in some cases, according to a recent study of 70 to 80% of savings on drugs from safe sources.  Reasons why medicines cost different in different countries is complex.  We can get into that in the Q&A.  The Internet can help.

The Internet is not all cats and roses.  Because of increased globalization of splay chains there is a stratification of legitimate and serious threats of criminals and others taking advantage of the marketplace that pose risk to health in substandard medicines.  This led to a restrictive enforcement approach.  In some cases, for example, this is entirely appropriate, like for example, this report that came out in the US a few years ago, particularly concerned with issues of opioids.  But if we are to adopt a patient centered public focus as the WHO is mandated to do, the argument around medicine regulation is one of finding the right balance.  That includes acknowledging that there is a risk to underregulation.  These as noted include public health risks from a free and uncontrolled market that exposes patients and also lack of trust in health professionals.  That poses a significant public health risk.

Likewise, there are risks in overregulating this issue.  How appropriately regulating the issues.  They can restrict access and risk to diversion and so these are also important risks.  So there is a number of papers that are coming out where social media platforms like Twitter, Instagram, Facebook are increasingly becoming unregulated markets for medicines.  The reality is desperate patients will find desperate ways to access medicines.

Really, what we're in need of is a regulatory sweet spot.  One that protects consumers against rogue websites, bad medicine and promoting access to safe and affordable essential medicines.  When you have a legitimate competing interest that needs reconciling you have a regulatory challenge.  Regulatory challenges are fundamentally about rules, who sets the rules, why, what interests inform the rules, what fora and where do the rules develop and where do they apply, under what methods or approaches you take, that ultimately dictates what is supplied.  How the issue is currently being regulated is something that I want to talk about.

As the Internet jurisdiction global status report unveiled yesterday quips, every problem has a solution and every solution has its problems.  Allow me to survey a few examples of state, nonstate, and Internet intermediary approaches to regulated pharmacies.

At the state level, different ways to approach the problem.  One of the credentialing companies puts out the pharmacy policy guides for countries that have laws around importation.

Many cases, regulation of medicines more broadly falls under either of the Ministry of Health or regulatory authorities.  If I use the U.S. as an example, that for example, falls under the ministries of health, the Department of Health and human services and the Food and Drug Administration.  The F.D.A. is bound to laws.  Because of the issues, there are two sets of laws.

There are additional agencies at the federal level that are involved and can be involved in this issue as well.  For those that are domestic and only sell for domestic market, there are a set of laws for Internet pharmacies.  The landscape is different, and if you want to import medicines.  This is important because cost is increasingly becoming an issue.  Not just LMIC, the low‑income countries, and places in the U.S., as this report illustrates, for the most commonly ‑‑ popular brand name drugs in that period of time, in the past 10 years, prices have increased by 208%.  Now, under federal law, importing medicines is technically illegal under the FDTA.  At the same time, the F.D.A. has a personal importation policy or discretionary guidelines, where under particular conditions, it urges the custom and border patrol not to enforce, but provide flexibility for patients.  Particularly for U.S. consumers that are importing 90‑day supply of noncontrolled medicines for personal use.  This remains in many ways discretionary and that is important when we look at some of the nonstate actors that are involved in this particular space.

Along with regulatory authorities, professional associations like pharmacists are important, in the U.S., again, the national association of pharmacies is an association that represents pharmacies.  And in other countries as well.  VIPPS is deeming what websites are safe, they take a technical interpretation that some argue may be too restrictive, whereby any website that markets or sells prescription importation into the U.S. are noncompliant.  There are non‑Governmental credential entities.  These websites like legit script for example, the Canadian international pharmacy association as well as pharmacychecker.com, provide information and guide patients on where they can access cheaper medicines from a select list of certified Internet pharmacies.

There is scholarship that is increasingly emerging that when the Internet pharmacies are credentialed the safety concerns are addressed as in the paper that argue that some ways peer review is not interested in the results showing the credential online pharmacies are safe.

Over the last few years, Internet intermediaries are increasing stakeholders shaping Internet governance.  Many ways, the intermediaries most of you are familiar with, reflect the quote and challenge that the U.N. Secretary‑General a couple of days ago invoked that innovation in some ways is outpacing the capacity to develop appropriate guide rails.  It is like the hare and tortoise challenge.  There are two intermediary approaches for the pharmacies and how to restrict potentially access.

In 2013, ICANN made about 1,500 top‑level domains publically available.  One of was the dot‑pharmacy domain.  The implementation is what was granted to the aforementioned, inform APB.  There were sets of concerns that the range of organizations issue said with this particular arrangement including a petition with about 24,000 signatures.

The first had to do with conflict of interest, should an organization, despite legitimacy and good intentions, but one that represents pharmaceutically pharmacy boards has received funding from minister including six pharmaceutical companies to file the application for the dot‑pharmacy domain, be interested with the dot‑pharmacy TLD.  Which has always in some ways, supported almost exclusively by entities with commercial interests, including some nonstate organizations.  Now, this related concern was whether a national association with a particular interpretation of even the own domestic law and importation can adjudicate that what can and quantity get a pharmacy domain.  The NADP adapted its criteria for VIPPS, the domestic verified program, any website marketing or sells medicines into the U.S. is ineligible for the dot‑pharmacy criteria for eligibility as well.

Now, last year, ICANN issued a notice of breach of domain agreement to the NABP for failing to be transparent and expeditious in allocating the applications for the dot‑pharmacy domain.  There is trusted notifier systems, these are around acute public legislate like opioids.  This taps into one of the most significant challenges and one that intermediaries like social media third‑party platforms are challenged on.  That is DNS abuse, and the issues around content DNS abuse.  In the current system, as the global status report shows, intermediaries are often receiving notices or take‑down requests that are increasingly happening without court orders which compel into intermediaries to censor or take down content.  They select experts and notify intermediary that prompt follow.

The idea is to move away from an informal, nonlegal, private notices to require court orders or follow‑up that is prompted by the advice of a group of select experts, trusted notifiers.  Some commentators noted there are challenges to be addressed, and these include in some ways, issues that that ‑‑ it ‑‑ before the trusted notifier system were true as well, in terms of who can be a trusted notifier.  How many of these trusted notifiers do you need to take action and can it in some ways morph into the nonlegal take down, content take down approaches.

Now, what we have and this is something that some have pointed out, including this particular book, which I urge for anyone interested in thinking in this idea of Internet intermediaries and regulatory role and the UNESCO report that in the beginning called into question the operation of Internet intermediaries that are influenced by the legal and policy values of the states.  There is state policies, laws, regions to varying degrees are inadequately aligned with the duty for the intermediary choice for expression.  And talks about the extra legal content restrictions are what can be classified as beyond regulation.

What I briefly described is a patchwork of interests that have a broad impact on public health access to medicines.  I would like to finish with a set of reflections for moving forward that the scoping reviewed allowed.

The first is that the Internet represents and the unification of the online in the physical world represents new jurisdictional and regulatory challenges.  This prompts the need to think about regulation not as a matter of if, but how to prompt the intermediaries as quasi legal functions they serve.  That is in the report as well.  But also the need to think about where we have these conversations.  And that in a sense, global problems cannot be addressed by international law.  In the report where it looked at over 200 key experts in the Internet governance space, 80% indicated that we have insufficient international coordination and coherence to address cross border legal issues into the Internet, Internet pharmacies being one.

Second, this is an issue of mediating trust and more broadly over the Internet as well.  Who does the mediating based on what values?  How is it reflected in the regulatory approach?  That gets us to this idea of balancing interest.  Not all interests are equal.  And foundationally we need norms and values to drive the decision‑making.  Some have argued for a broader set of human rights based on the U.N. declaration of human rights around cyber nation rights, ought to be identified beyond national jurisdictions.  That is an idea worth exploring.

I would like to talk about one example of type of norm diffusion and norm‑based process that led to ‑‑ in this particular space.  It started in 2017, in Brussels a group was brought together by a loud New Yorker you will hear from in the room, sought to develop a set of principles around which standards and guidelines and best practices could be shaped.  The following year, I participated in the process in Toronto at rights con about shaping, refining and debating these that became the Brussels principles on the sale of medicines over the Internet.  You can find the document at the end of the discussion paper.  It contains seven principles aligned with normative language adopted from international organizations and international organizational documents including U.N. declaration of human rights and World Health Organization.  The Brussels principles are not the final word, they represent one norm‑based multistakeholder approach that could inform a future action in this space.  Moving forward, there are other forums where the intersection of Internet governance and public health can be instrumentalized into harmonized standards, guidelines, best practices.  That includes fora like the IGF and fora like ICANN and jurisdictional fora like INJ or rights con.  At the same time, it is important to reach out to other international bodies that approach issues from a public health and human rights perspective including regulatory bodies.  WHO including a Department of Digital health.  They're working talking to.  I'm in dialogue with the WHO to subset and falsify, and put on the work plan for Internet pharmacies.  Other regulatory bodies such as ‑‑ what is this (mumbling)

As this group, for example, international Coalition of regulatory authorities that on a technical level deal with issues of regulatory harmonization and potentially thinking about standards organizations like international organization of standards.

Moving forward, we hope a norm‑based multistakeholder approach helps shape this issue.  We'll now hear from our next panelist.

(Applause)

>> MODERATOR: Thank you, Dr. Amad.  Indeed, lots of information.  I have to say I have been privy to the gathering of this information over the last period of time, and it is really exciting to see that there is a group of people gathering together from different parts of the stakeholders that are mand in this sector to really look forward to see how can we find a way to harmonize all of these very tricky issues to find a path forward that really is not a trade issue, but rather a health issue and look at it from that perspective.  Thank you for the work.  I'm looking forward to seeing how it unfolds in the years to come.

I would now like to turn the floor to Dr. Oki Olufuye to bring a developing nation's focus to the issues that aria highlighted.  Things are very different in Nigeria.

I will move this forward.  I'm sorry.  I was just saying that things are very different in Nigeria.  In 2018, this nation of 2 hundred million people got their first certified ISO standard lab so that Nigerians could actually do the quality control on medicines in their own country.  That's just quite literally within the last year and a half to two years.  So this is a very important aspect and information to understand that when we talk about the global north, it is a very different situation than the Global South.

So I think they're now working on getting your slides up.  So give them a moment.  I would like to also mention to those in the hubs, I received word that we need to have speakers announce their names before they begin speaking.  So if we can do that, that would be very helpful.  Thank you.

Mark, how are we with the slides?  You need a moment?

>> OKI OLUFUYE: Good morning, everybody.  I have been well introduced.

I'm a pharmacist.  I have a masters in health management.  I have been involved in a lot of issues concerning health.  For me, health is not just a profession, it is a passion.  This morning, I would like to start by referring you to the Sustainable Development Goals for health, specifically medicine, the third one, speaks about universal health coverage for all in relation to access to medicine.

We have the human rights injunction from the U.N.  It looks at the possibility of the highest possible health for all in the world.

That being said, we know there are a lot of issues concerning regulation of medicine in the world.  What do we want to regulate when we talk about medicine?  We need to regulate the research, development, manufacturing, the sales, that's marketing, and the dispensing, the prescription of medicine, all of these are factors to be regulated when you talk about medicines.

For patients, I titled my talk as a case for a patient centric and evidence‑based regulation for medicine.  Patient‑centric and evidence‑based policies for medicine regulation.  So this says that whatever anyone would be doing concerning the regulation of medicine and everyone that is involved in regulation of medicine, that is namely will be the Government, we'll talk about the Civil Society, the regulatory authorities themselves and then we have those that manufacture, the people that do the ME on medicine and all of that.  They all have to have a patient‑centered view on the regulation of medicine and the patient, inside, must be king and the center of all we do.

For statistics, I have good knowledge from the WHO that half of the world still lacks access to medicine or healthcare first and foremost.  30% of the world lacks access to essential medicine.  And 800 million people currently in the world spend 10% of their income on medicines and 10 million of the 800 million are poor as a result of this.  With all of this, with desperation to get healthcare and access medicine, people have turned ‑‑ okay.  Thank you.

People have turned to the Internet to get access to online health and medicines.  We have the emergence of the online pharmacies.  That is what Aria mentioned.  These are online practices to make access to medicine easier, with the globalization and Internet, we have a narrowing of the gap to knowing what is where at what time and how to access it.  Cost of products on the Internet.

This is unknown in the regulatory of some nations, in Nigeria, no regulation for online pharmacies.  Some places you have regional regulation.  And for now, Europe appears to be the only one that has a regional kind of regulation of online pharmacies.  For global there is zero regulation for online pharmacies as we speak.  This is a huge challenge.  Benefits of online pharmacies I would like to highlight at this point.  Sorry.  Just want to get this right.

Okay.

So we have benefits from the online pharmacy emergence.  One is lower prices.  We have privacy.  Some don't like walking into pharmacies to buy medicines if it they can help it and everybody knows they're going to do that.  We have the convenience they offer.  People that can walk even from being ill.  Walking into the pharmacy would be saved by doing an online transaction to get medicine.  We have medical information being increased.  A lot of the sites offer information on health and tips on health.  We have product choice in pricing and other areas because of the online pharmacies.  We also have access to locally labeled medicines now from the emergence of online pharmacies.  They also attempt to answer the issues from (?) and human rights situation I already mentioned.

Risks come along with the emergence.  One of it is inadequate protection of personal information and financial information of clients.  We have some of them lacking physical address and telephone numbers.  This makes jurisdiction difficult when it is needs from just not having a physical address.

We also have unexpected access fees.  When you do your ordering of the medicines, you think you are paying so.

When they are delivered or somewhere along the line, there were some fees not advertises.  We have erratic price changes on websites, offering online pharmacies.  The regulation is huge challenge.  That is also a risk.

The challenges, as we speak, would be the emergence of the rogue actors.  We also call them cyber criminals or illicit online pharmacies that engage in the illegal sale of controlled substances, products that should ordinarily not be sold without prescriptions, available from some online pharmacies we describe as cyber criminals and do the dispensing of medicine sometimes true online sense, pharmacist on pharmacist.

The challenges continued.  We have a lack of physical address on some of them, as I already mentioned, and this makes jurisdiction difficult when one has to seek one.

Global law enforcement, efforts so far are very limited.  Mainly from the Interpol and U.N. office on drugs and crimes.  These efforts have been very limited to get justice for those that have been affected by this.  The key issues then would be can we have in choosing the safety, that is an issue.  Could we have the emergence of an inclusive global governance mechanism that would engage in multidisciplinary actors or engage multidisciplinary actors from the global public health, the IT and global enforcement to sit at the table and form a standard of practice for online pharmacies.

Another key issue is the thought that it should be an ability to leverage on existing health and Internet governance structures.  To actually provide the standards.

More key issues that have come up include the low level of awareness of even the online pharmacies themselves.  And then the rogue actors.  Even the mode of operation keeps changing.  You try to shut them down somewhere, they go with a new name to another site.  And people continue to fall victims to their practices.

Key issues, can we push for the Internet Governance Forum for this year for one world, one net, one vision in the sales of medicine online by providing a kind of credentialing and accreditation system that will lead to a standard practice for all and the uniformity probably of pricing.

All key actors in the e‑commerce, specifically for pharmaceuticals now, I named some of them already.  But I would like to now include the advertising agencies, the people responsible for the borders, in countries, the regulatory authorities themselves, the Government of course.  Did I mention the Civil Societies?  All of those people that have something to do with the supply chain of medicines must become patient centric and use evidences in the promotion of their roles.

Currently, the attempt by some nations to kind of prevent a fair platform for regulation for me would be monopolistic and self‑serving, to say the least.  I would say it is an issue of immorality or morality and probably it needs to be reviewed.

Sorry about that.  Another key issue is, is there a reasonable justification for price discrepancy of same brands of medicines as we currently have it by same manufacturers across borders?  What this is saying is you have a drug from the same pharmaceutical company in two nations offering as much as 10% or should I say 10 times higher pricing.  Pfizer could have a drug in Nigeria for $10.  And maybe in Ukraine, for $800.  The discrepancy sometimes is that much.  Is it possible to actually sit down and find out if there is a justification for such a practice?  And why could it be surmounted?

Globalization on the Internet has narrowed the gap in lifestyle, culture, tradition, and if you will, religion as we see it today.  No doubt commerce is also affected.  We have to face the reality that eventually, there is going to be a pressure, even from the consumers, the patients on Governments, on the Civil Society.  Even the global governance system to ensure that pricing, the regulation of medicine, it's like we have as a theme this time, one world.

I would like to highlight the African situation where I come from.  Currently, in Africa, we have good training of pharmacists.  I hope I'm an evidence of that.  The national bodies are well coordinated.  They have strong national bodies of pharmacists in Nigeria and continuous education system yearly you bring pharmacists together to renew knowledge and note current global trends in pharmacy.  We have premise have to display licenses and for the premise itself and the pharmacists in charge of that permit.  And we have routine physical inspection of farm sees in Africa and lot of places in Nigeria where I come from.  The database for pharmacies and pharmacists is also pretty good.  You can even find some online.

However, medicine regulation also has the same applaud.  There is situations, no doubt.  Nigeria and African countries, we have the top opportunity to know the content of your medicine within seconds and know if they're genuine or not.  We have a verification code imputed on some medicines and allows you to actually do an SMS to a number and know if that medicine is also genuine.  These are great regulations and innovation in medicine in Africa, Nigeria.

In spite of this there is a 30% penetration of fake and counterfeit medicine in Africa, as against the 1% you have in the developing world.  Countries in Africa practically all of them have regulatory agencies apart from SRE.  Unfortunately, with the regulatory authorities, 7% are moderating capacity to regulate 19% capacity through regulation.

There is attempts to form an African regulatory authority that is brought to the table for discussion at AU, but as we speak today, it has not become a reality.  There is no regional regulatory authority in Africa.

Still on African situation.  The borders are very porous, but there is information, because in Nigeria, we have all land borders closed, just to enable the Government to review the things that go on at the border, to include the importation of pharmaceuticals.

Nigeria has a population of about 2 hundred million people.  Of those, one hundred million on the Internet.  I will come down to that.  Anyway.

Ron mentioned this already.  Just about two years ago, we had had our first international WHO prequalified lab that can do testing on medicines right in Nigeria.  Currently, we have about three of them.  For a population of 2 hundred million, you agree with me, that is definitely not enough.

For health seeking behavior in Africa, currently, you have people rely on prayers, they go to the traditional medicine manufacturers that mix a conduction together and tell you it will do this.  Maybe 10 indications from same drug.  You use them, the side effects are usually (?) because you have the active ingredient and the dangerous substances all combined in one and offered to patients.  This is another dangerous trend.

A lot of people cut off the hospital in Africa and Nigeria.  They prefer to go straight to pharmacies, where the pharmacy then becomes the doctor that will do the consultation, do the privilege and the dispensing of medicine at the same time.  This is another dangerous practice we have there.  Just as if you go to the public, the public ones are usually very loaded with people, sometimes you have a doctor attending to about 100 people in a day.  You don't want to go to the hospital to wait, if you can help it.  So people to save the waiting time, go to the pharmacy directly.  Do other things I already mentioned.

We also have just if you go to private hospitals, obviously, from a financial standpoint, many cannot afford to do that.

Tanzania as we speak today is the only country in Africa that has a WHO prequalification on the national regulatory authority as being well functioning.  Tanzania actually has two regulatory authorities for medicine.

All that we have talked about will point at a lack of adequate governance for medicine and regulation.  Tools, funding, expertise and legal framework for regulation of medicines.  Nigeria like other African countries, I mentioned this, you can get your medicine without prescription.  You can any to the traditional alternatives and medicines are sold in places like the market, on buses you get someone on a bus, tells you he has this product that can do this and do that and you see people, even enlightened ones, because of the issues surrounding access to medicine, actually asking to buy these products.

In Nigeria and some African countries it is possible for a nonpharmacist to own and run a pharmacy practice.

And you can imagine what comes out of that.  Still on the African situation ‑‑ I want to go to the Internet statistic, actually.  In Africa we have about 1.3 billion population, but of this 465 million alone are on the Internet.  That is obviously a very sad number.  We have a 10% rise annually in e‑commerce activities online.  e‑commerce activities.  This is said to be since 2014.  I got that from the United Nations trade and development authority.  Conference on trade and development.  In Nigeria, I mentioned already our population is 200 million.  We have 111 million Internet users and 27 million online shoppers.  This information is from 2017.  That, for me, should tell everyone here today, the opportunities in e‑commerce in Nigeria and Africa.

Currently, there is no data in online pharmacies in Africa, but in Nigeria, I know we have about 14 of them.  There is absolutely no regulation.  They offer medicines without prescription, just like the brick and mortar pharmacies.

So to conclude, the nations with poor regulatory systems, Africa, maybe some Asian countries.  We need medicine regulation.

The advocacy has to increase.  When we want to regulate globally we need to think of the patient and consider evidence‑based policies.  You don't just go around politics, income and profits, in doing things relating to health.  And I finally put that health ‑‑ just go here now.  Health is spring board for every other thing we do in life.  You need health to attain your full attention, independently, globally as well.  We can't afford the health as politics toy with it as we have it in the world today.

I end by saying that the patient remains king in everything we do concerning health.  We want a patient centric and evidence‑based attitude in policies when it comes to medicines.  Thank you very much.

(Applause)

 

>> MODERATOR: Thank you.  Oki Olufuye it was extraordinarily enlightening.  It is interesting to see just the size of the population and the Internet penetration and recognizing that with the 2030 goals that we have heard at this conference and other places, this is where the new people coming online are coming from.  If we can find a way to come together, create a set of standards under the Brussels principles that online pharmacies being have some regulation in the form of almost self‑regulation.  It is not necessarily having one Government or even the United Nations or others coming to ratified treaties, but set of protocols, standard, safety, patient centric.  This extraordinary.  I would say you are indeed evidence of good pharmacy training.  Thank you very much.

Now turn to Gabrielle Levitt.  He's an author of the original Brussels principles as mentioned earlier help he has a long history in this space.  As you will see very passionate views.  I'd like him to share with us the origins of the Brussels principles and how they are what they are today.  And with pharmacy checker perhaps you can share thoughts about medicine pricing.  Gabe, the floor is yours.

>> GABRIELLE LEVITT:  Hi.  I want to say it is an honor to be on a panel with Oki Olufuye and aria, thank you.  And Ron, thank you for setting this stage.  I might not go in the same order that Ron introduced me, in terms of topics but I'm from Brooklyn, New York, U.S.A.  So happy Thanksgiving.

It's an honor to be here at my first U.N. IGF.  Please bear with me, I know we're here to talk primarily about Internet governance and policy, but for a few minutes I'm going to talk about drug prices, public health and human rights.  Then I'll try to tie it into Internet governance.

First, I have a few questions.  I have been excited about being the guy that asks questions.  By a show of hands, how many of you believe that a person in one country who has a valid prescription, who cannot afford a life‑saving medicine should have the right to travel to another country that has much lower prices, buy, it and bring it back home?  Show of hands?  Okay.  Almost everybody.

Let's say they are too sick to travel.  Okay?  In principle how many of you believe they should be able to order it online from a safe online pharmacy that is mailed to them from that same pharmacy that they had previously traveled to?

Okay.  Last question.  Let's say a person with H.I.V. was traveling back from India to their home country with a three‑month supply of life‑saving antiviral medicine.  Would it be a violation of their human rights if a Government officer stopped them and took their medicine because their otherwise lawfully manufactured life‑saving drug was not technically a registered medicine in the home country?  Would that seizure be a violation of their human rights?

Thank you.  Thanks for answering.

>> MODERATOR: I would note for those who are not in the room, it was 80 to 90% show of hands on all three questions.  Sorry.

>> GABRIELLE LEVITT:  I'm wearing two hats today.  Let me start with hat number one.  50I78 cofounder and prosecute of pharmacychecker.com, which verifies online pharmacies and compares their drug prices.  We launched that service in 2003, pharmacy checker is one of four non‑Government online pharmacy credentialing agencies mentioned in aria's paper.  We have developed and operate a program with standards, rules, policies to evaluate and accredit safe international online pharmacies.  Our information is available on our website to consumers worldwide.  And it empowers people to afford medication while not getting burned financially or hurt or killed by a site selling bad medicines.

To talk about that I will put on hat number 2.  I founded nonprofit prescription justice, prescription justice advocates for reforms to bring down drug prices in the U.S.

That would mean fewer Americans are forced to buy medicines from other countries, whether through travel or online.  So what's going on with drug prices?  Let me tell you a story of a drug called Daraprim.  Maarten Shkreli, a former hedge fund manager turned drug company executive became the poster child for greed for raising Daraprim from $13 a pill to $750 a pill overnight.  It treats a serious infection called toxoplasmosis, that is serious for people with H.I.V. and cancer.  It sells for thee ‑‑ $3 in the U.K., and $750 in the U.S.

One more drug, the diabetes drug, type 2, Januvia, it is about $16 a pill in the U.S.

Less than $4 a pill in Canada.  $1 a pill in turkey.  Nam for the same formulation of the same product by the same brand name drug company Merck.  According to the World Health Organization, high drug price are a global public health crisis

In the U.S., people with cancer are twice as likely to end up in bankruptcy, young adults and older Americans alike are facing financial hardship and also dying because they can't afford essential medicines.  In fact, 29% of Americans report not having filled a prescription as directed because of cost within the last year.  Over 70 million people.  Again, prescription justice is advocating for reforms to bring down drug prices in the U.S., so the prices don't force people to buy medicine from other countries.  At the same time, we know ‑‑ I know that international law on online pharmacies are a lifeline for consumers worldwide that are slipping through the cracks of broken healthcare systems so we advocate to protect the ability of individual patients to import medicines if they cannot afford them domestically.

The pharmaceutical industry wants to kill international online access, where it harts their profits and appears be using the Domain Name System to do so.

In the fall of 2016, I published an Article in circle ID called protecting online access to safe and affordable medication.  In that Article I explain the position that the companies are extending the capture of the U.S. laws to the Internet.

One of their methods was funding an application by the national association of boards of pharmacy which opposes importable in the US to attain the dot‑pharmacy registry that was approved.  As I see it the domain name space increasing drug price, decreases competition and ends up misleading customers about what is and is not safe online.  The Article a wrote was a call to action for the medicine and rights communities to get together and talk about this.

I wrote in terms of access to medicines being a human rights, as such some in this community believe, access to the Internet is also a human rights.  As the Internet community seeks to infuse the principles of international human rights law of the discourse and practice of Internet governance, it can and should help maintain the widest possible access to safe and affordable medication.

I'm not an Internet governance and policy professional, although I have been learning a lot.  I had no idea what good publishing the Article would do.

But Nick D'Augustino, one of the lead organizers of rights con, read me Article and said it might be right for Brussels 2017.  That led to a panel of experts and first draft of principles written in concert with people from annual public citizen.  And a year later, at rights con in Toronto, we brought more stakeholders, Academics, including aria, who played an important role in finishing what is now the Brussels, principles on the sale of medicine over the Internet.

Aria writes in his paper, what are the core values that should information this discussion?  And it is it possible to reconcile competing, legitimate interests of stakeholders in it this Internet pharmacy world?  I liked reading competing legitimate interests.  There are indeed competing legitimate interests.  Here's the problem, as I've experienced it.  There is an incredible power asymmetry between the legitimate competing interests, pitting the U.S. pharmacy corporations and multinational companies, which have massive financial and political power against an evolving international online pharmacy industry, which at best is serving public interest of patient's worldwide but undermining the profit models of the old entrenched analog interests.

Quintessential example of this as I see it is the dot‑pharmacy application to ICANN.  It was funded with at least $360,000 from drug companies.

As I see it, it is used to stifle competition in a manner that hurts customers.  Why do I believe this?

There are clear flexibilities within U.S. law to allow import able.  The NABP has adopted the most restrictive interpretation, whereby any website that marks and sells prescriptions imported into the U.S. is automatically not eligible for a dot pharmacy.

So in essence, as I see it, a U.S. trade association's self‑serving interpretation of national law suddenly has an impact with dot pharmacy on the entire Internet global narcotic.  This, despite multiple Academic studies that show when Internet pharmacies are credentialed, prescription importation is safe.

The issue of people buying medications online because it is too expensive or not available locally it is not understood by most people in the Internet policy and activist communities.  It is just being better understood even among access to medicine, activists.

Understanding the Brussels principles does not require a Ph.D. in public health or Internet governance.  They are principles.  On which to build a better future on this issue of access to medicines.

So to bring balance to that power asymmetry that I mentioned and aria mentioned more academically.  And support the human right to safe and affordable medicines, supporting the Brussels principles is a great next step.

(Applause)

>> MODERATOR: Thank you.  Thank you very much, aria ‑‑ thank you very much, Gabe, I should say.  Excellent, excellent presentation in terms of the source and essence of it.  The Brussels principles for those in the room are on the screen.  Not sure if I see them on the hubs.  They could be found at Brusselsprinciples.org.  That is a good starting point.

Aria, if I can turn to you for a second.  When you saw the principles worked through the principles that led you to start thinking more about creating standards.  The essence of the standards, can you share about where that would take us?

>> ARIA AHMAD:  The way I thought about it coming from multistakeholder, multilateral forum approach is to what extent can norms form standards and best practices.  Taking the local governance approach that you sometimes don't need the bottom's up approach.  At the same time you need broad consensus, between states and stakeholders on a particular issue.  You talk about the right to health, make sure it means the same thing.  If you talk about access to pharmacies.  We talk about the same thing.  In a sense, establishing a set of norms predicated on the Universal Declaration of Human Rights and human being within the WHO and multilateral fora, where we have concurrence.

In a way, allowing the common understanding that the global status report argues sometimes underlies why regulation is so difficult when you talk about cross border issues.  How can they inform future action in the space?  One of those is coherence across and between and within countries but at the same time, thinking about the next step of how do you move from that to the mechanisms within the regions, countries, substantially that is through laws and regulations, in the idea of norm diffusion are informed by a broad, multi Standing Committee agreed on a lot of these.

>> MODERATOR: Thank you very much.  I believe we have a couple of questions coming from our hubs.  Is that true?  Do we have anyone online with questions or thoughts, comments?  None at this time.

I turn to the room.  Anyone have any thoughts or questions they would like to bring to the table on this panel discussion?  Thank you, sir, you have the floor, if you could kindly speak your name before you speak so the people in the room and also in the hubs know who is speaking.  Thank you.

>> AUDIENCE: Thank you, my name is Paul Rauly, I will confess this is not an area of my expertise.  I came on invitation.  I'm from the Global South.  There is a massive problem, particularly in Africa where I come from.  Where we're restricted on the top of medicine we can get, expensive, a whole middle man process, people in general are restricted where they can buy.  Even through prescription .  Even people prescribing are getting kickbacks.  And there is the risk of unsafe alternatives.

The concept of procurement of drugs online I find interesting.  But we need to be aware of the constraints within Africa, where we seem to have a number of people online.  That doesn't mean they have meaningful connectivity, doesn't mean they can access e‑commerce.  E‑commerce is not just Internet access, it is having the means to pay, you have to be digitally and financially included.  What I see is a more open way to enable our Governments who attend to be the bulk procurers of drugs through the different health systems to be able to buy drugs more affordably, which means they buy more.  We have the problem of getting the drugs to the clinics.  That is a different challenge.

It is good the independent pharmacists that fill a gap has access to more affordable drugs through different channels.

Our channels to drugs and medicines is quite restricted.  I know this is local regulations that can be adopted to make it more flexible, but with the trust.  Also from a couple of sources.  If independent pharmacies have access to less expensive drugs, it is important they pass on the savings.  Even though they get ‑‑ it is passed on to the end user.

Create better general public awareness in our country of what the options are, the possibilities are, keep them safe.  Today it is a reality.  In Africa people are dying due to the lack of the access to the most affordable drug.  It could be because it is not available in the community or they don't have the means to buy it.  You see cases where someone will be in the city, the drug is in the city, pay have the ability to get it there, but by the time they get there, the person is dead.  The issues are real, get the right drugs to the right place, in those communities tonight it is a complex issue.  I hope will it benefit to solve those questions.

>> Mr. Rowley, are you talking in terms of one particular nation or Africa in general?  For context?

>> Africa is a diverse and complex continent, each guarantee has different dynamics, although there is some common shared dynamics.  I'm from Namibia, in the south of Africa.

>> MODERATOR: Thank you very much.  That is helpful.  Any other thoughts or questions from the room?  I see Gigi Levine, would you like to come forward, please?  Thank you.  Then you will be next in the queue.  Thank you very much.  Please state your name and where you are from or affiliation, that is helpful for the transcript.  Thank you.

>> AUDIENCE: Gertrude Levine with National Association For Pharmacy, National Registrar for the dot TLD.  With the practice of pharmacy like the practice of medicine and law and many other professional sectors, being regulated at the jurisdictional level, I'm just having trouble envisioning those divergent regulatory bodies coming together on a single set of standards that is still strong and consistent enough to ensure competency of pharmacists, lawyers, doctors, and to ensure the patient is protected by those regulations.  I'm mot seeing how those are going to converge into a universal set of guidelines.  Do you have any thoughts on that?

>> MODERATOR: That is a very good question.  I see Gabe would like to speak to that and aria, I will give you a minute or two to talk about that.  Gabrielle, please.

>> GABRIELLE LEVITT:  Thank you for the question.  Quickly I will revert to the Brussels principles as the guidelines in order to get to this difficult consensus that Ms. Levine points out.  It is going to take time.  It will take independent inquiry.  It will take international bodies to governor the standards and governance mechanisms.  But these mechanics should be independent of industry, entirely, as some we can do.  As woe ‑‑ we get there, associations, I believe have vested commercial interests should not be holding the reigns.  As I see it, restraining trade.  There has to be a better bridge forward so that we're not blocking people's access to affordable medication on the Internet.  Where hopefully they can afford medications lily, the safest pharmacies, we have to make sure for people to obtain medication from them.

>> MODERATOR: I would like aria to speak.  Just for a minute.  We have six or seven minutes left and a few people in the queue.

>> ARIA AHMAD:  Thank you, Ms. Levine.  The question is pressing.  It is how to balance that issue.  This panel ought not be, I think, at least we shouldn't walk out of here, thinking that this is a blanket advocacy that we should open up this particular space because as parts to balance that interest, the role as a pharmacist and regulatory authorities that you point out are still deeply jurisdictional is to protect patient safety and consumer safety.  And particularly, when they go online.  These issues, sometimes there is sort of ‑‑ we look ‑‑ take a sort of blind eye with certain consumer goods, where they come from places where the regulatory standards are not the best.  And it is a public health issue, like, for example, with vaping pens, a few years ago, it is possible to take swift action with a jurisdictional capacity.

There are channels, that is the point of my paper, that is we can explore where harmonization is possible and there are precedence where on issues there are lateral or multilateral adherence.  On the bilateral level, for example, there are national medicines, regulatory authorities that have a mutual recognition of regulatory competence, for example.

Which allows for this idea of a caravan to Canada of Americans coming to Canada, purchasing drugs from registered Canadian pharmacies and importing them into the U.S.

In the regulations, there is clear guidelines on Canadian importation.  On the multilateral level as well, there are a couple of the fora.  The council of harmonization, that including regulatory agents and IFPMA, the pharmaceutical manufacturers, and the group that I showed, international Coalition of medicines regulatory authorities.  Where a big part of the goal is North Texas to impose but have greater cooperation and coordination around a common understanding of a problem.

Like for example, in my field what, do we 19 by a counterfeit drug.  Is it a market drawings problem, with an approved glove.  Or other good practices, good manufacturing.  It is North Texas be liberalization of the market but have greater conversations across countries to develop an understanding where there are risks and opportunities where harmonization can partially provide a great access and through that improved access, public access to medicines.

>> MODERATOR: Thank you.  I would tag on to that, in this room yesterday, about the same time Internet and jurisdiction were going through their new report, the global status report.  It appears more and more to me personally, that there is a convergence of the thinking in terms of the work that that body is undertaking and the work aria is undertaking.  I believe there is a pathway.  I am grateful you brought it to the table.

It is a question, how does one get there with the patchwork of regulation.  You are right, thank you for bringing that forward.

Madam, I don't know your name, state your name.

>> AUDIENCE: Karen O'Reilly, with statute 404.  I'm thrilled to have a pharmacist on the panel.  I work primarily for Internet policy but I'm an asthma patient who 12s around the world so could be there be subject to regulatory capture, healthcare should not be it.  We have the ‑‑ if I go to Spain, I can get an albuterol inhaler for five euro without a prescription.  In medicine, we have triage, treat the urgent problem first.  You should be under the care of the physician, but you can't breathe right now.  A woman in New Jersey was denied an albuterol inhaler because she lacked $1.50 for the co‑pay of $21.50.  She had to call an ambulance because of that.  In the United States as well.  Primatene Mist, an inhaled epinephrine is back over the country.  Which is contraindicated by a lot of pulmonologists, but you cannot get an albuterol inhaler.  It ranges from $5 co‑pay to $60 for something purchased every month.  I say have a pharmacist‑centered approach.  Have a medical‑centered approach.  We already have evidence of what works, what doesn't in terms of pharmacies.  And harmonization should not necessarily be the responsibility of lobbyist organizations.  I would like to have a lot more discussion among medical providers first.

>> MODERATOR: Thank you very much.  That is very valuable.

I see Claus.  It is now coming up to about one minute away from our closing time.  We might go over a minute, if there is anybody else with a burning question after Claus, let me know.  Otherwise you have the last word.

>> AUDIENCE: Very quickly, applaud all of the focus group.  It is a pity not a lot of people in the room.  Because basically what we are talking about all the time.  We're missing the point.  We're missing the point that this is all about digital governance as a whole.  And this should be discussed in full plenary.  Digital pharmacies, digital health, everything you mentioned on trademark, copyright, it is all belongs together, needs to be discussed.  We shouldn't be in that little silo medicine, pharmacy something like that.  No.  This is something which is a symbol for everything.  As somebody who is a little bit engaged with ICANN, when I hear about that thing with dot‑pharmacy, I still get a stomachache.

I still get the stomachache, that doesn't help us.  It helps us to find the right policies so these things don't happen again.

So what I would encourage everybody is don't see it as a pharmacy problem.  Don't see it as a medical thing.  This is digital governance as a whole.  Thank you.

>> MODERATOR: Sir, I think you summarized it as best as anyone could.  Thank you for that Claus.  I would like to thank all of my panelists today Oki Olufuye, Aria Ahmad, and Gabrielle Levitt.  And all the voices that came forward today, this is exactly what chancellor Merkel said, we need the voices to speak up.  The things I heard today really excite me.  I'm very much looking forward to seeing more contributions from all of you in this forum.  Thank you for coming, thank you for those online watching.  I will now bring this session to awe close.  Thank you again.

(Concluded)

 

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