Session
Organizer 1: Ron Andruff, ONR Consulting, Inc.
Organizer 2: Mark Datysgeld, Governance Primer
Speaker 1: Jillian Kohler, Intergovernmental Organization, Intergovernmental Organization
Speaker 2: Bertrand de La Chapelle, Civil Society, Western European and Others Group (WEOG)
Speaker 3: Aria Ahmad, Civil Society, Western European and Others Group (WEOG)
Speaker 4: Patrick Kane, Private Sector, Western European and Others Group (WEOG)
- Zina Hany, B.Pharm, MPH, MBA, CEPH (MENA region) will be replacing Jillian Kohler.
Ron Andruff, Private Sector, Western European and Others Group (WEOG)
Mark Datysgeld, Private Sector, Latin American and Caribbean Group (GRULAC)
Tim Smith, Private Sector, Western European and Others Group (WEOG)
Round Table - U-shape - 90 Min
1. In the absence of uniform procedures, policies, legislation and regulation regarding Internet pharmacies, institutional frameworks breakdown because there is no ‘health’ coordinating body stepping forward to gather all of the central actors to address growing public health issues. Devoid of any governmental or other coordination, which policies are needed to achieve universal access to safe and affordable medicines?
2. Governments, online platforms, civil society and other stakeholders as well as users are working to address the challenges of harmful content, contact and conduct online. In this case, the harmful content and conduct of rogue pharmacies. Which policy approaches and responses support effective and coordinated actions to identify legitimate online websites and to remove bad rogue pharmacies from the Internet?
3. Health-centered institutions from around the world rushed to create information websites/portals to keep citizens knowledgeable about all aspects of the pandemic and its impact on them. Which policy lessons have been learned from this implementation?
4. Internet Intermediaries 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 .Pharmacy gTLD and Trusted Notifier systems?
5. In the Internet and Jurisdiction Policy Network’s, Global Status Report, introduced at IGF Berlin 2019, stakeholders sent a strong message that current coordination efforts are insufficient. Asked whether there is sufficient international coordination and coherence to address cross-border legal challenges on the internet, no less than 79% of surveyed experts answered ‘no’, while only 4.5% answered ‘yes’. 16.5% responded that they have no view on this question. How do we advance policies that draw the needed international coordination into the discussion?
Our proposed Workshop directly speaks to a question raised within the MAG: “Can the IGF fulfil its promise to be the platform that leads to the development of globally-applicable rights-based public interest norms and principles for Internet governance, policy and regulation?” In fact, in our view, our proposed Workshop is a real world example that confirms the IGF is doing just that. Expanding on Dr. Aria Ilyad Ahmad’s Discussion Paper, introduced at IGF Berlin (Day Zero #47 and Workshop #92), Digital Governance of Public Health: Towards a Regulatory Framework for Internet Pharmacies, our IGF 2020 Poland Workshop will bring forward jurisdictional, moral, financial and other issues associated with the on-going development of Internet standards and norms under the Brussels Principles on the Sale of Medicines over the Internet. The first 3 of the 7 Brussels Principles state: #1 Access to affordable medical products is a fundamental component of the right to health. #2 Patients with a prescription should be able to use the Internet to order safe, quality and affordable medical products for personal use. #3 National and regional legislation, regulation, and enforcement policies and actions should not prevent and/or deter patients with a prescription from importing safe, quality and affordable medical products for personal use. The issues and challenges addressed in our session originate in the deadly consequences of pandemics, and consider how global viruses over-stress all systems, e.g. the COVID-19 pandemic demonstrated how antiquated legislation and regulation must be replaced by practices that sustain global humanitarian needs for access to medicines. Standards and norms bring order to a world of unrestrained rogue Internet pharmacies. On the one hand, the lack of regulatory coherence can undermine access to affordable and quality medicines from legitimate Internet pharmacies. At the same time, current efforts have failed to adequately respond to the risks posed by rogue websites. Rogue actors are imposter web sites that disguise themselves as legitimate pharmacies, but they are patently corrupt – the abuse of entrusted power for private gain – as defined by Transparency International. It is profit opportunities that have fostered the proliferation of ‘fake Internet pharmacies. Rogue actors who engage in the sale of medicines, particularly controlled substances without a prescription, pose a threat to public health and patient safety in normal circumstances. According to one of this year’s proposed panelists, “in times of pandemics, this malady is on steroids”. The bigger challenges come once the COVID-19 pandemic has passed: Will the shock of the virus provide the impetus to turn our united and undivided attention as a global community to call on governments to address global health issues, including access to medicines, and the widespread egregious disparities that leave our existence at risk? As noted at the top of this section, our proposed workshop is indeed one “…that leads to the development of globally-applicable rights-based public interest norms and principles for Internet governance, policy and regulation.”
GOAL 3: Good Health and Well-Being
GOAL 10: Reduced Inequalities
GOAL 12: Responsible Production and Consumption
Description:
Pandemics & Access to Medicines Over the Internet: A 2020 Assessment In 2019, the MAG for IGF Berlin selected our proposal for a Day Zero event (Pre-Event #47 Protecting Public Health Online: Shadow Regulation & Access to Medicines), as well as our Workshop #92 (Public Health Online: Shadow Regulation-Access to Medicines). At the IGF 2020 Poland, we will build from our prior work and contextualize it within the current COVID-19 pandemic; a clear and present danger to the health and well-being, social welfare, and the global economy. COVID-19 does not respect borders or political parties. This has created global prioritization of a distinct opportunity to reshape our world, prioritize health and well-being, and to build international solidarity around access to medicines as a human right.
At the center of this chaos, the Internet has emerged as a tool that enables students to study and parents to work from their homes, consume entertainment, and learn more information about the pandemic from a global perspective than any who have come before us, a privilege and benefit that previous generations did not have. Currently, 63% of all deaths worldwide occur from non-communicable diseases – chiefly cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. However, the disparate prescription prices for daily essential medicines that keep people alive boggle the mind. Why does it cost US$ 1028.00 for Zetia, for high cholesterol, in America and only US$ 259.00, in Canada? Or the asthma medicine Advair at US$ 1102.00 in the United States, but available for only US$ 436.00 in another country?
Current cross-border restrictions prevent the sale of approved pharmaceuticals, thereby impeding competition in a global marketplace, keeping prescriptions artificially high, and not in the consumer interest. Importantly, these medicines are the same products, manufactured by the same company at the same cost, so the 60-75% difference in pricing is considerable. What happens if Big Pharma were to take the same approach with anti-virals and the vaccine instrumental in the fight against COVID-19? Internet pharmacies, defined as websites that sell legally manufactured prescription medicines from licensed pharmacies upon receipt of a valid prescription and deliver the medicines through the mail directly to the patient, represent a challenge to outdated practices, rules and regulations of pharmacy, as well as with legal jurisdictions. ‘Price’ being the primary motivational factor for turning to an Internet pharmacy, ‘access’ being the second.
During a time of stay-at-home orders and mandated social distancing, the necessity of safe Internet pharmacies becomes even clearer. Drug supply problems are a critical constraint for making progress in health outcomes within the spectrum of treatable diseases globally. According to the World Health Organization (WHO) about one-third of the global population does not have regular access to medicines, so the advent of Internet pharmacy is creating opportunities for better access to medicines; at the same time, the global expansion of falsified/substandard medicines, if sufficient controls are not in place.
The WHO estimates that about 25 percent of drugs consumed in poor countries are falsified or substandard. Our workshop will bring experts who have been fighting the COVID-19 pandemic; leadership from the World Health Organization Center for Governance, Transparency, and Accountability in the Pharmaceutical sector; innovators in cross-border jurisdiction, and stalwarts in Internet governance to speak to key aspects of the pandemic and its direct impact on access to medicines and vaccines, all in the context of Internet Governance. Indeed, as we see it, the pandemic emphasizes the acute need for improved rules on access to medicines. In fact, the virus serves as a resounding call to wake up, to join together, and to care for each other.
Substantive discussions during our session will facilitate movement toward an open, transparent Internet, empowered by choice, competition and trust to shape a healthier future that, in point of fact, will attend to those in need of access to safe, affordable medicines. Our intention is to incorporate the information presented and gathered in this multi-stakeholder forum into our report, as well as to serve as a resource for our future actions. The moderator will open the session with scene-setting remarks, followed by 15 minute interventions from each of our 4 speakers.
We anticipate that our speakers’ remarks will showcase (1) the current state (pre-COVID 19) of tele-medicine/E-Health, and (2) what needs to be addressed to achieve the objective of access to medicines for all, as we move forward. Interventions from the attendees, both those online and those in the room (Q&A) will be brought forward during the final 30 minutes of the 90 minute session. Notably, we will be using a U-shaped table for the express purpose of encouraging participation and discussion with as many attendees as possible. The practical outcome of our session is detailed in Section 8 EXPECTED OUTCOMES, but it bears noting here that our objective at IGF 2020 is the development of protocols, standards and norms that can be easily implemented to enable safe and affordable access to medicines using the Internet.
As our health and our economies are severely threatened, at minimum governments have a responsibility to respect human rights, including the fundamental right to health, a key indicator of sustainable development. “Poor health threatens the rights of children to education, limits economic opportunities for men and women and increases poverty within communities and countries around the world. In addition to being a cause of poverty, health is also impacted by poverty itself and strongly connected to other aspects of sustainable development, including water and sanitation, gender equality, climate change and peace and stability…”, notes the British Medical Journal. In a new, post-COVID-19 world, can we shape compassionate laws with appropriate safety provisions to provide access to safe, affordable medicines from trusted sources in other countries? How do we move the governments of the world to prioritize public health? Addressing these questions, we have three expected outcomes: 1. To gain a thorough understanding of the issues, opportunities and obstacles relative to the creation of standards and norms which allow for access to safe and affordable medicines using the Internet; 2. A follow-on meeting of key stakeholders from across the spectrums of health, Internet governance, jurisdiction and pharmacy, hosted by a leading educational institution, in mid-2021, carrying the IGF 2020 Workshop outputs forward, with the objective of organizing a collection of internationally recognized standards and norms for safe Internet pharmacies. 3. A published, peer-reviewed paper on this topic, in a major medical journal, as is currently one of our 2019 IGF session expected outcomes, i.e. a peer-reviewed article around the Discussion Paper introduced by Dr. Aria Ilyad Ahmad in Berlin.
Drawing on prior experience, we intend to pose a series of compelling questions to engage the IGF audience, to encourage discussion and debate. Examples would be those listed in our Policy Questions segment, or others, more personal, such as: Since the start of 2020, can you think of a situation in which you relied on the Internet for personal health information? How do you think that experience evolved for other people in different regions of the world? What are the similarities? What are the differences? One of our main goals is to gather insightful perceptions that arise from these interactions, as was our experience at IGF 2019, in which we learned a great deal about the considerations and perspectives from others in attendance, including from the National Association of Boards of Pharmacy, the .Pharmacy Registry Operator. Our estimation of the IGF is that its unique format allows all attendees to feel confidence in the fact that their voices are truly heard, and thus, they tend to speak more freely than they would in other fora. Our moderators have the necessary skills through their experience in having collectively organized and moderated dozens of events, including Day Zero and Workshops at the IGF. As such we are confident that our moderators will manage a stimulating 90-minute discussion that produces specific outputs sought to carry this important work forward.
Relevance to Internet Governance: The impact of the COVID-19 pandemic has been profound. Our view is that not one thing on the planet will be left untouched by the virus. This means that we have an extraordinary opportunity to re-order the world we live in. The Internet is a powerful tool, the value of which, in many ways, is only just now being truly realized as the world stays home to stay safe. COVID-19 has re-enforced the fact that the Internet has become the critical resource for updates and information on the virus, the platform for both education and business to continue on, in a stay-at-home environment. But, notably, the Internet is equally being used for more nefarious acts today than at any other time in its history, which means that scores of innocent people are being harmed at many levels - in this case, with promises of cures, treatments, face masks, fake or substandard test kits and medicines. There is no doubt that E-Health is the future; therefore, we must get the ‘Internet governance’ of E-Health right. Standards, norms, international institutional agreement, are the basis for policies that mirror the reality of people’s daily lives and how they use, and how they trust, the Internet. In these unprecedented times, each of us individually – and extraordinarily governments, civil society and the private sector – all share an equivalent sense of anxiousness about the unknown that lays before us, as the virus recedes. At IGF Poland, we intend to empower the community and stakeholders who share the mutual desire to develop essential Internet industry standards and norms for Internet pharmacies, which, in many ways, is the definition of Internet Governance.
Relevance to Theme: Today, more than ever, citizens of the world are fearful and lack trust in both their leaders and their institutions. Despite the fact that health is a fundamental human right, many world leaders have demonstrated their disagreement, while in the battle against COVID-19, few were able to rise to the occasion. Therefore, in an almost-Utopian view, we, the people, must come together now to make the changes that allow us to re-establish the trust the world is lacking. Contributing to the narrative of the Thematic Track, TRUST, our proposed Workshop, Pandemics & Access to Medicines: A 2020 Assessment, first invokes trust through our commitment to Sustainable Development Goal #3: Aspiring to ensure health and well-being for all. More specifically, Goal #3.8: Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. Trust also comes from knowing your Internet pharmacy is appropriately licensed; moreover, that it is in accord with the Brussels Principles on the Sale of Medicines Over the Internet and has fully subscribed to the attendant Standards and Norms that the Principles embody. As we, the proponents of this Workshop, the stakeholders and the IGF community establish internationally respected standards and norms for Internet pharmacies, those actions themselves inherently build trust. Ultimately however, the patient-pharmacist bond of trust is renewed each and every time their prescription medicines arrive at the patient’s door. Through our IGF participation – in time – we hope the newfound legitimacy of ‘Internet pharmacies’ will engender the same deep level of trust as brick-and-mortar pharmacies do today.
Usage of IGF Official Tool.
Report
Areas of agreement:
- The use of the Internet for purchase of medicine is increasing at a rapid pace, and this has been further accelerated by the COVID-19 pandemic.
- There is no global (and mostly no interregional) regulatory framework in place to ensure the safety of consumers, often leading to outright prohibition of transnational purchases.
- There is a significant number of rogue online pharmacies selling falsified or substandard medicines, and more action needs to be taken to balance their incentive.
- An important issue relating to this theme is the lack of a clearly defined role for intermediaries, such as is the case of registries and registrars, which are vital, yet lack defined procedures to deal with or identify which are legitimate or illegitimate online pharmacies.
- The existing TLD that declared it was specifically for pharmacies (“.pharmacy”) has proven to be disinterested in the issue and thus, it is insufficient to cover both existing use-cases or to address the problem of rogue actors.
- The IGF is proving to have the potential to be ‘the suitable home’ for furthering dialogue and debate in this area, serving as a neutral space where all actors can engage.
Areas of no agreement:
- As there are many different levels where action can be taken, from the local to the global, it is as yet unclear where the starting point is that will yield the most optimal outcomes.
- The DNS can be leveraged to minimize problems, but the models that need to be put in place (white/black lists, trusted notifiers, and so on) have still to be agreed upon, signaling that more studies need to be carried out.
- It is yet unclear how to address this issue from a global perspective, accounting for the significant variances in development of different nations vis-à-vis the maturity of their respective markets.
It is clear that the discussion of the access to medicines using the Internet involves issues that have an impact ON the Internet’s technical infrastructure, as well as AROUND that infrastructure. This indicates that both technical bodies and political institutions need to be engaged to achieve the best outcome possible.
A similarity that this question shares with other jurisdictional issues is the need to balance a triangle composed of: Human Rights, security, and economic concerns. These matters of jurisdiction continue to grow in importance; therefore, addressing them in a focused, systemic manner will become ever-more necessary with each passing year.
There is no silver bullet solution at the DNS level, however beginning from the DNS would be a constructive start to enable ground rules to be set, which point toward norms that can be adopted in a broader manner. Dialogue within the ICANN community would also expedite actions around both the punishments and incentives for involved actors.
There is a need for a more permanent ‘dialogue space’ in which matters that intersect medicines and the Internet can be addressed, so that discussions can advance at a pace that more closely reflects the speed in which this theme is growing in importance.
The number of stakeholders involved in the deployment and sale of any given medicine is noteworthy. Only through proper mapping and research of their operations, cooperation and collaboration will we be able to achieve the objective of establishing Internet pharmacies as trustworthy as bricks and mortar drug stores. We hold as true that the goal is achievable.
- Ron Andruff, ONR Consulting, Inc.
- Bertrand de La Chapelle, Civil Society, Western European and Others Group (WEOG)
- Aria Ahmad, Civil Society, Western European and Others Group (WEOG)
- Zina Hany, B.Pharm, MPH, MBA, CEPH (MENA region)
Access to medicines is a universal subject affecting all people.
Moderator Ron Andruff introduced the concept of the sale of safe and affordable medicines over the Internet, emphasizing how there is no unified framework or set of norms in place to organize this market. Rather, the marketplace ends up relying on a variety of often incompatible local regulations, resulting in the emergence of gaps that both decrease access to medicines and end up being abused by bad actors using rogue pharmacies to harm consumers the world over, while legitimate Internet pharmacies often face complex regulatory challenges. COVID-19 accelerated an already ongoing process of people needing to rely on digital technology to ensure the maintenance of their health, bringing further pressure to the theme. There is a strong Human Rights dimension to this debate, but, at the same time, there is a need to ask which are the correct policy questions?
Panelist Bertrand de la Chapelle advanced the question of how highly-regulated medicines are and, in comparison to previous debates held in IG such as multimedia and pornography, Internet pharmacies is a much more complex and nuanced matter. There is a patchwork of regulation around the world that is legitimate, dictating: Who can prescribe? Who can distribute? Who can manufacture? There is a significant similarity to other issues that transcend jurisdiction, which fall into a triangle that needs to be balanced, composed of: security, Human Rights, and economic concerns. He further brought up the point that fighting bad actors via the DNS could be effective, but is often too blunt of a tool, so very clear guidelines need to be delineated for the DNS to be an effective tool in this effort. Finally, he laid out the matter of broad use gTLDs (e.g. COM) versus industry-specific ones (such as “.PHARMACY”) and how those can play a role in these concerns.
Panelist Aria Ilyad Ahmad warned of the need to find a regulatory sweet-spot; not overly open nor overly restrictive. He laid out how COVID-19 derailed potential progress within the WHO around the normalization of some aspects of a freer flow of medicines across the world. Aria referenced his Discussion Paper, “Towards a Regulatory Framework for Internet Pharmacies”, first presented at the 2019 Berlin IGF, outlining the need for national medicine regulatory authorities to be involved for these matters to be adequately addressed, as they are actors actively seeking harmonization. He recalled an important effort in 2014, when the issue of medicine quality was a contentious matter within the World Health Organization, but lacked any international mechanisms to address it.
Panelist Zina Hany grounded the discussion in real world examples, relaying extensive data from the MENA region that showcased the rather difficult situation most developing countries find themselves in. One very important point she raised is, how due to poor reimbursement policies, a lot of patient payments end up being out-of-pocket, which incentivizes bad practices. This is further compounded by how ownership of credit cards is conditional and not widely available in some regions, making the task of importation largely impossible. Furthermore, Zina underscored that governments in the region are protective about local drug manufacturers and, therefore, are reluctant to support the idea of a cross-border online platform for medicines, for fear of negatively impacting local manufacturing businesses.
The Workshop concluded that these questions need to be further explored and better systematized, so that a real comprehension can be achieved and effective action be taken. It is proposed that some of this work is housed under a new DC entitled: Access to Medicines Using the Internet. So, our Voluntary Commitment as requested by the IGF Secretariat is being fulfilled by the group committing to advance the dialogue during the coming year to find the most beneficial approaches to resolve the safe Internet pharmacy conundrum once and for all.
The organizers are committed towards advancing the creation of a group, probably in the form of an IGF Dynamic Coalition, to carry out more conversations around this subject in which all actors get to present their points of view, concerns, and solutions. The initiative will guided by the objective of advancing and promoting evidence-based research on access to medicines using the Internet.