IGF 2020 WS #116 Pandemics & Access to Medicines: A 2020 Assessment

Information

Session

Time:

Monday, 16 November, 2020 - 14:00 to 15:30 UTC

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Room:

Room 3

Thematic Track:

Trust

Topic(s):

Internet Standards
Norms
Safety by Design

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)

Format:

Round Table - U-shape - 90 Min

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.

Issues:

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.”

Policy Question(s):

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?

Expected Outcomes:

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.

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.

Moderator:

Ron Andruff, Private Sector, Western European and Others Group (WEOG)

Online Moderator:

Mark Datysgeld, Private Sector, Latin American and Caribbean Group (GRULAC)

Rapporteur:

Tim Smith, Private Sector, Western European and Others Group (WEOG)

Discussion Facilitation:

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.

Online Participation:

Usage of IGF Official Tool.

SDGs:

GOAL 3: Good Health and Well-Being
GOAL 10: Reduced Inequalities
GOAL 12: Responsible Production and Consumption

Background Paper

Reference Document

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IGF 2020 WS #116 Pandemics & Access to Medicines: A 2020 Assessment

Information