IGF 2019 WS #92 Public Health Online: Shadow Regulation-Access to Medicines

Information

Session

Theme:

Security, Safety, Stability and Resilience

Subtheme(s):

International Norms
Human Rights
Internet ethics

Organizer 1: Ron Andruff, ONR Consulting, Inc.
Organizer 2: Tim Smith, CIPA
Organizer 3: Aria Ahmad, York University

Speaker 1: Oki Olufuye, Government, African Group
Speaker 2: Jillian Kohler, Intergovernmental Organization, Western European and Others Group (WEOG)
Speaker 3: Aria Ahmad, Civil Society, Western European and Others Group (WEOG)

Policy Question(s):

Innovation and consumer choice are at the heart of the internet. In an increasingly globalized digital marketplace, however, there is a growing need to develop standards that protect the health and safety of consumers. The sale of medicines over the internet represent one of the fastest growing markets, driven largely by a lack of affordability and domestic availability. According to the World Health Organization (WHO), over two billion people lack regular access to essential medicines. Meanwhile, hundreds of millions of people have used the internet to fill legitimate prescriptions from both domestic and foreign pharmacies. While consumers increasingly turn to internet pharmacies, there is a critical gap in guiding principles or standards that apply across national boundaries. Instead, we have a legislative and regulatory patchwork with uneven jurisdictional coverage, frequently outdated, and enforced disproportionately. The lack of transnational principles, guidelines and/or standards as they apply to internet pharmacies has at least two implications to consumer choice and consumer safety. On the one hand, it undermines access to affordable and quality medical products from legitimate internet pharmacies, while simultaneously failing to address the risks posed by rogue actors that sell falsified or substandard medical products, often without a valid prescription. In order to fend off the growing public health moral hazard, there is a fundamental need to develop appropriate international regulatory guidelines. Every day, people all around the world use the internet to purchase products and services wherever they find them at a price they are prepared to pay, for a legitimate product. Pharmacy is no different. What is required, in other words, are ‘digital’ standards to augment outdated ‘analog’ laws. The aim of this Workshop will be to examine a practical and pressing case study of digital governance as it applies to a growing public health need. While the initiative may be novel in the context of an IGF event, it builds on years of work that culminated in 2018 with the adoption of the Brussels Principles on the Sale of Medicines Over the Internet (‘Brussels Principles’, www.BrusselsPrinciples.org) developed by a coalition of stakeholders, internet experts and civil society at RightsCon Brussels 2017 and Toronto 2018. For the IGF Workshop, however, we hope to convene a unique group of stakeholders to take up the outstanding technical and policy challenges while imagining the future of digital governance of transnational internet pharmacies. Participants at the Workshop will range across Governments, internet policy experts, professional associations, academia, civil society, the private sector, certification agencies, and online pharmacies. The objective will be to present the first multi-stakeholder-developed set of standards to meet appropriate legal and regulatory regimes, industry and consumer needs, while applying an approach that provides practical tools to address an increasingly global healthcare crisis. Building on the Brussels Principles, the IGF Workshop will attempt to address the following set of policy and technical questions: 1. How do we move beyond the Brussels Principles to adopting guidelines and/or standards that apply to transnational internet pharmacies which protect consumer choice but also patient safety? What are the outstanding technical internet governance and policy challenges? 2. Countries have differing regulatory models for approving and marketing medicines within national markets: can a global standard be advanced through a multi-stakeholder approach that applies to physical and online pharmacies? 3. Medical professionals are accredited nationally – how can a regional and/or global accreditation system work for online medicine dispensing? Who would undertake the accrediting? 4. Regulators are also often limited to working within national systems – is it possible to achieve a different accreditation system? What organization could oversee such a regulatory accreditation system, e.g. the World Health Organization? 5. Is a treaty needed? Given how slow and resource intensive treaty development can be, would it be possible to envision standards and multi-lateral agreements in providing the needed “governance” for online pharmacies – identifying standards for practice and oversight? Is there a possible model which could be examined, e.g. the World Intellectual Property Organization Patent Treaty? This Workshop will concentrate on legislative and internet policy challenges, while presenting the first and only multi-stakeholder-developed set of standards to move the dialogue forward with appropriate legal regimes, industry and consumer's needs.

Relevance to Theme: In the increasingly digitized world, as we work to achieve the UN’s Sustainable Development Goals that affect how quality healthcare affects all citizens, especially in resource-limited settings, safe and secure interactions online are of primary importance. High prices for medicines present a growing global health challenge to countries of all income levels, including higher-, middle- and low-income, both in developed and developing countries. In his address at the 2018 IGF Paris, the UN Secretary General stated that the digitization of the world affects all citizens, and both daily and business life. Accordingly, consumer rights, data protection as well as regulatory bodies in internet governance and the pharmaceutical sector need to coordinate and collaborate to allow for innovation while protecting consumer safety. The proposed IGF Workshop addresses implementation of the Brussels Principles that seek to develop standards based on safety by design and multi-stakeholder collaboration to improve access to medicines and advance the goal of the UN Human Rights Council Resolution on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including access to essential medicines. This session will introduce and debate a set of guidelines and standards that aim to promote the right to health while contributing to the on-going struggle to rid the internet of rogue actors that sell falsified or substandard medicines, often without a valid prescription.

Relevance to Internet Governance: The internet has served as a disruptive force to traditional industry in the practice of pharmacy and trade in pharmaceutical products, allowing for the international sale of medicines to patients upon receipt of a valid prescription. A new, comprehensive model, which recognizes and reflects how consumers comparison shop on the internet in the 21st Century, is required to create a safe and affordable solution for millions of internet users. Failure to regulate the sale of medicines over the internet, including failure to differentiate between legitimate online pharmacies and rogue websites, poses a major moral hazards and public health risk. Self-regulating online pharmacy practices, which include adherence to globally accepted pharmacy standards that ensure patient safety, are a mainstay of the safe online sale of medicines especially where online pharmacies have submitted to standards and rules of competent private credentialing organizations. Ethical online ecommerce, appropriate internet governance, and trade in medical products has relied on its participants following national regulations of safe pharmacy practice to which they are subject, but which are sometimes at cross purposes with the laws governing transnational transactions, the pharmacies and patients they serve.

Format:

Round Table - U-shape - 90 Min

Description: The session will open with a segment that will identify: (a) the lack of evidence, exacerbated by evidence gaps, misinformation and inflamed rhetoric about the dangers surrounding importation of safe and affordable medicines; (b) the absence of a shared, internationally-recognized standards in the online pharmacy space; and (c) the realities of what is happening in the online pharmacy marketplace. Expert panelists on digital rights, public health, access to medicines, and internet distance care – along with those in attendance at our session – will describe the current state of how innovation, shadow regulations and internet governance impact access to medicines and public health. The factual presentation will cover information both about dangerous websites that sell falsified and substandard medicines intentionally or due to negligence, and the policies of legitimate internet pharmacies that follow good standards of practice in accordance with local or international regulations. The second segment of the Workshop will invite discussion on the output of the research agenda on transnational internet pharmacies from the perspective of governance and comparative policy analysis, in the form of Standards and Guidelines that underpin the Brussels Principles. The goal of the organizers and Dr. Ahmad and Dr. Kohler’s research agenda is to move beyond the Principles to drafting standards and model legislation; the purpose of the IGF Berlin 2019 Workshop, however, will be to engage stakeholders and civil society in a larger discussion about appropriate governance practices that incorporate digital inclusion (in its broadest definition) and consumer safety, appropriately meeting critical needs of internet users today and into the future. The panelists will also detail the substantive policy decisions that have been developed, including the impact these policies will have on consumers and the online pharmacy marketplace. The third segment of the Workshop is committed to summing up the views expressed by participants, with clear identification of suggested outcomes and next steps. The moderator will manage the discussion in a manner that encourages engagement and interactivity both with those that are participating in the room and online.

Expected Outcomes: The discussion, inputs and feedback from participants will: 1. Contribute to, and enhance a working model of Standards and Guidelines that build on the Brussels Principles for the Sale of Medicines Over the Internet; 2. Support the examination of pros and cons of how the internet can become a safe marketplace that promotes access to safe medicines; 3. identify both risks and opportunities, and suggested inputs to such entities as national regulators and the World Health Organization; and 4. Advance a set of multi-stakeholder global standards that make delivery of safe and affordable medicines dispensed over the internet a reality. More generally, this Workshop will provide a platform for development for the potential of a dynamic coalition and ongoing dialogue to improve coordination and collaboration between academics, internet governance bodies, national pharmacy regulators, as well as international organizations such as the WHO and the OECD.

Onsite Moderator:

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

Online Moderator:

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

Rapporteur:

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

Discussion Facilitation:

Online Participation: The moderator will field queries when online participants wish to engage. The panel moderator will encourage online participation throughout the discussion, and incorporate their input appropriately. Discussion facilitation: Led by the session moderator, the invited experts will be asked questions regarding key takeaways about how the access to medicines could be advanced with and multi-stakeholder developed standards. The discussion will investigate international agreements and the worrying lack of coordination and communication between the health, pharmaceutical and internet governance bodies. The moderator will then turn the panelists to ask each other a round of questions, and then turn to the audience for an interactive discussion, dialogue and development of practical opportunities for coordination and collaboration.

Online Participation:

The moderator will field queries when online participants wish to engage. The panel moderator will encourage online participation throughout the discussion, and incorporate their input appropriately.

SDGs:

GOAL 3: Good Health and Well-Being
GOAL 9: Industry, Innovation and Infrastructure
GOAL 10: Reduced Inequalities
GOAL 12: Responsible Production and Consumption

Background Paper

Report

1. Key Policy Questions and Expectations:

1. How do we move beyond the Brussels Principles for the Sale of Medicines Over the Internet [www.brusselsprinciples.org] towards standards and guidelines that aim to protect public health and consumer choice? We hope to survey outstanding digital governance and regulatory challenges, while exploring potential regulatory, legislative and policy opportunities.

2. The Internet & Jurisdiction Global Status Report 2019 highlights the lack of international coordination and coherence to address cross-border legal and regulatory challenges associated with the Internet. Can the multi-stakeholder approach that led to the Brussels Principles serve as a model for advancing the discussion of digital governance of internet pharmacies?

3. What are the opportunities and challenges associated with the dot-pharmacy top-level domain as a digital governance approach to regulating internet pharmacies? We hope to examine how the dot-pharmacy domain is managed, including how minor adjustments could enable a ‘white list’ model that would improve consumer safety and choice.

2. Discussion Areas:

The panel discussed a practical case study on Internet pharmacies that reflected key challenges posed by German Chancellor Angela Merkel on translating rules from the physical to digital realm.

There was broad support among panelists and the audience that consumers should be able to acquire safe and legally manufactured medicines online. Little progress has been made in harmonizing rules and standards to enable such access to safe and affordable medicines over the Internet; a norm-based approach based on the right to health was seen as more favorable than the current restrictive enforcement approach. Panelists also recognized a “hybrid regulatory regime” formulation that provides for intermediaries and pharmaceutical industry influence, largely outside the purview of Internet users.

Since adequate regulation of online pharmacies has been limited at a global scale, confusion persists on the difference between rogue medication markets vs. legitimate Internet pharmacies. This has impeded the ability to generate trust in this important sphere.

It was also argued that the debate of health online has a basis in broader human rights questions, while touching on core Internet governance themes such as jurisdiction, responding to content abuse, and online security.

Panelists also agreed that there is a need for cross-national and international institutional approaches to defining frameworks that reconcile jurisdictional limitations.

There was consensus that the multi-stakeholder approach presents opportunities to further the development of standards and best practices. Credentialing and accreditation of online pharmacies should be global in scope, unbiased and targeted at blocking rogue actors.

The role of intermediaries was also noted, with the “.pharmacy” gTLD holding the potential to ameliorate matters, as well as pilot Trusted Notifier programs aimed at appropriate rapid takedowns.

A significant variety of stakeholders agreed that a whitelist model has better potential to protect consumers, to remove rogues actors, than blacklists.

3. Policy Recommendations or Suggestions for the Way Forward:

Organizational: The Internet increasingly shapes the lives of billions of people around the world, including the right to health. At the same time, the theme maintains little visibility within Internet governance, including the IGF. The subject should be given more attention by organizers, and receive space to be discussed at a main session or as a high-interest topic, so that the audience can engage this practical case study about access and health that shares many of the broader conversations across the Internet governance community.

Technical: It is critical to address malicious actors and “rogue pharmacies” that undermine the safety and choice of consumers online. This can be achieved by: exploring Trusted Notifier programs within registries, registrars and hosting providers; creating blacklists to slow down criminals, while pursuing whitelist approaches that facilitate trust and improve access among consumers. These technical approaches need to be discussed among relevant stakeholders in order for legitimate norms to be made viable.

4. Other Initiatives Addressing the Session Issues:

The panelists dedicated significant time to discussing the ‘Brussels Principles on the Sale of Medicines Over the Internet’ (www.brusselsprinciples.org). This was the product of two years of debate and discussion at RightsCon Brussels (2017) and Toronto (2018), as well as consultations with state-, non-state and technical experts. The outcome was seven principles that reflect human rights norms, in order to ensure “policies that affect online access to medical products aim to be evidence-based and patient-centered, including consideration of the fact that affordability and local availability can be significant barriers to access” [Principle V]. The Brussels Principles were also cited in the Internet & Jurisdiction Global Status Report 2019 as an innovative example of norms informing Internet governance rule-making.

Another relevant initiative is the multi-year research program at York University (Canada) that focuses on regulatory approaches to Internet pharmacies. This project is led by one of the IGF panelists (formerly of the World Health Organization), who also presented a comprehensive discussion paper that stimulated significant discussion. A range of private and non-profit organizations are also actively engaged on this issue. A forum like IGF, however, is essential to facilitate a multi-stakeholder approach to balance competing interests.

5. Making Progress for Tackled Issues:

IGF: Despite significant interest by community members, the IGF ecosystem has been largely disconnected from debates of health online. Organizers have an opportunity to facilitate dialogue at future events by expanding programming around practical case studies. In addition to endorsing the normative and forum-setting role of the UN, the increased visibility could also stimulate necessary multi-stakeholder engagement to address cross-jurisdictional issues with significant human impact.

ICANN: As the community moves towards discussions concerning DNS Abuse, the time is right to explore Trusted Notifiers programs, while further seeking avenues to better define the role of new gTLDs such as .pharmacy for the Internet as a whole.

Academia: research and policy streams are emerging at the intersection of Internet governance with regulation and global health, including the well-received discussion paper presented during the panel. Further opportunities include dialogue on collaborative, evidence-based approaches to cascading norms into standards and best practices.

6. Estimated Participation:

Participants: 20, Women: 10.

7. Reflection to Gender Issues:

The session discussed access to health online in relation to all people.