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

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 Instead, we have a legislative and regulatory patchwork with uneven jurisdictional coverage, frequently outdated, and enforced disproportionately.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 What is required, in other words, are ‘digital’ standards to augment outdated ‘analog’ laws.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.