Protecting Public Health Online: Shadow Regulation & Access to Medicines

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Pre-event 47

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About 10 years ago, the IGF community started to pay attention to issues related to the sale of medicines via the Internet. Today, there is a need to add more nuance to the discussion and overcome a simplistic ‘legalisation versus ban’ narrative. Internet pharmacies enable consumers to buy prescription medication online, medication that is either not available in their country or only available at a higher cost. It is a growing market driven by access to and affordability of medicines. However, when it comes to substandard or counterfeit medicine, online pharmacies also raise public health and consumer protection concerns. The session as a whole was dedicated to the discussion of a paper by Mr Aria Ilyad Ahmad (Global Health Foresighting Research Fellow) on Protecting Digital Public Health: Towards a Regulatory Framework for Internet Pharmacies.

According to session moderator, Mr Ron Andruff (President and CEO of dotSport LLC), there are three broad issues related to the topic: (a) A clear definition of so-called rogue pharmacies is needed to allow genuine online pharmacies to exist; (b) Standards for interoperability between various jurisdictions, for example when online pharmacy shipments cross country lines, need to be agreed; and (c) The issue of online pharmacies demands that public health concerns are balanced with questions around freedom of choice and access.

Further, addressing digital public health needs to include technological considerations (including the inseparability of the online and offline worlds), regulatory considerations (in particular the role played by Internet intermediaries), and jurisdictional considerations (in particular the fact that global problems cannot be addressed by national law).

A useful starting point is to look at supply chains for pharmaceuticals. These include manufacturers, wholesalers, pharmacies, and patients. With the emergence of the digital marketplace, access to other markets and additional price competition are introduced. While digital markets offer convenient access, they also introduce new vulnerabilities.

Broadly speaking, medicine regulation includes legal, administrative, and technical measures undertaken by state and non-state actors to ensure the quality, efficacy, and safety of medicines. With a globalised supply chain, interoperable standards are needed. At present, there are various legal regimes and pharmaceutical associations that certify online pharmacies and their standards differ. Issues around the allocation of the Internet top-level domain .pharmacy further highlight contradictions in the legal regime.

The concluding discussion emphasised issues around trust and the need to start with a norms-based perspective. Further comments emphasised that consumer protection issues are not specific to the online world. While they are exacerbated online, they were not invented online. Taking issue with the term ‘shadow regulation’ (describing voluntary agreements between companies), the discussion emphasised the alternative term ‘hybrid regulation’ to highlight the importance of bringing different stakeholders together.

By Katharina Hone

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