BRUSSELS PRINCIPLES ON THE SALE OF MEDICINES OVER THE INTERNET
The World Health Organization estimates that over two billion people lack regular access to essential medical products (i.e. medicines, vaccines, and diagnostics), which is exacerbated by a lack of affordability and local availability.
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 medical products to patients with a prescription.
Failure to regulate the sale of medical products over the internet, including failure to differentiate between legitimate online pharmacies and rogue websites, poses a major public health risk.
Governments are neglecting their human rights obligations when their populations do not have adequate access to affordable healthcare, including access to medical products.
We affirm the following principles relating to the sale of medical products ordered for personal use over the Internet:
Access to affordable medical products is a fundamental component of the right to health.
Patients with a prescription should be able to use the Internet to order safe, quality and affordable medical products for personal use.
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.
Governments, international organizations and non-governmental organizations should promote a competitive online marketplace for safe and quality medical products in order to protect and facilitate affordability and access for all populations.
Policies that affect online access to medical products should aim to be evidence-based and patient-centered, including consideration of the fact that affordability and local availability can be significant barriers to access.
National, regional and international regulatory efforts should promote guidelines and best practices to ensure that online pharmacies are a reliable and safe source of medical products for patients. They should also identify and, through enforcement actions, sanction those online marketplaces engaging in the intentional sale and distribution of falsified and substandard medical products, as defined by the World Health Organization, as well as the sale of medical products to patients without a prescription.
Internet intermediaries, such as domain name registries, advertising networks, payment processors, financial institutions as well as physical and electronic mail and delivery services should not misuse their commercial power to disrupt online access to safe, quality and affordable medical products.
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The Brussels Principles on the Sale of Medicines Over the Internet is an initiative of the Prescription Justice Institute (PJI), a New York-based, tax deductible non-profit organization. PJI’s mission is to advocate for, research, and build public awareness about online access to safe and affordable medications and personal importation.
While it is well-known that there are dangerous websites that sell substandard and/or falsified medicine intentionally and/or due to negligence, there are many online pharmacies that follow good standards of practice in accordance with their local or international regulations. When the Internet can facilitate safe access to affordable medicines, international organizations, countries, private companies, and non-governmental organizations must assist in collectively deterring dangerous rogue online ‘pharmacies’.
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The Brussels Principles
The Brussels Principles were created by academics, activists, companies, Internet policy experts, NGOs, and trade associations, who know that the Internet has helped millions of patients safely access affordable medicines, including obtaining them internationally through personal importation.
According to the World Health Organization, two billion people cannot obtain needed medicines. High drug prices are a global crisis, one that affects countries of all income levels. Hundreds of millions of people have purchased their medicines over the Internet to fill prescriptions from pharmacies in their own and other countries. Many of them would not have been able to do so if not for their online access and personal importation, due to affordability or accessibility. Unfortunately, there are many dangerous websites, often called “rogue online pharmacies,” that sell substandard and/or falsified medicine intentionally and/or due to negligence. In contrast, there are also online pharmacies that follow good standards of practice, ethically processing prescription orders filled internationally by licensed pharmacies operating in accordance with their local laws. International organizations, national and local governments, private companies, and non-governmental organizations should assist in protecting online access to safe medicines, while curtailing access to dangerous rogue online pharmacies. The Brussels Principles serve to encourage policies and practices to this end within a normative framework affirming access to affordable medicines is recognized as a critical component of the right to health.
History of the Brussels Principles
In 2016, Gabriel Levitt, founder of the Prescription Justice Institute, wrote a CircleID article, “Protecting Online Access to Safe and Affordable Medication.” He described how drug companies have strategically extended their regulatory capture of U.S. laws to the Internet, which is detrimental to patients who need more affordable medicines. The article was a call to action.
RightsCon, the world’s leading conference on human rights in the digital age heard the call, which resulted in an invitation to create a panel discussion/workshop to develop the world’s first set of principles on the sale of medicines using the Internet, with human rights and access to healthcare as guiding values. The title of the RightsCon 2017 workshop was “Online Access to Affordable Medication: Applying Human Rights Laws to Cyber Rule Making and Internet Governance.” Because the conference took place in Brussels, Belgium, the session output became known as the Brussels Principles.
The next year, at RightsCon Toronto 2018, academics Aria Ilyad Ahmad, the Balsille School of International Affairs and Dr. Jillian Kohler, Munk School of Global Affairs and Public Policy led an esteemed panel to thoroughly review the 2017 output, strengthen, and finalize the Brussels Principles.
Brussels Principles Contributing Drafters
- Aria Ilyad Ahmad, PhD Candidate, Balsillie School of International Affairs; Policy Advisor, Dahdaleh Institute for Global Health Research, York University; and Consultant on Substandard and Falsified Medical Products to the World Health Organization (2018)
- Ron Andruff, President, ONR Consulting Inc., former Representative to the Department of Public Information at the United Nations (New York) as a member of the International Council of the Association for World Education (NGO) (2018)
- Tracy Cooley, Executive Director, Campaign for Personal Prescription Importation (2018)
- Andrew Goldman, JD (formerly of Knowledge Ecology International) (2017)
- Robert Guerra, President, Privaterra, specializing in Internet governance, human rights, digital security and Internet freedom. Robert is an Honours graduate of the University of Western Ontario and alumni of the Universidad de Navarra’s Faculty of Medicine (2018)
- Burcu Kilic, JD, Public Citizen (2017)
- Jillian Kohler, PhD, Professor, Leslie Dan Faculty of Pharmacy, Dalla Lana School of Public Health and Munk School of Global Affairs and Public Policy, and Director, WHO Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector (2018)
- Gabriel Levitt, M.A, International Relations, President, Prescription Justice and PharmacyChecker, President Emeritus, United Nations Association of Brooklyn Chapter (2017/2018)
- Jeremy Malcom, JD, (formerly of Electronic Frontier Foundation) (2017)
- Shivam Patel, PharmD, BSPS, RPh Director of Pharmacy Verification, PharmacyChecker.com (2018)
- Tim Smith, Executive Director, Canadian International Pharmacy Association (2017/2018)
- Paul Zickler, MD, Canadian International Pharmacy Association (2017)