03 Jul 2019
img

Founder of Prescription Justice, Gabriel Levitt, submitted a public comment to the World Health Organization (WHO) on the role of personal importation and online access to safe and affordable medicine in meeting the UN Sustainable Development Goals. The Global Action Plan for Healthy Lives and Well-Being for All is a joint initiative led by twelve global health and development organizations under the auspices of the WHO. The signatory agencies of the Global Action Plan invited submission of comments through a public process to inform the final draft of the Global Action Plan, which will be presented during the United Nations General Assembly in September 2019.

Mr. Levitt’s comment below underscores the importance of online access to lower cost medications through safe international online pharmacies as a vital lifeline, especially for the tens of millions of Americans who struggle each year to pay for their medications.


Title: Accelerator Discussion. Determinants of Health: Providing regulatory space to promote safe international Internet pharmacy practice in furtherance of SDG 3.8 as it applies to access to affordable medicine.

Author: Gabriel Levitt. Affiliations: president and co-founder of PharmacyChecker.com; founder and president of Prescription Justice; president emeritus of the United Nations Association Brooklyn Chapter; Board of Advisors, Business Initiative for Health Policy. gabriel.levitt@gmail.com

In SDG 3.8, the international community envisions access to affordable medicine by 2030 for everyone. Access barriers to medicine is a problem that affects almost two billion people.[i] In many cases the obstacle is affordability for governments and individual patients.[ii] This problem is most acute in the poorest countries, but middle and high-income countries are also impacted.[iii] Among high-income countries, the United States is a troubling outlier with exceedingly high rates of cost-related prescription non-adherence.[iv]

In support of SDG 3.8, the Internet, via international online pharmacies, has helped tens of millions of Americans obtain medicines from pharmacies in other countries.[v] In many of those cases, patients would otherwise not be able to obtain a prescribed medicine because price often determines access.[vi] In recognizing that price is an obstacle to access to medicines, Global Health Organizations can play a more constructive, forward-thinking role by promoting an open Internet through which regulated medicines can be purchased across borders both safely and at lower cost.

While the World Health Organization has recognized the potential benefits of online pharmacies, it has mostly focused on the risks posed by rogue actors that sell falsified and substandard medicines.[vii] The WHO’s reports on this topic have yet to highlight the medicine affordability and access benefits of properly credentialed online pharmacies that sell across borders. The safety of properly credentialed international online pharmacies is clear in the relevant peer-reviewed literature.[viii]

The issue of online access to safe and affordable medicine is inextricably intertwined with conflicting pharmaceutical regulations among UN member states relating to international trade. In an exporting country, such as Canada, it may be legal to dispense prescription medicine internationally to a patient in the U.S.; whereas, the patient doing the importing in the U.S. may be violating national laws.[ix] Within the U.S., “illegal” imports for personal medication treatments are not deterred through prosecution– despite the technical illegality.[x] In Australia, in contrast, personal imports of most medicines are expressly legal, with important exceptions.[xi]

In many cases, patented products are imported by patients where there is no intellectual property violation. In other cases, patients seek lower-cost generic medicines that are unavailable locally from foreign countries through online pharmacies. In those instances, Article 60 of the WTO’s Trade Related Intellectual Property Rights agreement strongly discourages enforcement actions against such personal imports.[xii]

Recommendations

1. Create a taskforce to identify the safest international online pharmacy practices, the demographic of patients most benefiting from personal medicine imports ordered online, and policy suggestions for the Global Action Plan to promote online access to safe and affordable medicine.

2. To further the agenda above, participating multilateral global health and development organizations should consider adopting the Brussels Principles on the Sale of Medicines over the Internet. The Brussels Principles encapsulate a human rights framework to promote the greatest possible online access to safe and affordable medicine. Much of its normative intent mirrors the goals articulated by the UN High-Level Panel on Access to Medicine.


 

[i] Ten years in public health, 2007–2017: report by Dr Margaret Chan, Director-General, World Health Organization. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.

[ii] United Nations Secretary General’s High-Level Panel on Access to Medicines, see http://www.unsgaccessmeds.org/news-blogs/2015/12/21/united-nations-secretary-generals-high-level-panel-seeks-inputs-on-increasing-innovation-and-access-to-medicines [Last accessed 6/24/2019].

[iii] Ibid.

[iv] Osborn, R., Squires, D., Doty, M. M., Sarnak, D. O., & Schneider, E. C., MD. (2016, November 16). In New Survey of 11 Countries, U.S. Adults Still Struggle with Access to and Affordability of Health Care | Commonwealth Fund. Retrieved from https://www.commonwealthfund.org/publications/journal-article/2016/nov/new-survey-11-countries-us-adults-still-struggle-access-and?redirect_source=/publications/in-the-literature/2016/nov/2016-international-health-policy-survey-of-adultsr.

[v] Bluth, Rachel, “Faced With Unaffordable Drug Prices, Tens Of Millions Buy Medicine Outside U.S.,” Kaiser Health News, December 20, 2016. See https://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine-outside-u-s/ [Last accessed 6/23/19].

[vi] Morgan SG, Lee A Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7:e014287. doi: 10.1136/bmjopen-2016-014287

[vii] WHO Global Surveillance and Monitoring System for substandard and falsified medical products.

Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.

[viii] Bate, Roger, Ginger Zhe Jin, and Aparna Mather, “In Whom We Trust: The Role of Certification Agencies in Online Drug Markets,” The B.E. Journal of Economic Analysis & Policy. December 2013, Volume 14, Issue 1, Pages 111–150, ISSN (Online) 1935-1682, ISSN (Print) 2194-6108, DOI. See 10.1515/bejeap-2013-0085.

[ix] Elliott A. Foote, “Prescription Drug Importation: An Expanded FDA Personal Use Exemption and Qualified Regulators for Foreign-Produced Pharmaceuticals,” 27 Loy. Consumer L. Rev. 369 (2015). See http://lawecommons.luc.edu/lclr/vol27/iss3/2 [Last accessed 12/11/2016] and Gabriel Levitt, “Online Pharmacies, Personal Drug Importation and Public Health: Ill-Considered Enforcement Prevents Access to Safe and Affordable Medication” February 2015. See

https://www.pharmacychecker.com/online-pharmacies-personal-drug-importation-public-health.pdf [Last accessed 12/11/16.

[x] Sable-Smith, Bram, “Americans Cross Border Into Mexico To Buy Insulin At A Fraction Of U.S. Cost,” Kaiser Health News, February 12, 2019, see https://khn.org/news/americans-cross-border-into-mexico-to-buy-insulin-at-a-fraction-of-u-s-cost/ [Last accessed 6/23/2019].

[xi] Therapeutic Goods Administration, Department of Health, Australian Government, Personal Importation Scheme, see https://www.tga.gov.au/personal-importation-scheme [Last accessed 6/23/2019].

[xii] Article 60 of TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)

Post a Comment