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Online Access to Safe and Affordable Medication
Applying human rights law to cyber rule-making and Internet
governance
Access to Medicines:
a Global Public Health Crisis
• Two billion people can’t access essential medication.1
• According to the UN High Level Panel on Access to Medicine, prices are a barrier to
essential medicines not just in poor and middle income countries, but in rich
countries too.2
• Forty-five million Americans did not fill a prescription due to cost in 2016.3
• President of Medicines Sans Frontier: “There is a life attached to every calculation of
supply and demand for medicines.”4
Online Access: The Bottom Line
• Internet users are benefiting from online access to safe and affordable medications.5
• The pharmaceutical industry views Internet access as a threat and disruptive to its
profit model because consumers are paying less than the drug companies intended
for them to pay.6
• According to the UN Human Rights Council, access to affordable medication is a
human right.7
• As the Internet community seeks to infuse the principles of international human
rights law into the discourse and practice of Internet governance it should help
maintain the widest possible online access to safe and affordable medication.6
What is online access to affordable medication?
• Obtaining a medication from another country at a lower cost than is possible from a
local pharmacy ordering it online.
• Millions of Americans who can’t afford medication having an opportunity to do so
because of the Internet.8
• In London, people at risk for HIV are able to obtain affordable generic Truvada online
from India to protect themselves from HIV.9
• Cancer patients in China obtaining medication over the Internet.10
U.S. and Access to Healthcare
• 45 million Americans did not fill prescription in 2016 because of cost.11
• 27 million American adults don’t have insurance.12
• About 31 million are underinsured.12
Did not fill
prescription or
skipped doses AUS CAN FR GER NET NZ NOR SWE SWIZ UK US
2016 6% 10% 4% 3% 4% 6% 3% 6% 9% 2% 18%
Online Drug Price Comparisons
www.pharmacychecker.com
Drug U.S. Price1 Canadian Price2 /
(Savings)
International Price3 /
(Savings)
Advair Diskus
Condition: Asthma and COPD
$977.97 $341.07 (65.12%) $98.99 (89.88%)
Zetia4
Condition: High Cholesterol
$835.70 $227.49 (72.78%) $155.99 (81.33%)
Januvia
Condition: Type-2 Diabetes
$1,061.44 $350.67 (66.96%) $90.62 (91.46%)
Daraprim
Condition: Toxoplasmosis
$4,6043.4 N/A $97.20 (99.79%)
Epipen Autoinjector
Condition: Asthma / Allergic
$630.96 $225.42 (64.27%) $171.99 (72.74%)
Quick History of Online Pharmacy for Americans
• An extension of mail-order pharmacy, which dates back to the 1890s.
• In the U.S. about 30% of domestic retail pharmacy is by mail order.13
• International online pharmacy started in the late 1990s, an outgrowth of e-
commerce happening in all sector.
Bus Trips to Canada
“I will never forget the look on the faces of those
women who were struggling for their lives when
they bought breast cancer medicine at 10 percent
of the cost they were paying in the state of
Vermont. The drug was Tamoxifen, a widely
prescribed drug for those people who are
struggling with breast cancer.14”
The Internet Expands Access
• The Internet enabled more Americans to buy lower cost medications from Canada,
whereas before, access was mostly for border state residents.
• Government survey data show about four million Americans import medication for
personal use each year. [U.S. Centers for Disease Control and Prevention].16
So What’s the Problem?
• Regulatory Restrictions to Importing Affordable Medication
• Big Pharma/Pharmacy Doesn’t Like It!
• Rogue Online Pharmacies are dangerous.
U.S. Regulatory Barriers to Affordable Medication
• It’s technically illegal to import medication for personal use.
• FDA and Pharma say it’s a safety issue but the industry hypes the threat to Orwellian
heights of propaganda.
• The illegality is “technical” because individuals have never been prosecuted for
importing personal use quantities of medication.17
Big Pharma/Pharmacy Doesn’t Like It!
• Multinational pharmaceutical companies rely on the U.S. market for their
phenomenal profits.
• U.S. pharmacies don’t want the competition.
• Importation laws don’t stop Americans from personal importation.
Scare People from Ordering Affordable Medications
• PhRMA hired Edelman Public Relations to form focus groups, which found that fear
would work better than the yellow light of the law.18
• Wall Street Journal (2003): [Edelman’s] “report recommends that the U.S. industry
question the safety and effectiveness of medicines procured elsewhere.” 18
• Strategy: Conflate international online pharmacies with online counterfeit drug
sellers.
Commission A
Novel About
Terrorists and
Tainted Drugs in
Canada
Ecosystem of Pharma-allied and/or funded groups
• Partnership for Safe Medicines (PhRMA)
• National Association of Boards of Pharmacy (Funding by drug companies, represents
U.S. pharmacy boards)
• LegitScript (Contract with FDA, allied with Alliance for Safe Online Pharmacies)
• Alliance for Safe Online Pharmacies (Drug companies, U.S. chain pharmacies)
• Center for Safe Internet Pharmacies (Large Internet companies working with
LegitScript and Alliance Safe Online Pharmacies)
Actions to Curtail Online Access
1. NABP’s ICANN gTLD - .Pharmacy campaign, require VIPPS or LegitScript.
2. Google and Bing won’t allow Safe international online pharmacies to advertise.
3. VISA/MasterCard require LegitScript approval
4. Some registrars look to LegitScript and the NABP for White Lists.
5. BING has placed filters on its organic search results warning against websites that
the FDA has sent a letter to, which it refers to as “fake online pharmacies.”
Educating the Internet Community
• The Internet community needs to be able to distinguish safe international online
pharmacies from rogue online pharmacies.
• A safe online pharmacy requires a valid prescription, facilitates the processing of
orders sent by mail from lawfully operating and licensed pharmacies, protects the
privacy of patients, and makes sure customers have access to consult with a licensed
pharmacist.
• A rogue online pharmacy intentionally sells counterfeit or adulterated medication;
real medication but without requiring a prescription and/or not under the
supervision of licensed personnel.
Online Pharmacy Credentialing Programs
• PharmacyChecker, 2002 (Independently funded, revenue comes from verification
program and pharmacy/price listing fees)
• NABP and VIPPS, 1999 (Funded by program fees, U.S. state pharmacy boards, and
related programs, and drug companies)
• Canadian International Pharmacy Association , 2002 (Funded by international online
pharmacies)
• LegitScript, 2007 (Revenue from government contracts with U.S. FDA, Japan, large
Internet companies, other businesses focused on compliance issues)
• European Union (Funded by EU taxpayers)
PharmacyChecker Verification
What do we check/verify?
• pharmacy licenses
• prescription requirements
• marketing claims
• privacy protocols
• contact information
• transparency of pharmacy sources
• pharmacist consultation policies
• Written agreements among online pharmacies and filling pharmacies
• Inspections
• Mystery shopping
• Reverifications
Medicines Access Advocacy in the Internet Ecosystem
• Create a Code of Ethics or Statement of Principles for the online sale of medication.
• Registrars to refuse website takedown requests by NABP, LegitScript or regulators
without a court order, especially credentialed websites.
• Guide banks and businesses to provide service to websites processing prescription
orders filled by lawfully operating pharmacies.
• To help engage with ICANN to continue resisting pressure from the pharmaceutical
industry.
References
1 https://www.msfaccess.org/content/why-tpp-trade-deal-threat-public-health and
http://www.who.int/medicines/areas/human_rights/A63_263.pdf.
2https://www.isoc.org/internet/conduct/truth.shtml
3https://awarerx.pharmacy/news/2010/8/asop-seeks-changes-to-ensure-patient-
access-to-safe-online-pharmacies.
4 http://www.theglobeandmail.com/opinion/why-the-tpp-trade-deal-is-a-threat-to-
public-health/article25548162/.
5http://www.circleid.com/posts/20160912_protecting_online_access_to_safe_and_aff
ordable_medication/.
References
6 https://www.eff.org/deeplinks/2016/09/how-big-pharmas-shadow-regulation-censors-
internet
7 http://keionline.org/node/2605
8 http://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine-
outside-u-s/
9 https://www.newscientist.com/article/2117426-massive-drop-in-london-hiv-rates-may-be-
due-to-internet-drugs/.
10 http://time.com/4475469/china-health-drugs-cancer-taobao-internet-azd9291-
astrazeneca/
11 http://khn.org/news/trumps-promise-to-rein-in-drug-prices-could-open-dam-to-
importation-laws/
References
12 http://www.politifact.com/truth-o-meter/statements/2017/mar/22/chris-
murphy/house-gop-health-care-bill-would-cause-14-million-/ and
http://www.commonwealthfund.org/publications/press-
releases/2015/may/underinsurance-brief-release.
13 https://www.sanders.senate.gov/newsroom/press-releases/sanders-stands-up-to-
drug-companies.
15 http://articles.latimes.com/2004/may/27/local/me-drugs27
16 http://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-
medicine-outside-u-s/
17 http://www.moneytalksnews.com/is-it-safe-to-use-an-overseas-pharmacy/
18 https://www.wsj.com/articles/SB106418061476794700

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Online Access to Safe and Affordable Medication: Applying human rights law to cyber rule-making and Internet governance

  • 1. Online Access to Safe and Affordable Medication Applying human rights law to cyber rule-making and Internet governance
  • 2. Access to Medicines: a Global Public Health Crisis • Two billion people can’t access essential medication.1 • According to the UN High Level Panel on Access to Medicine, prices are a barrier to essential medicines not just in poor and middle income countries, but in rich countries too.2 • Forty-five million Americans did not fill a prescription due to cost in 2016.3 • President of Medicines Sans Frontier: “There is a life attached to every calculation of supply and demand for medicines.”4
  • 3. Online Access: The Bottom Line • Internet users are benefiting from online access to safe and affordable medications.5 • The pharmaceutical industry views Internet access as a threat and disruptive to its profit model because consumers are paying less than the drug companies intended for them to pay.6 • According to the UN Human Rights Council, access to affordable medication is a human right.7 • As the Internet community seeks to infuse the principles of international human rights law into the discourse and practice of Internet governance it should help maintain the widest possible online access to safe and affordable medication.6
  • 4. What is online access to affordable medication? • Obtaining a medication from another country at a lower cost than is possible from a local pharmacy ordering it online. • Millions of Americans who can’t afford medication having an opportunity to do so because of the Internet.8 • In London, people at risk for HIV are able to obtain affordable generic Truvada online from India to protect themselves from HIV.9 • Cancer patients in China obtaining medication over the Internet.10
  • 5. U.S. and Access to Healthcare • 45 million Americans did not fill prescription in 2016 because of cost.11 • 27 million American adults don’t have insurance.12 • About 31 million are underinsured.12 Did not fill prescription or skipped doses AUS CAN FR GER NET NZ NOR SWE SWIZ UK US 2016 6% 10% 4% 3% 4% 6% 3% 6% 9% 2% 18%
  • 6. Online Drug Price Comparisons www.pharmacychecker.com Drug U.S. Price1 Canadian Price2 / (Savings) International Price3 / (Savings) Advair Diskus Condition: Asthma and COPD $977.97 $341.07 (65.12%) $98.99 (89.88%) Zetia4 Condition: High Cholesterol $835.70 $227.49 (72.78%) $155.99 (81.33%) Januvia Condition: Type-2 Diabetes $1,061.44 $350.67 (66.96%) $90.62 (91.46%) Daraprim Condition: Toxoplasmosis $4,6043.4 N/A $97.20 (99.79%) Epipen Autoinjector Condition: Asthma / Allergic $630.96 $225.42 (64.27%) $171.99 (72.74%)
  • 7. Quick History of Online Pharmacy for Americans • An extension of mail-order pharmacy, which dates back to the 1890s. • In the U.S. about 30% of domestic retail pharmacy is by mail order.13 • International online pharmacy started in the late 1990s, an outgrowth of e- commerce happening in all sector.
  • 8. Bus Trips to Canada “I will never forget the look on the faces of those women who were struggling for their lives when they bought breast cancer medicine at 10 percent of the cost they were paying in the state of Vermont. The drug was Tamoxifen, a widely prescribed drug for those people who are struggling with breast cancer.14”
  • 9. The Internet Expands Access • The Internet enabled more Americans to buy lower cost medications from Canada, whereas before, access was mostly for border state residents. • Government survey data show about four million Americans import medication for personal use each year. [U.S. Centers for Disease Control and Prevention].16
  • 10. So What’s the Problem? • Regulatory Restrictions to Importing Affordable Medication • Big Pharma/Pharmacy Doesn’t Like It! • Rogue Online Pharmacies are dangerous.
  • 11. U.S. Regulatory Barriers to Affordable Medication • It’s technically illegal to import medication for personal use. • FDA and Pharma say it’s a safety issue but the industry hypes the threat to Orwellian heights of propaganda. • The illegality is “technical” because individuals have never been prosecuted for importing personal use quantities of medication.17
  • 12. Big Pharma/Pharmacy Doesn’t Like It! • Multinational pharmaceutical companies rely on the U.S. market for their phenomenal profits. • U.S. pharmacies don’t want the competition. • Importation laws don’t stop Americans from personal importation.
  • 13. Scare People from Ordering Affordable Medications • PhRMA hired Edelman Public Relations to form focus groups, which found that fear would work better than the yellow light of the law.18 • Wall Street Journal (2003): [Edelman’s] “report recommends that the U.S. industry question the safety and effectiveness of medicines procured elsewhere.” 18 • Strategy: Conflate international online pharmacies with online counterfeit drug sellers.
  • 14. Commission A Novel About Terrorists and Tainted Drugs in Canada
  • 15. Ecosystem of Pharma-allied and/or funded groups • Partnership for Safe Medicines (PhRMA) • National Association of Boards of Pharmacy (Funding by drug companies, represents U.S. pharmacy boards) • LegitScript (Contract with FDA, allied with Alliance for Safe Online Pharmacies) • Alliance for Safe Online Pharmacies (Drug companies, U.S. chain pharmacies) • Center for Safe Internet Pharmacies (Large Internet companies working with LegitScript and Alliance Safe Online Pharmacies)
  • 16. Actions to Curtail Online Access 1. NABP’s ICANN gTLD - .Pharmacy campaign, require VIPPS or LegitScript. 2. Google and Bing won’t allow Safe international online pharmacies to advertise. 3. VISA/MasterCard require LegitScript approval 4. Some registrars look to LegitScript and the NABP for White Lists. 5. BING has placed filters on its organic search results warning against websites that the FDA has sent a letter to, which it refers to as “fake online pharmacies.”
  • 17. Educating the Internet Community • The Internet community needs to be able to distinguish safe international online pharmacies from rogue online pharmacies. • A safe online pharmacy requires a valid prescription, facilitates the processing of orders sent by mail from lawfully operating and licensed pharmacies, protects the privacy of patients, and makes sure customers have access to consult with a licensed pharmacist. • A rogue online pharmacy intentionally sells counterfeit or adulterated medication; real medication but without requiring a prescription and/or not under the supervision of licensed personnel.
  • 18. Online Pharmacy Credentialing Programs • PharmacyChecker, 2002 (Independently funded, revenue comes from verification program and pharmacy/price listing fees) • NABP and VIPPS, 1999 (Funded by program fees, U.S. state pharmacy boards, and related programs, and drug companies) • Canadian International Pharmacy Association , 2002 (Funded by international online pharmacies) • LegitScript, 2007 (Revenue from government contracts with U.S. FDA, Japan, large Internet companies, other businesses focused on compliance issues) • European Union (Funded by EU taxpayers)
  • 19. PharmacyChecker Verification What do we check/verify? • pharmacy licenses • prescription requirements • marketing claims • privacy protocols • contact information • transparency of pharmacy sources • pharmacist consultation policies • Written agreements among online pharmacies and filling pharmacies • Inspections • Mystery shopping • Reverifications
  • 20. Medicines Access Advocacy in the Internet Ecosystem • Create a Code of Ethics or Statement of Principles for the online sale of medication. • Registrars to refuse website takedown requests by NABP, LegitScript or regulators without a court order, especially credentialed websites. • Guide banks and businesses to provide service to websites processing prescription orders filled by lawfully operating pharmacies. • To help engage with ICANN to continue resisting pressure from the pharmaceutical industry.
  • 21. References 1 https://www.msfaccess.org/content/why-tpp-trade-deal-threat-public-health and http://www.who.int/medicines/areas/human_rights/A63_263.pdf. 2https://www.isoc.org/internet/conduct/truth.shtml 3https://awarerx.pharmacy/news/2010/8/asop-seeks-changes-to-ensure-patient- access-to-safe-online-pharmacies. 4 http://www.theglobeandmail.com/opinion/why-the-tpp-trade-deal-is-a-threat-to- public-health/article25548162/. 5http://www.circleid.com/posts/20160912_protecting_online_access_to_safe_and_aff ordable_medication/.
  • 22. References 6 https://www.eff.org/deeplinks/2016/09/how-big-pharmas-shadow-regulation-censors- internet 7 http://keionline.org/node/2605 8 http://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine- outside-u-s/ 9 https://www.newscientist.com/article/2117426-massive-drop-in-london-hiv-rates-may-be- due-to-internet-drugs/. 10 http://time.com/4475469/china-health-drugs-cancer-taobao-internet-azd9291- astrazeneca/ 11 http://khn.org/news/trumps-promise-to-rein-in-drug-prices-could-open-dam-to- importation-laws/
  • 23. References 12 http://www.politifact.com/truth-o-meter/statements/2017/mar/22/chris- murphy/house-gop-health-care-bill-would-cause-14-million-/ and http://www.commonwealthfund.org/publications/press- releases/2015/may/underinsurance-brief-release. 13 https://www.sanders.senate.gov/newsroom/press-releases/sanders-stands-up-to- drug-companies. 15 http://articles.latimes.com/2004/may/27/local/me-drugs27 16 http://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy- medicine-outside-u-s/ 17 http://www.moneytalksnews.com/is-it-safe-to-use-an-overseas-pharmacy/ 18 https://www.wsj.com/articles/SB106418061476794700