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Could Legalizing Prescription Drug Imports Break Big Pharma?

Friday, April 07, 2017 By Fran Quigley, Truthout | News Analysis
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(Photo: Pexels; Edited: LW / TO)(Photo: Pexels; Edited: LW / TO)

During the January 2003 State of the Union address, President George W. Bush announced the President's Emergency Plan for AIDS Relief (PEPFAR), a landmark treatment program.  As Bush spoke, the cameras panned to a smiling guest of honor standing to the right of First Lady Laura Bush. The guest was Ugandan physician Dr. Peter Mugyenyi, and he was an illegal importer of medicines.

Mugyenyi had broken the law in order to save lives. An HIV/AIDS pandemic was sweeping the African continent in the early 2000s, and Mugyenyi's patients and millions of others were dying because they could not afford the monopoly-inflated prices of patented antiretroviral drugs to treat the disease. Mugyenyi's importing of cheaper versions of the medicine into Uganda, along with similar illegal imports by South African activists, dramatized the deadly impacts of lifesaving medicines being priced at hundreds of times manufacturing costs. Drug importation became part of a global campaign of pressure on pharmaceutical companies, which eventually responded by cutting the price of patented AIDS drugs by as much as 90 percent.

It was a monumental victory for the human right to health, and set the stage for the PEPFAR program announced by Bush during that 2003 speech, and the companion United Nations Global Fund to Fight AIDS, Tuberculosis, and Malaria. Thanks to brave grassroots activists who demanded the world pay attention to the devastation being caused by medicine monopolies and greed, these programs now provide to 18 million HIV-positive people the treatment that was once unaffordably priced. These programs demonstrate that it is possible to have a medicines system that prioritizes morality over intellectual property, and bypasses the record-breaking profits siphoned off by Big Pharma. 

Could a new proposal to allow US patients, drug wholesalers and pharmacies to import cheaper prescription drugs have a similar impact, allowing millions of people to access medicine they cannot currently afford?

At first glance, importation alone does not amount to groundbreaking reform, since it would leave most of the highly flawed pharmaceutical pricing model intact. "It is literally the smallest step we can take in the direction of fair drug pricing," Alex Lawson of Social Security Works, which is supporting the proposal, admits. But, as African HIV/AIDS activists showed, that small step could be the one that builds momentum for a long-delayed sprint toward overhauling our prescription drug pricing system.

The Affordable and Safe Prescription Drug Importation Act recently filed in the US House and Senate would allow medicines to be imported into the US, first from Canada and then from other high-income countries. The same medicines that are available in the US are also for sale in those countries, which have drug safety regimens comparable to the review conducted by the US Food and Drug Administration. But the price charged for medicines overseas is often as much as 50 percent less than the price paid by US patients. As many as 19 million Americans are already importing medicines for price reasons, and polls show seven in 10 support legalizing importation.

That makes importation a politically powerful proposal. And that matters because medicines pricing is at its root a political problem. The current prescription drug pricing system is a product of decades of remarkably effective pharmaceutical industry lobbying, with little impactful response on behalf of patients.

Pharma corporations, who have a long history of being top spenders on lobbying and campaign contributions, helped push through the Bayh-Dole Act, a remarkably pro-corporate law that allows the fruits of government-funded medicines research to be surrendered for private for-profit patenting. Generous corporate tax breaks support the follow-up drug research and marketing. Then, government health agencies buy the end-stage medicines in bulk, often without negotiating down the prices inflated by the same patent monopolies. This highly subsidized business model has made the pharmaceutical industry one of the most profitable in the world.

US patients are disproportionately responsible for those profits. Despite their government spending billions of dollars annually to support medicines research, Americans pay far higher prices for their medicines than residents of nations like Canada, France and the United Kingdom, where the governments retain the right to negotiate medicines prices. For example, one prostate cancer drug discovered with research funded by the US's National Institutes of Health and Department of Defense costs 200 percent more in the US than it does in countries like Canada and Japan.

Not surprisingly, US patients are not happy with this equation. With as many as one in six Americans each year not filling prescriptions due to cost, public opinion polls show 77 percent of Americans saying that drug prices are unreasonable. An even higher number say the government should limit the amount drug companies can charge for lifesaving medicines.

Anger at medicine pricing and at pharmaceutical companies more generally crosses ideological boundaries. "The people are out in front of this issue," says Social Security Works' Lawson. "The politicians have to catch up."

The new legislation, introduced by Sen. Bernie Sanders and fellow Big Pharma critics Reps. Elijah Cummings (D-Maryland) and Lloyd Doggett (D-Texas), aims to tap into that popular frustration. A dozen Republican senators, including John McCain and Ted Cruz, earlier this year voted in support of a similar bill amendment to allow medicine imports from Canada.  Even President Donald Trump has said the industry is "getting away with murder."

The growing political power of the drug pricing issue is reflected in the names of some of the new bill's co-sponsors. Senators Cory Booker (D-New Jersey), Bob Casey (D-Pennsylvania) and Mark Heinrich (D-New Mexico) were among 13 Democrats who opposed an importation proposal earlier this year. That vote earned those senators, who collectively had taken millions of dollars in campaign donations from the pharmaceutical industry, harsh criticism on liberal social media and blogs that labeled them "Big Pharma Dems."  Sanders called them out for lacking "guts," but predicted they would soon develop "the courage to stand up to Pharma." He was right. A month later, Booker, Casey and Heinrich all signed on to cosponsor the new bill.

The pharmaceutical industry response to the proposal focuses on safety concerns, arguing that importation could taint the US medicines supply. It is a well-honed industry scare tactic used to tarnish imports. Sometimes the approach is far from subtle: one television ad produced by pharmaceutical corporations in the UK showed a man swallowing a pill, presumably imported at lower cost, and then reacting in horror as he pulled a dead rat out of his mouth.

But the importation bill sponsors are trying to cut off those arguments before they begin. Sanders and his cosponsors cite multiple academic medical experts and a 2016 bipartisan Senate report saying that Canadian and European Union drug safety standards are a match for those in the US. The bill also would prohibit importation of controlled substances or compound medicines, and would require independent testing of the imported medicines.

Prominent progressive groups are lining up behind the legislation, including MoveOn, the NAACP and the National Organization for Women. A broader access to medicines bill introduced in March by Sen. Al Franken and championed by Public Citizen includes importation, too. As the precedent from the HIV/AIDS treatment movement suggests, the campaign for importation could succeed in transforming the generalized frustration about drug pricing into support for an easy-to-understand first step toward bringing down the medicine monopolies.

"This is the time," Sanders said when introducing the import bill. "The American people are sick of getting ripped off, and we're going to win this thing."

Copyright, Truthout. May not be reprinted without permission.

Fran Quigley

Fran Quigley teaches and directs the Health and Human Rights Clinic at Indiana University Robert H. McKinney School of Law.


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Could Legalizing Prescription Drug Imports Break Big Pharma?

Friday, April 07, 2017 By Fran Quigley, Truthout | News Analysis
  • font size decrease font size decrease font size increase font size increase font size
  • Print

(Photo: Pexels; Edited: LW / TO)(Photo: Pexels; Edited: LW / TO)

During the January 2003 State of the Union address, President George W. Bush announced the President's Emergency Plan for AIDS Relief (PEPFAR), a landmark treatment program.  As Bush spoke, the cameras panned to a smiling guest of honor standing to the right of First Lady Laura Bush. The guest was Ugandan physician Dr. Peter Mugyenyi, and he was an illegal importer of medicines.

Mugyenyi had broken the law in order to save lives. An HIV/AIDS pandemic was sweeping the African continent in the early 2000s, and Mugyenyi's patients and millions of others were dying because they could not afford the monopoly-inflated prices of patented antiretroviral drugs to treat the disease. Mugyenyi's importing of cheaper versions of the medicine into Uganda, along with similar illegal imports by South African activists, dramatized the deadly impacts of lifesaving medicines being priced at hundreds of times manufacturing costs. Drug importation became part of a global campaign of pressure on pharmaceutical companies, which eventually responded by cutting the price of patented AIDS drugs by as much as 90 percent.

It was a monumental victory for the human right to health, and set the stage for the PEPFAR program announced by Bush during that 2003 speech, and the companion United Nations Global Fund to Fight AIDS, Tuberculosis, and Malaria. Thanks to brave grassroots activists who demanded the world pay attention to the devastation being caused by medicine monopolies and greed, these programs now provide to 18 million HIV-positive people the treatment that was once unaffordably priced. These programs demonstrate that it is possible to have a medicines system that prioritizes morality over intellectual property, and bypasses the record-breaking profits siphoned off by Big Pharma. 

Could a new proposal to allow US patients, drug wholesalers and pharmacies to import cheaper prescription drugs have a similar impact, allowing millions of people to access medicine they cannot currently afford?

At first glance, importation alone does not amount to groundbreaking reform, since it would leave most of the highly flawed pharmaceutical pricing model intact. "It is literally the smallest step we can take in the direction of fair drug pricing," Alex Lawson of Social Security Works, which is supporting the proposal, admits. But, as African HIV/AIDS activists showed, that small step could be the one that builds momentum for a long-delayed sprint toward overhauling our prescription drug pricing system.

The Affordable and Safe Prescription Drug Importation Act recently filed in the US House and Senate would allow medicines to be imported into the US, first from Canada and then from other high-income countries. The same medicines that are available in the US are also for sale in those countries, which have drug safety regimens comparable to the review conducted by the US Food and Drug Administration. But the price charged for medicines overseas is often as much as 50 percent less than the price paid by US patients. As many as 19 million Americans are already importing medicines for price reasons, and polls show seven in 10 support legalizing importation.

That makes importation a politically powerful proposal. And that matters because medicines pricing is at its root a political problem. The current prescription drug pricing system is a product of decades of remarkably effective pharmaceutical industry lobbying, with little impactful response on behalf of patients.

Pharma corporations, who have a long history of being top spenders on lobbying and campaign contributions, helped push through the Bayh-Dole Act, a remarkably pro-corporate law that allows the fruits of government-funded medicines research to be surrendered for private for-profit patenting. Generous corporate tax breaks support the follow-up drug research and marketing. Then, government health agencies buy the end-stage medicines in bulk, often without negotiating down the prices inflated by the same patent monopolies. This highly subsidized business model has made the pharmaceutical industry one of the most profitable in the world.

US patients are disproportionately responsible for those profits. Despite their government spending billions of dollars annually to support medicines research, Americans pay far higher prices for their medicines than residents of nations like Canada, France and the United Kingdom, where the governments retain the right to negotiate medicines prices. For example, one prostate cancer drug discovered with research funded by the US's National Institutes of Health and Department of Defense costs 200 percent more in the US than it does in countries like Canada and Japan.

Not surprisingly, US patients are not happy with this equation. With as many as one in six Americans each year not filling prescriptions due to cost, public opinion polls show 77 percent of Americans saying that drug prices are unreasonable. An even higher number say the government should limit the amount drug companies can charge for lifesaving medicines.

Anger at medicine pricing and at pharmaceutical companies more generally crosses ideological boundaries. "The people are out in front of this issue," says Social Security Works' Lawson. "The politicians have to catch up."

The new legislation, introduced by Sen. Bernie Sanders and fellow Big Pharma critics Reps. Elijah Cummings (D-Maryland) and Lloyd Doggett (D-Texas), aims to tap into that popular frustration. A dozen Republican senators, including John McCain and Ted Cruz, earlier this year voted in support of a similar bill amendment to allow medicine imports from Canada.  Even President Donald Trump has said the industry is "getting away with murder."

The growing political power of the drug pricing issue is reflected in the names of some of the new bill's co-sponsors. Senators Cory Booker (D-New Jersey), Bob Casey (D-Pennsylvania) and Mark Heinrich (D-New Mexico) were among 13 Democrats who opposed an importation proposal earlier this year. That vote earned those senators, who collectively had taken millions of dollars in campaign donations from the pharmaceutical industry, harsh criticism on liberal social media and blogs that labeled them "Big Pharma Dems."  Sanders called them out for lacking "guts," but predicted they would soon develop "the courage to stand up to Pharma." He was right. A month later, Booker, Casey and Heinrich all signed on to cosponsor the new bill.

The pharmaceutical industry response to the proposal focuses on safety concerns, arguing that importation could taint the US medicines supply. It is a well-honed industry scare tactic used to tarnish imports. Sometimes the approach is far from subtle: one television ad produced by pharmaceutical corporations in the UK showed a man swallowing a pill, presumably imported at lower cost, and then reacting in horror as he pulled a dead rat out of his mouth.

But the importation bill sponsors are trying to cut off those arguments before they begin. Sanders and his cosponsors cite multiple academic medical experts and a 2016 bipartisan Senate report saying that Canadian and European Union drug safety standards are a match for those in the US. The bill also would prohibit importation of controlled substances or compound medicines, and would require independent testing of the imported medicines.

Prominent progressive groups are lining up behind the legislation, including MoveOn, the NAACP and the National Organization for Women. A broader access to medicines bill introduced in March by Sen. Al Franken and championed by Public Citizen includes importation, too. As the precedent from the HIV/AIDS treatment movement suggests, the campaign for importation could succeed in transforming the generalized frustration about drug pricing into support for an easy-to-understand first step toward bringing down the medicine monopolies.

"This is the time," Sanders said when introducing the import bill. "The American people are sick of getting ripped off, and we're going to win this thing."

Copyright, Truthout. May not be reprinted without permission.

Fran Quigley

Fran Quigley teaches and directs the Health and Human Rights Clinic at Indiana University Robert H. McKinney School of Law.


Hide Comments

blog comments powered by Disqus