California Western School of Law

Langston, Edward L.

English

The Quality Quandary

Shepherd,, Marv, Ph.D.

Drug Quality, Safety Issues and Threats of Drug Importation

Rosenberry, Katharine

ESSAY: Organizational Barriers to Creativity in Law Schools and the Legal Profession

International Law Journal, California Western

CALIFORNIA WESTERN
INTERNATIONAL LAW JOURNAL
VOLUME 35 SPRING 2005 NUMBER 2
TABLE OF CONTENTS
ARTICLES
Defining Private Life Under the European Convention on Human
Rights by Referring to Reasonable Expectations
H. Tomis G6mez-Arostegui ............................................................ 153
Vessels on the High Seas: Using a Model Flag State Compliance
Agreement to Control Marine Pollution
Carm en Casado .............................................................................. 203
SYMPOSIUM
Legal Reform: The Role of Public Institutions and Legal Culture ..... 237
COMMENTS
Powerful States, Customary Law and the Erosion of Human Rights
Through Regional Enforcement
M elissa R obbins .............................................................................. 275
Genocide and Ethnic Cleansing: Why the Distinction? A
Discussion in the Context of Atrocities Occurring in Sudan
Linnea D . M anashaw ...................................................................... 303
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Eide, Karissa

Can a Pharmacist Refuse to Fill Birth Control Prescriptions on Moral or Religious Grounds?

This article focuses on the use of actual public health problems to train law students in interdisciplinary problem solving.  The author describes the planning, structure, challenges and rewards in teaching her clinical course, Problem Solving and Prevention in Healthcare, to students initially reluctant to work collaboratively in teams, intimidated by a broader community context, and hesitant to interact strategically with other professionals

Morton, Linda H.

A New Approach to Health Care ADR: Training Law Students to be Problem Solvers in the Health Care Context

CALIFORNIA WESTERN
INTERNATIONAL LAW JOURNAL
VOLUME 36 FALL 2005 NUMBER 1
TABLE OF CONTENTS
SELECTED ESSAYS AND TRANSCRIPTS FROM THE INSTITUTE OF HEALTH
LAW STUDIES CONFERENCE ON INTERNATIONAL DRUG IMPORTATION:
ISSUES IN PUBLIC POLICY, PATIENT SAFETY, AND THE PUBLIC HEALTH
INTRODUCTION
B ryan A . L iang ................................................................................... 1
OVER THE VIRTUAL AND GEOGRAPHIC BORDERS:
UNDERSTANDING IMPORTATION AND COUNTERFEIT DRUGS
B ryan A . Liang ............................................................................... 7
THE QUALITY QUANDARY
Edward L. Langston ..................................................................... 19
MEDICATION USE, SAFETY, AND NURSING CULTURE: A
VIEW OF POTENTIAL COUNTERFEITS FROM THE FRONT LINES
A rlene D . Luu ............................................................................... 33
CONFUSION AND CONTRADICTION: UNTANGLING DRUG
IMPORTATION AND COUNTERFEIT DRUGS
Tim Gilbert & Sana Halwani ........................................................ 41
REIMPORTATION FROM CANADA AND BEYOND
A ndy Troszok ................................................................................ 55
DRUG WHOLESALING AND IMPORTATION: CHALLENGES
AND OPPORTUNITIES
Robert P. G iacalone .................................................................... 65
DRUG QUALITY, SAFETY ISSUES AND THREATS
OF DRUG IMPORTATION
M arv Shepherd ............................................................................. 77
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PIRACY 101
Jam es M . Cooper ......................................................................... 89
IMPORTATION OF PRESCRIPTION DRUGS AND RISKS
TO PATIENT SAFETY
W illiam P . B ro ................................................................................ 105
DRUG IMPORTATION AND THE HISPANIC PHYSICIAN
R ene F . R odriguez .......................................................................... 117
PRESCRIPTION DRUG IMPORTATION BEYOND CANADA
M ichael M oreno ............................................................................. 125
ARTICLES
DEFINING TERMS IN THE 1982 LAW OF THE SEA CONVENTION IV:
THE LAST ROUND OF DEFINITIONS PROPOSED BY THE
INTERNATIONAL LAW ASSOCIATION (AMERICAN BRANCH)
LAW OF THE SEA COMMITTEE
G eorge K . W alker ........................................................................... 133
UNOCAL AND THE DEMISE OF CORPORATE NEUTRALITY
M ark D . K ielsgard .......................................................................... 185
COMMENT
TRANSNATIONAL CORPORATE RESPONSIBILITY FOR INTERNATIONAL
ENVIRONMENTAL AND HUMAN RIGHTS VIOLATIONS: WILL THE
UNITED NATIONS' "NORMS" PROVIDE THE REQUIRED MEANS?
Tracy M . Schm idt ............................................................................ 2 17
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Moreno, Michael

PRESCRIPTION DRUG IMPORTATION BEYOND CANADA
MICHAEL MORENO*
ABSTRACT
Obtaining access to safe and affordable medicines is a critical
goal. AARP has long favored a system of prescription drug coverage
for the vulnerable. However, until recently, there was no public cov-
erage for medicines. With Medicare Part D, the issue becomes even
more important. Although not perfect, Medicare Part D provides us
with a start to addressing the problem of safe and affordable medi-
cines in the United States. Part of the discussion in improving Medi-
care Part D includes allowing cheaper drugs from other countries,
such as Canada, which has a strict regulatory structure. On the basis
of AARP trips and assessments, Canada is a good choice. Because of
its regulatory structure and the good experiences of patients who buy
their medications there, it is an available alternative for getting
cheaper drugs. The Dorgan-Snowe Bill, which would allow importa-
tion, is supported by AARP, because it allows importation from Can-
ada with safeguards to ensure legitimate drugs are being sold. How-
ever, overall, we need to improve the policy available for access to
prescription drugs, because of the increasing need for prescription
drugs as additional people face the high costs of health care.
INTRODUCTION
Good morning, and first of all, I want to thank you for the kind
invitation to speak on importation of medicines, and particularly, on
importation from beyond Canada.
Importation discussions are not new at AARP. When you look
back to 1966, our founder, Ethel Andres, went before Congress and
demanded some kind of a prescription drug benefit coverage for sen-
iors in this country. So, beginning forty-one years ago, we have had
* Interim State Director, AARP, Mississippi State Office, 6360 I 55 North, Suite 160,
Jackson, MS 39211. Email: MMoreno@aarp.org.
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both Republican and Democratic administrations, with nothing being
done on this topic until last year.
THE MEDICARE PRESCRI'TION DRUG BENEFIT AND AARP
We at AARP were the 800-pound gorilla at the table for the
Medicare Part D prescription drug benefit. But believe me, we were
only at the table. In fact, it would have been better if we sat outside
because we had no say in the details of the prescription drug benefit.
Hence, we had to compromise and accept the package given, because
we needed to have something. I will get into that later, but we felt that
it was, at least, a start. There were other details that made it difficult,
such as the initial $400 billion available for this benefit, and now we
know the true cost is somewhere around $800 billion. There will be
some discussion about that information later.
As I noted, we did not have much opportunity to change or to im-
prove the current legislation that was signed, into law. We at AARP
noted that it was a good beginning, and we are now working with the
prescription drug Medicare Part D rollout. But we know, and you
know, there are problems. For example, Medicare beneficiary pre-
scription drug costs will not be covered between roughly $2500 and
$5000 annually. In addition, there are many people in the middle
class who will suffer the brunt of the costs associated with Part D in
terms of premiums, co-pays, and providers. The Centers for Medicare
and Medicaid Services have not contemplated the regulations for the
final rollout. In fact, these regulations probably will not be completed
until after the law goes into effect in January 2006. So, there is a lot
of work to be done.
CANADIAN IMPORTATION
Prescription drug coverage is a huge issue at AARP. Our mem-
bers tell us their most pressing health care concern is the price of their
prescription drugs. They want affordable, meaningful, and safe pre-
scription drugs.
As you heard yesterday and today, we have gone to Canada. We,
with California Senator Debra Ortiz, took a delegation to Canada, be-
cause of many of the assertions you have made here today and yester-
day with respect to the safety of importation. I am pleased this con-
ference got it right in terms of importation, because forever some have
been saying "reimportation," implying these drugs are made here in
this country.
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2005] PRESCRIPTION DRUG IMPORTATION BEYOND CANADA 127
In fact, the bulk of the drugs we receive in this country are not
made in this country. And soon, most will be packaged outside of the
country and sent back to the United States. Therefore, it is not "reim-
portation;" it is "importation."
COSTS AND IMPORTATION
We are talking about importation because we are concerned about
costs. A survey we conducted revealed that, on average, prices for
195 brand name drugs most widely used by older Americans increased
at more than double the rate of general inflation from 2000 to 2004.
But the average annual increase in manufacturer's prices charged to
wholesalers and other direct purchasers increased from 4.1% in 2000
to 7.1% in 2004. For 153 brand name drugs on the market for the en-
tire five-year period, this translated into a cumulative average price
increase of over 35%, compared with the general inflation rate of
13.5% over the same period.
We know profits have gone up. To get a better handle on what
should be charged, we need to know how much it costs drug manufac-
turers to make these drugs. We do not know that answer. The reason
we do not know the actual costs is due to secret agreements. There
are agreements made with HMOs. There are agreements made with
the government. But we, as the general public, have never been able
to find out the true costs of these medications. This situation is some-
thing we have been fighting for years, because when you know what
the true cost is, then you have a point to start negotiating.
PERSONAL IMPORTATION
Another issue in regulation relates to the FDA. It is illegal to im-
port prescription medications from Canada and Mexico. But when
you look at the reality-that hundreds of thousands of people go to
Arizona and California to escape the snow-their number one priority
is to walk across the border to Mexico and get a ninety-day supply of
medicines.
That is what the people want. For example, my brother-in-law is
a chief border patrol inspector for the Yuma sector. With respect to
personal importation, the border patrol turn their backs on this issue,
because they know if they try to stop individuals from purchasing
medications over the border, they will have a revolution on their
hands. The FDA also has not aggressively pursued these individuals,
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nor stopped these individuals from coming across the border from
Mexico with medicines.
COUNTERFEIT DRUGS
We talk about phony drugs. We talk about fraud. But when you
look at the number of reports of people actually dying from medica-
tions they purchased from Mexico or Canada because they are not the
right dosage, the medications are fraudulent, or they are not the medi-
cations they should be, where is the fire in the theater? There has
been no testimony about this before any Congressional committees.
There have been no such reports and no evidence presented. We do
need to regulate. We at AARP do not support the importation from
Mexico because they do not have a regulatory system similar to Can-
ada's.
CANADA
As I mentioned previously, we traveled to Canada with Senator
Ortiz. We went to Winnipeg and Vancouver, and we saw the process.
We took a state pharmacist with us and individuals who directly
looked at the process in their health departments and county health
departments. We went to Canada, and we saw that process. We saw
that they do receive faxed prescriptions from the United States. Can-
ada has a large organization called CIPA: Canadian International
Pharmacy Association. And, as its guest, we visited mail order phar-
macy sites, looked at them, and saw how they processed orders and
medicines.
When they receive a prescription by fax, they contact the doctor in
the United States. They verify all of the information on the prescrip-
tion and verify that it is the right individual who is getting the medica-
tion. They have the information translated into English, or in some
cases Spanish; and, on the 800-number that you call to order, if you do
not speak English, they have people who speak many languages, in-
cluding Chinese, Japanese, Spanish, and English. When we looked at
their system and their process, we saw that if you do it right, if you
have regulations in place, if the packaging information is there, in-
cluding the DIN number, you can process prescription medications in
Canada and in this country with that same DIN number.
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2005] PRESCRIPTION DRUG IMPORTATION BEYOND CANADA
VULNERABLE PATIENTS
People who invested in 401(k)s and many companies that crashed
financially in 1999 are now living on fixed incomes. People who pre-
viously used their social security checks for golfing fees now use them
to help them maintain a standard of living above the poverty level. In
combination with state legislation, such as Medi-Cal (which is an in-
sured, subsidized health program for the disabled and elderly who live
on fixed incomes and who meet the poverty level guidelines to receive
totally subsidized healthcare), federal budget cuts, and the California
budget deficit, these people are going to have to start paying premi-
ums, paying co-pays, and sharing the cost of their care. If they cannot
pay for their medical care, providers are going to refuse or deny them
care. Now there are some legal problems with some of these cuts.
For example, federal law says that the elderly and disabled are guaran-
teed subsidized healthcare; therefore, there may be many lawsuits if
the state proposal passes in this state. While there are people who
abuse the Medicare or Medi-Cal services, there are far more people
who do not abuse the system. We owe them an obligation.
What is our obligation? We have an obligation to a person who is
thirty-five years old, working hard, who gets injured on the job and
has no medical benefits. If the employer has dropped or reduced the
benefit or capped the expenditures for care, who is going to pay for
that care? It is not limited to one kind of employer. Even when I was
with the United Farm Workers, our own health insurance was under-
insured; I was underinsured. For example, I had to have an MRI.
They paid $35 and I had to pay $4600. We had women with children
who were still paying for childbirth fees three years after they had
their babies. There are farm workers who, through no fault of their
own, came in contact with pesticides. Farm workers generally do not
have medical insurance, are paid minimum wage, and, in some cases,
are paid less than minimum wage. They pay into the social security
system, but they receive no benefit, because most of them are illegal.
Thus, they have little ability to pay for their health care costs.
We had legislation in California that was signed and passed, SB2,
which would require employers with over 100 employees to provide
some form of health care for their workers. The state would work
with them, partner with them, and help pay for some of the care.
A new governor was elected in California because of a recall. He put
an initiative on the ballot and SB2 was defeated, so now we do not
even have that protection.
129
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We have in-home support services that are partly subsidized by
the federal government and the state of California. The state wants to
cut back the collective bargaining agreements that were made for peo-
ple who care for their own family members, who give up careers, and
who give up their jobs. These collective bargaining agreements pro-
vide some form of health care. The agreements were repealed, and
their health care was taken away. What is the result? They gave up
their careers and are caring for loved ones.
The stories go on and on. We at AARP put a face on this, because
those are the people we represent: the frail, the disabled, the vulner-
able. We represent them in every aspect, whether it is health care or
consumer representation. There are always predators out there, just
like there are predators in the prescription drug business.
IMPORTATION FOR SAFE AND AFFORDABLE MEDICINE
We are looking for the most safe and effective way of getting two
things: (1) safe medicines and (2) less costly medicines. Those are the
two things our members are concerned about, more than anything else
we do for them.
We support the Dorgan-Snowe Bill, because it goes beyond Can-
ada and provides some safeguards. The legislation will at least start
the process for us to negotiate prescription drug medication costs. The
problem for us is that we cannot get that bill to a floor vote because
the leadership will not allow that to happen. We have got to work to-
gether.
We are open to dialogue. There is the phone number for our fed-
eral affairs department. It is important that if you agree or disagree
with our position, that you let us know what you think and feel. This
is all part of the bigger picture. If there is real abuse and fraud out
there-and we talked about Canada and India and other countries-
we want to know. And yes, we know that Canada cannot begin to
meet the medication demand of California. That is why Canada can-
not be the sole source of prescription drugs. We have chosen Canada
because it is close, and we know Canadians get up to 70% discount
compared to what we pay domestically. But there are other countries
where these drugs are manufactured, and there is a process in the Dor-
gan-Snowe Bill that will allow us to feel better about bringing these
medications into the United States.
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2005] PRESCRIPTION DRUG IMPORTATION BEYOND CANADA 131
CONCLUSION
So, in conclusion, we can attack the fraud in medicine sales and
we can attack the abuse. But as Dr. Rene Rodriguez said, we have got
to do something. We have got to start, just like we started on the
Medicare bill, to include medications. We are trying to improve the
access to prescription drugs and to address the higher cost of prescrip-
tions.
In conclusion, we ask for your help as people who are a brain
trust, who are creative, and who are very intelligent in terms of the
pros and. cons of the importation issue. We need that dialogue; we
need that discussion and invite it. Thank you.
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Prescription Drug Importation Beyond Canada

CALIFORNIA WESTERN
INTERNATIONAL LAW JOURNAL
VOLUME 35 FALL 2004 NUMBER 1
TABLE OF CONTENTS
ARTICLES
The Human Rights of Sexual Minorities in Africa
Sebastian M aguire .............................................................................. 1
Multinational Corporations and the Realisation of Economic, Social
and Cultural Rights
D aniel A guirre .............................................................................. 53
COMMENTS
Culture Clash: The Influence of Indigenous Cultures on the
International Whaling Regime
Anne M . Creason ......................................................................... 83
International BBB Ratings a la eBay: A Proposal for an
Improved Online Better Business Bureau to Facilitate
International Business Transactions
Lenden W ebb .................................................................................. 127
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The Quality Quandary

Drug Quality, Safety Issues and Threats of Drug Importation

ESSAY: Organizational Barriers to Creativity in Law Schools and the Legal Profession

Table of Contents

Can a Pharmacist Refuse to Fill Birth Control Prescriptions on Moral or Religious Grounds?

A New Approach to Health Care ADR: Training Law Students to be Problem Solvers in the Health Care Context

Table of Contents

Prescription Drug Importation Beyond Canada

Table of Contents

The New ADR: Aggregate Dispute Resolution and Green Tree Financial Corp. v. Bazzle

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