[Ip-health] One way to lower drug prices

Tahir Amin tahir at i-mak.org
Tue Jun 2 10:56:55 PDT 2015


http://edition.cnn.com/2015/06/02/opinions/radhakrishnan-drug-prices/index.html

By Priti Radhakrishnan
(CNN)Prescription drug prices are soaring, as exemplified by pharmaceutical
giant Gilead's $1,000-per-pill hepatitis C drug, Sovaldi. High prices for drugs
that treat deadly diseases
<http://www.nytimes.com/2015/05/05/opinion/runaway-drug-prices.html>are
creating barriers for patients, burdening governments
<http://www.wsj.com/articles/gileads-1-000-hep-c-pill-is-hard-for-states-to-swallow-1428525426>
and leading to rationing
<http://www.chicagobusiness.com/article/20140729/NEWS03/140729819/illinois-medicaid-restricts-who-can-get-game-changing-hepatitis-drug>
and denial of lifesaving treatments around the world.

One possible route to ensuring people get the care they need is passing new
laws. Indeed, in response to the growing backlash against skyrocketing drug
prices, U.S. states have introduced bills that would require price
transparency
<http://blogs.wsj.com/pharmalot/2015/04/24/angry-over-drug-prices-more-states-push-bills-for-pharma-to-disclose-costs/>
from pharmaceutical companies. But while these efforts are welcome, their
success is not assured, and they address only part of the problem.

Fortunately, there is another path that history shows is effective at
reining in the pharmaceutical industry's excesses. And globally, there is a
growing movement to remove artificial barriers to health that drug
companies create when they seek illegitimate patents.

Patents are rights that governments confer to products proven to be novel,
nonobvious and useful. But too often, pharmaceutical companies increase
profits through exclusive claims on science that is already in the public
domain. Lawyers, scientists and health advocates are pushing to end drug
companies' abuse of patents and remove obstacles to vital hepatitis C
treatment.

Today's struggle for hepatitis C treatment is the continuation of a global
movement that began over a decade ago in the successful effort to remove
patent barriers to HIV/AIDS medicines in India.

When India amended patent law in 2005 to comply with the World Trade
Organization, it opened the door for pharmaceutical companies to make
exclusive claims for drugs. At the time, the country's HIV/AIDS epidemic
was exploding, second only to South Africa's. Almost overnight,
pharmaceutical companies swept in to apply for thousands of drug patents,
and medicines suddenly cost ten times as much.

India decided to address the root problem of companies seeking illegitimate
patents: It created strict patent standards and a citizen review process
under which the public could challenge a patent's claim to being "novel,
nonobvious and useful," as the law required.

After patent attorneys and patient advocates filed patent challenges, the
Indian patent office dismissed many patent applications
<http://timesofindia.indiatimes.com/business/india-business/India-rejects-Boehringers-AIDS-drug-patent-plea/articleshow/3146786.cms>
for failing to meet the "nonobvious" requirement; some companies also withdrew
applications <http://www.i-mak.org/i-mak-blog-updates/category/abacavir>
and dropped their prices. By taking the legal requirements seriously, the
law prohibited patents that only sought to extend the duration of a
company's market hold, a strategy known in the industry as "life-cycle
management." Over the next five years, as a result, the continued
availability of generic drugs saved governments half a billion dollars
globally and medicines reached 13 million people living with HIV/AIDS
worldwide.

Today's hepatitis C epidemic
<http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/>
affects 150 million people around the world, killing 700,000 people
annually, according to the World Health Organization. And once again, drug
companies are claiming patents
<http://www.msfaccess.org/about-us/media-room/press-releases/gilead-attempt-secure-patent-hepatitis-c-drug-opposed-india>for
routine science and existing compounds, standing in the way of affordable
treatments.

Here in the U.S., Gilead has set a price tag of up to $84,000 per course of
treatment with its patented drug, Sovaldi, also known as sofosbuvir. Prices
are expected to be
<http://www.msfaccess.org/sites/default/files/MSF_assets/HepC/Docs/HepC_GileadsHCVTreatmentRestriction_ENG_2015.pdf>
out of reach for developing countries as well, particularly in
middle-income countries like Brazil and Argentina, where 73% of all people
with hepatitis C live.

But here's the catch: Despite Gilead's claims, sofosbuvir isn't new. It was
developed using previously published information and an existing compound.
A drug based on old science doesn't meet the legal requirements for a
patent.

In India, our organization partnered with an HIV advocacy group called the
Delhi Network of Positive People to file challenges to Gilead's patent
application for Sovaldi, where the patents for sofosbuvir are still pending.
<http://www.bloomberg.com/news/articles/2015-01-15/gilead-s-india-patent-snag-may-spur-more-low-cost-sovaldi-copies>
The Indian patent office ruled last July that the main compound in
sofosbuvir was a "molecule with minor changes
<http://blogs.wsj.com/pharmalot/2015/01/14/india-rejects-gilead-patent-bid-for-its-sovaldi-hepatitis-c-treatment/>"
and had the "same use in the treatment of HCV infection and flavivirus
infection," compared with an earlier compound. Following the challenges in
India, Egypt rejected the sofosbuvir patent.
<http://www.madamasr.com/opinion/egypt-will-not-patent-new-hepatitis-c-drug>

If low-cost generics were available, it is estimated they could cost as
little
<http://www.hepcoalition.org/advocate/advocacy-tools/article/minimum-costs-to-produce-hepatitis>as
$101 for a three-month course.

And just last month, we announced additional Sovaldi patent challenges with
partners in Brazil, China, Argentina, Ukraine and Russia. If these combined
efforts succeed, these health programs could save $270 billion. We based
our analysis on the difference in cost between the price Gilead is expected
to charge these five governments, and an estimated generic price for these
same countries.

To be sure, true innovation must be rewarded. And there is no question that
legitimate patents can be awarded to drugs if they meet the law's
requirements. But when a drug company claims a patent without
justification, price gouging often follows and the public suffers. If an
essential medicine isn't reaching the people who need it, the social
contract of a patent is clearly broken.

People who need sofosbuvir are dying preventable deaths. The global
movement of patient advocates, attorneys, doctors and scientists is growing
to stop pharmaceutical companies from padding profits by claiming existing,
public knowledge as their own.


-- 
Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472



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