Transcript Powerpoint

HCV drug pricing
« The future of HIV & HCV Treatment :
Patents, pricing and pharma, Special session »
Pauline Londeix
XX International AIDS conference - AIDS2014 - Melbourne, Australia
Acknowledgments
• Special thank to Françoise Barré-Sinoussi & Eric Fleutelot
• Karyn Kaplan
• Tracy Swan
• Kajal Bhardwaj
• Lorena Di Giano
• Marcela Cristina Fogaca Vieira
• ITPC-MENA (Middle-East & North Africa)
• Sidaction
• The International AIDS Society
• Act Up-Basel
Publication of the report
“New treatments for Hepatitis C Virus :
Strategies for Achieving Universal
Access”
(Médecins du Monde, March 2014)
• The aim of the study was to try to
understand what would the best
strategies be in terms of access to
new treatments used in the
treatment of Hepatitis C.
Methodology
FROM : hepcoalition.org
• We crossed epidemiological data
specific to HCV with the customary
strategies used by pharmaceutical
companies (in particular in the case of
HIV) and often based World Bank
categories Low income, Middle Income
and High income countries.
World Bank
categories
•High Income Countries
•Middle-Income Countries
(Upper and Lower Middle
Income Countries)
•High Income countries
What strategies for
pharmaceutical companies ?
•High Income Countries
➔ “Standardized pricing”
➔ DOES NOT WORK in terms of ACCESS
•Middle-Income Countries (Upper and Lower Middle Income
Countries)
➔ “Tiered pricing”
➔ DOES NOT WORK in terms of ACCESS
• Low Income countries
➔ Voluntary licensing ”
➔ OFTEN DOES NOT WORK in terms of
ACCESS and
➔ can also have perverse effects such as
binding generic producers, undermining the use of
TRIPS flexibilities, and preventing the supply of the
excluded countries.
Sofosbuvir/Sovaldi in the
United States ?
$84,000 for 12 weeks
Sofosbuvir in France ?
$76,000 for 12 weeks
127 000 people on Sofosbuvir
=
the budget of Paris public hospitals
for 2014
Tiered pricing :
the example of Egypt
Tiered pricing :
the example of Indonesia
Voluntary licence territory :
the example of Sofosbuvir
The solution
?
Generic
competition
Solutions exist. Including “generic competition” and are possible
including through the use of TRIPS flexibilities, including the article
31 of the TRIPS agreements which states that any country may use
compulsory licenses, and “allow someone else to produce the
patented product or use the patented process without the consent of
the patent holder”."
The solution ?
Compulsory licencing
The solution ?
Patent Opposition /
patent law reforms
EU nations join forces against 'exorbitant' hepatitis C drug
THURSDAY JUL10, 2014 | AGENCE FRANCE PRESSE
France said Thursday it has joined forces with 13 other European countries to negotiate a lower price for a
promising new hepatitis C drug that has drawn controversy for its astronomical cost. Sovaldi, made by US pharmaceutical
firm Gilead Sciences, has shown huge potential at helping cure the liver disease but its price -- more than 50,000 euros
($68,000) for a 12-week course of treatment -- has health authorities concerned. "If we accept such a high price, firstly we
won't be able to treat everyone and we will also be creating a risk for our social security system, which means for other
patients," French Health Minister Marisol Touraine said Thursday. She told BFMTV that Sovaldi would cost the country's
already heavily-indebted welfare system billions of euros."So I launched an initiative... to mobilise all European countries
and make sure we join forces to weigh on price negotiations with this US laboratory. "For the first time, 14 European
countries have made a commitment together. We will therefore negotiate country by country as that's how it's done, but we
will exchange information and discuss things between European countries."
Hepatitis C is caused by a virus that can be transmitted through sharing needles, receiving contaminated blood
transfusions or having sex with an infected person.Some 350,000 people die of hepatitis C-related liver diseases annually,
and as many as four million people are newly infected each year, according to the World Health Organization. Most of the
185 million people infected worldwide do not know they have the disease, with diagnoses often only discovered after a
person develops cirrhosis, end-stage liver disease or liver cancer.There is no vaccine for the disease, but Sovaldi, recently
approved in the United States and the European Union, has been shown to cure more than 90 percent of those treated, up
from 50 to 60 percent for the previous generation of drugs.
Results published in January of a clinical trial that involved 211 people showed that a daily combination of Sovaldi and
another drug still in the experimental phase cured 98 percent of participants. Dozens of medical associations in France
have issued a joint warning over the "exorbitant" cost of new generation hepatitis C drugs, including Sovaldi. Medecins du
Monde says the cost of treating just over half of France's 230,000 sufferers would amount to the annual budget of Paris'
public hospital network.Egypt, which has the world's highest infection rate of hepatitis C -- at more than 10 percent of the
population, because syringes are routinely re-used -- has negotiated a 12-week treatment price of just $900 from Gilead."
So how to reduce the price of Hepatitis C drugs ?
By understanding that this is not a one- time problem, it is a
systemic problem. The systems to negotiate pricing need to be urgently
reformed in countries such as the United States and in France.
- By using the TRIPS flexibilities :
Patent Opposition, Compulsory licences, Patent law reforms
-By refusing so-called “access initiatives” supporter by international
organisations including WHO, the MPP, and excluding millions of people
from the access to treatment.
www.hepcoalition.org
www.treatmentactiongroup.org