HCV drug pricing« The future of HIV & HCV Treatment :

Patents, pricing and pharma, Special session »

Pauline LondeixXX 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

FROM : hepcoalition.org

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

• 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

• 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.

What strategies for pharmaceutical companies ?

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

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 ?Generic competition

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