[ACT-UP Basel Press Release, Link] Act Up-Basel called the French government to learn from the current situation regarding access to new direct-acting antivirals (DAAs) molecules used in the treatment of hepatitis C (HCV), to exercise Article L613 -16 of the Code of Industrial Property on the transmission and loss of patent holder rights to issue a compulsory license [i] and make available generic versions of sofosbuvir.
Since Sofosbuvir was licensed for sell on the European market, hepatitis experts and organizations working on HCV in France are quite certain : According to their computation, access to HCV new treatments in France will only be possible through an out-of-reach spending from the national health insurance. To treat 55% of people infected with chronic HCV in France (133,000 patients, with an advanced stage of infection – stage 2-4 fibrosis or “F2” to “F4”), the national health insurance must pay the equivalent of the annual budget of all Parisian hospitals and health centres (Assistance Public – Hôpitaux de Paris – AP-HP) for the purchase of sofosbuvir (SOF) alone [ii] or € 7 billion. To cover the cost of the triple therapy with peg-interferon (PEG-IFN) and ribavirin (RBV) for genotype 1 (Western Europe’s most common genotype) and then, in the near future, another DAA, the price of a two-or triple therapy will be even higher. With a new DAA such as datasclavir (BMS-052), it would cost between €100,000 and 150,000 per person for a 12 week treatment, while the production cost of sofosbuvir and datasclavir combined is estimated between €57 and €122. The profit reached by Gilead Sciences, the pharmaceutical corporation marketing Sovaldi (followed by Bristol Myers Squibb for datasclavir very soon) is huge. It exceeds the margins of all other industries by far, including luxury industry. For example, Sovaldi currently marketed in the United States has already helped Gilead to rake approximately $2.3 billion in a quarter [iii].
A pill that costs €2.5 to produce, sold €650: the pharmaceutical industry is the most “profitable” for all industries.
If the French Ministry of Health does not currently appear to wish to select or to deny treatment initiation based on the infection stage – such as the raffles during the first moments of HAART -, can we accept the national health insurance subsidize such exorbitant prices which are more than ever unjustified? The French president and the government of the prime mister Manuel Valls pound the importance of bailing out public accounts and thus controlling state spending. In such a context, why should the pharmaceutical industry benefit from special favours? On which ground could this industry continue to benefit without limit during the current economic crisis?
France must urgently change its price negotiation mechanism for medicines. The committee in charge obviously failed, since they accepted Gilead’s price of €50,000 per person for a 12 week treatment with such low estimated production costs [iv].
“The acceptance of such a price, when we know Sofosbuvir’s low estimated production costs, the obvious lack of real innovation compared to existing molecules, and how quick generic formulation could be manufactured, all these show a glaring evidence of the incompetence and therefore failure of the health authorities in charge of this issue, “said Pauline Londeix, co-founder of Act Up-Basel and member of the International Treatment Preparedness Coalition (ITPC).
Solutions exist and they are in the hands of the French government.
For the 2001 Anthrax “crisis”, the United States exercised their right to issue a compulsory license for “government use” to make Bayer’s patented medicine broadly accessible. This measure led to a substantial decline in the medicine’s price.
In 2010, France ordered 94 million doses of H1N1 vaccine. Instead of questioning the price of this vaccine, France went for the €50 branded version, while generic alternatives existed and cost less than €5. The anti-H1N1 plan eventually cost more than €2 billion to the national health insurance [v].
Like the United States in 2001 for Anthrax, or low-or-middle-income countries such as India, Thailand, China, Brazil and Indonesia for AIDS, France must urgently take the lessons from such a situation and quickly use the flexibilities of the World Trade Organization (WTO) Agreement on Trade-Related Intellectual Property Rights (TRIPS) and, more specifically, the legal provisions that allow the use of generic versions even in the case of patented molecules, as it is the case for sofosbuvir.
Since public health interests are at stake, France’s Minister of Health Mrs. Marisol Touraine should ask Mr. Arnaud Montebourg in charge of the Ministry of Economy, Productive Recovery and Digital Media to submit a compulsory license for “government use”, in accordance with Article L. 613-16 and L. 613-17 of the Code of Industrial Property, against the patent granted to sofosbuvir [vi] and allow the use of a generic version.
France could also use another legal provision, under the WTO TRIPS in 1995 [vii] and reaffirmed by the Doha Declaration in 2001. In the Article 31, the TRIPS agreement 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”.
“In the past, countries, mostly low-and-middle-income ones, have used TRIPS flexibilities including compulsory licenses and patent oppositions especially for HIV /AIDS medicines. It would be very surprising that France puts Gilead’s interests before those of its citizens!” said Othoman Mellouk of the International Treatment Preparedness Coalition (ITPC).
Act Up-Basel calls the French government to take all measures, including political ones, to show that equality in health care access and public interests prevail over private interests of a pharmaceutical corporation.
”While our policymakers advocate austerity measures, it would be indecent to ask French citizens to fill the coffers of Gilead and its shareholders” concluded Arthur Vuattoux, in charge of France at Act Up-Basel.
[i] “If the interest of public health demands and in the absence of agreement with the patent holder, the Minister responsible for industrial property, at the request of the Minister of Public Health can submit an halt to the regime of statutory license in accordance to Article L. 613-17, any patent granted for: a) a medicine […]”
[ii] See the report of Médecins du Monde: Hepatitis C: A strategy for universal access to new treatments
[iv] See the study by Andrew Hill Minimum Costs for Producing Hepatitis C DAA
[v] See the article of Le Monde, “A Flu for two billion”
[vi] From nucleoside phosphoramidate prodrugs, Pharmasset / Gilead Sciences / Patent Number: WO 2008121634