The Observatory was invited to speak, on September 26, 2019, at the French National Assembly (Lower house) by the Member of Parliament (MP) François Ruffin (Somme Deputy, La France Insoumise) on the implementation of transparency in France, as part of a colloquium entitled « Sanitary scandals, economic scandals ». We publish here our full speech.
The Observatoire de la transparence dans les politiques du médicament first would like to thank the member of parliament (MP) François Ruffin for his invitation and for this critical initiative. We support the speakers at this debate on ‘sanitary scandals’, aspect of transparency that goes beyond our direct expertise area but that remains fundamental. And we fully support the other organizations and speakers in this room.
We launched the Observatory just after the World Health Assembly (WHA) in May 2019, where the French government, strongly pushed by civil society, committed to implement transparency in medicines and health products policies including on pricing.
However, to date, the public published pricing in the Official Bulletin are only tagged pricing, and do not include volumes, real paid prices, intermediary margins, etc. And these prices do not cover all health products. We ask for a full transparency.
Transparency in medicines policies is not a consensual or superficial matter. We believe that it is a critical tool to guide public health policies. It is unacceptable that the increasing prices of the new marketed medicines threaten our solidarity-based health system. In 2014, the new hepatitis C treatments were put on the French market for about 50 000€. The purchase by the public health insurance (Assurance maladie) of this treatment for all the people with hepatitis C in France in 2014, would had represented 13 billion euros, that is to say twice as much as the total budget of public Paris hospitals (AP-HP- Assistance publique des hôpitaux de Paris) in 2014; 7 billions euros!
As we pointed it out then, the prices of these new treatments created a precedent, as since then no more safeguard protects the Assurance maladie and the CEPS (Comité économique des produits de santé) from the abuses of pharmaceutical companies in the process of price negotiation. In 2017, several gene therapies were marketed for several hundreds of thousand euros. In 2019, the price of Zolgensma, a cure developed partly with Téléthon money, was proposed by the company Novartis for 2,1 millions euros!
Transparency on pricing and on who pays what during the research and development (R&D) phases, is therefore critical to guide health policies. It is unacceptable that arbitrary and illegitimate pricing threaten our public health system.
Because the explosion of these prices threatens the sustainability of our health system or of its principle of universality. It also pushes to neglect other areas of health spending that would also be critical.
Sanitary scandals are also, for us, the lack of financial means that threaten the safety of people in emergency rooms, as pointed out by health workers, who, to denounce this critical situation, have been more than 200 emergency rooms to be on strike for months, and who in response have been facing the contempt of the government. Sanitary scandals are also the State medical Aid (AME) [the public health insurance provided to migrant people] and the Universal health coverage (CMU) [the public health insurance provided to poorest people] who are currently being questioned by the government for supposedly economic reasons, but in reality mainly populist ones. Sanitary scandals are also the eligibility criteria that were in place to ration the access to hepatitis C treatment in 2014 and 2015 because of the very high price of the new medicines, which legitimacy and rational were never questioned.
Sanitary scandals is the fact of constantly favoring the interests of pharmaceutical multinationals over the interests of people and public interests.
To implement the World Health Assembly (WHA) transparency resolution, we [the Observatory] developed a check-list, which goal is to list a few items that should help the government to immediately start implementing transparency. Because this is unacceptable, that we do not know the details of the public spending for each health product. It is also unacceptable, that we can’t throw light on the abuse of pharmaceutical multinationals related to patents. Patents grant monopolies for a period of 20 years. In principle, they should reward a real innovation in exchange of this monopoly offered by the Society. But the inventive step and the novelty have to be rigorous to justify the granting of patents. However, in practice we notice that the reality is different. For instance, an antiviral such a tenofovir has been patented for a total period of 50 years. Initially for the main compound, its pro-drugs, its uses, against HIV, then hepatitis B, and then its preventive use. However, we notice that the French public research, through the Agence Nationale de Recherche sur le Sida (ANRS), among others, contributed to fund clinical trials to assess the preventive action of this medicine, while the multinational company that marketed it alone gets large financial benefits out of it.
If we dig more, we also find out that hepatitis C diagnostic tools, such as FibroScan and FibroTest were also developed with French public funding, by researchers from INSERM (Institut national de la santé et de la recherche médicale), AP-HP (Assistance publique- Hôpitaux de Paris), Public hospitals, universities and schools, such as ESPCI (Ecole supérieure de physique et de Chimie de la ville de Paris). However, the benefits are also here only private, either because the technologies were patented by private companies or because exclusive license were granted to private companies. Thus, our public health system pays twice for these technologies developed with public funding. It is time that we re-own medicines and health products, largely developed thanks to taxpayers’ money. These are our medicines!
We expect the member of Parliaments to seize this question and to propose concrete texts to the National Assembly and Senate, such as bills.
In parallel, we expect from the government to fully and immediately implement the World Health Assembly transparency resolution as initially proposed by Italy, as well as the adopted text. France cannot constantly hide behind the fact that it would be the only country among other to implement the text, and that it should therefore wait for other countries to act first, while countries such as Italy have already put in place measures to implement the resolution, including in regard to medicines reimbursement conditions. The French government should do the same, and without delay. »
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