French Parliament To Require Disclosure Of Public Funds Used In R&D For New Drugs Entering Market

The lower house of the French parliament has approved a milestone requirement that pharmaceutical companies must disclose the amount of public funding that was used in the research and development of new medicines entering the national market, as well as allowing those contributions to be factored into negotiations over final drug pricing.

After being initially rejected by the government, the new provision was adopted as an amendment to the French Social Security Budget Bill for 2020 in a nearly unanimous vote by the National Assembly, with 40 Members of Parliament voting in favor and only one opposed. The bill must still pass the French Senate in order to become law, but observers said the upper house was unlikely to drop the amendment after being approved in the National Assembly.

“Of course the adopted amendment is not perfect, but it’s still a historical first step toward the implementation of transparency at the French Parliament, and another proof that mobilization works,” said Pauline Londiex, co-founder of  l’Observatoire Transparence Médicaments (OTM), a French civil society watchdog that had lobbied heavily to see the provision passed by parliament.

The new requirement, enshrined in amendments n°474, n°505 and n°520 of the budget bill, stipulates that pharma companies must disclose the amount of public funding that was received for R&D of a new drug when applying for approval to market the product in France. Moreover, the government body in charge of negotiating drug prices, CEPS, will be able to take into account such public investments when negotiating the final drug price to be paid.

A series of other proposed requirements to disclosing the manufacturing costs of drugs, including costs of active ingredients, as well as profits such as the margins of intermediaries, were dropped from the final approved version of the amendment. A last minute sub-amendment was added to National Assembly approved-bill to further clarify that CEPS’ consideration of public R&D funding in drug price negotiations was optional.

Véran presenting the transparency amendment at the National Assembly on November 25.

Still, the parliamentary move is an important win for civil society groups advocating greater price transparency for health products after months of mobilization, following the approval in May of a landmark World Health Assembly (WHA) resolution on transparency in medicines markets.

The French National Assembly amendments appear to take the WHA resolution a step further – unlike the watered down WHA-approved language to only recommend voluntary disclosure by industry of public contributions to R&D costs, the National Assembly amendments appear to require companies report public funding.

The parliamentary proposal to require disclosure of public funds used for R&D costs had initially been shot down by French Minister of Health Agnéz Buzyn and the general rapporteur Olivier Véran at the first reading of the Social Security Budget Bill on October 24.

A month of political tensions followed, including the French Senate’s rejection of the original budget bill on November 14 in the wake of Prime Minister Emmanuel Macron’s announcement of an Emergency Funding Plan for Hospitals. Civil society groups continued to pressure the government to adopt the transparency amendment, publishing an open letter signed by over 80 notable French personalities that urged the government to support the amendment.

In a turn-around show of support, Véran presented the R&D cost amendment alongside presentations by La France Insoumise, and MP Caroline Janvier at a second meeting of the National Assembly on Monday where it was finally approved.

The final Social Security Budget Bill for 2020 must still be sent to the Senate for a first reading of the bill on Saturday, where the transparency amendment could then still be dropped  – or further expanded. But observers predict that the amendment may remain unchanged due to the wide consensus reached by the National Assembly, although there might be more attempts to weaken rather than strengthen the amendments in the Senate.

Image Credits: http://www.assemblee-nationale.fr.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.