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New step forward in transparency for France

04/12/2019

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France

The new amendment to be introduced under new article L. 162-17-4-3 in the French social security code, requires pharmaceutical companies to inform the French economic committee on health products (CEPS) of the amount of public research and development investments they have received for the development of a medicine. This amount is also to be made public. This would come in addition to the current transparency measures that require pharmaceutical companies to make public their links of interest with healthcare professionals on a dedicated database. However, here, the companies would have to declare the money they have received whereas in the current transparency system they must declare the money they have provided to healthcare professionals. The medical device sector is not concerned.

If the bill becomes a law, an implementing decree will specify the conditions for applying these provisions by January 2021, especially to standardise the declarations that pharmaceutical companies will have to submit.

This new "transparency" burden imposed on the pharmaceutical sector is the result of an international commitment by France to increase the transparency of the drug market in a global context of mistrust towards this sector that some people criticize as being allegedly too "opaque". However, whatever the data transmitted, the CEPS is free to take into account or not public investments received by any pharmaceutical company, depending on the contractual negotiations that are taking place with the latter. Some may consider that this is only a step forward for the CEPS which may obtain a more global understanding of the cost of the medicine for the company, but the reality is that this information is likely to be used by the CEPS as a very efficient tool to reduce medicine prices when there have been public investments in R&D in a company.

The fact that these data are made public will also be a big difference. According to parliamentarians, the underlying idea is that this would lead to increased accountability of pharmaceutical companies to patients by pushing the companies to reduce the price of medicines that have benefited from public funds. One may wonder whether this measure does not contribute to reinforcing the feeling of mistrust that sometimes appeared against the pharmaceutical sector. In any event, if this law comes into force, pharmaceutical companies will have to move forward with more transparency and introduce this new obligation in their compliance process.

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Life Sciences