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Rules Interviews

Regulating proximitytransparency of rules

When the rules are clear you should not be worried about the possibility to collaborate

Interview with Patrizia Popoli

President of the Technical Scientific Committee of the Italian Medicines Agency (AIFA)
Director of the National Centre for the Clinical and Preclinical Evaluation of Drugs of the Italian National Institute of Health

By December 2021April 26th, 2022No Comments
Photo by Lorenzo De Simone

Following the recent approval of a drug to treat Alzheimer in the USA Aaron Kesselheim, a Professor at Harvard Medical School, warned about the excessive closeness between the Food and Drug Administration and the pharmaceutical company, alleging that they worked together to adapt the ongoing research and to “optimise” its results. What is the right degree of proximity that partnerships between the public and the private healthcare sectors should adopt?

I believe that in the context of a partnership the notion of proximity is not something to be worried about. The partnership itself can bring positive outcomes. What matters is that there are very clear rules on the specific roles played by each party. The public healthcare sector should do its own work and the private one should do its own work. I think that when the rules are clear you should not be worried about the possibility to collaborate- all the opposite.

 

What is the minimal amount of time that should pass between Phase I of the drug development process and the sale of the drug on the market in order to guarantee the right to health of citizens?

Lately we are seeing some incredible accelerations around the development of drugs as these are approved after very brief clinical trials, even after single arm Phase I or Phase I-II trials, thus with very limited data. On one hand it is important to try and accelerate the drug development process in order to provide treatment options to patients who need them more quickly. However, such approaches are undoubtedly linked to a significant degree of uncertainty around the real therapeutic value provided by the drugs. Even though these registration trials might be simplified and/or accelerated they should at the very least be able to provide all the necessary data to ensure patients receive the treatment with a reasonable degree of safety. In terms of the ideal time that should pass between Phase I and the sale of the drug there is no fixed time period. Obviously it depends on the type of condition you are working with, whether you have the possibility of conducting a larger study, on the type of medical need there is and on how much you are rushing. Even if the European Medicines Agency might deem a Phase I or II registration trial acceptable in the face of a significant unmet need, this should at least provide enough data to support the hypothesis that there is a potential benefit and to ensure you are not exposing patients to unjustified risks. Either way, the potential benefits should always be assessed together with the potential associated risks.

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