Prescrire's annual Information Awards are based on the quality of the documentation and information provided by pharmaceutical companies in response to requests by Prescrire's Editorial Staff. We use this documentation when analysing new products or new indications and preparing the articles published in the Marketing Authorisations section of our French edition. Prescrire's Information Awards focus on the transparency or secrecy companies have exhibited over the year in response to our requests for information and documentation.

What documentation and information do we request from pharmaceutical companies?
The information which pharmaceutical companies hold on their drugs, from the earliest stages of development to data collected after their market introduction (or in some cases after their market withdrawal), is important for health care and patient safety. Prescrire primarily asks pharmaceutical companies to send us information concerning: efficacy and safety data; packaging items; and the conditions under which patients can access the drug, in particular whether it is reimbursed (by the French national health insurance system), the planned date of its market introduction or the reasons for its market withdrawal. We compare and contrast the data thus obtained with those gathered from the other sources we consult as part of a systematic search for information, including health authorities and the scientific literature.

Six companies honoured for their transparency.
Prescrire requested information from 92 pharmaceutical companies in 2022. Six of them chose to be open, which they demonstrated by providing detailed, appropriate documentation in response to our requests. These companies earned a place on the 2022 Information Awards Honours List. Three of them — Arrow Génériques, EG Labo and Rhythm Pharmaceuticals — were rated as "Outstanding", because they sent us particularly useful, detailed, explanatory documents and information in an extremely timely manner, sometimes without being asked.

All of the companies on the 2022 Information Awards Honours List supplied documents or information that are not publicly available, such as:

• Clinical study reports (CSRs), containing details on the protocols and results of clinical trials.
• Pharmacovigilance documents that are not in the public domain, which pharmaceutical companies submit to health agencies on marketed drugs, or agencies' assessment reports on these documents. These detailed pharmacovigilance data improve our understanding of the drug's risks outside the clinical trial setting.
• Documentation submitted to the French National Authority for Health (HAS) to request eligibility for reimbursement by the national health insurance system or approval for use in hospitals. These documents contain useful clinical and administrative data.
• Information concerning the timeline for the market introduction of generic drugs and market withdrawals. All of these companies acted in patients' interests by helping inform healthcare professionals about their drugs through Prescrire's analyses.

But the vast majority of companies chose secrecy.
Many more pharmaceutical companies responded to Prescrire’s requests by sending too little information, too irregularly or too late. These companies (13 of the 92 companies we contacted in 2022) received an Information Red Card, indicating persistent and multiple deficiencies in the provision of information.

Some companies did not respond at all to Prescrire’s requests, including several companies that market vaccines, a therapeutic field in which greater transparency might help reduce some people’s distrust of vaccines.

Other companies failed to respond in a timely manner or omitted the most important or sensitive data.

And some companies only responded to our repeated requests once our article had been published. Only then did they send us the documentation on which they based their rebuttal of Prescrire’s analysis.

Continue to demand transparency until it becomes a principle.
Drug companies and agencies hold a wealth of documents analysing detailed clinical data but, as of 2022, it is clearly still difficult, if not impossible, for healthcare professionals and independent teams such as Prescrire to gain access to them. The few pharmaceutical companies that respect the principle of transparency show that it is feasible. It is high time the rest of the industry viewed this principle as a priority.

> The Prescrire Drug Awards for 2022

Download the full article:

 FREE  "The Prescrire Awards for 2022" Prescrire International 2023; 32 (246): 80-81. (pdf, free)

Back to "The Prescrire Awards for 2022">

Produced by the Editorial Staff ©Prescrire March 2023

Share