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Patient access to innovative medicines: France is making progress, but can do better

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The wait will have seemed endless to the 5,000 patients in France suffering from cystic fibrosis and eligible for Kaftrio. While, on August 21, 2020, the European Medicines Agency granted this treatment, considered a major therapeutic innovation, marketing authorization within the European Union, French patients had to wait until August 28 June 2021 to finally be able to benefit from it. That is precisely 311 days of waiting. However, this delay is far from being among the longest in the tricolor charts. And compared to what is practiced on the scale of the European Union, it would even be almost among the shortest…

Indeed, it takes, on average, 511 days – nearly a year and a half – in Europe for a new drug approved by the European authority to finally be available to patients. This is one of the lessons of the WAIT study (“Waiting to Access Innovative Therapies”), published on Thursday May 12 by the European Federation of Pharmaceutical Industries and Associations (Efpia).

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As every year, the professional organization, which counts among its members the big names of the world pharmaceutical industry, has lifted the veil on the results of its survey relating to access to innovative drugs on the Old Continent. The study measures the lead times and availability rates in each country of the 160 treatments – including Kaftrio – which obtained, from 2017 to the end of 2020, the green light from the European Medicines Agency for use in Europe.

It is clear that there are great disparities between the different countries of the continent. According to the study, the time it takes patients to access new treatments varies from four months to two and a half years depending on the region. In Romania, the average wait is thus 899 days, while it reaches 844 days in Poland, 676 days in Portugal, and almost 600 days in Estonia. In general, patients in Southern and Eastern Europe wait six times longer for access to new drugs », underlines Efpia, which calls on industrialists and States to act. Conversely, Germany, with a delay of 133 days, is a good student, alongside Denmark (176 days) and Switzerland (191 days).

Administrative complexities

As for France, it is progressing in the ranking, gaining three places, but still remains very far from the top three. With an average waiting time of 497 days (compared to 527 a year ago), it stands at 18and rank out of the 39 countries assessed. A figure which however excludes taking into account the specific device of the temporary authorizations of use. The latter, which underwent an overhaul in 2021, makes it possible to grant early access, in certain cases, to drugs awaiting marketing. In the case of Kaftrio, more than 400 patients had thus been treated by 2020. By integrating this parameter, this would reduce the average time in France to 240 days.

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