New preparations could be in stores 400 days faster: Switzerland is waiting for drug approval

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It is annoying for pharmaceutical companies and patients: it takes a while before a new medicine ends up on the pharmacy shelf. Not only research and development takes time, but also approval. According to the Federal Audit Office (SFAO), this alone currently takes 900 days.

Ideally, it would be possible to use 400 days less: this could almost halve the duration of the approval process. That would be desirable, because health insurers usually only have to pay for a medicine if it has successfully completed all the correct processes: firstly, it has approval and secondly, it is on the so-called specialty list, on which the prices are stated. are also set.

Collaboration as an alternative

Faster procedures would still be possible, says the EFK, for example through international cooperation: for cancer therapies, for example, there is a cooperation program with the US FDA and other authorities, including from Canada, Australia and the United Kingdom. Six approval procedures were carried out in this way from 2019 to 2021.

Thanks to a second initiative called ‘Access’, in which different approval authorities closely exchange information, Swissmedic was able to reduce procedure time by 286 days between 2018 and 2021. However, Switzerland only carried out four entry procedures during this period.

The financial controllers now recommend that Swissmedic make greater use of these two procedures. “They reduce the time to potential reimbursement for patients by approximately 200 to 300 days.”

Pharmaceutical companies will submit a file here later

In its statement, Swissmedic confirmed that international cooperation could open up “efficiency potential”. But the authority also holds pharmaceutical companies liable. They would decide when and where an application for approval would be submitted. And in fact, the companies submit their applications to Swissmedic about 200 days later than to the European counterpart EMA.

“New medicines cannot be marketed in all countries at the same time,” counters René Buholzer, director of the Interpharma association. “As these general conditions have deteriorated in recent years, this may result in Switzerland no longer being prioritized and applications for approval in this country being submitted later or not at all.”

BAG also blames the pharmaceutical industry

The Federal Office for Public Health, which must put new drugs on the specialty list so that they can be paid for, also passes the ball back to the pharmaceutical representatives. When it was added to the specialty list, almost 80 percent of the time was spent negotiating prices with the pharmaceutical companies.

However, the financial audit states: “The duration of the process remains dependent on the level of competition in the industry.” But here too, Buholzer objects: “The outdated pricing mechanism in particular leads to record waiting times for patients, but makes the Swiss market, which is small internationally, increasingly unattractive.”

Here too, there are solutions for financial controllers: it would be conceivable to define price ranges in advance. Alternatively, temporary, provisional prices may be set after approval by Swissmedic. Or you can perform both approval steps in parallel. There are also initial pilot tests. But until these are used, we will probably have to wait a while.

Source:Blick