Swiss audit office suggests speeding access to new drugs

The Swiss Federal Audit Office believes that there are ways to optimize approval processes for new drugs to make them available to patients faster. © Keystone / Christian Beutler

In Switzerland today, it takes around two and a half years for a new treatment to be made available to patients. According to a new report by the Swiss Federal Audit Office, optimising the validation process could reduce this time by one year.

The Swiss Federal Audit Office points the finger at Swissmedic and the Federal Office of Public Health (FOPH). In its view, although the validation process is effective, it could be optimised for speed and efficiency.

At present, before patients can have access to a new drug, these two bodies have to give their approval one after the other. First, Swissmedic authorises the marketing of the product, then the FOPH negotiates the price with pharmaceutical companies and validates reimbursement of the treatment by health insurers.

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To speed up the process, the Swiss Federal Audit Office believes that these two procedures should be carried out in parallel. The Swiss government has already introduced a new system called “Early Access” on January 1. This allows life-saving drugs to be authorised and, at the same time, declared reimbursable by health insurers.

“In a number of situations, patients have had to wait a long time for reimbursement decisions on drugs that are important to them,” particularly for treatments for rare diseases, explained Thierry Buclin, Honorary Professor of Clinical Pharmacology at Lausanne University Hospital (CHUV), on Thursday in the Swiss public radio programme, RTS Matinale.

The current process forces doctors to request exceptions or negotiate with insurance companies to obtain special authorisations. “It’s futile work that could be simplified and avoided if we moved a little faster, particularly when it comes to decisions on reimbursements by compulsory basic insurance,” stressed Buclin.

Pharma industry push

Interpharma, the umbrella organisation for pharmaceutical companies, supports the idea of the FOPH and manufacturers agreeing a provisional price for new life-saving drugs. A recommendation has also been made by the Swiss Federal Audit Office.

“This would enable the drug to be brought to market much more quickly. At present, it takes 300 days from the date of Swissmedic’s marketing authorisation to pricing, for example, including the drug on the list of specialties”, explained Michèle Sierro, spokesperson for Interpharma.

But according to the audit, the pace will not be accelerated without more active participation from pharmaceutical companies.

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Switzerland being a small market, pharma companies, for example, only submit their medicines to Swissmedic for authorisation some 200 days after submitting the same application to the European Medicines Agency.

The Swiss Federal Audit Office therefore also recommends that Swissmedic step up its involvement in international projects that simplify the submission process for new treatments.

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