Between 2007 and 2011, Alkopharma distributed a cancer medicine that had already passed its expiry date. The Martigny-based company tried to conceal the fact by relabelling packs. This created an issue because the medicine’s efficacy was reduced and it was also used in children. The courts imposed a relatively mild sentence on the grounds that there had been no specific danger to health. A review of the case from Swissmedic's perspective.
Tha case
The case made headlines across Switzerland. Alkopharma falsified the labels on packs of an expired cancer treatment so that it could keep selling them. Between 2007 and 2011, the now-bankrupt Valais-based company supplied over 100,000 ampoules of out-of-date medicine. The majority went to France, but almost 2,500 doses ended up in Swiss hospitals. The medicinal product was manufactured in Germany, packaged in Martigny and sent from there to wholesalers in France, where it was authorised.
In 2016, the Cantonal Court of Valais sentenced the culprits to a suspended financial penalty and fines. The Court was of the opinion that there had been no specific threat to patients’ health. Swissmedic did not share that opinion and therefore appealed to the Federal Supreme Court. However, the Supreme Court corroborated the Cantonal Court’s ruling. No clear proof of any danger to health could be identified. Given that individual batches only had an active substance content of around 85 percent, Swissmedic finds this an astounding conclusion. Furthermore, there was very obvious criminal intent. Falsified labels had been applied to almost 100,000 of the just under 130,000 ampoules that had been sold. When the manufacturer’s documentation was examined, it became clear that a significant amount of time and energy had gone into falsifying the documents. Sampling records had also been deliberately manipulated. The primary motive appeared to be financial. The market price for an ampoule was around 100 euros, and several vials were needed for a course of treatment.
Investigator-in-Charge Olivier Flechtner’s perspective
“We found this case interesting and challenging for several reasons. It was my first case as a member of Swissmedic's Penal Division. I remember very clearly the day that proceedings against Alkopharma began. We received the French criminal complaint on 16 September 2011. Twelve days later, we searched premises in the Swiss cantons of Valais, Vaud and Geneva with assistance from the Federal Office of Police (fedpol) and relevant cantonal police forces. Our search of the company's premises and the first examination hearings took place under challenging conditions since the prime suspect was completely uncooperative, and this attitude filtered down to the company’s employees.
The investigation was extremely time-consuming and complex. To understand exactly what had happened and how the expired medicinal products had been returned to circulation, we had to reconstruct the entire goods flow from 2005. Swissmedic's laboratory tested the ampoules, which were found to only contain a fraction of the active substance they should have contained. However, the lab was unable to detect any decomposition products. Instead, the active substance was found to have formed a compound with the rubber stopper in the vials. IT specialists were able to prove that the falsified documents had been created on the principal defendant’s computer and stored on a USB stick that we found in her home. The report prepared by the forensics institute in Lausanne also proved that the falsified documentation had been printed on the printer in the principal defendant’s office.
«There were occasions when the defendant’s recalcitrance left me perplexed»
Proceedings lasted for a total of five years, and there were a large number of hearings. The primary suspect consistently refused to make any statement during this period, stating only that she had nothing to say. There were occasions when the defendant’s recalcitrance left me perplexed. She finally testified when she appeared in court.
The Valais District and Cantonal Court sentenced the operations manager of the Martigny facility to a suspended financial penalty, while the company’s proprietor was only given a fine since the Court ruled that there had been no specific threat to health. It said we had failed to prove that patients would not have been cured because the medicine was out of date. In our view, this line of reasoning was flawed, because we would then no longer be talking about a danger to health but about bodily harm. We therefore decided to appeal the verdict in the Supreme Court. Unfortunately, our appeal was rejected, and the Supreme Court backed the Cantonal Court’s ruling on the grounds that the expired medicine was always used in combination with other preparations which had the same effect. This being so, the Supreme Court believed, patients’ chances of a cure were unimpaired.
This ruling from Switzerland’s court of last resort was disillusioning. However, we also had to accept that we had done everything in our power and had tested how far we could go. As Swissmedic's prosecuting agency, that was all we could do. From our perspective, this gives extra weight to the fact that new legal provisions have been in force in the Therapeutic Products Act since 1 January 2019. It is likely that the verdict would be different today.”
New penal law provisions
Since 1 January 2019, offences such as that described here have been subject to tougher sentencing since there is no longer any requirement to prove a specific threat to health. The penalty for anyone found guilty is up to three years’ imprisonment or a financial penalty. If the offence has been committed on a commercial scale, offenders can be sentenced to up to ten years in prison. Furthermore, falsifying medicinal products and medical devices is now explicitly mentioned as an offence in its own right.
