The pharmaceutical scandal surrounding the procurement of insulin from Ukraine continues to develop in Moldova. In July 2019, the National Anti-Corruption Center (NAC) of Moldova initiated a criminal investigation regarding the public procurement of Strim insulin, produced by Ukraine’s Farmak, one of the largest pharmaceutical companies in the country.
Angela Starinschi, the spokesperson for the NAC, confirmed that the investigation concerns the «organization of public procurement procedures for medical products for diabetes patients.» Several individuals have been questioned, and documents have been seized as part of the case. The main suspect, according to Moldovan media, is Ivan Antoci, director of the Centralized Public Procurement Center for Healthcare. He was dismissed on July 26.
According to the tender documents, 20,000 doses of bio-insulin Strim, produced by Farmak, were delivered to Moldova through the company EsculapFarm. However, it was discovered that this product is not registered under this name in Ukraine, nor is it approved by the European Medicines Agency (EMA). Furthermore, it turned out that Strim is manufactured in India, and there is no credible evidence regarding its safety.
By 2017, more than 104,000 patients with diabetes had been registered in Moldova. In the fall of 2018, following a public tender, it was decided to import nearly 414,000 doses of the Ukrainian insulin. However, Moldovan media reports that the procurement process was not transparent: deadlines and terms were changed several times, and the initial budget of 21.6 million lei increased to 100 million.
After the investigation began, State Secretary of the Ministry of Health, Boris Gylka, stated that he had been blackmailed into signing the order for Strim’s procurement. “The insulin was registered suspiciously fast. It hadn’t been studied, there is no data on its effects on the body, and I don’t understand how it was allowed to participate in the tender,” Gylka said. He also claimed that several people with personal interests were involved in the matter.
The Strim insulin requires the use of an additional injection device, which, according to Gylka, hasn’t been used in EU countries for more than five years. Moldova had also previously refused the use of additional cartridges for patient convenience. Changes to the tender terms after Strim’s registration raised suspicions, especially since the product is reportedly used in Ukraine in just 3-4% of cases, primarily for prison inmates. In Moldova, patients avoided using this insulin due to a lack of trust in the product.
At the end of July, the Moldovan Medicines Committee denied the registration of Strim, as it was not clear what side effects the product might cause for diabetic patients. The Ministry of Health and Moldovan law enforcement agencies believe this is a large-scale fraud case.
Strim is a biosimilar insulin, a biological medicine containing a copy of the original active ingredient. The drug Insulin glargine, produced by the Indian company Biocon Limited, was registered in Ukraine in 2017, with the marketing authorization held by Ukraine’s Farmak. In Moldova, it was registered under the commercial name Strim.
However, the manufacturer failed to provide sufficient evidence of the drug’s effectiveness and safety in the registration dossier and used research data from the Indian manufacturer without conducting its own studies, violating the requirements for biosimilars’ clinical trials set by the FDA and EMA.
Moldovan journalists speculate that the Indian company Biocon Limited might not even be aware that their product has caused a multimillion-dollar insulin scandal in Moldova. The product entered the Moldovan market due to the corrupt ties between the Ukrainian company Farmak and Moldovan officials responsible for pharmaceutical procurement.
Farmak is considered one of Ukraine’s pharmaceutical giants, owned by Filia Zhebrivska, who consistently appears on the list of the country’s wealthiest individuals. In 2018, Deutsche Welle reported that the Zhebrivska family had transparency issues in Germany. The German company, part of the Zhebrivska pharmaceutical empire, violated anti-tax evasion and anti-money laundering laws by failing to register the names of its beneficiaries in the Transparency Register.
