EU Regulatory Roundup: Finland Fines Novartis for Violating Marketing Rules With Low-Cost Treatment

Regulatory NewsRegulatory News | 12 March 2020 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Finland Fines Novartis for Violating Marketing Rules With Low-Cost Treatment
The Finnish Medicines Agency (Fimea) has fined Novartis €100,000 ($113,000) for breaching its rules on marketing. Novartis Finland Oy received the fine and an order to cease the practices in relation to an agreement with a medical center.
Fimea said Novartis’ agreement with the medical center covered the provision of low-cost medical treatment for self-administration in outpatient settings. In Fimea’s view, the agreement breached section 91 of the Finnish Medicines Act, which features restrictions and requirements including a ban on inducements of unnecessary use of medicines and the mandating of the maintenance of lists of all direct and indirect financial and comparable support provided by marketing authorization holders.
In reviewing Novartis’ agreement, Fimea also identified an alleged violation of section 92 of the act. Fimea accused Novartis of trying to limit the pool of patients eligible for reduced-price treatment, thereby breaching the section of the Medicines Act on sales promotions.
According to Fimea, Novartis engaged in the practices from 26 September 2018 to 30 January 2019. Fimea’s punishment bans Novartis from restarting the activities and hits the Swiss drugmaker with a €100,000 fine.
Fimea used the statement about the punishment of Novartis to emphasize how marketing is defined and regulated in Finland. Reflecting the nature of its accusations against Novartis, Fimea said that it is possible for contractual agreements intended to increase use of a medicine to violate Finnish rules on marketing. That possibility is a consequence of Finland defining marketing as any information, ordering or promotion intended to increase the prescription, purchase or use of a medicine.
Fimea Notice (Finnish)
Denmark Imposes Enhanced Reporting Requirements on Medical Devices
The Danish Medicines Agency (DKMA) has introduced enhanced reporting requirements for medical devices. As of 3 March, DKMA has the power to impose the enhanced requirements on healthcare professionals if it deems it necessary to gain a fuller picture of the safety of a medical device.
When dealing with devices subject to the enhanced reporting requirements, healthcare professionals will need to report details of all incidents linked to the products, regardless of their severity. Under the standard reporting requirements, healthcare professionals only need to tell DKMA about serious or potentially serious incidents.
DKMA sees the power to make healthcare professionals report non-serious incidents as supportive of its aim to investigate all events thoroughly before corrective actions are taken. The agency cited changes to the construction of the device, production process and instructions for use as examples of corrective actions. Manufacturers may also need to issue warnings or recall their devices.
The Danish regulator plans to subject devices to the enhanced reporting requirements if it “suspects possible errors, failure or deficiencies in a medical device but needs a larger assessment basis.” When DKMA selects a device for enhanced reporting, it will inform stakeholders via its website.
DKMA Notice
Swiss Confiscations of Illegal Drug Imports Soar After Procedure Simplified
The Swiss Agency for Therapeutic Products (Swissmedic) and its collaborators seized 7,781 illegal imports of medicinal products last year, more than twice as many as in 2018. The sharp increase in confiscations follows the implementation of a fast-track procedure.
In 2018, Swissmedic seized 3,203 shipments of illegally imported medicinal products. Last year, the number jumped to 7,781. The increase came off a relatively high base. Swissmedic piloted the use of the simplified procedure in 2018 as part of its efforts to curb the importation of erectile dysfunction drugs into Switzerland, contributing to a 200% increase in total seizures over the previous year.
Back in 2017, the final year in which the old procedure was used exclusively, Swissmedic seized 1,060 shipments. The figure for last year was more than 600% higher, suggesting the adoption of the new procedure has had a significant impact on seizures.
While the number of shipments seized has changed in recent years, other aspects of the operation have remained constant. Last year, 43% of seized shipments originated in India, almost exactly the same proportion as in 2018. As in 2018, Poland, Singapore, the UK and Germany were among the other countries of origin singled out by Swissmedic.
The types of products seized also changed little year on year. Erectile stimulants again accounted for around 90% of seized products. Other prescription-only medicines were again the next item on the list, trailed by sleeping tablets and tranquilizers.
Swissmedic Statement
MHRA Suspends 6 Manufacturing and Wholesale Licenses in 3-Day Blitz
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has suspended six manufacturing and wholesale distribution authorizations. MHRA’s flurry of regulatory actions saw more authorizations suspended in three days than in the first two months of the year.
If MHRA identifies safety issues or needs to investigate a licence holder, it suspends the authorization. The action buys MHRA time to look into authorized organizations involved in the manufacture and wholesale distribution of medicines and ingredients while ensuring patients are safe for the duration of the review.
On 2 March, MHRA suspended the license of pharmaceutical wholesaler Webstar Dixon until 27 May. Two days later, the agency disclosed five more suspensions, imposing restrictions on Hathersage Healthcare, North Abingdon Healthcare, Sharief Healthcare, Oakfield Pharma and Bell Walk Healthcare until 3 December.
According to the UK’s registrar of companies, all five of the organizations are registered at the same address at an industrial park in the large English town of St. Helens. The nature of business for each organization is listed as “dispensing chemist in specialised stores.”
Some of the same people are involved with all the organizations. Suhail Sharief, for example, is listed as a director of all five organizations. Sharief, whose occupation is listed as pharmacist, is also a director at other organizations that share an address with the suspended companies but were not affected by the MHRA action.
MHRA Suspensions
DKMA Hires Kjær from Novo Nordisk to Lead New Data Analytics Center
DKMA has appointed Jesper Kjær as head of its data analytics center. Kjær is set to join the Danish regulator from Novo Nordisk at the start of next month.
The new analytics center is central to DKMA’s plans to see data “used on a much larger scale for the benefit of people and patient safety.” Having secured Danish government support for the creation of the center last year, DKMA has worked in recent months to be ready for a 2020 launch, culminating in the appointment of Kjær to lead the center.
Kjær has spent the past six years at Novo Nordisk, rising to the post of director of data management process and innovation. The role put Kjær at the center of Novo Nordisk’s efforts to apply artificial intelligence (AI), cloud solutions and other technologies to clinical data. Kjær also explored the use of blockchain in clinical research.
At DKMA, Kjær will apply the skills he gained and honed at Novo Nordisk to regulatory uses of data. DKMA is looking to the data analytics center to advance its efforts to use real-world data and AI in the monitoring of medicines and medical devices and to inform its advice to industry. Kjær is on board with the strategy.
“We need a strong, data-driven agency to set the direction of digitalization in the pharmaceutical industry, and we also need to be able to provide data-driven advice about patient groups, and to work on optimizing drug trial designs, so that we can correctly evaluate new drugs to the benefit of patients,” Kjær said.
DKMA Statement


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