Health activists have welcomed the Competition Commission’s announcement that it will launch an investigation into two pharmaceutical giants regarding potential anti-competitive practices in the insulin pen market.
MedicalBrief notes the probe into Novo Nordisk and Sanofi-Aventis South Africa will examine whether multiple device patents and proprietary designs are being used to exclude competition and prevent the entry of alternative suppliers.
The initiation was triggered by Novo Nordisk’s October 2023 decision to cease tendering for insulin pens to the National Department of Health, instead offering only insulin vials. This change left South Africa's public healthcare sector without a contracted supplier of insulin pens for 2024, potentially affecting thousands of diabetes patients.
“Just under 5m people in this country are estimated to have diabetes, yet access to modern insulin delivery systems is becoming increasingly restricted, so the investigation is long overdue,” said Fatima Hassan, director of Health Justice Initiative.
“There can be no room for monopolistic behaviour by big pharma when it comes to life-saving medicines and devices. It’s high time the government took action to hold both companies accountable and to better regulate the licensing, access, and pricing landscape, especially as the health department prepares to become the country’s single medical products procurer under National Health Insurance (NHI).”
She said the HJI also encouraged the Commission to “look into the licensing agreement between Novo Nordisk and its licensee Aspen Pharmacare, which may also be contributing to a generic monopoly on diabetes products”.
“We hope the Commission will also examine whether the recent shift in manufacturing focus towards weight-loss pens has contributed to insulin pen supply issues, potentially harming diabetes patients who must revert to using vials.”
The HJI and its partners were “committed to supporting the investigation by contributing detailed submissions, and also call for a comprehensive regulatory investigation into potential anti-competitive practices across the country’s entire insulin market”.
Despite their clinical advantages, insulin pens remain largely unavailable and unaffordable in low and middle-income countries (LMICs).
Last year HJI, the Treatment Action Campaign and Doctors Without Borders (MSF) called on Eli Lilly, Novo Nordisk, Sanofi, and other insulin manufacturers to make all insulin pen devices (human and analogue) available at $1 per pen in all LMICs, based on data published by MSF estimating that the pens could cost as little as $0.94 each, including a profit.
South Africa, one of the first LMICs to provide human insulin in pen devices – in 2014 – faced a major setback in diabetes care when the three major corporations Novo Nordisk, Sanofi and Eli Lily (who control approximately 90% of the global insulin market) refused to respond to the government tender issued in 2023.
With no other option left, the government was forced to start procuring expensive analogue pens from Sanofi at a much higher price, costing from $2,24 for long acting analogue pens to $4,26 for ultra-fast acting analogue pens.
In 2023, Novo Nordisk also signed an exclusive deal with SA manufacturer Aspen Pharmacare to supply human insulin in vials for Africa. However, the detailed conditions of this agreement were not made public.
HJI said the lack of access to the pens in this country had been further worsened by Novo Nordisk’s recent decision to discontinue the production of human insulin in pen devices, to focus on the production and marketing of more lucrative medicines in pens, such as Ozempic and Wegovy, which are sold at extremely high prices in high-income countries.
See more from MedicalBrief archives:
Time to force Big Pharma's hand on insulin production?
SA’s insulin pens supply dries up as weight-loss drugs take priority
Concern about insulin pen shortages in SA