Doctors Without Borders slams Novo Nordisk for SA insulin pen shortage

But multinational pharmaceutical company says it offered government solutions.

Doctors Without Borders, also known as Médecins Sans Frontières (MSF), and organisations representing people with diabetes picketed outside the offices of insulin manufacturer Novo Nordisk in Sandton on Thursday.

They are calling for the Danish multinational to withdraw its decision to discontinue its provision of human insulin pens “in South Africa and other developing countries”.

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Read: Millions left behind as diabetes drives surge in insulin demand

MSF also wants the company to lower prices for other insulin products.

Novo Nordisk has long supplied human insulin pens to the national health department. But last year it decided not to bid for the new tender, which began in May 2024. Since no other company applied for the tender, public health facilities across the country have been running low, with product shortages since earlier this year.

This has forced many diabetes patients to switch from easy-to-use pens to using glass vials of insulin with a syringe.

To use these vials, patients need to measure the dose themselves and inject it. By contrast, patients who use insulin pens can pre-set the dosage with a dial.

Candice Sehoma of MSF told GroundUp that “pens make it easier to ensure the correct dose is given, avoiding life threatening over-dosing”.

The pens are also “less stigmatising [than the vials] as it is discreet to use the device in public”.

Novo focusing on Ozempic

MSF and the South African health department have long argued that Novo Nordisk has been cutting back on its production of insulin pens to divert manufacturing capacity to the company’s more expensive GLP-1 products like Wegovy and Ozempic.

The sale of these products, which are used widely for weight loss, has catapulted Novo Nordisk’s share price.

The company is now Europe’s most valuable firm in terms of market capitalisation.

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Thabeng Leping, director of public affairs for Novo Nordisk’s South African office, told GroundUp that the company never completely stopped providing insulin pens to the South African government and is in communication with the health department.

“In October 2023 … we informed the department that we would not be bidding on insulin pens, and that our bid would be on vials alone,” said Leping. He said some time after this, officials “asked if we could help them, since other manufacturers were saying the same things – that they weren’t able to provide pens”.

“We [told the department] that our position is not that we don’t have pens at all, but that we don’t have the required volumes [to supply all patients]. So we continued to supply the public sector with insulin pens.

“What’s changed is that the supply is limited to patients who are deemed vulnerable,” he said.

This included four groups: children, elderly people, the visually impaired (who rely on the ticker of the pen dial to determine the dose), and patients who struggle to hold a vial, like people with arthritis. He said this covers 10 to 20% of patients.

The health department’s director for public procurement, Khadija Jamaloodien, confirmed that “some pens have been made available from Novo but the volumes are insufficient”.

Jamaloodien added that because there “isn’t a contract”, this makes the “actual purchasing process in the provinces difficult”. She said it would have been easier for the company to just submit a bid, even if it was to “supply a limited volume”.

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“Ultimately, our patients are impacted,” said Jamaloodien, who denied that Novo Nordisk provided the health department with a formal notice of its intention to stop supplying pens.

She said that “when bids are submitted, the information is confidential and accessible to the few who are responsible for evaluation and recommendation for contract award … [the health department] can only act after the contract is awarded”.

Contracts were awarded in mid-January, according to Jamaloodien, and the new tender would have started on 1 May, which didn’t give the department much time to find alternative suppliers.

MSF argues that the shortage of pens has been caused by diverting manufacturing capacity to meet the huge demand for new weight-loss drugs. Image: Doctors Without Borders

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Who’s responsible for the shortage?

The row over the shortages has raised difficult questions about the responsibilities of pharmaceutical corporations. Some may argue that the company is under no particular obligation to apply for any given tender, particularly since nothing stops other companies from bidding and providing the same product.

GroundUp asked MSF for its stance on the matter. In response, Sehoma said: “The manufacture and supply of insulin, discovered over 100 years ago, has been dominated for decades by three corporations – Novo Nordisk, Eli Lilly, and Sanofi … Novo Nordisk has grown to become the largest corporation in Europe. This dominant position in the insulin market comes with certain responsibilities.”

Sehoma said the multinational company was aware that it was the only supplier of human insulin pens to the national health department and that withdrawing from the tender could be disastrous if the health department could not find an alternative supplier.

“If they were withdrawing their human insulin pens, at a minimum Novo from the beginning should have ethically and responsibly offered to supply the alternative analogue insulins in pens, and price them the same as the human [insulin] pens (US$1.7 in the last tender),” she said.

Human insulin is a lab-made product with the same structure as the insulin our bodies make. Insulin analogues are produced in the same way, but they are genetically altered. For instance, they are sometimes changed to act more rapidly or slower than human insulin. Analogues have historically only been available in the private sector and are more expensive than human insulin.

MSF’s demand for manufacturers to cut insulin prices is based on a study published earlier this year. It found that current insulin prices are much higher than “what would be expected in competitive markets that afford manufacturers sustainable returns, while avoiding excessive profit margins”.

Novo Nordisk responds to MSF protest

According to Leping, Novo Nordisk has been working with the health department to devise remedies for the current shortage.

He told GroundUp that “the new solution we’ve offered is to provide insulin analogues … which are [administered] through flexpens”. He said they would produce enough of these to supply the whole public sector. As such, Leping said the MSF protest now represents a “moot point”.

Asked why Novo didn’t offer to supply the health department with analogue products in the first place, Leping said that insulin analogues weren’t on the Essential Medicines List (the catalogue of drugs that the government is obliged to buy for patients). But, says Leping, the health department had since told Novo that they would “grant EML [Essential Medicines List] status to insulin analogues”.

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“So now we can launch it in the public sector,” he said, noting, however, that this could only be done following a tender process. Leping said that the company would bid on the tender and anticipated that it would be awarded in the new year.

Jamaloodien confirmed that the department was working toward making analogue insulin pens available and that this tender was published on 8 November 2024.

“This is not ideal as the [analogues] come with [their] own issues related to switching patients safely as well as cost,” Jamaloodien said.

She confirmed that changes were being made to the Essential Medicines List.

“Insulin analogue pens were historically not included on the EML due to cost”, but “in light of current challenges, the National Essential Medicines List Committee will be undertaking a full technical review of insulins to determine which products to include”.

“For now, insulin analogues awarded on contract will be considered as EML, to ensure patient access but will be subject to the full technical review.”

According to Andy Gray, who serves on the National Essential Medicines List Committee, analogues are “claimed to offer some advantages [over human insulin], but whether those are significant enough to justify the additional costs, or long-term hard clinical outcomes, is contested”.

Responding to Leping’s claim that the MSF protest was advancing a moot point, Sehoma said: “We would be delighted to hear that Novo is willing to supply insulin analogues in Flex pens, but if the price is unaffordable then this offer is the moot point.”

© 2024 GroundUp. This article was first published here.

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