The South African Competition Commission has launched an investigation into insulin pen manufacturers Novo Nordisk and Sanofi Aventis. According to the Health Justice Initiative (HJI), the probe aims to determine whether multiple device patents and proprietary designs for insulin pens and cartridges are being used to stifle competition and block alternative suppliers from entering the market. 

The global insulin market has undergone significant changes in recent years, including the introduction of the Affordable Insulin Now Act in the U.S., which aims to reduce out-of-pocket insulin costs for Americans. In early 2023, Eli Lilly announced a 70% price reduction on insulin, with Novo Nordisk and Sanofi soon following suit with their price cuts. Additionally, Sanofi had already discontinued its pre-mixed insulin product, Insuman, before announcing the price reductions. Novo Nordisk later revealed plans to discontinue its long-acting insulin product, Levemir, by the end of 2024, while in March 2024, Eli Lilly announced limited availability of its Humalog and Lispro insulin products. 

In South Africa, the Competition Commission’s investigation was prompted by concerns over insulin pen availability in the public healthcare sector. Novo Nordisk, which had been supplying human insulin pens to the South African Health Department for a decade, decided not to participate in the 2024 tender for these devices. Instead, the company opted to phase out its human insulin pens globally and shifted its tender bid towards supplying insulin in vials, citing a strategic decision to ensure continued public sector access. Novo Nordisk stated that this decision was made after thorough discussions with the South African Department of Health, emphasizing that the public sector would still have adequate access to insulin through this route. Sanofi and Eli Lilly also did not participate in the 2024 tender process, though specific details regarding their decisions have not been disclosed. 

Concerns have been raised that patent and design restrictions are preventing alternative suppliers from entering the market, leaving South Africans with fewer and more expensive options for insulin pens. At the same time, pharmaceutical companies holding these patents have discontinued certain pen models. Critics argue that if alternative suppliers were allowed to enter the market, they could produce insulin pens at a lower cost, making them more accessible. Insulin pens are widely preferred by diabetics due to their ease of use and accuracy compared to traditional injections. 

One possible intervention that could address these concerns is the use of compulsory licenses under Section 56 of the South African Patents Act. This legal mechanism allows the government to grant licenses to alternative manufacturers if a patent holder is found to be abusing its rights, such as by restricting competition or limiting access to essential medical products. If the Competition Commission determines that Novo Nordisk, Sanofi, or Eli Lilly have used their patents to block competition while simultaneously withdrawing certain insulin pen models from the market, a compulsory license could be a viable solution. This would allow alternative suppliers to manufacture insulin pens at a lower cost, improving accessibility for South African diabetics. 

Compulsory licensing has been used in other cases where patent protections have created barriers to essential medicines, particularly in the case of HIV/AIDS treatments. If similar principles are applied here, it could ensure that South Africans continue to have access to affordable and effective insulin delivery options.