Medicine shortages: Why manufacturing is only part of the solution

The shortage of transdermal oestrogen medicines in Sweden recently brought attention to domestic, pharmacy-compounded manufacturing alternatives. As discussed in an interview with Swedish healthcare publication Dagens Medicin, medicine shortages are complex, and proposals for domestic, pharmacy-compounded manufacturing must be assessed against pharmaceutical, regulatory and commercial realities.

Authorised treatments vs. pharmacy-compounded medicines 

Pharmacy-compounded medicines can play an important role when patients are unable to access authorised treatments, including during prolonged shortages. However, they are primarily intended to address specific, temporary needs and do not provide a direct substitute for an authorised medicine supported by a complete development and registration programme.

The current discussion therefore points to a broader question: how can Sweden strengthen access to authorised medicines over the long term? From a pharmaceutical and regulatory perspective, sustainable supply requires more than the ability to manufacture a product. It also depends on suitable technology, robust development and documentation, regulatory expertise, commercial-scale manufacturing capacity and a viable market. Strengthening these capabilities could help create better conditions for the domestic production of authorised medicines. 

Closing remarks

Pharmacy-compounded alternatives will continue to have an important role when authorised products are unavailable, but long-term supply resilience ultimately depends on a strong pharmaceutical industry capable of developing, registering and reliably supplying medicines at scale.