Licence outsourcing has numerous benefits for rare disease patients

Richard Lunney

Managing Director, Therismos

Partnerships between niche drug companies and healthcare supply organisations are speeding up the process of getting essential drugs to patients with rare diseases.

By supporting small drug firms to navigate the licencing process to the wider marketplace after regulatory approval has been granted, logistics firms are helping innovative drug developers with significant cost savings in the process.

According to healthcare logistics expert Richard Lunney, this means patients with rare conditions benefit, while niche drug development companies can invest in further products.

Rare diseases

Drug manufacturers must secure a Wholesale Distribution Licence — also known as a WDA (Wholesale Distribution Authorisation) — before new drugs can be distributed to patients.

Traditionally, companies acquire it themselves, which may take up to nine months. Or — they strike a licencing deal with another organisation but lose ownership of the product.

A third, lesser-known, route is via a specialist distribution company, which can support smaller companies — that may have tighter cash flow — in the process, and thus facilitate patient access to groundbreaking medicines for rare diseases.

Health sector expertise

Lunney is managing director of Therismos Pharma, a distribution partner providing pre-wholesale services to innovative biotech companies across the UK and Europe.

He explains that to gain a WDA, drug companies need premises, a quality management system and qualified staff and then apply to the MHRA (Medicines and Healthcare products Regulatory Agency) for the licence to sell their product on the market.

Outsourcing the process also limits the risks of delays in product launches.

Therismos already has that infrastructure in place, with expertise across several health sectors, meaning companies can outsource this aspect of the drug marketing process.

Consequently, companies do not have to secure a WDA themselves or have the associated staff and time costs. Instead, they can focus on securing regulatory approval and refining the product before formally engaging Therismos in the weeks before the product goes to market.

Patient access

The general cost saving is about 80%, releasing funds to be reinvested by the Innovator. Outsourcing the process also limits the risks of delays in product launches.

“What we are trying to do is keep that cost as low as possible so these companies can continue to reinvest in the development of new gene therapy or specialist products while getting access to the market,” continues Lunney.

“It’s a quick service. We can go from initial contracting to having the product in the UK in about eight weeks, which is good for patient access to these drugs.”