Special licensed medicines help safeguard continuity of care when standard options are unavailable

By: Tiina Liipo, Head of Special Licensed Medicines, Oriola

What are special licensed medicines and when are they needed?

Special licensed medicines are supplied through a dedicated regulatory pathway in the Finnish and Swedish pharmaceutical systems. For many patients, they are an essential part of ensuring continuity of care. A special licensed medicine may be needed when no suitable marketing-authorised medicine is available, or when the available products are unsuitable for a patient due to their strength, pharmaceutical form, composition or another clinical reason. Special licensed medicines can also be used in certain shortage situations to prevent essential treatment from being interrupted.

This is not a minor area of pharmaceutical care. In 2025, the Finnish Medicines Agency Fimea processed more than 23,000 special licensed applications, approximately half of which were patient-specific and half institution-specific. In Sweden, the Swedish Medical Products Agency processes approximately 50,000 licensed applications for human medicines annually. In 2024, more than 56,000 patients collected at least one special licensed medicine from a community pharmacy in Sweden.

These figures illustrate the important role that special licensed medicines play in helping healthcare systems respond to individual treatment needs when authorised alternatives are unavailable or unsuitable.

Different systems in Finland and Sweden, but the same patient need

Oriola operates in two markets where the rules and practices governing special licensed medicines differ. Finland and Sweden have their own reimbursement systems and licensed application processes. Sometimes the differences are significant and sometimes more subtle. Despite these differences, the challenges experienced by patients during shortages are often very similar.

A medicine shortage may appear as one entry in a report or a statistic, but for the person whose treatment depends on that medicine, its unavailability can become a deeply personal challenge. Resolving the situation requires an entire chain of professionals. No single professional can solve the entire situation alone. Continuity of care is secured when all parts of the chain work together and information moves quickly between them.

Medicine shortages are only one reason special licensed medicines are needed

Medicine shortages have remained a challenge across Europe for several years, affecting patients, healthcare services, pharmacies and pharmaceutical companies. Most shortages can be resolved directly at the pharmacy by substituting the prescribed product with an interchangeable medicine. If direct substitution is not possible, the patient may need an alternative marketing-authorised medicine and a new prescription from their physician. This can increase the workload of both pharmacies and healthcare professionals while also creating additional inconvenience for patients.

In both Finland and Sweden, pharmaceutical wholesalers distribute available medicines to pharmacies across the country according to established distribution practices. As a result, medicine availability is generally determined by whether manufacturers are able to supply the medicine to the wholesale supply chain in the first place

A special licensed medicine becomes an option only when the shortage cannot be resolved through generic substitution, another pack size, a marketing-authorised alternative or expansion prescribed by a physician. Even then, the physician must assess whether the medicine is suitable for the individual patient.

However, shortages alone do not explain the need for special licensed medicines. According to an analysis by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), the increase in shortages has had only a limited impact on the use of special licensed medicines. More permanent gaps in the market also exist. A company may not apply for marketing authorisation in a relatively small Nordic market, an authorised medicine may not be commercially available in the country, or a patient may require a more individualised treatment option. 
For these reasons, special licensed medicines remain an important part of ensuring access to treatment, even outside shortage situations.

Continuity of care depends on collaboration

When medicine availability is disrupted, continuity of care depends on effective collaboration across the healthcare system. Physicians assess clinical needs. Pharmacies manage dispensing and licence applications. Authorities evaluate applications and regulatory requirements. Supply chain partners identify, source and deliver suitable products. Pharmaceutical companies contribute critical information about availability and product status.

In widespread shortage situations, authorities may also issue special permissions or time-limited authorisations that enable pharmacies to dispense medicines without a large number of individual licensed applications. The ability to respond quickly relies on information sharing, professional expertise and coordinated action throughout the value chain.

An international supply chain with many moving parts

Special licensed medicines are sourced from around the world. Approximately 75% of the packs sold in Sweden are authorised in another European country. Products sourced from outside Europe may include medicines that are not available in any European market.

Delivering a special licensed medicine is like putting together a puzzle. Finding a suitable product is only one piece.The process also requires an appropriately licensed and reliable supplier, assess the available product and quality information, ensure regulatory-compliant import procedures and suitable transport and storage conditions, and confirm current availability, pricing, and delivery times.

Every piece must be in place before the medicine can be delivered to the patient safely and on time. This complexity means that sourcing and delivery require both pharmaceutical expertise and specialised logistics capabilities.

Rising costs highlight the need for transparency and cooperation

The use of special licensed medicines has also attracted attention because of rising costs. In Sweden, the cost of special licensed medicines increased from approximately SEK 254 million in 2015 to SEK 592 million in 2024. In 2025, the cost remained at approximately SEK 600 million. The increase is not primarily the result of a higher number of packs being sold. The average price per pack increased by approximately 83% between 2015 and 2024, and the use of relatively expensive medicines has been a significant driver of the overall cost increase.

The increasing costs have contributed to discussions about pricing, transparency and reimbursement. At the same time, special licensed medicines continue to play an important role in situations where no suitable marketing-authorised alternative is available. Rising costs also highlight the importance of transparent pricing, responsible sourcing, reliable data and close cooperation between the different actors involved in the supply chain.

Expertise is needed throughout the process

A special licence is not a shortcut around marketing authorisation. A marketing-authorised medicine is always the primary treatment option, and there must be clear clinical grounds for using a special licensed medicine. Economic considerations alone are not sufficient grounds for granting a licence.

Special licensed medicines may not be marketed. At the same time, healthcare professionals need access to neutral and up-to-date information about medicines, availability and deliveries so that suitable alternatives can be identified and sourced safely. This requires expertise throughout the process, from identifying potential alternatives and evaluating documentation to sourcing, import procedures, storage, distribution and delivery.

At Oriola, our special licensed medicines service combines pharmaceutical expertise, international sourcing and compliant pharmaceutical logistics. We support pharmacies, hospital pharmacies, healthcare providers and veterinarians in responding to shortages and meeting individual treatment needs. Our extensive international supplier network helps identify medicines requiring a special licence for both human and veterinary use.

Patient safety remains the foundation of this work. By helping secure access to the required medicine, it is possible to support the continuation of treatment as planned and help safeguard continuity of care.

Ensuring patients receive the medicines they need

Ultimately, the goal is simple: when no suitable marketing-authorised treatment option is available for a patient or an animal, the medicine they need should reach them safely and without unnecessary delay. Special licensed medicines are an important part of making that possible.

Explore our service offering and contact our experts for more information about how we support pharmacies, healthcare providers and veterinary professionals in Finland and Sweden