How the crisis affects the availability of medicines
Various availability issues existed before the pandemic, but the current situation has made many risks more immediate on a global scale. Production and logistics chains are often long and rely on single suppliers, increasing the risk of interruptions.
This is why pharmaceutical companies and competent authorities are under immense pressure.
The moment borders were closed, transport of medicine became more difficult in the European Union. Large and unpredictable spikes in demand, especially for medicines critical to the treatment of coronavirus infections, have tested the production capacity of manufacturing sites. Productions sites around the world have been forced to shut down due to national coronavirus measures. Raw materials of several medicines are produced outside the EU, for example in China or India where quarantines have limited production and export restrictions have been adopted. It is common that a single raw material producer supplies an active substance or an excipient for several different finished product manufacturers.
As production recommences, there is going to be competition over who gets the raw material first and which markets are a priority for the finished product manufacturer. As a small market, Finland may face challenges as bigger markets are often given priority.
Authorities have an active role in ensuring availability
This year the Finnish Medicines Agency Fimea has approached industry operators with several requests for information concerning the national availability of medicine and risk management. The supply and sales of over-the-counter medicines and salbutamol products have recently been restricted in order to ensure the availability.
The European medicines regulatory network (the European Commission, the EMA and the national medicines agencies) has outlined government-regulated measures designed to facilitate the production and supply of medicines and reduce pandemic-related delays and interruptions.
The common policy is a major step for authorities, helping the industry prepare and facilitate required actions.
EU authorities are helping by carrying out the following
Prioritising variation applications critical to availability
The availability of medicines can be improved with, for example, adding alternative manufacturing sites or by increasing batch sizes. Variation applications concerning COVID-19-critical medicinal products are to be processed quickly, in as little as two days (so-called Exceptional Change Management Process, ECMP).
The use of medicinal products without market authorisations and expedited marketing authorisation procedures
How are we ensuring availability of medicines in Finland today, and what more could we do?
Even if a certain medicinal product has not been authorised for the Finnish market, Fimea may grant it a temporary special permit or a special permit for individual patient. This provides more opportunities to treat patients with alternative medicinal products. If a medicinal product is considered critical in the treatment of coronavirus infections, the new marketing authorisation application can be submitted for expedited processing. In addition, if a critical medicinal product has been granted market authorisation in another EU country, authorities may allow the use of so-called zero-day mutual recognition procedures in order to grant market authorisation for the product in another member state.
Providing flexibility for inspections
With travel restrictions in place, on-site factory audits and other inspections are not possible. The European medicines regulatory network has recently provided significant help measures which is a clear indication of how well medicines regulation works between European authorities.
Prioritising critical functions
During the pandemic, all industry operators must increasingly focus on functions that support the availability of medicines. Authorities have provided some relief: for instance, applications for renewal can be postponed, and the approval criteria of applications for sunset clause exemption are less strict.
Other means to ensure availability
Mandatory reserve supplies of medicines
In Finland, legislation concerning mandatory reserve supplies of medicines helps ensure the availability of critical medicines. This legislation requires even a ten-month reserve supply of specific medicinal products. The mandatory reserve supplies of medicines is unique to Finland, with such arrangements rare elsewhere in the world. Maintaining such a resource is challenging, but it is very useful in a time of need. The stock consists of products with several important active substances and groups of active substances. Pharmaceutical manufacturers, importers, and the Finnish Institute for Health and Welfare (THL) may request Fimea for permission to temporarily bring down the reserve stock capacity. The Ministry of Social Affairs and Health may also decide to take the mandatory reserve supplies of medicines into use under certain conditions in situations where security of supply may be at risk.
Foreign language packages
Should products specifically packed for the Finnish market run out, there may be products available in packages targeted for other markets, in Europe or elsewhere, that could be imported to Finland. In order to secure supply, Fimea may grant an exemption to sell medicine in foreign packages. Fimea processes these exemptions quickly. Similar procedures are in place in other countries, too.
Favouring multi-country packages in medicine production is an effective way to improve availability. While the process of creating and approving multi-country package may require more effort than single-country package, the benefits are realised over the lifecycle of the product. It helps increase total volume and simplifies distribution to various target markets.
Flexibility in implementation schedules
While many countries adhere to strict time limits in implementing updated package leaflets and packages to production or to market, no strict limits have been set in Finland. The EU should have a common policy to relax implementation schedules, especially in situations where ensuring availability is critical. Implementing updated artwork is not a quick process even under normal circumstances, let alone in a crisis.
It is great to see that authorities are keeping a close eye on the situation and cooperation within the EU has worked well despite various national interests.