Why pharmacies run short of medicines – should we be worried?
A woman at the pharmacy counter next to me had to leave the store empty-handed without her contraceptive pills. A man beside me in an aeroplane revealed that he is a bit nervous about having to travel without his usual migraine medicine. These kinds of stories have become commonplace lately.
Issues related to availability of medicines have been in the headlines in all over Europe. In Finland, news stories have reported shortages of individual products or groups of medicines and their impact on patients. In the Nordic countries, this topic made the headlines last spring at least in Sweden and Norway.
Centralisation of manufacturing is the primary reason for medicine shortages
Drug regulatory authorities in several countries have reported an increase in notifications on medicine shortages in recent times. This may partially be due to an increase in notification activity following more active public discussion about this topic. Other important factors include centralisation of manufacturing of medicines and active substances, more complex production chains than before, implementation of requirements of medicines verification, and in future possibly Brexit as well.
Placing medicines on the market is a multifaceted and expensive process. Companies have to think about profitability while the society is under pressure to control medicine costs. The tendency to manufacture medicines in only few, all the time expanding units increases vulnerability of activities significantly. For example, a natural catastrophe may paralyze operation of several manufacturers located in the same area at one stroke. Or a quality defect at a manufacturer of an active substance may lead to a global availability issue with the final product because several operators acquire their raw material from this same manufacturer.
Local affiliates have only limited possibilities to influence
Local affiliates of global pharmaceutical companies are in a tight spot. They are responsible for sales in their own countries and for the availability of medicines on their part, but in practice it is difficult – if not impossible – for them to prevent medicine shortages entirely. Measures which could be taken to help ensure uninterrupted supply of medicines include as accurate forecasting on order volumes as possible, proficient management of package materials and the use of multi-country packs. All situations leading to a disruption in supply, such as unexpected quality defects of medicines, cannot however be predicted and taken into account in advance locally by the affiliates.
Exemptions and special permits mitigate medicine shortages
Medicine shortages can be mitigated by exemptions granted by the authorities. For example, a marketing authorisation holder may be granted a permit to import foreign-language packs if the medicine shortage is about a critical preparation for which there are no generic alternatives available or the market share of which is too big for the other countries to deliver compensating quantities quickly or sufficiently. Applications for an exemption are usually given high priority by the Nordic drug regulatory authorities and processed swiftly and in close cooperation with the pharmaceutical company.
In Finland, modifications to the special permit practice by the Finnish Medicines Agency Fimea have aroused discussion lately. A special permit can be granted for a medicinal product which has no marketing authorisation in Finland. Previously, special permits were also granted for centrally authorised products not placed on the Finnish market. This allowed companies to import foreign-language packs to Finland from bigger markets and thereof to avoid the relatively high costs from placing the product on a small market. Fimea’s new approach to special permits has caused challenges in terms of medicines’ availability. Consequently, we are no longer talking about mere temporary medicine shortages but about a larger-scale problem which may leave Finnish patients without important medicines if these are not imported at all.
Will the selection of medicines available to Finnish patients shrink?
The availability of medicines at EU level and the selection of medicines available to the Finnish patients will be discussed during Finland’s presidency of the Council of the EU and the current Finnish Government’s term of office because these issues are political decisions to some extent. Also EU-wide collaboration is needed to resolve availability issues. Would it be possible to reverse the current centralisation trend so that manufacturing of medicines would again take place closer to the patients? How could security stockpiling of medicines be developed? If the requirement on Finnish-language packs restricts import of essential products due to poor profitability, how could this be solved in practice? Is Finland’s low wholesale price level compared with the European level a partial reason for why all medicines are not placed on the market?
A lot of open questions and issues remain to be resolved but I’m confident that cooperation amongst all the parties involved will secure continuity of patients’ pharmacotherapy.
Good, functional cooperation amongst various operators in the medicines supply chain, authorities and prescribers is essential in minimising the duration of disruptions and their negative impacts. This topic was also discussed at an open discussion meeting for experts organised by DRA Consulting last spring.