Mid September ReAct met with the European Commissioner Vytenis Andriukaitis to amongst other topics discuss what European wide solutions to the problem of some old, but still effective antibiotics being reported unavailable in many European countries.
Varying underlying reasons
The reasons for unavailability vary. Market withdrawals where the market is small and not considered economically attractive by companies is one reason which has been documented. Shortages due to disruptions in the production and supply chain are another. Finally lack of robust competition in markets may lead to overnight price hikes, which may in turn affect prescribing patterns.
Consequences for patients
The consequences of unavailability are serious. For patients, unavailability of old antibiotics can have direct serious consequences, when prescribers turn to alternatives that may have more side effects or are less effective treatment options. From a public health perspective, this suboptimal use of alternative antibiotics is also a driver of resistance development.
Long known problem
The European Member States have recognized this problem for many years. It was first raised during the Swedish Presidency of the European Council in 2009 and again in 2016, when the issue was put on the agenda for discussion among the European Member States by the Slovakian Presidency of the Council of the European Union. Leading academics in the field have also warned about the issue of unavailability of old effective antibiotics.
Member States not ready to tackle issue at European level
Solutions, like European level joint procurement have been mentioned in such discussions. Pooling of demand for the whole European market could likely help address the problem with unavailability due to market size faced by many smaller countries, as well as where the market for certain antibiotics is small in many countries due to limited demand and use of that particular antibiotic. To address the problem of unavailability due to disruptions at the level of production and supply chain is another challenge which requires more analysis, but could be somewhat addressed by having several producers form a robust production base.
Tool exist but yet unused
While the European Commission has already created a joint procurement mechanism, its use has been so far been minimal by European Member States. Instead a proliferation of smaller joint procurement projects between a smaller number of countries, like the Beneluxa, have emerged. Whether they will be able to effectively address the problems of unavailability of older antibiotics is unclear.
Should inform system for new antibiotics
The current challenges of ensuring continued production of old effective antibiotics should however inform the current discussions the design of novel system to develop and produce new antibiotics. Measures to ensure sustainable production must be developed to ensure that patient can have access to the most appropriate treatment option. For this purpose, much more analysis is needed of what incentives would be appropriate for a broader set of actors involved in production of antibiotics – such as the generic manufacturers for example.