Pro Generika presents reports on international best practice in the event of drug shortages

24.03.2015 15:31

The industry association Pro Generika presented the report “Best practice approaches to drug shortages in an international comparison” in Berlin, which was commissioned from the consulting company IMS HEALTH. The report examines approaches in seven selected countries to dealing with bottlenecks to see whether these have actually led to a reduction in bottlenecks. A particular focus was on generics, which are of particular importance for security of supply, and not just in Germany.

Dr. Frank Wartenberg, President Central Europe, IMS HEALTH, summarizes the most important results of the report as follows: “In our analysis, in addition to Germany, we included the USA, Canada, France, Switzerland, Finland, the Netherlands and Great Britain. This happened against the background that shortages of medicines are also an issue in these countries, generics play a major role in supply and - as in the case of the USA - the regulations there for dealing with shortages have been taken up again and again in the public discussion . In addition to IMS market experts in the respective countries, we also included experts from pharmacies, companies, regulatory authorities and clinics.

The analysis revealed that although the causes of bottlenecks vary in specific individual cases, they can be classified overall. Production-related bottlenecks, which involve quality assurance measures, for example, must be distinguished from demand-related bottlenecks, which are based on an unplanned increase in demand.

The instruments available to combat bottlenecks are limited. It also became clear that although a number of measures have been taken - such as public shortage registers, creation of lists of essential medicines, import regulations for medicines at risk of shortages, increased storage - shortages apparently cannot be avoided. From our point of view, a multi-stakeholder approach that brings all market players together at the same table and is particularly concerned with the management of bottlenecks seems to be particularly effective.”

Wolfgang Späth, Chairman of the Board of Pro Generika, assesses the IMS analysis from the perspective of the industry: “We commissioned the report because the public debate often refers to the situation in other countries. It was therefore important to us to enrich the debate with even more empirical evidence. The analysis by IMS HAELTH shows us one thing above all: the measures taken in the countries examined to combat drug shortages are very similar. However, no country has actually managed to completely prevent drug shortages.

This shows us three things: Firstly, there is no so-called “one size fits all” solution. Bottlenecks have various causes. Successful solutions are obviously those that address the respective causes. Secondly, this brings the management of “successful handling” of drug shortages to the fore. What is particularly important here is the interaction between the various players – companies, doctors, pharmacists, wholesalers, clinics. In the Netherlands and Canada, for example, there are B. Approaches that bring all affected actors together at the same table. And the Federal Ministry of Health also began coordinating with all stakeholders some time ago. This underlines that all actors have a responsibility and must accept it.

Thirdly, the report shows that in the area of generics in the countries examined, price pressure in particular plays a decisive role as a cause of bottlenecks - be it that manufacturers have to withdraw from certain active ingredient markets or, as in the case of the German discount agreements, that making it difficult to plan needs-based production. Those who prioritize low prices when shopping are also accepting a higher risk of bottlenecks. It is good if there is more and more recognition in Germany that in the case of generics, the economic context must also be taken into account when discussing shortages,” concluded Wolfgang Späth.

The report “Best practice approaches to drug shortages in an international comparison” can be found at www.progenerika.de be downloaded.