Dr. Michael Horn, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, E-Mail: Michael.Horn@bfarm.de
Gabriele Eibenstein M.A., Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, E-Mail: Gabriele.Eibenstein@bfarm.de
Shortages in the supply of medicines pose a variety of challenges for all those involved in the supply of medicines. Above all, they can have serious consequences for patients if it is not feasible to continue a therapy with the "known" medicinal product, if therapies have to be interrupted or cannot be carried out at all. Any non-availability of a medicinal product can have a negative impact on patient compliance and thus endanger the success of the therapy. The effort to procure suitable alternative preparations can be considerable in both the outpatient and inpatient sectors.
Not every shortage of supply is also relevant to care. For some years now, however, there have been an increasing number of cases where, for example, the global supply of medicinal products is affected by the loss of a single manufacturer. The dependence on individual companies is therefore regarded by the BfArM as particularly critical with regard to the secure supply of drugs.
Role of the BfArM
At the beginning of 2016, the Federal Institute for Drugs and Medical Devices (BfArM), in coordination with the Federal Ministry of Health (BMG), decided to become actively involved in situations of shortages in supply and thus contribute to an improvement of the situation. Furthermore, as a result of the "Pharmaceutical Dialogue of the Federal Government", the "Jour fixe on Delivery and Supply Shortages" was also established in 2016.
In 2013, BfArM introduced a first procedure for the submission and publication of reports of shortages, with the aim of improving the transparency of any shortage of medicines for the treatment of life-threatening or serious illnesses. The first notification BfArM received in April 2013 and since then the structure of the organisation and processes is under continuous development in order to provide BfArM with a valid basis for dealing with shortages in a differentiated manner.
A contact point for shortages has been set up, which is responsible for monitoring. The BfArM provides extensive information on its website and information about shortages is structured and entered into a federal shortages database using a reporting form. They are therefore permanently available to the public.
As part of the so-called criticality check, the BfArM assesses to what extent a reported shortage situation could have a supply relevance and which measures could be taken if necessary.
In the event of an impending or existing supply shortage, the BfArM can investigate facts, obtain information, carry out assessments and evaluations, establish contacts with all relevant actors and initiate the priority processing of existing procedures.
The BfArM takes a comparable approach in case of reliable information about possible shortage situations transmitted by citizens, state authorities, professional associations, specialist circles or other organisations.
The "Jour fixe on Delivery and Supply Shortages" specified the reporting system and the reporting criteria for industry and published the present state on the BfArM website. Against the background of transparent criteria and parameters, there was already a significant increase in reports of supply shortages in 2017. This development has continued continuously. On the one hand, this is due to the improved acceptance of the reporting criteria and the continuous monitoring of availabilities by the BfArM. On the other hand, they are also an indication of a general increase in supply shortages.
The notifications are required by the pharmaceutical companies and are based on the voluntary commitment to notify shortages for supply-related medicines that was declared in the pharma dialogue.
Reasons of shortages
Medicinal products are a special kind of goods, the development, approval, manufacture, storage, distribution and monitoring of which are subject to high quality standards.
When reporting shortages of medicinal products, "production problems" mentioned as the reason in over 90 % of the cases. Production problems include facts such as a change in the manufacturing process, GMP deficiencies, a change of manufacturer, difficulties in final approval, inadequate production capacity or an increased demand that cannot be met in the short term by increasing the own production.
Jour fixe on Delivery and Supply Shortages
In 2016, the pharmaceutical dialogue of the federal government agreed that a "Jour fixe" on the subject of shortages of medicinal products should be set up with the participation of the higher federal authorities, the specialist circles and interested parties under the direction of the BfArM. The first meeting took place on September 8, 2016 at the BfArM. So far, 14 regular meetings have been held.
The jour fixe serves to monitor and assess the supply situation. The decisions of the jour fixe are of an advisory nature, but are widely accepted. The jour fixe, for example, agreed the currently applicable regulations on reporting shortages by mutual agreement and worked out a recommendation on how the robustness of supply excellence for hospitals can be better taken into account in the context of contract design between the pharmaceutical industry and pharmacy operators.
Various new legal regulations to improve the ability to deliver and the transparency of shortage situations are currently being discussed. Among other things, there is discussion
- To anchor in the AMG the jour fixe as an advisory board headed by the BfArM
- To convert the voluntary commitment into a statutory reporting obligation
- About the possibilities of the enforceability of targeted measures (e.g. for extended warehousing and the allocation) for the BfArM and PEI
- To introduce a legal obligation with the aim of providing the BfArM with information on inventory from pharmaceutical companies and the pharmaceutical wholesale trade on request.
If these measures were implemented, the higher federal authorities would also receive a legal mandate in relation to official measures in the event of shortages.
The BfArM welcomes these proposed measures, especially as the BfArM is regarded as the central competent body already. The BfArM is ready to continue the path of active coordination that started in 2016 with the aim of providing patients with the best possible medication. This concerns both the improvement of the care situation in the event of acute events and the medium-term reduction of dependencies and thus the creation of resilient structural improvements for the supply of medicines. The BfArM is committed to this at national, European and global level.
Extensive information on shortages of medicinal products is available on the BfArM website: www.bfarm.de/lieferengpaesse.
Questions can be directed to the email address: Lieferengpaesse@bfarm.de.