It is the aim of all medicines manufacturers to be ready to supply at any time, to suit market needs and produce in compliance with high quality standards. Nonetheless, supply shortages can emerge. There are medicines supply shortages in varying degrees in countries all over the world. They are due to a wide variety of reasons and so there are no simple solutions for the problem.
It is of great importance to patients whether the supply shortage is transient and they can be adequately cared for in an alternative way, or whether there is a real shortage in which no equivalent medicine is available as a substitute.
This differentiation need to be taken into account in the discussion, even if every change of medication is connected with additional effort for the physician, the pharmacist and the patient. Although experts agree that the supply of medicines in Germany is not at stake, supply shortages may emerge for various reasons.
The reasons for supply shortages include the following:
- Increasing regulatory requirements
During recent years, the regulatory requirements relating to the development, registration, manufacture and storage, as well as the import and export of medicinal products have increased significantly.
However, more and more regulatory requirements also boost costs and expenditures to manufacturers for drug registrations, maintenance of registrations, manufacture and marketing as well as manifold pharmacovigilance activities. This can create costs pressure, especially in the area of generic medicines.
- Pricing and rebate pressure
The rules for pricing and reimbursement are factors that make it difficult for manufacturers to offer certain medicinal products or presentations in the outpatient and hospital sectors. For some medicines, this leads to narrowing of the market, which means that only a few companies can continue to manufacture these medicines. For many years pricing and rebate pressure in Germany has increased, resulting in a cost pressure in the generics sector which is one of the highest in Europe.
- Lacking planning reliability for demand-oriented manufacture
Production capacities of medicines as “goods of a special kind” cannot be modified “on short call”. The regular lead-time from the planning of production until shipment of medicinal products amounts to an average of six months.
If health funds enter supply agreements with companies within rebate contracts, other companies are usually disqualified over a longer period. In such a situation, disqualified companies can switch their productions to utilize their capacities., If one of the rebate contract companies cannot meet the contractual claims, other companies are regularly not able to instantly satisfy the increased demand.
Approaches for the minimisation of delivery / supply shortages
The pharmaceutical industry takes shortages of medicinal products very seriously. In regular consultations with the German Ministry of Health, physicians, pharmacists, hospitals and medicines manufacturers contribute their expertise for the development of approaches for minimisation of supply shortages.
In February 2013, a definition of supply shortages was agreed as a start: A supply shortage is a disruption of the usual scope of supply that is expected to exceed two weeks, or a distinctly increased demand that cannot be satisfied adequately.
Furthermore, it was agreed to establish an online register that notifies of shortages, predominantly of those medicines which are used in serious diseases and for which alternative products are not available. This register has been freely accessible for everybody since 1 April 2013 on the website of the German Federal Institute for Drugs and Medical Devices (BfArM) Internetseite des BfArM (Link setzen). The register improves transparency of actual shortages and will enable physicians, pharmacists and hospitals to get prepared for eventual shortages.
A glance at the drug registration authority of the USA, the FDA, whose successes in terms of the avoidance of shortages have often been referred to in the German (expert) public, shows that besides a register on supply shortages no further regulatory measures have been taken there. The focus is rather placed on better coordination of existing measures. This includes e. g. speeding up regulatory procedures of competent authorities, such as changes to manufacturing processes, marketing authorisation of new medicines, inspections and approval of production facilities, as well as the issue of import licenses.
However, in this context certain rules for reimbursement which contribute to concentration of the market must also be put to the test. This applies to both the outpatient and the hospital sectors and includes, besides the rebate contracts, the German provision for the promotion of imports that boosts supply shortages in other EU countries.
In the end, the supply of medicines is a community task. This implies that – in the interest of patients – all players must contribute their individual part: policy by appropriate framework conditions, health funds by the design of their reimbursement rules, hospitals with their procurement pools by their sourcing policy, pharmaceutical companies by an anticipatory production and wholesalers and pharmacists by an adequate storage and ordering conduct.
Together with other trade associations BAH has elaborated a position paper (German language) on the topic.