Supply Shortages – is a Solution in Sight?

Actually the BfArM website lists 475 supply shortages for human medicines in Germany. How alarming is that?

First of all, a distinction must be made between delivery shortages and supply shortages: Delivery shortages are unpleasant, but there are alternatives. In the case of supply shortages, there are no alternatives. Patient safety is clearly at risk here. However, in the case of antibiotics and cytostatics, which have a very specific effect, even delivery shortages can be critical for patients.

Are supply shortages a problem unique to Germany?

No, the problem exists throughout the EU. Consumables are also becoming increasingly scarce.

What are the underlying causes of the problem?

Unfortunately, there is a whole package of causes... on the one hand, the implementation of the new Annex 1 is a burden for non-EU manufacturers importing to the EU, as they also have to “retrofit” in order to meet the increased requirements. This costs time and money and requires appropriate know-how.

In addition, the pharmaceutical industry in the EU is burdened by new requirements such as the Urban Wastewater Directive. Many pharmaceuticals are already too cheap compared to their high manufacturing standards. If costs continue to rise and cheap products are no longer economically viable for manufacturers, they will focus on expensive products to remain competitive. Then there will be protests from the statutory health insurance companies - and patients will lose out.

One of the main reasons for many delivery and supply shortages is the migration of the active ingredient industry to Asia. There is often only one manufacturer and/or only one country from which the active ingredient can be sourced.

Would it be a solution to bring production back to Europe?

Given the existing dependency, this would certainly be desirable. However, there is a great deal of reluctance in Europe towards the chemical and pharmaceutical industries, which still have a "poison kitchen" image among the masses. Everyone wants medicines - but no one wants the necessary industry on their doorstep. On top of that, there are increasing demands and ever higher costs – see the Urban Wastewater Directive. None of this creates a welcoming culture in Germany and the EU.

What measures can be expected from the new EU medicines package?

The new EU pharmaceutical legislation provides for a number of regulations aimed at improving the security of supply. All in all, this is well-intentioned, but much of it is too bureaucratic, overshoots the mark or does not address the actual causes of the problem:

• A so-called „Shortage Prevention Plan“ is to become mandatory for ALL medicinal products. The drawing up of such a comprehensive template is associated with high costs. It would be more pragmatic and effective to focus on critical medicines.
• The planned reporting obligations cannot prevent supply shortages either, but at best ensure a timely response. However, this can also lead to “panic purchases”.
• Potential supply shortages that last longer than two weeks should be reported at least six months in advance. This may not always be feasible.

How do you see the future development?

Skeptically, I'm afraid to say. There are many strong approaches, but they are not enough to solve the problems Bureaucracy burdens many things excessively. There is also often a lack of impact assessment. Focusing on one improvement often creates new issues due to unseen connections and consequences. Certain things are taken to the point of absurdity. Here are some examples:

• Many excipients are being regulated more strictly without considering the impact on the supply of medicine.
  • For example, PFAS (perfluorinated and polyfluorinated alkyl compounds) are required for the manufacture of sterile filters. A ban on this class of substances would therefore have a significant impact on the manufacture of sterile medicinal products.
  • Moreover, the processing of critical substances such as PFAS is expected to lead to higher insurance premiums, consequently affecting the cost of medications.
• Ethanol is to be classified as carcinogenic, based on data on alcohol abuse. However, this also applies to ethanol for external use, e.g. for disinfection in hospitals and care facilities. However, the risk group that should avoid handling ethanol includes women of childbearing age who work in the care sector.
• The Packaging Ordinance stipulates, among other things, that folding cartons should be made thinner. In terms of the environment and resources, this is certainly a good idea. However, the consequences for the packaging processes are not taken into account. The changed material properties mean that the machines run more slowly, i.e. reducing productivity.

What can be done about it?

It is important to take a stand and get involved! The associations are doing their best to point out the consequences for the pharmaceutical industry. Unfortunately, these objections are not being taken seriously by politicians. Instead, they keep sawing the branch on which we all sit. Excessive bureaucracy, coupled with insufficient foresight and expertise, will negatively impact not just the pharmaceutical industry, but the entire healthcare system and, critically, the patient.