Berlin / Brüssel - What could a European strategy against shortages of medicines look like? This question was discussed by the German Medical Association (BÄK)* and the Kassenärztliche Bundesvereinigung (KBV)* on 23 January 2020 in Brussels with representatives of the European Commission, European Parliament, the medical profession, producers of generic medicines and health insurance funds.
Delivery bottlenecks and their potentially detrimental impact on patient care have increasingly become a problem for patients, physicians and pharmacists in Germany and many other EU countries.
The root causes are multifaceted and include, among others, a relocation of the production of active substances and medicines to countries outside Europe, a market concentration on few producers, quality issues and insufficient transparency regarding existing or impending shortages.
Several EU member states have adopted or are considering measures to address this issue. These include a binding obligation to report shortages, extended stockpiling duties or export restrictions. However, there is a risk that unilateral national action could exacerbate the supply situation in other member states without improving overall availability.
Dr. Klaus Reinhardt, president of the German Medical Association, advocates efforts to relocate the production of medicines and active substances to Europe. As he states, “this would shorten delivery routes and facilitate the supervision of production”. Such a move could ensure compliance with European standards, e.g. for environmental protection, good manufacturing practices and working conditions.
The chairman of the Drug Commission of the German Medical Association, Prof. Dr. Wolf-Dieter Ludwig, emphasises the need for pragmatic solutions. Mutual finger-pointing is not very helpful: “The challenge of medicine shortages provides an opportunity for the EU to demonstrate its ability to act and to create a real added value for its member states.”
Dr. Andreas Gassen, chair of the KBV Board, and Dr. Stephan Hofmeister, deputy chair, suggest diversifying the production of active substances to as many producers as possible. “Moreover, reporting of shortages by producers should be mandatory. An EU level task force could develop proposals on how such an obligation should be designed,” explains Dr. Hofmeister.
As the representatives of the medical profession emphasise, coordinated action at the EU level is necessary. A European strategy should include proposals both on preventing and handling shortages. It is the European Commission’s responsibility to propose effective and feasible measures.
Substantiate obligations of manufacturers
The current EU Directive 2001/83/EC (Community code relating to medicinal products for human use) contains duties of manufacturers to report shortages and the intended cessation of production. However, these obligations need to be consistently implemented and substantiated if necessary.
A European reporting system for shortages
Based on a European list of essential medicines for patient care, manufacturers should be obliged to report existing or foreseeable shortages to the national competent authorities and the European Medicines Agency. To this end, a uniform electronic European reporting format should be developed. Reports should be forwarded to all national competent authorities to enable these to take the necessary measures.
These reports should also be accessible to physicians, hospitals and pharmacists in a suitable, aggregated format to enable them to be informed of shortages in due time and to take the necessary precautions.
*The German Medical Association (Bundesärztekammer / BÄK) is the central organisation in the system of medical self-governance in Germany. As the joint association of the 17 State Chambers of Physicians in Germany (Landesärztekammern), it represents the professional interests of physicians in the Federal Republic of Germany and plays an active role in opinion-forming processes with regard to health and social policy.
The National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung / KBV) plays a key role in the statutory health insurance system, ensuring that compulsorily insured people can consult a physician or a psychotherapist of their own choice at any time and anywhere in the country. The KBV represents the political interests of all office-based physicians and psychotherapists in the Federal Republic of Germany.