BfArM: Production of Active Substances should partially be brought back home from Asia

Prof. Schwerdtfeger, president of BfArM has demanded a rethinking in policy  and pharmaceutical industry in an interview with the the German daily paper "Die Welt" (Interview in German language). In the interview which has attracted much attention he also talked about the actual supply shortages.

Many supply shortages concerning medicinal products are not transparent at the moment. On the actual list on supply shortages of the BfArM are listed 14 medicinal products. But according to pharmacies and hospitals the supply shortages are much more extensive. The reason for this partially incomplete or wrong information is the fact that the data is based exclusively on voluntary information given by the manufacturers. Therefore, Prof. Schwerdtfeger encourages to establish binding rules according to which companies are required to report production problems and supply difficulties immediately.

Supply shortages caused by GMP problems have become a major problem in Europe and in the USA. Active ingredients for medicinal products that are produced for the European market originate in about 70 to 80 percent from non-European countries, especially Asia. The list is headed by India and China. And especially in these countries we have untenable situations again and again concerning not only GMP deficiencies but also fraud and forgery of data. Prof. Schwerdtfeger explains in his interview with "Die Welt": "It will never be possible to completely exclude deficiencies in the manufacture of medicinal products. The situation is aggravated by the fact that pharmaceutical companies increasingly use starting materials originating from emerging countries. The frequency of supervision in the manufacturing sites is much lower in these countries than in Europe or the USA. Problems arise when hidden defects or in some cases even deliberate falsifications aren't recognised prior to the further processing of the substances. This has happened already a couple of times with active ingredients not only from emerging countries, and the possibility of it happening again cannot be totally ruled out in the future. According to the rules of statistics it has therefore to be expected that these deficiencies may sooner or later even lead to a major damage."

According to Prof. Schwerdtfeger policy should provide incentives that "reward the safety in the production of medicinal products more strongly." He further explains: "From my point of view it would be desirable that the manufacturers bring back at least a part of their manufacture back to Europe, especially the manufacture of particularly important starting materials. Until now almost all companies refuse to do this for cost reasons." The European Medicines Agency (EMA) also targets the topic supply shortages. Thus, EMA published a reflection paper on supply shortages caused by GMP problems already at the end of 2012. In the USA the competent authority FDA already has taken very extensive measures (see the FDA's drug shortages website).

Actually, the GMP supervision is not equipped sufficiently. In Germany, supervision is subject to the authorities of the Länder (Federal States) and not to the BfArM. This means that in contrast to other European countries the marketing authorisation agency does not carry out the GMP supervision itself. For an extensive supervision at home and abroad "staffing levels of the supervisory authorities would probably need to be twice as high".