The real reasons for drug deficiency
Shortage of medicines is a pan-European problem that the European Medicines Agency (EMA) relates to the following main reasons: shortage of raw materials in the manufacturing of medicinal products, problems with compliance with good manufacturing practice, discontinuation of obsolete medicines or those with low profitability and only then with export between member states. The multifactorial nature of the causes is also confirmed by periodic reports of critical drug shortages in the United States, Serbia or Switzerland, where parallel distribution is not taking place.
The shortage of medicines in the European Union is the subject of a number of studies and analyzes conducted by European institutions and industry organizations. The findings in these studies outline the following leading causes of drug shortages in Europe:
- Suspension of production of specific products, including due to their replacement by new formulas or the expiry of patents
- Limited production capacity or problems with the active substances from which the medicines are manufactured
- Lack of regulatory compliance with Good Manufacturing Practice
- Lack of economic benefit for the sale of certain medicines on the relevant market
The allegation that parallel distribution can be a cause of drug shortage is unjustified and is confirmed by the global manifestation of the problem of drug shortage. One example is from the United States, where parallel trade does not apply. The US authorities are registering a drug shortage, which concerns 267 drugs in 2011, and as of April 2013 - 300 products. The US institutions' analysis gives the following reasons for the reported deficiency:
- In 22% of cases, production problems are identified
- In 20% of the cases, it is a drug withdrawal from the market
- The 15% shortage is due to increased demand.