GIAN MARIO BACCALINI
EFCG Board member, Brussels, Belgium, Aschimfarma Past President, Milan, Italy
Bulk & Pharma Development President, Milan, Italy

Abstract

There are many problems in Europe related to the normal distribution and production of essential drugs, due to the shortage of APIs (Active pharmaceutical ingredient) and key intermediates utilized in the synthesis of API. These products are mainly coming from Asia, particularly from China, that, during the last years had to face many problems related to the imposed shutdown of many factories.
The situation is more and more difficult, but there are solutions. With good politics, good industrial actions plans and a careful vision of the future, including not only our needs, but the worldwide needs, we can overcome the current difficulties, and, even more important, to be prepared to other crisis.

Pandemic highlighted that there are many problems in Europe related to the normal distribution of essential drugs. This is basically related to the shortage of active pharmaceutical ingredient (API).

In fact, many API are produced in Asia, in India and in China. Generics’ market in Europe is filled up by active ingredient from Asia in the reason of 70-75%. At the same time, the production in Europe of many important active ingredients is related to key intermediates produced in China.

During the last 2-3 years, many facilities in China were shutdown. This was politically decided as many facilities are not conformed to the basic rules of waste treatment for liquid, solid and gas.

The second big issue is that the safety level as standard procedure applied in China in some facilities is very poor, and many accidents occurred in the last five years, with people dead in too many cases.

The last big problem is related to the consumption of energy: everybody knows that now, the consumption of charcoal must be under strict control.
At the same time, everybody knows that more than 80% of ...