The unprecedented health crisis that the world is facing reminds us, if necessary, of the great dependence of our countries on health products and materials designed overseas.

Will we face a shortage of medicines, for which China and India are the main suppliers, escalate the terrible difficulties of the moment? Will globalisation of the supply chain, without a complete assessment of the risks of supply disruption, deprive us of essential pharmaceutical active ingredients? Could the relocation of production in Europe be the solution[1] [2]?

• Until the 60’s, the pharmaceutical industry was grounded on chemotherapy : each chemical preparation’s compound has a therapeutic target. The active molecules were made out of 4 to 5 steps of chemical synthesis, on which the chemical industry has initiated its development through R&D.

• Since then, the rise of biotechnologies has superseded chemotherapy. A new technology pathway opened up new innovation avenues to make new molecules. Through broad collaborations between companies and research institutions, the increasing knowledge, intellectual property and know-how have allowed to develop more sophisticated molecules out of more and more complex synthesis process including up to 25 steps. This went with significant capital and R&D costs.

• Western countries’ politicians are worried about their health spending rise and, in order to cut costs, in particular for generic molecules. This led to a massive manufacturing relocation. As a matter of evidence, paracetamol, ibuprofen and penicillin, amongst many others, are respectively 60%, 50% and up to 90% made in China. This manufacturing dependence has reached a point that, under the current circumstances, a shortage of antibiotics is a matter of concern, as expressed recently by the European Chamber of Commerce in China.

• European and US regulatory files relating to new molecules and their processes, have built up and become more complex.
  • Quality framework for active ingredients and patient safety imposes increasingly stringent rules throughout the design and production phase of the manufacturing units; this requires the development of cumbersome, time-consuming and costly files. Given the challenges of developing active ingredients, should we be pragmatic somehow ?
  • Authorisation dossiers have also become more complex …. A FDA file can be 100,000 pages long while it used to be only one third of it 30 years ago.[4]

• Innovative molecule’s development cost has significantly increased, leading manufacturers to outsource all or part of the active ingredients synthesis steps, with the manufacture of building blocks (part of molecules) made in China at a height of about 50%.

As a result, pharmaceutical companies have kept on rationalising their footprint while containing their industrial investments. These were meant to control the erosion of their return on R&D investments with a very limited success [5].