Do you still remember? In the 1970s the Dutch wrote and typed letters. Postmen rode their bicycles in all types of weather to deliver thousands of envelopes every day. That time is over. Thirty years ago, a digital highway arose, which turned our world upside down in no time and provided unprecedented opportunities.
When technology offers new possibilities, you need to quickly adjust your system accordingly. It is also important to have some foresight. In digitalisation, consider appropriate legislation in order to prevent criminals running off with all those internet data. Those laws and regulations were missing, but are here now. We have become wiser but have learnt the hard way.
It is somewhat different with medicines. For these, we do have laws and regulations – a lot of them, actually – but they are no longer relevant to the current situation. Innovative medicines have not been pills in a brown jar for a long time now. In recent years, a new generation of patient treatments has arrived, called Advanced Therapy Medicinal Products (ATMPs). These are medical therapies that are based on cells, genes, or a combination of these.
What is special is that these therapies can be curative, or in any case provide a long-term and significant improvement in quality of life. In this way, they prevent many treatment rounds and future suffering. Since 2009, the European Medicines Agency, EMA, has authorised 12 of these therapies. The good news is that there are still more than 1,000 gene and cell therapies in the pipeline.
However, there is also reason for concern. We see that the playing field does change, but the rules and routines do not. As a result, innovations do not quickly reach the person who is often anxiously awaiting them – the patient. Cell and gene therapies are so different from common medicines that they run up against the limits of existing regulations: for example, for the official registration at the medicines authority, EMA. Doctors are not always fully informed about all of the new possibilities. There are also long-term discussions about costs.
That is why the Association Innovative Medicines is committed to having all of the parties involved more familiar with these new opportunities. We need to get to a system that supports the 21st century opportunities in order to help the patient quickly and properly. Future-proofing is the keyword.
This Medicines Monitor, by the way, not only presents numbers about drug development. Subjects such as affordability and access to new medicines are also discussed in detail.
Enjoy your read!
Director general, Dutch Association Innovative Medicines
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