The sixth session of this year’s AFI symposium is dedicated to APIs (active pharmaceutical ingredients), on which Piero Iamartino is an expert as well as a representative of the AFI study group precisely on APIs.
On the occasion of this interview, we spoke with Dr. Iamartino about the European Union’s proposal for new pharmaceutical legislation, which came out just a few days earlier and is therefore still being studied.
This reform will be the focus of much discussion during the symposium precisely because it has been strongly desired and expected for almost two decades. One of the primary goals of this reform is patient centralization, ensuring the best possible pharmaceutical environment. The second main principle of the reform is to improve the European pharmaceutical industry from a regulatory point of view, and last but not least, much more consideration is given to the ecological and environmental protection aspect at every stage of the health supply chain, from production to API consumption and disposal.
Broadly tracing the content of the new legislation, one aspect that is given much attention is that of medicine shortages, a critical issue that has come to the fore more in recent years as a result of the supply chain difficulties suffered during the Covid-19 pandemic.
All changes that the reform envisions are aimed at innovation and increasing the competitiveness of the European pharmaceutical industry.
The symposium session, Iamartino reminds us, focuses on APIs, which of course are affected in their production and distribution by the proposed legislation. Especially the focus is on supply chain vulnerability, and the directive is aimed at implementing security of supply of APIs for drug manufacturing.
During the session there will be an opportunity to discuss the new legislation among various experts in the field, including Dr. Maggie Saikali director of the European Finechemicals Group who will certainly make an important contribution. Gathering opinions and suggestions from members of the pharmaceutical industry will be of great importance given that consultations on the European proposal will not be over yet, so there will still be room for different views to be expressed.
